Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Nixon J

PROVIDER: S-EPMC6833358 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Nixon Jane J Smith Isabelle L IL Brown Sarah S McGinnis Elizabeth E Vargas-Palacios Armando A Nelson E Andrea EA Coleman Susanne S Collier Howard H Fernandez Catherine C Gilberts Rachael R Henderson Valerie V Muir Delia D Stubbs Nikki N Walker Kay K Wilson Lyn L Hulme Claire C

EClinicalMedicine 20190903

<h4>Background</h4>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.<h4>Methods</h4>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-pat ...[more]

PMID: 31709401

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Project description:BackgroundPressure ulcers are a prevalent and global issue and support surfaces are widely used for preventing ulceration. However, the diversity of available support surfaces and the lack of direct comparisons in RCTs make decision-making difficult.ObjectivesTo determine, using network meta-analysis, the relative effects of different support surfaces in reducing pressure ulcer incidence and comfort and to rank these support surfaces in order of their effectiveness.MethodsWe conducted a systematic review, using a literature search up to November 2016, to identify randomised trials comparing support surfaces for pressure ulcer prevention. Two reviewers independently performed study selection, risk of bias assessment and data extraction. We grouped the support surfaces according to their characteristics and formed evidence networks using these groups. We used network meta-analysis to estimate the relative effects and effectiveness ranking of the groups for the outcomes of pressure ulcer incidence and participant comfort. GRADE was used to assess the certainty of evidence.Main resultsWe included 65 studies in the review. The network for assessing pressure ulcer incidence comprised evidence of low or very low certainty for most network contrasts. There was moderate-certainty evidence that powered active air surfaces and powered hybrid air surfaces probably reduce pressure ulcer incidence compared with standard hospital surfaces (risk ratios (RR) 0.42, 95% confidence intervals (CI) 0.29 to 0.63; 0.22, 0.07 to 0.66, respectively). The network for comfort suggested that powered active air-surfaces are probably slightly less comfortable than standard hospital mattresses (RR 0.80, 95% CI 0.69 to 0.94; moderate-certainty evidence).ConclusionsThis is the first network meta-analysis of the effects of support surfaces for pressure ulcer prevention. Powered active air-surfaces probably reduce pressure ulcer incidence, but are probably less comfortable than standard hospital surfaces. Most prevention evidence was of low or very low certainty, and more research is required to reduce these uncertainties.

Project description:BackgroundThe clinical decision-making process in pressure ulcer management is complex, and its quality depends on both the nurse's experience and the availability of scientific knowledge. This process should follow evidence-based practices incorporating health information technologies to assist health care professionals, such as the use of clinical decision support systems. These systems, in addition to increasing the quality of care provided, can reduce errors and costs in health care. However, the widespread use of clinical decision support systems still has limited evidence, indicating the need to identify and evaluate its effects on nursing clinical practice.ObjectiveThe goal of the review was to identify the effects of nurses using clinical decision support systems on clinical decision making for pressure ulcer management.MethodsThe systematic review was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) recommendations. The search was conducted in April 2019 on 5 electronic databases: MEDLINE, SCOPUS, Web of Science, Cochrane, and CINAHL, without publication date or study design restrictions. Articles that addressed the use of computerized clinical decision support systems in pressure ulcer care applied in clinical practice were included. The reference lists of eligible articles were searched manually. The Mixed Methods Appraisal Tool was used to assess the methodological quality of the studies.ResultsThe search strategy resulted in 998 articles, 16 of which were included. The year of publication ranged from 1995 to 2017, with 45% of studies conducted in the United States. Most addressed the use of clinical decision support systems by nurses in pressure ulcers prevention in inpatient units. All studies described knowledge-based systems that assessed the effects on clinical decision making, clinical effects secondary to clinical decision support system use, or factors that influenced the use or intention to use clinical decision support systems by health professionals and the success of their implementation in nursing practice.ConclusionsThe evidence in the available literature about the effects of clinical decision support systems (used by nurses) on decision making for pressure ulcer prevention and treatment is still insufficient. No significant effects were found on nurses' knowledge following the integration of clinical decision support systems into the workflow, with assessments made for a brief period of up to 6 months. Clinical effects, such as outcomes in the incidence and prevalence of pressure ulcers, remain limited in the studies, and most found clinically but nonstatistically significant results in decreasing pressure ulcers. It is necessary to carry out studies that prioritize better adoption and interaction of nurses with clinical decision support systems, as well as studies with a representative sample of health care professionals, randomized study designs, and application of assessment instruments appropriate to the professional and institutional profile. In addition, long-term follow-up is necessary to assess the effects of clinical decision support systems that can demonstrate a more real, measurable, and significant effect on clinical decision making.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42019127663; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=127663.

