Dataset Information

Informed consent, shared-decision making and a reasonable patient's wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario.

ABSTRACT:

Objective

In approximately half the states in the USA, and more recently in the UK, informed consent is legally defined as what a reasonable patient would wish to know. Our objective was to discern the information needs of a hospitalised, 'reasonable patient' during the informed-consent process.

Design

We performed a cross-sectional study to develop a survey instrument and better define 'reasonable person' in relation to informed consent in a hypothetical scenario where an invasive procedure may be an option.

Setting

A 10-question survey was administered from April 19 through 22 October 2018 to three groups: student nurses (n=76), health professions educators (n=63) and a US national population (n=1067).

Primary and secondary outcome measures

The primary outcome measure was the average intensity, on a 5-point scale, by which survey groups wished to have each of 10 questions answered. The secondary outcome was to discern relationships between survey demographics and the intensity by which participants wanted an answer.

Results

Despite substantial demographic differences in the nursing-student group and health-professions-educator group, the average intensity scores were within 0.2 units on nine of 10 questions. The national survey revealed a strong desire to have an answer to each question (range 3.98-4.60 units). It showed that women desired answers more than men and older adults desired answers more than younger adults.

Conclusions

Based on responses to 10 survey questions regarding wishes of people in a situation where an invasive procedure may be necessary, the vast majority want an answer to each question. They wanted to know about all treatment options, risky drugs, decision aids, who will perform the procedure, and the cost. They wanted their advocate present, periodic review of their medical record, a full day to review documents and expected outcomes and restrictions after the procedure.

SUBMITTER: James JT

PROVIDER: S-EPMC6678025 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Informed consent, shared-decision making and a reasonable patient's wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario.

James John T JT Eakins Darwin Jay DJ Scully Robert R RR

BMJ open 20190730 7

<h4>Objective</h4>In approximately half the states in the USA, and more recently in the UK, informed consent is legally defined as what a reasonable patient would wish to know. Our objective was to discern the information needs of a hospitalised, 'reasonable patient' during the informed-consent process.<h4>Design</h4>We performed a cross-sectional study to develop a survey instrument and better define 'reasonable person' in relation to informed consent in a hypothetical scenario where an invasiv ...[more]

PMID: 31366653

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Project description:BackgroundThe current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures.MethodsWe surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues.ResultsRespondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure's name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009).Conclusions1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a "reasonable" patient's standard is to be met.

Project description:BackgroundInformed consent is one of the safeguarding of the patient in medical practice at different standards such as ethical, legal, and administrative purposes. Patient knowledge and perception of informed consent are one of the priority concerns in surgical procedures. Patient knowledge and perception towards informed consent increased patient satisfaction, feeling high power on their determination, and accountability for the management, and facilitated positive treatment outcomes. Despite this, in Ethiopia, there are small-scale primary studies with inconsistent and inconclusive findings. Therefore, this systematic review and meta-analysis study estimated the pooled prevalence of patient knowledge and perception of informed consent and its determinants in Ethiopia.MethodsWe searched major databases such as PubMed, Hinary, MEDLINE, Cochrane Library, EMBASE, Scopus, African Journal Online (AJO), Semantic Scholar, Google Scholar, google, and reference lists. Besides this, University databases in the country were also searched from August 20, 2023, until September 30, 2023,. All published and unpublished studies that report the prevalence of patient knowledge and perception toward informed consent and its associated factors were included. All studies reported in English were included. Studies conducted between January 01, 2015 to September 30, 2023 were included. There are three outcome measurements pooled level of patient knowledge towards informed consent, pooled level of patient perception towards informed consent, and pooled effect that affects patient knowledge of informed consent. Three reviewers (MMM, NK, and YT) independently screened the articles that fulfilled the inclusion criteria to avoid the risk of bias. The studies' quality was appraised using a modified Newcastle-Ottawa Scale (NOS) version.ResultsThe pooled prevalence of appropriate patient knowledge and perception towards informed consent was 32% (95% CI: 21, 43) and 40% (95% CI: 16, 65) respectively. Having formal education 2.69 (95% CI: 1.18, 6.15) and having a history of signed informed consent before 3.65 (95% CI:1.02,13.11) had a statistically significant association with good patient knowledge towards informed consent.ConclusionThe appropriate patient knowledge and perception of informed consent in Ethiopia is low. Formal education and history of signed informed consent were positive factors for appropriate patient knowledge of informed consent in Ethiopia. Physicians, policymakers, and health facility managers should focus on patients without prior experience with signed informed consent and not have formal education to improve patient knowledge towards informed consent. The protocol was registered at Prospero with number CRD42023445409 and is available from: https://www.crd.york.ac.uk/PROSPERO/#myprospero .

