Healthcare Sciences and e-Health, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Department of Paediatrics and Adolescent Medicine, TYKS Turku University Hospital, Turku, Finland.
BMJ Open. 2022 Apr 1;12(4):e056758. doi: 10.1136/bmjopen-2021-056758.
Difficulties with recruitment into clinical trials are common. An opt-out recruitment strategy, whereby potential participants can decline further contact about a study (opt-out), and non-responders are contacted, may facilitate participation. Primary objectives examined opt-out and consent rates, mode and time point of opt-out, and sociodemographic characteristics of those who opted out versus those who chose to participate in a single-arm feasibility trial (ENGAGE) of a guided, internet-administered, cognitive-behavioural therapy-based intervention for parents of children treated for cancer. Secondary objectives examined reasons for non-participation.
A cross-sectional survey nested within the ENGAGE feasibility trial.
The intervention was delivered from Uppsala University, with parents located throughout Sweden.
Potential participants were recruited 3 months-5 years following their child ending treatment for cancer and were identified via their personal identification number (via the Swedish Childhood Cancer Registry and Swedish Tax Agency) and invited via postal invitation packs and could opt out via post, online, telephone or email. Those who did not opt out or consent, within 4 weeks, received up to five telephone calls and/or one postal reminder.
Of 509 invited, 164 (32.2%) opted out, 78 (47.6%) via post, 53 (32.3%) via telephone, 24 (14.6%) online, and 6 (3.7%) via email, 88 (53.7%) opted out after at least one telephone call and/or postal reminder. There was a trend for parents with lower educational levels to opt out. No need of psychological support, lack of time, and no interest in internet-administered self-help were frequently reported reasons for non-participation.
Results emphasise the importance of using different opt-out modes and suggest future research should consider how to widen study participation for parents with lower education levels. Self-identifying a need for psychological support and the acceptability of internet-administered self-help are important factors for participation and should be considered in future research to increase recruitment.
ISRCTN57233429.
临床试验招募困难较为常见。一种“选择退出”的招募策略，即潜在参与者可以选择不再进一步了解研究（选择退出），并联系未回复者，可能有助于提高参与度。本研究主要目的是评估选择退出率和同意率、选择退出的方式和时间点，以及选择退出与选择参与基于指导的、互联网管理的认知行为疗法干预的癌症患儿家长的单臂可行性试验（ENGAGE）的那些参与者的社会人口学特征。次要目的是研究非参与的原因。
ENGAGE 可行性试验的嵌套横断面调查。
干预措施由乌普萨拉大学开展，家长来自瑞典各地。
潜在参与者在其孩子结束癌症治疗后 3 个月至 5 年内被招募，通过个人身份识别号（通过瑞典儿童癌症登记处和瑞典税务署）识别，并通过邮寄邀请包邀请，并可通过邮件、在线、电话或电子邮件选择退出。在 4 周内未选择退出或同意的人，最多会接到 5 个电话和/或 1 个邮寄提醒。
在 509 名受邀者中，164 名（32.2%）选择退出，78 名（47.6%）通过邮件，53 名（32.3%）通过电话，24 名（14.6%）通过在线，6 名（3.7%）通过电子邮件，88 名（53.7%）在至少一次电话和/或邮寄提醒后选择退出。父母教育水平较低的人选择退出的趋势明显。经常报告的不参与原因包括不需要心理支持、缺乏时间和对互联网管理的自助服务不感兴趣。
结果强调了使用不同的选择退出模式的重要性，并表明未来的研究应考虑如何扩大教育程度较低的父母的研究参与度。自我认定需要心理支持以及对互联网管理的自助服务的可接受性是参与的重要因素，应在未来的研究中考虑，以增加招募。
ISRCTN57233429。
