BackgroundThis study explores patients' need for information and support in deciding on esophageal cancer treatment, when experimental active surveillance and standard surgery are both feasible.... Show moreBackgroundThis study explores patients' need for information and support in deciding on esophageal cancer treatment, when experimental active surveillance and standard surgery are both feasible. MethodsThis psychological companion study was conducted alongside the Dutch SANO-trial (Surgery As Needed for Oesophageal cancer). In-depth interviews and questionnaires were used to collect data from patients who declined participation in the trial because they had a strong preference for either active surveillance (n = 20) or standard surgery (n = 20). Data were analyzed using both qualitative and quantitative techniques. ResultsPatients prefer to receive information directly from their doctors and predominantly rely on this information to make a treatment decision. Other information resources are largely used to confirm their treatment decision. Patients highly value support from their loved ones and appreciate emphatic doctors to actively involve them in the decision-making process. Overall, patients' needs for information and support during decision-making were met. ConclusionsThe importance of shared decision-making and the role doctors have in this process is underlined. The role of doctors is essential at the initial phase of decision-making: Once patients seem to have formed their treatment preference for either active surveillance or surgery, the influence of external resources (including doctors) may be limited. Show less
Berkhout-Byrne, N.C.; Voorend, C.G.N.; Meuleman, Y.; Mooijaart, S.P.; Brunsveld-Reinders, A.H.; Bos, W.J.W.; Buren, M. van 2023
BackgroundDialysis might not benefit all older patients with kidney failure, particularly those with multimorbid conditions and frailty. Patients' and healthcare professionals' awareness of the... Show moreBackgroundDialysis might not benefit all older patients with kidney failure, particularly those with multimorbid conditions and frailty. Patients' and healthcare professionals' awareness of the presence of geriatric impairments could improve outcomes by tailoring treatment plans and decisions for individual patients. ObjectiveWe aimed to explore the perspectives of patients and healthcare professionals on nephrology-tailored geriatric assessment to fuel decision-making for treatment choices in older patients with kidney failure. DesignIn an exploratory qualitative study using focus groups, participants discussed perspectives on the use and value of nephrology-tailored geriatric assessment for the decision-making process to start or forego dialysis. Participants and MeasurementsPatients (n = 18) with kidney failure, caregivers (n = 4), and professionals (n = 25) were purposively sampled from 10 hospitals. Interviews were audio-recorded, transcribed verbatim and inductively analysed using thematic analysis. ResultsThree main themes emerged that supported or impeded decision-making in kidney failure: (1) patient psycho-social situation; (2) patient-related factors on modality choice; (3) organisation of health care. Patients reported feeling vulnerable due to multiple chronic conditions, old age, experienced losses in life and their willingness to trade longevity for quality of life. Professionals recognised the added value of nephrology-tailored geriatric assessment in three major themes: (i) facilitating continual holistic assessment, (ii) filling the knowledge gap, and (iii) uncovering important patient characteristics. Conclusionsnephrology-tailored geriatric assessment was perceived as a valuable tool to identify geriatric impairments in older patients with kidney failure. Integration of its outcomes can facilitate a more holistic approach to inform choices and decisions about kidney replacement therapy. Show less
Background Shared decision-making (SDM) is often considered the ideal for decision-making in oncology. Views of specific groups such as ethnic minorities have seldom been considered in its... Show moreBackground Shared decision-making (SDM) is often considered the ideal for decision-making in oncology. Views of specific groups such as ethnic minorities have seldom been considered in its development. Aim In this study we seek to assess in oncology if there is a need for adaptation of the current SDM model to ethnic minorities and to formulate possible adjustments. Design This study is embedded in empirical bioethics, an interdisciplinary approach integrating empirical data with ethical reasoning to formulate normative conclusions regarding a practice. For the empirical social scientific part, a cross-sectional qualitative study will be conducted; for the ethical reflection the Reflective Equilibrium will be used to develop a coherent view on the application of SDM among ethnic minorities in oncology. Method Semi-structured interviews combined with visual methods (timelines and relational maps) will be held with healthcare professionals (HCPs), ethnic minority patients, and their relatives to identify values steering the behavior of these actors in SDM. In addition, focus groups (FGs) will be held with ethnic minority community members to identify value structures at the group level. Respondents will be recruited through organizations with access to ethnic minorities and collaborating hospitals. Data will be analyzed using a reflexive thematic analysis through the lens of Schwartz's value theory. The results of the empirical phase will be included in the RE to formulate possible adjustments of the SDM model, if needed. Discussion The integration of empirical data with ethical reflection is an innovative method in decision-making. This method enables a systematic and profound assessment of the need for adaptation of SDM and the formulation of theoretically and empirically based suggestions for adaptations of the model. Findings of this study may enrich the SDM model. Show less
