Evidence map›Paper›PMID 28710065›Full record

ReviewEvidence-based mental health2018

The limitations of using randomised controlled trials as a basis for developing treatment guidelines.

Roger Mulder, Ajeet B Singh, Amber Hamilton, Pritha Das, Tim Outhred, Grace Morris, Darryl Bassett, Bernhard T Baune, Michael Berk, Philip Boyce and 3 more

Abstract readReview
In one paragraph

Review in Evidence-based mental health, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 7 pooled it
–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

52 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  7. Economic Evaluations Informed Exclusively by Real World Data: A Systematic Review.International journal of environmental research and public health · 2020
    Pooled it
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  12. Beyond RCTs-Better Research Designs and Methods for Psychosocial Efficacy Studies in Mental Health.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2026
    Review
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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

13 authors.

Roger MulderMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Ajeet B SinghMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Amber HamiltonMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Pritha DasMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Tim OuthredMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Grace MorrisMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Darryl BassettMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Bernhard T BauneMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Michael BerkMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Philip BoyceMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Bill LyndonMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Gordon ParkerMood Assessment and Classification (MAC) Committee, Sydney, Australia.
Gin S MalhiMood Assessment and Classification (MAC) Committee, Sydney, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Randomised controlled trials (RCTs) are considered the 'gold standard' by which novel psychotropic medications and psychological interventions are evaluated and consequently adopted into widespread clinical practice. However, there are some limitations to using RCTs as the basis for developing treatment guidelines. While RCTs allow researchers to determine whether a given medication or intervention is effective in a specific patient sample, for practicing clinicians it is more important to know whether it will work for their particular patient in their particular setting. This information cannot be garnered from an RCT. These inherent limitations are exacerbated by biases in design, recruitment, sample populations and data analysis that are inevitable in real-world studies. While trial registration and CONSORT have been implemented to correct and improve these issues, it is worrying that many trials fail to achieve such standards and yet their findings are used to inform clinical decision making. This perspective piece questions the assumptions of RCTs and highlights the widespread distortion of findings that currently undermine the credibility of this powerful design. It is recommended that the clinical guidelines include advice as to what should be considered good and relevant evidence and that external bodies continue to monitor RCTs to ensure that the outcomes published indeed reflect reality.

Indexed as

Clinical Decision-MakingHumansPractice Guidelines as TopicPsychiatryRandomized Controlled Trials as Topicclinical trialsmedical ethicsprotocols & guidelinespsychiatrystatistics & research methods

Identifiers

PMID28710065
PMCPMC10270454

What OpenQuestion holds

Textmetadata
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.