Project description:ObjectiveInvestigated clinical effectiveness and cost-effectiveness of a person-centred intervention for informal carers/caregivers of stroke survivors.DesignPragmatic cluster randomised controlled trial (cRCT) with economic and process evaluation.SettingClusters were services, from a UK voluntary sector specialist provider, delivering support primarily in the homes of stroke survivors and informal carers.ParticipantsAdult carers in participating clusters were referred to the study by cluster staff following initial support contact.InterventionsIntervention was the Carer Support Needs Assessment Tool for Stroke: a staff-facilitated, carer-led approach to help identify, prioritise and address the specific support needs of carers. It required at least one face-to-face support contact dedicated to carers, with reviews as required. Control was usual care, which included carer support (unstructured and variable).Outcome measuresParticipants provided study entry and self-reported outcome data by postal questionnaires, 3 and 6 months after first contact by cluster staff.Primary outcome3-month caregiver strain (Family Appraisal of Caregiving Questionnaire, FACQ).Secondary outcomesFACQ subscales of caregiver distress and positive appraisals of caregiving, mood (Hospital Anxiety and Depression Scale) and satisfaction with stroke services (Pound). The economic evaluation included self-reported healthcare utilisation, intervention costs and EQ-5D-5L.Randomisation and maskingClusters were recruited before randomisation to intervention or control, with stratification for size of service. Cluster staff could not be masked as training was required for participation. Carer research participants provided self-reported outcome data unaware of allocation; they consented to follow-up data collection only.ResultsBetween 1 February 2017 and 31 July 2018, 35 randomised clusters (18 intervention; 17 control) recruited 414 cRCT carers (208 intervention; 206 control). Study entry characteristics were well balanced.Primary outcome measureintention-to-treat analysis for 84% retained participants (175 intervention; 174 control) found mean (SD) FACQ carer strain at 3 months to be 3.11 (0.87) in the control group compared with 3.03 (0.90) in the intervention group, adjusted mean difference of -0.04 (95% CI -0.20 to 0.13). Secondary outcomes had similarly small differences and tight CIs. Sensitivity analyses suggested robust findings. Intervention fidelity was not achieved. Intervention-related group costs were marginally higher with no additional health benefit observed on EQ-5D-5L. No adverse events were related to the intervention.ConclusionsThe intervention was not fully implemented in this pragmatic trial. As delivered, it conferred no clinical benefits and is unlikely to be cost-effective compared with usual care from a stroke specialist provider organisation. It remains unclear how best to support carers of stroke survivors. To overcome the implementation challenges of person-centred care in carers' research and service development, staff training and organisational support would need to be enhanced.Trial registration numberISRCTN58414120.

Project description:BackgroundThe prevalence of knee osteoarthritis is increasing worldwide. Obesity is an important modifiable risk factor for both the incidence and progression of knee osteoarthritis. Consequently, international guidelines recommend all patients with knee osteoarthritis who are overweight receive support to lose weight. However, few overweight patients with this condition receive care to support weight loss. Telephone-based interventions are one potential solution to provide scalable care to the many patients with knee osteoarthritis. The objective of this study is to evaluate, from a societal perspective, the cost-utility and cost-effectiveness of a telephone-based weight management and healthy lifestyle service for patients with knee osteoarthritis, who are overweight or obese.MethodsAn economic evaluation was undertaken alongside a pragmatic randomised controlled trial. Between May 19 and June 30, 2015, 120 patients with knee osteoarthritis were randomly assigned to an intervention or usual care control group in a 1:1 ratio. Participants in the intervention group received a referral to an existing non-disease specific 6-month telephone-based weight management and healthy lifestyle service. Quality-adjusted life years (QALYs) was the utility measure and knee pain intensity, disability, weight, and body mass index (BMI) were the clinical measures of effect. Costs included intervention costs, healthcare utilisation costs (healthcare services and medication use) and absenteeism costs due to knee pain. Data was collected at baseline, 6 weeks and 26 weeks. The primary cost-effectiveness analysis was performed from the societal perspective.ResultsMean cost differences between groups (intervention minus control) were $493 (95%CI: -3513 to 5363) for healthcare costs, $-32 (95%CI: -73 to 13) for medication costs, and $125 (95%CI: -151 to 486) for absenteeism costs. The total mean difference in societal costs was $1197 (95%CI: -2887 to 6106). For QALYs and all clinical measures of effect, the probability of the intervention being cost-effective compared with usual care was less than 0.36 at all willingness-to-pay values.ConclusionsFrom a societal perspective, telephone-based weight loss support, provided using an existing non-disease specific 6-month weight management and healthy lifestyle service was not cost-effective in comparison with usual care for overweight and obese patients with knee osteoarthritis.Trial registration numberACTRN12615000490572 , registered 18th May 2015.

Dataset Information

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

Background

Methods

Findings

Interpretation

Publications

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

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