Research Appraisals
Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.
Showing 10 appraisals
JMIR mHealth and uHealth
WeChat-Delivered Mobile Medical Nutrition Therapy Intervention in Gestational Diabetes Mellitus: Randomized Controlled Trial
BACKGROUND: Medical nutrition therapy (MNT) serves as the foundational intervention in the clinical management of gestational diabetes mellitus (GDM) management. However, inadequate supportive care often hinders patients' ability to sustain dietary modifications and self-management behaviors, particularly for complex regimens. Flexible online interventions are thus gaining interest as adjuncts to clinical care, with the potential to improve the outcomes of GDM self-management. OBJECTIVE: This study sought to evaluate the benefits of WeChat-delivered medical nutrition therapy (WeMNT), a WeChat-delivered MNT intervention, for patients with GDM. METHODS: A parallel-group, single-blind randomized controlled trial (with outcome assessor blinding) was implemented at a university hospital's obstetric clinic. Eligible participants were those with a 24- to 28-week singleton pregnancy, a GDM diagnosis confirmed by the 75 g oral glucose tolerance test, no requirement for insulin therapy, and the ability to use a smartphone and WeChat, as well as to communicate in Chinese. Participants were randomized 1:1 to the intervention (n=47, 50%) or control group (n=47, 50%) using a random number table. The WeMNT intervention was designed per the behavior change wheel framework: (1) analyze capability-, opportunity-, and motivation-based barriers related to MNT adherence; (2) formulate targeted intervention functions; and (3) select evidence-based behavior change techniques. Three WeChat mini-programs served as the core delivery platform to implement the multifaceted intervention functions. The primary outcomes measured in this study included fasting blood glucose, 2-hour postprandial glucose (2hPG), hemoglobin A1c (HbA1c), and gestational weight gain (GWG). The secondary outcomes assessed included obstetric complications and neonatal parameters. Intention-to-treat analysis using adjusted generalized linear mixed models was conducted to evaluate the effects of the intervention. RESULTS: From March 2023 to October 2023, a total of 94 participants were enrolled in this study. Among the participants, 88 (93.62%) individuals (mean age 32.18, SD 5.04 years) successfully completed the study, 44 (46.81%) in the intervention group and 44 (46.81%) in the control group. Approximately 68.18% (30/44) of the participants in the intervention group demonstrated sustained adherence, as expected, adhered to the diet plan ≥60% of the days. Compared with the control group, the intervention group showed a significantly greater decrease in GWG over time (group×time interaction: β=-1.96, 95% CI -3.58 to -0.34; P=.02), with no significant effects on fasting blood glucose. Conversely, significant decreases in 2hPG (β=-0.12, 95% CI -0.19 to -0.04; P<.001) and HbA1c (β=-0.49, 95% CI -0.74 to -0.23; P<.001) were noted in the intervention group. No unexpected maternal adverse events occurred, and no significant effects on other health outcomes were detected. CONCLUSIONS: As a WeChat-delivered, behavior change wheel-informed intervention, WeMNT successfully reduced 2hPG, HbA1c, and GWG in GDM management. Its integrated self-management model yields robust evidence, validating this patient-centered tool as a viable option for clinical adoption.
