Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review
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.
SourceAvailable from: Kenneth A Wallston[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
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ABSTRACT: Hematopoietic cell transplantation (HCT) is a complex and highly specialized medical treatment that is associated with significant risks, including death. Furthermore, transplantation is offered to patients who often have no other curative treatment alternatives. The routine-consent process for HCT typically occurs before HCT and is influenced by many factors related to patients, physicians and the transplant per se. These factors can impede the consent process and subsequently result in a failure of proper engagement in and an understanding of the procedure with resultant adverse consequences influencing patients and even the patient-physician relationship. We contend that informed consent is a dynamic and ongoing process and that better patient education can assist in the decision making, fulfill the ethical principle of respect for autonomy and engage the patient to maximize compliance and adherence to therapy. This manuscript reviews the key literature pertaining to the decision-making and consent process in HCT and proposes guidelines for improving the consent process. Strategies for improving patient comprehension, engagement and enhancing consent forms are discussed.Bone Marrow Transplantation advance online publication, 22 September 2014; doi:10.1038/bmt.2014.207.Bone Marrow Transplantation 09/2014; 50(1). DOI:10.1038/bmt.2014.207 · 3.47 Impact Factor
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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.