Patient-Reported Questionnaires to Identify Adverse Drug Reactions: A Systematic Review

Lim, Renly; Ellett, Lisa M. Kalisch; Roughead, Elizabeth E.; Cheah, Phaik Yeong; Masnoon, Nashwa

doi:10.3390/ijerph182211877

Cited by 9 publications

(9 citation statements)

References 40 publications

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“…The initial content for the SideRep system was primarily based on findings from our systematic review. Detailed findings of the review has been published elsewhere [ 21 ]. Of the 19 questionnaires identified, 15 were for a specific condition or medication, and 4 were general questionnaires applicable to any medication [ 21 ].…”

Section: Resultsmentioning

confidence: 99%

“…Detailed findings of the review has been published elsewhere [ 21 ]. Of the 19 questionnaires identified, 15 were for a specific condition or medication, and 4 were general questionnaires applicable to any medication [ 21 ]. Two of the generic questionnaires, developed by Jarensiripornkul et al [ 24 ] and de Vries et al [ 25 ], were considered the most relevant for our study objective.…”

Section: Resultsmentioning

confidence: 99%

“…The first step of the project was therefore to determine relevant questions that should be included in the system. A systematic literature review was carried out to identify available consumer-reported medicine side effects questionnaires [ 21 ]. Variables considered relevant to our app content development were extracted, including the number and types of questions asked, the use of scoring system, the presence of open-ended questions, and the time taken to complete the questionnaire.…”

Section: Methodsmentioning

confidence: 99%

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Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study

Lim¹,

Thornton²,

Staněk³

et al. 2022

JMIR Form Res

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Background Medicine use is the most common intervention in health care. The frequency with which medicines are used means medication-related problems are very common. One common type of medication-related problems is adverse drug events, which are unintended and harmful effects associated with use of medicines. Reporting of adverse drug events to regulatory authorities is important for evaluation of safety of medicines; however, these adverse effects are frequently unreported due to various factors, including lack of consumer-friendly reporting tools. Objective The aim of this study was to develop a user-friendly digital tool for consumers to report medication-related adverse effects. Methods The project consisted of 3 parts: (1) content development, including a systematic literature search; (2) iterative system development; and (3) usability testing. The project was guided by participatory design principles, which suggest involving key stakeholders throughout the design process. The first 2 versions were developed as a mobile app and were tested with end users in 2 workshops. The third version was developed as a web application and was tested with consumers who were taking regular medicines. Consumers were asked to complete a modified version of the mHealth app usability questionnaire (MAUQ), an 18-item questionnaire with each item scored using a 7-point Likert scale ranging from 0 (strongly disagree) to 7 (strongly agree). The MAUQ assessed 3 subscales including ease of use (5 items), interface and satisfaction (7 items), and usefulness (6 items). Continuous variables were reported as mean (SD) values, whereas categorical variables were presented as frequencies (percentages). Data analysis was conducted in Microsoft Excel. Results The content for the system was based on a systematic literature search and short-listing of questions, followed by feedback from project team members and consumers. Feedback from consumers in the 2 workshops were incorporated to improve the functionality, visual design, and stability of the third (current) version. The third version of the system was tested with 26 consumers. A total of 79% (N=307/390) of all responses on the MAUQ were scored 6 or 7, indicating that users generally strongly agree with the usability of the system. When looking at the individual domains, the system had an average score of 6.3 (SD 0.9) for “ease of use,” 6.3 (SD 0.8) for “interface and satisfaction,” and 5.2 (SD 1.4) for “usefulness.” Conclusions The web-based system for medicine adverse effects reporting is a user-friendly tool developed using an iterative participatory design approach. Future research includes further improving the system, particularly the usefulness of the system, as well as testing the scalability and performance of the system in practice.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study

Lim¹,

Thornton²,

Staněk³

et al. 2022

JMIR Form Res

Self Cite

View full text Add to dashboard Cite

show abstract

“…Reasons for missed dosages, adverse effects, symptom improvement, and other clinically related information were also documented in a specific questionnaire. The questionnaire was developed based on the Patient-Reported Adverse Drug Event Questionnaire and the Generic Symptoms Questionnaire [18]. The questionnaire was mainly check-list based, which was believed to be more sensitive in determining adverse effects.…”

Section: Outcome Assessmentmentioning

confidence: 99%

Application of a WeChat-based mini-app as a patient reminder in Helicobacter pylori eradication: a prospective multi-center randomized controlled study

et al. 2022

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Background To improve the eradication rate of H. pylori, researchers have investigated the role of WeChat-based mini-app as an electronic reminding system in H. pylori treatment. Methods Subjects from three medical centers were divided into two groups. Patients in the daily mini-app-based notification system group received daily notifications via the WeChat mini-app. Patients in the control group received one-time verbal education on the first clinical visit. Both groups received a 14-day quadruple therapy to eradicate H. pylori infection. Eradication rate, compliance, adverse events and satisfaction were evaluated. Results Both intention-to-treat (ITT) and per-protocol (PP) analyses were conducted. The eradication rate in the daily mini-app-based notification system group was slightly higher compared with the control group (ITT analysis: 76.70% vs. 70.73%, p = 0.312; PP analysis: 85.87% vs. 82.86%, p = 0.562). The compliance was significantly higher in the daily mini-app-based notification system group (ITT analysis: 85.52% vs. 70.48%, p = 0.028; PP analysis: 92.39% vs. 81.90%, p = 0.030). The adverse event rates were similar between the two groups (PP analysis: 36.96% vs. 40.95%, p = 0.566). No significant difference in eradication rate was seen in each subgroup analysis by age, place of residence, grade of education, or endoscopic findings. Conclusion The study showed that daily mini-app-based notification improved patient compliance but not H. pylori eradication rate. Trial registration The research was registered in the Chinese Clinical Trial Registry (ChiCTR2000031011, 21/03/2020).

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“…There was an error in the original publication [ 1 ]. We stated that none of the questionnaires included information on how long it took to complete, which is incorrect.…”

Section: Text Correctionmentioning

confidence: 99%

Correction: Lim et al. Patient-Reported Questionnaires to Identify Adverse Drug Reactions: A Systematic Review. Int. J. Environ. Res. Public Health 2021, 18, 11877

Lim

Ellett

Roughead

et al. 2022

IJERPH

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Patient-Reported Questionnaires to Identify Adverse Drug Reactions: A Systematic Review

Cited by 9 publications

References 40 publications

Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study

Development of a Web-Based System to Report Medication-Related Adverse Effects: Design and Usability Study

Application of a WeChat-based mini-app as a patient reminder in Helicobacter pylori eradication: a prospective multi-center randomized controlled study

Correction: Lim et al. Patient-Reported Questionnaires to Identify Adverse Drug Reactions: A Systematic Review. Int. J. Environ. Res. Public Health 2021, 18, 11877

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