Strategies to improve retention in randomised trials.
Strategies to improve retention in randomised trials.
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DOI：
10.1002/14651858.mr000032.pub2
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发表时间：
2013-12-03
影响因子：
8.4
通讯作者：
Rait, Greta
中科院分区：
文献类型：
--
作者：
Brueton, Valerie C;Tierney, Jayne;Stenning, Sally;Harding, Seeromanie;Meredith, Sarah;Nazareth, Irwin;Rait, Greta
随机试验的随访缺失可能会引入偏倚，降低研究能力，影响结果的普遍性、有效性和可靠性。许多策略用于减少后续损失和提高保留率，但很少进行正式评估。量化提高留用率的策略对随机试验中留用率的影响，并调查该效果是否因试验策略和试验环境而异。我们检索了Cochrane中央对照试验登记（Central）、MEDLINE、PreMEDLINE、EMBASE、PsycINFO、DARE、CINAHL、Campbell协作的社会、心理、教育和犯罪学试验登记以及ERIC。我们手工检索了会议记录和出版物参考列表，以获得合格的保留试验。我们还调查了所有英国临床试验单位，以确定进一步的研究。我们纳入了符合条件的滞留试验，这些试验是对来自所有疾病领域和医疗环境的“宿主”随机试验中嵌入的提高滞留策略的随机或准随机评估。我们排除了旨在提高治疗依从性的研究。我们联系作者补充或确认我们提取的数据。对于保留试验，我们记录了随机化方法、评估策略类型、比较物、主要结果、计划样本量、随机数量和保留数量的数据。我们使用风险比（RR）来评估增加策略以提高保留率的有效性。我们使用Chi2和I2统计来评估试验之间的异质性。对于包含保留试验的主要试验，我们提取了有关疾病区域、干预措施、人口、医疗保健环境、序列生成和分配隐藏的数据。我们确定了38个符合条件的保留率试验。纳入的试验评估了六种提高记忆保留的策略。这些是激励、沟通策略、新的问卷格式、参与者案例管理、行为和方法干预。在其中34项试验中，保留是对有或没有医疗测试包的邮寄和电子调查表的答复。在四项试验中，保留率是指留在试验中的参与者人数。纳入的试验在一系列疾病领域、国家、卫生保健和社区环境中进行。策略改进审判保留没有动力的货币激励而返回试验相关邮政问卷(相对危险度1.18,95%可信区间1.09到1.28,P值< 0.0001),增加的货币激励而没有提供返回的电子问卷(相对危险度1.25,95%可信区间1.14到1.38,P值< 0.00001)和20英镑的提供凭证为10英镑返回邮政问卷和生物医学测试套件(RR 1.12;95% CI 1.04 ~ 1.22， P值< 0.005)。较短的问卷优于较长的问卷的证据不明确（RR 1.04; 95% CI 1.00 ~ 1.08， P值= 0.07），与疾病/状况相关的问卷的证据也不明确（RR 1.07; 95% CI 1.01 ~ 1.14）。虽然每一种方法都是基于单一试验的结果，但记录问卷的传递似乎比电话提醒更有效（RR 2.08; 95% CI 1.11至3.87，P值= 0.02），带有提醒信的邮政通信策略“一揽子”似乎比标准程序更好（RR 1.43; 95% CI 1.22至1.67，P值< 0.0001）。在一项预防骨折试验中，开放试验设计在问卷回收方面也比盲法试验设计更有效（RR 1.37; 95% CI 1.16 ~ 1.63， P值= 0.0003）。没有充分的证据表明，增加非货币激励、提供非货币激励、“增强”信件、优先邮递递送信件、额外提醒或问卷问题顺序会增加或减少试验问卷的响应/保留。也没有证据表明电话调查比金钱奖励和问卷调查更有效或更无效。由于我们的分析是基于单次试验，使用慈善捐赠的报价、向试验地点发送提醒以及发送问卷的时间对问卷反应的影响可能需要进一步评估。用于保留试验的病例管理和行为策略也可能需要进一步评估。我们确定的大多数留存试验都是评估问卷的反应。很少有评估的方法来改善参与者返回试验地点进行试验随访。金钱奖励和提供金钱奖励增加了邮政和电子问卷的回应。在单个试验中评估的其他一些策略看起来很有希望，但需要进一步评估。本综述结果的应用将取决于试验环境、人群、疾病领域、数据收集和随访程序。大多数试验在受试者被招募后通过个人接触跟踪收集数据。一些试验从其他来源获得数据，例如常规收集的数据或疾病登记。从试验中的人那里收集数据的方法有很多，包括使用信件、互联网、电话、短信、面对面会议或退还医疗检测试剂盒。例如，大多数试验都缺少数据，因为人们太忙而没有时间回复，无法去诊所，已经搬家或不再想参加。有时数据没有在研究地点记录下来，或者没有发送到试验协调中心。研究人员将这种情况称为“失去随访”、“退出”或“流失”，它会影响试验的结果。例如，如果症状最严重或最不严重的人不返回问卷或参加随访，这将使试验结果产生偏差。研究人员使用了许多方法来保持人们在试验中。这些措施鼓励人们通过问卷传回数据，返回诊所或医院进行与试验相关的测试，或由卫生或社区护理工作者进行治疗。研究特点：本综述确定了鼓励人们留在试验中的方法。我们在科学数据库中搜索了随机研究（人们以随机方式被分配到两种或两种以上可能的治疗方法中的一种）或准随机研究（分配不是真正随机的，例如基于出生日期，他们去诊所的顺序），这些研究比较了试验中增加保留率的方法。我们纳入了来自任何年龄、性别、种族、文化、语言和地理群体的试验参与者。似乎有效的方法是提供或给予少量的钱，以换取完成问卷的回报，并在问卷中附上少量的钱，并承诺再提供少量的钱，以换取填写问卷的回报。其他让人们留在试验中的方法的效果仍然不清楚，需要更多的研究来看看这些方法是否真的有效。这些方法包括较短的调查问卷，通过记录递送的方式发送调查问卷，使用人们知道他们将接受哪种治疗的试验设计，发送专门设计的信件，信封上印有回复自己地址的邮票，然后是一些提醒，向慈善机构捐款或参加抽奖，向研究地点发送关于参与者随访的提醒，在接近患者最后一次随访的时间发送调查问卷，管理人员的随访，通过电话进行随访，改变问卷问题的顺序。我们确定的方法在许多不同疾病领域和环境的试验中进行了测试，在某些情况下，仅在一项试验中进行了测试。因此，需要更多的研究来帮助确定我们的发现是否可以用于其他研究领域。
Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These were incentives, communication strategies, new questionnaire format, participant case management, behavioural and methodological interventions. For 34 of the included trials, retention was response to postal and electronic questionnaires with or without medical test kits. For four trials, retention was the number of participants remaining in the trial. Included trials were conducted across a spectrum of disease areas, countries, healthcare and community settings. Strategies that improved trial retention were addition of monetary incentives compared with no incentive for return of trial-related postal questionnaires (RR 1.18; 95% CI 1.09 to 1.28, P value < 0.0001), addition of an offer of monetary incentive compared with no offer for return of electronic questionnaires (RR 1.25; 95% CI 1.14 to 1.38, P value < 0.00001) and an offer of a GBP20 voucher compared with GBP10 for return of postal questionnaires and biomedical test kits (RR 1.12; 95% CI 1.04 to 1.22, P value < 0.005). The evidence that shorter questionnaires are better than longer questionnaires was unclear (RR 1.04; 95% CI 1.00 to 1.08, P value = 0.07) and the evidence for questionnaires relevant to the disease/condition was also unclear (RR 1.07; 95% CI 1.01 to 1.14). Although each was based on the results of a single trial, recorded delivery of questionnaires seemed to be more effective than telephone reminders (RR 2.08; 95% CI 1.11 to 3.87, P value = 0.02) and a 'package' of postal communication strategies with reminder letters appeared to be better than standard procedures (RR 1.43; 95% CI 1.22 to 1.67, P