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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: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.

Project description:BackgroundInformed consent in medical practice is essential and a global standard that should be sought at all the times doctors interact with patients. Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment. To our knowledge there has not been any systematic review of consent practices to document best practices and identify areas that need improvement in our setting. The objective of the study was to evaluate the informed consent practices of surgeons at University teaching Hospitals in a low resource setting.MethodsA cross-sectional study conducted at three university teaching hospitals in Uganda. Self-guided questionnaires were left at a central location in each of the surgical departments after verbally communicating to the surgeons of the intention of the study. Filled questionnaires were returned at the same location by the respondents for collection by the research team. In addition, 20 in-depth interviews were held with surgeons and a review of 384 patients' record files for informed consent documentation was done.ResultsA total of 132 (62.1%) out of 214 questionnaires were completed and returned. Respondents were intern doctors, residents and specialists from General surgery, Orthopedic surgery, Ear, Nose and Throat, Ophthalmology, Dentistry, Obstetrics and Gynaecology departments. The average working experience of respondents was 4.8 years (SD 4.454, range 0-39 years). 48.8% of the respondents said they obtained consent all the time surgery is done while 51.2% did not obtain consent all the time. Many of the respondents indicated that informed consent was not obtained by the surgeon who operated the patient but was obtained either at admission or by nurses in the surgical units. The consent forms used in the hospitals were found to be inadequate and many times signed at admission before diagnosing the patient's disease.ConclusionsInformed consent administration and documentation for surgical health care is still inadequate at University teaching hospitals in Uganda.

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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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