Reasons for participation and non-participation in a randomized controlled trial: postal questionnaire surveys of women eligible for TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears)

L. Sharp, Seonaidh Claire Cotton, L. Alexander, E. Williams, Nicola Mary Gray, J. M. Reid, The TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) Group

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Background: Better understanding of motivators for, and barriers to, participation in randomized controlled trials (RCTs) in different study populations and settings has the potential to improve participation of historically under-represented groups (eg, women) in future trials.

Purpose: To investigate reasons why women agreed, or declined, to participate in a RCT.

Methods: In two postal questionnaire-based studies, we investigated women's reasons for participation or non-participation in TOMBOLA, a RCT comparing management policies for low-grade cervical abnormalities. Four-hundred and ninety-two TOMBOLA participants (response rate 56%) completed questionnaires on reasons for participation. One-hundred and thiry-seven women (38%) who declined TOMBOLA participation completed questionnaires on reasons for this.

Results: Eighty percent of women reported that one of their reasons for attending their TOMBOLA recruitment appointment was worries about their smear result. Ninety-four percent participated in the RCT because it was a worthwhile contribution to the cervical screening programme and other women; for 70% this was the most important reason. These proportions did not vary by socio-demographic factors. Thirty-two percent thought participation would result in better care. The most common reason for non-participation was preference for follow-up from the woman's GP. Logistical issues (eg, inconvenient appointments, travel time, arranging time off work or child-care) were commonly cited. Fourteen percent were too frightened to participate; this was unrelated to the grade of the recruitment smear.

Limitations: Response rates were not high, but there was little evidence of response bias. Structured questionnaires were used.

Conclusions: Future research should address how best to deliver information to ensure different social groups appreciate potential benefits of RCT participation and provide reassurance regarding fears about participation. Simple strategies (eg, appealing to the altruism of potential participants or offering flexible recruitment clinic locations and times) might enhance RCT recruitment rates. This in turn would ensure best use of research resources thus bringing the greatest benefits to participants and the population.

Original languageEnglish
Pages (from-to)431-442
Number of pages11
JournalClinical Trials
Publication statusPublished - Nov 2006


  • cancer clinical-trials
  • informed-consent
  • breast-cancer
  • primary-care
  • therapeutic misconception
  • patients enter
  • older women
  • recruitment
  • barriers
  • health

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