Cargando…
Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial
BACKGROUND: Pressure 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. METHODS: Multicentre, Phase III, open, prospective, paral...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6833358/ https://www.ncbi.nlm.nih.gov/pubmed/31709401 http://dx.doi.org/10.1016/j.eclinm.2019.07.018 |
_version_ | 1783466367593218048 |
---|---|
author | Nixon, Jane Smith, Isabelle L. Brown, Sarah McGinnis, Elizabeth Vargas-Palacios, Armando Nelson, E. Andrea Coleman, Susanne Collier, Howard Fernandez, Catherine Gilberts, Rachael Henderson, Valerie Muir, Delia Stubbs, Nikki Walker, Kay Wilson, Lyn Hulme, Claire |
author_facet | Nixon, Jane Smith, Isabelle L. Brown, Sarah McGinnis, Elizabeth Vargas-Palacios, Armando Nelson, E. Andrea Coleman, Susanne Collier, Howard Fernandez, Catherine Gilberts, Rachael Henderson, Valerie Muir, Delia Stubbs, Nikki Walker, Kay Wilson, Lyn Hulme, Claire |
author_sort | Nixon, Jane |
collection | PubMed |
description | BACKGROUND: Pressure 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. METHODS: Multicentre, 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. FINDINGS: Between 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 treatment phase time to event sensitivity analysis, Fine and Gray model HR = 0.66, 95%CI, 0.46–0.93; exact P = 0.0176); 2.6% absolute difference). Economic analyses indicate that APM are cost-effective. There were no safety concerns. INTERPRETATION: In 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. |
format | Online Article Text |
id | pubmed-6833358 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-68333582019-11-08 Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial Nixon, Jane Smith, Isabelle L. Brown, Sarah McGinnis, Elizabeth Vargas-Palacios, Armando Nelson, E. Andrea Coleman, Susanne Collier, Howard Fernandez, Catherine Gilberts, Rachael Henderson, Valerie Muir, Delia Stubbs, Nikki Walker, Kay Wilson, Lyn Hulme, Claire EClinicalMedicine Research Paper BACKGROUND: Pressure 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. METHODS: Multicentre, 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. FINDINGS: Between 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 treatment phase time to event sensitivity analysis, Fine and Gray model HR = 0.66, 95%CI, 0.46–0.93; exact P = 0.0176); 2.6% absolute difference). Economic analyses indicate that APM are cost-effective. There were no safety concerns. INTERPRETATION: In 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. Elsevier 2019-09-03 /pmc/articles/PMC6833358/ /pubmed/31709401 http://dx.doi.org/10.1016/j.eclinm.2019.07.018 Text en © 2019 Published by Elsevier Ltd. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Research Paper Nixon, Jane Smith, Isabelle L. Brown, Sarah McGinnis, Elizabeth Vargas-Palacios, Armando Nelson, E. Andrea Coleman, Susanne Collier, Howard Fernandez, Catherine Gilberts, Rachael Henderson, Valerie Muir, Delia Stubbs, Nikki Walker, Kay Wilson, Lyn Hulme, Claire Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial |
title | Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial |
title_full | Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial |
title_fullStr | Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial |
title_full_unstemmed | Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial |
title_short | Pressure Relieving Support Surfaces for Pressure Ulcer Prevention (PRESSURE 2): Clinical and Health Economic Results of a Randomised Controlled Trial |
title_sort | pressure relieving support surfaces for pressure ulcer prevention (pressure 2): clinical and health economic results of a randomised controlled trial |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6833358/ https://www.ncbi.nlm.nih.gov/pubmed/31709401 http://dx.doi.org/10.1016/j.eclinm.2019.07.018 |
work_keys_str_mv | AT nixonjane pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT smithisabellel pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT brownsarah pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT mcginniselizabeth pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT vargaspalaciosarmando pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT nelsoneandrea pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT colemansusanne pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT collierhoward pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT fernandezcatherine pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT gilbertsrachael pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT hendersonvalerie pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT muirdelia pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT stubbsnikki pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT walkerkay pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT wilsonlyn pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial AT hulmeclaire pressurerelievingsupportsurfacesforpressureulcerpreventionpressure2clinicalandhealtheconomicresultsofarandomisedcontrolledtrial |