Dataset Information

Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient's Perspective.

ABSTRACT:

Introduction

There is a need for more extensive information about adverse drug reactions (ADRs) for patients than currently available, including information on the course of ADRs. Aspects characterising the course of ADRs from the patient perspective have not been identified before.

Objective

We aimed to develop a framework based on common themes in the course of ADRs identified from patient descriptions in patient-reported ADRs.

Methods

In this qualitative study, patient descriptions of the course of patient-reported ADRs were analysed by a thematic analysis with an inductive approach using three different existing datasets containing patient-reported ADRs. Two datasets included patient-reported ADRs from cohort event monitoring of biologics and direct oral anticoagulants and one dataset included spontaneous reports from patients concerning medication for lower urinary tract symptoms. A conceptual framework was developed from the identified main themes and subthemes.

Results

Patient-reported data concerning 3888 ADRs were analysed. Six main themes with multiple subthemes were identified from patient descriptions of the course of ADRs. Four themes were descriptive: frequency of an ADR episode, duration of an ADR episode, moment or period of ADR occurrence, and development in the intensity of the ADR. Two themes concerned factors influencing the course of ADRs: triggering factors and improving factors.

Conclusions

The presented framework illustrates that patients describe extensive details on the course and timeframe of ADRs. The identified themes provide a basis for improving the systematic data collection of more extensive details about ADRs from patients as a first step towards the provision of more comprehensive ADR information to patients.

SUBMITTER: van Lint JA

PROVIDER: S-EPMC10584729 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient's Perspective.

van Lint Jette A JA Sonnenberg Marlieke M Vonkeman Harald E HE van den Bemt Bart J F BJF van Puijenbroek Eugene P EP Jessurun Naomi T NT

Drug safety 20230831 10

<h4>Introduction</h4>There is a need for more extensive information about adverse drug reactions (ADRs) for patients than currently available, including information on the course of ADRs. Aspects characterising the course of ADRs from the patient perspective have not been identified before.<h4>Objective</h4>We aimed to develop a framework based on common themes in the course of ADRs identified from patient descriptions in patient-reported ADRs.<h4>Methods</h4>In this qualitative study, patient d ...[more]

PMID: 37651084

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Project description:BackgroundNumerous observational studies suggest that preventable adverse drug reactions are a significant burden in healthcare, but no meta-analysis using a standardised definition for adverse drug reactions exists. The aim of the study was to estimate the percentage of patients with preventable adverse drug reactions and the preventability of adverse drug reactions in adult outpatients and inpatients.MethodsStudies were identified through searching Cochrane, CINAHL, EMBASE, IPA, Medline, PsycINFO and Web of Science in September 2010, and by hand searching the reference lists of identified papers. Original peer-reviewed research articles in English that defined adverse drug reactions according to WHO's or similar definition and assessed preventability were included. Disease or treatment specific studies were excluded. Meta-analysis on the percentage of patients with preventable adverse drug reactions and the preventability of adverse drug reactions was conducted.ResultsData were analysed from 16 original studies on outpatients with 48797 emergency visits or hospital admissions and from 8 studies involving 24128 inpatients. No studies in primary care were identified. Among adult outpatients, 2.0% (95% confidence interval (CI): 1.2-3.2%) had preventable adverse drug reactions and 52% (95% CI: 42-62%) of adverse drug reactions were preventable. Among inpatients, 1.6% (95% CI: 0.1-51%) had preventable adverse drug reactions and 45% (95% CI: 33-58%) of adverse drug reactions were preventable.ConclusionsThis meta-analysis corroborates that preventable adverse drug reactions are a significant burden to healthcare among adult outpatients. Among both outpatients and inpatients, approximately half of adverse drug reactions are preventable, demonstrating that further evidence on prevention strategies is required. The percentage of patients with preventable adverse drug reactions among inpatients and in primary care is largely unknown and should be investigated in future research.

Dataset Information

Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient's Perspective.

Introduction

Objective

Methods

Results

Conclusions

Publications

Development of a Framework Structuring Themes in the Course of Adverse Drug Reactions from a Patient's Perspective.

Similar Datasets

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