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1.
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Rennie D. CONSORT revised—improving the reporting of randomized trials. JAMA 2001;285:2006-7.
[PMID: 11308440]
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2.
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Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12.
[PMID: 7823387]
Uses:
Show back-links to citation
CONSORT - Randomisation: sequence generation: ...is unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.
CONSORT - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.
CONSORT - Randomisation: sequence generation: ...participants does not know in advance which treatment the next person will get, a process termed allocation concealment.
CONSORT - Randomisation: allocation concealment mechanism: ...prevent selection bias, protects the assignment sequence until allocation, and can always be successfully implemented.
PRO - Randomisation: sequence generation: ...is unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.
PRO - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.
PRO - Randomisation: sequence generation: ...participants does not know in advance which treatment the next person will get, a process termed allocation concealment.
PRO - Randomisation: allocation concealment mechanism: ...prevent selection bias, protects the assignment sequence until allocation, and can always be successfully implemented.
Pragmatic trials - Randomisation: sequence generation: ...is unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.
Pragmatic trials - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.
Pragmatic trials - Randomisation: sequence generation: ...participants does not know in advance which treatment the next person will get, a process termed allocation concealment.
Pragmatic trials - Randomisation: allocation concealment mechanism: ...prevent selection bias, protects the assignment sequence until allocation, and can always be successfully implemented.
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...prevent selection bias, protects the assignment sequence until allocation, and can always be successfully implemented.
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...participants does not know in advance which treatment the next person will get, a process termed allocation concealment.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...is unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...participants does not know in advance which treatment the next person will get, a process termed allocation concealment.
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...prevent selection bias, protects the assignment sequence until allocation, and can always be successfully implemented.
Abstracts - Randomisation: allocation concealment mechanism: ...prevent selection bias, protects the assignment sequence until allocation, and can always be successfully implemented.
Abstracts - Randomisation: allocation concealment mechanism: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.
Abstracts - Randomisation: allocation concealment mechanism: ...participants does not know in advance which treatment the next person will get, a process termed allocation concealment.
Harms - Randomisation: sequence generation: ...is unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.
Harms - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.
Harms - Randomisation: sequence generation: ...participants does not know in advance which treatment the next person will get, a process termed allocation concealment.
Harms - Randomisation: allocation concealment mechanism: ...prevent selection bias, protects the assignment sequence until allocation, and can always be successfully implemented.
Herbal medicine interventions - Randomisation: sequence generation: ...is unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.
Herbal medicine interventions - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.
Herbal medicine interventions - Randomisation: sequence generation: ...participants does not know in advance which treatment the next person will get, a process termed allocation concealment.
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...prevent selection bias, protects the assignment sequence until allocation, and can always be successfully implemented.
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3.
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4.
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5.
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Jüni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials. BMJ. 2001;323:42-46.
[PMID: 0011440947]
Uses:
Show back-links to citation
CONSORT - Generalisability: ...of the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.
PRO - Generalisability: ...of the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.
Non-inferiority and equivalence trials - Generalisability: ...of the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.
Abstracts - Generalisability: ...of the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.
Harms - Generalisability: ...of the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.
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6.
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Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, Peterson TC, Nyren O, Bradley LA, et al. Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials. Am J Gastroenterol 1996;91:660-73.
[PMID: 0008677926]
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7.
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Talley NJ, Owen BK, Boyce P, Paterson K. Psychological treatments for irritable bowel syndrome: a critique of controlled treatment trials. Am J Gastroenterol. 1996;91:277-83.
[PMID: 0008607493]
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8.
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Adetugbo K, Williams H. How well are randomized controlled trials reported in the dermatology literature? Arch Dermatol. 2000;136:381-5.
[PMID: 0010724201]
Uses:
Show back-links to citation
CONSORT - Sample size: ...small. The median sample size was 54 patients in 196 trials in arthritis,(108) 46 patients in 73 trials in dermatology,
CONSORT - Sample size: ...was 80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.
CONSORT - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
CONSORT - Blinding: ...506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,(108) and 38% of 68 trials in dermatology
PRO - Sample size: ...small. The median sample size was 54 patients in 196 trials in arthritis,(108) 46 patients in 73 trials in dermatology,
PRO - Sample size: ...was 80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.
PRO - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
PRO - Blinding: ...506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,(108) and 38% of 68 trials in dermatology
Pragmatic trials - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
Non-pharmacologic treatment - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
Non-inferiority and equivalence trials - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
Non-inferiority and equivalence trials - Blinding: ...506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,(108) and 38% of 68 trials in dermatology
Cluster trials - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
Abstracts - Sample size: ...small. The median sample size was 54 patients in 196 trials in arthritis,(108) 46 patients in 73 trials in dermatology,
Abstracts - Sample size: ...was 80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.
Abstracts - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
Harms - Sample size: ...small. The median sample size was 54 patients in 196 trials in arthritis,(108) 46 patients in 73 trials in dermatology,
Harms - Sample size: ...was 80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.
Harms - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
Harms - Blinding: ...506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,(108) and 38% of 68 trials in dermatology
Herbal medicine interventions - Sample size: ...small. The median sample size was 54 patients in 196 trials in arthritis,(108) 46 patients in 73 trials in dermatology,
Herbal medicine interventions - Sample size: ...was 80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.
Herbal medicine interventions - Randomisation: type: ...of the reports mentioned the use of restricted randomisation. However, these studies and that of Adetugbo and Williams
Herbal medicine interventions - Blinding: ...506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,(108) and 38% of 68 trials in dermatology
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9.
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Kjaergård LL, Nikolova D, Gluud C. Randomized clinical trials in HEPATOLOGY: predictors of quality. Hepatology. 1999;30:1134-8.
[PMID: 10534332]
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10.
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Schor S, Karten I. Statistical evaluation of medical journal manuscripts. JAMA. 1966;195:1123-8.
[PMID: 0005952081]
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11.
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Gore SM, Jones IG, Rytter EC. Misuse of statistical methods: critical assessment of articles in BMJ from January to March 1976. Br Med J. 1977;1:85-7.
[PMID: 0000832023]
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12.
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Hall JC, Hill D, Watts JM. Misuse of statistical methods in the Australasian surgical literature. Aust N Z J Surg. 1982;52:541-3.
[PMID: 0006959608]
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13.
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14.
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Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med. 1987;317:426-32.
[PMID: 0003614286]
Uses:
Show back-links to citation
CONSORT - Sample size: ...80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8)
CONSORT - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
CONSORT - Participant Flow: ...Some information, such as the number of individuals assessed for eligibility, may not always be known,(14) and, dependin
PRO - Sample size: ...80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8)
PRO - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Pragmatic trials - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Non-pharmacologic treatment - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Non-inferiority and equivalence trials - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Non-inferiority and equivalence trials - Participant Flow: ...Some information, such as the number of individuals assessed for eligibility, may not always be known,(14) and, dependin
Cluster trials - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Abstracts - Sample size: ...80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8)
Abstracts - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Harms - Sample size: ...80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8)
Harms - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Harms - Participant Flow: ...Some information, such as the number of individuals assessed for eligibility, may not always be known,(14) and, dependin
Herbal medicine interventions - Sample size: ...80 across both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8)
Herbal medicine interventions - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Herbal medicine interventions - Participant Flow: ...Some information, such as the number of individuals assessed for eligibility, may not always be known,(14) and, dependin
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15.
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16.
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Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005;365:1159-62.
[PMID: 15794971]
Uses:
Show back-links to citation
CONSORT - Trial Design: ...randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design.
CONSORT - Outcomes: ...been reported elsewhere.(110) (111) Only 45% of a cohort of 519 RCTs published in 2000 specified the primary outcome;
CONSORT - Sample size: ...These small sample sizes are consistent with those of a study of 519 trials indexed in PubMed in December 2000
CONSORT - Randomisation: sequence generation: ...sample of PubMed indexed trials in 2000, only 21% reported an adequate approach to random sequence generation
CONSORT - Randomisation: allocation concealment mechanism: ...PubMed, only 18% reported any allocation concealment mechanism, but some of those reported mechanisms were inadequate.
CONSORT - Funding: ...PubMed indexed randomised trials published in December 2000, source of funding was reported for 66% of the 519 trials.
PRO - Trial Design: ...randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design.
PRO - Sample size: ...These small sample sizes are consistent with those of a study of 519 trials indexed in PubMed in December 2000
PRO - Randomisation: sequence generation: ...sample of PubMed indexed trials in 2000, only 21% reported an adequate approach to random sequence generation
PRO - Randomisation: allocation concealment mechanism: ...PubMed, only 18% reported any allocation concealment mechanism, but some of those reported mechanisms were inadequate.
PRO - Funding: ...PubMed indexed randomised trials published in December 2000, source of funding was reported for 66% of the 519 trials.
Pragmatic trials - Trial Design: ...randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design.
Pragmatic trials - Randomisation: sequence generation: ...sample of PubMed indexed trials in 2000, only 21% reported an adequate approach to random sequence generation
Pragmatic trials - Randomisation: allocation concealment mechanism: ...PubMed, only 18% reported any allocation concealment mechanism, but some of those reported mechanisms were inadequate.
Pragmatic trials - Funding: ...PubMed indexed randomised trials published in December 2000, source of funding was reported for 66% of the 519 trials.
Non-pharmacologic treatment - Trial Design: ...randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design.
Non-pharmacologic treatment - Outcomes: ...been reported elsewhere.(110) (111) Only 45% of a cohort of 519 RCTs published in 2000 specified the primary outcome;
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...PubMed, only 18% reported any allocation concealment mechanism, but some of those reported mechanisms were inadequate.
Non-pharmacologic treatment - Funding: ...PubMed indexed randomised trials published in December 2000, source of funding was reported for 66% of the 519 trials.
Non-inferiority and equivalence trials - Trial Design: ...randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...sample of PubMed indexed trials in 2000, only 21% reported an adequate approach to random sequence generation
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...PubMed, only 18% reported any allocation concealment mechanism, but some of those reported mechanisms were inadequate.
Non-inferiority and equivalence trials - Funding: ...PubMed indexed randomised trials published in December 2000, source of funding was reported for 66% of the 519 trials.
Cluster trials - Funding: ...PubMed indexed randomised trials published in December 2000, source of funding was reported for 66% of the 519 trials.
Abstracts - Sample size: ...These small sample sizes are consistent with those of a study of 519 trials indexed in PubMed in December 2000
Abstracts - Randomisation: allocation concealment mechanism: ...PubMed, only 18% reported any allocation concealment mechanism, but some of those reported mechanisms were inadequate.
Harms - Trial Design: ...randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design.
Harms - Outcomes: ...been reported elsewhere.(110) (111) Only 45% of a cohort of 519 RCTs published in 2000 specified the primary outcome;
Harms - Sample size: ...These small sample sizes are consistent with those of a study of 519 trials indexed in PubMed in December 2000
Harms - Randomisation: sequence generation: ...sample of PubMed indexed trials in 2000, only 21% reported an adequate approach to random sequence generation
Harms - Randomisation: allocation concealment mechanism: ...PubMed, only 18% reported any allocation concealment mechanism, but some of those reported mechanisms were inadequate.
Harms - Funding: ...PubMed indexed randomised trials published in December 2000, source of funding was reported for 66% of the 519 trials.
Herbal medicine interventions - Trial Design: ...randomised to one of two “parallel” groups. In fact, little more than half of published trials have such a design.
Herbal medicine interventions - Sample size: ...These small sample sizes are consistent with those of a study of 519 trials indexed in PubMed in December 2000
Herbal medicine interventions - Randomisation: sequence generation: ...sample of PubMed indexed trials in 2000, only 21% reported an adequate approach to random sequence generation
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...PubMed, only 18% reported any allocation concealment mechanism, but some of those reported mechanisms were inadequate.
Herbal medicine interventions - Funding: ...PubMed indexed randomised trials published in December 2000, source of funding was reported for 66% of the 519 trials.
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18.
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Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999;319:670-4.
[PMID: 0010480822]
Uses:
Show back-links to citation
CONSORT - Statistical methods: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
CONSORT - Numbers analysed: ...used—for example, when those who did not receive the first dose of a trial drug are excluded from the analyses.
CONSORT - Numbers analysed: ...with more than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.
PRO - Numbers analysed: ...used—for example, when those who did not receive the first dose of a trial drug are excluded from the analyses.
PRO - Numbers analysed: ...with more than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.
PRO - Statistical Methods: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Pragmatic trials - Statistical methods: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Pragmatic trials - Numbers analysed: ...used—for example, when those who did not receive the first dose of a trial drug are excluded from the analyses.
Pragmatic trials - Numbers analysed: ...with more than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.
Pragmatic trials - Numbers analysed: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Non-pharmacologic treatment - Numbers analysed: ...used—for example, when those who did not receive the first dose of a trial drug are excluded from the analyses.
Non-pharmacologic treatment - Numbers analysed: ...with more than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.
Non-pharmacologic treatment - Numbers analysed: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Non-inferiority and equivalence trials - Participant Flow: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Non-inferiority and equivalence trials - Numbers analysed: ...used—for example, when those who did not receive the first dose of a trial drug are excluded from the analyses.
Non-inferiority and equivalence trials - Numbers analysed: ...with more than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.
Abstracts - Statistical methods: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Harms - Statistical methods: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Harms - Numbers analysed: ...used—for example, when those who did not receive the first dose of a trial drug are excluded from the analyses.
Harms - Numbers analysed: ...with more than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.
Harms - Numbers analysed: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Herbal medicine interventions - Statistical methods: ...two conditions define an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.
