HRB Centre for Primary Care Research, Department of General Practice, RCSI University of Medicine and Health Sciences, Dublin 2, Ireland.
School of Social Work and Social Policy, Trinity College Dublin, Dublin 2, Ireland.
Fam Pract. 2023 Dec 22;40(5-6):810-819. doi: 10.1093/fampra/cmad039.
Older patients with multimorbidity are under-represented in experimental research.
To explore the barriers and facilitators to general practitioner (GP) and older patient recruitment and retention in a cluster randomized controlled trial (RCT).
This descriptive study uses qualitative and quantitative data from a cluster RCT, designed to evaluate the effectiveness of a medicines optimization intervention. The SPPiRE cluster RCT enrolled 51 general practices and 404 patients aged ≥65 years and prescribed ≥15 medicines. Quantitative data were collected from all recruited practices and 32 additional practices who were enrolled, but unable to recruit sufficient participants. Qualitative data were collected from purposive samples of intervention GPs (18/26), patients (27/208), and researcher logs and analysed thematically using inductive coding.
Enrolment rates for practices and patients were 37% and 25%, respectively. Barriers to GP recruitment were lack of resources and to patient recruitment were difficulty understanding trial material and concern about medicines being taken away. GPs' primary motivation was perceived importance of the research question, whereas patients' primary motivation was trust in their GP. All general practices were retained. Thirty-five patients (8.6%) were lost to follow-up for primary outcomes, mainly because they had died and 45% did not return patient-reported outcome measures (PROMs).
Patient retention for the primary outcome was high, as it was collected directly from patient records. Patient completion of PROM data was poor, reflecting difficulty in understanding trial material. Recruiting older patients with multimorbidity to clinical trials is possible but requires significant resource and planning.
ISRCTN Registry ISRCTN12752680.
患有多种疾病的老年患者在实验研究中代表性不足。
探讨在一项整群随机对照试验（RCT）中招募和保留全科医生（GP）和老年患者的障碍和促进因素。
本描述性研究使用来自一项整群 RCT 的定性和定量数据，该 RCT 旨在评估一种药物优化干预措施的有效性。SPPiRE 整群 RCT 招募了 51 家全科诊所和 404 名年龄≥65 岁且开处≥15 种药物的患者。定量数据来自所有招募的诊所和另外 32 家招募但未能招募足够参与者的诊所收集。定性数据来自干预全科医生（18/26）、患者（27/208）的目的抽样和研究人员日志，并使用归纳编码进行主题分析。
诊所和患者的入组率分别为 37%和 25%。GP 招募的障碍是缺乏资源，而患者招募的障碍是难以理解试验材料和担心药物被拿走。GP 的主要动机是认为研究问题的重要性，而患者的主要动机是信任他们的 GP。所有的全科诊所都保留了下来。35 名患者（8.6%）因主要结局而失访，主要是因为他们已经死亡，45%的患者没有返回患者报告结局测量（PROMs）。
主要结局的患者保留率很高，因为它是直接从患者记录中收集的。患者完成 PROM 数据的情况较差，反映出理解试验材料的困难。招募患有多种疾病的老年患者参加临床试验是可能的，但需要大量的资源和规划。
ISRCTN 注册 ISRCTN8205326。
