Dataset Information

Under-reporting and Poor Adherence to Monitoring Guidelines for Severe Cases of Isoniazid Hepatotoxicity.

ABSTRACT: BACKGROUND & AIMS:Isoniazid is a leading cause of liver injury but it is not clear how many cases are reported or how many clinicians and patients adhere to American Thoracic Society (ATS) guidelines. We collected data on cases of isoniazid hepatotoxicity and assessed adherence to ATS guidelines and reports to the Centers for Disease Control's (CDC) isoniazid severe adverse events program. METHODS:We analyzed Drug-Induced Liver Injury Network (DILIN) cases considered definite, highly likely, or probable for isoniazid injury from 2004 through 2013. We assessed the delays in isoniazid discontinuance according to ATS criteria and hepatotoxicity severity by Severity Index Score. We checked reporting to the CDC by matching cases based on age, latency, indication, reporting period, and comorbidities. RESULTS:Isoniazid was the second most commonly reported agent in the DILIN, with 69 cases; 60 of these met inclusion criteria. The median age of cases was 49 years (range, 4-68 y), 70% were female, 97% had latent tuberculosis, and 62% were hospitalized. Patients took a median of 9 days to stop taking isoniazid (range, 0-99 days). Thirty-three cases (55%) continued taking isoniazid for more than 7 days after the ATS criteria for stopping were met. Twenty-four cases (40%) continued isoniazid for more than 14 days after meeting criteria for stopping. A delay in stopping was associated with more severe injury (P < .05). Of 13 patients who died or underwent liver transplantation, 9 (70%) continued taking isoniazid for more than 7 days after meeting criteria for stopping. Only 1 of 25 cases of isoniazid hepatotoxicity eligible for reporting to the CDC was reported. CONCLUSIONS:Poor adherence to ATS guidelines is common in cases of hepatotoxicity and is associated with more severe outcomes including hospitalization, death, and liver transplantation. Isoniazid continues to be a leading cause of DILI in the United States, and its hepatotoxicity is under-reported significantly.

SUBMITTER: Hayashi PH

PROVIDER: S-EPMC4653068 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Under-reporting and Poor Adherence to Monitoring Guidelines for Severe Cases of Isoniazid Hepatotoxicity.

Hayashi Paul H PH Fontana Robert J RJ Chalasani Naga P NP Stolz Andrew A AA Talwalkar Jay A JA Navarro Victor J VJ Lee William M WM Davern Timothy J TJ Kleiner David E DE Gu Jiezhun J Hoofnagle Jay H JH

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 20150224 9

<h4>Background & aims</h4>Isoniazid is a leading cause of liver injury but it is not clear how many cases are reported or how many clinicians and patients adhere to American Thoracic Society (ATS) guidelines. We collected data on cases of isoniazid hepatotoxicity and assessed adherence to ATS guidelines and reports to the Centers for Disease Control's (CDC) isoniazid severe adverse events program.<h4>Methods</h4>We analyzed Drug-Induced Liver Injury Network (DILIN) cases considered definite, hig ...[more]

PMID: 25724701

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Project description:Aims of the studyDespite the widespread existence of guidelines regarding undernutrition monitoring and reporting, there is scarce information whether they are followed. We aimed to evaluate the adherence to guidelines regarding undernutrition monitoring and reporting as well as their determinants in a university hospital.MethodsRetrospective analysis of discharged patients with data on Nutritional Risk Screening score (NRS-2002) from the department of internal medicine of the Lausanne University Hospital for years 2013-14. Adherence to the hospital monitoring guidelines, i.e.: 1) discharged patients with NRS-2002 score≥3 should have prealbumin levels measured, and 2) discharged patients with prealbumin levels<0.20 g/l should be rechecked 7 days afterwards, was assessed. Reporting of nutritionally 'at-risk' status in the discharge letter was also assessed. Multivariable logistic regression was used to examine potential determinants of adherence to guidelines.ResultsOf the 2,539 discharged patients with NRS-2002 data, 1,605 (63.0%) were nutritionally 'at-risk'. Complete adherence to the monitoring guideline was observed in 238 (14.8%) of 'at-risk' patients. After multivariable analysis, adherence to the first step of monitoring guideline was associated with older age (≥ 80 years) [OR (95% CI): 2.03 (1.29-3.18)], high comorbidity index [1.36 (1.05-1.77)], and nutritional management [5.57 (4.38-7.07)]. Nutritional management was also associated with adherence to the second step of monitoring [3.98 (2.33-6.78)]. Adherence to the reporting guideline was observed in 343 (21.4%) of 'at-risk' patients. Multivariable analysis showed that adherence to the reporting guideline was associated with NRS-2002 score>4 [1.97 (1.47-2.64)], nutritional management [3.80 (2.85-5.07)], and adherence to the monitoring guideline [3.33 (2.35-4.71)].ConclusionsOur results show a poor adherence to guidelines regarding undernutrition monitoring and reporting, possibly due to lack of training, staff, and time.

Project description:INTRODUCTION:There is evidence that the use of some reporting guidelines, such as the Consolidated Standards for Reporting Trials, is associated with improved completeness of reporting in health research. However, the current levels of adherence to reporting guidelines are suboptimal. Over the last few years, several actions aiming to improve compliance with reporting guidelines have been taken and proposed. We will conduct a scoping review of interventions to improve adherence to reporting guidelines in health research that have been evaluated or suggested, in order to inform future interventions. METHODS AND ANALYSIS:Our review will follow the Joanna Briggs Institute scoping review methods manual. We will search for relevant studies in MEDLINE, EMBASE and Cochrane Library databases. Moreover, we will carry out lateral searches from the reference lists of the included studies, as well as from the lists of articles citing the included ones. One reviewer will screen the full list, which will be randomly split into two halves and independently screened by the other two reviewers. Two reviewers will perform data extraction independently. Discrepancies will be solved through discussion. In addition, this search strategy will be supplemented by a grey literature search. The interventions found will be classified as assessed or suggested, as well as according to different criteria, in relation to their target (journal policies, journal editors, authors, reviewers, funders, ethical boards or others) or the research stage at which they are performed (design, conducting, reporting or peer review). Descriptive statistical analysis will be performed. ETHICS AND DISSEMINATION:A paper summarising the findings from this review will be published in a peer-reviewed journal. This scoping review will contribute to a better understanding and a broader perspective on how the problem of adhering better to reporting guidelines has been tackled so far. This could be a major first step towards developing future strategies to improve compliance with reporting guidelines in health research.

Dataset Information

Under-reporting and Poor Adherence to Monitoring Guidelines for Severe Cases of Isoniazid Hepatotoxicity.

Publications

Under-reporting and Poor Adherence to Monitoring Guidelines for Severe Cases of Isoniazid Hepatotoxicity.

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