Citations

Objective Digital health applications (health apps) are increasingly integrated in clinical care. Yet the information describing these apps varies across curated app repositories supporting prescription. We aimed to identify the information items used to describe health apps in repositories; and to quantify the completeness of publicly displayed app-entry information across repositories. Methods We conducted a cross-sectional study of seven national or international curated health app repositories: mHealthBelgium, DiGA, AppThera, ORCHA, GGD AppStore, MIND, and AppGuide. In January 2025, we randomly selected 140 health apps, with 20 apps per repository. For each app, one reviewer extracted the publicly available information displayed in the repository entry and inductively identified the information items reported (i.e., atomic information elements used to describe apps). These information items were then grouped into categories by an expert committee. We calculated, for each repository, the median number of items reported across apps, overall and by category. Results Health apps were described by 32 information items grouped into 10 categories: general information, regulatory information, compatibility, costs, indication, functions, evidence, user experience, data governance and security, and change history. The median number of items reported in repositories ranged from a median of 9/32 items, IQR 9 to 11 in MIND to 27/32, IQR 26 to 28 in DiGA. Only, three repositories (AppThera, DiGA and AppGuide) systematically reported information on the evidence supporting the apps for all listed apps. Conclusions Curated health app repositories differed in the information items presented to clinicians and patients. Incomplete reporting of clinically relevant information, particularly evidence and data governance, may limit informed app selection and prescription. Minimum reporting standards are needed to enable safe prescription and reliable integration of health apps into clinical practice.

Abstract Aim This study aims to assess the treatment burden and health‐related quality of life (HRQoL) in young adults with type 1 diabetes (T1D). Methods Online survey on experienced treatment burden (Treatment Burden Questionnaire, TBQ, 0–150, higher scores indicate higher burden) and HRQoL (Type 1 Diabetes and Life questionnaire for ages 18–25 and 26–45, T1DAL, 0–100, higher scores indicate better HRQoL) among Dutch young adults with T1D (aged 18–30). Results In total, 294 young adults with T1D completed the survey. Mean TBQ score was 59.5 (SD = 24.9). Regular medical care reminding participants of their health problems scored highest. Mean T1DAL scores were 55.9 (SD = 12.9) for ages 18–25, and 62.1 (SD = 13.2) for ages 26–30. Lowest scores were in the subcategory ‘Emotional experiences and daily activities’ (18–25: median = 41.7, IQR = 24.9; 26–30: median = 47.8, IQR = 22.5). TBQ was strongly negatively correlated with T1DAL ( r = −0.69, 95% CI [−0.74, −0.62], p < 0.001). Characteristics associated with higher treatment burden and lower HRQoL included female gender, lower time in range and dissatisfaction with diabetes management approach. Conclusion Young adults with T1D report considerable treatment burden and moderate HRQoL, suggesting a high impact of diabetes care on their lives. Treatment burden is particularly affected by regular medical care activities, whereas diabetes affects the daily functioning and emotional experiences domains of HRQoL. Further research is needed to understand how young adults make care fit and to improve care for these patients, resulting in minimally disruptive care plans. While cautiously interpreted, this may be especially relevant for women and those with adverse clinical outcomes.

Abstract Aim This study aimed to identify what young adults with type 1 diabetes (T1D) do to make diabetes care fit in their lives and the impact of diabetes and diabetes care on living. Methods Dutch young adults with T1D (18–30 years old) submitted photographed real‐life situations of efforts to make care fit and of the impact of care on their lives. Participants organised their photos in themes, which guided the focus group discussions. We added a reflective questionnaire, semi‐structured interview and iterative validation to identify participant‐defined themes and summarise the data. Results Participants ( N = 18) submitted 240 photographs in total, showing a broad range of situations and emotions. Participants identified 16 themes, grouped into four overarching categories describing their experiences with diabetes: (1) My diabetes: glucose levels, workload, 24/7 present; (2) My life: flow of (daily) life, special and irregular circumstances, life changes, body and health; (3) Support: devices and technology, social network, clinical (diabetes) care; (4) Mental aspects: emotional processes, perspective, being a patient. In the overlap of My diabetes and My life, they identified eating and counting carbohydrates, activity and exercise, recreational substances. Conclusion Young adults with T1D face the complex challenge of fitting their care into their ever‐changing lives. While support systems, such as devices, healthcare professionals and social networks can help, they can also create burdens. Participants emphasised the importance of mental health in their lives with T1D. This study highlights the need for diabetes care that acknowledges the emotional, social and practical realities of young adults' lives.