Herbal medicine interventions - Numbers analysed: ...used—for example, when those who did not receive the first dose of a trial drug are excluded from the analyses.
Herbal medicine interventions - Numbers analysed: ...with more than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.
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19.
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Lai TY, Wong VW, Lam RF, Cheng AC, Lam DS, Leung GM. Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals. Ophthalmic Epidemiol 2007;14:390-8.
[PMID: 18161613]
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20.
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Moher D, Fortin P, Jadad AR, Jüni P, Klassen T, Le LJ, et al. Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews. Lancet 1996;347:363-6.
[PMID: 0008598702]
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21.
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Junker CA. Adherence to published standards of reporting: a comparison of placebo-controlled trials published in English or German. JAMA 1998;280:247-9.
[PMID: 0009676671]
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23.
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Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA 1994;272:125-8.
[PMID: 0008015122]
Uses:
Show back-links to citation
CONSORT - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.(2)
CONSORT - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
CONSORT - Randomisation: allocation concealment mechanism: ...the trial (see box 1, below). A generated allocation schedule should be implemented by using allocation concealment,
CONSORT - Randomisation: allocation concealment mechanism: ...to prevent performance and ascertainment bias, protects the sequence after allocation, and cannot always be implemented.
CONSORT - Randomisation: allocation concealment mechanism: ...omitted in reports of 89% of trials in rheumatoid arthritis,(108) 48% of trials in obstetrics and gynaecology journals,
CONSORT - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
PRO - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.(2)
PRO - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
PRO - Randomisation: allocation concealment mechanism: ...into the trial (see box 1). A generated allocation schedule should be implemented by using allocation concealment,
PRO - Randomisation: allocation concealment mechanism: ...to prevent performance and ascertainment bias, protects the sequence after allocation, and cannot always be implemented.
PRO - Randomisation: allocation concealment mechanism: ...omitted in reports of 89% of trials in rheumatoid arthritis,(108) 48% of trials in obstetrics and gynaecology journals,
Pragmatic trials - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.(2)
Pragmatic trials - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
Pragmatic trials - Randomisation: allocation concealment mechanism: ...into the trial (see box 1). A generated allocation schedule should be implemented by using allocation concealment,
Pragmatic trials - Randomisation: allocation concealment mechanism: ...to prevent performance and ascertainment bias, protects the sequence after allocation, and cannot always be implemented.
Pragmatic trials - Randomisation: allocation concealment mechanism: ...omitted in reports of 89% of trials in rheumatoid arthritis,(108) 48% of trials in obstetrics and gynaecology journals,
Pragmatic trials - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
Non-pharmacologic treatment - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...into the trial (see box 1). A generated allocation schedule should be implemented by using allocation concealment,
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...to prevent performance and ascertainment bias, protects the sequence after allocation, and cannot always be implemented.
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...omitted in reports of 89% of trials in rheumatoid arthritis,(108) 48% of trials in obstetrics and gynaecology journals,
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.(2)
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.(2)
Non-inferiority and equivalence trials - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...into the trial (see box 1). A generated allocation schedule should be implemented by using allocation concealment,
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...to prevent performance and ascertainment bias, protects the sequence after allocation, and cannot always be implemented.
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...omitted in reports of 89% of trials in rheumatoid arthritis,(108) 48% of trials in obstetrics and gynaecology journals,
Non-inferiority and equivalence trials - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
Cluster trials - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
Abstracts - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
Abstracts - Randomisation: allocation concealment mechanism: ...into the trial (see box 1). A generated allocation schedule should be implemented by using allocation concealment,
Abstracts - Randomisation: allocation concealment mechanism: ...to prevent performance and ascertainment bias, protects the sequence after allocation, and cannot always be implemented.
Abstracts - Randomisation: allocation concealment mechanism: ...omitted in reports of 89% of trials in rheumatoid arthritis,(108) 48% of trials in obstetrics and gynaecology journals,
Abstracts - Randomisation: allocation concealment mechanism: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.(2)
Abstracts - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
Harms - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.(2)
Harms - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
Harms - Randomisation: allocation concealment mechanism: ...into the trial (see box 1). A generated allocation schedule should be implemented by using allocation concealment,
Harms - Randomisation: allocation concealment mechanism: ...to prevent performance and ascertainment bias, protects the sequence after allocation, and cannot always be implemented.
Harms - Randomisation: allocation concealment mechanism: ...omitted in reports of 89% of trials in rheumatoid arthritis,(108) 48% of trials in obstetrics and gynaecology journals,
Harms - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
Herbal medicine interventions - Randomisation: sequence generation: ...generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs.(2)
Herbal medicine interventions - Randomisation: type: ...Only 9% of 206 reports of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported us
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...into the trial (see box 1). A generated allocation schedule should be implemented by using allocation concealment,
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...to prevent performance and ascertainment bias, protects the sequence after allocation, and cannot always be implemented.
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...omitted in reports of 89% of trials in rheumatoid arthritis,(108) 48% of trials in obstetrics and gynaecology journals,
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27.
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Armitage P. The role of randomization in clinical trials. Stat Med 1982;1:345-52.
[PMID: 0007187102]
Uses:
Show back-links to citation
CONSORT - Randomisation: sequence generation: ...participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments.
PRO - Randomisation: sequence generation: ...participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments.
Pragmatic trials - Randomisation: sequence generation: ...participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments.
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments.
Abstracts - Randomisation: allocation concealment mechanism: ...participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments.
Harms - Randomisation: sequence generation: ...participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments.
Herbal medicine interventions - Randomisation: sequence generation: ...participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments.
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28.
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Kleijnen J, Gøtzsche PC, Kunz R, Oxman AD, Chalmers I. So what’s so special about randomisation. In: Maynard A, Chalmers I, eds. Non-random reflections on health services research. BMJ Books, 1997:93-106.
Uses:
Show back-links to citation
CONSORT - Randomisation: sequence generation: ...of treatments.(27) Of these three advantages, reducing selection bias at trial entry is usually the most important.
PRO - Randomisation: sequence generation: ...of treatments.(27) Of these three advantages, reducing selection bias at trial entry is usually the most important.
Pragmatic trials - Randomisation: sequence generation: ...of treatments.(27) Of these three advantages, reducing selection bias at trial entry is usually the most important.
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...of treatments.(27) Of these three advantages, reducing selection bias at trial entry is usually the most important.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...of treatments.(27) Of these three advantages, reducing selection bias at trial entry is usually the most important.
Abstracts - Randomisation: allocation concealment mechanism: ...of treatments.(27) Of these three advantages, reducing selection bias at trial entry is usually the most important.
Harms - Randomisation: sequence generation: ...of treatments.(27) Of these three advantages, reducing selection bias at trial entry is usually the most important.
Herbal medicine interventions - Randomisation: sequence generation: ...of treatments.(27) Of these three advantages, reducing selection bias at trial entry is usually the most important.
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29.
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30.
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Nicolucci A, Grilli R, Alexanian AA, Apolone G, Torri V, Liberati A. Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A lost opportunity for meta-analysis. JAMA 1989;262:2101-7.
[PMID: 0002677423]
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31.
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Ah-See KW, Molony NC. A qualitative assessment of randomized controlled trials in otolaryngology. J Laryngol Otol 1998;112:460-3.
[PMID: 0009747475]
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32.
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Altman DG, Doré CJ. Randomisation and baseline comparisons in clinical trials. Lancet 1990;335:149-53.
[PMID: 0001967441]
Uses:
Show back-links to citation
CONSORT - Sample size: ...both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8) (14)
CONSORT - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
CONSORT - Randomisation: allocation concealment mechanism: ...arthritis,(108) 48% of trials in obstetrics and gynaecology journals,(23) and 44% of trials in general medical journals.
CONSORT - Baseline Data: ...equivalent at baseline. Any differences in baseline characteristics are, however, the result of chance rather than bias.
CONSORT - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
PRO - Sample size: ...both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8) (14)
PRO - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
PRO - Randomisation: allocation concealment mechanism: ...arthritis,(108) 48% of trials in obstetrics and gynaecology journals,(23) and 44% of trials in general medical journals.
Pragmatic trials - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
Pragmatic trials - Randomisation: allocation concealment mechanism: ...arthritis,(108) 48% of trials in obstetrics and gynaecology journals,(23) and 44% of trials in general medical journals.
Pragmatic trials - Baseline Data: ...equivalent at baseline. Any differences in baseline characteristics are, however, the result of chance rather than bias.
Pragmatic trials - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
Non-pharmacologic treatment - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...arthritis,(108) 48% of trials in obstetrics and gynaecology journals,(23) and 44% of trials in general medical journals.
Non-inferiority and equivalence trials - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...arthritis,(108) 48% of trials in obstetrics and gynaecology journals,(23) and 44% of trials in general medical journals.
Non-inferiority and equivalence trials - Baseline Data: ...equivalent at baseline. Any differences in baseline characteristics are, however, the result of chance rather than bias.
Non-inferiority and equivalence trials - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
Cluster trials - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
Abstracts - Sample size: ...both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8) (14)
Abstracts - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
Abstracts - Randomisation: allocation concealment mechanism: ...arthritis,(108) 48% of trials in obstetrics and gynaecology journals,(23) and 44% of trials in general medical journals.
Abstracts - Baseline Data: ...equivalent at baseline. Any differences in baseline characteristics are, however, the result of chance rather than bias.
Abstracts - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
Harms - Sample size: ...both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8) (14)
Harms - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
Harms - Randomisation: allocation concealment mechanism: ...arthritis,(108) 48% of trials in obstetrics and gynaecology journals,(23) and 44% of trials in general medical journals.
Harms - Baseline Data: ...equivalent at baseline. Any differences in baseline characteristics are, however, the result of chance rather than bias.
Harms - Baseline Data: ...Unfortunately significance tests of baseline differences are still common(23) (32) (210); they were reported in half of
Herbal medicine interventions - Sample size: ...both years. Moreover, many reviews have found that few authors report how they determined the sample size.(8) (14)
Herbal medicine interventions - Randomisation: type: ...of trials in specialty journals (23) and 39% of 80 trials in general medical journals reported use of stratification.
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...arthritis,(108) 48% of trials in obstetrics and gynaecology journals,(23) and 44% of trials in general medical journals.
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33.
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Thornley B, Adams C. Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ 1998;317:1181-4.
[PMID: 0009794850]
Uses:
Show back-links to citation
CONSORT - Outcomes: ...and 640 different instruments had been used in 2000 trials in schizophrenia, of which 369 had been used only once.
CONSORT - Sample size: ...trials in arthritis,(108) 46 patients in 73 trials in dermatology,(8) and 65 patients in 2000 trials in schizophrenia.
PRO - Sample size: ...trials in arthritis,(108) 46 patients in 73 trials in dermatology,(8) and 65 patients in 2000 trials in schizophrenia.
Non-pharmacologic treatment - Outcomes: ...and 640 different instruments had been used in 2000 trials in schizophrenia, of which 369 had been used only once.
Abstracts - Sample size: ...trials in arthritis,(108) 46 patients in 73 trials in dermatology,(8) and 65 patients in 2000 trials in schizophrenia.
Harms - Outcomes: ...and 640 different instruments had been used in 2000 trials in schizophrenia, of which 369 had been used only once.
Harms - Sample size: ...trials in arthritis,(108) 46 patients in 73 trials in dermatology,(8) and 65 patients in 2000 trials in schizophrenia.
Herbal medicine interventions - Sample size: ...trials in arthritis,(108) 46 patients in 73 trials in dermatology,(8) and 65 patients in 2000 trials in schizophrenia.
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34.
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DerSimonian R, Charette LJ, McPeek B, Mosteller F. Reporting on methods in clinical trials. N Engl J Med 1982;306:1332-7.
[PMID: 0007070458]
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35.
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The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. JAMA 1994;272:1926-31.
[PMID: 0007990245]
Uses:
Show back-links to citation
CONSORT - Similarity of interventions: ...similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).
PRO - Similarity of interventions: ...similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).
Pragmatic trials - Similarity of interventions: ...similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).
Non-inferiority and equivalence trials - Similarity of interventions: ...similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).
Cluster trials - Similarity of interventions: ...similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).
Abstracts - Similarity of interventions: ...similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).
Harms - Similarity of interventions: ...similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).
Herbal medicine interventions - Similarity of interventions: ...similarity of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).
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36.
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Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med 1994;121:894-5.
[PMID: 0007978706]
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37.
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Rennie D. Reporting randomized controlled trials. An experiment and a call for responses from readers. JAMA 1995;273:1054-5.
[PMID: 0007897791]
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38.
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Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996;276:637-9.
[PMID: 0008773637]
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39.
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Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006;295:1152-60.
[PMID: 16522836]
Uses:
Show back-links to citation
CONSORT - Trial Design: ...such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,(40) and factorial designs.
PRO - Trial Design: ...such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,(40) and factorial designs.
Pragmatic trials - Trial Design: ...such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,(40) and factorial designs.
Non-pharmacologic treatment - Trial Design: ...such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,(40) and factorial designs.
Non-inferiority and equivalence trials - Trial Design: ...such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,(40) and factorial designs.
Harms - Trial Design: ...such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,(40) and factorial designs.
Herbal medicine interventions - Trial Design: ...such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,(40) and factorial designs.
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40.
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Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702-8.
[PMID: 15031246]
Uses:
Show back-links to citation
CONSORT - Trial Design: ...of published trials have such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,
PRO - Trial Design: ...of published trials have such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,
Pragmatic trials - Trial Design: ...of published trials have such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,
Non-pharmacologic treatment - Trial Design: ...of published trials have such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,
Non-inferiority and equivalence trials - Trial Design: ...of published trials have such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,
Harms - Trial Design: ...of published trials have such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,
Herbal medicine interventions - Trial Design: ...of published trials have such a design.(16) The main alternative designs are multi-arm parallel, crossover, cluster,
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41.
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Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390.
[PMID: 19001484]
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42.
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Ioannidis JP, Evans SJ, Gøtzsche PC, O’Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8.
[PMID: 15545678]
Uses:
Show back-links to citation
CONSORT - Abstract: ...omitting important harms from the abstract could seriously mislead someone’s interpretation of the trial findings.
CONSORT - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
CONSORT - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
PRO - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
PRO - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
PRO - Abstract: ...omitting important harms from the abstract could seriously mislead someone’s interpretation of the trial findings.
Pragmatic trials - Abstract: ...omitting important harms from the abstract could seriously mislead someone’s interpretation of the trial findings.
Pragmatic trials - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
Pragmatic trials - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
Non-pharmacologic treatment - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
Non-pharmacologic treatment - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
Non-inferiority and equivalence trials - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
Non-inferiority and equivalence trials - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
Cluster trials - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
Cluster trials - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
Abstracts - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
Abstracts - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
Harms - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
Harms - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
Herbal medicine interventions - Abstract: ...omitting important harms from the abstract could seriously mislead someone’s interpretation of the trial findings.
Herbal medicine interventions - Harms: ...CONSORT statement has been developed to provide detailed recommendations on the reporting of harms in randomised trials.
Herbal medicine interventions - Harms: ...withdrawn due to harms should be presented. Finally, authors should provide a balanced discussion of benefits and harms.
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43.
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Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295-309.
[PMID: 18283207]
Uses:
Show back-links to citation
CONSORT - Interventions: ...and their particular reporting requirements (such as expertise, details of how the interventions were standardised).
CONSORT - Outcomes: ...specify who assessed outcomes (for example, if special skills are required to do so) and how many assessors there were.
PRO - Interventions: ...and their particular reporting requirements (such as expertise, details of how the interventions were standardised).
Non-pharmacologic treatment - Interventions: ...and their particular reporting requirements (such as expertise, details of how the interventions were standardised).
Non-pharmacologic treatment - Outcomes: ...specify who assessed outcomes (for example, if special skills are required to do so) and how many assessors there were.
Harms - Interventions: ...and their particular reporting requirements (such as expertise, details of how the interventions were standardised).
Harms - Outcomes: ...specify who assessed outcomes (for example, if special skills are required to do so) and how many assessors there were.
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44.
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Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006;144:364-7.
[PMID: 16520478]
Uses:
Show back-links to citation
CONSORT - Interventions: ...their particular reporting requirements (such as expertise, details of how the interventions were standardised).(43)
PRO - Interventions: ...their particular reporting requirements (such as expertise, details of how the interventions were standardised).(43)
Non-pharmacologic treatment - Interventions: ...their particular reporting requirements (such as expertise, details of how the interventions were standardised).(43)
Harms - Interventions: ...their particular reporting requirements (such as expertise, details of how the interventions were standardised).(43)
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45.
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46.
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Siegel JE, Weinstein MC, Russell LB, Gold MR. Recommendations for reporting cost-effectiveness analyses. Panel on Cost-Effectiveness in Health and Medicine. JAMA 1996;276:1339-41.
[PMID: 0008861994]
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47.
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Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party. BMJ. 1996;313:275-83.
[PMID: 0008704542]
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48.
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Lang TA, Secic M. How to report statistics in medicine. Annotated guidelines for authors, editors, and reviewers. ACP, 1997.
Uses:
Show back-links to citation
CONSORT - Statistical methods: ...differ. Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.
CONSORT - Outcomes and estimation: ...For all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(
CONSORT - Baseline Data: ...should not be treated as continuous variables; instead, numbers and proportions should be reported for each category.
PRO - Statistical Methods: ...differ. Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.
Pragmatic trials - Statistical methods: ...differ. Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.
Pragmatic trials - Outcomes and estimation: ...For all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(
Pragmatic trials - Baseline Data: ...should not be treated as continuous variables; instead, numbers and proportions should be reported for each category.
Non-pharmacologic treatment - Outcomes and estimation: ...For all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(
Non-inferiority and equivalence trials - Baseline Data: ...should not be treated as continuous variables; instead, numbers and proportions should be reported for each category.
Abstracts - Statistical methods: ...differ. Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.
Abstracts - Baseline Data: ...should not be treated as continuous variables; instead, numbers and proportions should be reported for each category.
Harms - Statistical methods: ...differ. Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.
Harms - Outcomes and estimation: ...For all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(
Harms - Baseline Data: ...should not be treated as continuous variables; instead, numbers and proportions should be reported for each category.
Herbal medicine interventions - Statistical methods: ...differ. Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.
Herbal medicine interventions - Outcomes and estimation: ...For all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(
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49.
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Davidoff F. News from the International Committee of Medical Journal Editors. Ann Intern Med 2000;133:229-31.
[PMID: 0010906840]
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50.
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51.
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Egger M, Jüni P, Bartlett C. Value of flow diagrams in reports of randomized controlled trials. JAMA 2001;285:1996-9.
[PMID: 11308437]
Uses:
Show back-links to citation
CONSORT - Participant Flow: ...some participants did not receive the treatment as allocated, were lost to follow-up, or were excluded from the analysis
CONSORT - Participant Flow: ...with regard to the number of participants receiving the allocated intervention and the number lost to follow-up.
CONSORT - Participant Flow: ...who underwent randomisation and the number excluded from analyses was not available in up to 20% of articles.
Non-inferiority and equivalence trials - Participant Flow: ...some participants did not receive the treatment as allocated, were lost to follow-up, or were excluded from the analysis
Non-inferiority and equivalence trials - Participant Flow: ...with regard to the number of participants receiving the allocated intervention and the number lost to follow-up.
Non-inferiority and equivalence trials - Participant Flow: ...who underwent randomisation and the number excluded from analyses was not available in up to 20% of articles.
Harms - Participant Flow: ...some participants did not receive the treatment as allocated, were lost to follow-up, or were excluded from the analysis
Harms - Participant Flow: ...with regard to the number of participants receiving the allocated intervention and the number lost to follow-up.
Harms - Participant Flow: ...who underwent randomisation and the number excluded from analyses was not available in up to 20% of articles.
Herbal medicine interventions - Participant Flow: ...some participants did not receive the treatment as allocated, were lost to follow-up, or were excluded from the analysis
Herbal medicine interventions - Participant Flow: ...with regard to the number of participants receiving the allocated intervention and the number lost to follow-up.
Herbal medicine interventions - Participant Flow: ...who underwent randomisation and the number excluded from analyses was not available in up to 20% of articles.
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52.
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53.
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54.
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55.
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Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457-65.
[PMID: 15161896]
Uses:
Show back-links to citation
History: ...new concerns regarding the reporting of randomized controlled trials, such as selective outcome reporting.
CONSORT - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
CONSORT - Outcomes and estimation: ...were statistically significant or “interesting.” Selective reporting within a study is a widespread and serious problem.
CONSORT - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.
PRO - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
PRO - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.
Pragmatic trials - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
Pragmatic trials - Outcomes and estimation: ...were statistically significant or “interesting.” Selective reporting within a study is a widespread and serious problem.
Pragmatic trials - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.
Non-pharmacologic treatment - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
Non-pharmacologic treatment - Outcomes and estimation: ...were statistically significant or “interesting.” Selective reporting within a study is a widespread and serious problem.
Non-pharmacologic treatment - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.
Non-inferiority and equivalence trials - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
Non-inferiority and equivalence trials - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.
Cluster trials - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
Cluster trials - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.
Abstracts - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
Harms - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
Harms - Outcomes and estimation: ...were statistically significant or “interesting.” Selective reporting within a study is a widespread and serious problem.
Harms - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.
Herbal medicine interventions - Changes to outcomes: ...of trials reports had at least one primary outcome that was changed, introduced, or omitted compared with the protocol.
Herbal medicine interventions - Outcomes and estimation: ...were statistically significant or “interesting.” Selective reporting within a study is a widespread and serious problem.
Herbal medicine interventions - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.
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56.
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Al-Marzouki S, Roberts I, Evans S, Marshall T. Selective reporting in clinical trials: analysis of trial protocols accepted by the Lancet. Lancet 2008;372:201.
[PMID: 18640445]
Uses:
Show back-links to citation
History: ...new concerns regarding the reporting of randomized controlled trials, such as selective outcome reporting.(55)
CONSORT - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.(55)
PRO - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.(55)
Pragmatic trials - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.(55)
Non-pharmacologic treatment - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.(55)
Non-inferiority and equivalence trials - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.(55)
Cluster trials - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.(55)
Harms - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.(55)
Herbal medicine interventions - Registration: ...of outcomes within trials, and of per protocol rather than intention-to-treat analysis have been well documented.(55)
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57.
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58.
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Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134:663-94.
[PMID: 11304107]
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59.
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Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
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60.
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61.
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Meinert CL. Clinical trials: design, conduct and analysis. Oxford University Press, 1986.
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62.
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Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 3rd ed. Springer, 1998.
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63.
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64.
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65.
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66.
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67.
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68.
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Harris AH, Standard S, Brunning JL, Casey SL, Goldberg JH, Oliver L, et al. The accuracy of abstracts in psychology journals. J Psychol 2002;136:141-8.
[PMID: 12081089]
Uses:
Show back-links to citation
CONSORT - Abstract: ...of the full publication have found claims that are inconsistent with, or missing from, the body of the full article.
PRO - Abstract: ...of the full publication have found claims that are inconsistent with, or missing from, the body of the full article.
Pragmatic trials - Abstract: ...of the full publication have found claims that are inconsistent with, or missing from, the body of the full article.
Herbal medicine interventions - Abstract: ...of the full publication have found claims that are inconsistent with, or missing from, the body of the full article.
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69.
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Pitkin RM, Branagan MA, Burmeister LF. Accuracy of data in abstracts of published research articles. JAMA 1999;281:1110-1.
[PMID: 10188662]
Uses:
Show back-links to citation
CONSORT - Abstract: ...the full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68)
PRO - Abstract: ...the full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68)
Pragmatic trials - Abstract: ...the full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68)
Herbal medicine interventions - Abstract: ...the full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68)
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70.
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Ward LG, Kendrach MG, Price SO. Accuracy of abstracts for original research articles in pharmacy journals. Ann Pharmacother 2004;38:1173-7.
[PMID: 15150375]
Uses:
Show back-links to citation
CONSORT - Abstract: ...full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69)
PRO - Abstract: ...full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69)
Pragmatic trials - Abstract: ...full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69)
Herbal medicine interventions - Abstract: ...full publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69)
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71.
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Gøtzsche PC. Believability of relative risks and odds ratios in abstracts: cross sectional study. BMJ 2006;333:231-4.
[PMID: 16854948]
Uses:
Show back-links to citation
CONSORT - Abstract: ...publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69) (70)
CONSORT - Blinding: ...time points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.
PRO - Blinding: ...time points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.
PRO - Abstract: ...publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69) (70)
Pragmatic trials - Abstract: ...publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69) (70)
Non-inferiority and equivalence trials - Blinding: ...time points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.
Harms - Blinding: ...time points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.
Herbal medicine interventions - Abstract: ...publication have found claims that are inconsistent with, or missing from, the body of the full article.(68) (69) (70)
Herbal medicine interventions - Blinding: ...time points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.
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72.
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73.
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Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med 1990;113:69-76.
[PMID: 0002190518]
Uses:
Show back-links to citation
CONSORT - Abstract: ...information about the trial under a series of headings pertaining to the design, conduct, analysis, and interpretation.
PRO - Abstract: ...information about the trial under a series of headings pertaining to the design, conduct, analysis, and interpretation.
Pragmatic trials - Abstract: ...information about the trial under a series of headings pertaining to the design, conduct, analysis, and interpretation.
Herbal medicine interventions - Abstract: ...information about the trial under a series of headings pertaining to the design, conduct, analysis, and interpretation.
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74.
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75.
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76.
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77.
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Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, et al. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet 2007;369:1929-37.
[PMID: 17544497]
Uses:
Show back-links to citation
CONSORT - Background: ...quality of life, pathological staging, resectability rates, extent of surgery, and time to and site of relapse.”
Non-pharmacologic treatment - Background: ...quality of life, pathological staging, resectability rates, extent of surgery, and time to and site of relapse.”
Abstracts - Background: ...quality of life, pathological staging, resectability rates, extent of surgery, and time to and site of relapse.”
Harms - Background: ...quality of life, pathological staging, resectability rates, extent of surgery, and time to and site of relapse.”
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78.
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79.
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80.
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81.
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82.
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83.
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84.
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85.
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Blumer JL, Findling RL, Shih WJ, Soubrane C, Reed MD. Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/hyperactivity disorder in children 6 to 17 years of age. Pediatrics 2009;123:e770-e776.
[PMID: 19403468]
Uses:
Show back-links to citation
CONSORT - Trial Design: ...randomisation [2:1]), double-blind, placebo-controlled, parallel-group study conducted in the United States (41 sites).”
PRO - Trial Design: ...randomisation [2:1]), double-blind, placebo-controlled, parallel-group study conducted in the United States (41 sites).”
Pragmatic trials - Trial Design: ...randomisation [2:1]), double-blind, placebo-controlled, parallel-group study conducted in the United States (41 sites).”
