Document Detail


Comorbidity assessment using the Index of Coexistent Diseases in a multicenter clinical trial.
MedLine Citation:
PMID:  11576365     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The Hemodialysis (HEMO) Study is a multicenter trial designed to determine whether hemodialysis dose and membrane flux affect survival. Comorbid conditions are also important determinants of survival, and thus, an accurate and reliable method to assess comorbidity was required. Comorbidity was being assessed at baseline and annually in the HEMO Study using the Index of Coexistent Disease (ICED). We describe the instrument, its implementation in the HEMO Study, and the results of comorbidity assessment in the first 1000 randomized patients in the trial. METHODS: The ICED aggregated the presence and severity of 19 medical conditions and 11 physical impairments within two scales: the Index of Disease Severity (IDS) and the Index of Physical Impairment (IPI). The final ICED score was determined by an algorithm combining the peak scores for the IDS and IPI. The range of the ICED was from 0 to 3, reflecting increasing severity. RESULTS: Study personnel at 15 clinical centers were trained to update and abstract data from the dialysis medical records. Availability of data, measures of construct validity, and measures of reliability were adequate; 99.8% and 60.6% of patients had comorbid conditions in at least one IDS or IPI category, respectively. The distribution of patients by ICED level was 0 (0.2%), 1 (34.9%), 2 (31.2%), and 3 (33.7%). In multivariable analysis, the following factors were significantly associated with more severe comorbidity: older age, diabetes and other causes of renal disease, a lower level of education, employment status (unemployed and retired), longer duration of dialysis, and lower serum creatinine. There was a significant variation in the severity of comorbidity among clinical centers after adjustment for other factors. The R2 of the model was 25.3%, indicating that a substantial proportion of the variation in the ICED was not explained by these factors. CONCLUSIONS: We conclude that comorbidity assessment using the ICED is feasible in multicenter clinical trials of dialysis patients. There is a large burden of comorbidity in dialysis patients, which is not well explained by the cause of renal disease, demographic, and socioeconomic factors and common clinical and laboratory measurements. These variables should not be considered substitutes for comorbid conditions in case-mix adjustment. Comorbidity assessment is useful to describe the sample population, to improve the precision of the treatment effect, and to use possibly as an outcome measurement.
Authors:
D C Miskulin; N V Athienites; G Yan; A A Martin; D B Ornt; J W Kusek; K B Meyer; A S Levey;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Kidney international     Volume:  60     ISSN:  0085-2538     ISO Abbreviation:  Kidney Int.     Publication Date:  2001 Oct 
Date Detail:
Created Date:  2001-09-28     Completed Date:  2002-01-03     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0323470     Medline TA:  Kidney Int     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1498-510     Citation Subset:  IM    
Affiliation:
New England Medical Center, Division of Nephrology, Boston, Massachusetts 0211, USA. dmiskulin@lifespan.org
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MeSH Terms
Descriptor/Qualifier:
Comorbidity
Feasibility Studies
Health Status Indicators*
Humans
Kidney Diseases / epidemiology*,  therapy*
Observer Variation
Pilot Projects
Prospective Studies
Renal Dialysis*
Grant Support
ID/Acronym/Agency:
U01 DK 46114/DK/NIDDK NIH HHS; U01DK 46109/DK/NIDDK NIH HHS; U01DK 46126/DK/NIDDK NIH HHS; U01DK 46143/DK/NIDDK NIH HHS; U01DK 49240/DK/NIDDK NIH HHS; U01DK 49241/DK/NIDDK NIH HHS; U01DK 49243/DK/NIDDK NIH HHS; U01DK 49244/DK/NIDDK NIH HHS; U01DK 49249/DK/NIDDK NIH HHS; U01DK 49252/DK/NIDDK NIH HHS; U01DK 49254/DK/NIDDK NIH HHS; U01DK 49259/DK/NIDDK NIH HHS; U01DK 49261/DK/NIDDK NIH HHS; U01DK 49264/DK/NIDDK NIH HHS; U01DK 49271/DK/NIDDK NIH HHS; UO1DK49242/DK/NIDDK NIH HHS

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