Evidence map›Paper›PMID 26873063›Full record

SynthesisBMC medical research methodology2016

The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials: a methodological systematic review.

Segun Bello, Maoling Wei, Jørgen Hilden, Asbjørn Hróbjartsson

Abstract readSystematic Review
In one paragraph

Synthesis in BMC medical research methodology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 4 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

10 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Article
  7. Article
  8. Intense bitterness of molecules: Machine learning for expediting drug discovery.Computational and structural biotechnology journal · 2021
    Article
  9. Article
  10. How placebo characteristics can influence estimates of intervention effects in trials.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
    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

4 authors.

Segun BelloThe Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark. sb@cochrane.dk.
Maoling WeiThe Chinese Cochrane Centre, West China Hospital, Sichuan University, No. 37 Guo Xue Xiang, Chengdu, Sichuan, 610041, P.R. China. maolingwei@hotmail.com.
Jørgen HildenDepartment of Biostatistics, University of Copenhagen, Copenhagen, Denmark. jhilden37@mail.dk.
Asbjørn HróbjartssonThe Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen Ø, Denmark. asbjorn.hrobjartsson@rsyd.dk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBlinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching.

methodsSystematic review. We searched PubMed, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study eligibility and extracted data independently. Our primary analysis was based on the conclusions of each study. In supportive analyses, we defined a low and a high threshold for inadequate matching. We summarised results qualitatively.

resultsWe included studies of 36 trials, of which 28 (78%) were published before 1977. The studies differed considerably with regard to design, methodology and analysis. Sixteen of the 36 studies (44%) concluded inadequate matching. When we adapted high or low thresholds for inadequate matching, the number of trials with inadequate matching was reduced to 12 (33%) or increased to 26 (72%). Inadequate matching was concluded in 7 of 22 trials (32%) based on a defined cohort of trials. Inadequate matching was concluded in 9 of 14 trials (64%) which were not based on a trial cohort, and therefore at a higher risk of publication bias. The proportion of inadequate matching did not seem to depend on publication year. Typical mechanisms of inadequate matching were differences in taste or colour.

conclusionWe identified matching quality studies of 36 randomized clinical drug trials. Sixteen of the 36 studies (44%) concluded inadequate matching. Few studies of matching quality in contemporary trials have been published, but show similar results as found for older trials. Inadequate matching in drug trials may be more prevalent than commonly believed.

Indexed as

Databases, BibliographicDouble-Blind MethodDrug TherapyHumansOutcome Assessment, Health CareQuality ControlRandomized Controlled Trials as TopicReproducibility of ResultsResearch DesignSingle-Blind Method

Identifiers

PMID26873063
PMCPMC4752749

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.