Publications by authors named "Susanne Coleman"

26 Publications

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Pressure ulcer risk assessment-registered nurses´ experiences of using PURPOSE T: A focus group study.

J Clin Nurs 2021 Jun 9. Epub 2021 Jun 9.

Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.

Aim: To evaluate the clinical usability of PURPOSE T among registered nurses in Sweden.

Background: Pressure ulcers are an adverse event and a problem worldwide. Risk assessment is a cornerstone, and a first step in pressure ulcer prevention is to identify possible risk patients and/or pressure ulcers. There are many pressure ulcer risk assessment instruments; however, they are not updated and/or evidence-based. PURPOSE T has been psychometrically evaluated in the UK and in Sweden with good inter-rater and test-retest reliability, and convergent validity was reported as moderate.

Design: A descriptive study design with a qualitative approach.

Methods: A total of six focus group interviews with 29 registered nurses were conducted. They were recruited from May 2018 to November 2018 from a university hospital and two nursing homes in Sweden. Data analysis was performed as described by Krueger. The study adheres to the COREQ guidelines.

Results: Four categories were identified: "An efficient risk assessment instrument performed at the bedside," "Deeper understanding and awareness of risk factors," "Benefits compared to the Modified Norton Scale" and "Necessity of integration of PURPOSE T in the electronic health record and team collaboration."

Conclusion: The registered nurses acknowledged an overall positive perception of PURPOSE T´s clinical usability. Future research is needed to evaluate the feasibility of PURPOSE T.

Relevance To Clinical Practice: PURPOSE T has the potential to replace outdated pressure ulcers risk assessment instruments that are used today.
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http://dx.doi.org/10.1111/jocn.15901DOI Listing
June 2021

Pressure Relieving Support Surfaces: a Randomised Evaluation 2 (PRESSURE 2): using photography for blinded central endpoint review.

Trials 2021 Apr 28;22(1):308. Epub 2021 Apr 28.

Clinical Trials Research Unit, University of Leeds, Leeds, UK.

Background: PRESSURE 2 is a randomised evaluation of the clinical and cost-effectiveness of two types of mattress for the prevention of pressure ulcers (PUs). The primary clinical endpoint was time to development of a category ≥2 PU. The current 'gold standard' for PU identification is expert clinical assessment. Due to the mattress appearance, a blinded assessment of the endpoint is not possible. This poses a risk to the internal validity of the study. A possible approach is to use photographs of skin sites, with central blinded review. However, there are practical and scientific concerns including patients' consent to photographs, burden of data collection, photograph quality, data completeness and comparison of photographs to the current 'gold standard'. This paper reports the findings of the PRESSURE 2 photographic validation sub-study.

Method: Where consent was obtained, photographs were taken of all category ≥2 PUs on the first presentation to assess over-reporting, and for the assessment of under-reporting, a random sample of 10% patients had an assessment by an independent clinical assessor who also photographed two skin sites. The staff were trained in taking and transferring photographs using standardised procedures and equipment. A card included in the photograph recorded participant details and a 'greyscale' for correction of white balance during processing. Three blinded reviewers assessed the photographs and rated how confident they were in their assessment.

Results: The trial recruited 2029 patients; 85% consented to photography, and 532 photographs were received and used in the blinded central review. The level of confidence varied by skin classification with more confidence observed when the skin was assessed as being less severe than a category ≥2 PU. Overall, there was a very good reliability compared to the gold standard expert clinical assessment (87.8%, kappa 0.82).

Conclusion: Study findings have usefully informed the scientific and practical issues of blinded assessment of PU status to reducing the risk of bias in medical device trials. The reliability of central blinded expert photography was found to be 'very good' (PABAK). Photographs have been found to be an acceptable method of data validation for participants. Methods to improve the quality of photographs would increase the confidence in the assessments.

Trial Registration: ISRCTN Registry ISRCTN01151335 . Registered on 19 April 2013.
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http://dx.doi.org/10.1186/s13063-021-05262-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8080319PMC
April 2021

Searching for Programme theories for a realist evaluation: a case study comparing an academic database search and a simple Google search.

BMC Med Res Methodol 2020 08 26;20(1):217. Epub 2020 Aug 26.

Department of Sociology and Social Policy, University of Leeds, Leeds, LS2 9JT, UK.

Background: Realist methodologies are increasingly being used to evaluate complex interventions in health and social care. Programme theory (ideas and assumptions of how a particular intervention works) development is the first step in a realist evaluation or a realist synthesis, with literature reviews providing important evidence to support this. Deciding how to search for programme theories is challenging and there is limited guidance available. Using an example of identifying programme theories for a realist evaluation of Pressure Ulcer Risk Assessment Instruments in clinical practice, the authors explore and compare several different approaches to literature searching and highlight important methodological considerations for those embarking on a programme theory review.

Methods: We compared the performance of an academic database search with a simple Google search and developed an optimised search strategy for the identification primary references (i.e. documents providing the clearest examples of programme theories) associated with the use of Pressure Ulcer Risk Assessment Instruments (PU-RAIs). We identified the number of primary references and the total number of references retrieved per source. We then calculated the number needed to read (NNR) expressed as the total number of titles and abstracts screened to identify one relevant reference from each source.