Noseworthy, P.A.; Branda, M.E.; Kunneman, M.; Hargraves, I.G.; Sivly, A.L.; Brito, J.P.; ... ; SDM4AFib Shared Decision-Making At 2022
BACKGROUND Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC)... Show moreBACKGROUND Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision-making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. METHODS AND RESULTS We conducted a multicenter, encounter-level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. CONCLUSIONS In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Show less
Backgrounds Research on shared decision-making (SDM) has mainly focused on decisions about treatment (e.g., medication or surgical procedures). Little is known about the decision-making process for... Show moreBackgrounds Research on shared decision-making (SDM) has mainly focused on decisions about treatment (e.g., medication or surgical procedures). Little is known about the decision-making process for the numerous other decisions in consultations. Objectives We assessed to what extent patients are actively involved in different decision types in medical specialist consultations and to what extent this was affected by medical specialist, patient, and consultation characteristics. Design Analysis of video-recorded encounters between medical specialists and patients at a large teaching hospital in the Netherlands. Participants Forty-one medical specialists (28 male) from 18 specialties, and 781 patients. Main Measure Two independent raters classified decisions in the consultations in decision type (main or other) and decision category (diagnostic tests, treatment, follow-up, or other advice) and assessed the decision-making behavior for each decision using the Observing Patient Involvement (OPTION)(5) instrument, ranging from 0 (no SDM) to 100 (optimal SDM). Scheduled and realized consultation duration were recorded. Key Result In the 727 consultations, the mean (SD) OPTION5 score for the main decision was higher (16.8 (17.1)) than that for the other decisions (5.4 (9.0), p < 0.001). The main decision OPTION5 scores for treatment decisions (n = 535, 19.2 (17.3)) were higher than those for decisions about diagnostic tests (n = 108, 14.6 (16.8)) or follow-up (n = 84, 3.8 (8.1), p < 0.001). This difference remained significant in multilevel analyses. Longer consultation duration was the only other factor significantly associated with higher OPTION5 scores (p < 0.001). Conclusion Most of the limited patient involvement was observed in main decisions (versus others) and in treatment decisions (versus diagnostic, follow-up, and advice). SDM was associated with longer consultations. Physicians' SDM training should help clinicians to tailor promotion of patient involvement in different types of decisions. Physicians and policy makers should allow sufficient consultation time to support the application of SDM in clinical practice. Show less
ObjectiveShared decision making integrates health care provider expertise with patient values and preferences. The MAPPIN'SDM is a recently developed measurement instrument that incorporates... Show moreObjectiveShared decision making integrates health care provider expertise with patient values and preferences. The MAPPIN'SDM is a recently developed measurement instrument that incorporates physician, patient, and observer perspectives during medical consultations. This review sought to critically appraise the development, sensibility, reliability, and validity of the MAPPIN'SDM and to determine in which settings it has been used.MethodsThis critical appraisal was performed through a targeted review of the literature. Articles outlining the development or measurement property assessment of the MAPPIN'SDM or that used the instrument for predictor or outcome purposes were identified.ResultsThirteen studies were included. The MAPPIN'SDM was developed by both adapting and building on previous shared decision making measurement instruments, as well as through creation of novel items. Content validity, face validity, and item quality of the MAPPIN'SDM are adequate. Internal consistency ranged from 0.91 to 0.94 and agreement statistics from 0.41 to 0.92. The MAPPIN'SDM has been evaluated in several populations and settings, ranging from chronic disease to acute oncological settings. Limitations include high reading levels required for self-administered patient questionnaires and the small number of studies that have employed the instrument to date.ConclusionThe MAPPIN'SDM generally shows adequate development, sensibility, reliability, and validity in preliminary testing and holds promise for shared decision making research integrating multiple perspectives. Further research is needed to develop its use in other patient populations and to assess patient understanding of complex item wording. Show less
