Dataset Information

Measuring the quality of observational study data in an international HIV research network.

ABSTRACT: Observational studies of health conditions and outcomes often combine clinical care data from many sites without explicitly assessing the accuracy and completeness of these data. In order to improve the quality of data in an international multi-site observational cohort of HIV-infected patients, the authors conducted on-site, Good Clinical Practice-based audits of the clinical care datasets submitted by participating HIV clinics. Discrepancies between data submitted for research and data in the clinical records were categorized using the audit codes published by the European Organization for the Research and Treatment of Cancer. Five of seven sites had error rates >10% in key study variables, notably laboratory data, weight measurements, and antiretroviral medications. All sites had significant discrepancies in medication start and stop dates. Clinical care data, particularly antiretroviral regimens and associated dates, are prone to substantial error. Verifying data against source documents through audits will improve the quality of databases and research and can be a technique for retraining staff responsible for clinical data collection. The authors recommend that all participants in observational cohorts use data audits to assess and improve the quality of data and to guide future data collection and abstraction efforts at the point of care.

SUBMITTER: Duda SN

PROVIDER: S-EPMC3320898 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Measuring the quality of observational study data in an international HIV research network.

Duda Stephany N SN Shepherd Bryan E BE Gadd Cynthia S CS Masys Daniel R DR McGowan Catherine C CC

PloS one 20120406 4

Observational studies of health conditions and outcomes often combine clinical care data from many sites without explicitly assessing the accuracy and completeness of these data. In order to improve the quality of data in an international multi-site observational cohort of HIV-infected patients, the authors conducted on-site, Good Clinical Practice-based audits of the clinical care datasets submitted by participating HIV clinics. Discrepancies between data submitted for research and data in the ...[more]

PMID: 22493676

Similar Datasets

Project description:BackgroundLongitudinal follow-up of older persons living with HIV is essential for the ascertainment of aging-related clinical and behavioral outcomes, and self-administered questionnaires are necessary for collecting behavioral information in research involving persons living with HIV. Web-based self-reported data collection results in higher data quality than paper-and-pencil questionnaires in a wide range of populations. The option of remote web-based surveys may also increase retention in long-term research studies. However, the acceptability and feasibility of web-based data collection in clinical research involving older persons living with HIV have never been studied.ObjectiveThis study aims to assess the acceptability and feasibility of a web-based survey to collect information on sexual, substance use, and physical activity behaviors; compare the data quality of the web-based survey with that of a paper-and-pencil questionnaire; and summarize web-based survey metrics.MethodsThis pilot study took place within the AIDS Clinical Trials Group A5322 study, a longitudinal cohort of men and women living with HIV (aged ≥40 years), followed at 32 clinical sites in the United States and Puerto Rico. A total of 4 sites participated in this study. A web-based survey was created using self-administered questionnaires typically completed in A5322 via paper and pencil. Pilot study participants completed these questionnaires via web-based survey at one research visit in lieu of paper-and-pencil administration. Two questions were added to assess feasibility, defined as participants' perception of the ease of web-based survey completion (very hard, hard, easy, very easy), and their preferred format (computer or tablet, paper and pencil, no preference) for completing the questions in the future (acceptability). Feasibility and acceptability were summarized overall and by demographic and clinical characteristics; the proportion of evaluable data by web-based survey versus previously administered paper-and-pencil questionnaires (data quality) was compared for each question.ResultsAcceptability and feasibility were high overall: 50.0% (79/158) preferred computer or tablet, 38.0% (60/158) reported no preference, and 12.0% (19/158) preferred paper and pencil; 93.0% (147/158) reported survey completion easy or very easy. Older age was associated with lower odds of preferring computer or tablet to paper and pencil (odds ratio per 1-year increase in age: 0.91, 95% CI 0.85-0.98). Individuals who found the survey hard or very hard had a lower median neurocognitive test score than those who found it easy or very easy. Data quality with web-based survey administration was similar to or higher than that with paper-and-pencil administration for most questions.ConclusionsWeb-based survey administration was acceptable and feasible in this cohort of older adults living with HIV, and data quality was high. Web-based surveys can be a useful tool for valid data collection and can potentially improve retention in long-term follow-up studies.

Dataset Information

Measuring the quality of observational study data in an international HIV research network.

Publications

Measuring the quality of observational study data in an international HIV research network.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets