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'Hobson's choice': a qualitative study of consent in acute surgery.

ABSTRACT: OBJECTIVES:The study aimed to understand through qualitative research what patients considered material in their decision to consent to an acute surgical intervention. PARTICIPANTS, SETTING AND INTERVENTION:The patients selected aged between 18 and 90, having been admitted to a major trauma centre to undergo an acute surgical intervention within 14 days of injury, where English was their first language. Data saturation point was reached after 21 patients had been recruited. Data collection and analysis were conducted simultaneously, through interviews undertaken immediately prior to surgery. The data were coded using NVIVO V.12 software. RESULTS:The key theme that originated from the data analysis was patients were unable to identify any individual risk that would modify their decision-making process around giving consent. The patient's previous experience and the experience of others around them were a further theme. Patients sensed that there were no non-operative options for their injuries. CONCLUSION:This is the first study investigating what patient considered a material risk in the consent process. Patients in this study did attribute significance to past experiences of friends and family as material, prompting us to suggest that the surgeon asks about these experiences as part of the consent process. Concern about functional recovery was important to patients but insufficient to stop them from consenting to surgery, thus could not be classified as material risk.

SUBMITTER: Howard A

PROVIDER: S-EPMC7545640 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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'Hobson's choice': a qualitative study of consent in acute surgery.

Howard Anthony A Webster Jonathan J Quinton Naomi N Giannoudis Peter V PV

BMJ open 20201008 10

<h4>Objectives</h4>The study aimed to understand through qualitative research what patients considered material in their decision to consent to an acute surgical intervention.<h4>Participants, setting and intervention</h4>The patients selected aged between 18 and 90, having been admitted to a major trauma centre to undergo an acute surgical intervention within 14 days of injury, where English was their first language. Data saturation point was reached after 21 patients had been recruited. Data c ...[more]

PMID: 33033090

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Project description:BackgroundInformed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set (COS) to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the informed consent process.MethodsThis qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies.ResultsSearches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making.ConclusionsThis qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery.RegistrationThe study protocol was registered on the international prospective register for systematic reviews (PROSPERO ID: CRD42017077101).

Project description:BackgroundThere is no consensus on which risks to communicate to a prospective surgical patient during informed consent or how. Complicating the process, patient preferences may diverge from clinical assumptions and are often not considered for discussion. Such discrepancies can lead to confusion and resentment, raising the potential for legal action. To overcome these issues, we propose a visual consent tool that incorporates patient preferences and communicates personalized risks to patients using data visualization. We used this platform to identify key effective visual elements to communicate personalized surgical risks.ObjectiveOur main focus is to understand how to best communicate personalized risks using data visualization. To contextualize patient responses to the main question, we examine how patients perceive risks before surgery (research question 1), how suitably the visual consent tool is able to present personalized surgical risks (research question 2), how well our visualizations convey those personalized surgical risks (research question 3), and how the visual consent tool could improve the informed consent process and how it can be used (research question 4).MethodsWe designed a visual consent tool to meet the objectives of our study. To calculate and list personalized surgical risks, we used the American College of Surgeons risk calculator. We created multiple visualization mock-ups using visual elements previously determined to be well-received for risk communication. Semistructured interviews were conducted with patients after surgery, and each of the mock-ups was presented and evaluated independently and in the context of our visual consent tool design. The interviews were transcribed, and thematic analysis was performed to identify major themes. We also applied a quantitative approach to the analysis to assess the prevalence of different perceptions of the visualizations presented in our tool.ResultsIn total, 20 patients were interviewed, with a median age of 59 (range 29-87) years. Thematic analysis revealed factors that influenced the perception of risk (the surgical procedure, the cognitive capacity of the patient, and the timing of consent; research question 1); factors that influenced the perceived value of risk visualizations (preference for rare event communication, preference for risk visualization, and usefulness of comparison with the average; research question 3); and perceived usefulness and use cases of the visual consent tool (research questions 2 and 4). Most importantly, we found that patients preferred the visual consent tool to current text-based documents and had no unified preferences for risk visualization. Furthermore, our findings suggest that patient concerns were not often represented in existing risk calculators.ConclusionsWe identified key elements that influence effective visual risk communication in the perioperative setting and pointed out the limitations of the existing calculators in addressing patient concerns. Patient preference is highly variable and should influence choices regarding risk presentation and visualization.

