An absence of equipoise: Examining surgeons' decision talk during encounters with women considering breast cancer surgery.
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SUBMITTER: Politi MC
PROVIDER: S-EPMC8675712 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionEquipoise, generally defined as uncertainty about the relative effects of the treatments being compared in a trial, is frequently referenced as an ethical standard for the conduct of randomized clinical trials. However, it seems to be defined in several different ways and may be used differently by different individuals. We explored how clinical researchers, chairs of research ethics boards, and philosophers of science define and reason with this term.MethodsWe completed semi-structured interviews about clinical trial ethics with 15 clinical researchers, 15 research ethics board chairs, and 15 philosophers of science/bioethicists. Each participant was asked a standardized set of 10 questions, 4 of which were specifically about equipoise. All interviews were conducted telephonically and transcribed. Responses were grouped and analysed via a modified grounded theory method.ResultsForty-three respondents defined equipoise in 7 logically distinct ways, and 2 respondents could not explicitly define it. The most common definition, offered by 14 respondents (31%), defined "equipoise" as a disagreement at the level of a community of physicians. There was significant variability in definitions offered between and within groups. When asked how they would "operationalize" equipoise - i.e. check or test for its presence - respondents provided 7 alternatives, the most common being in relation to a literature review (15/45, 33%). The vast majority of respondents (35/45, 78%) felt the concept was helpful, though many acknowledged that the lack of a clear definition or operationalization was problematic.ConclusionThere is significant variation in definitions of equipoise offered by respondents, suggesting that parties within groups and between groups may be referring to different concepts when they reference "equipoise". This non-uniformity may impact fairness and transparency and opens the door to potential ethical problems in the evaluation of clinical trials - for instance, a patient may understand equipoise very differently than the researchers enrolling her in a trial, which could cause her agreement to participate to be based upon false premises.
| S-EPMC10024829 | biostudies-literature
Project description:Introduction and hypothesisFollowing the design, face validation and publication of a novel PDA for women considering SUI surgery, the main objective of the study is to evaluate the usefulness of SUI-PDA© by using a validated tool to obtain patient feedback.MethodsFrom July 2018 to March 2019, the PDA, already incorporated into the patient care pathway, was objectively evaluated using the Decisional Conflict Scale (DCS) to determine patients' views. Patients recorded their values and reasons for requests and declines of treatment. The total DCS score, scores from each DCS subgroup and individual patient responses were calculated and analysed.ResultsThe mean age of the first 20 patients to complete the DCS was 54 years, the mean BMI was 30.1 and the median parity was 3. The average total DCS score was only 9.29 out of 100 (range 0-29.69) suggesting that the PDA was quite useful for patients considering SUI surgery. Overall, the PDA had largely favourable responses across all five DCS subgroups. The 'informed' subgroup had the best score (6.67) while the 'uncertainty' subgroup had the least favourable score (14.58). Despite the procedure pause, the mesh tape option remained on the PDA; however, no patient had chosen this option, with a large proportion citing 'safety' issues as the main reason. Bulking agent injections were the most popular choice (40.0%) and the most commonly performed procedures (50.0%) mainly because of quicker 'recovery'. The second most popular participant choice was colposuspension (35.0%) followed by autologous fascial sling (25.0%), with women citing 'efficacy' as the main reason behind their choice.ConclusionSUI-PDA© was reported by patients and clinicians to be useful with clinical decision-making for SUI surgery. Further validation in a larger patient group is underway.
