Psychological burden and clinical risk profiling in type 2 diabetes: evidence from PROMs in the REWINDER project

Abstract

Objectives
Patient-Reported Outcome Measures (PROMs) are rarely embedded in routine diabetes care, although they provide information not captured by clinical and administrative data alone. The REWINDER project aimed to integrate PROMs with real-world diabetes data from Emilia-Romagna to describe psychological burden in people with type 2 diabetes and explore its relationship with metabolic and clinical indicators, particularly glycaemic control and patient risk profiling.

Methods
REWINDER is a multicentre observational study with a mixed retrospective/prospective design involving AUSL Romagna, AUSL Reggio Emilia and AOU Parma. A sample including N=521 people with Type 2 diabetes was enrolled by diabetes clinics to monitor the psychological evolution through the administration of three PROMs: PAID-5 for diabetes distress, PHQ-9 for depressive symptoms and WHO-5 for psychological well-being. Questionnaires collected at baseline were expected to be evaluated after 6 months, linked with demographic, clinical and service-related data, including HbA1c, disease duration, blood pressure, body mass index and lifestyle information. Descriptive analyses were conducted overall and according to HbA1c target status. A multivariable logistic regression model estimated the probability of reporting a high total PROMs score, indicating psychological compromise, according to sex, age, disease duration and HbA1c target status.

Results
A total of N=353 subjects included in the baseline cohort reported a valid follow-up between 4-10 months. Most participants were men (60.6%), prevalently aged between 50-59 years. Disease duration was 1-5 years in 34.3% and 6-15 years in 44.1%. The sample reported a clinical profile with relevant cardiometabolic and lifestyle difficulties: 54.1% had uncontrolled HbA1c (>7%), 69.1% had systolic blood pressure >=130 mmHg and 66.0% had diastolic blood pressure >=80 mmHg. Among those with lifestyle data, 25.2% reported no physical activity, 30.0% were current smokers and 24.7% former smokers. Approximately 80% were overweight or obese. PROMs identified substantial psychological burden: diabetes distress was present in 30.3%, depressive symptoms in 36.5% and poor psychological well-being in 22.4%. Diabetes distress and depressive symptoms were more frequent among participants outside glycaemic target. Being in HbA1c target was associated with a lower probability of reporting a high total PROMs score (OR=0.59; p=0.0496; 95% CI 0.35-0.99), whereas female sex was strongly associated with higher psychological risk (OR=2.67; p=0.0002; 95% CI 1.61-4.47). Age showed a small inverse association, while disease duration was not significant. Probability curves confirmed higher predicted risk among women and among those outside HbA1c target.

Conclusions
The REWINDER study provided a practical demonstration of how PROMs can help clinicians integrating patient experience and psychological risk assessment into diabetologic consultations. These findings support the inclusion of diabetes distress assessment in routine care to activate timely and targeted psychological, educational and integrated interventions, as recommended by recent international guidelines. The gender difference suggests areas of concern among women at higher risk. Further studies are needed to clarify the relationship between glycaemic values and psychological burden. A companion abstract discusses critical issues regarding the scalability of the approach within the complex federated infrastructure of REWINDER and the hurdles experienced in data collection and regular follow-up of PROMs.