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Case record review of adverse events: a new approach.

ABSTRACT: OBJECTIVES:To redesign the existing clinical review form (RF2) used in previous retrospective case record review studies in order to clarify the review process and provide a more powerful analysis of adverse events; and then to ask clinicians to pilot and evaluate the new modular review form (MRF2). The review form is divided into five sections, each with a defined purpose, providing a modular structure. DESIGN:Design and testing of the MRF2 on a sample of medical and nursing records, and evaluation of the reviewers' responses regarding the new review form. SETTING:Hospital based teams from eight countries. RESULTS:The modular review form was reported to be comprehensive, well structured, and clear. Most of the reviewers agreed with the positive statements regarding the review form. Overall, the modular structure was thought to be helpful. Several modifications have been made to the final version to take account of criticisms and suggestions. CONCLUSIONS:The full potential of case record review has yet to be explored. The benefits of this review form include a modular format which enables reviewers or project leaders to select the focus of their review based on resources and the purpose of the review, and to identify contributory factors which indicate areas for improvement and prevention. The training of reviewers is of vital importance for record review. Record review remains one of the primary methods for assessing the incidence of adverse events and the new format is suitable for both prospective and retrospective review.

SUBMITTER: Woloshynowych M

PROVIDER: S-EPMC1758034 | biostudies-literature | 2003 Dec

REPOSITORIES: biostudies-literature

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Case record review of adverse events: a new approach.

Woloshynowych M M Neale G G Vincent C C

Quality & safety in health care 20031201 6

<h4>Objectives</h4>To redesign the existing clinical review form (RF2) used in previous retrospective case record review studies in order to clarify the review process and provide a more powerful analysis of adverse events; and then to ask clinicians to pilot and evaluate the new modular review form (MRF2). The review form is divided into five sections, each with a defined purpose, providing a modular structure.<h4>Design</h4>Design and testing of the MRF2 on a sample of medical and nursing reco ...[more]

PMID: 14645755

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Project description:Six weeks of zidovudine (ZDV) is recommended for postnatal prophylaxis of HIV-exposed infants, but combination antiretrovirals are indicated if HIV transmission risk is increased. We investigated the frequency and severity of adverse events (AE) in infants receiving multiple drug prophylaxis compared to ZDV alone. In this retrospective review of 148 HIV-exposed uninfected infants born between 1997-2009, we determined clinical and laboratory AE that occurred between days of life 8-42. Thirty-six infants received combination prophylaxis; among those, a three-drug regimen containing ZDV, lamivudine, and nevirapine was most common (53%). Rates of laboratory AE grade ?1 were as follows for the combination prophylaxis and ZDV alone groups, respectively: neutropenia 55% and 39%; anemia 50% and 39%; thrombocytopenia 0 and 3%; elevated aspartate aminotransferase 3% and 3%; elevated alanine aminotransferase 0 and 1%; hyperbilirubinemia 19% and 42%. Anemia occurred more frequently in infants who received three-drug prophylaxis compared to infants who received ZDV alone (63% vs. 39%, p = 0.04); all anemia AE were grade 1 or 2 in the three-drug prophylaxis group. Overall, 75% of infants on combination prophylaxis and 66% of infants on ZDV alone developed grade ?1 AE (p = 0.32), and 17% of infants in either group developed grade ?3 AE. Stavudine was substituted for ZDV in 23 infants due to anemia or neutropenia. After this antiretroviral change, 50% of evaluable infants demonstrated improvement in AE grade, and 25% had no change. In conclusion, low grade anemia, neutropenia, and hyperbilirubinemia occurred frequently regardless of the prophylactic regimen, but serious AE were uncommon. Although most AE were typical of ZDV toxicity, the combination of ZDV with lamivudine and nevirapine resulted in an increased frequency of low-grade anemia. Further studies are needed to identify prophylactic regimens with less toxicity for infants born to HIV-infected mothers.

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Case record review of adverse events: a new approach.

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Case record review of adverse events: a new approach.

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