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.
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.
Authors: D Lamunu; K N Chapman; P Nsubuga; G Muzanyi; Y Mulumba; M A Mugerwa; S Goldberg; L Bozeman; M Engle; J Saukkonen; S Mastranunzio; H Mayanja-Kizza; J L Johnson Journal: Int J Tuberc Lung Dis Date: 2012-04 Impact factor: 2.373
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Authors: Ricki Carroll; Jules Antigua; Darren Taichman; Harold Palevsky; Paul Forfia; Steven Kawut; Scott D Halpern Journal: Clin Trials Date: 2012-03-02 Impact factor: 2.486
Authors: Brent W Kinder; A C Sherman; L R Young; J T Hagaman; N Oprescu; S Byrnes; Francis X McCormack Journal: Respir Med Date: 2009-12-04 Impact factor: 3.415
Authors: Terrance L Albrecht; Susan S Eggly; Marci E J Gleason; Felicity W K Harper; Tanina S Foster; Amy M Peterson; Heather Orom; Louis A Penner; John C Ruckdeschel Journal: J Clin Oncol Date: 2008-06-01 Impact factor: 44.544
Authors: Donna P Manca; Maeve O'Beirne; Teresa Lightbody; David W Johnston; Dayna-Lynn Dymianiw; Katarzyna Nastalska; Lubna Anis; Sarah Loehr; Anne Gilbert; Bonnie J Kaplan Journal: BMC Pregnancy Childbirth Date: 2013-03-22 Impact factor: 3.007