Purpose: This study focusses on identifying values and preferences of patients, caregivers and healthcare professionals who have dealt with lower limb amputation for no-option chronic limb... Show morePurpose: This study focusses on identifying values and preferences of patients, caregivers and healthcare professionals who have dealt with lower limb amputation for no-option chronic limb threatening ischemia. No-option chronic limb threatening ischemia is defined as limb ischemia for which no treatment options exist and where lower limb amputation is necessary in the short term. The values and preferences identified in this study can help improve decision-making processes.Patients and Methods: This was a qualitative study, using semi-structured interviews to gather data from patients, caregivers and healthcare professionals. Participants were selected from the patient and employee population of an academic medical center in The Netherlands. Nine patients and seven caregivers who dealt with lower limb amputation for no-option chronic limb threatening ischemia six to twelve months prior to the interview and were not cognitively impaired were selected. Nine healthcare professionals dealing with patients with no-option chronic limb threatening ischemia and lower limb amputation were selected.Results: Lower limb amputation was explicitly discussed late in the disease process, sometimes during an emergency setting. Patients stated goals were never discussed, healthcare professionals stated they were. The most important goal for patients was to live independently after lower limb amputation. Patients and caregivers feel healthcare professionals should be upfront about the possible necessity of lower limb amputation. Reasons to undergo lower limb amputation were absence of treatment options, pain and wanting to enjoy life again. Participants indicated accelerating lower limb amputation was not a viable option.Conclusion: All stakeholders reported overlapping values and preferences regarding main reasons for lower limb amputation, the primary goals after lower limb amputation, and the absence of a desire to accelerate lower limb amputation. The main difference in values and preferences is the preferred timing of discussing lower limb amputation. Show less
Objectives. To examine the treatment decision-making process of patients with dcSSc in the context of haematopoietic stem cell transplantation (HSCT).Methods. A qualitative semi-structured... Show moreObjectives. To examine the treatment decision-making process of patients with dcSSc in the context of haematopoietic stem cell transplantation (HSCT).Methods. A qualitative semi-structured interview study was done in patients before or after HSCT, or patients who chose another treatment than HSCT. Thematic analysis was used. Shared decision-making (SDM) was assessed with the 9-item Shared Decision Making Questionnaire (SDM-Q-9).Results. Twenty-five patients [16 male/nine female, median age 47 (range 27-68) years] were interviewed: five pre-HSCT, 16 post-HSCT and four following other treatment. Whereas the SDM-Q-9 showed the decision-making process was perceived as shared [median score 81/100 (range 49-100)], we learned from the interviews that the decision was predominantly made by the rheumatologist, and patients were often steered towards a treatment option. Strong guidance of the rheumatologist was appreciated because of a lack of accessible, reliable and SSc-specific information, due to the approach of the decision-making process of the rheumatologist, the large consequence of the decision and the trust in their doctor. Expectations of outcomes and risks also differed between patients. Furthermore, more than half of patients felt they had no choice but to go for HSCT, due to rapid deterioration of health and the perception of HSCT as 'the holy grail'.Conclusion. This is the first study that provides insight into the decision-making process in dcSSc. This process is negatively impacted by a lack of disease-specific education about treatment options. Additionally, we recommend exploring patients' preferences and understanding of the illness to optimally guide decision-making and to provide tailor-made information. Show less
Objective To develop a model and methodology for predicting the risk of Gleason upgrading in patients with prostate cancer on active surveillance (AS) and using the predicted risks to create risk... Show moreObjective To develop a model and methodology for predicting the risk of Gleason upgrading in patients with prostate cancer on active surveillance (AS) and using the predicted risks to create risk-based personalised biopsy schedules as an alternative to one-size-fits-all schedules (e.g. annually). Furthermore, to assist patients and doctors in making shared decisions on biopsy schedules, by providing them quantitative estimates of the burden and benefit of opting for personalised vs any other schedule in AS. Lastly, to externally validate our model and implement it along with personalised schedules in a ready to use web-application. Patients and Methods Repeat prostate-specific antigen (PSA) measurements, timing and results of previous biopsies, and age at baseline from the world's largest AS study, Prostate Cancer Research International Active Surveillance (PRIAS; 7813 patients, 1134 experienced upgrading). We fitted a Bayesian joint model for time-to-event and longitudinal data to this dataset. We then validated our model externally in the largest six AS cohorts of the Movember Foundation's third Global Action Plan (GAP3) database (>20 000 patients, 27 centres worldwide). Using the model predicted upgrading risks; we scheduled biopsies whenever a patient's upgrading risk was above a certain threshold. To assist patients/doctors in the choice of this threshold, and to compare the resulting personalised schedule with currently practiced schedules, along with the timing and the total number of biopsies (burden) planned, for each schedule we provided them with the time delay expected in detecting upgrading (shorter is better). Results The cause-specific cumulative upgrading risk at the 5-year follow-up was 35% in PRIAS, and at most 50% in the GAP3 cohorts. In the PRIAS-based model, PSA velocity was a stronger predictor of upgrading (hazard ratio [HR] 2.47, 95% confidence interval [CI] 1.93-2.99) than the PSA level (HR 0.99, 95% CI 0.89-1.11). Our model had a moderate area under the