Tran, Viet‐Thi

Abstract Background Patients living with diabetes and chronic conditions may face significant burden managing their health. Many of these patients use digital medicine tools such as continuous glucose monitoring systems. Although measures exist to assess treatment burden from tasks such as managing medications and attending healthcare visits, there is no patient-reported measure that captures the burden of digital care. Therefore, the purpose of this study is to validate the Treatment Burden Questionnaire Plus Digital (TBQ + D), a patient-reported measure of treatment burden that includes using digital tools for adults with diabetes. Methods Adult patients with type 1 or type 2 diabetes mellitus completed the 25-item TBQ + D (scored 0 [none] to 10 [maximum] per item; total score range 0–250). We evaluated ease of administration, internal consistency, and tested hypotheses about the relationship between TBQ + D scores and treatment complexity, digital tool use intensity, social risk factors, and digital comfort to assess TBQ + D’s validity. Results Of 324 patients approached, 300 (93%) consented and completed the TBQ + D (mean age 57 [SD 17]; 50% female; 50% with type 2). The mean TBQ + D score was 53.7 (SD 41.6). Internal consistency was excellent (Cronbach’s α = 0.94). As hypothesized, higher TBQ + D scores were reported by patients with type 1 vs. type 2 diabetes mellitus (61.7 vs. 45.7; p = .0008), maximal/moderate vs. minimal to no digital tool use (56.5/60.7 vs. 41.3; p = .001), those on intensive insulin therapy vs. other treatments (61.4 vs. 38.0; p < .0001), and those with greater social vulnerability (p < .0106). TBQ + D scores were not significantly higher in patients with HbA1c ≥ 8% (p = .055) or less comfortable with digital technology (p = .08). Conclusions TBQ + D is a novel and valid measure of treatment burden in patients living with diabetes, inclusive of digital burden, that can play a role in fostering minimally disruptive care for patients with diabetes.

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.