Outcome Measures and Implications for Sample-Size Calculations
- Statistics Notes: Concealing treatment allocation in randomised trials. Altman, Douglas G; Schulz, Kenneth F // BMJ: British Medical Journal (International Edition);8/25/2001, Vol. 323 Issue 7310, p446
Discusses the importance of concealing treatment allocation until a patient has entered a randomised clinical trial. Attempts to eliminate bias; How to ensure that allocation sequence will be concealed, including using external help; Difference between randomised and double blind trials.
- Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey. Hanley, Bec; Truesdale, Ann; King, Andy; Elbourne, Diana; Chalmers, Iain // BMJ: British Medical Journal (International Edition);03/03/2001, Vol. 322 Issue 7285, p519
Conclusions: Consumer involvement in the design and conduct of controlled trials seems to be growing and seems to be welcomed by most researchers. Such involvement seems likely to improve the relevance to consumers of the questions addressed and the results obtained in controlled trials.
- Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. Evans; Pocock; Lievre, Michel; Menard, Joel; Bruckert, Eric; Cogneau, Joel; Delahaye, Francois; Giral, Philippe; Leitersdorf, Eran; Luc, Gerald; Masana, Luis; Moulin, Philippe; Passa, Philippe; Pouchain, Denis; Siest, Gerard // BMJ: British Medical Journal (International Edition);03/10/2001, Vol. 322 Issue 7286, p603
Discusses premature discontinuation of clinical trial for reasons not related to efficacy, safety or feasibility. Reasons why some trials are discontinued prematurely by their sponsor for strategic reasons; How public financial and scientific participation in some trials and increasing the...
- Monitoring and Ensuring Safety During Clinical Research. Morse, Michael A.; Califf, Robert M.; Sugarman, Jeremy // JAMA: Journal of the American Medical Association;3/7/2001, Vol. 285 Issue 9, p1201
Addresses concerns regarding the protection of human subjects in clinical trials. Description of the manner in which adverse event reporting might function to enhance safety; Role of data monitoring committees in using aggregate data from these reports; Problems that exist for institutional...
- Intention-to-treat analysis: Protecting the integrity of randomization. Mahaniah, Kiame J.; Rao, Goutham // Journal of Family Practice;Aug2004, Vol. 53 Issue 8, p644
Randomization is a crucial part of most clinical trials. The purpose of randomization in a trial comparing 2 groups is to ensure that the groups differ only with respect to the interventions being compared. Randomization determines not only which treatment subjects receive, but also how the...
- CONSORT statement: extension to cluster randomised trials. Campbell, Marion K.; Elbourne, Diana R.; Altman, Douglas G. // BMJ: British Medical Journal (International Edition);3/20/2004, Vol. 328 Issue 7441, p702
Offers a look at the effective reporting of randomized controlled trials. Guidelines in the Consolidated Standards of Reporting Trials (CONSORT) statement; Discussion of methodological issues in cluster randomized trials; Quality of reporting of cluster trials; Extension of CONSORT statement to...
- A systematic review of physical activity in prostate cancer survivors: outcomes, prevalence, and determinants. Lene Thorsen; Kerry Courneya; Clare Stevinson; Sophie Fosså // Supportive Care in Cancer;Sep2008, Vol. 16 Issue 9, p987
Abstract IntroductionÂ Â We reviewed physical activity (PA) studies in prostate cancer (PC) survivors investigating (a) the effects of PA on health outcomes, (b) the prevalence of PA, and (c) the determinants of PA. Materials and methodsÂ Â A systematic search of the literature...
- Frankincense: systematic review. Ernst, E. // BMJ: British Medical Journal (International Edition);12/20/2008, Vol. 337 Issue 7684, p1439
Objective To assess evidence from randomised clinical trials about the effectiveness of extracts of Boswellia serrata (frankincense). Design Systematic review. Data sources Electronic searches on Medline, Embase, Cinahl, Amed, and Cochrane Library. Hand searches of conference proceedings,...
- Communicating the Results of Clinical Research to Participants: Attitudes, Practices, and Future Directions. Shalowitz, David I.; Miller, Franklin G. // PLoS Medicine;May2008, Vol. 5 Issue 5, pe91
The authors discuss the available data on the effects of communicating aggregate and individual research results on participants, investigators, and the research enterprise.