A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms

DeWitt, Jane E.; Sorofman, Bernard A.

doi:10.1177/009286159903300332

Cited by 24 publications

(24 citation statements)

References 22 publications

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“…Studies in both the UK and the US have proposed that patients could identify their ADRs related to the suspected medicines based on both timing issues and their own knowledge [18][19]. Our study also confirmed this, with some being aware of individual drugs' potential for causing ADRs, However beliefs about medicines also influenced some individuals' views on the association.…”

Section: Main Findingssupporting

confidence: 81%

Public confidence in ADR identification and their views on ADRreporting: mixed methods study

Jarernsiripornkul

Patsuree

Krska

2016

Eur J Clin Pharmacol

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Word count: 248 (abstract)Word count: 4353 (manuscript) 2 Abstract Purpose: The value of patients as potential reporters into pharmacovigilance systems is acknowledged worldwide and allowed in Thailand. However, nothing is known about the Thai public's awareness of direct patient reporting facility or their views concerning it. This study aimed to determine confidence among members of the public in identifying suspected ADRs, information sources they use and their views towards direct ADR reporting.Methods: Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with members of the public, recruited in primary care centres, pharmacies and public places during October 2013 to February 2015. All questionnaire respondents reporting an ADR were invited to participate in Phase 2. Written informed consent was made before the start of the interview.Results: There were 414 (17.2%) of 2400 questionnaire respondents who had experienced an ADR, almost half (46%) of whom used their own experience to identify ADRs. Having a degree, having a severe ADR and consulting a physician increased respondent confidence in the association between medicine and suspected ADR. The majority (27)

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Section: Main Findingssupporting

confidence: 81%

Public confidence in ADR identification and their views on ADRreporting: mixed methods study

Jarernsiripornkul

Patsuree

Krska

2016

Eur J Clin Pharmacol

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“…A qualitative study in the USA explored the processes used by patients to decide possible causes of symptoms and potential attribution as a suspected ADR. The results indicated that ‘people have knowledge about ADR symptoms that is substantially accurate’ and that they may use a ‘prototype’ to facilitate identification of symptoms as an adverse effect [23].…”

Section: Resultsmentioning

confidence: 99%

Patient reporting of suspected adverse drug reactions: a review of published literature and international experience

Blenkinsopp

Wilkie

Wang³

et al. 2006

Brit J Clinical Pharma

273

224

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AimsTo synthesize data from published studies and international experience to identify evidence of potential benefits and drawbacks of direct patient reporting of suspected adverse drug reactions (ADRs) by patients. MethodsStructured search of MEDLINE, CINAHL and PsycINFO supplemented by internet searches and requests for information to key contacts. ResultsSeven studies (eight papers) were included in the review. None of the studies concerned spontaneous reporting by patients. Information on patient reporting systems was obtained for six countries, with summary data repor ted by four. Patient reports identified possible new ADRs that had not previously been repor ted by health professionals. The quality of patient reports appears to be similar to that of health professional reports. There is some evidence that patients report an ADR when they consider their health professional has not paid attention to their concerns. Patient reports may, at least initially, be more time consuming to process. ConclusionsOverall, the evidence indicates that patient reporting of suspected ADRs has more potential benefits than drawbacks. Evaluation of patient reporting systems is needed to provide further evidence.

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“…Relevant known attributes of ADEs were duration, frequency, severity, and seriousness of the ADE; its impact on activities; and the patient's benefit-risk assessment of the drug [24,[30][31][32]. Existing questionnaires were screened for questions covering these topics [26,27,[33][34][35].…”

Section: Assessing Nature and Causality Of Adesmentioning

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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A Model for Understanding Patient Attribution of Adverse Drug Reaction Symptoms

Cited by 24 publications

References 22 publications

Public confidence in ADR identification and their views on ADRreporting: mixed methods study

Public confidence in ADR identification and their views on ADRreporting: mixed methods study

Patient reporting of suspected adverse drug reactions: a review of published literature and international experience

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

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