value < 0.0001). An open trial design also appeared more effective than a blind trial design for return of questionnaires in one fracture prevention trial (RR 1.37; 95% CI 1.16 to 1.63, P value = 0.0003). There was no good evidence that the addition of a non-monetary incentive, an offer of a non-monetary incentive, 'enhanced' letters, letters delivered by priority post, additional reminders, or questionnaire question order either increased or decreased trial questionnaire response/retention. There was also no evidence that a telephone survey was either more or less effective than a monetary incentive and a questionnaire. As our analyses are based on single trials, the effect on questionnaire response of using offers of charity donations, sending reminders to trial sites and when a questionnaire is sent, may need further evaluation. Case management and behavioural strategies used for trial retention may also warrant further evaluation. Most of the retention trials that we identified evaluated questionnaire response. There were few evaluations of ways to improve participants returning to trial sites for trial follow-up. Monetary incentives and offers of monetary incentives increased postal and electronic questionnaire response. Some other strategies evaluated in single trials looked promising but need further evaluation. Application of the findings of this review would depend on trial setting, population, disease area, data collection and follow-up procedures. Background Most trials follow people up to collect data through personal contact after they have been recruited. Some trials get data from other sources, such as routine collected data or disease registers. There are many ways to collect data from people in trials, and these include using letters, the internet, telephone calls, text messaging, face-to-face meetings or the return of medical test kits. Most trials have missing data, for example, because people are too busy to reply, are unable to attend a clinic, have moved or no longer want to participate. Sometimes data has not been recorded at study sites, or are not sent to the trial co-ordinating centre. Researchers call this 'loss to follow-up', 'drop out' or 'attrition' and it can affect the trial's results. For example, if the people with the most or least severe symptoms do not return questionnaires or attend a follow-up visit, this will bias the findings of the trial. Many methods are used by researchers to keep people in trials. These encourage people to send back data by questionnaire, return to a clinic or hospital for trial-related tests, or be seen by a health or community care worker. Study characteristics This review identified methods that encouraged people to stay in trials. We searched scientific databases for randomised studies (where people are allocated to one of two or more possible treatments in a random manner) or quasi-randomised studies (where allocation is not really random, e.g. based on date of birth, order in which they attended clinic) that compared methods of increasing retention in trials. We included trials of participants from any age, gender, ethnic, cultural, language and geographic groups. Key results The methods that appeared to work were offering or giving a small amount of money for return of a completed questionnaire and enclosing a small amount of money with a questionnaire with the promise of a further small amount of money for return of a filled in questionnaire. The effect of other ways to keep people in trials is still not clear and more research is needed to see if these really do work. Such methods are shorter questionnaires, sending questionnaires by recorded delivery, using a trial design where people know which treatment they will receive, sending specially designed letters with a reply self addressed stamped envelope followed by a number of reminders, offering a donation to charity or entry into a prize draw, sending a reminder to the study site about participants to follow-up, sending questionnaires close to the time the patient was last followed-up, managing peoples' follow-up, conducting follow-up by telephone and changing the order of questionnaire questions. Quality of evidence The methods that we identified were tested in trials run in many different disease areas and settings and, in some cases, were tested in only one trial. Therefore, more studies are needed to help decide whether our findings could be used in other research fields.