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, E. Andrea Nelson, Jane Nixon*, PRESSURE 2 Trial Group

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Downloads (Pure)

Abstract

BACKGROUND: PRESSURE 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.

METHOD: Where 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.

RESULTS: The 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).

CONCLUSION: Study 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 REGISTRATION: ISRCTN Registry ISRCTN01151335 . Registered on 19 April 2013.

Original languageEnglish
Article number308
Number of pages10
JournalTrials
Volume22
DOIs
Publication statusPublished - 28 Apr 2021

Keywords

  • pressure ulcer, wound photography, blinded outcome assessment, randomised controlled trial

Fingerprint

Dive into the research topics of 'Pressure relieving support surfaces: a randomised evaluation 2 (PRESSURE 2): using photography for blinded central endpoint review'. Together they form a unique fingerprint.

Cite this