ArticleValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research2014
A questionnaire to assess the relevance and credibility of observational studies to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report.
Article in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 53 papers, 7 of them syntheses 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
53 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Tucatinib in patients with HER2-positive advanced/metastatic breast cancer: A systematic literature review of real-world evidence.Breast (Edinburgh, Scotland) · 2026Pooled it
- Pooled it
- Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making.BMJ evidence-based medicine · 2022Pooled it
- A systematic literature review of frequency of vaso-occlusive crises in sickle cell disease.Orphanet journal of rare diseases · 2021Pooled it
- How well can we assess the validity of non-randomised studies of medications? A systematic review of assessment tools.BMJ open · 2021Pooled it
- The Economic Burden of Abuse of Prescription Opioids: A Systematic Literature Review from 2012 to 2017.Applied health economics and health policy · 2018Pooled it
- Risk of All-Cause Mortality in Alcohol-Dependent Individuals: A Systematic Literature Review and Meta-Analysis.EBioMedicine · 2015Pooled it
- Key Real-World Data Management Practices for Registry Evaluation and Quality Assurance.Therapeutic innovation & regulatory science · 2026Article
- Review
- Investigating Real-World Evidence and Reported Survival Outcomes of CDK4/6 Inhibitors in HR+/HER2- Advanced Breast Cancer.Oncology and therapy · 2026Article
- APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2025Article
- Finding the right tool for the specific task: navigating RWE tools and checklists.Future oncology (London, England) · 2025Review
- Real-world effectiveness of CDK4/6i in first-line treatment of HR+/HER2- advanced/metastatic breast cancer: updated systematic review.Frontiers in oncology · 2025Review
- Podcast: Need for Quality Evidence for Decision-Making on Seasonal Influenza Vaccines.Infectious diseases and therapy · 2024Article
- Article
- Article
- Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers.Therapeutic innovation & regulatory science · 2023Article
- HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.Pharmacoepidemiology and drug safety · 2023Article
- Article
- Prevalence of Avoidable and Bias-Inflicting Methodological Pitfalls in Real-World Studies of Medication Safety and Effectiveness.Clinical pharmacology and therapeutics · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
10 authors.
Funding
Abstract
Evidence-based health care decisions are best informed by comparisons of all relevant interventions used to treat conditions in specific patient populations. Observational studies are being performed to help fill evidence gaps. Widespread adoption of evidence from observational studies, however, has been limited because of various factors, including the lack of consensus regarding accepted principles for their evaluation and interpretation. Two task forces were formed to develop questionnaires to assist decision makers in evaluating observational studies, with one Task Force addressing retrospective research and the other Task Force addressing prospective research. The intent was to promote a structured approach to reduce the potential for subjective interpretation of evidence and drive consistency in decision making. Separately developed questionnaires were combined into a single questionnaire consisting of 33 items. These were divided into two domains: relevance and credibility. Relevance addresses the extent to which findings, if accurate, apply to the setting of interest to the decision maker. Credibility addresses the extent to which the study findings accurately answer the study question. The questionnaire provides a guide for assessing the degree of confidence that should be placed from observational studies and promotes awareness of the subtleties involved in evaluating those.
Indexed as
Identifiers
What 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.