Effect of social support on informed consent in older adults with Parkinson disease and their caregivers

Ford, Marvella E.; Kallen, Michael A.; Richardson, Pamela; Matthiesen, Ellen; Cox, Vincent CM; Teng, Ellen J.; Cook, Karon F.; Petersen, Nancy J.

doi:10.1136/jme.2006.018192

Cited by 16 publications

(17 citation statements)

References 13 publications

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“…Two of the five new miscellaneous interventions showed significant improvement in understanding [47,48]. While Flory and Emanuel presented one of three randomized trials with significant improvement (33%) [14], we observed improvement in two out of seven total trials (29%).…”

Section: Resultsmentioning

confidence: 65%

“…The seven interventions in the multimedia and enhanced form categories significantly improved knowledge retention rates [25,36,37,50]. Three interventions in the other categories had insignificant results for retention [24,46,48]. …”

Section: Resultsmentioning

confidence: 99%

“…Standardized, verified examinations have been developed specifically for the informed consent process, yet only several studies in our review made use of them. For example, the MacCAT-CR, BICEP and QuIC are all pre-established assessment tools that were used in several studies [19,31,48]. However, the majority of studies used custom-created assessment forms.…”

Section: Discussionmentioning

confidence: 99%

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Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

et al. 2013

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BackgroundObtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. PurposeTo systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods.MethodsThe search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique.ResultsMeta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats.ConclusionsEnhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.

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Section: Resultsmentioning

confidence: 65%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

et al. 2013

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“…38,62,66 Information provided to patients, physician’s communication with patients, role of medical staff, and patient companions are some of the factors that affect patient understanding. 21,22,35 Investigators in 5 studies suggested educational intervention or computer-based tutorials to improve patient understanding. 26,29,42,76,90 Other aids to decision making that could improve patient understanding are visual aids, 33,37,38,42,79 audiotapes, 33,37,38,42 photographs, diagrams, and vignettes.…”

Section: Resultsmentioning

confidence: 99%

Informed consent in dental care and research for the older adult population

Mukherjee¹,

Livinski²,

Millum³

et al. 2017

The Journal of the American Dental Association

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Background Ethics in health care and research is based on the fundamental principle of informed consent. However, informed consent in geriatric dentistry is not well documented. Poor health, cognitive decline, and the passive nature of many geriatric patients complicate this issue. Methods The authors completed this systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The authors searched the MEDLINE PubMed, Web of Science, PsycINFO, and Cochrane Library databases. The authors included studies if they involved participants 65 years or older and discussed topics related to informed consent beyond obtaining consent for health care. The authors explored informed consent issues in dentistry and other biomedical care and research. Results The authors included 80 full-text articles on the basis of the inclusion criteria. Of these studies, 33 were conducted in the United States, 30 addressed consent issues in patients with cognitive impairment, 29 were conducted in patients with medical issues, and only 3 involved consent related to dental care or research. Conclusions Informed consent is a neglected topic in geriatric dental care and research. Substantial knowledge gaps exist between the understanding and implementation of consent procedures. Additional research in this area could help address contemporary consent issues typically encountered by dental practitioners and to increase active participation from the geriatric population in dental care and research. Practical Implications This review is the first attempt, to the authors’ knowledge, to identify informed consent issues comprehensively in geriatric dentistry. There is limited information in the informed consent literature covering key concepts applicable to geriatric dentistry. Addressing these gaps could assist dental health care professionals in managing complex ethical issues associated with geriatric dental patients.

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“…Communication plays a significant role in enhancing comprehension of consent information among patients [20]. However, this study also showed most of the staff had not discussed with patients or their guardians patients' participation in clinical trials.…”

Section: Discussionmentioning

confidence: 96%

Ethics, patient rights and staff attitudes in Shanghai's psychiatric hospitals

Huang

Yang

et al. 2012

BMC Med Ethics

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BackgroundAdherence to ethical principles in clinical research and practice is becoming topical issue in China, where the prevalence of mental illness is rising, but treatment facilities remain underdeveloped. This paper reports on a study aiming to understand the ethical knowledge and attitudes of Chinese mental health professionals in relation to the process of diagnosis and treatment, informed consent, and privacy protection in clinical trials.MethodsA self-administered survey was completed by 1110 medical staff recruited from Shanghai’s 22 psychiatric hospitals. Simple random selection methods were used to identify target individuals from the computerized registry of staff.ResultsThe final sample for analysis consisted 1094 medical staff (including 523 doctors, 542 nurses, 8 pharmacologists and 21 other staff). The majority reported that their medical institutions had not established an Ethics Committee (87.8%) and agreed that Ethics Committees should be set up in their institutions (72.9%). Approximately half (52%) had not received systematic education in ethics, and almost all (89.1%) of the staff thought it was necessary. Nearly all participants (90.0%) knew the Shanghai Mental Health Regulations which was the first local regulations relating to mental health in China, but only 11% and 16.6% respectively knew of the Nuremberg Code and the Declaration of Helsinki. About half (51.8%) thought that the guardian should make the decision as to whether the patient participated in clinical trials or not.ConclusionsThe study indicates that most psychiatric hospitals in Shanghai have no Medical Ethics Committee. More than half the medical staff had not received systematic education and training in medical ethics and they have insufficient knowledge of the ethical issues related to clinical practice and trials. Training in ethics is recommended for medical staff during their training and as ongoing professional development.

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Effect of social support on informed consent in older adults with Parkinson disease and their caregivers

Abstract: Social support played a significant role in enhancing comprehension and recall of consent form information among patients.

Cited by 16 publications

References 13 publications

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

Informed consent in dental care and research for the older adult population

Ethics, patient rights and staff attitudes in Shanghai's psychiatric hospitals

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