Evidence map›Paper›PMID 39574419›Full record

ArticleBMJ medicine2024

Characteristics of non-randomised studies of drug treatments: cross sectional study.

Sally Yaacoub, Raphael Porcher, Anna Pellat, Hillary Bonnet, Viet-Thi Tran, Philippe Ravaud, Isabelle Boutron

Abstract read
In one paragraph

Article in BMJ medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. Article
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

7 authors.

Sally YaacoubUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.ORCID 0000-0003-0819-1561
Raphael PorcherUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.
Anna PellatUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.
Hillary BonnetUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.
Viet-Thi TranUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.ORCID 0000-0003-1863-6739
Philippe RavaudUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.
Isabelle BoutronUniversité Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAe, Centre for Research in Epidemiology and Statistics (CRESS), Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractObjective: To examine the characteristics of comparative non-randomised studies that assess the effectiveness or safety, or both, of drug treatments. Design: Cross sectional study. Data sources: Medline (Ovid), for reports published from 1 June 2022 to 31 August 2022. Eligibility criteria for selecting studies: Reports of comparative non-randomised studies that assessed the effectiveness or safety, or both, of drug treatments were included. A randomly ordered sample was screened until 200 eligible reports were found. Data on general characteristics, reporting characteristics, and time point alignment were extracted, and possible related biases, with a piloted form inspired by reporting guidelines and the target trial emulation framework. Results: Of 462 reports of non-randomised studies identified, 262 studies were excluded (32% had no comparator and 25% did not account for confounding factors). To assess time point alignment and possible related biases, three study time points were considered: eligibility, treatment assignment, and start of follow-up. Of the 200 included reports, 70% had one possible bias, related to: inclusion of prevalent users in 24%, post-treatment eligibility criteria in 32%, immortal time periods in 42%, and classification of treatment in 23%. Reporting was incomplete, and only 2% reported all six of the key elements considered: eligibility criteria (87%), description of treatment (46%), deviations in treatment (27%), causal contrast (11%), primary outcomes (90%), and confounding factors (88%). Most studies used routinely collected data (67%), but only 7% reported using validation studies of the codes or algorithms applied to select the population. Only 7% of reports mentioned registration on a trial registry and 3% had an available protocol. Conclusions: The findings of the study suggest that although access to real world evidence could be valuable, the robustness and transparency of non-randomised studies need to be improved.

Indexed as

Drug therapyEpidemiologyResearch design

Identifiers

PMID39574419
PMCPMC11579539

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Registered trials

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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.