Non-pharmacologic treatment - Trial Design: ...randomisation [2:1]), double-blind, placebo-controlled, parallel-group study conducted in the United States (41 sites).”
Non-inferiority and equivalence trials - Trial Design: ...randomisation [2:1]), double-blind, placebo-controlled, parallel-group study conducted in the United States (41 sites).”
Harms - Trial Design: ...randomisation [2:1]), double-blind, placebo-controlled, parallel-group study conducted in the United States (41 sites).”
Herbal medicine interventions - Trial Design: ...randomisation [2:1]), double-blind, placebo-controlled, parallel-group study conducted in the United States (41 sites).”
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86.
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Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, et al. Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet 2009;374:787-95.
[PMID: 19717184]
Uses:
Show back-links to citation
CONSORT - Changes to trial design: ...were subsequently randomly assigned in 2:2:2:2:1 ratio to the remaining otamixaban and control groups, respectively.”
PRO - Changes to trial design: ...were subsequently randomly assigned in 2:2:2:2:1 ratio to the remaining otamixaban and control groups, respectively.”
Pragmatic trials - Changes to trial design: ...were subsequently randomly assigned in 2:2:2:2:1 ratio to the remaining otamixaban and control groups, respectively.”
Non-pharmacologic treatment - Changes to trial design: ...were subsequently randomly assigned in 2:2:2:2:1 ratio to the remaining otamixaban and control groups, respectively.”
Non-inferiority and equivalence trials - Changes to trial design: ...were subsequently randomly assigned in 2:2:2:2:1 ratio to the remaining otamixaban and control groups, respectively.”
Abstracts - Changes to trial design: ...were subsequently randomly assigned in 2:2:2:2:1 ratio to the remaining otamixaban and control groups, respectively.”
Harms - Changes to trial design: ...were subsequently randomly assigned in 2:2:2:2:1 ratio to the remaining otamixaban and control groups, respectively.”
Herbal medicine interventions - Changes to trial design: ...were subsequently randomly assigned in 2:2:2:2:1 ratio to the remaining otamixaban and control groups, respectively.”
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87.
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Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005;9:1-iv.
[PMID: 15763038]
Uses:
Show back-links to citation
CONSORT - Changes to trial design: ...randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).
PRO - Changes to trial design: ...randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).
Pragmatic trials - Changes to trial design: ...randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).
Non-pharmacologic treatment - Changes to trial design: ...randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).
Non-inferiority and equivalence trials - Changes to trial design: ...randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).
Abstracts - Changes to trial design: ...randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).
Harms - Changes to trial design: ...randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).
Herbal medicine interventions - Changes to trial design: ...randomisation ratio, or duration of follow-up) or trial conduct (such as dropping a centre with poor data quality).
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88.
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Gallo P, Krams M. PhRMA Working Group on adaptive designs, “White Paper.” Drug Information Journal 2006;40:421-82.
Uses:
Show back-links to citation
CONSORT - Changes to trial design: ...data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”
CONSORT - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
PRO - Changes to trial design: ...data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”
PRO - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
Pragmatic trials - Changes to trial design: ...data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”
Pragmatic trials - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
Non-pharmacologic treatment - Changes to trial design: ...data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”
Non-pharmacologic treatment - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
Non-inferiority and equivalence trials - Changes to trial design: ...data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”
Non-inferiority and equivalence trials - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
Cluster trials - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
Abstracts - Changes to trial design: ...data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”
Abstracts - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
Harms - Changes to trial design: ...data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”
Harms - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
Herbal medicine interventions - Changes to trial design: ...data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.”
Herbal medicine interventions - Changes to outcomes: ...on unblinded data is much more problematic, although it may be specified in the context of an adaptive trial design.
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89.
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Brown CH, Ten Have TR, Jo B, Dagne G, Wyman PA, Muthen B, et al. Adaptive designs for randomized trials in public health. Annu Rev Public Health 2009;30:1-25.
[PMID: 1929677]
Uses:
Show back-links to citation
CONSORT - Changes to trial design: ...use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.
PRO - Changes to trial design: ...use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.
Pragmatic trials - Changes to trial design: ...use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.
Non-pharmacologic treatment - Changes to trial design: ...use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.
Non-inferiority and equivalence trials - Changes to trial design: ...use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.
Abstracts - Changes to trial design: ...use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.
Harms - Changes to trial design: ...use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.
Herbal medicine interventions - Changes to trial design: ...use of resources. There are, however, important ethical, statistical, and practical issues in considering such a design.
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90.
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Kelly PJ, Sooriyarachchi MR, Stallard N, Todd S. A practical comparison of group-sequential and adaptive designs. J Biopharm Stat 2005;15:719-38.
[PMID: 16022175]
Uses:
Show back-links to citation
CONSORT - Changes to trial design: ...resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89)
PRO - Changes to trial design: ...resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89)
Pragmatic trials - Changes to trial design: ...resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89)
Non-pharmacologic treatment - Changes to trial design: ...resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89)
Non-inferiority and equivalence trials - Changes to trial design: ...resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89)
Abstracts - Changes to trial design: ...resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89)
Harms - Changes to trial design: ...resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89)
Herbal medicine interventions - Changes to trial design: ...resources. There are, however, important ethical, statistical, and practical issues in considering such a design.(89)
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91.
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Pildal J, Chan AW, Hróbjartsson A, Forfang E, Altman DG, Gøtzsche PC. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ 2005;330:1049.
[PMID: 15817527]
Uses:
Show back-links to citation
CONSORT - Changes to trial design: ...primary outcomes.(57) Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,
PRO - Changes to trial design: ...primary outcomes.(57) Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,
Pragmatic trials - Changes to trial design: ...primary outcomes.(57) Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,
Non-pharmacologic treatment - Changes to trial design: ...primary outcomes.(57) Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,
Non-inferiority and equivalence trials - Changes to trial design: ...primary outcomes.(57) Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,
Abstracts - Changes to trial design: ...primary outcomes.(57) Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,
Harms - Changes to trial design: ...primary outcomes.(57) Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,
Herbal medicine interventions - Changes to trial design: ...primary outcomes.(57) Frequent unexplained discrepancies have also been observed for details of randomisation, blinding,
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92.
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Chan AW, Hróbjartsson A, Jørgensen KJ, Gøtzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ 2008;337:a2299.
[PMID: 19056791]
Uses:
Show back-links to citation
CONSORT - Changes to trial design: ...unexplained discrepancies have also been observed for details of randomisation, blinding,(91) and statistical analyses.
CONSORT - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
PRO - Changes to trial design: ...unexplained discrepancies have also been observed for details of randomisation, blinding,(91) and statistical analyses.
PRO - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
Pragmatic trials - Changes to trial design: ...unexplained discrepancies have also been observed for details of randomisation, blinding,(91) and statistical analyses.
Pragmatic trials - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
Non-pharmacologic treatment - Changes to trial design: ...unexplained discrepancies have also been observed for details of randomisation, blinding,(91) and statistical analyses.
Non-pharmacologic treatment - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
Non-inferiority and equivalence trials - Changes to trial design: ...unexplained discrepancies have also been observed for details of randomisation, blinding,(91) and statistical analyses.
Non-inferiority and equivalence trials - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
Cluster trials - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
Abstracts - Changes to trial design: ...unexplained discrepancies have also been observed for details of randomisation, blinding,(91) and statistical analyses.
Abstracts - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
Harms - Changes to trial design: ...unexplained discrepancies have also been observed for details of randomisation, blinding,(91) and statistical analyses.
Harms - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
Herbal medicine interventions - Changes to trial design: ...unexplained discrepancies have also been observed for details of randomisation, blinding,(91) and statistical analyses.
Herbal medicine interventions - Ancillary analyses: ...were found for all 25 trials reporting subgroup analyses and for 23 of 28 trials reporting adjusted analyses.
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93.
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Ndekha MJ, van Oosterhout JJ, Zijlstra EE, Manary M, Saloojee H, Manary MJ. Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded, controlled trial. BMJ 2009;338:1867-75.
[PMID: 19465470]
Uses:
Show back-links to citation
CONSORT - Participants: ...BMI <18.5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding programme.”
CONSORT - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
PRO - Participants: ...BMI <18.5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding programme.”
PRO - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
Pragmatic trials - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
Non-pharmacologic treatment - Participants: ...BMI <18.5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding programme.”
Non-pharmacologic treatment - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
Non-inferiority and equivalence trials - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
Cluster trials - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
Abstracts - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
Harms - Participants: ...BMI <18.5. Exclusion criteria were pregnancy and lactation or participation in another supplementary feeding programme.”
Harms - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
Herbal medicine interventions - Study settings: ...commercial city of Malawi, with a population of 1 000 000 and an estimated HIV prevalence of 27% in adults in 2004.”
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94.
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95.
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96.
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97.
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98.
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99.
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100.
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101.
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Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Macé Y, et al. Splint for base-of-thumb osteoarthritis: a randomized trial. Ann Intern Med 2009;150:661-9.
[PMID: 1945157]
Uses:
Show back-links to citation
CONSORT - Interventions: ...because, to our knowledge, no placebo for splinting has achieved successful blinding of patients, as recommended.”
PRO - Interventions: ...because, to our knowledge, no placebo for splinting has achieved successful blinding of patients, as recommended.”
Non-pharmacologic treatment - Interventions: ...because, to our knowledge, no placebo for splinting has achieved successful blinding of patients, as recommended.”
Harms - Interventions: ...because, to our knowledge, no placebo for splinting has achieved successful blinding of patients, as recommended.”
Herbal medicine interventions - Interventions: ...because, to our knowledge, no placebo for splinting has achieved successful blinding of patients, as recommended.”
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102.
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103.
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Mease PJ, Goffe BS, Metz J, VanderStoep A, Finck B, Burge DJ. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet. 2000;356:385-90.
[PMID: 0010972371]
Uses:
Show back-links to citation
CONSORT - Outcomes: ...Additional analyses were done on the percentage change in PASI scores and improvement in target psoriasis lesions.”
CONSORT - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
CONSORT - Outcomes and estimation: ... (Adpated from table 2 of Mease et al(103)
PRO - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
Pragmatic trials - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
Pragmatic trials - Outcomes and estimation: ... (Adpated from table 2 of Mease et al(103)
Non-pharmacologic treatment - Outcomes: ...Additional analyses were done on the percentage change in PASI scores and improvement in target psoriasis lesions.”
Non-pharmacologic treatment - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
Non-pharmacologic treatment - Outcomes and estimation: ... (Adpated from table 2 of Mease et al(103)
Non-inferiority and equivalence trials - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
Cluster trials - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
Abstracts - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
Harms - Outcomes: ...Additional analyses were done on the percentage change in PASI scores and improvement in target psoriasis lesions.”
Harms - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
Harms - Outcomes and estimation: ... (Adpated from table 2 of Mease et al(103)
Herbal medicine interventions - Additional analyses: ...treatment groups with the Mantel-Haenszel ᵪ2 test, adjusted for the stratification variable, methotrexate use.”
Herbal medicine interventions - Outcomes and estimation: ... (Adpated from table 2 of Mease et al(103)
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104.
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105.
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106.
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107.
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108.
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Gøtzsche PC. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clin Trials 1989;10:31-56.
[PMID: 0002702836]
Uses:
Show back-links to citation
CONSORT - Outcomes: ...More than 70 outcomes were used in 196 RCTs of non-steroidal anti-inflammatory drugs for rheumatoid arthritis,(108) and
CONSORT - Sample size: ...the reported sample sizes in trials seem small. The median sample size was 54 patients in 196 trials in arthritis,
CONSORT - Randomisation: allocation concealment mechanism: ...details. The mechanism used to allocate interventions was omitted in reports of 89% of trials in rheumatoid arthritis,
CONSORT - Blinding: ...used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,
CONSORT - Statistical methods: ...Incorrect analysis of multiple observations per individual was seen in 123 (63%) of 196 trials in rheumatoid arthritis.
PRO - Sample size: ...the reported sample sizes in trials seem small. The median sample size was 54 patients in 196 trials in arthritis,
PRO - Randomisation: allocation concealment mechanism: ...details. The mechanism used to allocate interventions was omitted in reports of 89% of trials in rheumatoid arthritis,
PRO - Blinding: ...used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,
PRO - Statistical Methods: ...Incorrect analysis of multiple observations per individual was seen in 123 (63%) of 196 trials in rheumatoid arthritis.
Pragmatic trials - Randomisation: allocation concealment mechanism: ...details. The mechanism used to allocate interventions was omitted in reports of 89% of trials in rheumatoid arthritis,
Pragmatic trials - Statistical methods: ...Incorrect analysis of multiple observations per individual was seen in 123 (63%) of 196 trials in rheumatoid arthritis.
Non-pharmacologic treatment - Outcomes: ...More than 70 outcomes were used in 196 RCTs of non-steroidal anti-inflammatory drugs for rheumatoid arthritis,(108) and
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...details. The mechanism used to allocate interventions was omitted in reports of 89% of trials in rheumatoid arthritis,
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...details. The mechanism used to allocate interventions was omitted in reports of 89% of trials in rheumatoid arthritis,
Non-inferiority and equivalence trials - Blinding: ...used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,
Abstracts - Sample size: ...the reported sample sizes in trials seem small. The median sample size was 54 patients in 196 trials in arthritis,
Abstracts - Randomisation: allocation concealment mechanism: ...details. The mechanism used to allocate interventions was omitted in reports of 89% of trials in rheumatoid arthritis,
Abstracts - Statistical methods: ...Incorrect analysis of multiple observations per individual was seen in 123 (63%) of 196 trials in rheumatoid arthritis.
