PDF(Pubmed)
Abstract：
BACKGROUND: Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol.
METHODS: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate.
RESULTS: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use \"combined strategies\" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies).
CONCLUSIONS: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.
METHODS: Ninety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate.
RESULTS: Plans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use \"combined strategies\" to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies).
CONCLUSIONS: Retention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.
摘要：
背景：在随机对照试验（RCT）中保留参与者具有挑战性，通常需要试验团队使用策略来确保保留或改善保留。除货币激励外，没有要求向参与者披露保留策略的使用情况。此外,并非所有保留策略都是在计划阶段制定的，即协议制定期间的后资助，但一些方案包括参与者保留策略,因为在试验计划阶段早期考虑并计划保留.尚不清楚这些计划是否在相应的参与者信息传单（PIL）中传达。我们研究的目的是确定PIL是否传达促进参与者保留的计划，如果是,这些都在相应的试验方案中概述。
方法：分析了来自英国临床试验单位（CTU）的92例成人PIL及其90种相应的方案。使用定向(演绎)内容分析来分析来自PIL的参与者保留文本。在适当的情况下，使用叙述性摘要和频率来呈现数据。
结果：促进参与者保留的计划在81.5%（n=75/92）的PIL中进行了沟通。57％（n=43/75）的PIL传达了使用“组合策略”来促进参与者保留的计划。最常见的个人保留策略是告诉参与者，试验的数据收集将安排在常规护理访视期间（16％；n=12/75PIL）。保留的重要性以及缺失或删除数据（删除前收集的数据）对回答研究问题的能力的影响分别在6.5％（n=6/92）和5.4％（n=5/92）的PIL中进行了解释。在59个PIL和58个匹配协议中，这两个协议都传达了使用策略来促进参与者保留的计划，18.6%(n=11/59)传达了相同的信息，其余81.4%(n=48/59)的PIL仅部分传达(45.8%;n=27/59)相同的信息,或未与方案传达相同的信息(35.6%;n=21/59)。
结论：保留策略经常传达给PILs的潜在试验参与者；然而，提供的信息通常与相应协议中的内容不同。参与者的保留考虑最好在试验的计划阶段完成，我们鼓励试验团队在方案和PIL中这些策略的沟通保持一致。
方法：分析了来自英国临床试验单位（CTU）的92例成人PIL及其90种相应的方案。使用定向(演绎)内容分析来分析来自PIL的参与者保留文本。在适当的情况下，使用叙述性摘要和频率来呈现数据。
结果：促进参与者保留的计划在81.5%（n=75/92）的PIL中进行了沟通。57％（n=43/75）的PIL传达了使用“组合策略”来促进参与者保留的计划。最常见的个人保留策略是告诉参与者，试验的数据收集将安排在常规护理访视期间（16％；n=12/75PIL）。保留的重要性以及缺失或删除数据（删除前收集的数据）对回答研究问题的能力的影响分别在6.5％（n=6/92）和5.4％（n=5/92）的PIL中进行了解释。在59个PIL和58个匹配协议中，这两个协议都传达了使用策略来促进参与者保留的计划，18.6%(n=11/59)传达了相同的信息，其余81.4%(n=48/59)的PIL仅部分传达(45.8%;n=27/59)相同的信息,或未与方案传达相同的信息(35.6%;n=21/59)。
结论：保留策略经常传达给PILs的潜在试验参与者；然而，提供的信息通常与相应协议中的内容不同。参与者的保留考虑最好在试验的计划阶段完成，我们鼓励试验团队在方案和PIL中这些策略的沟通保持一致。