Results: The academic database search (comprising CINAHL, The Cochrane Library, EMBASE, HMIC, Medline) identified 2 /10 primary references with a NNR of 1395.The Google search identified 7/10 primary references with a NNR of 10.1. The combined NNR was 286.3. The optimised search combining Google and CINAHL identified 10/10 primary references with a NNR of 40.2.

Conclusion: The striking difference between the efficiency of the review's academic database and Google searches in finding relevant references prompted an in-depth comparison of the two types of search. The findings indicate the importance of including grey literature sources such as Google in this particular programme theory search, while acknowledging the need for transparency of methods. Further research is needed to facilitate improved guidance for programme theory searches to enhance practice in the realist field and to save researcher time and therefore resource.
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http://dx.doi.org/10.1186/s12874-020-01084-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7450563PMC
August 2020

PURPOSE T in Swedish hospital wards and nursing homes: A psychometric evaluation of a new pressure ulcer risk assessment instrument.

J Clin Nurs 2020 Nov 19;29(21-22):4066-4075. Epub 2020 Aug 19.

Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.

Aim: To evaluate the psychometric characteristics of the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE T); reliability (inter-rater and test-retest) and validity (convergent validity) in a Swedish context.

Background: Pressure ulcers are considered as an adverse event and are a problem in healthcare worldwide. The first step in pressure ulcer prevention is to identify patients that are at risk. PURPOSE T is a new pressure ulcer risk assessment instrument that was developed in the UK using "golden standard" instrument method.

Design: Observational, descriptive and comparative.

Methods: A total of 235 patients and 28 registered nurses were recruited (May 2018-November 2018) from six hospital wards at a university hospital and two community nursing homes in Sweden. Blinded (ward/nursing home nurses and expert nurses) PURPOSE T assessments and follow-up retests were undertaken. Cross-tabulation and kappa statistics were used to examine the reliability, and phi correlation was used to test the convergent validity. The study followed the STROBE guideline.

Results: The clinical evaluation showed "very good" (kappa) inter-rater and test-retest reliability for PURPOSE T assessment decision overall. The agreement of "at risk"/"not at risk" for both inter-rater and test-retest was also high, at least 95.5%. The convergent validity between PURPOSE T and other traditional assessment instruments was moderate.

Conclusion: The evaluation of PURPOSE T demonstrated good psychometric characteristics. Further research is needed to evaluate PURPOSE T's usability among registered nurses.

Relevance To Clinical Practice: There is a lack of evidence-based validated pressure ulcer risk assessment instruments for use in health care. According to our findings, the Swedish version of PURPOSE T could be used in hospitals and nursing homes to identify patients in risk or with pressure ulcers.
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http://dx.doi.org/10.1111/jocn.15433DOI Listing
November 2020

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

EClinicalMedicine 2019 Sep 3;14:42-52. Epub 2019 Sep 3.

Health Economics Group, Institute of Health Research, University of Exeter Medical School, South Cloisters, St Luke's Campus, Exeter EX1 2LU, UK.

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 , 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.
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http://dx.doi.org/10.1016/j.eclinm.2019.07.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6833358PMC
September 2019

Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: the PRESSURE 2 RCT.

Health Technol Assess 2019 09;23(52):1-176

Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Background: Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients.

Primary Objective: Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM).

Design: A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori sample size of 2954 participants. Randomisation used minimisation (incorporating a random element).

Setting: The trial was set in 42 secondary and community inpatient facilities in the UK.

Participants: Adult inpatients with evidence of acute illness and at a high risk of PU development.

Interventions And Follow-up: APM or HSFM - the treatment phase lasted a maximum of 60 days; the final 30 days were post-treatment follow-up.

Main Outcome Measures: Time to event.

Results: From August 2013 to November 2016, 2029 participants were randomised to receive either APM ( = 1016) or HSFM ( = 1013). Primary end point - 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04; exact -value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. 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 to 0.93;  = 0.0176 and 2.6% absolute difference). Secondary end points - 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02; -value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62;  = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed - there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68;  = 0.6122 and absolute difference 2.9%). Health economics - the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy - the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was 'very good' (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy - the Pressure Ulcer Quality of Life - Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness.

Limitations: A lower than anticipated event rate.

Conclusions: In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and individualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU.

Future Work: Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore 'what works for whom and in what circumstances'.

Trial Registration: Current Controlled Trials ISRCTN01151335.

Funding: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 52. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta23520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6790649PMC
September 2019

A systematic review and meta-analysis estimating the population prevalence of comorbidities in children and adolescents aged 5 to 18 years.

Obes Rev 2019 10 24;20(10):1341-1349. Epub 2019 Jul 24.

Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Evidence for the health impact of obesity has largely focussed on adults. We estimated the population prevalence and prevalence ratio of obesity-associated comorbidities in children and adolescents aged 5 to 18 years. Five databases were searched from inception to 14 January 2018. Population-based observational studies reporting comorbidity prevalence by weight category (healthy weight/overweight/obese) in children and adolescents aged 5 to 18 years from any country were eligible. Comorbidity prevalence, stratified by weight category, was extracted and prevalence ratios (relative to healthy weight) estimated using random effects meta-analyses. Of 9183 abstracts, 52 eligible studies (1 553 683 participants) reported prevalence of eight comorbidities or risk markers including diabetes and nonalcoholic fatty liver disease (NAFLD). Evidence for psychological comorbidities was lacking. Meta-analyses suggested prevalence ratio for prediabetes (fasting glucose ≥ 100 mg/dL) for those with obesity relative to those of a healthy weight was 1.4 (95% confidence interval [CI], 1.2-1.6) and for NAFLD 26.1 (9.4-72.3). In the general population, children and adolescents with overweight/obesity have a higher prevalence of comorbidities relative to those of a healthy weight. This review provides clinicians with information when assessing children and researchers a foundation upon which to build a comprehensive dataset to understand the health consequences of childhood obesity.
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http://dx.doi.org/10.1111/obr.12904DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851579PMC
October 2019

Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions.

