Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review

Department of Medicine, Miller School of Medicine at the University of Miami, 1120 NW 14th St, Suite 971 (H-201), Miami, FL, 33136, USA, .
Journal of General Internal Medicine (Impact Factor: 3.42). 07/2012; 28(1). DOI: 10.1007/s11606-012-2133-2
Source: PubMed

ABSTRACT BACKGROUND: Inadequate health literacy may impair research subjects' ability to participate adequately in the informed consent (IC) process. Our aim is to evaluate the evidence supporting interventions, to improve comprehension of the IC process in low literacy subjects. METHODS: We performed a MEDLINE database search (1966 to November 2011) supplemented by manual searches of bibliographies of key relevant articles. We selected all studies in which a modification of the IC was tested to improve comprehension in low literacy populations. Study design, quality criteria, population, interventions and outcomes for each trial were extracted. The main outcome evaluated was comprehension, measured using a written test or verbal comprehension. RESULTS: Our search strategy yielded 281 studies, of which only six met our eligibility criteria. The six studies included 1620 research participants. The studies predominantly included populations that were older (median age 61, range 48-64), ethnic minority, and with literacy level of 8th grade or below. Only one study had a randomized design. The specific intervention differed in each study. Two of the studies included the teach-back method or teach to goal method and achieved the highest level of comprehension. Two studies changed the readability level of the IC and resulted in the lowest comprehension among study subjects. CONCLUSIONS: The evidence supporting interventions to improve the informed consent process in low literacy populations is extremely limited. Among the interventions evaluated, having a study team member spend more time talking one-on-one to study participants was the most effective strategy for improving informed consent understanding; however, this finding is based on the results of a single study.

  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Objective To conduct a systematic review and meta-analysis to assess the level of participants’ understanding of all components of informed consent in clinical trials. Methods Relevant studies were identified by a search of PubMed, Scopus, Google Scholar, and manual approach with data up to October, 2013. The event rate was pooled using a random-effects model. Findings One hundred and three studies evaluating 135 populations were included. Correct understanding of the freedom to withdraw from the study at any time, nature of study, voluntary nature of participation, understanding of benefit, purpose, awareness of potential risks and side effects, confidentiality, alternative treatment if withdrawn from the study, recognizing the comparator (treatment or placebo), and no therapeutic misconception, was noted in 75.8% (95% CI: 70.6-80.3), 74.7% (68.8-79.8), 74.7% (67.9-80.5), 74.0% (65.0-81.3), 69.6% (63.5-75.1), 67.0% (57.4-75.4), 66.2% (55.3-75.7), 64.1% (53.7-73.4), 62.9% (45.5-77.5), and 62.4% (50.1-73.2), respectively. The figures for comprehension of randomization, comprehension of placebo, and naming at least one risk were 52.1% (41.3-62.7), 53.3% (38.4-67.6), and 54.9% (43.3-65.0), respectively. Subgroup and meta-regression analyses identified some co-variates significantly affecting the results and revealed no change in the understanding of all components over a 30 – year period. Conclusion: Mixed levels of correct understanding of components of informed consent were recorded in this meta-analysis. There is still much to be done to assist research participants achieve a comprehensive and complete understanding of informed consent, so that meaningful decision-making can be made and their best interest is protected.
    Bulletin of the World Health Organisation 12/2014; DOI:10.2471/BLT.14.141390 · 5.11 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Little research has examined the association of health literacy and numeracy with patients' preferred involvement in the problem-solving and decision-making process in the hospital. Using a sample of 1,249 patients hospitalized with cardiovascular disease from the Vanderbilt Inpatient Cohort Study (VICS), we assessed patients' preferred level of involvement using responses to two scenarios of differing symptom severity from the Problem-Solving Decision-Making Scale. Using multivariable modeling, we determined the relationship of health literacy, subjective numeracy, and other patient characteristics with preferences for involvement in decisions, and how this differed by scenario. The authors found that patients with higher levels of health literacy desired more participation in the problem-solving and decision-making process, as did patients with higher subjective numeracy skills, greater educational attainment, female gender, less perceived social support, or greater health care system distrust (p < .05 for each predictor in multivariable models). Patients also preferred to participate more in the decision-making process when the hypothetical symptom they were experiencing was less severe (i.e., they deferred more to their physician when the hypothetical symptom was more severe). These findings underscore the role that patient characteristics, especially health literacy and numeracy, play in decisional preferences among hospitalized patients.
    Journal of Health Communication 10/2014; 19 Suppl 2:29-43. DOI:10.1080/10810730.2014.938841 · 1.61 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.
    Clinical Trials 12/2014; DOI:10.1177/1740774514560831 · 1.94 Impact Factor