Mix of methods is needed to identify adverse events in general practice: A prospective observational study

Wetzels, Raymond; Wolters, René; Weel, Chris van; Wensing, Michel

doi:10.1186/1471-2296-9-35

Cited by 60 publications

(77 citation statements)

References 18 publications

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“…Patient self-reports of adverse drug events (ADEs) are an important additional source of information on the safety of drugs because they differ from healthcare professional reports [2][3][4][5][6][7]. Healthcare professionals often underestimate symptomatic ADEs experienced by patients [7,8].…”

Section: Introductionmentioning

confidence: 99%

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

et al. 2013

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Background Direct patient reporting of adverse drug events (ADEs) is relevant for the evaluation of drug safety. To collect such data in clinical trials and postmarketing studies, a valid questionnaire is needed that can measure all possible ADEs experienced by patients. Objective Our aim was to develop and test a generic questionnaire to identify ADEs and quantify their nature and causality as reported by patients. Methods We created a draft list of common ADEs in layterms, which were classified in body categories and mapped to the Medical Dictionary for Regulatory Activities (MedDRA Ò ) terminology. Questions about the nature and causality were derived from existing questionnaires and causality scales. Content validity was tested through cognitive debriefing, revising the questionnaire in an iterative process. Feasibility and reliability were assessed using a Web-based version of the questionnaire. Patients received the questionnaire twice. Feasibility was assessed by the reported time needed for completion and ease of use. Reliability was calculated using Cohen's kappa and proportion of positive agreement (PPA) on: (1) any ADE at patient level; (2) similar ADEs at MedDRA Ò System Organ Class level; and (3) the same ADE at ADE-specific level.Results In the development phase, 28 patients with type 2 diabetes or asthma/chronic obstructive pulmonary disease (COPD) participated. Questions and answer options were rephrased, layout was improved, and changes were made in the classification of ADEs. The final questionnaire consisted of 252 ADEs organized in 16 body categories, and included 14 questions per reported ADE. A total of 135 patients using a median of five different drugs completed the Web-based questionnaire twice. The median completion time was 15 min for patients not reporting any ADE, and 30 min for patients reporting at least one ADE. Three quarters of the patients found the questionnaire easy to use. Test-retest reliability was acceptable at patient level (j = 0.50, PPA 0.64) and at MedDRA Ò System Organ Class level (j = 0.52, PPA 0.54), but was low at ADEspecific level (j = 0.38, PPA 0.38). Conclusion We developed a generic patient-reported ADE questionnaire and confirmed its content validity. The questionnaire was feasible and reliable for reporting any ADE and similar ADEs at MedDRA Ò System Organ Class level. Additional work is, however, needed to reliably quantify specific ADEs reported by patients.

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Section: Introductionmentioning

confidence: 99%

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

et al. 2013

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“…Four studies 26,31,38,39 defined adverse event related to the existence of harm to the patient caused by care. In four other studies 15,17,21,37 adverse event did not necessarily express harm to the patient as a result of care. In two studies 16,33 , patient safety culture was defined similarly as individual and/or group values, attitudes, perceptions, and behavioral patterns that led to a safety management team or organizational commitment ( Table 2).…”

Section: Resultsmentioning

confidence: 99%

“…There was a balance in the yearly distribution of the articles' publication: four in 2007 9,10,11,12 , six in 2008 13,14,15,16,17,18 , three in 2009 19,20,21 , ten in 2010 22,23,24,25,26,27,28,29,30,31 , six in 2011 32,33,34,35,36,37 and four in 2012 38,39,40,41 (Table 2).…”

Section: Resultsmentioning

confidence: 99%

“…All the studies were descriptive. Nine studies were retrospective 9,13,14,15,18,19,32,37,38 , 14 prospective 10,16,20,22, 23,24,25,26,27,28,33,34,39,40 , and ten cross-sectional 11,12,17,21,29,30,31,35,36,41 .…”

Section: Resultsmentioning

confidence: 99%

“…Other studies used a combination of methods for data sources: incident reporting systems, direct observation, and focus groups 35 ; incident reporting systems, direct observation, and interviews 11 ; direct observation with audio recording 29 ; direct observation and expert consensus 36 ; incident reporting systems, patient file review, and interviews 41 ; incident reporting systems and patient file review 21 ; incident reporting systems, interviews, and questionnaires 30 ; expert consensus, questionnaires for patients, and focus groups 31 ; incident reporting systems, patient file review, and questionnaires 41 (Table 2). Six studies 12,17,21,30,31,41 used a combination of data sources. Reporting system were the most frequent data source: 15 studies (45%) 9,11,12,13,14,15,18,19,21,30,32,35,37,38,41 .…”

Section: Resultsmentioning

confidence: 99%

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Franklin

Birch

Savage

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Mix of methods is needed to identify adverse events in general practice: A prospective observational study

Abstract: Background: The validity and usefulness of incident reporting and other methods for identifying adverse events remains unclear. This study aimed to compare five methods in general practice.

Cited by 60 publications

References 18 publications

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

Development and Initial Validation of a Patient-Reported Adverse Drug Event Questionnaire

Patient safety in primary health care: a systematic review

Methodological variability in detecting prescribing errors and consequences for the evaluation of interventions

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