receiver operating characteristic curve (0.6-0.7) in the validation cohorts. The prediction error was moderate (0.1-0.2) in theGAP3 cohorts where the impact of the PSA level and velocity on upgrading risk was similar to PRIAS, but large (0.2-0.3) otherwise. Our model required re-calibration of baseline upgrading risk in the validation cohorts. We implemented the validated models and the methodology for personalised schedules in a web-application (). Conclusions We successfully developed and validated a model for predicting upgrading risk, and providing risk-based personalised biopsy decisions in AS of prostate cancer. Personalised prostate biopsies are a novel alternative to fixed one-size-fits-all schedules, which may help to reduce unnecessary prostate biopsies, while maintaining cancer control. The model and schedules made available via a web-application enable shared decision-making on biopsy schedules by comparing fixed and personalised schedules on total biopsies and expected time delay in detecting upgrading. Show less
Rodenburg-Vandenbussche, S.; Carlier, I.; Hemert, I. van; Hemert, A. van; Stiggelbout, A.; Zitman, F. 2019
Rationale, aims, and objectives People worldwide are affected by psychiatric disorders that lack a "best" treatment option. The role of shared decision-making (SDM) in psychiatric care seems... Show moreRationale, aims, and objectives People worldwide are affected by psychiatric disorders that lack a "best" treatment option. The role of shared decision-making (SDM) in psychiatric care seems evident, yet remains limited. Research on SDM in specialized mental health is scarce, concentrating on patients with depressive disorder or psychiatric disorders in general and less on patients with anxiety and obsessive-compulsive disorder (OCD). Furthermore, recent research concentrates on the evaluation of interventions to promote and measure SDM rather than on the feasibility of SDM in routine practice. This study investigated patients' and clinicians' perspectives on SDM to treat depression, anxiety disorders, and OCD as to better understand SDM in specialized psychiatric care and its challenges in clinical practice. Methods Transcripts of eight focus groups with 17 outpatients and 33 clinicians were coded, and SDM-related codes were analysed using thematic analyses. Results Motivators, responsibilities, and preconditions regarding SDM were defined. Patients thought SDM should be common practice given the autonomy they have over their own bodies and felt responsible for their treatments. Clinicians value SDM for obtaining patients' consent, promoting treatment adherence, and establishing a good patient-clinician relationship. Patients and clinicians thought clinicians assumed the most responsibility regarding the initiation and achievement of SDM in clinical practice. According to clinicians, preconditions were often not met, were influenced by illness severity, and formed important barriers (eg, patient's decision-making capacity, treatment availability, and clinicians' preferences), leading to paternalistic decision-making. Patients recognized these difficulties, but felt none of these preclude the implementation of SDM. Personalized information and more consultation time could facilitate SDM. Conclusions Patients and clinicians in specialized psychiatric care value SDM, but adapting it to daily practice remains challenging. Clinicians are vital to the implementation of SDM and should become versed in how to involve patients in the decision-making process, even when this is difficult. Show less
Balen, E.C. van; Krawczyk, M.; Gue, D.; Jackson, S.; Gouw, S.C.; Bom, J.G. van der; Sawatzky, R. 2019
Introduction and Aim The British Columbia Adult Haemophilia Team recently adopted a patient-centred care approach. The team presented visual information on an individual's pharmacokinetic profile... Show moreIntroduction and Aim The British Columbia Adult Haemophilia Team recently adopted a patient-centred care approach. The team presented visual information on an individual's pharmacokinetic profile and bleed history and encouraged patients to participate in treatment decisions. This qualitative study explored how this approach changed patients' understanding of haemophilia and how it facilitated them to make treatment decisions. Methods We interviewed 18 males with mild, moderate or severe haemophilia, using a convenience sample from the adult haemophilia clinic at St. Paul's hospital in Vancouver, Canada. Interviews were recorded and transcribed verbatim and analyzed using descriptive content analysis. Results Most participants reported that reviewing visual information with the Clinic Team helped them in their communication with their care providers during their annual review clinic appointment. Despite this improved communication, for some the most important feature of their treatment was that they had switched from on-demand treatment to prophylactic treatment in recent years and were able to prevent bleeds. Almost half of the participants reported that the visual information presented increased their understanding of haemophilia and the pharmacokinetics of coagulation factor. Three patients improved their treatment adherence or had changed their prophylaxis schedules based on this. Most participants felt that they were involved in decision-making about their treatment schedule, which they appreciated. On the other hand, two participants thought the Clinic Team should make these decisions. Conclusion Participants perceived the patient-centred prophylaxis approach helpful because it enhanced communication with the Clinic Team, increased their understanding of haemophilia and pharmacokinetics of coagulation factor and facilitated treatment decisions. Show less