Trials 2019 Jul 22;20(1):449. Epub 2019 Jul 22.

Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, UK.

Background: Core outcome sets (COS) are being developed in many clinical areas to increase the quality and comparability of clinical trial results as well as to ensure their relevance for patients. A COS represents an agreed standardized set of outcomes that describes the minimum that should be consistently reported in all clinical trials of a defined area. It comprises a core domain set (defining what core outcomes should be measured) and a core measurement set (defining measurement/assessment instruments for each core domain). For pressure ulcer prevention trials a COS is lacking. The great heterogeneity of reported outcomes in this field indicates the need for a COS.

Methods/design: The first part of this project aims to develop a core domain set by following established methods, which incorporates four steps: (1) definition of the scope, (2) conducting a scoping review, (3) organizing facilitated workshops with service users, (4) performing Delphi surveys and establishing consensus in a face-to-face meeting with different stakeholders.

Discussion: After achieving consensus on the core domain set, further work will be undertaken to determine a corresponding core measurement set. This will lead to better pressure ulcer prevention research in the future. There are a number of methodological challenges in the field of COS development. To meet these challenges and to ensure a high-quality COS, the OUTPUTS project affiliates to current standards and works in close collaboration with international experts and with existing international service user groups.

Trial Registration: The OUTPUTs project is registered in the COMET database: ( http://www.comet-initiative.org/studies/details/283 ). Registered on 2015.
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http://dx.doi.org/10.1186/s13063-019-3543-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647312PMC
July 2019

Comparison of generic and disease-specific measures in their ability to detect differences in pressure ulcer clinical groups.

Wound Repair Regen 2019 07 30;27(4):396-405. Epub 2019 Mar 30.

Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.

Patient-reported outcomes can be included as end points in pressure ulcer (PU) intervention trials to provide information to inform decision-making and improve the lives of patients. However, the challenge for researchers and clinicians is identifying and choosing an appropriate instrument for each particular application that suits their research questions and clinical context. To provide researchers and clinicians with the information needed to inform choice of patient-reported outcome measures, we compared a generic and disease-specific measures' ability to discriminate between clinical groups known to differ, and determined their responsiveness to change. We performed analyses on a subset of patients recruited to the PRESSURE 2 trial that completed the pressure ulcer quality of life instrument-prevention version (PU-QOL-P) and Short Form 12 Questionnaire (SF12) measures at baseline and 30-day posttreatment. Known-group validity and responsiveness-to-change analyses were conducted. The analysis sample consisted of 617 patients that completed both measures at baseline. Known-group validity revealed that some PU-QOL-P symptoms and function scales differentiated between people with category 2 PUs and those without PUs. A less meaningful pattern of results was observed for the SF12 scales, suggesting that the PU-QOL-P is more sensitive to differences between PU and non-PU populations. Responsiveness analysis revealed that the PU-QOL-P was more responsive in detecting disease severity than the SF12. The PU-QOL-P provides a standardized method for assessing PU-specific symptoms and functioning outcomes and is suitable for quantifying the benefits of PU interventions from the patient's perspective. Generic measures are useful for group comparisons of global quality of life domains. Choice of measure for each particular application should be determined by the purpose of the measurement and the information required.
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http://dx.doi.org/10.1111/wrr.12716DOI Listing
July 2019

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

Health Qual Life Outcomes 2018 Dec 10;16(1):227. Epub 2018 Dec 10.

Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK.

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.
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http://dx.doi.org/10.1186/s12955-018-1049-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6288857PMC
December 2018

Development of a generic wound care assessment minimum data set.

J Tissue Viability 2017 Nov 18;26(4):226-240. Epub 2017 Sep 18.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, LS2 9JT, UK.

Background: At present there is no established national minimum data set (MDS) for generic wound assessment in England, which has led to a lack of standardisation and variable assessment criteria being used across the country. This hampers the quality and monitoring of wound healing progress and treatment.

Aim: To establish a generic wound assessment MDS to underpin clinical practice.

Method: The project comprised 1) a literature review to provide an overview of wound assessment best practice and identify potential assessment criteria for inclusion in the MDS and 2) a structured consensus study using an adapted Research and Development/University of California at Los Angeles Appropriateness method. This incorporated experts in the wound care field considering the evidence of a literature review and their experience to agree the assessment criteria to be included in the MDS.

Results: The literature review identified 24 papers that contained criteria which might be considered as part of generic wound assessment. From these papers 68 potential assessment items were identified and the expert group agreed that 37 (relating to general health information, baseline wound information, wound assessment parameters, wound symptoms and specialists) should be included in the MDS.

Discussion: Using a structured approach we have developed a generic wound assessment MDS to underpin wound assessment documentation and practice. It is anticipated that the MDS will facilitate a more consistent approach to generic wound assessment practice and support providers and commissioners of care to develop and re-focus services that promote improvements in wound care.
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http://dx.doi.org/10.1016/j.jtv.2017.09.007DOI Listing
November 2017

Clinical evaluation of a new pressure ulcer risk assessment instrument, the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE T).

J Adv Nurs 2018 Feb 28;74(2):407-424. Epub 2017 Sep 28.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Aim: To test the psychometric properties and clinical usability of a new Pressure Ulcer Risk Assessment Instrument including inter-rater and test-retest reliability, convergent validity and data completeness.

Background: Methodological and practical limitations associated with traditional Pressure Ulcer Risk Assessment Instruments, prompted a programme to work to develop a new instrument, as part of the National Institute for Health Research funded, Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056).

Design: Observational field test.

Method: For this clinical evaluation 230 patients were purposefully sampled across four broad levels of pressure ulcer risk with representation from four secondary care and four community NHS Trusts in England. Blinded and simultaneous paired (ward/community nurse and expert nurse) PURPOSE-T assessments were undertaken. Follow-up retest was undertaken by the expert nurse. Field notes of PURPOSE-T use were collected. Data were collected October 2012-January 2013.

Results: The clinical evaluation demonstrated "very good" (kappa) inter-rater and test-retest agreement for PURPOSE-T assessment decision overall. The percentage agreement for "problem/no problem" was over 75% for the main risk factors. Convergent validity demonstrated moderate to high associations with other measures of similar constructs.

Conclusion: The PURPOSE-T evaluation facilitated the initial validation and clinical usability of the instrument and demonstrated that PURPOSE-T is suitable of use in clinical practice. Further study is needed to evaluate the impact of using the instrument on care processes and outcomes.
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http://dx.doi.org/10.1111/jan.13444DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5846883PMC
February 2018

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) photographic validation sub-study: study protocol for a randomised controlled trial.

Trials 2017 03 20;18(1):132. Epub 2017 Mar 20.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Background: PRESSURE 2 is a randomised evaluation of the clinical and cost effectiveness of two types of pressure relieving mattress for the prevention of pressure ulcers. The primary endpoint is the time to development of a Category ≥2 pressure ulcer. The current 'gold standard' for the identification of a Category ≥2 pressure ulcer is expert clinical assessment. Due to the appearance of the bed, it is not possible to achieve blinding of the endpoint. This therefore poses a risk to the internal validity of the study. A possible approach is to use photographs of skin sites, with central blinded review. However, there are practical and scientific concerns including whether patients would agree to photographs; the burden of data collection; the quality of photographs; the completeness of data; and how the use of photographs compares with the current 'gold standard'. This validation sub-study aims to assess and quantify potential bias in the reporting of the trial endpoint.

Methods/design: Patients will be specifically asked to consent to photographs being taken of their skin sites. Photographs will be taken at first observation or when patients develop a new Category ≥2 pressure ulcer (to assess over-reporting). A 10% random sample of patients will be identified for additional photographs of two skin sites (one torso and one limb) with and without a pressure ulcer (if present) by an independent assessor (to assess the potential for under-reporting). Staff will be trained to take photographs using a standardised camera and photographic technique. A 'grey scale' will be included in the photo to correct white balance. Photographs will be securely transferred for central review. Photographs will have white balance corrected, and the computer monitor will be calibrated prior to review. Analysis will include assessment of under- and over-reporting, acceptability of photography to patients, secure transfer of data, quality of and confidence in blinded photograph review and sensitivity analysis using photograph assessment of primary outcome.

Discussion: This study will use photographs to contribute to the primary outcome of the trial. It will inform our understanding of the acceptability of photography for prevention trials and the possibility of other uses of photographic data in clinical work and research.

Trial Registration: ISRCTN, ISRCTN01151335 . Registered on 14 May 2013.
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http://dx.doi.org/10.1186/s13063-017-1851-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5360042PMC
March 2017

Exploring the role of pain as an early predictor of category 2 pressure ulcers: a prospective cohort study.

BMJ Open 2017 01 20;7(1):e013623. Epub 2017 Jan 20.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Objective: To explore pressure area related pain as a predictor of category ≥2 pressure ulcer (PU) development.

Design: Multicentre prospective cohort study.

Setting: UK hospital and community settings.

Participants Inclusion: Consenting acutely ill patients aged ≥18 years, defined as high risk (Braden bedfast/chairfast AND completely immobile/very limited mobility; pressure area related pain or; category 1 PU).

Exclusion: Patients too unwell, unable to report pain, 2 or more category ≥2 PUs.

Follow-up: Twice weekly for 30 days.

Primary And Secondary Outcome Measures: Development and time to development of one or more category ≥2 PUs.

Results: Of 3819 screened, 1266 were eligible, 634 patients were recruited, 32 lost to follow-up, providing a 602 analysis population. 152 (25.2%) developed one or more category ≥2 PUs. 464 (77.1%) patients reported pressure area related pain on a healthy, altered or category 1 skin site of whom 130 (28.0%) developed a category ≥2 PU compared with 22 (15.9%) of those without pain. Full stepwise variable selection was used throughout the analyses. (1) Multivariable logistic regression model to assess 9 a priori factors: presence of category 1 PU (OR=3.25, 95% CI (2.17 to 4.86), p<0.0001), alterations to intact skin (OR=1.98, 95% CI (1.30 to 3.00), p=0.0014), pressure area related pain (OR=1.56, 95% CI (0.93 to 2.63), p=0.0931). (2) Multivariable logistic regression model to account for overdispersion: presence of category 1 PU (OR=3.20, 95% CI (2.11 to 4.85), p<0.0001), alterations to intact skin (OR=1.90, 95% CI (1.24 to 2.91), p=0.0032), pressure area related pain (OR=1.85, 95% CI (1.07 to 3.20), p=0.0271), pre-existing category 2 PU (OR=2.09, 95% CI (1.35 to 3.23), p=0.0009), presence of chronic wound (OR=1.66, 95% CI (1.06 to 2.62), p=0.0277), Braden activity (p=0.0476). (3) Accelerated failure time model: presence of category 1 PU (AF=2.32, 95% CI (1.73 to 3.12), p<0.0001), pressure area related pain (AF=2.28, 95% CI (1.59 to 3.27), p<0.0001). (4) 2-level random-intercept logistic regression model: skin status which comprised 2 levels (versus healthy skin); alterations to intact skin (OR=4.65, 95% CI (3.01 to 7.18), p<0.0001), presence of category 1 PU (OR=17.30, 95% CI (11.09 to 27.00), p<0.0001) and pressure area related pain (OR=2.25, 95% CI (1.53 to 3.29), p<0.0001).

Conclusions: This is the first study to assess pain as a predictor of category ≥2 PU development. In all 4 models, pain emerged as a risk factor associated with an increased probability of category ≥2 PU development.
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http://dx.doi.org/10.1136/bmjopen-2016-013623DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5253581PMC
January 2017

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial.

Trials 2016 12 20;17(1):604. Epub 2016 Dec 20.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Background: Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual's functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers.

Methods/design: PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 'high-risk' patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee.

Discussion: The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for demonstrating either superiority, inferiority of mattresses or futility of the trial. The trial optimises the potential for producing robust clinical evidence on the effectiveness of two commonly used mattresses in clinical practice earlier than in a conventional design.

Trial Registration: ISRCTN01151335 . Registered on 14 May 2013. Protocol version: 5.0, dated 25 September 2015 Trial sponsor: Clare Skinner, Faculty Head of Research Support, University of Leeds, Leeds, LS2 9JT; 0113 343 4897; [email protected]
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http://dx.doi.org/10.1186/s13063-016-1703-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5168811PMC
December 2016

Pressure ulcer and wounds reporting in NHS hospitals in England part 1: Audit of monitoring systems.

J Tissue Viability 2016 Feb 24;25(1):3-15. Epub 2015 Nov 24.

Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Unlabelled: Internationally, health-care systems have attempted to assess the scale of and demonstrate improvement in patient harms. Pressure ulcer (PU) monitoring systems have been introduced across NHS in-patient facilities in England, including the Safety Thermometer (STh) (prevalence), Incident Reporting Systems (IRS) and the Strategic Executive Information System (STEIS) for serious incidents. This is the first of two related papers considering PU monitoring systems across NHS in-patient facilities in England and focusses on a Wound Audit (PUWA) to assess the accuracy of these systems. Part 2 of this work and recommendations are reported pp *-*. The PUWA was undertaken in line with 'gold-standard' PU prevalence methods in a stratified random sample of NHS Trusts; 24/34 (72.7%) invited NHS Trusts participated, from which 121 randomly selected wards and 2239 patients agreed to participate.

Prevalence Of Existing Pus: The PUWA identified 160 (7.1%) patients with an existing PU, compared to 105 (4.7%) on STh. STh had a weighted sensitivity of 48.2% (95%CI 35.4%-56.7%) and weighted specificity of 99.0% (95%CI 98.99%-99.01%).

Existing/healed Pus: The PUWA identified 189 (8.4%) patients with an existing/healed PU compared to 135 (6.0%) on IRS. IRS had an unweighted sensitivity of 53.4% (95%CI 46.3%-60.4%) and unweighted specificity of 98.3% (95%CI 97.7%-98.8%). 83 patients had one or more potentially serious PU on PUWA and 8 (9.6%) of these patients were reported on STEIS. The results identified high levels of under-reporting for all systems and highlighted data capture challenges, including the use of clinical staff to inform national monitoring systems and the completeness of clinical records for PUs.
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http://dx.doi.org/10.1016/j.jtv.2015.11.001DOI Listing
February 2016

Pressure ulcer and wounds reporting in NHS hospitals in England part 2: Survey of monitoring systems.

J Tissue Viability 2016 Feb 23;25(1):16-25. Epub 2015 Nov 23.

Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

This is the second of a two related papers describing work undertaken to compare and contrast Pressure Ulcer (PU) monitoring systems across NHS in-patient facilities in England. The work comprised 1) a PU/Wound Audit (PUWA) and 2) a survey of PU monitoring systems. This second paper focusses on the survey which explores differences in the implementation of PU adverse event monitoring systems in 24 NHS hospital Trusts in England. The survey questionnaire comprised 41 items incorporating single and multiple response options and free-text items and was completed by the PUWA Trust lead in liaison with key people in the organisation. All 24 (100%) Trusts returned the questionnaire, with high levels of data completeness (99.1%). The questionnaire results showed variation between Trusts in relation to the recording of PUs and their reporting as part of NHS prevalence and incident monitoring systems and to Trust boards and healthcare commissioners including the inclusion (or not) of device ulcers, unstageable ulcers, Deep Tissue Injury, combined PUs/Incontinence Associated Dermatitis, category ≥ 1 ulcers or category ≥ 2 ulcers, inherited ulcers, acquired ulcers, avoidable and unavoidable ulcers and the definition of Present On Admission. These fundamental differences in reporting preclude Trust to Trust comparisons of PU prevalence and incident reporting and monitoring systems due to variation in local application and data collection methods. The results of this work and the PUWA led to the development of recommendations for PU monitoring practice, many of which are internationally relevant.
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http://dx.doi.org/10.1016/j.jtv.2015.11.002DOI Listing
February 2016

Pressure ulcer related pain in community populations: a prevalence survey.

BMC Nurs 2014 21;13:16. Epub 2014 Jun 21.

Clinical Trials Research Unit Leeds, Leeds, UK.

Background: Pressure ulcers are costly to the healthcare provider and can have a major impact on patient's quality of life. One of the most distressing symptoms reported is pain. There is very little published data on the prevalence and details of pain experienced by patients with pressure ulcers, particularly in community populations. The study was conducted in two community NHS sites in the North of England.

Methods: The aim was to estimate the prevalence of pressure area related pain within a community population. We also explored the type and severity of the pain and its association with pressure ulcer classification. A cross-sectional survey was performed of community nurses caseloads to identify adult patients with pressure ulcers and associated pain. Consenting patients then had a full pain assessment and verification of pressure ulcer grade.

Results: A total of 287 patients were identified with pressure ulcers (0.51 per 1000 adult population). Of the 176 patients who were asked, 133 (75.6%) reported pain. 37 patients consented to a detailed pain assessment. Painful pressure ulcers of all grades and on nearly all body sites were identified. Pain intensity was not related to number or severity of pressure ulcer. Both inflammatory and neuropathic pain were reported at all body sites however the proportion of neuropathic pain was greater in pressure ulcers on lower limbs.

Conclusions: This study has identified the extent and type of pain suffered by community patients with pressure ulcers and indicates the need for systematic and regular pain assessment and treatment.
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http://dx.doi.org/10.1186/1472-6955-13-16DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4094922PMC
July 2014

Developing a pressure ulcer risk factor minimum data set and risk assessment framework.

J Adv Nurs 2014 Oct 21;70(10):2339-52. Epub 2014 May 21.

Leeds Institute of Clinical Trials Research, University of Leeds, UK.

Aim: To agree a draft pressure ulcer risk factor Minimum Data Set to underpin the development of a new evidenced-based Risk Assessment Framework.

Background: A recent systematic review identified the need for a pressure ulcer risk factor Minimum Data Set and development and validation of an evidenced-based pressure ulcer Risk Assessment Framework. This was undertaken through the Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056), funded by the National Institute for Health Research and incorporates five phases. This article reports phase two, a consensus study.

Design: Consensus study.

Method: A modified nominal group technique based on the Research and Development/University of California at Los Angeles appropriateness method. This incorporated an expert group, review of the evidence and the views of a Patient and Public Involvement service user group. Data were collected December 2010-December 2011.

Findings: The risk factors and assessment items of the Minimum Data Set (including immobility, pressure ulcer and skin status, perfusion, diabetes, skin moisture, sensory perception and nutrition) were agreed. In addition, a draft Risk Assessment Framework incorporating all Minimum Data Set items was developed, comprising a two stage assessment process (screening and detailed full assessment) and decision pathways.

Conclusion: The draft Risk Assessment Framework will undergo further design and pre-testing with clinical nurses to assess and improve its usability. It will then be evaluated in clinical practice to assess its validity and reliability. The Minimum Data Set could be used in future for large scale risk factor studies informing refinement of the Risk Assessment Framework.
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http://dx.doi.org/10.1111/jan.12444DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4368619PMC
October 2014

A new pressure ulcer conceptual framework.

J Adv Nurs 2014 Oct 31;70(10):2222-34. Epub 2014 Mar 31.

Leeds Institute of Clinical Trials Research, University of Leeds, UK.

Aim: This paper discusses the critical determinants of pressure ulcer development and proposes a new pressure ulcer conceptual framework.

Background: Recent work to develop and validate a new evidence-based pressure ulcer risk assessment framework was undertaken. This formed part of a Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056), funded by the National Institute for Health Research. The foundation for the risk assessment component incorporated a systematic review and a consensus study that highlighted the need to propose a new conceptual framework.

Design: Discussion Paper.

Data Sources: The new conceptual framework links evidence from biomechanical, physiological and epidemiological evidence, through use of data from a systematic review (search conducted March 2010), a consensus study (conducted December 2010-2011) and an international expert group meeting (conducted December 2011).

Implications For Nursing: A new pressure ulcer conceptual framework incorporating key physiological and biomechanical components and their impact on internal strains, stresses and damage thresholds is proposed. Direct and key indirect causal factors suggested in a theoretical causal pathway are mapped to the physiological and biomechanical components of the framework. The new proposed conceptual framework provides the basis for understanding the critical determinants of pressure ulcer development and has the potential to influence risk assessment guidance and practice. It could also be used to underpin future research to explore the role of individual risk factors conceptually and operationally.

Conclusion: By integrating existing knowledge from epidemiological, physiological and biomechanical evidence, a theoretical causal pathway and new conceptual framework are proposed with potential implications for practice and research.
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http://dx.doi.org/10.1111/jan.12405DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4263098PMC
October 2014

Why do patients develop severe pressure ulcers? A retrospective case study.

BMJ Open 2014 Jan 2;4(1):e004303. Epub 2014 Jan 2.

Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Objectives: This study focuses on the ways in which the organisational context can influence the development of severe pressure ulcers. Severe pressure ulcers are important indicators of failures in the organisation and delivery of treatment and care. We have a good understanding of patients' risk factors, but a poor understanding of the role played by the organisational context in their development.

Setting: The study was undertaken in six sites in Yorkshire, England. The settings were sampled in order to maximise diversity, and included patients' own homes, acute hospital medical and surgical wards, a community hospital and a nursing home during a period of respite care.

Participants: Data were collected about eight individuals who developed severe pressure ulcers, using a retrospective case study design. The data sources included interviews with individuals with severe pressure ulcers, and with staff who had treated and cared for them, and clinical notes.

Results: 4 accounts indicated that specific actions by clinicians contributed to the development of severe pressure ulcers. Seven of the 8 accounts indicated that they developed in organisational contexts where (1) clinicians failed to listen and respond to the patients' or carers' observations about their risks or the quality of their treatment and care, (2) clinicians failed to recognise and respond to clear signs that a patient had a pressure ulcer or was at risk of developing one and (3) services were not effectively coordinated.

Conclusions: Patient accounts could only be partially explained in terms of specific events or sequences of events. The findings support the conclusion that there was general acceptance of suboptimal clinical practices in 7 of the 8 contexts where patients developed severe pressure ulcers.
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http://dx.doi.org/10.1136/bmjopen-2013-004303DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3902507PMC
January 2014

The prevalence of pain at pressure areas and pressure ulcers in hospitalised patients.

BMC Nurs 2013 Jul 31;12(1):19. Epub 2013 Jul 31.

Centre for Pain Research, Queens Square House, Leeds Metropolitan University, Leeds LS1 3HE, UK.

Background: Patients with pressure ulcers (PUs) report that pain is their most distressing symptom, but there are few PU pain prevalence studies. We sought to estimate the prevalence of unattributed pressure area related pain (UPAR pain) which was defined as pain, soreness or discomfort reported by patients, on an "at risk" or PU skin site, reported at a patient level.

Methods: We undertook pain prevalence surveys in 2 large UK teaching hospital NHS Trusts (6 hospitals) and a district general hospital NHS Trust (3 hospitals) during their routine annual PU prevalence audits. The hospitals provide secondary and tertiary care beds in acute and elective surgery, trauma and orthopaedics, burns, medicine, elderly medicine, oncology and rehabilitation. Anonymised individual patient data were recorded by the ward nurse and PU prevalence team. The analysis of this prevalence survey included data summaries; no inferential statistical testing was planned or undertaken. Percentages were calculated using the total number of patients from the relevant population as the denominator (i.e. including all patients with missing data for that variable).

Results: A total of 3,397 patients in 9 acute hospitals were included in routine PU prevalence audits and, of these, 2010 (59.2%) patients participated in the pain prevalence study. UPAR pain prevalence was 16.3% (327/2010). 1769 patients had no PUs and of these 223 patients reported UPAR pain, a prevalence of 12.6%. Of the 241 people with pressure ulcers, 104 patients reported pain, a UPAR pain prevalence of 43.2% (104/241).

Conclusion: One in six people in acute hospitals experience UPAR pain on 'at risk' or PU skin sites; one in every 8 people without PUs and, more than 2 out of every five people with PUs. The results provide a clear indication that all patients should be asked if they have pain at pressure areas even when they do not have a PU.
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http://dx.doi.org/10.1186/1472-6955-12-19DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3765382PMC
July 2013

Development and validation of a new patient-reported outcome measure for patients with pressure ulcers: the PU-QOL instrument.

Health Qual Life Outcomes 2013 Jun 13;11:95. Epub 2013 Jun 13.

Clinical Trials Research Unit (CTRU), University of Leeds, Leeds LS2 9JT, UK.

Background: Patient-reported outcome (PRO) data are integral to patient care, policy decision making and healthcare delivery. PRO assessment in pressure ulcers is in its infancy, with few studies including PROs as study outcomes. Further, there are no pressure ulcer PRO instruments available.

Methods: We used gold-standard methods to develop and evaluate a new PRO instrument for people with pressure ulcers (the PU-QOL instrument). Firstly a conceptual framework was developed forming the basis of PU-QOL scales. Next an exhaustive item pool was used to produce a draft instrument that was pretested using mixed methods (cognitive interviews and Rasch Measurement Theory). Finally, we undertook psychometric evaluation in two parts. This first part was item reduction, using PU-QOL data from 227 patients. The second part was reliability and validity evaluation of the item-reduced version using both Traditional and Rasch methods, on PU-QOL data from 229 patients.