Harms - Outcomes: ...More than 70 outcomes were used in 196 RCTs of non-steroidal anti-inflammatory drugs for rheumatoid arthritis,(108) and
Harms - Sample size: ...the reported sample sizes in trials seem small. The median sample size was 54 patients in 196 trials in arthritis,
Harms - Randomisation: allocation concealment mechanism: ...details. The mechanism used to allocate interventions was omitted in reports of 89% of trials in rheumatoid arthritis,
Harms - Blinding: ...used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,
Harms - Statistical methods: ...Incorrect analysis of multiple observations per individual was seen in 123 (63%) of 196 trials in rheumatoid arthritis.
Herbal medicine interventions - Sample size: ...the reported sample sizes in trials seem small. The median sample size was 54 patients in 196 trials in arthritis,
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...details. The mechanism used to allocate interventions was omitted in reports of 89% of trials in rheumatoid arthritis,
Herbal medicine interventions - Blinding: ...used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,(167) 33% of 196 trials in rheumatoid arthritis,
Herbal medicine interventions - Statistical methods: ...Incorrect analysis of multiple observations per individual was seen in 123 (63%) of 196 trials in rheumatoid arthritis.
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109.
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110.
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111.
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112.
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113.
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114.
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115.
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116.
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Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ. 1995;311:1145-8.
[PMID: 0007580713]
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117.
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118.
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Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet 2005;365:1348-53.
[PMID: 15823387]
Uses:
Show back-links to citation
CONSORT - Sample size: ...trials may be acceptable because they could ultimately be combined in a systematic review and meta-analysis,(117)
CONSORT - Sample size: ...be unbiased, reported properly, and published irrespective of the results, thereby becoming available for meta-analysis.
CONSORT - Sample size: ...the power of a trial, authors need to properly report their intended size with all their methods and assumptions.
PRO - Sample size: ...trials may be acceptable because they could ultimately be combined in a systematic review and meta-analysis,(117)
PRO - Sample size: ...be unbiased, reported properly, and published irrespective of the results, thereby becoming available for meta-analysis.
PRO - Sample size: ...the power of a trial, authors need to properly report their intended size with all their methods and assumptions.
Abstracts - Sample size: ...trials may be acceptable because they could ultimately be combined in a systematic review and meta-analysis,(117)
Abstracts - Sample size: ...be unbiased, reported properly, and published irrespective of the results, thereby becoming available for meta-analysis.
Abstracts - Sample size: ...the power of a trial, authors need to properly report their intended size with all their methods and assumptions.
Harms - Sample size: ...trials may be acceptable because they could ultimately be combined in a systematic review and meta-analysis,(117)
Harms - Sample size: ...be unbiased, reported properly, and published irrespective of the results, thereby becoming available for meta-analysis.
Harms - Sample size: ...the power of a trial, authors need to properly report their intended size with all their methods and assumptions.
Herbal medicine interventions - Sample size: ...trials may be acceptable because they could ultimately be combined in a systematic review and meta-analysis,(117)
Herbal medicine interventions - Sample size: ...be unbiased, reported properly, and published irrespective of the results, thereby becoming available for meta-analysis.
Herbal medicine interventions - Sample size: ...the power of a trial, authors need to properly report their intended size with all their methods and assumptions.
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119.
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120.
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Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ.
[PMID: 0007647644]
Uses:
Show back-links to citation
CONSORT - Sample size: ...conclusion that the intervention groups do not differ, when in fact too few patients were studied to make such a claim.
CONSORT - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
PRO - Sample size: ...conclusion that the intervention groups do not differ, when in fact too few patients were studied to make such a claim.
PRO - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
Pragmatic trials - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
Non-pharmacologic treatment - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
Non-inferiority and equivalence trials - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
Cluster trials - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
Abstracts - Sample size: ...conclusion that the intervention groups do not differ, when in fact too few patients were studied to make such a claim.
Abstracts - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
Harms - Sample size: ...conclusion that the intervention groups do not differ, when in fact too few patients were studied to make such a claim.
Harms - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
Herbal medicine interventions - Sample size: ...conclusion that the intervention groups do not differ, when in fact too few patients were studied to make such a claim.
Herbal medicine interventions - Limitations: ...insight into whether the trial result is compatible with a clinically important effect, regardless of the P value.
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121.
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122.
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123.
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124.
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125.
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126.
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127.
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128.
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129.
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130.
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131.
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132.
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133.
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Sydes MR, Altman DG, Babiker AB, Parmar MK, Spiegelhalter DJ. Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study. Clin Trials 2004;1:48-59.
[PMID: 16281462]
Uses:
Show back-links to citation
CONSORT - Interim analyses and stopping guidelines: ...interim data by allocation, or some time thereafter. This information is often not included in published trial reports,
PRO - Interim analyses and stopping guidelines: ...interim data by allocation, or some time thereafter. This information is often not included in published trial reports,
Pragmatic trials - Interim analyses and stopping guidelines: ...interim data by allocation, or some time thereafter. This information is often not included in published trial reports,
Non-pharmacologic treatment - Interim analyses and stopping guidelines: ...interim data by allocation, or some time thereafter. This information is often not included in published trial reports,
Abstracts - Interim analyses and stopping guidelines: ...interim data by allocation, or some time thereafter. This information is often not included in published trial reports,
Harms - Interim analyses and stopping guidelines: ...interim data by allocation, or some time thereafter. This information is often not included in published trial reports,
Herbal medicine interventions - Interim analyses and stopping guidelines: ...interim data by allocation, or some time thereafter. This information is often not included in published trial reports,
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134.
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Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, et al. Randomized trials stopped early for benefit: a systematic review. JAMA 2005;294:2203-9.
[PMID: 16264162]
Uses:
Show back-links to citation
CONSORT - Interim analyses and stopping guidelines: ...is often not included in published trial reports,(133) even in trials that report stopping earlier than planned.
CONSORT - Reason for stopped trial: ...including reporting the role the funding agency played in the deliberations and in the decision to stop the trial.
CONSORT - Reason for stopped trial: ...trials with fewer events yielding the largest treatment effects (odds ratio 31, 95% confidence interval 12 to 82).
CONSORT - Reason for stopped trial: ...interim analysis after which the trial was stopped (n=45), or whether a stopping rule informed the decision (n=48).
PRO - Interim analyses and stopping guidelines: ...is often not included in published trial reports,(133) even in trials that report stopping earlier than planned.
PRO - Reason for stopped trial: ...including reporting the role the funding agency played in the deliberations and in the decision to stop the trial.
PRO - Reason for stopped trial: ...trials with fewer events yielding the largest treatment effects (odds ratio 31, 95% confidence interval 12 to 82).
PRO - Reason for stopped trial: ...interim analysis after which the trial was stopped (n=45), or whether a stopping rule informed the decision (n=48).
Pragmatic trials - Interim analyses and stopping guidelines: ...is often not included in published trial reports,(133) even in trials that report stopping earlier than planned.
Pragmatic trials - Reason for stopped trial: ...including reporting the role the funding agency played in the deliberations and in the decision to stop the trial.
Pragmatic trials - Reason for stopped trial: ...trials with fewer events yielding the largest treatment effects (odds ratio 31, 95% confidence interval 12 to 82).
Pragmatic trials - Reason for stopped trial: ...interim analysis after which the trial was stopped (n=45), or whether a stopping rule informed the decision (n=48).
Non-pharmacologic treatment - Interim analyses and stopping guidelines: ...is often not included in published trial reports,(133) even in trials that report stopping earlier than planned.
Non-pharmacologic treatment - Reason for stopped trial: ...including reporting the role the funding agency played in the deliberations and in the decision to stop the trial.
Non-pharmacologic treatment - Reason for stopped trial: ...trials with fewer events yielding the largest treatment effects (odds ratio 31, 95% confidence interval 12 to 82).
Non-pharmacologic treatment - Reason for stopped trial: ...interim analysis after which the trial was stopped (n=45), or whether a stopping rule informed the decision (n=48).
Non-inferiority and equivalence trials - Reason for stopped trial: ...including reporting the role the funding agency played in the deliberations and in the decision to stop the trial.
Non-inferiority and equivalence trials - Reason for stopped trial: ...trials with fewer events yielding the largest treatment effects (odds ratio 31, 95% confidence interval 12 to 82).
Non-inferiority and equivalence trials - Reason for stopped trial: ...interim analysis after which the trial was stopped (n=45), or whether a stopping rule informed the decision (n=48).
Abstracts - Interim analyses and stopping guidelines: ...is often not included in published trial reports,(133) even in trials that report stopping earlier than planned.
Abstracts - Reason for stopped trial: ...including reporting the role the funding agency played in the deliberations and in the decision to stop the trial.
Abstracts - Reason for stopped trial: ...trials with fewer events yielding the largest treatment effects (odds ratio 31, 95% confidence interval 12 to 82).
Abstracts - Reason for stopped trial: ...interim analysis after which the trial was stopped (n=45), or whether a stopping rule informed the decision (n=48).
Harms - Interim analyses and stopping guidelines: ...is often not included in published trial reports,(133) even in trials that report stopping earlier than planned.
Harms - Reason for stopped trial: ...including reporting the role the funding agency played in the deliberations and in the decision to stop the trial.
Harms - Reason for stopped trial: ...trials with fewer events yielding the largest treatment effects (odds ratio 31, 95% confidence interval 12 to 82).
Harms - Reason for stopped trial: ...interim analysis after which the trial was stopped (n=45), or whether a stopping rule informed the decision (n=48).
Herbal medicine interventions - Interim analyses and stopping guidelines: ...is often not included in published trial reports,(133) even in trials that report stopping earlier than planned.
Herbal medicine interventions - Reason for stopped trial: ...including reporting the role the funding agency played in the deliberations and in the decision to stop the trial.
Herbal medicine interventions - Reason for stopped trial: ...trials with fewer events yielding the largest treatment effects (odds ratio 31, 95% confidence interval 12 to 82).
Herbal medicine interventions - Reason for stopped trial: ...interim analysis after which the trial was stopped (n=45), or whether a stopping rule informed the decision (n=48).
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135.
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Coutinho IC, Ramos de Amorim MM, Katz L, Bandeira de Ferraz AA. Uterine exteriorization compared with in situ repair at cesarean delivery: a randomized controlled trial. Obstet Gynecol 2008;111:639-47.
[PMID: 18310366]
Uses:
Show back-links to citation
CONSORT - Randomisation: sequence generation: ...“For allocation of the participants, a computer-generated list of random numbers was used.”(135
PRO - Randomisation: sequence generation: ...“For allocation of the participants, a computer-generated list of random numbers was used.”(135
Pragmatic trials - Randomisation: sequence generation: ...“For allocation of the participants, a computer-generated list of random numbers was used.”(135
Non-pharmacologic treatment - Randomisation: sequence generation: ...“For allocation of the participants, a computer-generated list of random numbers was used.”(135
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...“For allocation of the participants, a computer-generated list of random numbers was used.”(135
Harms - Randomisation: sequence generation: ...“For allocation of the participants, a computer-generated list of random numbers was used.”(135
Herbal medicine interventions - Randomisation: sequence generation: ...“For allocation of the participants, a computer-generated list of random numbers was used.”(135
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136.
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Jüni P, Altman DG, Egger M. Assessing the quality of controlled clinical trials. In: Egger M, Davey Smith G, Altman DG, eds. Systematic reviews in health care: meta-analysis in context. BMJ Books, 2001.
Uses:
Show back-links to citation
CONSORT - Randomisation: sequence generation: ...unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.(2) (3) (4)
CONSORT - Generalisability: ...the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.(5)
PRO - Randomisation: sequence generation: ...unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.(2) (3) (4)
PRO - Generalisability: ...the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.(5)
Pragmatic trials - Randomisation: sequence generation: ...unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.(2) (3) (4)
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.(2) (3) (4)
Non-inferiority and equivalence trials - Generalisability: ...the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.(5)
Abstracts - Generalisability: ...the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.(5)
Harms - Randomisation: sequence generation: ...unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.(2) (3) (4)
Harms - Generalisability: ...the participants included in the trial, the trial setting, the treatment regimens tested, and the outcomes assessed.(5)
Herbal medicine interventions - Randomisation: sequence generation: ...unacceptable for describing such trials. Trials based on non-random methods generally yield biased results.(2) (3) (4)
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137.
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Creinin MD, Meyn LA, Borgatta L, Barnhart K, Jensen J, Burke AE, et al. Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial. Obstet Gynecol 2008;111:267-77.
[PMID: 18238962]
Uses:
Show back-links to citation
CONSORT - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
PRO - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
Pragmatic trials - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
Non-pharmacologic treatment - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
Non-inferiority and equivalence trials - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
Cluster trials - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
Abstracts - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
Harms - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
Herbal medicine interventions - Randomisation: type: ...TX) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6.”
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138.
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139.
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140.
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141.
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Schulz KF, Grimes DA. The Lancet handbook of essential concepts in clinical research. Elsevier, 2006.
Uses:
Show back-links to citation
CONSORT - Randomisation: type: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
PRO - Randomisation: sequence generation: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
Pragmatic trials - Randomisation: sequence generation: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
Non-pharmacologic treatment - Randomisation: type: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
Cluster trials - Randomisation: type: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
Abstracts - Randomisation: type: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
Harms - Randomisation: type: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
Herbal medicine interventions - Randomisation: type: ...randomisation include replacement, biased coin, and urn randomisation, although these are used much less frequently.
