Reporting Gaps in mHealth Intervention Studies for Adults With Diabetes: Systematic Review.

چکیده اصلی

BACKGROUND: Diabetes self-management education and support requires scalable digital solutions, making mobile health (mHealth) interventions increasingly vital. Despite their proven clinical efficacy, the real-world translation and scalability of these interventions are severely hindered by fragmented and opaque reporting. To address this methodological gap, the World Health Organization developed the mHealth evidence reporting and assessment (mERA) checklist to standardize reporting transparency. OBJECTIVE: This study aimed to systematically evaluate the reporting completeness of published randomized controlled trials (RCTs) on mHealth interventions for adult diabetes using the mERA checklist; identify critical reporting gaps; analyze how these deficiencies undermine feasibility, scalability, and sustainability; and propose targeted strategies for future optimization. METHODS: A PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)-compliant systematic review was conducted. Five major databases (PubMed, Embase, Web of Science, MEDLINE, and the Cochrane Library) were systematically searched for relevant RCTs published from inception to July 2026. Data extraction and reporting completeness assessments were conducted using the 16-item mERA core checklist. Nonparametric and categorical analyses were used to evaluate factors associated with reporting completeness. RESULTS: A total of 144 RCTs conducted across 49 countries were included in the final analysis. The mean overall mERA reporting score was 6.74 out of 16 (SD 2.71). While basic characteristics such as intervention delivery (n=128, 88.9%) and technology platform (n=117, 81.3%) were well reported, critical system-level domains were largely omitted. Specifically, interoperability (n=12, 8.3%), data security (n=28, 19.4%), compliance with guidelines (n=41, 28.5%), and intervention fidelity (n=53, 36.8%) were severely underreported. Additionally, reporting completeness was significantly higher in studies published between 2016 and 2026 (P=.01) and in multicomponent interventions compared to single-component ones (P=.04). CONCLUSIONS: Empirical research on mHealth interventions for adult diabetes exhibits systemic structural flaws in reporting, particularly concerning system integration, data security, and regulatory compliance. These omissions significantly undermine the transparency, reproducibility, and real-world scalability of digital diabetes care solutions. Future trials must rigorously adopt standardized reporting frameworks such as the mERA checklist to bridge the gap between clinical efficacy and large-scale public health policy translation.

ترجمه فارسی چکیده

مدیریت خودمراقبتی دیابت نیازمند راهکارهای دیجیتال مقیاس‌پذیر است، که اهمیت مداخلات سلامت همراه (mHealth) را افزایش می‌دهد. با وجود اثربخشی بالینی اثبات شده، ترجمه و مقیاس‌پذیری این مداخلات در دنیای واقعی به شدت با گزارش‌دهی پراکنده و مبهم محدود شده است. این مطالعه با استفاده از چک‌لیست mERA (ارزیابی و گزارش شواهد سلامت همراه) WHO، به ارزیابی جامع گزارش‌دهی مطالعات تصادفی‌کنترل‌شده (RCT) منتشر شده در مورد mHealth برای بزرگسالان مبتلا به دیابت پرداخت. نتایج نشان داد میانگین امتیاز گزارش‌دهی mERA 6.74 از 16 بود. در حالی که ویژگی‌های پایه مانند روش ارائه مداخله و پلتفرم فناوری خوب گزارش شده‌اند، حوزه‌های حیاتی سطح سیستم به طور گسترده حذف شده‌اند. به طور خاص، قابلیت همکاری (interoperability)، امنیت داده، رعایت دستورالعمل‌ها و وفاداری مداخله به شدت کمتر گزارش شده‌اند. این خلاء‌ها به شفافیت، تکرارپذیری و مقیاس‌پذیری راهکارهای مراقبت دیابت دیجیتال در دنیای واقعی آسیب جدی می‌زنند.

متن کامل اصلی