Predictors of the Level of Shared Decision Making in Vascular Surgery: A Cross Sectional Study.

OBJECTIVE: Although patients with vascular diseases often face multiple treatment options with different risks and benefits, the application of shared decision making (SDM) remains low. In SDM, clinicians and their patients work together to decide upon the treatment option that best fits the patient's situation and preference. This study aimed to reveal predictors of the extent to which the SDM process occurs in vascular surgery. METHODS: This was a cross sectional cohort substudy of the OVIDIUS trial, a multicentre, randomised, stepped wedge trial on the effect of implementing SDM supporting tools. The data of outpatients visiting university and general hospitals and suffering from abdominal aortic aneurysms (AAAs), intermittent claudication (IC), or varicose veins (VV) were used. Consultations were audio recorded. SDM levels were scored independently by two evaluators, using the OPTION-5 instrument, on a scale from 0% (no SDM effort) to 100% (exemplary SDM effort). Possible associations between the OPTION-5 scores and patient, clinician, and consultation characteristics were investigated using multivariable linear regression analysis. RESULTS: Of the 342 patients included (AAA, n = 87; VV, n = 143; IC, n = 112), 60% were male and mean age was 64 years. Overall, the SDM score was relatively low; mean ± SD 33.8% ± 13.2%, mainly due to insufficient support for the patient in deliberating their options. Regression analysis showed that the mean SDM scores in consultation with patients with IC and patients with VV were -9.9 (95% confidence interval [CI] -13.2 - -6.5; p < .001) and -12.7 (95% CI -17.3 - -8.0; p < .001) points lower than in patients with AAA, respectively. Consultations by a resident in training or nurse practitioner resulted in a -8.6 (95% CI -13.1 - -4.0; p < .001) and -4.2 (95% CI -7.9 - -0.42; p = .029) point lower SDM score than by a surgeon, respectively. A consultation longer than 30 minutes resulted in a 5.8 (95% CI 1.3 - 10.3; p = .011) point higher SDM score than consultations lasting fewer than 10 minutes. CONCLUSION: In this study, it was found that SDM can still be improved, especially by helping patients understand and deliberate about their options. Spending time weighing up the options, notably with patients with IC and VV, will help improve the SDM process. Training in SDM consultations is important, particularly for junior clinicians.

Improving Shared Decision Making in Vascular Surgery: A Stepped Wedge Cluster Randomised Trial.

OBJECTIVE: Different treatment options are available and feasible for various vascular surgical disorders. Hence, vascular surgery seems an area par excellence for shared decision making (SDM), in which clinicians incorporate the patient's preferences into the final treatment decision. However, current SDM levels in vascular surgical outpatient clinics are below expectations. To improve this, different decision support tools (DSTs) have been developed: online patient decision aids, consultation cards, and decision cards. METHODS: This stepped wedge cluster randomised trial was conducted in 13 Dutch hospitals. Besides the developed DSTs, training on how to apply SDM during the clinician patient encounter was used in this study. Data were obtained via questionnaires and audio recordings. The primary outcome was the OPTION-5 score, an objective tool to assess the level of SDM, expressed as a percentage of exemplary performance. Main secondary outcomes were patients' disease specific knowledge, consultation duration, and treatment choice. Factors influencing OPTION-5 scores were studied using linear regression analysis. RESULTS: Included in the study were 342 patients with an abdominal aortic aneurysm (AAA; n = 87), intermittent claudication (IC; n = 143), or varicose veins (VV; n = 112). Audiotapes of 395 consultations were analysed. Overall the mean OPTION-5 score significantly improved from 28.7% to 37.8% (mean difference 9.1%, 95% CI 6.5% - 11.8%) after implementation of the DSTs. Also, patient knowledge increased significantly (median increase: 13%, effect size: 0.13, p = .025). The number of patients choosing non-surgical treatment choices increased, with 21.4% to 28.8% for patients with AAA and doubled (16.0% to 32.0%) among patients with IC. For surgeons, the SDM training and for patients the decision aid significantly and independently increased OPTION-5 scores (p < .001 and p = .047, respectively). CONCLUSION: Introducing DSTs improves the level of shared decision making in vascular surgery, improves patient knowledge, and shifts their preference towards more non-surgical treatments. The SDM training for clinicians and the decision aid for patients appeared the most effective means of improving SDM. TRIAL REGISTRATION: NTR6487.

Effectiveness of Individual Feedback and Coaching on Shared Decision-making Consultations in Oncology Care: Protocol for a Randomized Clinical Trial.

