Show simple item record

dc.creatorDonovan, Jennyen
dc.creatorMills, Nicolaen
dc.creatorSmith, Monicaen
dc.creatorBrindle, Lucyen
dc.creatorJacoby, Annen
dc.creatorPeters, Timen
dc.creatorFrankel, Stephenen
dc.creatorNeal, Daviden
dc.creatorHamdy, Freddieen
dc.date.accessioned2016-01-09T00:16:54Zen
dc.date.available2016-01-09T00:16:54Zen
dc.date.created2002-10-05en
dc.date.issued2002-10-05en
dc.identifier.bibliographicCitationBMJ: British Medical Journal 2002 October 5; 325(7367): 766- 770en
dc.identifier.urihttp://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=Improving+design+and+conduct+of+randomised+trials+by+embedding+them+in+qualitative+research:+ProtecT+study&title=BMJ:+British+Medical+Journal+&volume=325&issue=7367&spage=770&date=2002-10&au=Donovan,+Jenny;+Mills,+Nicola;+Smith,+Monica;+Brindle,+Lucy;+Jacoby,+Ann;+Peters,+Tim;+Frankel,+Stephen;+Neal,+David;+Hamdy,+Freddieen
dc.identifier.urihttp://hdl.handle.net/10822/1006958en
dc.description.abstractPROBLEM: Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be "impossible." DESIGN: Controversial ProtecT (prostate testing for cancer and treatment) trial embedded within qualitative research. BACKGROUND AND SETTING: Screening for prostate cancer is hotly debated, and evidence from trials about the effectiveness of treatments (surgery, radiotherapy, and monitoring) is lacking. Mounting a treatment trial is controversial because of past failures and concerns that differences in complications of treatment but not survival make randomisation unacceptable to patients and clinicians, particularly for a trial including monitoring. STRATEGY FOR CHANGE: In-depth interviews explored interpretation of study information. Audiotape recordings of recruitment appointments enabled scrutiny of content and presentation of study information by recruiters. Initial qualitative findings showed that recruiters had difficulty discussing equipoise and presenting treatments equally; they unknowingly used terminology that was misinterpreted by participants. Findings were used to determine changes to content and presentation of information. EFFECTS OF CHANGE: Changes to the order of presenting treatments encouraged emphasis on equivalence, misinterpreted terms were avoided, the non-radical arm was redefined, and randomisation and clinical equipoise were presented more convincingly. The randomisation rate increased from 40% to 70%, all treatments became acceptable, and the three arm trial became the preferred design. LESSONS LEARNT: Changes to information and presentation resulted in efficient recruitment acceptable to patients and clinicians. Embedding this controversial trial within qualitative research improved recruitment. Such methods probably have wider applicability and may enable even the most difficult evaluative questions to be tackled.en
dc.formatArticleen
dc.languageenen
dc.sourceeweb:251023en
dc.subjectCanceren
dc.subjectClinical Equipoiseen
dc.subjectInterviewsen
dc.subjectMethodsen
dc.subjectPatientsen
dc.subjectProstate Canceren
dc.subjectQualitative Researchen
dc.subjectResearchen
dc.subjectSurgeryen
dc.subjectTerminologyen
dc.subject.classificationHuman Experimentation Policy Guidelines / Institutional Review Boardsen
dc.subject.classificationInformed Consent or Human Experimentationen
dc.titleImproving Design and Conduct of Randomised Trials by Embedding Them in Qualitative Research: ProtecT (Prostate Testing for Cancer and Treatment) Studyen
dc.provenanceCitation prepared by the Library and Information Services group of the Kennedy Institute of Ethics, Georgetown University for the ETHXWeb database.en
dc.provenanceCitation migrated from OpenText LiveLink Discovery Server database named EWEB hosted by the Bioethics Research Library to the DSpace collection EthxWeb hosted by DigitalGeorgetown.en


This item appears in the following Collection(s)

Show simple item record


Georgetown University Seal
©2009—2022 Bioethics Research Library
Box 571212 Washington DC 20057-1212
202.687.3885