ReviewEuropean journal of clinical pharmacology2019
'Engagement' of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework.
Review in European journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Empowering citizens to spontaneously report suspected adverse drug reaction: Systematic literature review of interventions and their impact.British journal of clinical pharmacology · 2026Pooled it
- Incorporating Patient Needs and Perspectives in Additional Risk Minimization Measures and Other Pharmacovigilance Deliverables - A Framework and Implementation Roadmap.Therapeutic innovation & regulatory science · 2025Article
- Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study.Drug safety · 2025Article
- Pharmacovigilance - Technological Advancements, Recent Developments and Innovations.Current drug safety · 2025Review
- The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.Drug safety · 2024Review
- Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies.Drug safety · 2024Article
- A scoping review of theories, models and frameworks used or proposed to evaluate knowledge mobilization strategies.Health research policy and systems · 2024Article
- Integrating participants as partners in research governance and operations: an approach from theBMJ open · 2023Review
- The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed.Drug safety · 2023Article
- Review
- How do patients and other members of the public engage with the orphan drug development? A narrative qualitative synthesis.Orphanet journal of rare diseases · 2023Review
- Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis.Drug safety · 2022Review
- Pharmacovigilance and Its Importance for Primary Health Care Professionals.Korean journal of family medicine · 2022Article
- Public-private partnership (3Ps) in ensuring safe use of medicines: An Indian experience.Frontiers in public health · 2022Article
- Pharmacovigilance: reporting requirements throughout a product's lifecycle.Therapeutic advances in drug safety · 2022Review
- Article
- Survery of healthcare professionals to assess the awareness, knowledge and self-reported behavior regarding recent fluoroquinolones safety issues.Medicine and pharmacy reports · 2021Article
- Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.Clinical pharmacology and therapeutics · 2021Article
- Understanding multi-stakeholder needs, preferences and expectations to define effective practices and processes of patient engagement in medicine development: A mixed-methods study.Health expectations : an international journal of public participation in health care and health policy · 2021Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEngagement of patients and healthcare professionals is increasingly considered as fundamental to pharmacovigilance and risk minimisation activities. Few empirical studies of engagement exist and a lack of explicit conceptualisations impedes effective measurement, research and the development of evidence-based engagement interventions.
aimsThis article (1) develops a widely applicable conceptualisation, (2) considers various methodological challenges to researching engagement, proposing some solutions, and (3) outlines a basis for converting the conceptualisation into specific measures and indicators of engagement among stakeholders.
methodWe synthesise social science work on risk governance and public understandings of science with insights from studies in the pharmacovigilance field.
findingsThis leads us to define engagement as an ongoing process of knowledge exchange among stakeholders, with the adoption of this knowledge as the outcome which may feed back into engagement processes over time. We conceptualise this process via three dimensions; breadth, depth and texture. In addressing challenges to capturing each dimension, we emphasise the importance of combining survey approaches with qualitative studies and secondary data on medicines use, prescribing, adverse reaction reporting and health outcomes. A framework for evaluating engagement intervention processes and outcomes is proposed. Alongside measuring engagement via breadth and depth, we highlight the need to research the engagement process through attentiveness to texture-what engagement feels like, what it means to people, and how this shapes motivations based on values, emotions, trust and rationales.
conclusionCapturing all three dimensions of engagement is vital to develop valid understandings of what works and why, thus informing engagement interventions of patients and healthcare professionals to given regulatory pharmacovigilance scenarios.
Indexed as
Identifiers
31240364What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.