Direct-to-patient digital diagnostics in primary care: Opportunities, challenges, and conditions necessary for responsible digital diagnostics.

BACKGROUND: Diagnostics are increasingly shifting to patients' home environment, facilitated by new digital technologies. Digital diagnostics (diagnostic services enabled by digital technologies) can be a tool to better respond to the challenges faced by primary care systems while aligning with patients' and healthcare professionals' needs. However, it needs to be clarified how to determine the success of these interventions. OBJECTIVES: We aim to provide practical guidance to facilitate the adequate development and implementation of digital diagnostics. STRATEGY: Here, we propose the quadruple aim (better patient experiences, health outcomes and professional satisfaction at lower costs) as a framework to determine the contribution of digital diagnostics in primary care. Using this framework, we critically analyse the advantages and challenges of digital diagnostics in primary care using scientific literature and relevant casuistry. RESULTS: Two use cases address the development process and implementation in the Netherlands: a patient portal for reporting laboratory results and digital diagnostics as part of hybrid care, respectively. The third use case addresses digital diagnostics for sexually transmitted diseases from an international perspective. CONCLUSIONS: We conclude that although evidence is gathering, the often-expected value of digital diagnostics needs adequate scientific evidence. We propose striving for evidence-based 'responsible digital diagnostics' (sustainable, ethically acceptable, and socially desirable digital diagnostics). Finally, we provide a set of conditions necessary to achieve it. The analysis and actionable guidance provided can improve the chance of success of digital diagnostics interventions and overall, the positive impact of this rapidly developing field.

Direct Access for Patients to Diagnostic Testing and Results Using eHealth: Systematic Review on eHealth and Diagnostics.

BACKGROUND: The number of people with chronic diseases and the subsequent pressure on health care is increasing. eHealth technology for diagnostic testing can contribute to more efficient health care and lower workload. OBJECTIVE: This systematic review examines the available methods for direct web-based access for patients to diagnostic testing and results in the absence of a health care professional in primary care. METHODS: We searched the PubMed, Embase, Web of Sciences, Cochrane Library, Emcare, and Academic Search Premier databases in August 2019 and updated in July 2021. The included studies focused on direct patient access to web-based triage leading to diagnostic testing, self-sampling or testing, or web-based communication of test results. A total of 45 studies were included. The quality was assessed using the Mixed Methods Appraisal Tool. RESULTS: Most studies had a quantitative descriptive design and discussed a combination of services. Diagnostic test services mainly focused on sexually transmitted infections. Overall, the use was high for web-based triage (3046/5000, >50%, who used a triage booked a test), for self-sampling or self-testing kits (83%), and the result service (85%). The acceptability of the test services was high, with 81% preferring home-based testing over clinic-based testing. There was a high rate of follow-up testing or treatment after a positive test (93%). CONCLUSIONS: The results show that direct access to testing and result services had high use rates, was positively evaluated, and led to high rates of follow-up treatment. More research on cost-effectiveness is needed to determine the potential for other diseases. Direct access to diagnostic testing can lower the threshold for testing in users, potentially increase efficiency, and lower the workload in primary care.

The Effect of Integration of Self-Management Web Platforms on Health Status in Chronic Obstructive Pulmonary Disease Management in Primary Care (e-Vita Study): Interrupted Time Series Design.

BACKGROUND: Worldwide nearly 3 million people die from chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves quality of life for COPD patients and can reduce hospitalization. Self-management of COPD through eHealth is an effective method to improve IDM and clinical outcomes. OBJECTIVES: The objective of this implementation study was to investigate the effect of 3 chronic obstructive pulmonary disease eHealth programs applied in primary care on health status. The e-Vita COPD study compares different levels of integration of Web-based self-management platforms in IDM in 3 primary care settings. Patient health status is examined using the Clinical COPD Questionnaire (CCQ). METHODS: The parallel cohort design includes 3 levels of integration in IDM (groups 1, 2, 3) and randomization of 2 levels of personal assistance for patients (group A, high assistance, group B, low assistance). Interrupted time series (ITS) design was used to collect CCQ data at multiple time points before and after intervention, and multilevel linear regression modeling was used to analyze CCQ data. RESULTS: Of the 702 invited patients, 215 (30.6%) registered to a platform. Of these, 82 participated in group 1 (high integration IDM), 36 in group 1A (high assistance), and 46 in group 1B (low assistance); 96 participated in group 2 (medium integration IDM), 44 in group 2A (high assistance) and 52 in group 2B (low assistance); also, 37 participated in group 3 (no integration IDM). In the total group, no significant difference was found in change in CCQ trend (P=.334) before (-0.47% per month) and after the intervention (-0.084% per month). Also, no significant difference was found in CCQ changes before versus after the intervention between the groups with high versus low personal assistance. In all subgroups, there was no significant change in the CCQ trend before and after the intervention (group 1A, P=.237; 1B, P=.991; 2A, P=.120; 2B, P=.166; 3, P=.945). CONCLUSIONS: The e-Vita eHealth-supported COPD programs had no beneficial impact on the health status of COPD patients. Also, no differences were found between the patient groups receiving different levels of personal assistance. TRIAL REGISTRATION: Netherlands Trial Registry NTR4098; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4098 (Archived by WebCite at http://www.webcitation.org/6sbM5PayG).