Results: The final PU-QOL contains 10 scales for measuring symptoms, physical functioning, psychological well-being and social participation specific to pressure ulcers. It is intended for administration and patients rate the amount of "bother" attributed during the past week on a 3-point response scale. Scale scores are generated by summing items, with lower scores indicating better outcome. The PU-QOL instrument was found to be acceptable, reliable (Cronbach's alpha values ranging 0.89-0.97) and valid (hypothesised correlations between PU-QOL and SF-12 scores (r>0.30) and PU-QOL scales and sociodemographic variables (r<0.30) were consistent with predictions).

Conclusions: The PU-QOL instrument provides a standardised method for assessing PROs, reflecting the domains in a pressure ulcer-specific conceptual framework. It is intended for evaluating patient orientated differences between interventions and in particular the impact from the perspective of patients.
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http://dx.doi.org/10.1186/1477-7525-11-95DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3698102PMC
June 2013

The prevalence of pressure ulcers in community settings: an observational study.

Int J Nurs Stud 2013 Nov 10;50(11):1550-7. Epub 2013 Jun 10.

Clinical Trials Research Unit, University of Leeds, Clinical Trials Research House, 71-71 Clarendon Road, Leeds LS2 9PH, United Kingdom. Electronic address:

Background: Changes in healthcare and ageing populations have led to an increasing emphasis on the provision of healthcare in the community. Quality initiatives in healthcare have led to a focus upon pressure ulcer rates. However, published data on pressure ulcer prevalence in a community setting is currently very limited.

Objective: The objective of this cross-sectional observational study was to determine the prevalence of patients with pressure ulcers in a community setting in the United Kingdom.

Design: A cross-sectional observational study.

Setting: Two community settings in the North of England.

Participants: Patients in the community who were aged 18 years or older at the time of the pressure ulcer prevalence audit were included. There were no exclusion criteria and consent was not a requirement.

Methods: Each site used a different method to collect the data as per their usual method of prevalence data collection. Site 1 assessed all patients on the community nursing caseload: patients in residential homes, rehabilitation units, specialist palliative care units and all nursing homes in the locality, whether they were known to have a pressure ulcer or not. Site 2 assessed only those on the community nursing caseload who were known to have a pressure ulcer. Site 1 collected data between 8th February and 2nd April 2010 and site 2 between 12th April and 7th May 2010.

Results: In site 1, 185 patients were assessed as having a pressure ulcer Grade ≥ 1, a prevalence rate of 0.77 per 1000 adults. In Site 2 102 patients were assessed as having a Grade ≥ 1 pressure ulcer, a prevalence rate of 0.40 per 1000 adults. Removing patients in nursing homes from the calculation gives a prevalence of 0.38 per 1000 adults for site 1 and 0.39 per 1000 adults for site 2.

Conclusions: This study provides prevalence data in a community setting which can be used to assess resource allocation and staff training. This study has highlighted that differences in methodology can affect prevalence results, and this should be taken into account in future research.
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http://dx.doi.org/10.1016/j.ijnurstu.2013.04.001DOI Listing
November 2013

Patient risk factors for pressure ulcer development: systematic review.

Int J Nurs Stud 2013 Jul 1;50(7):974-1003. Epub 2013 Feb 1.

Clinical Trials Research Unit, University of Leeds, UK.

Objective: To identify risk factors independently predictive of pressure ulcer development in adult patient populations?

Design: A systematic review of primary research was undertaken, based upon methods recommended for effectiveness questions but adapted to identify observational risk factor studies.

Data Sources: Fourteen electronic databases were searched, each from inception until March 2010, with hand searching of specialist journals and conference proceedings; contact with experts and a citation search. There was no language restriction.

Review Methods: Abstracts were screened, reviewed against the eligibility criteria, data extracted and quality appraised by at least one reviewer and checked by a second. Where necessary, statistical review was undertaken. We developed an assessment framework and quality classification based upon guidelines for assessing quality and methodological considerations in the analysis, meta-analysis and publication of observational studies. Studies were classified as high, moderate, low and very low quality. Risk factors were categorised into risk factor domains and sub-domains. Evidence tables were generated and a summary narrative synthesis by sub-domain and domain was undertaken.

Results: Of 5462 abstracts retrieved, 365 were identified as potentially eligible and 54 fulfilled the eligibility criteria. The 54 studies included 34,449 patients and acute and community patient populations. Seventeen studies were classified as high or moderate quality, whilst 37 studies (68.5%) had inadequate numbers of pressure ulcers and other methodological limitations. Risk factors emerging most frequently as independent predictors of pressure ulcer development included three primary domains of mobility/activity, perfusion (including diabetes) and skin/pressure ulcer status. Skin moisture, age, haematological measures, nutrition and general health status are also important, but did not emerge as frequently as the three main domains. Body temperature and immunity may be important but require further confirmatory research. There is limited evidence that either race or gender is important.

Conclusions: Overall there is no single factor which can explain pressure ulcer risk, rather a complex interplay of factors which increase the probability of pressure ulcer development. The review highlights the limitations of over-interpretation of results from individual studies and the benefits of reviewing results from a number of studies to develop a more reliable overall assessment of factors which are important in affecting patient susceptibility.
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http://dx.doi.org/10.1016/j.ijnurstu.2012.11.019DOI Listing
July 2013