Details

Autor(en) / Beteiligte

• Menon, Usha
• Gentry-Maharaj, Aleksandra
• Ryan, Andy
• Sharma, Aarti
• Burnell, Matthew
• Hallett, Rachel
• Lewis, Sara
• Lopez, Alberto
• Godfrey, Keith
• Oram, David
• Herod, Jonathan
• Williamson, Karin
• Seif, Mourad
• Scott, Ian
• Mould, Tim
• Woolas, Robert
• Murdoch, John
• Dobbs, Stephen
• Amso, Nazar
• Leeson, Simon
• Cruickshan, Derek
• McGuire, Ali
• Campbell, Stuart
• Fallowfield, Lesley
• Skates, Steve
• Parmar, Mahesh
• Jacobs, Ian

Titel

Recruitment to Multicentre Trials -- Lessons from UKCTOCS: Descriptive Study

Ist Teil von

• BMJ (British Medical Journal), 2008-11, Vol.337 (7681), p.1283-1286

Erscheinungsjahr

2008

Quelle

Applied Social Sciences Index & Abstracts (ASSIA)

Beschreibungen/Notizen

• To describe the factors that contributed to successful recruitment of more than 200000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomized controlled trials. Descriptive study. 13 NHS trusts in England, Wales, & Northern Ireland. Postmenopausal women aged 50-74; exclusion criteria included ovarian malignancy, bilateral oophorectomy, increased risk of familial ovarian cancer, active non-ovarian malignancy, & participation in other ovarian cancer screening trials. Achievement of target recruitment, acceptance rates of invitation, & recruitment rates. The trial was set up in 13 centres with 27 adjoining local health authorities. The coordinating centre team was led by one of the senior investigators, who was closely involved in planning & day to day trial management. Of 1243282 women invited, 23.2% (288955) replied that they were eligible & would like to participate. Of those sent appointments, 73.6% (205 090) attended for recruitment. The acceptance rate varied from 19% to 33% between trial centres. Measures to ensure target recruitment included named coordinating centre staff supporting & monitoring each centre, prompt identification & resolution of logistic problems, varying the volume of invitations by centre, using local nonattendance rates to determine the size of recruitment clinics, & organizing large ad hoc clinics supported by coordinating centre staff. The trial randomized 202,638 women in 4.3 years. Planning & trial management are as important as trial design & require equal attention from senior investigators. Successful recruitment needs constant monitoring by a committed proactive management team that is willing to explore individual solutions for different centres & use central resources to improve local recruitment. Automation of trial processes with web based trial management systems is crucial in large multicentre randomized controlled trials. Recruitment can be further enhanced by using information videos & group discussions. Adapted from the source document.