Evidence map›Paper›PMID 8664772›Full record

ArticleBMJ (Clinical research ed.)1996

Trials to assess equivalence: the importance of rigorous methods.

B Jones, P Jarvis, J A Lewis, A F Ebbutt

Erratum issued 5 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ (Clinical research ed.), 1996. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 5 registered trials, which are not on this map. Cited by 245 papers, 24 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
245citing papers in PubMed, 24 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.

NCT00307138 phase3completednot on this mapstarted 2004, after this paper: background citation

Hetastarch (Hextend) and Bleeding Complications After Off-Pump Coronary Bypass Surgery

TypeinterventionalSponsorKaiser PermanenteRan2004 to 2005Enrolled330ConditionsPostoperative HemorrhageArmshetastarch
NCT00825604 phase2withdrawnnot on this mapstarted 2009, after this paper: background citation

Quality of Life and Achievement of Target of Treatment After Optimized Medical Treatment, Physical Training and Smoking Cessation With or Without Percutaneous Coronary Intervention in Patients With Stable Angina Pectoris.

TypeinterventionalSponsorGöteborg UniversityRan2009 to 2010Enrolled0ConditionsStable Angina PectorisArmsPercutaneous coronary angioplasty (PCI)
NCT02621658 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Clear Liquid vs Liberalized Diet in Preparation for Colonoscopy

TypeinterventionalSponsorSan Antonio Military Medical CenterRan2016 to 2016Enrolled1,000ConditionsColorectal CancerArmsClear Liquid Diet, Full Liquid Diet
NCT02909322 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

Analgesic and Hemodynamic Effects of Continuous Epidural Analgesia Compared to Paravertebral Block in Liver Resection Patients

TypeinterventionalSponsorDr. Anthony HoRan2016 to 2023Enrolled50ConditionsPain Control After Elective HepatectomyArmsBupivacaine and Hydromorphone, Ropivacaine and Hydromorphone
NCT06754982 narecruitingnot on this mapstarted 2025, after this paper: background citation

Temporal Differences in Pain, Muscle Stiffness, and Function in Subjects With Plantar Fasciitis After Myofascial Release Therapy

TypeinterventionalSponsorUniversidad Católica del MauleRan2025 to 2027Enrolled50ConditionsPlantar Fasciitis of Both FeetArmsMyofascial release
3 · Its place in the literature

Who cites it

245 citing papers in PubMed, 24 syntheses or guidelines pooled it.

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  12. Duration of treatment for asymptomatic bacteriuria during pregnancy.The Cochrane database of systematic reviews · 2015
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  15. Pentoxifylline for diabetic kidney disease.The Cochrane database of systematic reviews · 2012
    Pooled it
  16. Treatments for symptomatic urinary tract infections during pregnancy.The Cochrane database of systematic reviews · 2011
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  20. Systemic corticosteroids for acute gout.The Cochrane database of systematic reviews · 2008
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185 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

B JonesDepartment of Medical Statistics, School of Computing Sciences, De Montfort University, Leicester.
P Jarvis
J A Lewis
A F Ebbutt

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of an equivalence trial is to show the therapeutic equivalence of two treatments, usually a new drug under development and an existing drug for the same disease used as a standard active comparator. Unfortunately the principles that govern the design, conduct, and analysis of equivalence trials are not as well understood as they should be. Consequently such trials often include too few patients or have intrinsic design biases which tend towards the conclusion of no difference. In addition the application of hypothesis testing in analysing and interpreting data from such trials sometimes compounds the drawing of inappropriate conclusions, and the inclusion and exclusion of patients from analysis may be poorly managed. The design of equivalence trials should mirror that of earlier successful trials of the active comparator as closely as possible. Patient losses and other deviations from the protocol should be minimised; analysis strategies to deal with unavoidable problems should not centre on an "intention to treat" analysis but should seek to show the similarity of results from a range of approaches. Analysis should be based on confidence intervals, and this also carries implications for the estimation of the required numbers of patients at the design stage.

Indexed as

Drug TherapyTherapeutic EquivalencyClinical Trials as TopicConfidence IntervalsHumansReproducibility of ResultsResearch DesignSample SizeSensitivity and SpecificityStatistics, Nonparametric

Identifiers

PMID8664772
PMCPMC2351444

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.