Article type
Year
Abstract
Background: shedding and missing data on retention for clinical trials have greatly undermined their value. The strategies used to improve the retention of participants in clinical trials vary from disease to disease, from country to country, and from trial to trial.
Objectives: we hoped to collect suggestions from published methodological papers to improve participant retention and the quality of the clinical trials.
Methods: we comprehensively searched databases of published studies from their inception to April 2019: PubMed, the Cochrane Library, Embase, Chinese National Knowledge Infrastructure Database (CNKI), VIP Chinese Science and Technique Journals Database, Wanfang Database, and SinoMed Database (see figure 1). We systematically evaluated methodological studies on participant retention published in the last six years. We screened all methodological studies about retention regardless of language, publication date or state.
Results: we included a total of 52 methodological studies (see table 1). We detected and outlined 19 different participant-dependent factors affecting participant retention and 15 methods of improving participant retention (see table 2). Our research also finds that there is no scientific, systematic and overall evaluation system for methodological research on retention; and the critical role of such quality-assessment indicators is ignored in clinical trials, such as the number of centres, the type of disease, the specific details of the trial treatment (the frequency of follow-ups, the frequency of blood draw, etc.).
Conclusions: our study divided the factors that influence retention and the method sof improving retention into recruitment, informed consent, and follow-up phases. At the same time we made recommendations. In particular, investigators need to pay attention to factors about whether the participant is fully informed, the disease, randomness, and drug. These may affect retention. We also suggested that in clinical trials, researchers should pay attention to methods such as motivational interviews to improve retention.
Patient or healthcare consumer involvement: our study is based on participants in clinical trials. Because we think only by improving participant compliance can retention be improved. So we hope to explore how to ensure benefit for participants in clinical trials to improve their compliance.
Objectives: we hoped to collect suggestions from published methodological papers to improve participant retention and the quality of the clinical trials.
Methods: we comprehensively searched databases of published studies from their inception to April 2019: PubMed, the Cochrane Library, Embase, Chinese National Knowledge Infrastructure Database (CNKI), VIP Chinese Science and Technique Journals Database, Wanfang Database, and SinoMed Database (see figure 1). We systematically evaluated methodological studies on participant retention published in the last six years. We screened all methodological studies about retention regardless of language, publication date or state.
Results: we included a total of 52 methodological studies (see table 1). We detected and outlined 19 different participant-dependent factors affecting participant retention and 15 methods of improving participant retention (see table 2). Our research also finds that there is no scientific, systematic and overall evaluation system for methodological research on retention; and the critical role of such quality-assessment indicators is ignored in clinical trials, such as the number of centres, the type of disease, the specific details of the trial treatment (the frequency of follow-ups, the frequency of blood draw, etc.).
Conclusions: our study divided the factors that influence retention and the method sof improving retention into recruitment, informed consent, and follow-up phases. At the same time we made recommendations. In particular, investigators need to pay attention to factors about whether the participant is fully informed, the disease, randomness, and drug. These may affect retention. We also suggested that in clinical trials, researchers should pay attention to methods such as motivational interviews to improve retention.
Patient or healthcare consumer involvement: our study is based on participants in clinical trials. Because we think only by improving participant compliance can retention be improved. So we hope to explore how to ensure benefit for participants in clinical trials to improve their compliance.