Document Detail

Informing evidence-based decision-making for patients with comorbidity: availability of necessary information in clinical trials for chronic diseases.
MedLine Citation:
PMID:  22870234     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The population with multiple chronic conditions is growing. Prior studies indicate that patients with comorbidities are frequently excluded from trials but do not address whether information is available in trials to draw conclusions about treatment effects for these patients.
METHODS AND FINDINGS: We conducted a literature survey of trials from 11 Cochrane Reviews for four chronic diseases (diabetes, heart failure, chronic obstructive pulmonary disease, and stroke). The Cochrane Reviews systematically identified and summarized trials on the effectiveness of diuretics, metformin, anticoagulants, longacting beta-agonists alone or in combination with inhaled corticosteroids, lipid lowering agents, exercise and diet. Eligible studies were reports of trials included in the Cochrane reviews and additional papers that described the methods of these trials. We assessed the exclusion and inclusion of people with comorbidities, the reporting of comorbidities, and whether comorbidities were considered as potential modifiers of treatment effects. Overall, the replicability of both the inclusion criteria (mean [standard deviation (SD)]: 6.0 (2.1), range (min-max): 1-9.5) and exclusion criteria (mean(SD): 5.3 (2.1), range: 1-9.5) was only moderate. Trials excluded patients with many common comorbidities. The proportion of exclusions for comorbidities ranged from 0-42 percent for heart failure, 0-55 percent for COPD, 0-44 percent for diabetes, and 0-39 percent for stroke. Seventy of the 161 trials (43.5%) described the prevalence of any comorbidity among participants with the index disease. The reporting of comorbidities in trials was very limited, in terms of reporting an operational definition and method of ascertainment for the presence of comorbidity and treatments for the comorbidity. It was even less common that the trials assessed whether comorbidities were potential modifiers of treatment effects.
CONCLUSIONS: Comorbidities receive little attention in chronic disease trials. Given the public health importance of people with multiple chronic conditions, trials should better report on comorbidities and assess the effect comorbidities have on treatment outcomes.
Cynthia M Boyd; Daniela Vollenweider; Milo A Puhan
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.; Review     Date:  2012-08-03
Journal Detail:
Title:  PloS one     Volume:  7     ISSN:  1932-6203     ISO Abbreviation:  PLoS ONE     Publication Date:  2012  
Date Detail:
Created Date:  2012-08-07     Completed Date:  2013-02-19     Revised Date:  2013-07-12    
Medline Journal Info:
Nlm Unique ID:  101285081     Medline TA:  PLoS One     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e41601     Citation Subset:  IM    
Division of Geriatric Medicine and Gerontology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, United States of America.
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MeSH Terms
Access to Information*
Chronic Disease
Clinical Trials as Topic / instrumentation,  methods*
Decision Making*
Diabetes Mellitus* / drug therapy,  mortality
Evidence-Based Medicine / instrumentation,  methods*
Pulmonary Disease, Chronic Obstructive* / drug therapy,  mortality
Stroke* / drug therapy,  mortality
Grant Support
K23 AG032910/AG/NIA NIH HHS; K23 AG032910/AG/NIA NIH HHS; R21 HS018597-01/HS/AHRQ HHS

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