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A patient-reported pressure ulcer health-related quality of life instrument for use in prevention trials (PU-QOL-P): psychometric evaluation.

ABSTRACT: INTRODUCTION:Pressure ulcer-specific patient-reported outcome (PRO) instruments should be used to inform patient care and provide a strong evidence base for interventions aimed at preventing pressure ulcers. The aim was to carry out a comprehensive evaluation of the psychometric properties of a PRO instrument designed to assess symptoms and functional outcomes in patients at high-risk of developing pressure ulcers, the PU-QOL-P instrument. METHODS:We modified the original PU-QOL instrument to be suitable for patients at high risk of pressure ulcer development based on feedback from patients, specialist nurses and PRO methodologists. The modified PU-QOL-P instrument was administered to a sub-set of patients participating in the PRESSURE 2 trial. Patients completed PU-QOL-P and SF12 instruments at baseline, weeks 1 and 3, and 30?days post-treatment. We undertook psychometric evaluation of the modified PU-QOL-P to test scale targeting, scaling assumptions, reliability, validity and responsiveness. RESULTS:The analysis sample consisted of 617 patients that completed both instruments at baseline. We found that the PU-QOL-P instrument, consisting of nine PU-specific outcomes: three symptom and six function scales, meets established criteria for reliability, construct validity, and responsiveness. Internal consistency reliability was high with all scale Cronbach alpha >?0.795 (range 0.795-0.970). The factor analysis mostly supported the six-function scale structure. Scaling assumptions were satisfied; all item-total correlations above 0.30. Convergent validity was confirmed by significant correlations between hypothesized scales as expected. PU-QOL-P scales were responsive to change: mean scale scores from baseline to 30?days post-treatment were statistically significant for all scales apart the daily activities scale (effect sizes ranged from moderate to high). As expected, worse symptoms and functioning was observed in patients who had a category 1 or 2 PU compared to patients who did not have a PU. CONCLUSIONS:The PU-QOL-P provides a standardised method for assessing pressure ulcer-specific symptoms and functional outcomes for quantifying the benefits of associated interventions from the patient's perspective. It can be used in research with adults at risk of pressure ulcer development in all UK healthcare settings.

SUBMITTER: Rutherford C

PROVIDER: S-EPMC6288857 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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A patient-reported pressure ulcer health-related quality of life instrument for use in prevention trials (PU-QOL-P): psychometric evaluation.

Rutherford Claudia C Brown Julia M JM Smith Isabelle I McGinnis Elizabeth E Wilson Lyn L Gilberts Rachael R Brown Sarah S Coleman Susanne S Collier Howard H Nixon Jane J

Health and quality of life outcomes 20181210 1

<h4>Introduction</h4>Pressure ulcer-specific patient-reported outcome (PRO) instruments should be used to inform patient care and provide a strong evidence base for interventions aimed at preventing pressure ulcers. The aim was to carry out a comprehensive evaluation of the psychometric properties of a PRO instrument designed to assess symptoms and functional outcomes in patients at high-risk of developing pressure ulcers, the PU-QOL-P instrument.<h4>Methods</h4>We modified the original PU-QOL i ...[more]

PMID: 30526657

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Project description:BackgroundRandomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects.PurposeWe describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury.MethodsIndividuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes.ResultsPUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination.LimitationsWe have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings.ConclusionsOvercoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

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: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 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.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.

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A patient-reported pressure ulcer health-related quality of life instrument for use in prevention trials (PU-QOL-P): psychometric evaluation.

Publications

A patient-reported pressure ulcer health-related quality of life instrument for use in prevention trials (PU-QOL-P): psychometric evaluation.

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