Reliability of adverse symptom event reporting by clinicians.

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Title: Reliability of adverse symptom event reporting by clinicians.
Authors: Atkinson, Thomas, Li, Yuelin, Coffey, Charles, Sit, Laura, Shaw, Mary, Lavene, Dawn, Bennett, Antonia, Fruscione, Mike, Rogak, Lauren, Hay, Jennifer, Gönen, Mithat, Schrag, Deborah, Basch, Ethan
Source: Quality of Life Research. Sep2012, Vol. 21 Issue 7, p1159-1164. 6p. 2 Charts, 1 Graph.
Subjects: Drug toxicity, Reliability (Personality trait), Symptoms, Adverse health care events, Risk assessment, Data analysis, Retrospective studies
Abstract: Purpose: Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk-benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit. Methods: A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26-91, M = 62.39) from lung ( n = 134), prostate ( n = 113), and Ob/Gyn ( n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials. Results: The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation (0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%). Conclusion: Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches to adverse symptom reporting, such as patient self-reporting, should be considered. [ABSTRACT FROM AUTHOR]
Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: <searchLink fieldCode="JN" term="%22Quality+of+Life+Research%22">Quality of Life Research</searchLink>. Sep2012, Vol. 21 Issue 7, p1159-1164. 6p. 2 Charts, 1 Graph.
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  Data: Purpose: Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk-benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit. Methods: A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26-91, M = 62.39) from lung ( n = 134), prostate ( n = 113), and Ob/Gyn ( n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials. Results: The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation (0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%). Conclusion: Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches to adverse symptom reporting, such as patient self-reporting, should be considered. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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