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.

Abstract The demands associated with ongoing disease management may overwhelm middle aged and older adults living with two or more chronic conditions. Treatment burden refers to both (a) the numerous demands—such as the time and costs of travel to clinical appointment, administrative burden, and coordinating fragmented care—healthcare makes on patients and (b) the negative impact on the patient’s wellbeing. We evaluated data from respondents of the treatment burden experimental module included in the 2022 Health and Retirement Study data collection wave (N=1,888). We analyzed responses to the 15-item Treatment Burden Questionnaire (TBQ; 15 questions scored 0-10; total sum 0-150; &gt;59 considered unsustainable burden). We compared mean total TBQ score by sociodemographic and multimorbidity combination groups using either a t-test (among 2 groups) or ANOVA (among &gt;2 groups). We compared sustainability across groups using a chi-square test. Respondents (mean 69 years; 62% female, 71% living with 2+ chronic conditions) had a mean TBQ score of 20.3/150 (SD 22.7) with 125 (6.6%) reporting unsustainable burden. Administrative and financial tasks and lifestyle changes were the most burdensome activities. Unsustainable burden was significantly more likely among younger (51-64 vs. older), lower educated (&lt; high school vs. ≥high school), and Black and Latino (vs. non-Latino White) respondents, and in those living with 2+ chronic conditions. In this nationally-representative sample of US adults, participants reported less treatment burden than previously reported in international studies. Certain sociodemographic groups reported high and unsustainable burden of treatment, informing future interventions to reduce treatment burden in mid and late life.

Abstract Background Remote digital monitoring (RDM, i.e., using digital devices to monitor patients' health and behavior) is a novel care model that can improve health outcomes for people with chronic conditions. However, it could be intrusive to patients' lives. We sought to understand which aspects of RDM make it intrusive to patients and why. Methods We performed content analysis of qualitative data collected by using open-ended questions in an international, online survey with a convenience sample of adults with type 1 or 2 diabetes (February-July 2019). Participants were first shown scenarios describing possible RDM features (i.e. different RDM tools [for glucose or food monitoring], feedback loops [receiving feedback in consultation, or remotely by a physician, or by artificial intelligence], and data handling options [by the public or private sector]). Results We analyzed data from 709 participants from 24 countries (38% men, median age 38, 54% type 1). Participants found RDM burdensome (n = 468). Burden arose from RDM features that caused disruption in daily life (e.g., alerts), features that may invite undesirable attention in public (e.g., visible wearable sensors may invite questions about one's health), or from having to adapt one's life to fit in RDM (e.g., adapt one's mealtime routine around food monitoring). Participants wanted control, particularly over sharing food-monitoring data with health care professionals in real-time to receive feedback (n = 440). They felt RDM could expose a delicate topic to 'surveillance' by authority figures (i.e., their data may 'reveal' poor dietary habits, leading to criticism by physicians). Intrusion could take the form of RDM eroding the patient-physician relationship (n = 34), or fear of data misuse (n = 206), which was associated with private-sector financial interests. Conclusions Our findings offer directions for minimally intrusive RDM design and show that digital health may cause concerns about stigma and treatment burden. Key messages Remote digital monitoring is intrusive when it increases treatment burden and limits patients’ control over their own health. “Minimally intrusive” digital health design could increase patient acceptability and, ultimately, foster scalability.

