Recruitment and adherence of randomized controlled trials for mild cognitive impairment: A systematic review and

Zijun Xu1, Wen Sun1, Dexing Zhang1

  • 1Division of Family Medicine and Primary Health Care, JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China.

Abstract

Insights

Recruitment and adherence in randomized controlled trials (RCTs) for mild cognitive impairment (MCI) patients are critical. This meta-analysis reveals pooled recruitment and adherence rates, offering insights for future trial strategies.

Area of Science:

  • Clinical Trials
  • Neuroscience
  • Gerontology

Background:

  • Recruitment and adherence are crucial for the validity of randomized controlled trials (RCTs) in populations with mild cognitive impairment (MCI).
  • Limited data exists on the status of recruitment and adherence in MCI-focused RCTs.
  • Understanding these factors is essential for designing effective future trials.

Purpose of the Study:

  • To explore the recruitment and adherence status of RCTs involving patients with MCI.
  • To identify factors associated with recruitment and adherence challenges in MCI RCTs.

Main Methods:

  • A systematic literature search was conducted across multiple databases (MEDLINE, EMBASE, Cochrane Library, CINAHL, PsycINFO, PsycARTICLES) up to July 2019.
  • Included studies were RCTs with available data on invitation, eligibility, randomization, recruitment, adherence, and barriers.
  • Pooled proportions and confidence intervals were calculated using random-effects meta-analysis, with meta-regression and subgroup analyses performed.

Main Results:

  • 110 articles met inclusion criteria from over 10,000 initial records.
  • Pooled rates included: eligibility 55%, randomization 86%, recruitment 44%, intervention adherence 88%, and follow-up adherence 85%.
  • Common reasons for screen failure included non-MCI status (47.5%) and medical problems (13.8%). Frequent reasons for drop-out were refusal without reason (36.6%) and adverse events (30.9%).

Conclusions:

  • This meta-analysis provides essential data on recruitment and adherence rates in MCI RCTs.
  • Findings highlight the need for targeted strategies to enhance participant recruitment and adherence in this population.
  • Future research should focus on developing and testing interventions to improve trial participation and completion among individuals with MCI.

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