Evidence map›Paper›PMID 33910607›Full record

ArticleTrials2021

Pressure Relieving Support Surfaces: a Randomised Evaluation 2 (PRESSURE 2): using photography for blinded central endpoint review.

Elizabeth McGinnis, Isabelle L Smith, Howard Collier, Lyn Wilson, Susanne Coleman, Nikki Stubbs, Sarah Brown, Rachael Gilberts, Valerie Henderson, Kay Walker and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.5field-weighted citation impact, top 36% of its field
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

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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 at 3 institutions in 1 country.

Elizabeth McGinnisClinical Trials Research Unit, University of Leeds, Leeds, UK.ORCID http://orcid.org/0000-0002-2848-9149
Isabelle L SmithClinical Trials Research Unit, University of Leeds, Leeds, UK.
Howard CollierClinical Trials Research Unit, University of Leeds, Leeds, UK.
Lyn WilsonMid Yorks Hospitals NHS Trust, Wakefield, UK.
Susanne ColemanClinical Trials Research Unit, University of Leeds, Leeds, UK.
Nikki StubbsLeeds Community Healthcare NHS Trust, Leeds, UK.
Sarah BrownClinical Trials Research Unit, University of Leeds, Leeds, UK.
Rachael GilbertsClinical Trials Research Unit, University of Leeds, Leeds, UK.
Valerie HendersonIndependent Tissue Viability Consultant, London, UK.
Kay WalkerPressure Ulcer Research Service User Network, Leeds, UK.
E Andrea NelsonCaledonian University, Glasgow, UK.
Jane NixonClinical Trials Research Unit, University of Leeds, Leeds, UK. j.e.nixon@leeds.ac.uk.
PRESSURE 2 Trial Group
University of Leeds · GBGlasgow Caledonian University · GBIndependent Age · GB

Funding

Health Technology Assessment Programme 11/36/33
6 · The paper itself

Abstract

backgroundPRESSURE 2 is a randomised evaluation of the clinical and cost-effectiveness of two types of mattress for the prevention of pressure ulcers (PUs). The primary clinical endpoint was time to development of a category ≥2 PU. The current 'gold standard' for PU identification is expert clinical assessment. Due to the mattress appearance, a blinded assessment of the endpoint is not possible. This poses a risk to the internal validity of the study. A possible approach is to use photographs of skin sites, with central blinded review. However, there are practical and scientific concerns including patients' consent to photographs, burden of data collection, photograph quality, data completeness and comparison of photographs to the current 'gold standard'. This paper reports the findings of the PRESSURE 2 photographic validation sub-study.

methodWhere consent was obtained, photographs were taken of all category ≥2 PUs on the first presentation to assess over-reporting, and for the assessment of under-reporting, a random sample of 10% patients had an assessment by an independent clinical assessor who also photographed two skin sites. The staff were trained in taking and transferring photographs using standardised procedures and equipment. A card included in the photograph recorded participant details and a 'greyscale' for correction of white balance during processing. Three blinded reviewers assessed the photographs and rated how confident they were in their assessment.

resultsThe trial recruited 2029 patients; 85% consented to photography, and 532 photographs were received and used in the blinded central review. The level of confidence varied by skin classification with more confidence observed when the skin was assessed as being less severe than a category ≥2 PU. Overall, there was a very good reliability compared to the gold standard expert clinical assessment (87.8%, kappa 0.82).

conclusionStudy findings have usefully informed the scientific and practical issues of blinded assessment of PU status to reducing the risk of bias in medical device trials. The reliability of central blinded expert photography was found to be 'very good' (PABAK). Photographs have been found to be an acceptable method of data validation for participants. Methods to improve the quality of photographs would increase the confidence in the assessments.

trial registrationISRCTN Registry ISRCTN01151335 . Registered on 19 April 2013.

Indexed as

PhotographyPressure UlcerBedsHumansReproducibility of ResultsSkinBlinded outcome assessmentPressure ulcerRandomised controlled trialWound photography

Identifiers

PMID33910607
PMCPMC8080319
OpenAlexW3159517631

What OpenQuestion holds

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LicenceCC BY
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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.