Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU), London, SM2 5NG, UK.
Institute of Cancer Sciences, Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.
Trials. 2020 Jul 8;21(1):629. doi: 10.1186/s13063-020-04559-w.
The utility of patient screening logs and their impact on improving trial recruitment rates are unclear. We conducted a retrospective exploratory analysis of screening data collected within a multicentre randomised controlled trial investigating chemotherapy for upper tract urothelial carcinoma.
Participating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC). Sites recorded the number of patients ineligible, not approached, declined and randomised. The CTC monitored proportions of eligible patients, approach rate (proportion of eligible patients approached) and acceptance rate (proportion recruited of those approached). Data were retrospectively analysed to identify patterns of screening activity and correlation with recruitment.
Data were collected between May 2012 and August 2016, during which time 71 sites were activated-a recruitment period of 2768 centre months. A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received. A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation. The approach rate was 91% (344/380), and the acceptance rate was 40% (137/344); these rates remained consistent throughout the data collection. The main reason patients provided for declining (99/207, 48%) was not wanting to receive chemotherapy. There was a moderately strong correlation (r = 0.47) between the number reported on screening logs and the number recruited per site. Considerable variation in data between centres was observed, and 54/191 trial participants (28%) enrolled during this period were not reported on logs.
Central collection of screening logs can identify reasons for patients declining trial participation and help monitor trial activity at sites; however, obtaining complete data can be challenging. There was a correlation between the number of patients reported on logs and recruitment; however, this was likely confounded by sites' available patient population. The use of screening logs may not be appropriate for all trials, and their use should be carefully considered in relation to the associated workload. No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation.
ISRCTN98387754 . Registered on 31 January 2012.
患者筛选日志的效用及其对提高试验招募率的影响尚不清楚。我们对一项多中心随机对照试验的筛选数据进行了回顾性探索性分析，该试验研究了上尿路尿路上皮癌的化疗。
参与中心记录了符合试验方案规定的基本筛选标准的患者情况，并定期向临床试验协调中心（CTC）提交日志。各中心记录了不合格、未接触、拒绝和随机分组的患者人数。CTC 监测合格患者的比例、接触率（合格患者的接触比例）和接受率（接触患者的招募比例）。对数据进行了回顾性分析，以确定筛选活动的模式，并与招募情况进行关联。
数据收集于 2012 年 5 月至 2016 年 8 月期间，在此期间，有 71 个中心参与，招募期为 2768 个中心月。筛选日志共记录了 1138 名患者，CTC 共发送了 2300 份日志请求，收到了 47%的预期日志。共有 758 名患者被报告为不合格，36 名合格患者未接受接触，207 名拒绝参加试验。接触率为 91%（344/380），接受率为 40%（137/344）；这些比例在整个数据收集过程中保持一致。患者拒绝的主要原因（99/207，48%）是不想接受化疗。筛选日志中报告的人数与每个中心招募的人数之间存在中度强相关性（r=0.47）。各中心之间的数据差异较大，在此期间，191 名试验参与者中有 54 名（28%）未在日志中报告。
中央收集筛选日志可以确定患者拒绝参与试验的原因，并有助于监测各中心的试验活动；然而，获得完整的数据可能具有挑战性。报告的日志患者人数与招募人数之间存在相关性；然而，这可能与各中心的可用患者群体有关。筛选日志的使用可能并不适用于所有试验，应根据相关工作量仔细考虑其使用。本研究未发现中央收集筛选日志能提高招募率，其继续使用值得进一步研究。
ISRCTN98387754。于 2012 年 1 月 31 日注册。
