Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study

Abstract

Objective To describe the factors that contributed to successful recruitment of more than 200 000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomised controlled trials. Design Descriptive study. Setting 13 NHS trusts in England, Wales, and Northern Ireland. Participants Postmenopausal women aged 50-74; exclusion criteria included ovarian malignancy, bilateral oophorectomy, increased risk of familial ovarian cancer, active non-ovarian malignancy, and participation in other ovarian cancer screening trials. Main outcome measures Achievement of target recruitment, acceptance rates of invitation, and recruitment rates. Results 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 and day to day trial management. Of 1 243 282 women invited, 23.2% (288 955) replied that they were eligible and 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 and monitoring each centre, prompt identification and resolution of logistic problems, varying the volume of invitations by centre, using local nonattendance rates to determine the size of recruitment clinics, and organising large ad hoc clinics supported by coordinating centre staff. The trial randomised 202 638 women in 4.3 years.

Assessing Individual Breast Cancer Risk within the U.K. National Health Service Breast Screening Program: A New Paradigm for Cancer Prevention

“…Average uptake to the study was 35%, somewhat lower than in the CADET II study (31), which obtained average recruitment of 46% using a very similar process to recruit participants, but higher than the U.K. Collaborative Trial of Ovarian Cancer Screening in which uptake averaged 25% (32). As in CADET II, we found that recruitment was increased when an additional member of staff was based at the screening site.…”

Psychological morbidity associated with ovarian cancer screening: results from more than 23 000 women in the randomised trial of ovarian cancer screening (UKCTOCS)

“…9 The study was approved by the North West research ethics committee (MREC 00/8/34), and written informed consent was obtained from all participants. Of the postmenopausal women included in UKCTOCS, 91.6% (185 693/202 638) participated in the psychosocial substudy.…”

Discovery of serum biomarkers of ovarian cancer using complementary proteomic profiling strategies

“…Serum samples came from women diagnosed with primary invasive epithelial ovarian cancer ( n = 70) or benign ovarian neoplasms ( n = 89) and from healthy age‐matched controls ( n = 173). Healthy volunteers were recruited from women attending annual screening in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) 21, 22 also between 2005 and 2009. They had no family history of ovarian cancer and no diagnosis of a cancer during follow‐up.…”