Methods to Evaluate the Effects of Internet-Based Digital Health Interventions for Citizens: Systematic Review of Reviews (Preprint)

BACKGROUND Digital health can empower citizens to manage their health and address health care system problems including poor access, uncoordinated care and increasing costs. Digital health interventions are typically complex interventions. Therefore, evaluations present methodological challenges. OBJECTIVE The objective of this study was to provide a systematic overview of the methods used to evaluate the effects of internet-based digital health interventions for citizens. Three research questions were addressed to explore methods regarding approaches (study design), effects and indicators. METHODS We conducted a systematic review of reviews of the methods used to measure the effects of internet-based digital health interventions for citizens. The protocol was developed a priori according to Preferred Reporting Items for Systematic review and Meta-Analysis Protocols and the Cochrane Collaboration methodology for overviews of reviews. Qualitative, mixed-method, and quantitative reviews published in English or French from January 2010 to October 2016 were included. We searched for published reviews in PubMed, EMBASE, The Cochrane Database of Systematic Reviews, CINHAL and Epistemonikos. We categorized the findings based on a thematic analysis of the reviews structured around study designs, indicators, types of interventions, effects and perspectives. RESULTS A total of 20 unique reviews were included. The most common digital health interventions for citizens were patient portals and patients' access to electronic health records, covered by 10/20 (50%) and 6/20 (30%) reviews, respectively. Quantitative approaches to study design included observational study (15/20 reviews, 75%), randomized controlled trial (13/20 reviews, 65%), quasi-experimental design (9/20 reviews, 45%), and pre-post studies (6/20 reviews, 30%). Qualitative studies or mixed methods were reported in 13/20 (65%) reviews. Five main categories of effects were identified: (1) health and clinical outcomes, (2) psychological and behavioral outcomes, (3) health care utilization, (4) system adoption and use, and (5) system attributes. Health and clinical outcomes were measured with both general indicators and disease-specific indicators and reported in 11/20 (55%) reviews. Patient-provider communication and patient satisfaction were the most investigated psychological and behavioral outcomes, reported in 13/20 (65%) and 12/20 (60%) reviews, respectively. Evaluation of health care utilization was included in 8/20 (40%) reviews, most of which focused on the economic effects on the health care system. CONCLUSIONS Although observational studies and surveys have provided evidence of benefits and satisfaction for patients, there is still little reliable evidence from randomized controlled trials of improved health outcomes. Future evaluations of digital health interventions for citizens should focus on specific populations or chronic conditions which are more likely to achieve clinically meaningful benefits and use high-quality approaches such as randomized controlled trials. Implementation research methods should also be considered. We identified a wide range of effects and indicators, most of which focused on patients as main end users. Implications for providers and the health system should also be included in evaluations or monitoring of digital health interventions.