BACKGROUND: Shared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and risks. However, the implementation of SDM in oncology care is challenging, and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM but is considered time consuming. OBJECTIVE: This study aims to address the effectiveness of an individual SDM training program using the concept of deliberate practice. METHODS: This multicenter, single-blinded randomized clinical trial will be performed at 12 Dutch hospitals. Clinicians involved in decisions with oncology patients will be invited to participate in the study and allocated to the control or intervention group. All clinicians will record 3 decision-making processes with 3 different oncology patients. Clinicians in the intervention group will receive the following SDM intervention: completing e-learning, reflecting on feedback reports, performing a self-assessment and defining 1 to 3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group will not receive the SDM intervention until the end of the study. The primary outcome will be the extent to which clinicians involve their patients in the decision-making process, as scored using the Observing Patient Involvement-5 instrument. As secondary outcomes, patients will rate their perceived involvement in decision-making, and the duration of the consultations will be registered. All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. RESULTS: This trial was retrospectively registered on August 03, 2021. Approval for the study was obtained from the ethical review board (medical research ethics committee Delft and Leiden, the Netherlands [N20.170]). Recruitment and data collection procedures are ongoing and are expected to be completed by July 2022; we plan to complete data analyses by December 2022. As of February 2022, a total of 12 hospitals have been recruited to participate in the study, and 30 clinicians have started the SDM training program. CONCLUSIONS: This theory-based and blended approach will increase our knowledge of effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target the knowledge, attitude, and skills of clinicians. The patients will also be involved in the design and implementation of the study. TRIAL REGISTRATION: Netherlands Trial Registry NL9647; https://www.trialregister.nl/trial/9647. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35543.

Comparison of the CollaboRATE and SDM-Q-9 questionnaires to appreciate the patient-reported level of shared decision-making.

OBJECTIVE: To compare CollaboRATE and SDM-Q-9 questionnaires when appreciating patient-perceived level of shared decision-making (SDM) in doctor-patient consultations. METHODS: Data were harvested from five separate studies on SDM, conducted in three university and one large community hospital in the Netherlands, using Dutch versions of both questionnaires. CollaboRATE and SDM-Q-9 scores were expressed as percentages. Correlation was assessed using Spearman's Rho coefficient. Bland&Altman analysis was used to assess the degree of agreement. Top scores were calculated to assess possible ceiling effects. RESULTS: The five studies included 442 patients. Median CollaboRATE scores (88.9%, IQR 81.5-100%) were significantly higher (p < 0.001) than SDM-Q-9 scores (80.0%, IQR 64.4-100%). Correlation was moderate (Rho=0.53, p < 0.001). A systematic, 12.5-point higher score was found across the range of scores when using CollaboRATE. Top scores for CollaboRATE and SDM-Q-9 were present in 37.5% and 17% of questionnaires, respectively. CONCLUSIONS: Overall, CollaboRATE and SDM-Q-9 questionnaires showed a high level of patient-perceived SDM. However, CollaboRATE only moderately correlated with SDM-Q-9 and had a stronger ceiling effect. PRACTICE IMPLICATIONS: When choosing a SDM-measurement tool, its benefits and limitations should be weighed. These metrics should be combined with objective scores of SDM, as these may differ from the patients' subjective interpretation.

Development of three different decision support tools to support shared decision-making in vascular surgery.

BACKGROUND: Shared decision-making (SDM) is known to improve quality of care. Particularly in vascular surgery treatment options are often preference-sensitive. Unfortunately, vascular surgeons infrequently apply SDM. Decision support tools (DSTs) have been shown to be helpful in SDM. OBJECTIVE: This article describes the development process of three different DSTs to help vascular surgeons and patients apply SDM. PATIENT INVOLVEMENT: Patients' information needs were obtained via focus group meetings. Fifty-two patients and eighteen vascular surgeons not involved in the development process evaluated the comprehensibility and usability of the DST-prototypes. METHODS: A multidisciplinary steering group commissioned the development of the three DSTs according to international standards. RESULTS: Digital decision aids and paper-based consultation cards and decision cards were developed for patients with an abdominal aortic aneurysm, carotid artery disease, intermittent claudication or varicose veins. Patients preferred the use of the decision aids followed by consultation cards, whereas vascular surgeons preferred to use decision cards followed by decision aids. DISCUSSION: Decision aids, consultation cards and decision cards for four vascular diseases are now available to all vascular surgeons and patients in the Netherlands. The DSTs were well received by both surgeons and patients. English versions are also available.

Treatment of varicose veins, international consensus on which major complications to discuss with the patient: A Delphi study.

OBJECTIVE: To reach consensus on which complications of varicose vein treatments physicians consider major or minor, in order to standardize the informed consent procedure and improve shared decision-making. METHODS: Using the e-Delphi method, expert physicians from 10 countries were asked to rate complications as "major" or "minor" on a 5-point Likert scale. Reference articles from a Cochrane review on varicose veins were used to compose the list of complications. RESULTS: Participating experts reached consensus on 12 major complications: allergic reaction, cellulitis requiring intravenous antibiotics/intensive care, wound infection requiring debridement, hemorrhage requiring blood transfusion/surgical intervention, pulmonary embolism, skin necrosis requiring surgery, arteriovenous fistula requiring repair, deep venous thrombosis, lymphocele, thermal injury, transient ischemic attack/stroke, and permanent discoloration. CONCLUSION: An international consensus was reached about what physicians consider to be major complications of varicose vein treatments. This consensus may assist in standardizing the information physicians discuss with patients prior to varicose vein treatment.

