Evidence map›Paper›PMID 28606102›Full record

ReviewTrials2017

Choosing the target difference ('effect size') for a randomised controlled trial - DELTA

Jonathan A Cook, Steven A Julious, William Sones, Joanne C Rothwell, Craig R Ramsay, Lisa V Hampson, Richard Emsley, Stephen J Walters, Catherine Hewitt, Martin Bland and 4 more

Abstract readConsensus StatementReview
In one paragraph

Review in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. DELTABMJ (Clinical research ed.) · 2018
    Article
  6. Article
  7. 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

14 authors.

Jonathan A CookCentre for Statistics in Medicine, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, Oxford, OX3 7LD, UK. jonathan.cook@ndorms.ox.ac.uk.
Steven A JuliousMedical Statistics Group, School of Health and Related Research (ScHARR), The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
William SonesCentre for Statistics in Medicine, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, Oxford, OX3 7LD, UK.
Joanne C RothwellMedical Statistics Group, School of Health and Related Research (ScHARR), The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Craig R RamsayHealth Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
Lisa V HampsonDepartment of Mathematics and Statistics, Lancaster University, Lancaster, LA1 4YF, UK.
Richard EmsleyCentre for Biostatistics, School of Health Sciences, The University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.
Stephen J WaltersMedical Statistics Group, School of Health and Related Research (ScHARR), The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
Catherine HewittDepartment of Health Sciences, University of York, Heslington, Seebohm Rowntree Building, York, YO10 5DD, UK.
Martin BlandDepartment of Health Sciences, University of York, Heslington, Seebohm Rowntree Building, York, YO10 5DD, UK.
Dean A FergussonClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada.
Jesse A BerlinJohnson & Johnson, 1125 Trenton-Harbourton Road, MS TE3-15, PO Box 200, Titusville, NJ, 08560, USA.
Doug AltmanCentre for Statistics in Medicine, Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, Oxford, OX3 7LD, UK.
Luke D ValeInstitute of Health and Society, Newcastle University, The Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.

Funding

Cancer Research UK 16895Chief Scientist OfficeMedical Research Council MC_PC_16101
6 · The paper itself

Abstract

backgroundA key step in the design of a randomised controlled trial (RCT) is the estimation of the number of participants needed. By far the most common approach is to specify a target difference and then estimate the corresponding sample size; this sample size is chosen to provide reassurance that the trial will have high statistical power to detect such a difference between the randomised groups (at the planned statistical significance level). The sample size has many implications for the conduct of the study, as well as carrying scientific and ethical aspects to its choice. Despite the critical role of the target difference for the primary outcome in the design of an RCT, the manner in which it is determined has received little attention. This article reports the protocol of the Difference ELicitation in TriAls (DELTA METHODS/

designThe DELTA DISCUSSION: Specification of the target difference for the primary outcome is a key component of the design of an RCT. There is a need for better guidance for researchers and funders regarding specification and reporting of this aspect of trial design. The aim of this project is to produce consensus based guidance for researchers and funders.

Indexed as

Delphi TechniqueSample SizeConsensusEndpoint DeterminationHumansRandomized Controlled Trials as TopicResearch DesignClinically important differenceEffect sizeGuidancePilot studyRandomised controlled trialSample sizeTarget difference

Identifiers

PMID28606102
PMCPMC5469157

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.