Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .
Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial.
Clozapine is associated with significant weight gain and metabolic disturbances .  This multicentre , r and omized study comprised a double-blind , placebo-controlled treatment phase of 16 wk , and an open-label extension phase of 12 wk . Out patients who met DSM-IV-TR criteria for schizophrenia , who were not optimally controlled while on stable dosage of clozapine for > or =3 months and had experienced weight gain of > or = 2.5 kg while taking clozapine , were r and omized ( n=207 ) to aripiprazole at 5 -  15  mg/d or placebo , in addition to a stable dose of clozapine . The primary endpoint was mean change from baseline in body weight at week 16 ( last observation carried forward ) . Secondary endpoints included clinical efficacy , body mass index ( BMI ) and waist circumference . A statistically significant difference in weight loss was reported for aripiprazole vs. placebo ( -2.53 kg vs. -0.38 kg , respectively , difference=-2.15 kg , p<0.001 ) . Aripiprazole-treated patients also showed BMI ( median reduction 0.8 kg/m(2 ) ) and waist circumference reduction ( median reduction 2.0 cm ) vs. placebo ( no change in either parameter , p<0.001 and p=0.001 , respectively ) . Aripiprazole-treated patients had significantly greater reductions in total and low-density lipoprotein ( LDL ) cholesterol . There were no significant differences in Positive and Negative Syndrome Scale total score changes between groups but Clinical Global Impression Improvement and Investigator 's Assessment Question naire scores favoured aripiprazole over placebo .  Safety and tolerability were generally comparable between groups . Combining aripiprazole and clozapine result ed in significant weight , BMI and fasting cholesterol benefits to patients suboptimally treated with clozapine . Improvements may reduce metabolic risk factors associated with clozapine treatment
Discussion The proposed core outcome set will provide clear guidance about what outcomes should be measured , as a minimum , in trials of interventions for people with coexisting type-2 diabetes and SMI , and improve future synthesis of trial evidence in this area .
Background People with diabetes and comorbid severe mental illness ( SMI ) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone .
There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities .
However , there is a lack of consensus about which outcomes are important for this comorbid population , with trials differing in their focus on physical and mental health .
A core outcome set , which includes outcomes across both conditions that are relevant to patients and other key stakeholders , is needed .