Developing a Decision Support Tool to Guide Shared Decision‐Making in Bipolar Depression Treatment: Results From a Collaboration Between Clinicians and People With Lived Experience
ABSTRACTObjectiveTo build consensus from different stakeholders on the content and digital interactivity of a shared decision making (SDM) tool to guide patient‐clinician collaborative conversations about treatment for bipolar depression.Patients and MethodsThis study was conducted between September 2022 and September 2023. In the first phase, we conducted a narrative review on pharmacological, neuromodulatory, and psychotherapeutic treatments available for bipolar depression. For each option, we assessed treatment effectiveness, side effects, need for clinical monitoring, clinical considerations, and cost. In the second phase, committees comprised of mental health clinicians and people with lived experience with bipolar disorder from a national mood disorders advocacy group identified key features and content to be included in the SDM tool. A thematic analysis of these data then contributed to populate the SDM tool.ResultsTwenty‐one evidence‐based treatment options identified from the narrative review were presented to the four convened committees (clinical, lived experience, peer council, and integrated steering committees) in five meetings. After discussions and thematic analysis, 12 outcomes of interest for each of the therapeutic interventions were delineated for inclusion in a web‐based SDM tool. A detailed description of the development process and SDM tool is provided.ConclusionThis is the first partnership between clinicians and persons with bipolar disorder lived experience charged with the development of a patient‐centered SDM tool to integrate clinical evidence with real‐world clinical practice and patient preferences for use during clinical encounters. Human‐centered design and testing in real clinical encounters will now contribute to refining the instrument and readying it for rigorous evaluation and implementation in practice.
Core GRADE 7: principles for moving from evidence to recommendations and decisions
Background Heart failure self‐care can contribute to a high daily workload and treatment burden. The goal of this cohort study was to assess the characteristics and outcomes associated with burden of treatment (BoT). Methods Surveys comprising validated instruments to measure BoT and other constructs were mailed to patients with heart failure in Southeastern Minnesota. Participants were divided into tertiles by BoT scores. Associations of clinical variables with BoT were examined using multinomial logistic regression. Associations of BoT with mortality and hospitalizations were examined using Cox proportional hazard regression and Andersen–Gill models, respectively. Results A total of 609 participants (mean age 76.3 years, 60.3% men, 55.2% urban, 64.3% preserved ejection fraction) completed surveys. Higher BoT was associated with worse health status, more depressive symptoms, lower resilience, less social support, lower medication adherence, and worse health literacy. Mean±SD follow‐up was 14.4 (4.1) months. Estimated 1‐year mortality (8.3% [95% CI, 4.3%–12.1%], 11.0% [95% CI, 6.5%–15.2%], 16.0% [95% CI, 10.8%–21.0%]) and 1‐year mean cumulative hospitalizations (0.57 [95% CI, 0.45–0.72], 0.83 [95% CI, 0.66–1.05], 1.15 [95% CI, 0.93–1.42]) increased across patients reporting low, medium, and high BoT, respectively. Adjustment for health status eliminated any significant association of BoT with risks of death and hospitalization (adjusted hazard ratio [HR], 1.10 [95% CI, 0.58–2.07] and 1.09 [95% CI, 0.74–1.61], respectively, highest versus lowest BoT tertile). Conclusions BoT in heart failure varies by clinical and psychosocial factors. Higher BoT identifies patients at increased risk of adverse health outcomes due to their worse health status. These findings can serve as a foundation for interventions to minimize workload and improve quality of life.
Core GRADE 4: rating certainty of evidence—risk of bias, publication bias, and reasons for rating up certainty
Importance Digital health technologies (DHTs) aiming to monitor, treat, and manage diseases can be prescribed for patients with multimorbidity; yet most DHTs are designed for individual conditions or problems, while approximately half of patients with chronic conditions have multiple chronic conditions. Objectives To identify DHTs approved by the US Food and Drug Administration (FDA) or listed in the Organisation for the Review of Care and Health Apps (ORCHA) library and prescribable for a hypothetical patient with 5 conditions and to model the number of DHTs this patient should be prescribed to receive benefits health professionals considered important. Evidence Review The FDA databases (Premarket Notification 510(k), Premarket Approval, and De Novo) and the ORCHA App Library from National Health Service Somerset were systematically searched for DHTs registered or updated between January 1, 2019, and December 31, 2022, that could be prescribed to a hypothetical woman with 5 chronic conditions (type 2 diabetes, hypertension, chronic obstructive pulmonary disease, osteoporosis, and osteoarthritis). After abstracting each DHT’s elementary functions (ie, simple and delineated features to monitor, treat, and/or manage conditions), an assessment was undertaken to determine the fewest DHTs this hypothetical patient should be prescribed to receive benefit from digital functions health professionals considered important. Findings A total of 148 DHTs were identified (68 [46%] from FDA databases), of which 96 (65%) involved devices and 52 (35%) were standalone health apps. Only 5 DHTs (3.4%) were intended for 2 or more conditions. DHTs offered 140 elementary functions, ranging from recording, tracking, or visualizing health parameters to providing information to digital therapeutics with just-in-time interventions. The hypothetical patient would need to be prescribed up to 13 apps and 7 devices (a blood pressure monitor, a smartwatch, a pulse oximeter, a connected weight scale, a sensor-attached inhaler to monitor adherence, a lung function monitor, and a blood glucose sensor) to receive benefits from 28 functions at least 3 of 5 health professionals considered important. Conclusions and Relevance This systematic review found that almost all prescribable DHTs were developed for a single condition or problem. Thus, patients with multiple chronic conditions would have to routinize many DHTs concurrently in daily life to benefit from digital functions health professionals considered important.