Informing Evidence-Based Decision-Making for Patients with Comorbidity: Availability of Necessary Information in Clinical Trials for Chronic Diseases

• Published in: PloS one Vol. 7; no. 8; p. e41601
• Main Authors: Boyd, Cynthia M., Vollenweider, Daniela, Puhan, Milo A.
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 03.08.2012; Public Library of Science (PLoS)
• Subjects: Access to Information; Anticholesteremic agents; Anticoagulants; Asthma; Chronic conditions; Chronic Disease; Chronic diseases; Chronic illnesses; Chronic obstructive pulmonary disease; Clinical decision making; Clinical trials; Clinical Trials as Topic - instrumentation; Clinical Trials as Topic - methods; Comorbidity; Coronary artery disease; Corticoids; Corticosteroids; Decision Making; Diabetes mellitus; Diabetes Mellitus - drug therapy; Diabetes Mellitus - mortality; Disease control; Diuretics; Evidence-Based Medicine - instrumentation; Evidence-Based Medicine - methods; Female; Heart diseases; Humans; Lung diseases; Male; Medical research; Medicine; Metformin; Obstructive lung disease; Patients; Public health; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - mortality; Stroke; Stroke - drug therapy; Stroke - mortality; Studies; Surveys; United States > US; Maryland; Baltimore Maryland
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0041601

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. 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. 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.