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Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) photographic validation sub-study: study

Elizabeth McGinnis1,2, Sarah Brown3, Howard Collier3

  • 1Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. e.mcginnis@leeds.ac.uk.

Trials
|March 22, 2017
PubMed
Summary

This study validates using photographs to assess pressure ulcers in clinical trials, addressing potential bias and patient acceptance. Findings inform the use of photographic data in prevention research and clinical practice.

Keywords:
Blinded outcome assessmentPressure ulcerRandomised controlled trialWound photography

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Area of Science:

  • Medical Technology
  • Clinical Trials Methodology
  • Dermatology

Background:

  • PRESSURE 2 trial evaluates pressure-relieving mattresses for preventing pressure ulcers.
  • Current gold standard for assessment (expert clinical judgment) lacks blinding, risking study validity.
  • Photographic assessment is explored as an alternative to overcome blinding limitations.

Purpose of the Study:

  • To validate the use of patient photographs for assessing pressure ulcer development in a clinical trial.
  • To quantify potential bias (under- and over-reporting) introduced by photographic assessment.
  • To evaluate patient consent and data quality for photographic wound assessment.

Main Methods:

  • Patients consented to skin site photography, taken at observation or ulcer development.
  • A 10% sample underwent additional blinded assessment with and without ulcers.
  • Standardized photography, secure transfer, and calibrated central review were employed.

Main Results:

  • The study assessed the acceptability of photography to patients and staff.
  • Data quality, secure transfer, and confidence in blinded review were evaluated.
  • Sensitivity analysis was performed using photographic assessment of the primary outcome.

Conclusions:

  • Photographic assessment can supplement primary outcome data in pressure ulcer prevention trials.
  • This method informs the potential use of photographic data in clinical practice and future research.
  • Addressing bias and ensuring data integrity are crucial for photographic wound assessment.