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for the INDEPENDENT Study Group IMPORTANCE Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented.OBJECTIVE To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression. DESIGN, SETTING, AND PARTICIPANTSParallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A 1c (HbA 1c ) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018.INTERVENTIONS Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months. MAIN OUTCOMES AND MEASURESThe primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA 1c , 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA 1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (Ն50% reduction in SCL-20 score, Ն0.5-percentage point reduction in HbA 1c , Ն5-mm Hg reduction in SBP, Ն10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA 1c , SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA 1c , SBP, and LDL cholesterol. RESULTS Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0). CONCLUSIONS AND RELEVANCE Among patients with diabetes and ...

BackgroundDiabetes mellitus is a major chronic disease, which is connected to direct and indirect costs and productivity losses. However, its effects on labour market participation are not straightforward to identify, nor are they consistently included in cost-of-illness studies. First, this study aims to synthesise existing evidence regarding the impact of diabetes on labour market outcomes that imply a complete absence of work. Second, the analysis takes a particular look at relevant methodological choices and the resulting quality of the studies included.MethodsWe conducted a systematic literature research (PubMed, Embase, PsychINFO), by applying a standard screening, selection and results extraction process, which considered all types of studies including cross-sectional and longitudinal approaches. Risk-of-bias and quality within the studies were assessed and results were compared. We dedicated special attention to the modelling of potential reverse causality between diabetes and labour market outcomes and the consideration of comorbidities and complications.ResultsOverall, 30 studies satisfied our inclusion criteria. We identified four main labour participation outcomes: absence of employment, unemployment, early retirement, and disability pension. The studies reviewed show a negative impact of diabetes on the labour market participation outcomes considered. However, only a few studies controlled for endogeneity, differentiated between type 1 and type 2 diabetes or modelled the impact of comorbidities. We report how modelling choices affect the directions and interpretations of the effects.ConclusionsThe available evidence mainly suggests a negative impact of diabetes on several outcomes indicating labour market participation. The methodological limitations identified can guide future research with respect to both outcomes and methods. This study provides therefore an empirical contribution to the discussion on how to model the economic impact of diabetes.Electronic supplementary materialThe online version of this article (10.1186/s12889-018-6324-6) contains supplementary material, which is available to authorized users.