Investigating Digital Patient-Reported Outcome Measures in Patient-Centered Diabetes Specialist Outpatient Care (DigiDiaS): Protocol for a Multimethod Prospective Observational Study.

BACKGROUND: Living with type 1 diabetes is challenging, and to support self-management, repeated consultations in specialist outpatient care are often required. The emergence of new digital solutions has revolutionized how health care services can be patient centered, providing unprecedented opportunities for flexible, high-quality care. However, there is a lack of studies exploring how the use of digital patient-reported outcome measures (PROMs) for flexible specialist care affects diabetes self-management. To provide new knowledge on the relevance of using PROMs in standard care, we have designed a multimethod prospective study. OBJECTIVE: The overall aim of this protocol is to describe our prospective multimethod observational study designed to investigate digital PROMs in a routine specialist outpatient setting for flexible patient-centered diabetes care (DigiDiaS). METHODS: This protocol outlines the design of a multimethod prospective observational cohort study that includes data from electronic health records, self-reported questionnaires, clinical consultation field observations, and individual in-depth interviews with patients and diabetes health care personnel. All patients with type 1 diabetes at a designated outpatient clinic were invited to participate and use the digital PROM implemented in clinical care. Both users and nonusers of the digital PROM were eligible for the prospective study, allowing for a comparison of the two groups. Data were collected at baseline and after 12 months, including self-management as the primary outcome assessed using the Patient Activation Measure, along with the secondary outcomes of digital health literacy, quality of life, health economy, and clinical variables such as glycated hemoglobin. RESULTS: The digital solution was implemented for routine clinical care in the department in November 2021, and data collection for the prospective study started in October 2022. As of September 6, 2023, 84.6% (186/220) of patients among those in the digital PROM and 15.5% (34/220) of patients among the nonusers have consented to participate. We expect the study to have enough participants by the autumn of 2023. With 1 year of follow-up, the results are expected by spring 2025. CONCLUSIONS: In conclusion, a multimethod prospective observational cohort study can offer valuable insights into the relevance, effectiveness, and acceptability of digital tools using PROMs in diabetes specialist care. Such knowledge is crucial for achieving broad and successful implementation and use of these tools in a large diabetes outpatient clinic. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52766.

Patient-reported outcome measures in diabetes outpatient care: a scoping review.

BACKGROUND: Patient-reported outcome (PRO) measures are increasingly used in clinical diabetes care to increase patient involvement and improve healthcare services. The objectives were to identify instruments used to measure PROs in outpatient diabetes clinics and to investigate the use of these PRO measures alongside the experiences of patients and healthcare personnel in a clinical setting. RESEARCH DESIGN AND METHODS: A scoping review was conducted according to the framework of Arksey and O'Malley with scoping searches of Cinahl, EMBASE, Medline and Health and Psychosocial Instruments. Studies reporting on adults with diabetes in a clinical setting where the PRO measure response directly affected patient care were eligible for inclusion. RESULTS: In total, 35 197 citations were identified, of which 7 reports presenting 4 different PRO measures were included in the review. All four of the included items measured psychosocial aspects of diabetes, and three included elements of the Problem Areas in Diabetes scale. All the patients were satisfied with the use of PRO measures in clinical care, whereas the level of satisfaction among healthcare personnel with PRO measures varied within and among studies. CONCLUSIONS: The limited number of eligible studies in this review suggests that research on PRO measures for diabetes outpatient care is scarce. Patients welcome the opportunity to express their concerns through the systematic collection of PRO measures, and some healthcare personnel value the broader insight that PRO measures provide into the impact of diabetes on patients' lives. However, the heterogeneity among services and among patients challenges the implementation of PRO measures. Research is needed to explore how PRO measures in clinical outpatient care affect healthcare personnel workflow. REVIEW REGISTRATION: https://doi.org/10.17605/OSF.IO/46AHC.

Adapting a Patient-Reported Outcome Measure to Digital Outpatient Specialist Health Care Services for Type 1 Diabetes: User Involvement Study.

BACKGROUND: Diabetes self-management is crucial for patients with type 1 diabetes, and digital services can support their self-management and facilitate flexible follow-up. The potential of using digital patient-reported outcome (PRO) measures in routine outpatient care is not fully used owing to a lack of adapted PRO measures. OBJECTIVE: This study presents the process of identifying and adapting a digital PRO measure for use in clinical diabetes practice and describes the preferred item topics of the adapted PRO measure, as reported by patients and diabetes specialist nurses. METHODS: With the involvement of patients, diabetes specialist nurses, management, and researchers, we hosted a series of workshops and 2 dialogue conferences. Scoping searches to identify relevant PRO measures formed the foundation for the process. An in-person dialogue conference was conducted with diabetes specialist nurses as participants, and a digital dialogue conference was conducted with patients with type 1 diabetes as participants. A diabetes-specific PRO measure was translated and adapted to our digital platform. Notes and summaries from the dialogue conferences were imported into NVivo (QSR International) and thematically analyzed as a single combined data set. RESULTS: The thematic analysis of the 2 dialogue conferences aimed to explore the views of patients with type 1 diabetes and diabetes specialist nurses on the outcomes necessary to measure. An overarching theme, Ensuring that the PRO measure captures the patients' needs precisely and accurately, in a way that facilitates care and communication with health care personnel, was identified and supported with data from both the patients and diabetes specialist nurses. This theme contained four categories: The need for explanatory text after questions to ensure understanding and accurate response, Capturing individual needs in standardized questions, getting to the heart of the patient's problem, and The questions increase patient reflection. CONCLUSIONS: We successfully conducted an iterative process that identified a PRO measure aligned with the topics raised by the diabetes specialist nurses. Similarly, the patients found the PRO measure to be relevant and one that was addressing their needs. Only minor adjustments were necessary when programming the PRO measure in the digital platform. Our management, patients, and diabetes specialist nurses had a valuable impact on the results. User involvement facilitated a specific focus on the clinical requests to be met by PRO measures and how they must be adapted to local and digital platforms. Overall, this has facilitated the current implementation of the adapted digital PRO measure.

Bisphenol A Is More Potent than Phthalate Metabolites in Reducing Pancreatic ß-Cell Function.

Bisphenol A (BPA) and phthalates are common environmental contaminants that have been proposed to influence incidence and development of types 1 and 2 diabetes. Thus, effects of BPA and three phthalate metabolites (monoisobutyl phthalate (MiBP), mono-n-butyl phthalate (MnBP), and mono-(2-ethylhexyl) phthalate (MEHP)) were studied in the pancreatic ß-cell line INS-1E, after 2-72 h of exposure to 5-500 µM. Three endpoints relevant to accelerated development of types 1 or 2 diabetes were investigated: ß-cell viability, glucose-induced insulin secretion, and ß-cell susceptibility to cytokine-induced cell death. BPA and the phthalate metabolites reduced cellular viability after 72 h of exposure, with BPA as the most potent chemical. Moreover, BPA, MEHP, and MnBP increased insulin secretion after 2 h of simultaneous exposure to chemicals and glucose, with potency BPA > MEHP > MnBP. Longer chemical exposures (24-72 h) showed no consistent effects on glucose-induced insulin secretion, and none of the environmental chemicals affected susceptibility to cytokine-induced cell death. Overall, BPA was more potent than the investigated phthalate metabolites in affecting insulin secretion and viability in the INS-1E pancreatic ß-cells. In contrast to recent literature, concentrations with relevance to human exposures (1-500 nM) did not affect the investigated endpoints, suggesting that this experimental model displayed relatively low sensitivity to environmental chemical exposure.