Abstract Background: The Treatment Burden Questionnaire (TBQ) is a self-reported measure of the effect of treatment workload on patient wellbeing. We sought to validate the TBQ in Spanish and use it to estimate the burden of treatment in Argentinian patients with multiple sclerosis (MS). Methods: The TBQ was forward-backward translated into Spanish. Two focus groups and 25 semi-structured interviews focused on wording and possible item exclusion. Validation was performed in 2 steps. First, 162 patients across a range of MS severity completed the questionnaire. Confirmatory factor analysis assessed the dimensional structure of the TBQ. Construct validity was assessed by studying correlations with fatigue and quality of life (QoL). Then, in a second cohort of 171 patients, we evaluated the association between TBQ scores and patients’ sex, age, education level, employment status, type of MS, disease duration, comorbidities, EDSS, pharmacological treatment and medication adherence. Results: The questionnaire presented a 3-factor structure in which burden was related to pharmacological treatment; comprehensive health assistance; and psycho-social-economic context. Composite reliability was > 0.8 for all factors. TBQ showed positive correlation with fatigue (rs= 0.467, p=0.006), negative correlation with QoL (rs -0.446, p=0.009). For the second cohort, total TBQ score was 43 (SD 29). Lowest scores were observed on self-monitoring (0.53, SD 1.3) and highest for administrative load (4.2, SD 3.4). Inverse association was found between the TBQ score and medication adherence (r 0.243 p=0.001). TBQ scores also correlated with daily patient pill/injection requirements (r 0.175 p=0.020). Individuals receiving injectable treatment scored higher than patients on oral drugs (total TBQ 51 (SD 32) vs 39 (SD 27) p=0.002). Conclusions: The TBQ in Spanish is a reliable instrument and showed adequate correlation with QoL and adherence scales in MS patients. TBQ may benefit health resources allocation and provide tailor therapeutic interventions to construct a minimally disruptive care.

Abstract Background: The Treatment Burden Questionnaire (TBQ) is a self-reported measure of the effect of treatment workload on patient wellbeing. We sought to validate the TBQ in Spanish and use it to estimate the burden of treatment in Argentinian patients with multiple sclerosis (MS). Methods: The TBQ was forward-backward translated into Spanish. Two focus groups and 25 semi-structured interviews focused on wording and possible item exclusion. Validation was performed in 2 steps. First, 162 patients across a range of MS severity completed the questionnaire. Confirmatory factor analysis assessed the dimensional structure of the TBQ. Construct validity was assessed by studying correlations with fatigue and quality of life (QoL). Then, in a second cohort of 171 patients, we evaluated the association between TBQ scores and patients’ sex, age, education level, employment status, type of MS, disease duration, comorbidities, EDSS, pharmacological treatment and medication adherence. Results: The questionnaire presented a 3-factor structure in which burden was related to pharmacological treatment; comprehensive health assistance; and psycho-social-economic context. Composite reliability was > 0.8 for all factors. TBQ showed positive correlation with fatigue (rs= 0.467, p=0.006), negative correlation with QoL (rs -0.446, p=0.009). For the second cohort, total TBQ score was 43 (SD 29). Lowest scores were observed on self-monitoring (0.53, SD 1.3) and highest for administrative load (4.2, SD 3.4). Inverse association was found between the TBQ score and medication adherence (r 0.243 p=0.001). TBQ scores also correlated with daily patient pill/injection requirements (r 0.175 p=0.020). Individuals receiving injectable treatment scored higher than patients on oral drugs (total TBQ 51 (SD 32) vs 39 (SD 27) p=0.002). Conclusions: The TBQ in Spanish is a reliable instrument and showed adequate correlation with QoL and adherence scales in MS patients. TBQ may benefit health resources allocation and provide tailor therapeutic interventions to construct a minimally disruptive care.