| S-EPMC6861540 | biostudies-literature
Project description:BackgroundVarious kinds of breast reconstruction (BR) options, including implants and autologous, and surgery techniques, including traditional and endoscope assisted, can be used to perform surgery. All options have their own advantages and disadvantages. Women decide on an option depending on the values and preferences they emphasize. Lacking knowledge about BR or having decision difficulties during the treatment decision process makes women experience more decision regret, psychological distress, and poor body image. Delivering decision support with a values clarification exercise using eHealth approaches would be beneficial for patient outcomes.ObjectiveThis study aims to examine the effects of a decision support app on decision-making quality and psychological morbidity for women considering BR surgery.MethodsThis randomized controlled trial included women who were over 20 years of age and were newly diagnosed with breast cancer and candidates for mastectomy. Women having an option for breast conservation were excluded. After being referred from the outpatient physician, the women provided consent and completed the baseline assessment. Women allocated to the control group (CG) received usual care and were provided with a pamphlet with information about types of surgery and the advantages and disadvantages of different surgery types. Women allocated to the intervention group (IG) were given the same pamphlet and guided to use the Pink Journey app to support their decision. Then they were also prompted to discuss the opinions with their significant others. Finally, the decision-making process of using the app was printed out for women that they could take home. Decision conflict, anxiety, and depression were measured at baseline. At 1 week after the intervention (T1) and at 1 month (T2), 8 months (T3), and 12 months (T4) after surgery, the women completed decision conflict, decision regret, anxiety, depression, and body image scales. An intention-to-treat analysis was performed.ResultsFrom February 2018 to July 2019, 96 women were randomly assigned to the CG (n=48) or the IG (n=48). Results revealed that body image distress declined significantly for the IG but increased for the CG. The interaction of time and group also reached significance, indicating a significant decrease in body image distress from baseline in the IG compared with the CG after the 12th month (T4) follow-up (β=-2.25, standard error=1.01, P=.027). However, there was no significant difference in decision conflict (P=.21-.87), decision regret (P=.44-.55), anxiety (P=.26-.33), and depression (P=.20-.75), indicating that the decrease in these outcomes in the IG was not greater than those in the CG.ConclusionsAlthough we found no effect on decision conflict, decision regret, anxiety, and depression, a decision aid that combines surgery information and values clarification can help women reduce their body image distress.Trial registrationClinicalTrials.gov NCT04190992; https://clinicaltrials.gov/ct2/show/NCT04190992.
| S-EPMC8709911 | biostudies-literature
Project description:BackgroundLittle data exists regarding decision-making preferences for parents and surgeons in pediatric surgery. Here we investigate whether parents and surgeons have similar decision-making preferences as well as which factors influence those preferences. Specifically, we compare parents' and surgeons' assessments of the urgency and complexity of pediatric surgical scenarios and the impact of their assessments on decision-making preferences.MethodsA survey was emailed to parents of patients evaluated in a university-based pediatric surgery clinic and surgeons belonging to the American Pediatric Surgical Association. The survey asked respondents to rate 6 clinical vignettes for urgency, complexity, and desired level of surgeon guidance using the Controlled Preferences Scale (CPS).ResultsRegarding urgency, parents were more likely than surgeons to rate scenarios as emergent when cancer was involved (parents: 68.8% cancer vs. 29.5% non-cancer, p < .001; surgeons: 19.2% cancer vs. 25.4% non-cancer, p = .051). Parents and surgeons were more likely to rate a scenario as emergent when a baby was involved (parents: 45.2% baby vs. 36.2% child, p = .001; surgeons: 28.0% baby vs. 14.0% child, p < .001). Regarding decision-making preferences, parents and surgeons had similar CPS scores (2.56 vs. 2.72, respectively). Multivariable analysis showed parents preferred more surgeon guidance when scenarios involved a baby (OR 1.22; 95% CI 1.08-1.37; p < 0.01) or a cancer diagnosis (OR 1.29; 95% CI 1.11-1.49; p < 0.01), and that both parents and surgeons preferred more surgeon guidance when a scenario was considered emergent (parents: OR 1.81; 95% CI 1.37-2.38, p < 0.001; surgeons: OR 2.48 95% CI 1.76-3.49, p < 0.001).ConclusionsWhen a pediatric patient is a baby or has cancer, parents are more likely then surgeons to perceive the clinical situation to be emergent, and both parents and surgeons prefer more surgeon guidance in decision-making when a clinical scenario is considered emergent. More research is needed to understand how parents' decision-making preferences depend on clinical context.
