Trials Research and Methodologies Unit (TRAMS), Health Research Board Clinical Research Facility at University College Cork, Cork, Ireland.
School of Public Health, University College Cork, Cork, Ireland.
Trials. 2022 May 12;23(1):396. doi: 10.1186/s13063-022-06223-x.
Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the UK.
We selected the top ten most routinely used retention strategies by Clinical Trial Units in the UK and made assumptions as to how each of these strategies was most likely to be implemented and the costs involved in doing this. We applied our costing model to a hypothetical trial scenario in both Ireland and the UK as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel.
Retention strategies were often poorly specified, meaning we had to make assumptions about implementation and in some cases about the strategy itself. Based on our assumptions, some retention strategies can be extremely expensive; some of the costliest strategies included "data collection scheduled with routine care" (€900-€32,503.25), "a timeline of participant visits for sites"-with integrated participant reminder (€304.74-€14,803.70), and "routine site visits by CTU staff" and "investigator meetings face to face", both costing (€777.67-€14,753.48). Others such as "telephone reminders for questionnaire response" (€34.58-€568.62), "a timeline of participant visits for sites"-site reminder alone (€79.18-€112.23), and "targeted recruitment of sites/GPs" (€30-€1620) were less costly compared to the other strategies.
The resources invested in the use of some retention strategies may outweigh known or imagined benefits on retention. Where benefits are currently unknown, evaluation should be a priority.
More evaluation of the effectiveness and cost of trial retention strategies is needed to avoid widespread use of strategies that are both expensive and ineffective.
缺乏支持临床试验中使用许多保留策略的证据。尽管如此，试验团队仍需要在其试验中采用某种形式的保留策略，以尽量避免高脱落率。本研究旨在估计这种缺乏保留证据可能会使爱尔兰和英国的试验损失多少成本。
我们选择了英国临床试验单位最常使用的前 10 种保留策略，并假设每种策略最有可能以何种方式实施，以及实施这些策略所涉及的成本。我们将我们的成本模型应用于爱尔兰和英国的一个假设试验方案以及三个已发表的试验方案。我们在 Microsoft Excel 中开发了成本模型并计算了成本。
保留策略通常规定得很差，这意味着我们必须对实施策略做出假设，在某些情况下还必须对策略本身做出假设。根据我们的假设，一些保留策略可能非常昂贵；一些最昂贵的策略包括“与常规护理一起安排数据收集”（€900-€32,503.25）、“为站点制定参与者访问时间表-带有集成的参与者提醒”（€304.74-€14,803.70），以及“由 CTU 员工进行常规站点访问”和“面对面的研究者会议”，两者的成本均为（€777.67-€14,753.48）。其他策略，如“用于问卷回复的电话提醒”（€34.58-€568.62）、“仅站点提醒的参与者访问时间表”（€79.18-€112.23）和“有针对性地招募站点/GP”（€30-€1620）与其他策略相比成本较低。
在保留策略的使用方面投入的资源可能超过保留方面已知或想象的收益。在目前尚不清楚收益的情况下，评估应是当务之急。
需要对试验保留策略的有效性和成本进行更多评估，以避免广泛使用既昂贵又无效的策略。
