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Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors
OBJECTIVES: To perform a systematic review of the frequency of (preventable) adverse events (AE/PAE) and to analyse contributing factors, such as sample size, settings, type of events, terminology, methods of collecting data and characteristics of study populations. REVIEW METHODS: Search of Medline...
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Formato: | Texto |
Lenguaje: | English |
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BMJ Group
2010
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002821/ https://www.ncbi.nlm.nih.gov/pubmed/20679137 http://dx.doi.org/10.1136/qshc.2008.031435 |
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author | Lessing, Constanze Schmitz, Astrid Albers, Bernhard Schrappe, Matthias |
author_facet | Lessing, Constanze Schmitz, Astrid Albers, Bernhard Schrappe, Matthias |
author_sort | Lessing, Constanze |
collection | PubMed |
description | OBJECTIVES: To perform a systematic review of the frequency of (preventable) adverse events (AE/PAE) and to analyse contributing factors, such as sample size, settings, type of events, terminology, methods of collecting data and characteristics of study populations. REVIEW METHODS: Search of Medline and Embase from 1995 to 2007. Included were original papers with data on the frequency of AE or PAE, explicit definition of study population and information about methods of assessment. Results were included with percentages of patients having one or more AE/PAE. Extracted data enclosed contributing factors. Data were abstracted and analysed by two researchers independently. RESULTS: 156 studies in 152 publications met our inclusion criteria. 144/156 studies reported AE, 55 PAE (43 both). Sample sizes ranged from 60 to 8 493 876 patients (median: 1361 patients). The reported results for AE varied from 0.1% to 65.4%, and for PAE from 0.1% to 33.9%. Variation clearly decreased with increasing sample size. Estimates did not differ according to setting, type of event or terminology. In studies with fewer than 1000 patients, chart review prevailed, whereas surveys with more than 100 000 patients were based mainly on administrative data. No effect of patient characteristics was found. CONCLUSIONS: The funnel-shaped distribution of AE and PAE rates with sample size is a probable consequence of variation and can be taken as an indirect indicator of study validity. A contributing factor may be the method of data assessment. Further research is needed to explain the results when analysing data by types of event or terminology. |
format | Text |
id | pubmed-3002821 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | BMJ Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-30028212010-12-23 Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors Lessing, Constanze Schmitz, Astrid Albers, Bernhard Schrappe, Matthias Qual Saf Health Care Original Research OBJECTIVES: To perform a systematic review of the frequency of (preventable) adverse events (AE/PAE) and to analyse contributing factors, such as sample size, settings, type of events, terminology, methods of collecting data and characteristics of study populations. REVIEW METHODS: Search of Medline and Embase from 1995 to 2007. Included were original papers with data on the frequency of AE or PAE, explicit definition of study population and information about methods of assessment. Results were included with percentages of patients having one or more AE/PAE. Extracted data enclosed contributing factors. Data were abstracted and analysed by two researchers independently. RESULTS: 156 studies in 152 publications met our inclusion criteria. 144/156 studies reported AE, 55 PAE (43 both). Sample sizes ranged from 60 to 8 493 876 patients (median: 1361 patients). The reported results for AE varied from 0.1% to 65.4%, and for PAE from 0.1% to 33.9%. Variation clearly decreased with increasing sample size. Estimates did not differ according to setting, type of event or terminology. In studies with fewer than 1000 patients, chart review prevailed, whereas surveys with more than 100 000 patients were based mainly on administrative data. No effect of patient characteristics was found. CONCLUSIONS: The funnel-shaped distribution of AE and PAE rates with sample size is a probable consequence of variation and can be taken as an indirect indicator of study validity. A contributing factor may be the method of data assessment. Further research is needed to explain the results when analysing data by types of event or terminology. BMJ Group 2010-08-02 2010-12 /pmc/articles/PMC3002821/ /pubmed/20679137 http://dx.doi.org/10.1136/qshc.2008.031435 Text en © 2010, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode. |
spellingShingle | Original Research Lessing, Constanze Schmitz, Astrid Albers, Bernhard Schrappe, Matthias Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors |
title | Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors |
title_full | Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors |
title_fullStr | Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors |
title_full_unstemmed | Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors |
title_short | Impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors |
title_sort | impact of sample size on variation of adverse events and preventable adverse events: systematic review on epidemiology and contributing factors |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002821/ https://www.ncbi.nlm.nih.gov/pubmed/20679137 http://dx.doi.org/10.1136/qshc.2008.031435 |
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