| S-EPMC7863410 | biostudies-literature
Project description:Trials of decision aids developed for use in shared decision making find that patients engaged in that process tend to choose more conservative treatment for preference-sensitive conditions. Shared decision making is a collaborative process in which clinicians and patients discuss trade-offs and benefits of specific treatment options in light of patients' values and preferences. Decision aids are paper, video, or web-based tools intended to help patients match personal preferences with available treatment options. We analyzed data for 2012-15 about patients within the ten High Value Healthcare Collaborative member systems who were exposed to condition-specific decision aids in the context of consultations for hip and knee osteoarthritis, with the intention that the aids be used to support shared decision making. Compared to matched patients not exposed to the decision aids, those exposed had two-and-a-half times the odds of undergoing hip replacement surgery and nearly twice the odds of undergoing knee replacement surgery within six months of the consultation. These findings suggest that health care systems adopting decision aids developed for use in shared decision making, and used in conjunction with hip and knee osteoarthritis consultations, should not expect reduced surgical utilization.
| S-EPMC7082857 | biostudies-literature
Project description:BackgroundIn parallel to women entering general surgery training, acute care surgery (ACS) has been developing as a team-based approach to emergency general surgery (EGS). We sought to examine predictors of women surgeons in EGS generally, and ACS particularly.MethodsFrom our national survey, we determined the proportion of women surgeons within EGS hospitals. We compared the proportion of women surgeons based on hospitals characteristics using chi-squared tests, then used regression models to measure odds of ACS relative to the proportion of women.Results779 (50.4%) hospitals had zero women surgeons. These hospitals were more likely non-ACS and non-teaching with <200 beds. ACS had a higher median proportion of women surgeons (17%) compared to non-ACS (0%).ConclusionOur study highlights the dearth of women representation within EGS hospitals nationally and illuminates some of the underlying characteristics of ACS that may draw women: urban, academic, and staffed by more recently trained surgeons.SummaryUsing a national survey of Emergency General Surgery (EGS) hospitals, we sought to examine predictors of women surgeons in EGS generally, and acute care surgery (ACS) particularly. We found that 779 (50.4%) hospitals had zero women surgeons. Women were more likely to be among EGS surgeons at hospitals with ACS models. Our study highlights the dearth of women representation within EGS hospitals nationally and illuminates some of the underlying characteristics of ACS that may draw women: urban, academic, and staffed by a higher proportion of newly trained surgeons.
| S-EPMC8278361 | biostudies-literature
Project description:To evaluate feasibility and potential effectiveness of a patient decision aid (PtDA) for patients and a preference report for surgeons to reduce wait times and improve decision quality in patients with osteoarthritis considering total knee replacement.A prospective two-arm pilot randomized controlled trial. Patients with osteoarthritis were eligible if they understood English and were referred for surgical consultation about an initial total knee arthroplasty at a Canadian orthopaedic joint assessment clinic. Patients were randomized to the PtDA intervention or usual education. The intervention was an osteoarthritis PtDA for patients and a one-page preference report summarizing patients' clinical and decisional data for their surgeon. The main feasibility outcomes were rates of recruitment and questionnaire completion; the preliminary effectiveness outcomes were wait times and decision quality.Of 180 patients eligible for surgical consultation, 142 (79%) were recruited and randomized to the PtDA intervention (n = 71) or usual education (n = 71). Data collection yielded a 93% questionnaire completion rate with less than 1% missing items. After one year, 13% of patients remained on the surgical wait list. The median time from referral to being off the wait list (censored using survival analysis techniques) was 33.4 weeks for the PtDA group (n = 69, 95% CI: 26.0, 41.4) and 33.0 weeks for usual education (n = 71, 95% CI: 26.1, 39.9). Patients exposed to the PtDA had higher decision quality based on knowledge (71% versus 47%; p < 0.0001) and quality decision being an informed choice that is consistent with their values for option outcomes (56.4% versus 25.0%; p < 0.001).Recruitment of patients with osteoarthritis considering surgery and data collection were feasible. As some patients remained on the surgical waiting list after one year, follow-up should be extended to two years. Patients exposed to the PtDA achieved higher decision quality compared to those receiving usual education but there was no difference in wait for surgery.ClinicalTrials.Gov NCT00743951.
