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The use of claims data algorithms to recruit eligible participants into clinical trials
Leonardo Tamariz1, Ana Palacio, Jennifer Denizard
1Miller School of Medicine, University of Miami, 1120 NW 14th St, Ste 971 (H- 201), Miami, FL 33136.
Insights
A new algorithm effectively identifies elderly veterans with hypertension for clinical trials using administrative data. This method, incorporating age and excluding diabetes or stroke, shows high accuracy in participant selection.
Area of Science:
- Clinical Research
- Health Informatics
- Geriatric Medicine
Background:
- Traditional recruitment for hypertension trials often relies on single diagnostic codes, potentially limiting participant pools.
- Exclusion criteria are infrequently integrated into claims-based recruitment strategies, impacting precision.
Purpose of the Study:
- To validate a claims-based algorithm for identifying eligible participants for hypertension trials using Veterans Affairs administrative data.
- To improve the accuracy of participant recruitment by incorporating multiple diagnostic codes and exclusion criteria.
Main Methods:
- A cross-sectional study was conducted using Veterans Affairs administrative data.
- An algorithm was developed to identify subjects aged 75 years or older with hypertension (ICD-9-CM codes 401.x-405.x, 437.2) and without diabetes (250.xx) or stroke (430.x-436.x, 437.1, 437.9, 438.x).
- The algorithm's positive predictive value (PPV) was calculated by comparing identified subjects against their medical records (gold standard).
Main Results:
- The algorithm identified 3591 elderly veterans meeting the specified criteria.
- A review of 76 randomly selected medical records showed a mean age of 83 years, with 48% having coronary artery disease.
- The PPV for the entire algorithm, including age and exclusion criteria, was 83% (95% CI, 73%-91%).
Conclusions:
- Utilizing any International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for hypertension is valuable for identifying elderly patients.
- The developed algorithm serves as an effective tool for recruiting eligible elderly patients with hypertension, excluding those with diabetes or stroke, into clinical trials.
Objectives:
Recruitment strategies usually focused on a single International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code and rarely included exclusion criteria. The purpose of this study was to validate a claims-based algorithm to identify, from Veterans Affairs administrative data, eligible participants to be recruited into a hypertension trial.
Study Design:
Cross-sectional.
Methods:
Subjects were labeled as eligible if they were 75 years or older, had a hypertension ICD-9-CM code (401.x-405.x, 437.2) and did not have a diabetes (250.xx) or stroke (430.x-436.x, 437.1, 437.9, 438.x) ICD-9-CM code. We compared the eligible subjects with the medical record-which was considered the gold standard-and we calculated the positive predictive value (PPV) of identifying a subject in the medical record.
Results:
The algorithm identified 3591 elderly veterans with hypertension with no diabetes or stroke, and we reviewed the medical records of 76 randomly selected patients. In the sample of medical record review, the mean age in years was 83 ± 5.3, 48% had coronary artery disease, and the mean systolic blood pressure was 134 mm Hg ± 15.5. When compared with the medical record, the PPV for any hypertension code was 93% (95% CI, 85%-98%), and for the entire algorithm, including 75 years or older and the absence of both diabetes and stroke, the PPV was 83% (95% CI, 73%-91%).
Conclusions:
The use of any ICD-9-CM code for hypertension is useful to identify elderly patients with hypertension. The algorithm to identify elderly patients with hypertension and without diabetes or stroke is a useful tool to also identify eligible patients for clinical trial participation.
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