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142.
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Altman DG, Bland JM. How to randomise. BMJ. 1999;319:703-4.
[PMID: 0010480833]
Uses:
Show back-links to citation
CONSORT - Randomisation: type: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
PRO - Randomisation: sequence generation: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
Pragmatic trials - Randomisation: sequence generation: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
Non-pharmacologic treatment - Randomisation: type: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
Cluster trials - Randomisation: type: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
Abstracts - Randomisation: type: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
Harms - Randomisation: type: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
Herbal medicine interventions - Randomisation: type: ...during the trial. For every block of eight participants, for example, four would be allocated to each arm of the trial.
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143.
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144.
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Enas GG, Enas NH, Spradlin CT, Wilson MG, Wiltse CG. Baseline comparability in clinical trials: prevention of poststudy anxiety. Drug Information Journal 1990;24:541-8.
Uses:
Show back-links to citation
CONSORT - Randomisation: type: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
PRO - Randomisation: sequence generation: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
Pragmatic trials - Randomisation: sequence generation: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
Non-pharmacologic treatment - Randomisation: type: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
Cluster trials - Randomisation: type: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
Abstracts - Randomisation: type: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
Harms - Randomisation: type: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
Herbal medicine interventions - Randomisation: type: ...be well matched for baseline characteristics, such as age and stage of disease. This weakens the trial’s credibility.
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145.
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Treasure T, MacRae KD. Minimisation: the platinum standard for trials?. Randomisation doesn't guarantee similarity of groups; minimisation does. BMJ. 1998;317:362-3.
[PMID: 0009694748]
Uses:
Show back-links to citation
CONSORT - Randomisation: type: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
PRO - Randomisation: sequence generation: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
Pragmatic trials - Randomisation: sequence generation: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
Non-pharmacologic treatment - Randomisation: type: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
Non-inferiority and equivalence trials - Randomisation: sequence generation: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
Cluster trials - Randomisation: type: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
Abstracts - Randomisation: type: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
Harms - Randomisation: type: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
Herbal medicine interventions - Randomisation: type: ...trial. Minimisation offers the only acceptable alternative to randomisation, and some have argued that it is superior.
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146.
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147.
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148.
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Chalmers TC, Levin H, Sacks HS, Reitman D, Berrier J, Nagalingam R. Meta-analysis of clinical trials as a scientific discipline. I: Control of bias and comparison with large co-operative trials. Stat Med. 1987;6:315-28.
[PMID: 0002887023]
Uses:
Show back-links to citation
CONSORT - Randomisation: allocation concealment mechanism: ...made, and informed consent should be obtained from the participant, in ignorance of the next assignment in the sequence.
PRO - Randomisation: allocation concealment mechanism: ...made, and informed consent should be obtained from the participant, in ignorance of the next assignment in the sequence.
Pragmatic trials - Randomisation: allocation concealment mechanism: ...made, and informed consent should be obtained from the participant, in ignorance of the next assignment in the sequence.
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...made, and informed consent should be obtained from the participant, in ignorance of the next assignment in the sequence.
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...made, and informed consent should be obtained from the participant, in ignorance of the next assignment in the sequence.
Abstracts - Randomisation: allocation concealment mechanism: ...made, and informed consent should be obtained from the participant, in ignorance of the next assignment in the sequence.
Harms - Randomisation: allocation concealment mechanism: ...made, and informed consent should be obtained from the participant, in ignorance of the next assignment in the sequence.
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...made, and informed consent should be obtained from the participant, in ignorance of the next assignment in the sequence.
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149.
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Pocock SJ. Statistical aspects of clinical trial design. Statistician 1982;31:1-18.
Uses:
Show back-links to citation
CONSORT - Randomisation: allocation concealment mechanism: ...Without adequate allocation concealment, however, even random, unpredictable assignment sequences can be subverted.(2)
PRO - Randomisation: allocation concealment mechanism: ...Without adequate allocation concealment, however, even random, unpredictable assignment sequences can be subverted.(2)
Pragmatic trials - Randomisation: allocation concealment mechanism: ...Without adequate allocation concealment, however, even random, unpredictable assignment sequences can be subverted.(2)
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...Without adequate allocation concealment, however, even random, unpredictable assignment sequences can be subverted.(2)
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...Without adequate allocation concealment, however, even random, unpredictable assignment sequences can be subverted.(2)
Abstracts - Randomisation: allocation concealment mechanism: ...Without adequate allocation concealment, however, even random, unpredictable assignment sequences can be subverted.(2)
Harms - Randomisation: allocation concealment mechanism: ...Without adequate allocation concealment, however, even random, unpredictable assignment sequences can be subverted.(2)
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...Without adequate allocation concealment, however, even random, unpredictable assignment sequences can be subverted.(2)
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150.
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151.
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152.
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153.
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Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008;336:601-5.
[PMID: 18316340]
Uses:
Show back-links to citation
CONSORT - Randomisation: allocation concealment mechanism: ...A number of methodological studies provide empirical evidence to support these precautions.(152) (153) Trials in which t
CONSORT - Blinding: ...by this knowledge. Blinding is an important safeguard against bias, particularly when assessing subjective outcomes.
CONSORT - Blinding: ...they are aware of their treatment assignment (such as responding more favourably when they receive the new treatment).
CONSORT - Blinding: ...points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71)
PRO - Randomisation: allocation concealment mechanism: ...A number of methodological studies provide empirical evidence to support these precautions.(152) (153) Trials in which t
PRO - Blinding: ...by this knowledge. Blinding is an important safeguard against bias, particularly when assessing subjective outcomes.
PRO - Blinding: ...they are aware of their treatment assignment (such as responding more favourably when they receive the new treatment).
PRO - Blinding: ...points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71)
Pragmatic trials - Randomisation: allocation concealment mechanism: ...A number of methodological studies provide empirical evidence to support these precautions.(152) (153) Trials in which t
Non-pharmacologic treatment - Randomisation: allocation concealment mechanism: ...A number of methodological studies provide empirical evidence to support these precautions.(152) (153) Trials in which t
Non-inferiority and equivalence trials - Randomisation: allocation concealment mechanism: ...A number of methodological studies provide empirical evidence to support these precautions.(152) (153) Trials in which t
Non-inferiority and equivalence trials - Blinding: ...by this knowledge. Blinding is an important safeguard against bias, particularly when assessing subjective outcomes.
Non-inferiority and equivalence trials - Blinding: ...they are aware of their treatment assignment (such as responding more favourably when they receive the new treatment).
Non-inferiority and equivalence trials - Blinding: ...points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71)
Abstracts - Randomisation: allocation concealment mechanism: ...A number of methodological studies provide empirical evidence to support these precautions.(152) (153) Trials in which t
Harms - Randomisation: allocation concealment mechanism: ...A number of methodological studies provide empirical evidence to support these precautions.(152) (153) Trials in which t
Harms - Blinding: ...by this knowledge. Blinding is an important safeguard against bias, particularly when assessing subjective outcomes.
Harms - Blinding: ...they are aware of their treatment assignment (such as responding more favourably when they receive the new treatment).
Harms - Blinding: ...points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71)
Herbal medicine interventions - Randomisation: allocation concealment mechanism: ...A number of methodological studies provide empirical evidence to support these precautions.(152) (153) Trials in which t
Herbal medicine interventions - Blinding: ...by this knowledge. Blinding is an important safeguard against bias, particularly when assessing subjective outcomes.
Herbal medicine interventions - Blinding: ...they are aware of their treatment assignment (such as responding more favourably when they receive the new treatment).
Herbal medicine interventions - Blinding: ...points or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71)
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154.
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McCandlish R, Bowler U, van Asten H, Berridge G, Winter C, Sames L, et al. A randomised controlled trial of care of the perineum during second stage of normal labour. Br J Obstet Gynaecol 1998;105:1262-72.
[PMID: 9883917]
Uses:
Show back-links to citation
CONSORT - Randomisation: implementation: ...birth was imminent. To enter a women into the study, the midwife opened the next consecutively numbered envelope.”
PRO - Randomisation: implementation: ...birth was imminent. To enter a women into the study, the midwife opened the next consecutively numbered envelope.”
Pragmatic trials - Randomisation: implementation: ...birth was imminent. To enter a women into the study, the midwife opened the next consecutively numbered envelope.”
Non-pharmacologic treatment - Randomisation: implementation: ...birth was imminent. To enter a women into the study, the midwife opened the next consecutively numbered envelope.”
Non-inferiority and equivalence trials - Randomisation: implementation: ...birth was imminent. To enter a women into the study, the midwife opened the next consecutively numbered envelope.”
Abstracts - Randomisation: implementation: ...birth was imminent. To enter a women into the study, the midwife opened the next consecutively numbered envelope.”
Harms - Randomisation: implementation: ...birth was imminent. To enter a women into the study, the midwife opened the next consecutively numbered envelope.”
Herbal medicine interventions - Randomisation: implementation: ...birth was imminent. To enter a women into the study, the midwife opened the next consecutively numbered envelope.”
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155.
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Webster J, Clarke S, Paterson D, Hutton A, van Dyk S, Gale C, et al. Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial. BMJ 2008;337:a339.
[PMID: 18614482]
Uses:
Show back-links to citation
CONSORT - Randomisation: implementation: ...patient’s consent, she telephoned a contact who was independent of the recruitment process for allocation consignment.”
PRO - Randomisation: implementation: ...patient’s consent, she telephoned a contact who was independent of the recruitment process for allocation consignment.”
Pragmatic trials - Randomisation: implementation: ...patient’s consent, she telephoned a contact who was independent of the recruitment process for allocation consignment.”
Non-pharmacologic treatment - Randomisation: implementation: ...patient’s consent, she telephoned a contact who was independent of the recruitment process for allocation consignment.”
Non-inferiority and equivalence trials - Randomisation: implementation: ...patient’s consent, she telephoned a contact who was independent of the recruitment process for allocation consignment.”
Abstracts - Randomisation: implementation: ...patient’s consent, she telephoned a contact who was independent of the recruitment process for allocation consignment.”
Harms - Randomisation: implementation: ...patient’s consent, she telephoned a contact who was independent of the recruitment process for allocation consignment.”
Herbal medicine interventions - Randomisation: implementation: ...patient’s consent, she telephoned a contact who was independent of the recruitment process for allocation consignment.”
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156.
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Smith SA, Shah ND, Bryant SC, Christianson TJ, Bjornsen SS, Giesler PD, et al. Chronic care model and shared care in diabetes: randomized trial of an electronic decision support system. Mayo Clin Proc 2008;83:747-57.
[PMID: 18613991]
Uses:
Show back-links to citation
CONSORT - Blinding: ...group were aware of the allocated arm, outcome assessors and data analysts were kept blinded to the allocation.”
PRO - Blinding: ...group were aware of the allocated arm, outcome assessors and data analysts were kept blinded to the allocation.”
Non-pharmacologic treatment - Blinding: ...group were aware of the allocated arm, outcome assessors and data analysts were kept blinded to the allocation.”
Non-inferiority and equivalence trials - Blinding: ...group were aware of the allocated arm, outcome assessors and data analysts were kept blinded to the allocation.”
Harms - Blinding: ...group were aware of the allocated arm, outcome assessors and data analysts were kept blinded to the allocation.”
Herbal medicine interventions - Blinding: ...group were aware of the allocated arm, outcome assessors and data analysts were kept blinded to the allocation.”
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157.
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Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, et al. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med 2009;360:859-73.
[PMID: 19246357]
Uses:
Show back-links to citation
CONSORT - Blinding: ...measurements. All investigators, staff, and participants were kept masked to outcome measurements and trial results.”
PRO - Blinding: ...measurements. All investigators, staff, and participants were kept masked to outcome measurements and trial results.”
Non-pharmacologic treatment - Blinding: ...measurements. All investigators, staff, and participants were kept masked to outcome measurements and trial results.”
Non-inferiority and equivalence trials - Blinding: ...measurements. All investigators, staff, and participants were kept masked to outcome measurements and trial results.”
Harms - Blinding: ...measurements. All investigators, staff, and participants were kept masked to outcome measurements and trial results.”
Herbal medicine interventions - Blinding: ...measurements. All investigators, staff, and participants were kept masked to outcome measurements and trial results.”
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158.
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159.
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Guyatt GH, Pugsley SO, Sullivan MJ, Thompson PJ, Berman L, Jones NL, et al. Effect of encouragement on walking test performance. Thorax 1984;39:818-22.
[PMID: 6505988]
Uses:
Show back-links to citation
CONSORT - Blinding: ...or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71) (153)
PRO - Blinding: ...or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71) (153)
Non-inferiority and equivalence trials - Blinding: ...or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71) (153)
Harms - Blinding: ...or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71) (153)
Herbal medicine interventions - Blinding: ...or outcomes, and by decisions to remove patients from the analyses. These biases have been well documented.(71) (153)
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160.
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161.
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162.
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163.
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164.
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Schulz KF, Chalmers I, Altman DG. The landscape and lexicon of blinding in randomized trials. Ann Intern Med 2002;136:254-9.
[PMID: 11827510]
Uses:
Show back-links to citation
CONSORT - Blinding: ...however, lack of participant or healthcare provider blinding can lead to other problems, such as differential attrition.
PRO - Blinding: ...however, lack of participant or healthcare provider blinding can lead to other problems, such as differential attrition.
Non-inferiority and equivalence trials - Blinding: ...however, lack of participant or healthcare provider blinding can lead to other problems, such as differential attrition.