Project description:BACKGROUND: Care home residents, especially those lacking capacity to provide consent for themselves, are frequently excluded from research, thus limiting generalisability of study findings. We set out to explore stakeholders' views about the ethical and practical challenges associated with recruiting care home residents into research studies. METHODS: Qualitative individual interviews with care home residents (n = 14), their relatives (n = 14), and general practitioners (GPs) (n = 10), and focus groups (n = 2) with care home staff. Interviews focused on the issues of older adults consenting to research in care homes, including advanced consent, in general and through reference to a particular study on the use of probiotics to prevent Antibiotic Associated Diarrhoea. Data were analysed using a thematic approach incorporating themes that had been identified in advance, and themes derived from the data. Researchers discussed evidence for themes, and reached consensus on the final themes. RESULTS: Respondents were generally accepting of low risk observational studies and slightly less accepting of low risk randomised trials of medicinal products. Although respondents identified some practical barriers to informed consent, consenting arrangements were considered workable. Residents and relatives varied in the amount of detail they wanted included in information sheets and consent discussions, but were generally satisfied that an advanced consent model was acceptable and appropriate. Opinions differed about what should happen should residents lose capacity during a research study. CONCLUSIONS: Research staff should be mindful of research guidance and ensure that they have obtained an appropriate level of informed consent without overwhelming the participant with unnecessary detail. For research involving medicinal products, research staff should also be more explicit when recruiting that consent is still valid should an older person lose capacity during a trial provided the individual did not previously state a wish to be withdrawn if they lose capacity, and provided they do not indicate objection or resistance after loss of capacity.

Project description:OBJECTIVE:To identify the different perceptions on informed surgical consent in a group of Sri Lankan patients. METHODS:A qualitative study was conducted in a single surgical unit at a tertiary care hospital from January to May 2018. The protocol conformed to the Declaration of Helsinki. Patients undergoing elective major surgeries were recruited using initial purposive and later theoretical sampling. In-depth interviews were conducted in their native language based on the grounded theory. Initial codes were generated after analysing the transcripts. Constant comparative method was employed during intermediate and advanced coding. Data collection and analyses were conducted simultaneously, until the saturation of the themes. Finally, advanced coding was used for theoretical integrations. RESULTS:Thirty patients (male:female=12:18) were assessed. The mean age was 41±9 years. Sinhalese predominated (50.0%, n=15). Majority underwent thyroidectomy (36.7%, n=11). The generated theory categorises the process of obtaining informed consent in four phases: initial interaction phase, reasoning phase, convincing phase and decision-making phase. Giving consent for surgery was a dependent role between patient, family members and the surgeon, as opposed to an individual decision by the patient. Some patients abstained from asking questions from doctors since doctors were 'busy', 'short-tempered' or 'stressed out'. Some found nurses to be more approachable than doctors. Patients admitted that having a bystander while obtaining consent would relieve their stress. They needed doctors to emphasise more on postoperative lifestyle changes and preprocedure counselling at the clinic level. To educate patients about their procedure, some suggested leaflets or booklets to be distributed at the clinic before ward admission. The majority disliked watching educational videos because they were 'scared' to look at surgical dissections and blood. CONCLUSION:The informed consent process should include key elements that are non-culture specific along with elements or practices that consider the cultural norms of the society.

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'Hobson's choice': a qualitative study of consent in acute surgery.

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'Hobson's choice': a qualitative study of consent in acute surgery.

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