| S-EPMC3937455 | biostudies-literature
Project description:ObjectivesExplore the function of three specific modes of talk (discourse types) in decision-making processes.DesignTen real-life admissions of patients with critical illness were audio/video recorded and transcribed. Activity-type analysis (a qualitative discourse analytical method) was applied.SettingInterdisciplinary emergency teams admitting patients with critical illness in a Norwegian university hospital emergency department (ED).ParticipantsAll emergency teams consisted of at least two internal medicine physicians, two ED nurses, one anaesthetist and one nurse anaesthetist. The number of healthcare professionals involved in each emergency team varied between 11 and 20, and some individuals were involved with more than one team.ResultsThe three discourse types played significant roles in team decision-making processes when negotiating meaning. Online commentaries (ONC) and metacommentaries (MC) created progression while offline commentaries (OFC) temporarily placed decisions on hold. Both ONC and MC triggered action and distributed tasks, resources and responsibility in the team. OFC sought mutual understanding and created a broader base for decisions.ConclusionA discourse analytical perspective on team talk in medical emergencies illuminates both the dynamics and complexity of teamwork. Here, we draw attention to the way specific modes of talk function in negotiating mutual understanding and distributing tasks and responsibilities in non-algorithm-driven activities. The analysis uncovers a need for an enhanced focus on how language can trigger safe team practice and integrate this knowledge in teamwork training to improve communication skills in ad hoc emergency teams.
| S-EPMC6231597 | biostudies-literature
Project description:BackgroundClinical guidelines recommend a personalized approach to mammography screening for women in their forties; however, methods to do so are lacking. An evidence-based mammography screening decision aid was developed as an electronic mobile application and evaluated in a before-after study.MethodsThe decision aid (Mammopad) included modules on breast cancer, mammography, risk assessment, and priority setting about screening. Women aged 40-49 years who were patients of rural primary care clinics, had no major risk factors for breast cancer, and no mammography during the previous year were invited to use the decision aid. Twenty women participated in pretesting of the decision aid and 75 additional women completed the before-after study. The primary outcome was decisional conflict measured before and after using Mammopad. Secondary outcomes included decision self-efficacy and intention to begin or continue mammography screening. Differences comparing measures before versus after use were determined using Wilcoxon signed rank tests.ResultsAfter using Mammopad, women reported reduced decisional conflict based on mean Decisional Conflict Scale scores overall (46.33 versus 8.33; Z = -7.225; p < 0.001) and on all subscales (p < 0.001). Women also reported increased mean Decision Self-Efficacy Scale scores (79.67 versus 95.73; Z = 6.816, p < 0.001). Although 19% of women changed their screening intentions, this was not statistically significant.ConclusionsWomen reported less conflict about their decisions for mammography screening, and felt more confident to make decisions after using Mammopad. This approach may help guide women through the decision making process to determine personalized screening choices that are appropriate for them.
| S-EPMC4683542 | biostudies-literature
Project description:INTRODUCTION:In shared decision-making (SDM), physicians encourage the patient to participate in the care process. The theory of planned behaviour describes that behaviour is dependent on intention. In its turn, intention is explained by attitude, subjective norm and perceived behavioural control. In orthopaedics, little is known about current SDM behaviour and how to promote it.The aim of the present study was to gain insight into the SDM behaviour of orthopaedic residents and supervisors by measuring levels of intention, attitudes, subjective norms and perceived behavioural control. Furthermore, we aimed to determine the predictors of intention for SDM. METHODS:A questionnaire survey study was conducted among orthopaedic surgeons and residents working in the care of hip and knee osteoarthritis, to determine their intentions, attitudes, subjective norms and perceived behavioural control regarding SDM. RESULTS:Of the 385 physicians approached, 71 residents and 64 orthopaedic surgeons participated. Residents and the supervisors alike had positive intentions regarding SDM. Intention for SDM behaviour was explained by attitude, subjective norm and perceived behavioural control, with perceived behavioural control having the strongest association. In residents, the intention to engage in SDM was more hampered by a lower level of perceived behavioural control than in surgeons. CONCLUSIONS:Physicians are willing to perform SDM and consider SDM as favourable in the orthopaedic clinic. The implementation of SDM is mainly hampered by experienced barriers that they cannot control. These findings underline the importance of incorporating SDM in the curriculum of postgraduates. Possibilities for efficient SDM implementation should be explored, to overcome perceived barriers.
| S-EPMC6850155 | biostudies-literature