RESUMEN
BACKGROUND: Engaging diverse stakeholders in developing core outcome sets (COSs) can produce more meaningful metrics as well as research responsive to patient needs. The most common COS prioritisation method, Delphi surveys, has limitations related to selection bias and participant understanding, while qualitative methods like group discussions are less frequently used. This study aims to test a co-creation approach to COS development for type 1 diabetes (T1DM) in Peru. METHODS: Using a co-creation approach, we aimed to prioritise outcomes for T1DM management in Peru, incorporating perspectives from people with T1DM, caregivers, healthcare professionals, and decision-makers. A set of outcomes were previously identified through a systematic review and qualitative evidence synthesis. Through qualitative descriptive methods, including in-person workshops, each group of stakeholders contributed to the ranking of outcomes. Decision-makers also discussed the feasibility of measuring these outcomes within the Peruvian healthcare system. RESULTS: While priorities varied among participant groups, all underscored the significance of monitoring healthcare system functionality over mortality. Participants recognized the interconnected nature of healthcare system performance, clinical outcomes, self-management, and quality of life. When combining the rankings from all the groups, metrics related to economic impact on the individual and structural support, policies promoting health, and protecting those living with T1DM were deemed more important in comparison to measuring clinical outcomes. CONCLUSION: We present the first COS for T1DM focused on low-and-middle-income countries and show aspects of care that are relevant in this setting. Diverse prioritisation among participant groups underscores the need of inclusive decision-making processes. By incorporating varied perspectives, healthcare systems can better address patient needs and enhance overall care quality.
RESUMEN
BACKGROUND: The use of technologies has served to reduce gaps in access to treatment, and digital health interventions show promise in the care of mental health problems. However, to understand what and how these interventions work, it is imperative to document the aspects related to their challenging implementation. OBJECTIVE: The aim of this study was to determine what evidence is available for synchronous digital mental health implementation and to develop a framework, informed by a realist review, to explain what makes digital mental health interventions work for people with mental health problems. METHODS: The SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, and Research type) framework was used to develop the following review question: What makes digital mental health interventions with a synchronous component work on people with mental health problems, including depression, anxiety, or stress, based on implementation, economic, quantitative, qualitative, and mixed methods studies? The MEDLINE, EBM Reviews, PsycINFO, EMBASE, SCOPUS, CINAHL Complete, and Web of Science databases were searched from January 1, 2015, to September 2020 with no language restriction. A Measurement Tool to Assess Systematic Reviews-2 (AMSTAR-2) was used to assess the risk of bias and Confidence in Evidence from Reviews of Qualitative Research (CERQual) was used to assess the confidence in cumulative evidence. Realist synthesis analysis allowed for developing a framework on the implementation of synchronous digital mental health using a grounded-theory approach with an emergent approach. RESULTS: A total of 21 systematic reviews were included in the study. Among these, 90% (n=19) presented a critically low confidence level as assessed with AMSTAR-2. The realist synthesis allowed for the development of three hypotheses to identify the context and mechanisms in which these interventions achieve these outcomes: (1) these interventions reach populations otherwise unable to have access because they do not require the physical presence of the therapist nor the patient, thereby tackling geographic barriers posed by in-person therapy; (2) these interventions reach populations otherwise unable to have access because they can be successfully delivered by nonspecialists, which makes them more cost-effective to implement in health services; and (3) these interventions are acceptable and show good results in satisfaction because they require less need of disclosure and provide more privacy, comfortability, and participation, enabling the establishment of rapport with the therapist. CONCLUSIONS: We developed a framework with three hypotheses that explain what makes digital mental health interventions with a synchronous component work on people with mental health problems. Each hypothesis represents essential outcomes in the implementation process. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020203811; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020203811. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.12688/f1000research.27150.2.