14 June 2026
Read appraisal →Lancet (London, England)
Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial
BACKGROUND: Retatrutide is a GIP, GLP-1, and glucagon triple hormone receptor agonist, under clinical development for type 2 diabetes, obesity, and related complications. We aimed to assess the efficacy and safety of retatrutide as a monotherapy in people with type 2 diabetes that is inadequately controlled by diet and exercise alone. METHODS: In this 40-week, phase 3, randomised, double-blind, placebo-controlled trial at 48 sites in the USA, Mexico, and India, we recruited adults (aged ≥18 years) with type 2 diabetes that is inadequately controlled by diet and exercise alone, glycated haemoglobin (HbA1c) between 7·0% and 9·5% (53-80 mmol/mol), and BMI of at least 23 kg/m2. Participants were randomly assigned (1:1:1:1) to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection. The primary endpoint was the change in HbA1c concentration from baseline to week 40. A key secondary endpoint was the percentage change in bodyweight from baseline to week 40. This trial is registered with ClinicalTrials.gov, NCT06354660, and is completed. FINDINGS: Between April 10, 2024, and April 21, 2025, 930 participants were screened and 537 (296 [55%] female and 241 [45%] male) were randomly assigned: 134 to retatrutide 4 mg, 133 to retatrutide 9 mg, 136 to retatrutide 12 mg, and 134 to placebo. Baseline mean age was 48·8 years (SD 12·1), mean HbA1c concentration was 7·9% (SD 1·1), mean duration of diabetes was 2·5 years (SD 4·4), and mean BMI was 35·8 kg/m2 (SD 7·0). 490 (91%) participants completed the treatment period on study drug and 504 (94%) completed the study. For the treatment regimen estimand, the mean change from baseline in HbA1c concentration was -1·69% (SE 0·11) with retatrutide 4 mg, -1·86% (0·10) with 9 mg, and -1·94% (0·08) with 12 mg, versus -0·81% (0·12) with placebo, resulting in estimated treatment differences versus placebo of -0·88% (95% CI -1·18 to -0·59) with retatrutide 4 mg, -1·04% (-1·32 to -0·76) with 9 mg, and -1·12% (-1·39 to -0·85) with 12 mg (all p<0·0001). The mean percentage change from baseline in bodyweight was -11·5% (SE 0·7) with retatrutide 4 mg, -13·9% (0·8) with 9 mg, and -15·3% (0·8) with 12 mg, versus -2·6% (0·5) with placebo. The most frequent adverse events with retatrutide were generally mild to moderate gastrointestinal events, which subsided over time. Study intervention discontinuations due to adverse events were 2-5% with retatrutide and 0% with placebo. No severe hypoglycaemia was reported. Two deaths occurred during the study, both in the retatrutide 4 mg group and unrelated to the study drug. INTERPRETATION: Retatrutide showed significant improvements in glycaemic control and bodyweight reduction as a monotherapy in adults with type 2 diabetes that is inadequately controlled with diet and exercise alone, with an adverse event profile consistent with molecules with GLP-1 agonist activity, supporting its potential as an effective treatment for type 2 diabetes. FUNDING: Eli Lilly and Company.
13 June 2026
Read appraisal →Medicine
Triple oral therapy combining metformin, SGLT-2 and DPP-4 inhibitors versus dual therapy in type 2 diabetes mellitus: A systematic review and meta-analysis
BACKGROUND: Triple oral therapy combining metformin, sodium-glucose cotransporter 2 inhibitor, and a dipeptidyl peptidase-4 inhibitor has been proposed as a synergistic approach to intensify glycemic control in patients with type 2 diabetes mellitus. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of triple therapy compared to dual therapy (metformin plus either sodium-glucose cotransporter 2 or dipeptidyl peptidase-4 inhibitor). METHODS: Following preferred reporting items for systematic review and meta-analysis guidelines, we searched PubMed, Embase, Scopus, and Web of Science through January 2026. Studies included randomized controlled trials comparing triple versus dual therapy in adults with type 2 diabetes mellitus. Outcomes included hemoglobin A1c (HbA1c), fasting plasma glucose, body weight, achievement of HbA1c < 7%, and adverse events (AEs). Pooled standardized mean differences (SMDs) and risk ratios (RRs) were calculated using random-effects models. RESULTS: Eight studies encompassing 2606 participants were included. Findings indicate triple therapy significantly reduced HbA1c levels compared to dual therapy, with a SMD of - 0.54 (95% confidence interval [CI]: -0.92 to -0.16; P = .005). Triple therapy resulted in greater reduction in fasting plasma glucose, with an SMD of -0.30 (95% CI: -0.62 to 0.01; P = .06). Patients on triple therapy were more likely to achieve HbA1c levels below 7% (RR: 2.02; 95% CI: 1.55-2.63; P < .0001). Weight reduction was modest, with an SMD: -0.14 (95% CI: -0.22 to -0.07; P = .0002). No significant differences were found in total AEs (RR = 0.97; P = .69) or hypoglycemia (RR = 1.32; P = .32), although there was higher discontinuation due to AEs (RR = 2.62; P = .03). CONCLUSION: Triple therapy offers superior glycemic control over dual therapy without major safety trade-offs, though tolerability may affect long-term adherence.
