Outcome Instruments: Rationale for Their Use
- Systematic review to determine whether participation in a trial influences outcome. Vist, Gunn Elisabeth; Birger Hagen, Kåre; Devereaux, P.J.; Bryant, Dianne; Tove Kristoffersen, Doris; Oxman, Andrew David // BMJ: British Medical Journal (International Edition);5/21/2005, Vol. 330 Issue 7501, p1175
Objective To systematically compare the outcomes of participants in randomized controlled trials (RCTs) with those in comparable non-participants who received the same or similar treatment. Data sources Bibliographic databases, reference lists from eligible articles, medical journals, and study...
- 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.
- 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...
- 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.
- 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...
- 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...
- Randomization Not Well Understood in Pediatric Trials. Arnold, Katherine // JNCI: Journal of the National Cancer Institute;2/18/2004, Vol. 96 Issue 4, p260
Relates the results of a study showing that randomization is not well understood in pediatric clinical trials, published in the "Journal of the American Medical Association."