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Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.

ABSTRACT: OBJECTIVE:To develop a patient-centered informed consent and assessment tool written at a 6th grade-level that is multimodal, affordable, transportable, and readily modifiable for protocol updates. METHODS:This quality improvement initiative was performed in two phases on an actively-recruiting study at a pediatric diabetes clinic. In phase I, 38 volunteers underwent the standard-paper consent process, a comprehension assessment and provided feedback. Using feedback and the structure of the Plan-Do-Study-Act cycle a multimodal consent and assessment were developed. In phase II, volunteers were randomized to the standard (n?=?25) or the multimodal consent (n?=?25) and all completed the same comprehension assessment via touch-screen tablet. Primary outcomes were comparison of the individual and total comprehension assessment scores. RESULTS:Total comprehension scores were higher in the multimodal versus the standard consent group (p?

SUBMITTER: Lindsley KA

PROVIDER: S-EPMC7429926 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.

Lindsley Karen A KA

Patient education and counseling 20181221 5

<h4>Objective</h4>To develop a patient-centered informed consent and assessment tool written at a 6th grade-level that is multimodal, affordable, transportable, and readily modifiable for protocol updates.<h4>Methods</h4>This quality improvement initiative was performed in two phases on an actively-recruiting study at a pediatric diabetes clinic. In phase I, 38 volunteers underwent the standard-paper consent process, a comprehension assessment and provided feedback. Using feedback and the struct ...[more]

PMID: 30635222

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Project description:BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged "appropriate"; 19 were judged "uncertain"; and none was judged "inappropriate". After the second round, 9 "uncertains" changed to "appropriate". All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = "extremely inappropriate", 5 = "uncertain", 9 = "extremely appropriate"). The sections "General recommendations" and "Gender perspective during the consent process for clinical studies" showed the highest "uncertainty" rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators' communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant's possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged "appropriate" by all stakeholders involved in the informed consent process.

Project description:BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa. Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial. The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent. Cross-sectional study conducted over a 4 month period.MethodsConsent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured.ResultsThe majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%-77% and for understanding 75% (IQR = 50%-87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 - 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35-5.07) to obtain such scores for recall than those who were not.ConclusionNotwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent.

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Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.

Publications

Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.

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