Chatters Robin, Newbould Louise, Sprange Kirsty, Hind Daniel, Mountain Gail, Shortland Katy, Powell Lauren, Gossage-Worrall Rebecca, Chater Tim, Keetharuth Anju, Lee Ellen, Woods Bob
School of Health and Related Research, The University of Sheffield, Regent Court, Regent Street, Sheffield, S1 4DA, UK.
Research Fellow Mental Health and Addiction Research Group Department of Health Sciences ARRC Building University of York, Heslington, York, YO10 5DD, UK.
Trials. 2018 Feb 20;19(1):121. doi: 10.1186/s13063-018-2482-1.
Recruiting isolated older adults to clinical trials is complex, time-consuming and difficult. Previous studies have suggested querying existing databases to identify appropriate potential participants. We aim to compare recruitment techniques (general practitioner (GP) mail-outs, community engagement and clinician referrals) used in three randomised controlled trial (RCT) studies assessing the feasibility or effectiveness of two preventative interventions in isolated older adults (the Lifestyle Matters and Putting Life In Years interventions).
During the three studies (the Lifestyle Matters feasibility study, the Lifestyle Matters RCT, the Putting Life In Years RCT) data were collected about how participants were recruited. The number of letters sent by GP surgeries for each study was recorded. In the Lifestyle Matters RCT, we qualitatively interviewed participants and intervention facilitators at 6 months post randomisation to seek their thoughts on the recruitment process.
Referrals were planned to be the main source of recruitment in the Lifestyle Matters feasibility study, but due to a lack of engagement from district nurses, community engagement was the main source of recruitment. District nurse referrals and community engagement were also utilised in the Lifestyle Matters and Putting Life In Years RCTs; both mechanisms yielded few participants. GP mail-outs were the main source of recruitment in both the RCTs, but of those contacted, recruiting yield was low (< 3%). Facilitators of the Lifestyle Matters intervention questioned whether the most appropriate individuals had been recruited. Participants recommended that direct contact with health professionals would be the most beneficial way to recruit.
Recruitment to the Lifestyle Matters RCT did not mirror recruitment to the feasibility study of the same intervention. Direct district nurse referrals were not effective at recruiting participants. The majority of participants were recruited via GP mail-outs, which may have led to isolated individuals not being recruited to the trials. Further research is required into alternative recruitment techniques, including respondent-driven sampling plus mechanisms which will promote health care professionals to recruit vulnerable populations to research.
International Standard Randomised Controlled Trial Registry, ID: ISRCTN28645428 (Putting Life In Years RCT). Registered on 11 April 2012; International Standard Randomised Controlled Trial Registry, ID: ISRCTN67209155 (Lifestyle Matters RCT). Registered on 22 March 2012; ClinicalTrials.gov , ID: NCT03054311 (Lifestyle Matters feasibility study). Registered retrospectively on 19 January 2017.
招募独居老年人参与临床试验复杂、耗时且困难。以往研究建议查询现有数据库以识别合适的潜在参与者。我们旨在比较三项随机对照试验（RCT）研究中使用的招募技术（全科医生（GP）邮寄、社区参与和临床医生转诊），这三项研究评估了两种针对独居老年人的预防干预措施（“生活方式重要性”和“延年益寿”干预措施）的可行性或有效性。
在三项研究（“生活方式重要性”可行性研究、“生活方式重要性”RCT、“延年益寿”RCT）期间，收集了关于参与者招募方式的数据。记录了每个研究中全科医生诊所发出的信件数量。在“生活方式重要性”RCT中，我们在随机分组后6个月对参与者和干预促进者进行了定性访谈，以了解他们对招募过程的看法。
在“生活方式重要性”可行性研究中，转诊原本计划作为主要招募来源，但由于地区护士参与度不足，社区参与成为主要招募来源。地区护士转诊和社区参与在“生活方式重要性”和“延年益寿”RCT中也有使用；这两种方式招募到的参与者都很少。全科医生邮寄是两项RCT中的主要招募来源，但在被联系者中，招募成功率较低（<3%）。“生活方式重要性”干预措施的促进者质疑是否招募到了最合适的个体。参与者建议直接与卫生专业人员联系是招募的最有效方式。
“生活方式重要性”RCT的招募情况与同一干预措施的可行性研究不同。地区护士直接转诊在招募参与者方面效果不佳。大多数参与者是通过全科医生邮寄招募的，这可能导致独居个体未被纳入试验。需要进一步研究替代招募技术，包括应答驱动抽样以及促进卫生保健专业人员招募弱势群体参与研究的机制。
国际标准随机对照试验注册库，编号：ISRCTN28645428（“延年益寿”RCT）。于2012年4月11日注册；国际标准随机对照试验注册库，编号：ISRCTN67209155（“生活方式重要性”RCT）。于2012年3月22日注册；ClinicalTrials.gov，编号：NCT03054311（“生活方式重要性”可行性研究）。于2017年1月19日追溯注册。