31 May 2026
Read appraisal →The British journal of general practice : the journal of the Royal College of General Practitioners
General practice incentives: a review of the international literature.
BACKGROUND: In Australia, the general practice sector faces significant challenges, leading to a re-evaluation of its predominantly fee-for-service (FFS) funding models. AIM: To conduct a systematic review of reviews that evaluated the efficacy of funding models in general practice on quality outcomes in multidisciplinary primary and preventive care for people with complex chronic conditions, as well as the contextual factors that have influenced their implementation. DESIGN AND SETTING: Only systematic reviews and meta-analyses were included. Search terms covered funding mechanisms, primary care, and general practice. The review followed PRISMA guidelines for systematic reviews. METHOD: PubMed, Cochrane, Embase, CINAHL, PsycInfo, PAIS, and Web of Science databases were searched in November 2023 for publications from 2010 onwards. RESULTS: Twenty reviews were included. Blended payment models incorporating pay-for-performance (P4P) with either capitation payments or FFS were associated with small improvements in quality outcomes, particularly in multidisciplinary settings. Changes in intermediate health outcomes and process measures for people with complex chronic conditions were most evident in diabetes care but inconclusive for other health outcomes and conditions. Improvements were mainly observed in incentivised activities and in less rigorously designed studies, with ceiling effects and variation reported across healthcare systems. There was no evidence that introducing capitation payments as part of blended payments improved quality of care. CONCLUSION: Although blended payment models show promise, evidence for the effectiveness of models including P4P is highly variable. If adopted, careful evaluation of each incentive's impact on both quality and equity will be essential.
31 May 2026
Read appraisal →Endocrine
Female sexual dysfunction in type 1 diabetes: a systematic review and meta-analysis
BACKGROUND: Female sexual dysfunction (FSD) in type 1 diabetes mellitus (T1DM) is an under-appreciated complication. Despite its profound impact on female health, including reduced quality of life and psychological distress, it remains underrepresented in major diabetes guidelines. Current data synthesis is limited, often excluding older populations or failing to compare diabetes subtypes. We aimed to collate the prevalence of FSD in T1DM, pool the risk of FSD in T1DM compared to controls, compare the risk in T1DM vs. T2DM and to investigate the impact of different variables on these effects. METHODS: PubMed/MEDLINE, Embase, Scopus, and Web of Science were searched to identify cross-sectional/cohort studies including T1DM participants. Proportion of women with FSD in T1DM versus age-matched control/T2DM population (if reported), and population characteristics were extracted. RESULTS: The pooled analysis of 18 studies (N = 2476) indicated FSD prevalence of 37% in adults with T1DM (95% CI: 30%, 43%; I2 = 89%; random-effects model). Analysis restricted to studies (n = 12) using standard FSFI cut-off ≤ 26.5 confirmed the summary estimate as 34% (95% CI: 26%, 41%; I2 = 89%). Trim and fill analysis for publication bias found higher FSD risk in T1DM versus age-matched controls (N = 10, adjusted Risk ratio 2.10; 95% CI: 1.30, 3.39; p = 0.002; I2 = 76%). The higher incidence of FSD in T1DM versus T2DM on subgroup analysis (p-interaction < 0.01) appeared to be influenced by diabetes duration (p < 0.01, R2 = 70%). Depression and diabetes control indicators were among most consistent predictors of FSD, whereas continuous subcutaneous insulin infusion had a protective role. CONCLUSIONS: FSD is prevalent in approximately one-third of women with T1DM, with a higher risk compared to those with T2DM, likely due to earlier onset and longer diabetes duration. Comprehensive care strategies that address both the physiological and psychological aspects of T1DM are warranted to improve sexual health and overall well-being in affected women.