A Web-Based Application to Communicate Benefits and Risks of Surgical Treatments.

BACKGROUND: In general, communication is an important aspect during surgeon-patient consultations. However, clear communication of the benefits and risks of the possible treatment options can be challenging. Visual presentation of information may increase patient comprehension. We developed and piloted a web-based application that provides graphical representations of the numerical benefits and risks of surgical treatment options. MATERIALS AND METHODS: The app was developed by assessing functional requirements, developing a prototype, pilot-testing and adjusting the prototype, and evaluating the final app. In the app, the surgeon enters the benefits and risks of the surgical treatment options as percentages. The app shows the possible outcomes ad libitum as bar charts, icon arrays, or natural frequency trees. Subsequently, we investigated clinicians' and patients' satisfaction with the prototype by means of questionnaires, semi-structured interviews, and by observing their conversations. RESULTS: The MAPPING app ("Mapping All Patient Probabilities In Numerical Graphs") was pilot-tested among five surgeons and 12 patients with various surgical disorders. Nine patients welcomed the app and were eager to understand the risks and benefits involved when presented as graphs. The surgeons judged the app as simple to use and valuable. The prototype was improved based on their suggestions. CONCLUSION: The MAPPING app was developed successfully and has the potential to facilitate surgical risk communication in a more structured and uniform manner. Future research will focus on its validation and promotion of SDM in different types of patients and disorders.

Shared Decision-Making in the Management of Congenital Vascular Malformations.

BACKGROUND: In shared decision-making, clinicians and patients arrive at a joint treatment decision, by incorporating best available evidence and the patients' personal values and preferences. Little is known about the role of shared decision-making in managing patients with congenital vascular malformations, for which preference-sensitive decision-making seems obvious. The authors investigated preferences regarding decision-making and current shared decision-making behavior during physician-patient encounters. METHODS: In two Dutch university hospitals, adults and children with congenital vascular malformations facing a treatment-related decision were enrolled. Before the consultation, patients (or parents of children) expressed their preference regarding decision-making (Control Preferences Scale). Afterward, participants completed shared decision-making-specific questionnaires (nine-item Shared Decision-Making Questionnaire, CollaboRATE, and satisfaction), and physicians completed the Shared Decision-Making Questionnaire-Physician questionnaire. Consultations were audiotaped and patient involvement was scored by two independent researchers using the five-item Observing Patient Involvement instrument. All questionnaire results were expressed on a scale of 0 to 100 (optimum shared decision-making). RESULTS: Fifty-five participants (24 parents and 31 adult patients) were included. Two-thirds preferred the shared decision-making approach (Control Preferences Scale). Objective five-item Observing Patient Involvement scores were low (mean ± SD, 31 ± 15), whereas patient and physician Shared Decision-Making Questionnaire scores were high, with means of 68 ± 18 and 68 ± 19, respectively. The median CollaboRATE score was 93. There was no clear relationship between shared decision-making and satisfaction scores. CONCLUSIONS: Although adults and parents of children with vascular malformations express a strong desire for shared decision-making, objective shared decision-making behavior is still lacking, most likely because of poor awareness of the shared decision-making concept among patients, parents, and physicians. To improve shared decision-making practice, targeted interventions (e.g., decision aids, staff training) are essential.

OPTION(5) versus OPTION(12) instruments to appreciate the extent to which healthcare providers involve patients in decision-making.

OBJECTIVE: The 12-item "observing patient involvement" (OPTION(12))-instrument is commonly used to assess the extent to which healthcare providers involve patients in health-related decision-making. The five-item version (OPTION(5)) claims to be a more efficient measure. In this study we compared the Dutch versions of the OPTION-instruments in terms of inter-rater agreement and correlation in outpatient doctor-patient consultations in various settings, to learn if we can safely switch to the shorter OPTION(5)-instrument. METHODS: Two raters coded 60 audiotaped vascular surgery and oncology patient consultations using OPTION(12) and OPTION(5). Unweighted Cohen's kappa was used to compute inter-rater agreement on item-level. The association between the total scores of the two OPTION-instruments was investigated using Pearson's correlation coefficient (r) and a Bland & Altman plot. RESULTS: After fine-tuning the OPTION-manuals, inter-rater agreement for OPTION(12) and OPTION(5) was good to excellent (kappa range 0.69-0.85 and 0.63-0.72, respectively). Mean total scores were 23.7 (OPTION(12); SD=7.8) and 39.3 (OPTION(5); SD=12.7). Correlation between the total scores was high (r=0.71; p=0.01). OPTION(5) scored systematically higher with a wider range than OPTION(12). CONCLUSION: Both OPTION-instruments had a good inter-rater agreement and correlated well. OPTION(5) seems to differentiate better between various levels of patient involvement. PRACTICAL IMPLICATION: The OPTION(5)-instrument is recommended for clinical application.