Evidence map›Paper›PMID 29713485›Full record

ReviewOpen heart

Strengths and weaknesses of 'real-world' studies involving non-vitamin K antagonist oral anticoagulants.

A John Camm, Keith A A Fox

Registry-linked trialOpen access · goldAbstract readReview
In one paragraph

Review in Open heart. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04490798 (A Retrospective Longitudinal Cohort Study to Determine the Effectiveness of Integrated a Clinical Pathway Approach for Chronic Pain Treatment With Acupuncture in a Pain Clinic), which is not on this map. Cited by 77 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 3 pooled it
9.0field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04490798 completednot on this map

A Retrospective Longitudinal Cohort Study to Determine the Effectiveness of Integrated a Clinical Pathway Approach for Chronic Pain Treatment With Acupuncture in a Pain Clinic

TypeobservationalSponsorHospital Son LlatzerRan2020 to 2021Enrolled3,245ConditionsChronic Pain, Lumbar Back Pain, Osteoarthritis, Knee, HeadacheArmsElectroacupuncture
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 3 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Effect ofWorld journal of gastroenterology · 2024
    Trial
  5. Observational
  6. Article
  7. Observational
  8. A Review of the Importance and Relevance of Real-World Data and Real-World Evidence.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
  9. Article
  10. Article
  11. Article
  12. Observational
  13. Article
  14. Review
  15. Article
  16. Article
  17. Physician-reported patient involvement and treatment decisions in first-line ovarian cancer in the USA and Europe.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2024
    Article
  18. Article
  19. Article
  20. Article

17 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors at 2 institutions in 1 country.

A John CammMolecular and Clinical Sciences Institute, St George's University of London, London, UK.
Keith A A FoxCentre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, UK.
NIHR Imperial Biomedical Research Centre · GBUniversity of Edinburgh · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Randomised controlled trials (RCTs) provide the reference standard for comparing the efficacy of one therapy or intervention with another. However, RCTs have restrictive inclusion and exclusion criteria; thus, they are not fully representative of an unselected real-world population. Real-world evidence (RWE) studies encompass a wide range of research methodologies and data sources and can be broadly categorised as non-interventional studies, patient registries, claims database studies, patient surveys and electronic health record studies. If appropriately designed, RWE studies include a patient population that is far more representative of unselected patient populations than those of RCTs, but they do not provide a robust basis for comparing treatment strategies. RWE studies can have very large sample sizes, can provide information on treatments in patient groups that are usually excluded from RCTs, are generally less expensive and quicker than RCTs, and can assess a broad range of outcomes. Limitations of RWE studies can include low internal validity, lack of quality control surrounding data collection and susceptibility to multiple sources of bias for comparing outcomes. RWE studies can complement the findings from RCTs by providing valuable information on treatment practices and patient characteristics among unselected patients. This information is necessary to guide treatment decisions and for reimbursement and payment decisions. RWE studies have been extensively applied in the postmarketing approval assessment of non-vitamin K antagonist oral anticoagulants since 2010. However, the benefits, costs, limitations and methodological challenges associated with the different types of RWE must be considered carefully when interpreting the findings.

Indexed as

anticoagulantlimitationsreal-world evidence

Identifiers

PMID29713485
PMCPMC5922572
OpenAlexW2801850987

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.