30 May 2026
Read appraisal →JMIR formative research
Self-Monitoring Risk Factors for Diabetic Foot Ulceration With the Feetchecker App: Mixed Methods Study
BACKGROUND: A prevalent and serious complication of diabetes mellitus is the development of diabetic foot ulcer (DFU). There is a need for effective solutions that help prevent DFU to support our increasingly stressed health care systems. The use of mobile health (mHealth) tools has been shown to improve awareness and effective self-care management skills in people at risk of developing diabetic foot ulceration. OBJECTIVE: In this study, we aimed to investigate the perceived usefulness, engagement, and overall user experience of the Feetchecker app, a self-monitoring mHealth app for people at risk of DFU. METHODS: A total of 24 patients (mean age 71, SD 8.6 years) with type 2 diabetes mellitus at risk of developing diabetic foot ulceration completed a 3-month evaluation period (70 recruited, 36 included, 12 dropped out) of a self-monitoring mobile app called Feetchecker app. A mixed methods approach was used to combine insights from app data with qualitative data from a pre- and postsurvey as well as interviews with patients and involved podiatrists. Data were analyzed using descriptive statistics and thematic analysis. We evaluated overall use of the app, patient engagement, and user experiences. RESULTS: Patients who fully completed the study conducted 393 feetchecks. In total, 7 patients sent in 9 pictures; all 7 were called for follow-up by a podiatrist. Overall, patients had a positive experience with the app and perceived the Feetchecker app as a valuable tool to monitor their feet for potential risk factors of DFU. Ease of use in performing a feetcheck and sending the podiatrist a picture was described as an important feature. Three main types of engagement with the Feetchecker app emerged: continuous, frequent, and no to little engagement. These patterns highlight enablers for self-monitoring such as ease-of-use, easy access to a podiatrist, and social support, as well as barriers such as digital skills and sustained engagement. Podiatrists highlighted the benefits of having patients report potential issues quicker and the ability to monitor their patients remotely. Challenges remain in integrating the promotion of the Feetchecker app into their consultations. CONCLUSIONS: The Feetchecker app supported patients in self-monitoring risk factors associated with DFU through routine checks and quick contact with a health care professional in case of a potential issue. Overall, patients described a positive user experience and considered the app helpful. While mHealth tools are not for everyone, user engagement for many patients was high and shows that such apps can offer support for people able to use them. Future research should focus on improving usability and engagement with the app as well as extend the way patients can communicate with health care professionals beyond a picture.
29 May 2026
Read appraisal →JMIR research protocols
Evaluating Patient-Entered Electronic Health Data as a Strategy to Improve Quality of Care in a Diabetes Clinic: Protocol for a Randomized Controlled Trial
BACKGROUND: Quality care for pediatric type 1 diabetes (T1D) requires frequent, multidisciplinary visits. Technological and clinical innovation have led to changes in T1D management, resulting in increasing data exchange required during these visits. Capturing comprehensive personal health and diabetes-related information discretely and integrating it into the clinical workflow is critical for optimal T1D care but is time-consuming. Time spent on data transfer often results in less time for holistic care and can lead to unmet needs for patients, families, and health care providers, as well as increased time pressures in clinic. To address this, the Children's Hospital of Eastern Ontario developed a caregiver proxy-reported questionnaire distributed via the MyChart patient portal, allowing families to input care information ahead of visits with the aim of dedicating more clinic time to personalized care. The launch of this tool, which integrates caregiver-entered information into the physician's documentation workflow, brings