Project description:BackgroundInformed consent is the first step of every medical procedure and is considered a standard of care for patients undergoing medical interventions. Our study seeks to evaluate patients' understanding of the procedure they consented to and the factors affecting the degree of understanding.MethodsIn this cross-sectional study, we used an anonymous postprocedural questionnaire to assess our patients' understanding of the procedure being performed and their level of satisfaction. It was conducted between June 2021 and January 2022 on every consenting patient who declined English interpreter services and was undergoing a first elective lumbar epidural steroid injection.ResultsThe mean age of 201 subjects was 57.3 (23-90) years, with a race distribution of Black (44.3%), White (31.8%), and other races (23.9%). 15.9% of our subjects worked in the medical field. Older age and patients identified as Black and other races had a positive correlation with the propensity to predict a poor understanding of consent. This study failed to demonstrate any difference in understanding of informed consent content between the different subgroups when stratified by assigned sex at birth, level of education, and profession. Patients' expectation from the treatment was classified as desperate (will take any help they can) in 78 patients (38.8%), feeling hopeful (expecting partial improvement in their symptoms) in 52 patients (25.9%), and being optimistic (will obtain full recovery from this injection) in 71 patients (35.3%). 192 patients (95.5%) were very satisfied with the consent process. Seven patients (3.5%) stated that they wanted more information, and 2 patients (1.0%) did not understand the explanation. 180 patients (89.6%) were satisfied with the overall experience, while 21 patients (10.4%) were not. The Wilks test (likelihood-ratio test) resulted in a p value of 0.023 and was deemed statistically significant for a relationship between understanding of consent and the satisfaction of the patient from the procedure.ConclusionsAlthough patients carry a variable expectation of procedures, most patients in our pain clinic have a high level of satisfaction despite having a poor understanding of the procedure provided via informed consent. Although our patients' level of objective comprehension is low, those with a better understanding of the procedure tend to have a more satisfactory experience.

Project description:The aims of this study were to investigate the role of the veterinarian characteristics (e.g., age, gender, self-estimation, use of the internet), and their attitudes concerning animal owners seeking self-information. A particular focus was laid on any association between shared decision making (SDM), age and gender. In an online survey, 527 German veterinarians were asked about their attitude regarding SDM principles and their experiences with self-informed animal owners. The factors associated with veterinarians' perception of SDM were investigated in a multivariable linear regression model. A recently published structural equation model consolidated the application of SDM, empathic behavior, and veterinarians' evaluation of self-education as latent factors. Interconnected questionnaire items were processed using an exploratory factor analysis to 11 interpretable factors. Veterinarians who assumed therapy failure was associated with themselves had significantly higher rates of SDM (p = 0.002). In contrast, SDM was significantly lower (p = 0.002) if they assumed that therapy failure was due to the animal's owners. SDM was negatively associated with the perceived quality of the pet owners' self-information (p < 0.001) and if skepticism was perceived as the reason for seeking the self-information (p = 0.001). Veterinarians who advised against self-information (p = 0.006) and those who assumed that self-information of animal owners goes along with uncertainty (p = 0.001) had low SDM values (p = 0.006). Asking the animal owner for self-information (p = 0.001), and recommendations of good information sources (p = 0.022) were positively associated with SDM. Looking at the influence of age and gender on the application of SDM, older people and males rated higher. However, the evaluation of the latent factor SDM was based on the self-estimation of the participants. Assuming that younger women were less self-confident, we cannot exclude that young female participants self-evaluated their SDM skills lower than older male participants, although both groups would objectively have the same SDM level. Practitioners who have a positive attitude toward animal owners, who enjoy contact with animal owners and welcome their interest in further (self-)information, show empathic behavior, and have a positive attitude toward SDM are more likely to have better veterinarian-animal owner-relationships.

Dataset Information

Informed consent, shared-decision making and a reasonable patient's wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario.

Objective

Design

Setting

Primary and secondary outcome measures

Results

Conclusions

Publications

Informed consent, shared-decision making and a reasonable patient's wishes based on a cross-sectional, national survey in the USA using a hypothetical scenario.

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