- CONSORT Statement
- CONSORT Statement Extensions
- Evidence underpinning CONSORT
- Accrual and sample size
- Attitudes to trials
- Adverse events (Harms)
- Baseline data
- Blinding
- Compliance
- Early stopping
- Eligibility
- Follow-up
- Funding
- Harms
- Generalizability
- Intention to treat
- Interpretation
- Interventions
- Outcome reporting
- Random allocation
- Recruitment
- Statistical analysis
- Statistical methods
- Trial design issues
- Trial registration
- Uptake of CONSORT by journals
- Impact of and adherence to CONSORT
- Endorsement of CONSORT
Generalizability
Bartlett C, Doyal L, Ebrahim S, Davey P,
Bachmann M, Egger M, Dieppe P. The causes and effects of socio-demographic
exclusions from clinical trials. Health Technol Assess 2005; 9(38):iii-x, 1.
PMID: 16181564
Begg CB, Engstrom PF. Eligibility and extrapolation in
cancer clinical trials. J Clin Oncol 1987; 5(6):962-968.
PMID: 3585451
Bonell C, Oakley A, Hargreaves J, Strange V, Rees R.
Assessment of generalisability in trials of health interventions: suggested
framework and systematic review. BMJ 2006; 333(7563):346-349.
PMID: 16902217
Bornhoft G, Maxion-Bergemann S, Wolf U, Kienle GS,
Michalsen A, Vollmar HC, Gilbertson S, Matthiessen PF. Checklist for the
qualitative evaluation of clinical studies with particular focus on external
validity and model validity. BMC Med Res Methodol 2006; 6:56.
PMID: 17156475
Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people
from clinical research: a descriptive study of published reports. BMJ 1997;
315(7115):1059.
PMID: 9366735
Dans AL, Dans LF, Guyatt GH, Richardson S. Users' guides to
the medical literature: XIV. How to decide on the applicability of clinical
trial results to your patient. Evidence-Based Medicine Working Group. JAMA
1998; 279(7):545-549.
PMID: 9480367
Djulbegovic B, Lacevic M, Cantor A, Fields KK, Bennett CL,
Adams JR, Kuderer NM, Lyman GH. The uncertainty principle and
industry-sponsored research. Lancet 2000; 356(9230):635-638.
PMID: 10968436
Glasgow R, Green L, Klesges L, Abrams D, Fisher E,
Goldstein M, Hayman L, Ockene J, Orleans C. External Validity: We need to do
more. Ann Behav Med 2006; 31(2):105-108. Glasgow RE, Green LW, Ammerman A. A
focus on external validity. Eval Health Prof 2007; 30(2):115-117.
PMID: 17476025
Glasziou P, Guyatt GH, Dans AL, Dans LF, Straus S, Sackett
DL. Applying the results of trials and systematic reviews to individual
patients. ACP J Club 1998; 129(3):A15-A16.
PMID: 9825009
Green LW, Glasgow RE. Evaluating the relevance,
generalization, and applicability of research: issues in external validation
and translation methodology. Eval Health Prof 2006; 29(1):126-153.
PMID: 16510882
Gurwitz JH, Col NF, Avorn J. The exclusion of the elderly
and women from clinical trials in acute myocardial infarction. JAMA 1992;
268(11):1417-1422.
PMID: 1512909
Howard SC, Algra A, Warlow CP, Rothwell PM. Potential
consequences for recruitment, power, and external validity of requirements for
additional risk factors for eligibility in randomized controlled trials in
secondary prevention of stroke. Stroke 2006; 37(1):209-215.
PMID: 16339480
King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M,
Sibbald B, Lai R. Conceptual framework and systematic review of the effects of
participants' and professionals' preferences in randomised controlled trials.
Health Technol Assess 2005; 9(35):1-iv.
PMID: 16153352
Laupacis A, Sackett DL, Roberts RS. An assessment of
clinically useful measures of the consequences of treatment. N Engl J Med 1988;
318(26):1728-1733.
PMID: 3374545
Mulrow CD, Cornell JA, Herrera CR, Kadri A, Farnett L,
Aguilar C. Hypertension in the elderly. Implications and generalizability of
randomized trials. JAMA 1994; 272(24):1932-1938.
PMID: 7990246
Rothwell PM. External validity of randomised controlled
trials: "to whom do the results of this trial apply?". Lancet 2005;
365(9453):82-93.
PMID: 15639683
Rothwell PM. Factors that can affect the external validity
of randomised controlled trials. PLoS Clin Trials 2006; 1(1):e9.
PMID: 16871331
Page last edited: 05 May 2009
