title: Methodological review: quality of randomized controlled trials in health literacy.
abstract: The growing move towards patient-centred care has led to substantial research into improving the health literacy skills of patients and members of the public. Hence, there is a pressing need to assess the methodology used in contemporary randomized controlled trials (RCTs) of interventions directed at health literacy, in particular the quality (risk of bias), and the types of outcomes reported.
  
  
  
  We conducted a systematic database search for RCTs involving interventions directed at health literacy in adults, published from 2009 to 2014. The Cochrane Risk of Bias tool was used to assess quality of RCT implementation. We also checked the sample size calculation for primary outcomes. Reported evidence of efficacy (statistical significance) was extracted for intervention outcomes in any of three domains of effect: knowledge, behaviour, health status. Demographics of intervention participants were also extracted, including socioeconomic status.
  
  
  
  We found areas of methodological strength (good randomization and allocation concealment), but areas of weakness regarding blinding of participants, people delivering the intervention and outcomes assessors. Substantial attrition (losses by monitoring time point) was seen in a third of RCTs, potentially leading to insufficient power to obtain precise estimates of intervention effect on primary outcomes. Most RCTs showed that the health literacy interventions had some beneficial effect on knowledge outcomes, but this was typically for less than 3 months after intervention end. There were far fewer reports of significant improvements in substantive patient-oriented outcomes, such as beneficial effects on behavioural change or health (clinical) status. Most RCTs featured participants from vulnerable populations.
  
  
  
  Our evaluation shows that health literacy trial design, conduct and reporting could be considerably improved, particularly by reducing attrition and obtaining longer follow-up. More meaningful RCTs would also result if health literacy trials were designed with public and patient involvement to focus on clinically important patient-oriented outcomes, rather than just knowledge, behaviour or skills in isolation.
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
authors.forename: Julii
authors.initials: J
authors.lastname: Brainard
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
authors.forename: Stephanie Howard
authors.initials: SH
authors.lastname: Wilsher
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Salter
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK. y.loke@uea.ac.uk.
authors.forename: Yoon Kong
authors.initials: YK
authors.lastname: Loke
mesh_terms: D000328:Adult; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D057220:Health Literacy; D006304:Health Status; D006801:Humans; D008297:Male; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012959:Socioeconomic Factors
keywords: Health literacy; Public health; Quality of Evidence; Randomised controlled trial; Risk of Bias