PDF(Pubmed)
Abstract：
BACKGROUND: Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require \"plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols\" be included in trial protocols. It is unknown how often protocols report this retention information. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial.
METHODS: A scoping review with searches in key databases (PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014 to 2019 inclusive) to identify randomised controlled trial protocols. We produced descriptive statistics on the characteristics of the trial protocols and also on those adhering to SPIRIT item 18b. A narrative synthesis of the retention strategies was also conducted.
RESULTS: Eight-hundred and twenty-four protocols met our inclusion criteria. RCTs (n = 722) and pilot and feasibility trial protocols (n = 102) reported using the SPIRIT guidelines during protocol development 35% and 34.3% of the time respectively. Of these protocols, only 9.5% and 11.4% respectively reported all aspects of SPIRIT item 18b \"plans to promote participant retention and to complete follow-up, including list of any outcome data for participants who discontinue or deviate from intervention protocols\". Of the RCT protocols, 36.8% included proactive \"plans to promote participant retention\" regardless of whether they reported using SPIRIT guidelines or not. Most protocols planned \"combined strategies\" (48.1%). Of these, the joint most commonly reported were \"reminders and data collection location and method\" and \"reminders and monetary incentives\". The most popular individual retention strategy was \"reminders\" (14.7%) followed by \"monetary incentives- conditional\" (10.2%). Of the pilot and feasibility protocols, 40.2% included proactive \"plans to promote participant retention\" with the use of \"combined strategies\" being most frequent (46.3%). The use of \"monetary incentives - conditional\" (22%) was the most popular individual reported retention strategy.
CONCLUSIONS: There is a lack of reporting of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct.
METHODS: A scoping review with searches in key databases (PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014 to 2019 inclusive) to identify randomised controlled trial protocols. We produced descriptive statistics on the characteristics of the trial protocols and also on those adhering to SPIRIT item 18b. A narrative synthesis of the retention strategies was also conducted.
RESULTS: Eight-hundred and twenty-four protocols met our inclusion criteria. RCTs (n = 722) and pilot and feasibility trial protocols (n = 102) reported using the SPIRIT guidelines during protocol development 35% and 34.3% of the time respectively. Of these protocols, only 9.5% and 11.4% respectively reported all aspects of SPIRIT item 18b \"plans to promote participant retention and to complete follow-up, including list of any outcome data for participants who discontinue or deviate from intervention protocols\". Of the RCT protocols, 36.8% included proactive \"plans to promote participant retention\" regardless of whether they reported using SPIRIT guidelines or not. Most protocols planned \"combined strategies\" (48.1%). Of these, the joint most commonly reported were \"reminders and data collection location and method\" and \"reminders and monetary incentives\". The most popular individual retention strategy was \"reminders\" (14.7%) followed by \"monetary incentives- conditional\" (10.2%). Of the pilot and feasibility protocols, 40.2% included proactive \"plans to promote participant retention\" with the use of \"combined strategies\" being most frequent (46.3%). The use of \"monetary incentives - conditional\" (22%) was the most popular individual reported retention strategy.
CONCLUSIONS: There is a lack of reporting of plans to promote participant retention in trial protocols. Proactive planning of retention strategies during the trial design stage is preferable to the reactive implementation of retention strategies. Prospective retention planning and clear communication in protocols may inform more suitable choice, costing and implementation of retention strategies and improve transparency in trial conduct.
摘要：
背景：保留试验对于确保试验结果有效和可靠很重要。SPIRIT指南（18b）要求“计划促进参与者的保留和完整的后续行动，包括为停止或偏离干预方案的参与者收集的任何结局数据列表,并纳入试验方案.未知协议报告此保留信息的频率。我们范围审查的目的是确定，以及如何，试验团队在试验设计阶段报告保留计划.
方法：在关键数据库中进行搜索的范围审查（PubMed，Scopus,EMBASE,CINAHL(EBSCO)，和2014年至2019年的WebofScience），以确定随机对照试验方案。我们对试验方案的特征以及遵守SPIRIT项目18b的特征进行了描述性统计。还对保留策略进行了叙述性综合。
结果：八百二十四方案符合我们的纳入标准。RCT（n=722）和试点和可行性试验协议（n=102）在协议开发过程中使用SPIRIT指南分别报告了35％和34.3％的时间。在这些协议中，分别只有9.5%和11.4%报告了SPIRIT项目18b的所有方面“促进参与者保留和完成后续行动的计划”，包括停止或偏离干预方案的参与者的任何结果数据列表。"在RCT协议中，36.8%包括主动“促进参与者保留的计划”，无论他们是否使用SPIRIT指南报告。大多数协议计划“组合策略”(48.1%)。其中,最常报告的联合报告是“提醒和数据收集位置和方法”和“提醒和金钱激励”。最受欢迎的个人保留策略是“提醒”（14.7％），其次是“有条件的金钱激励”（10.2％）。在试点和可行性协议中，40.2％包括主动“促进参与者保留的计划”，而使用“组合策略”最为频繁（46.3％）。使用“有条件的货币激励”（22％）是最受欢迎的个人报告保留策略。
结论：缺乏在试验方案中促进参与者保留的计划报告。在试验设计阶段对保留策略进行主动计划比对保留策略进行被动实施更可取。预期的保留计划和协议中的清晰沟通可能会提供更合适的选择，保留策略的成本计算和实施，并提高审判进行的透明度。
方法：在关键数据库中进行搜索的范围审查（PubMed，Scopus,EMBASE,CINAHL(EBSCO)，和2014年至2019年的WebofScience），以确定随机对照试验方案。我们对试验方案的特征以及遵守SPIRIT项目18b的特征进行了描述性统计。还对保留策略进行了叙述性综合。
结果：八百二十四方案符合我们的纳入标准。RCT（n=722）和试点和可行性试验协议（n=102）在协议开发过程中使用SPIRIT指南分别报告了35％和34.3％的时间。在这些协议中，分别只有9.5%和11.4%报告了SPIRIT项目18b的所有方面“促进参与者保留和完成后续行动的计划”，包括停止或偏离干预方案的参与者的任何结果数据列表。"在RCT协议中，36.8%包括主动“促进参与者保留的计划”，无论他们是否使用SPIRIT指南报告。大多数协议计划“组合策略”(48.1%)。其中,最常报告的联合报告是“提醒和数据收集位置和方法”和“提醒和金钱激励”。最受欢迎的个人保留策略是“提醒”（14.7％），其次是“有条件的金钱激励”（10.2％）。在试点和可行性协议中，40.2％包括主动“促进参与者保留的计划”，而使用“组合策略”最为频繁（46.3％）。使用“有条件的货币激励”（22％）是最受欢迎的个人报告保留策略。
结论：缺乏在试验方案中促进参与者保留的计划报告。在试验设计阶段对保留策略进行主动计划比对保留策略进行被动实施更可取。预期的保留计划和协议中的清晰沟通可能会提供更合适的选择，保留策略的成本计算和实施，并提高审判进行的透明度。