Harms - Blinding: ...however, lack of participant or healthcare provider blinding can lead to other problems, such as differential attrition.
Herbal medicine interventions - Blinding: ...however, lack of participant or healthcare provider blinding can lead to other problems, such as differential attrition.
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165.
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166.
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Montori VM, Bhandari M, Devereaux PJ, Manns BJ, Ghali WA, Guyatt GH. In the dark: the reporting of blinding status in randomized controlled trials. J Clin Epidemiol 2002;55:787-90.
[PMID: 12384193]
Uses:
Show back-links to citation
CONSORT - Blinding: ...Unfortunately, authors often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in
PRO - Blinding: ...Unfortunately, authors often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in
Non-inferiority and equivalence trials - Blinding: ...Unfortunately, authors often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in
Harms - Blinding: ...Unfortunately, authors often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in
Herbal medicine interventions - Blinding: ...Unfortunately, authors often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in
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167.
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Cheng K, Smyth RL, Motley J, O'Hea U, Ashby D. Randomized controlled trials in cystic fibrosis (1966-1997) categorized by time, design, and intervention. Pediatr Pulmonol. 2000;29:1-7.
[PMID: 0010613779]
Uses:
Show back-links to citation
CONSORT - Blinding: ...often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,
PRO - Blinding: ...often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,
Non-inferiority and equivalence trials - Blinding: ...often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,
Harms - Blinding: ...often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,
Herbal medicine interventions - Blinding: ...often do not report whether blinding was used.(166) For example, reports of 51% of 506 trials in cystic fibrosis,
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168.
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169.
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170.
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Haahr MT, Hróbjartsson A. Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors. Clin Trials 2006;3:360-5.
[PMID: 17060210]
Uses:
Show back-links to citation
CONSORT - Blinding: ...five of these trials—reported as double blind—did not blind participants, healthcare providers, or data collectors.
PRO - Blinding: ...five of these trials—reported as double blind—did not blind participants, healthcare providers, or data collectors.
Non-inferiority and equivalence trials - Blinding: ...five of these trials—reported as double blind—did not blind participants, healthcare providers, or data collectors.
Harms - Blinding: ...five of these trials—reported as double blind—did not blind participants, healthcare providers, or data collectors.
Herbal medicine interventions - Blinding: ...five of these trials—reported as double blind—did not blind participants, healthcare providers, or data collectors.
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171.
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172.
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Mills E, Prousky J, Raskin G, Gagnier J, Rachlis B, Montori VM, et al. The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903]. BMC Clin Pharmacol 2003;3:4.
[PMID: 14614780]
Uses:
Show back-links to citation
CONSORT - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
PRO - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
Pragmatic trials - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
Non-pharmacologic treatment - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
Non-inferiority and equivalence trials - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
Cluster trials - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
Abstracts - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
Harms - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
Herbal medicine interventions - Similarity of interventions: ...and contained microcrystalline cellulose, silicon dioxide, dicalcium phosphate, magnesium stearate, and stearic acid.”
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173.
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Schulz KF, Grimes DA, Altman DG, Hayes RJ. Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology. BMJ. 1996;312:742-4.
[PMID: 0008605459]
Uses:
Show back-links to citation
CONSORT - Similarity of interventions: ...of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35)
CONSORT - Numbers analysed: ...reported exclusions are methodologically weaker in other respects than those that report on some excluded participants,
PRO - Similarity of interventions: ...of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35)
PRO - Numbers analysed: ...reported exclusions are methodologically weaker in other respects than those that report on some excluded participants,
Pragmatic trials - Similarity of interventions: ...of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35)
Pragmatic trials - Numbers analysed: ...reported exclusions are methodologically weaker in other respects than those that report on some excluded participants,
Non-pharmacologic treatment - Numbers analysed: ...reported exclusions are methodologically weaker in other respects than those that report on some excluded participants,
Non-inferiority and equivalence trials - Similarity of interventions: ...of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35)
Non-inferiority and equivalence trials - Numbers analysed: ...reported exclusions are methodologically weaker in other respects than those that report on some excluded participants,
Cluster trials - Similarity of interventions: ...of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35)
Abstracts - Similarity of interventions: ...of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35)
Harms - Similarity of interventions: ...of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35)
Harms - Numbers analysed: ...reported exclusions are methodologically weaker in other respects than those that report on some excluded participants,
Herbal medicine interventions - Similarity of interventions: ...of the characteristics of the interventions (such as appearance, taste, smell, and method of administration).(35)
Herbal medicine interventions - Numbers analysed: ...reported exclusions are methodologically weaker in other respects than those that report on some excluded participants,
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174.
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175.
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176.
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177.
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Altman DG, Gore SM, Gardner MJ, Pocock SJ. Statistical guidelines for contributors to medical journals. In: Altman DG, Machin D, Bryant TN, Gardner MJ, eds. Statistics with confidence: confidence intervals and statistical guidelines. 2nd ed. BMJ Books, 2000:171-90.
Uses:
Show back-links to citation
CONSORT - Statistical methods: ...Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.(48)
CONSORT - Baseline Data: ...distribution, a preferable approach may be to quote the median and a centile range (such as the 25th and 75th centiles).
PRO - Statistical Methods: ...Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.(48)
Pragmatic trials - Statistical methods: ...Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.(48)
Pragmatic trials - Baseline Data: ...distribution, a preferable approach may be to quote the median and a centile range (such as the 25th and 75th centiles).
Non-inferiority and equivalence trials - Baseline Data: ...distribution, a preferable approach may be to quote the median and a centile range (such as the 25th and 75th centiles).
Abstracts - Statistical methods: ...Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.(48)
Abstracts - Baseline Data: ...distribution, a preferable approach may be to quote the median and a centile range (such as the 25th and 75th centiles).
Harms - Statistical methods: ...Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.(48)
Harms - Baseline Data: ...distribution, a preferable approach may be to quote the median and a centile range (such as the 25th and 75th centiles).
Herbal medicine interventions - Statistical methods: ...Actual P values (for example, P=0.003) are strongly preferable to imprecise threshold reports such as P<0.05.(48)
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178.
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179.
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180.
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181.
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182.
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Matthews JN, Altman DG. Interaction 3: How to examine heterogeneity. BMJ.
[PMID: 0008870577]
Uses:
Show back-links to citation
CONSORT - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
PRO - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
Pragmatic trials - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
Non-pharmacologic treatment - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
Non-inferiority and equivalence trials - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
Cluster trials - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
Abstracts - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
Harms - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
Herbal medicine interventions - Additional analyses: ...in complementary subgroups (for example, older and younger participants), a comparison known as a test of interaction.
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183.
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Assmann SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet. 2000;355:1064-9.
[PMID: 0010744093]
Uses:
Show back-links to citation
CONSORT - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
CONSORT - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
CONSORT - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
CONSORT - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
CONSORT - Baseline Data: ...still common(23) (32) (210); they were reported in half of 50 RCTs trials published in leading general journals in 1997.
PRO - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
PRO - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
PRO - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
PRO - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
Pragmatic trials - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
Pragmatic trials - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
Pragmatic trials - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
Pragmatic trials - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
Pragmatic trials - Baseline Data: ...still common(23) (32) (210); they were reported in half of 50 RCTs trials published in leading general journals in 1997.
Non-pharmacologic treatment - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
Non-pharmacologic treatment - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
Non-pharmacologic treatment - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
Non-pharmacologic treatment - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
Non-inferiority and equivalence trials - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
Non-inferiority and equivalence trials - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
Non-inferiority and equivalence trials - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
Non-inferiority and equivalence trials - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
Non-inferiority and equivalence trials - Baseline Data: ...still common(23) (32) (210); they were reported in half of 50 RCTs trials published in leading general journals in 1997.
Cluster trials - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
Cluster trials - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
Cluster trials - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
Cluster trials - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
Abstracts - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
Abstracts - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
Abstracts - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
Abstracts - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
Abstracts - Baseline Data: ...still common(23) (32) (210); they were reported in half of 50 RCTs trials published in leading general journals in 1997.
Harms - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
Harms - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
Harms - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
Harms - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
Harms - Baseline Data: ...still common(23) (32) (210); they were reported in half of 50 RCTs trials published in leading general journals in 1997.
Herbal medicine interventions - Additional analyses: ...subgroups (for example, older and younger participants), a comparison known as a test of interaction.(182)
Herbal medicine interventions - Additional analyses: ...decision to adjust should not be determined by whether baseline differences are statistically significant (see item 16).
Herbal medicine interventions - Ancillary analyses: ...create a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.
Herbal medicine interventions - Ancillary analyses: ...In one survey, 35 of 50 trial reports included subgroup analyses, of which only 42% used tests of interaction.(183) It w
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184.
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185.
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Oxman AD, Guyatt GH. A consumer's guide to subgroup analyses. Ann Intern Med. 1992;116:78-84.
[PMID: 0001530753]
Uses:
Show back-links to citation
CONSORT - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
CONSORT - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
PRO - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
PRO - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
Pragmatic trials - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Pragmatic trials - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
Non-pharmacologic treatment - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Non-pharmacologic treatment - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
Non-inferiority and equivalence trials - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Non-inferiority and equivalence trials - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
Cluster trials - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Cluster trials - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
Abstracts - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Abstracts - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
Harms - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Harms - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
Herbal medicine interventions - Additional analyses: ...Because of the high risk for spurious findings, subgroup analyses are often discouraged.(14) (185) Post hoc subgroup com
Herbal medicine interventions - Ancillary analyses: ...a risk for false positive findings.(246) Authors should resist the temptation to perform many subgroup analyses.(183)
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186.
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Steyerberg EW, Bossuyt PM, Lee KL. Clinical trials in acute myocardial infarction: should we adjust for baseline characteristics? Am Heart. 2000;139:745-51.
[PMID: 0010783203]
Uses:
Show back-links to citation
CONSORT - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
PRO - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
Pragmatic trials - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
Non-pharmacologic treatment - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
Non-inferiority and equivalence trials - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
Cluster trials - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
Abstracts - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
Harms - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
Herbal medicine interventions - Additional analyses: ...studies, an adjusted analysis may be sensible, especially if one or more variables is thought to be prognostic.
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187.
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188.
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Müllner M, Matthews H, Altman DG. Reporting on statistical methods to adjust for confounding: a cross-sectional survey. Ann Intern Med 2002;136:122-6.
[PMID: 11790063]
Uses:
Show back-links to citation
CONSORT - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
CONSORT - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
PRO - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
PRO - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
Pragmatic trials - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
Pragmatic trials - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
Non-pharmacologic treatment - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
Non-pharmacologic treatment - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
Non-inferiority and equivalence trials - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
Non-inferiority and equivalence trials - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
Cluster trials - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
Cluster trials - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
Abstracts - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
Abstracts - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
Harms - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
Harms - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
Herbal medicine interventions - Additional analyses: ...indicate how continuous variables were handled, and specify whether the analysis was planned or suggested by the data.
Herbal medicine interventions - Additional analyses: ...Reviews of published studies show that reporting of adjusted analyses is inadequate with regard to all of these aspects.
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189.
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190.
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191.
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192.
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193.
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194.
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195.
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196.
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197.
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198.
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Brown MJ, Palmer CR, Castaigne A, et al. Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Lancet. 2000;356:366-72.
[PMID: 0010972368]
Uses:
Show back-links to citation
CONSORT - Losses and exclusions: ...existence of some patients could not be proved, or other serious violations of good clinical practice had occurred.”
Pragmatic trials - Losses and exclusions: ...existence of some patients could not be proved, or other serious violations of good clinical practice had occurred.”
Non-pharmacologic treatment - Losses and exclusions: ...existence of some patients could not be proved, or other serious violations of good clinical practice had occurred.”
Non-inferiority and equivalence trials - Losses and exclusions: ...existence of some patients could not be proved, or other serious violations of good clinical practice had occurred.”
Abstracts - Losses and exclusions: ...existence of some patients could not be proved, or other serious violations of good clinical practice had occurred.”
Harms - Losses and exclusions: ...existence of some patients could not be proved, or other serious violations of good clinical practice had occurred.”
Herbal medicine interventions - Losses and exclusions: ...existence of some patients could not be proved, or other serious violations of good clinical practice had occurred.”
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199.
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200.
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Shuster JJ. Median follow-up in clinical trials. J Clin Oncol. 1991;9:191-2.
[PMID: 0001985169]
Uses:
Show back-links to citation
CONSORT - Recruitment: ...date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.
PRO - Recruitment: ...date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.
Pragmatic trials - Recruitment: ...date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.
Non-pharmacologic treatment - Recruitment: ...date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.
Non-inferiority and equivalence trials - Recruitment: ...date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.
Cluster trials - Recruitment: ...date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.
Harms - Recruitment: ...date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.
Herbal medicine interventions - Recruitment: ...date. This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.
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201.
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Altman DG, De Stavola BL, Love SB, Stepniewska KA. Review of survival analyses published in cancer journals. Br J Cancer. 1995;72:511-8.
[PMID: 0007640241]
Uses:
Show back-links to citation
CONSORT - Recruitment: ...This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200)
CONSORT - Recruitment: ...A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearl
PRO - Recruitment: ...This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200)
PRO - Recruitment: ...A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearl
Pragmatic trials - Recruitment: ...This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200)
Pragmatic trials - Recruitment: ...A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearl
Non-pharmacologic treatment - Recruitment: ...This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200)
Non-pharmacologic treatment - Recruitment: ...A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearl
Non-inferiority and equivalence trials - Recruitment: ...This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200)
Non-inferiority and equivalence trials - Recruitment: ...A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearl
Cluster trials - Recruitment: ...This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200)
Cluster trials - Recruitment: ...A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearl
Harms - Recruitment: ...This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200)
Harms - Recruitment: ...A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearl
Herbal medicine interventions - Recruitment: ...This date should be given, and it is also useful to report the minimum, maximum, and median duration of follow-up.(200)
Herbal medicine interventions - Recruitment: ...A review of reports in oncology journals that used survival analysis, most of which were not RCTs,(201) found that nearl
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202.