High Level of Integration in Integrated Disease Management Leads to Higher Usage in the e-Vita Study: Self-Management of Chronic Obstructive Pulmonary Disease With Web-Based Platforms in a Parallel Cohort Design.

BACKGROUND: Worldwide, nearly 3 million people die of chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves disease-specific quality of life and exercise capacity for people with COPD, but can also reduce hospital admissions and hospital days. Self-management of COPD through eHealth interventions has shown to be an effective method to improve the quality and efficiency of IDM in several settings, but it remains unknown which factors influence usage of eHealth and change in behavior of patients. OBJECTIVE: Our study, e-Vita COPD, compares different levels of integration of Web-based self-management platforms in IDM in three primary care settings. The main aim of this study is to analyze the factors that successfully promote the use of a self-management platform for COPD patients. METHODS: The e-Vita COPD study compares three different approaches to incorporating eHealth via Web-based self-management platforms into IDM of COPD using a parallel cohort design. Three groups integrated the platforms to different levels. In groups 1 (high integration) and 2 (medium integration), randomization was performed to two levels of personal assistance for patients (high and low assistance); in group 3 there was no integration into disease management (none integration). Every visit to the e-Vita and Zorgdraad COPD Web platforms was tracked objectively by collecting log data (sessions and services). At the first log-in, patients completed a baseline questionnaire. Baseline characteristics were automatically extracted from the log files including age, gender, education level, scores on the Clinical COPD Questionnaire (CCQ), dyspnea scale (MRC), and quality of life questionnaire (EQ5D). To predict the use of the platforms, multiple linear regression analyses for the different independent variables were performed: integration in IDM (high, medium, none), personal assistance for the participants (high vs low), educational level, and self-efficacy level (General Self-Efficacy Scale [GSES]). All analyses were adjusted for age and gender. RESULTS: Of the 702 invited COPD patients, 215 (30.6%) registered to a platform. Of the 82 patients in group 1 (high integration IDM), 36 were in group 1A (personal assistance) and 46 in group 1B (low assistance). Of the 96 patients in group 2 (medium integration IDM), 44 were in group 2A (telephone assistance) and 52 in group 2B (low assistance). A total of 37 patients participated in group 3 (no integration IDM). In all, 107 users (49.8%) visited the platform at least once in the 15-month period. The mean number of sessions differed between the three groups (group 1: mean 10.5, SD 1.3; group 2: mean 8.8, SD 1.4; group 3: mean 3.7, SD 1.8; P=.01). The mean number of sessions differed between the high-assistance and low-assistance groups in groups 1 and 2 (high: mean 11.8, SD 1.3; low: mean 6.7, SD 1.4; F1,80=6.55, P=.01). High-assistance participants used more services (mean 45.4, SD 6.2) than low-assistance participants (mean 21.2, SD 6.8; F1,80=6.82, P=.01). No association was found between educational level and usage and between GSES and usage. CONCLUSIONS: Use of a self-management platform is higher when participants receive adequate personal assistance about how to use the platform. Blended care, where digital health and usual care are integrated, will likely lead to increased use of the online program. Future research should provide additional insights into the preferences of different patient groups. TRIAL REGISTRATION: Nederlands Trial Register NTR4098; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4098 (Archived by WebCite at http://www.webcitation.org/6qO1hqiJ1).

An eHealth Platform to Manage Chronic Disease in Primary Care: An Innovative Approach.

The number of individuals with chronic illness and multimorbidity is growing due to the rapid ageing of the population and the greater longevity of individuals. This causes an increasing workload in care, which results in a growing need for structural changes of the health care system. In recent years this led to a strong focus on promoting "self-management" in chronically ill patients. Research showed that patients who understand more about their disease, health, and lifestyle have better experiences and health outcomes, and often use less health care resources; the effect is even more when these patients are empowered to and responsible for managing their health and disease. In addition to the skills of patients, health care professionals need to shift to a role of teacher, partner, and professional supervisor of their patients. One way of supervising patients is by the use of electronic health (eHealth), which helps patients manage and control their disease. The application of eHealth solutions can provide chronically ill patients high-quality care, to the satisfaction of both patients and health care professionals, alongside a reduction in health care consumption and costs.