the opportunity to systematically evaluate its impact on care quality and efficiency, with potential implications for broader adoption. OBJECTIVE: Our objective is to evaluate the impact of a caregiver proxy-reported, electronic health record-integrated preclinic questionnaire (MyChart questionnaire) on the quality of care in a pediatric diabetes clinic, through measurement of its impact on caregiver-perceived quality of care compared to the standard of care using 2 validated measures of care quality. We also aim to explore the impact of the intervention on glycemic control and visit efficiency. METHODS: We conducted a single-center, parallel-group randomized controlled trial designed for 222 children with T1D. Participants were randomly allocated in a 1:1 ratio to either the intervention (MyChart questionnaire) or standard care. Our primary outcome is caregiver-perceived quality of care, as measured by the Patient's Evaluation of the Quality of Diabetes Care at 8 months, administered with caregivers serving as proxy respondents for patients. Secondary outcomes are the Patient's Evaluation of the Quality of Diabetes Care at 4 months and Perceived Quality of Medical Care at 4 and 8 months. Tertiary outcomes include glycemic control and physician-reported visit efficiency at 4 and 8 months. Analysis of covariance models will be used to assess changes between baseline and postintervention outcomes across treatment groups. RESULTS: Recruitment for this study began in April 2023 and was completed in February 2024, with a total of 139 participants enrolled. Data collection has concluded, and the first results are expected in the spring of 2026. CONCLUSIONS: This study is the first randomized trial to assess the impact of a caregiver proxy-reported, electronic health record-integrated, preclinic questionnaire distributed via a patient portal on caregiver-perceived quality of care in a pediatric care setting. The results will guide changes in health service infrastructure and delivery to enhance comprehensive data capture and improve care quality within and beyond pediatric T1D.
13 May 2026
Read appraisal →Molecular neurobiology
Establishing a Diagnostic Model Based on Plasma CDR1as and Alpha-Synuclein for Mild Cognitive Impairment in Type 2 Diabetes
Emerging evidence implicates cerebellar degeneration-related protein 1 antisense transcript (CDR1as) and alpha-synuclein (α-Syn) in diabetes and cognitive decline, suggesting their potential to serve as biomarkers. This study aimed to evaluate their diagnostic efficacy for type 2 diabetes mellitus-associated mild cognitive impairment (T2DM-MCI) and establish a corresponding diagnostic model using machine learning. T2DM-MCI-associated differentially expressed genes were identified from the hippocampus using the Gene Expression Omnibus and predictive databases. The study involved 529 T2DM patients in two phases (training set = 408, test set = 121). Levels of plasma CDR1as, α-Syn, Aβ1-40/1-42, and ApoE genotype were detected. Three diagnostic models were identified using least absolute shrinkage and selection operator (LASSO) and logistic regression. Their performance was assessed using the area under the curve (AUC), net reclassification index (NRI), and integrated discrimination improvement (IDI). The best-performing model was selected from nine machine learning algorithms. Personalized risk assessment was achieved with the SHapley Additive exPlanations (SHAP). Bio-informatics analysis identified CDR1as and α-Syn as potential biomarkers. Their inclusion in multi-modal panels markedly improved diagnostic accuracy. The Random Forest (RF) model outperformed eight other machine learning classifiers (AUC = 0.975, 95% CI: 0.946-0.999) with the lowest Brier score (0.054). When evaluated on a test set, the RF model maintained robust performance (AUC = 0.901, accuracy = 0.850). An online diagnostic tool was established ( https://www.xsmartanalysis.com/model/list/predict/model/html?mid=6734&symbol=816GyBh9ag1Wr9367341 ). The study preliminarily identified CDR1as and α-Syn as promising biomarkers for T2DM-MCI. Integrating these markers with conventional blood tests showed potential clinical utility for improving diagnostic precision.
