Evidence map›Paper›PMID 30826796›Full record

ReviewBMJ open2019

Analysis and reporting of adverse events in randomised controlled trials: a review.

Rachel Phillips, Lorna Hazell, Odile Sauzet, Victoria Cornelius

Open access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 129 papers, 34 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
129citing papers in PubMed, 34 pooled it
28.4field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

129 citing papers in PubMed, 34 syntheses or guidelines pooled it, 223 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and Safety ofNutrients · 2026
    Pooled it
  3. Pooled it
  4. Evaluating the Use of Anxiety Patient-Reported Outcome Measures (PROMs) in Dementia Clinical Trials: A Systematic Review.Health expectations : an international journal of public participation in health care and health policy · 2026
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Pooled it
  19. Pooled it
  20. Pooled it

69 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

4 authors at 3 institutions in 3 countries.

Rachel PhillipsFaculty of Medicine, School of Public Health, Imperial College London, London, UK.ORCID 0000-0002-3634-7845
Lorna HazellClinical Research, Drug Safety Research Unit, Southampton, UK.
Odile SauzetEpidemiologie & International Public Health, Faculty of Health Sciences, Universität Bielefeld, Bielefeld, Germany.
Victoria CorneliusFaculty of Medicine, School of Public Health, Imperial College London, London, UK.
Faculty of Public Health · GBBielefeld University · DEDrug Safety Research Unit · GB

Funding

Department of Health DRF-2017-10-131
6 · The paper itself

Abstract

objectiveTo ascertain contemporary approaches to the collection, reporting and analysis of adverse events (AEs) in randomised controlled trials (RCTs) with a primary efficacy outcome.

designA review of clinical trials of drug interventions from four high impact medical journals. DATA SOURCES: Electronic contents table of the

methodsA prepiloted checklist was used and single data extraction was performed by three reviewers with independent check of a randomly sampled subset to verify quality. We extracted data on collection methods, assessment of severity and causality, reporting criteria, analysis methods and presentation of AE data.

resultsWe identified 184 eligible reports (

conclusionsThis review highlighted that the collection, reporting and analysis of AE data in clinical trials is inconsistent and RCTs as a source of safety data are underused. Areas to improve include reducing information loss when analysing at patient level and inappropriate practice of underpowered multiple hypothesis testing. Implementation of standard reporting practices could enable a more accurate synthesis of safety data and development of guidance for statistical methodology to assess causality of AEs could facilitate better statistical practice.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsDrug TherapyHumansRandomized Controlled Trials as Topicadverse drug reactionsadverse eventsharm datainvestigational drugrandomised controlled trialssystematic review

Identifiers

PMID30826796
PMCPMC6398660
OpenAlexW2919004480

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.