Evidence map›Paper›PMID 35663143›Full record

ArticleSkin health and disease2021

Do patient characteristics matter when calculating sample size for eczema clinical trials?

L Howells, S Gran, J R Chalmers, B Stuart, M Santer, L Bradshaw, D M Gaunt, M J Ridd, L A A Gerbens, P I Spuls and 3 more

Abstract read
In one paragraph

Article in Skin health and disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

13 authors.

L HowellsCentre of Evidence Based Dermatology School of Medicine University of Nottingham King's Meadow Campus Nottingham UK.ORCID https://orcid.org/0000-0003-4157-7394
S GranCentre of Evidence Based Dermatology School of Medicine University of Nottingham King's Meadow Campus Nottingham UK.ORCID https://orcid.org/0000-0002-2443-5100
J R ChalmersCentre of Evidence Based Dermatology School of Medicine University of Nottingham King's Meadow Campus Nottingham UK.ORCID https://orcid.org/0000-0002-2281-7367
B StuartPrimary Care Research Centre School of Primary Care Population Sciences and Medical Education University of Southampton Southampton UK.ORCID https://orcid.org/0000-0001-5432-7437
M SanterPrimary Care Research Centre School of Primary Care Population Sciences and Medical Education University of Southampton Southampton UK.ORCID https://orcid.org/0000-0001-7264-5260
L BradshawNottingham Clinical Trials Unit University of Nottingham Nottingham UK.
D M GauntBristol Medical School: Population Health Sciences University of Bristol Bristol UK.
M J RiddBristol Medical School: Population Health Sciences University of Bristol Bristol UK.ORCID https://orcid.org/0000-0002-7954-8823
L A A GerbensDepartment of Dermatology Amsterdam Public Health Infection and Immunity Amsterdam UMC University of Amsterdam Amsterdam the Netherlands.ORCID https://orcid.org/0000-0002-5244-5058
P I SpulsDepartment of Dermatology Amsterdam Public Health Infection and Immunity Amsterdam UMC University of Amsterdam Amsterdam the Netherlands.
C HuangHull York Medical School University of Hull Hull UK.
N A FrancisPrimary Care Research Centre School of Primary Care Population Sciences and Medical Education University of Southampton Southampton UK.
K S ThomasCentre of Evidence Based Dermatology School of Medicine University of Nottingham King's Meadow Campus Nottingham UK.ORCID https://orcid.org/0000-0001-7785-7465

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The Patient-Oriented Eczema Measure (POEM) is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To ensure that the statistical significance of clinical trial results is meaningful, trials are often designed by specifying the target difference in the primary outcome as part of the sample size calculation. One method used to specify the target difference is a score that corresponds to a standardized effect size. Objectives: to assess how the standardized effect size of POEM scores vary across age, gender, ethnicity and disease severity. Methods: This study combined data from five UK-based randomized clinical trials of eczema treatments in order to assess differences in self-reported eczema symptoms (POEM) corresponding to a standardized effect size (0.5 SD of baseline POEM scores) across age, gender, ethnicity and disease severity. Results: POEM scores corresponding to 0.5 SD Conclusions: This study provides information that can support those designing clinical trials to determine their sample size and can aid individuals interpreting trial results. Further exploration of differences in populations beyond the United Kingdom is needed.

Identifiers

PMID35663143
PMCPMC9060078

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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.