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Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med 2005;2:e298.
[PMID: 16231970]
Uses:
Show back-links to citation
CONSORT - Reason for stopped trial: ...a full follow-up on that date, and their visits that were not yet completed are described as “planned” in this article.”
PRO - Reason for stopped trial: ...a full follow-up on that date, and their visits that were not yet completed are described as “planned” in this article.”
Pragmatic trials - Reason for stopped trial: ...a full follow-up on that date, and their visits that were not yet completed are described as “planned” in this article.”
Non-pharmacologic treatment - Reason for stopped trial: ...a full follow-up on that date, and their visits that were not yet completed are described as “planned” in this article.”
Non-inferiority and equivalence trials - Reason for stopped trial: ...a full follow-up on that date, and their visits that were not yet completed are described as “planned” in this article.”
Abstracts - Reason for stopped trial: ...a full follow-up on that date, and their visits that were not yet completed are described as “planned” in this article.”
Harms - Reason for stopped trial: ...a full follow-up on that date, and their visits that were not yet completed are described as “planned” in this article.”
Herbal medicine interventions - Reason for stopped trial: ...a full follow-up on that date, and their visits that were not yet completed are described as “planned” in this article.”
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203.
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204.
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205.
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206.
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207.
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Psaty BM, Rennie D. Stopping medical research to save money: a broken pact with researchers and patients. JAMA 2003;289:2128-31.
[PMID: 12709471]
Uses:
Show back-links to citation
CONSORT - Reason for stopped trial: ...of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping.
PRO - Reason for stopped trial: ...of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping.
Pragmatic trials - Reason for stopped trial: ...of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping.
Non-pharmacologic treatment - Reason for stopped trial: ...of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping.
Non-inferiority and equivalence trials - Reason for stopped trial: ...of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping.
Abstracts - Reason for stopped trial: ...of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping.
Harms - Reason for stopped trial: ...of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping.
Herbal medicine interventions - Reason for stopped trial: ...of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping.
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208.
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209.
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210.
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211.
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212.
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213.
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214.
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215.
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216.
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217.
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218.
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Sheiner LB, Rubin DB. Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther. 1995;57:6-15.
[PMID: 0007828382]
Uses:
Show back-links to citation
CONSORT - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.
PRO - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.
Pragmatic trials - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.
Non-pharmacologic treatment - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.
Non-inferiority and equivalence trials - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.
Harms - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.
Herbal medicine interventions - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.
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219.
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Nagelkerke N, Fidler V, Bernsen R, Borgdorff M. Estimating treatment effects in randomized clinical trials in the presence of non-compliance. Stat Med. 2000;19:1849-64.
[PMID: 0010867675]
Uses:
Show back-links to citation
CONSORT - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.(218)
PRO - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.(218)
Pragmatic trials - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.(218)
Non-pharmacologic treatment - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.(218)
Non-inferiority and equivalence trials - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.(218)
Harms - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.(218)
Herbal medicine interventions - Numbers analysed: ...benefit of the treatment, and additional analyses, such as a per protocol analysis, may therefore be considered.(218)
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220.
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Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326:1171-3.
[PMID: 12775615]
Uses:
Show back-links to citation
CONSORT - Numbers analysed: ...may therefore be considered.(218) (219) It should be noted, however, that such analyses are often considerably flawed.
PRO - Numbers analysed: ...may therefore be considered.(218) (219) It should be noted, however, that such analyses are often considerably flawed.
Pragmatic trials - Numbers analysed: ...may therefore be considered.(218) (219) It should be noted, however, that such analyses are often considerably flawed.
Non-pharmacologic treatment - Numbers analysed: ...may therefore be considered.(218) (219) It should be noted, however, that such analyses are often considerably flawed.
Non-inferiority and equivalence trials - Numbers analysed: ...may therefore be considered.(218) (219) It should be noted, however, that such analyses are often considerably flawed.
Harms - Numbers analysed: ...may therefore be considered.(218) (219) It should be noted, however, that such analyses are often considerably flawed.
Herbal medicine interventions - Numbers analysed: ...may therefore be considered.(218) (219) It should be noted, however, that such analyses are often considerably flawed.
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221.
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222.
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223.
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Herman A, Botser IB, Tenenbaum S, Chechick A. Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials. J Bone Joint Surg Am 2009;91:2137-43.
[PMID: 19723990]
Uses:
Show back-links to citation
CONSORT - Statistical methods: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
CONSORT - Numbers analysed: ...than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.(18) (222)
PRO - Numbers analysed: ...than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.(18) (222)
PRO - Statistical Methods: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Pragmatic trials - Statistical methods: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Pragmatic trials - Numbers analysed: ...than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.(18) (222)
Pragmatic trials - Numbers analysed: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Non-pharmacologic treatment - Numbers analysed: ...than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.(18) (222)
Non-pharmacologic treatment - Numbers analysed: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Non-inferiority and equivalence trials - Participant Flow: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Non-inferiority and equivalence trials - Numbers analysed: ...than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.(18) (222)
Abstracts - Statistical methods: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Harms - Statistical methods: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Harms - Numbers analysed: ...than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.(18) (222)
Harms - Numbers analysed: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Herbal medicine interventions - Statistical methods: ...an “intention-to-treat” analysis, which is widely recommended as the preferred analysis strategy.(18)
Herbal medicine interventions - Numbers analysed: ...than 60% of articles having missing data in their primary analysis.(221) Other studies show similar findings.(18) (222)
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224.
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225.
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226.
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Wood AM, White IR, Thompson SG. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clin Trials 2004;1:368-76.
[PMID: 16279275]
Uses:
Show back-links to citation
CONSORT - Statistical methods: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
PRO - Statistical Methods: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
Pragmatic trials - Statistical methods: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
Pragmatic trials - Numbers analysed: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
Non-pharmacologic treatment - Numbers analysed: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
Non-inferiority and equivalence trials - Participant Flow: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
Abstracts - Statistical methods: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
Harms - Statistical methods: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
Harms - Numbers analysed: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
Herbal medicine interventions - Statistical methods: ...outcomes will not cause a problem, in half of trials more than 10% of randomised patients may have missing outcomes.
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227.
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Streiner DL. Missing data and the trouble with LOCF. Evid Based Ment Health 2008;11:3-5.
Uses:
Show back-links to citation
CONSORT - Statistical methods: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
PRO - Statistical Methods: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
Pragmatic trials - Statistical methods: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
Pragmatic trials - Numbers analysed: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
Non-pharmacologic treatment - Numbers analysed: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
Non-inferiority and equivalence trials - Participant Flow: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
Abstracts - Statistical methods: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
Harms - Statistical methods: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
Harms - Numbers analysed: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
Herbal medicine interventions - Statistical methods: ...the analysis to conform to intention-to-treat analysis but requires strong assumptions, which may be hard to justify.
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228.
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Molnar FJ, Hutton B, Fergusson D. Does analysis using “last observation carried forward” introduce bias in dementia research? CMAJ 2008;179:751-3.
[PMID: 18838445]
Uses:
Show back-links to citation
CONSORT - Statistical methods: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
PRO - Statistical Methods: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
Pragmatic trials - Statistical methods: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
Pragmatic trials - Numbers analysed: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
Non-pharmacologic treatment - Numbers analysed: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
Non-inferiority and equivalence trials - Participant Flow: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
Abstracts - Statistical methods: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
Harms - Statistical methods: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
Harms - Numbers analysed: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
Herbal medicine interventions - Statistical methods: ...the participant was lost to follow up. This is appealing through its simplicity, but the method may introduce bias,
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Abraha I, Montedori A, Romagnoli C. Modified intention to treat: frequency, definition and implication for clinical trials [abstract]. Sao Paulo, Brazil: XV Cochrane Colloquium, 2007: 86-7.
Uses:
Show back-links to citation
CONSORT - Statistical methods: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
PRO - Statistical Methods: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
Pragmatic trials - Statistical methods: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
Pragmatic trials - Numbers analysed: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
Non-pharmacologic treatment - Numbers analysed: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
Non-inferiority and equivalence trials - Participant Flow: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
Abstracts - Statistical methods: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
Harms - Statistical methods: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
Harms - Numbers analysed: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
Herbal medicine interventions - Statistical methods: ...adequately adhere to the protocol, in particular those who did not receive a defined minimum amount of the intervention.
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233.
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234.
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Altman DG. Clinical trials and meta-analyses. In: Altman DG, Machin D, Bryant TN, Gardner MJ, eds. Statistics with confidence. 2nd ed. BMJ Books, 2000:120-38.
Uses:
Show back-links to citation
CONSORT - Outcomes and estimation: ...all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(48)
Pragmatic trials - Outcomes and estimation: ...all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(48)
Non-pharmacologic treatment - Outcomes and estimation: ...all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(48)
Harms - Outcomes and estimation: ...all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(48)
Herbal medicine interventions - Outcomes and estimation: ...all outcomes, authors should provide a confidence interval to indicate the precision (uncertainty) of the estimate.(48)
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International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors. Ann Intern Med. 1997;126:36-47.
[PMID: 0008992922]
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237.
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238.
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239.
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Bland JM. Quoting intermediate analyses can only mislead. BMJ. 1997;314:1907-8.
[PMID: 0009224157]
Uses:
Show back-links to citation
CONSORT - Outcomes and estimation: ...were performed, interpretation should focus on the final results at the close of the trial, not the interim results.
Pragmatic trials - Outcomes and estimation: ...were performed, interpretation should focus on the final results at the close of the trial, not the interim results.
Non-pharmacologic treatment - Outcomes and estimation: ...were performed, interpretation should focus on the final results at the close of the trial, not the interim results.
Harms - Outcomes and estimation: ...were performed, interpretation should focus on the final results at the close of the trial, not the interim results.
Herbal medicine interventions - Outcomes and estimation: ...were performed, interpretation should focus on the final results at the close of the trial, not the interim results.
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240.
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241.
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242.
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Sorensen L, Gyrd-Hansen D, Kristiansen IS, Nexøe J, Nielsen JB. Laypersons’ understanding of relative risk reductions: randomised cross-sectional study. BMC Med Inform Decis Mak 2008;8:31.
[PMID: 18631406]
Uses:
Show back-links to citation
CONSORT - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
PRO - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
Pragmatic trials - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
Non-pharmacologic treatment - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
Non-inferiority and equivalence trials - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
Cluster trials - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
Abstracts - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
Harms - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
Herbal medicine interventions - Binary outcomes: ...risk, but both doctors and lay people tend to overestimate the effect when it is presented in terms of relative risk.
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244.
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245.
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246.
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247.
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248.
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Hahn S, Williamson PR, Hutton JL, Garner P, Flynn EV. Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies. Stat Med. 2000;19:3325-36.
[PMID: 0011122498]
Uses:
Show back-links to citation
CONSORT - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
PRO - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
Pragmatic trials - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
Non-pharmacologic treatment - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
Non-inferiority and equivalence trials - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
Cluster trials - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
Abstracts - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
Harms - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
Herbal medicine interventions - Ancillary analyses: ...if they were prespecified, and how many were prespecified. Selective reporting of subgroup analyses could lead to bias.
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249.
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250.
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251.
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Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol 2006;24:3933-8.
[PMID: 16921045]
Uses:
Show back-links to citation
CONSORT - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
PRO - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
Pragmatic trials - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
Non-pharmacologic treatment - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
Non-inferiority and equivalence trials - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
Cluster trials - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
Abstracts - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
Harms - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
Herbal medicine interventions - Harms: ...inconsistently in the articles, and the information regarding attribution to investigational drugs was incomplete.
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252.
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Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009;169:1756-61.
[PMID: 19858432]
Uses:
Show back-links to citation
CONSORT - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
PRO - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
Pragmatic trials - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
Non-pharmacologic treatment - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
Non-inferiority and equivalence trials - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
Cluster trials - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
Abstracts - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
Harms - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
Herbal medicine interventions - Harms: ...adverse events and withdrawal of patients due to an adverse event was given on 27% and 48% of articles, respectively.
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253.
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Boden WE, O’Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007;356:1503-16.
[PMID: 17387127]
Uses:
Show back-links to citation
CONSORT - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
PRO - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
Pragmatic trials - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
Non-pharmacologic treatment - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
Non-inferiority and equivalence trials - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
Cluster trials - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
Abstracts - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
Harms - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
Herbal medicine interventions - Limitations: ...stable coronary artery disease who receive drug-eluting stents, as compared with those who receive bare-metal stents.”
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254.
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255.
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256.
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257.
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Purcell GP, Donovan SL, Davidoff F. Changes to manuscripts during the editorial process: characterizing the evolution of a clinical paper. JAMA. 1998;280:227-8.
[PMID: 0009676663]
Uses:
Show back-links to citation
CONSORT - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
PRO - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
Pragmatic trials - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
Non-pharmacologic treatment - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
Non-inferiority and equivalence trials - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
Cluster trials - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
Abstracts - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
Harms - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
Herbal medicine interventions - Limitations: ...Although discussion of limitations is frequently omitted from research reports,(257) identification and discussion of th
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258.
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