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 .
Patient-important outcomes in registered diabetes trials.
CONTEXT Concerns about the safety and efficacy of diabetes interventions persist , in part because r and omized clinical trials ( RCTs ) have not measured their effect on patient-important outcomes , ie , death and quality of life ( morbidity , pain , function ) . OBJECTIVE To systematic ally determine the extent to which ongoing and future RCTs in diabetes will ascertain patient-important outcomes . DATA SOURCES On November 10 , 2007 , we search ed primary RCT registries Clinical Trials.gov ( http://www . clinical trials.gov ) , International St and ard R and omized Controlled Trial Number Register ( http://is rct n.org ) , and Australian New Zeal and Clinical Trials Registry ( http://www.anzctr.org.au ) . STUDY SELECTION We identified phase 2 through 4 RCTs  enrolling patients with diabetes . Of 2019 RCTs , 1054 proved eligible . We r and omly sample d 50 % of the eligible RCTs ( 527 of 1054 ) and selected 436 registered since registration became m and atory ( 2004 ) . DATA EXTRACTION Pairs of review ers working independently collected study characteristics and determined the outcomes measured and their type ( physiological outcomes , surrogate outcomes thought to reflect an increased risk for patient-important outcomes , and patient-important outcomes ) . RESULTS Of the 436 registered RCTs included in this analysis , 24 ( 6 % ) had not started enrollment , 109 ( 25 % ) were actively enrolling , and 303 ( 69 % ) had completed enrollment . Primary outcomes were patient-important outcomes in only 78 of 436 RCTs ( 18 % ; 95 % confidence interval [ CI ] , 14%-22 % ) , physiological and laboratory outcomes in 69 of 436 ( 16 % ; 95 % CI , 13%-20 % ) , and surrogate outcomes in 268 of 436 ( 61 % ; 95 % CI , 57%-66 % ) . Patient-important outcomes were reported as primary or secondary outcomes in 201 of 436 ( 46 % ; 95 % CI , 41%-51 % ) . In multivariate analysis , large trials ( odds ratio [ OR ] , 1.10 ; 95 % CI , 1.02 - 1.19 for every additional 100 patients ) and trials of longer duration ( OR , 1.03 ; 95 % CI , 1.01 - 1.06 for every additional 30 days ) were more likely while parallel design RCTs ( OR , 0.15 ; 95 % CI , 0.05 - 0.44 ) and type 2 diabetes trials ( OR , 0.23 ; 95 % CI , 0.09 - 0.61 ) were less likely to assess patient-important outcomes as a primary outcome . CONCLUSION In this sample of registered ongoing RCTs in diabetes , only 18 % included patient-important outcomes as primary outcomes
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 .