Evidence map›Paper›PMID 30170553›Full record

ArticleBMC medical research methodology2018

Pure intervention effect or effect in routine health care - blinded or non-blinded randomized controlled trial.

Antti Malmivaara

Abstract read
In one paragraph

Article in BMC medical research methodology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

1 author.

Antti MalmivaaraCentre for Health and Social Economics, National Institute for Health and Welfare, Mannerheimintie 166, 00270, Helsinki, Finland. antti.malmivaara@thl.fi.ORCID 0000-0002-9042-4450

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomized trials provide the most valid evidence of effectiveness of interventions. The study aims to determine the primary study question for randomized controlled trials; to evaluate the study questions in trials on effectiveness of arthroscopic meniscectomy for meniscal rupture of the knee; and to explore the clinical and research implications.

methodsPrevious studies on benchmarking controlled trials were utilized. A literature search was undertaken to find the trials on arthroscopic surgery for meniscal rupture of the knee, data was extracted, and checked for accuracy twice.

resultsThe first question in RCTs is whether to assess the pure intervention effect, or intervention effect in routine health care circumstances. The former necessitates a double blinded design and the latter a non-blind design. The trials on arthroscopic meniscectomy of the knee showed considerable differences in study characteristics.

conclusionsThe study question in RCTs on pure intervention effect dictates use of blinded design, while question of intervention effect in routine health care dictates use of non-blinded design. Blinding should not be considered a validity criterion when study question is on effectiveness in routine health care. When informing patients, the potential for other effects besides the pure intervention effect should be considered.

Indexed as

ArthroscopyCost-Benefit AnalysisDouble-Blind MethodHumansKnee InjuriesOsteoarthritis, KneeOutcome Assessment, Health CareRandomized Controlled Trials as TopicReproducibility of ResultsSingle-Blind MethodApplicabilityArthroscopic partial meniscectomyBlindingClinical comparabilityCost-effectivenessEffectivenessRandomized controlled trialStudy question analysis

Identifiers

PMID30170553
PMCPMC6119259

What OpenQuestion holds

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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.