2 May 2026
Read appraisal →Neurology
Type 1 Diabetes and Incident Dementia: An Analysis in the All of Us Cohort
BACKGROUND AND OBJECTIVES: Although diabetes mellitus (DM) is a well-established determinant of dementia risk, most studies have evaluated type 2 DM (T2DM) or any DM. The influence of type 1 DM (T1DM) on dementia risk remains unclear. We evaluated associations of T1DM and T2DM, separately, with incident dementia using linked electronic health records (EHRs). METHODS: This prospective cohort study used previously collected survey and EHR data from the All of Us (AoU) cohort, a convenience sample of US adults. Eligible participants were 50 years or older and completed baseline surveys. Enrollment began in 2017, with data available through October 2023, along with records before enrollment. Mean follow-up from baseline was 2.4 years. We developed an algorithm to distinguish DM type based on count of T1DM encounters. This algorithm was validated against 2 reference measures: self-reported diabetes type and C-peptide values. Using AoU data, we classified participants as having no DM, T1DM, or T2DM. We ascertained incident dementia using ICD-9, ICD-10, and Systematized Nomenclature of Medicine codes in participants' EHRs. We estimated hazard ratios (HRs) and 95% CIs for the association of diabetes type with incident dementia using Cox proportional hazards models. RESULTS: Among 283,772 participants (mean [SD] age 64.62 [8.96] years; 56.7% women), 60.3% identified as non-Hispanic White and 13.3% as Hispanic/Latino. Optimal DM classification algorithm cutoffs varied by reference standard: self-reported diabetes: ≥1 T1DM EHR encounter (sensitivity: 0.59; specificity: 0.90) and C-peptide: ≥3 T1DM EHR encounters (sensitivity: 0.76; specificity: 0.79). Defining T1DM as having ≥1 T1DM encounter, 5,442 participants had T1DM. Compared with those without DM, participants with T1DM had higher dementia incidence (sociodemographic-adjusted HR 2.82; 95% CI 2.28-3.48) and those with T2DM also had elevated risk (sociodemographic-adjusted HR 2.08; 95% CI 2.87-2.31). Results were similar across sex, race, and ethnicity strata. DISCUSSION: In AoU, DM was associated with elevated dementia risk, with the highest risk among those with T1DM. These findings highlight the need to better understand mechanisms tying T1DM to dementia.
14 Apr 2026
Read appraisal →JMIR research protocols
Remote Management of Patients With Diabetic Macular Edema Receiving Long-Term Intravitreal Anti-Vascular Endothelial Growth Factor Therapy (RE-SHINE Study): Protocol for a Real-World Study
BACKGROUND: Long-term intravitreal anti-vascular endothelial growth factor therapy is the gold standard for treating diabetic macular edema (DME). However, poor treatment adherence in real-world settings often leads to suboptimal visual outcomes. Evidence-based remote management strategies are required to bridge the gap between clinical protocols and patient self-management. OBJECTIVE: This study aims to describe a remote management program based on the Behavior Change Wheel model designed to increase treatment adherence and improve disease outcomes for patients with DME receiving long-term anti-vascular endothelial growth factor therapy, and to report the study protocol. METHODS: The RE-SHINE study was structured into three phases: theoretical modeling, digital platform development, and a validation cohort study. The intervention included a smartphone-based app providing personalized health education, self-monitoring of vision (Amsler grid), injection reminders, and direct communication with health care providers. The efficacy of the remote management model was tested in a real-world cohort study. Participants were assessed at baseline and at each follow-up visit over 12 months. The primary outcome measure was best-corrected visual acuity, and secondary outcome measures included central retinal thickness and treatment adherence (injection rate and follow-up frequency). RESULTS: A total of 1006 patients with DME underwent initial screening, and 958 (95.2%) patients met the inclusion criteria, with only 7 patients declining follow-up. We anticipate that the remote management system will be both feasible and acceptable for patients with DME. It is hypothesized that the intervention group would demonstrate significantly higher levels of treatment adherence and better visual preservation compared to the retrospective control group. In addition, we intend to assess the impact of the digital intervention on patient-reported outcomes, encompassing quality of life and self-efficacy. Participant recruitment began in September 2023 and was completed by the time of submission. The data analysis is yet to begin. The results are expected to be published in 2026. CONCLUSIONS: A Behavior Change Wheel-based remote management approach could be a scalable and sustainable method to enhance adherence in patients requiring long-term intravitreal therapy. If proven effective, this model could be integrated into routine ophthalmic care to mitigate the risk of vision loss due to undertreatment in DME.
7 Apr 2026
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