Kalpakidou Anastasia K, Todd Chris, Omar Rumana Z, Keeley Vaughan, Griffiths Jane, Spencer Karen, Vickerstaff Victoria, Christidoulides Karolina, Perry Rachel, Katsampa Dafni, Stone Patrick
Marie Curie Palliative Care Research Department, University College London, London, UK.
Faculty of Biology, Medicine and Health, The University of Manchester School of Health Sciences, Manchester, UK.
BMJ Support Palliat Care. 2024 Dec 19;14(e3):e2603-e2610. doi: 10.1136/bmjspcare-2020-002670.
The Prognosis in Palliative care Study II (PiPS2) was a large multicentre observational study validating prognostic tools in patients with advanced cancer. Many palliative care studies fail to reach their recruitment target. To inform future studies, PiPS2 rigorously monitored and identified any potential recruitment barriers.
Key recruitment stages (ie, whether patients were eligible for the study, approached by the researchers and whether consent was obtained for enrolment) were monitored via comprehensive screening logs at participating sites (inpatient hospices, hospitals and community palliative care teams). The reasons for patients' ineligibility, inaccessibility or decision not to consent were documented.
17 014 patients were screened across 27 participating sites over a 20-month recruitment period. Of those, 4642 (27%) were ineligible for participation in the study primarily due to non-cancer diagnoses. Of 12 372 eligible patients, 9073 (73%) were not approached, the most common reason being a clinical decision not to do so. Other reasons included patients' death or discharge before they were approached by the researchers. Of the 3299 approached patients, 1458 (44%) declined participation mainly because of feeling too unwell, experiencing severe distress or having other competing priorities. 11% (n=1841/17 014) of patients screened were enrolled in the study, representing 15% (n=1841/12 372) of eligible patients. Different recruitment patterns were observed across inpatient hospice, hospital and community palliative care teams.
The main barrier to recruitment was 'accessing' potentially eligible patients. Monitoring key recruitment stages may help to identify barriers and facilitators to enrolment and allow results to be put into better context.
ISRCTN13688211.
姑息治疗预后研究II（PiPS2）是一项大型多中心观察性研究，旨在验证晚期癌症患者的预后工具。许多姑息治疗研究未能达到其招募目标。为指导未来的研究，PiPS2对潜在的招募障碍进行了严格监测和识别。
通过参与研究的机构（住院临终关怀机构、医院和社区姑息治疗团队）的综合筛查日志，对关键招募阶段（即患者是否符合研究条件、研究人员是否接触过患者以及是否获得入组同意）进行监测。记录患者不符合条件、无法接触或决定不同意的原因。
在20个月的招募期内，27个参与研究的机构共筛查了17014名患者。其中，4642名（27%）患者因非癌症诊断而不符合参与研究的条件。在12372名符合条件的患者中，9073名（73%）未被研究人员接触，最常见的原因是临床决定不接触。其他原因包括患者在研究人员接触之前死亡或出院。在3299名被接触的患者中，1458名（44%）拒绝参与，主要原因是感觉身体过于不适、经历严重痛苦或有其他更重要的事情。被筛查的患者中有11%（n = 1841/17014）入组，占符合条件患者的15%（n = 1841/12372）。住院临终关怀机构、医院和社区姑息治疗团队的招募模式各不相同。
招募的主要障碍是“接触到潜在符合条件的患者”。监测关键招募阶段可能有助于识别招募的障碍和促进因素，并使结果能更好地结合实际情况。
ISRCTN13688211。
