Evidence map›Paper›PMID 31709401›Full record

ArticleEClinicalMedicine2019

Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial.

Jane Nixon, Isabelle L Smith, Sarah Brown, Elizabeth McGinnis, Armando Vargas-Palacios, E Andrea Nelson, Susanne Coleman, Howard Collier, Catherine Fernandez, Rachael Gilberts and 6 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 6 pooled it
15.6field-weighted citation impact, top 1% 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

11 citing papers in PubMed, 6 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Alternating pressure (active) air surfaces for preventing pressure ulcers.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Beds, overlays and mattresses for treating pressure ulcers.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Reactive air surfaces for preventing pressure ulcers.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Foam surfaces for preventing pressure ulcers.The Cochrane database of systematic reviews · 2021
    Pooled it
  6. Pooled it
  7. Article
  8. Article
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  11. 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

16 authors at 5 institutions in 1 country.

Jane NixonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Isabelle L SmithClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Sarah BrownClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Elizabeth McGinnisClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Armando Vargas-PalaciosAcademic Unit of Health Economics, Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds LS2 9JT, UK.
E Andrea NelsonSchool of Health and Life Sciences, Glasgow Caledonian University, Glasgow G4 0BA, UK.
Susanne ColemanClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Howard CollierClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Catherine FernandezClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Rachael GilbertsClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Valerie HendersonIndependent Tissue Viability Consultant.
Delia MuirClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Nikki StubbsLeeds Community Healthcare NHS Trust, Leeds, UK.
Kay WalkerPressure Ulcer Research Service User Network, UK.
Lyn WilsonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK.
Claire HulmeHealth Economics Group, Institute of Health Research, University of Exeter Medical School, South Cloisters, St Luke's Campus, Exeter EX1 2LU, UK.
University of Leeds · GBGlasgow Caledonian University · GBLeeds Community Healthcare NHS Trust · GBNIHR Research Delivery Network · GBUniversity of Exeter · GB

Funding

Department of Health 11/36/33
6 · The paper itself

Abstract

backgroundPressure ulcers (PUs) are complications of serious acute/chronic illness. Specialist mattresses used for prevention lack high quality effectiveness evidence. We aimed to compare clinical and cost effectiveness of 2 mattress types.

methodsMulticentre, Phase III, open, prospective, parallel group, randomised controlled trial in 42 UK secondary/community in-patient facilities.2029 high risk (acutely ill, bedfast/chairfast and/or Category 1 PU/pain at PU site) adult in-patients were randomised (1:1, allocation concealment, minimisation with random element) factors including: centre, PU status, facility and consent type. Interventions were alternating pressure mattresses (APMs) or high specification foam (HSF) for maximum treatment phase 60 days. Primary outcome was time to development of new PU Category ≥ 2 from randomisation to 30 day post-treatment follow-up in intention-to treat population. Trial registration: ISRCTN 01151335.

findingsBetween August 2013 and November 2016, we randomised 2029 patients (1016 APMs: 1013 HSF) who developed 160(7.9%) PUs. There was insufficient evidence of a difference between groups for time to new PU Category ≥ 2 Fine and Gray Model Hazard Ratio HR = 0.76, 95%CI0.56-1.04); exact P = 0.0890; absolute difference 2%). There was a statistically significant difference in the

interpretationIn high risk (acutely ill, bedfast/chairfast/Category 1 PU/ pain on a PU site) in-patients, we found insufficient evidence of a difference in time to PU development at 30-day final follow-up, which may be related to a low event rate affecting trial power. APMs conferred a small treatment phase benefit. Patient preference, low PU incidence and small group differences suggests the need for improved targeting of APMs with decision making informed by patient preference/comfort/rehabilitation needs and the presence of potentially modifiable risk factors such as being completely immobile, nutritional deficits, lacking capacity and/or altered skin/Category1 PU.

Indexed as

Medical devicePressure ulcerPreventionRandomised controlled trial

Identifiers

PMID31709401
PMCPMC6833358
OpenAlexW2970653653

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.