ReviewDrug safety2012
Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities?
Review in Drug safety, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The value of patient reporting to the pharmacovigilance system: a systematic review.British journal of clinical pharmacology · 2017Pooled it
- Social media data and its potential for pharmacovigilance: a comparative analysis of reported prevalences regarding drug-induced gingival overgrowth (DIGO).Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Detection of adverse drug events in e-prescribing and administrative health data: a validation study.BMC health services research · 2021Article
- Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe.Drug safety · 2019Article
- A qualitative exploration of knowledge, attitudes and practices of hospital pharmacists towards adverse drug reaction reporting system in Lahore, Pakistan.Journal of pharmaceutical policy and practice · 2018Article
- Article
- Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study.Journal of comparative effectiveness research · 2017Article
- Patient Participation and the Use of Ehealth Tools for Pharmacoviligance.Frontiers in pharmacology · 2016Review
- Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014Article
- Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation.Drug safety · 2014Review
- Quality of life in organ transplant recipients participating in an online transplant community.The patient · 2014Article
- The emerging agenda of stratified medicine in neurology.Nature reviews. Neurology · 2014Review
- Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.Drug safety · 2013Article
- Pharmacovigilance as a tool for safety and monitoring: a review of general issues and the specific challenges with end-stage renal failure patients.Drug, healthcare and patient safety · 2013Article
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
Patient-reported outcomes (PROs) from web-based sources are becoming increasingly important, providing opportunities for industry and regulators to understand the benefits and risks of medicines in a real-world context. Although some guidance exists for the use of adverse event (AE) reports from company-sponsored social network sites, this does not cover non-company-sponsored sites. Additionally, there are concerns about the validity of data from social media sources. Techniques for the collection, analysis and reporting of safety data from patients should be defined, and guidelines agreed, to cover PROs and patient-reported adverse drug-related events from more organized sources of patient outcomes. This review considers drivers for web-based PRO adoption in drug safety, the current regulatory framework and potential methodologies, and concludes that there is an urgent unmet need for guidelines on web-based PRO AEs. Stakeholders for the development of any such guidance should include industry, patients, regulators, academic groups and prescribers.
Indexed as
Identifiers
22551007What OpenQuestion 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 OpenQuestion graph.