Using PURPOSE-T in clinical practice: A realist evaluation.

AIM: To explain how the clinical and organisational context influenced the way the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE-T) is used by nursing staff to support their clinical judgement and decision making about care planning and delivery. METHODS: A realist process evaluation was undertaken in a large acute hospital trust using mixed methods incorporating organisational policy review, staff semi-structured, ethnographic observation of clinical care and patient record review. Approximately 75 h of ethnographic field work involving 72 patients, 15 patient record reviews and 16 staff interviews were undertaken on 4 wards. FINDINGS: Findings suggest PURPOSE-T assisted nurses differently depending on their level of experience. Those with less experience use it as an educational guide, while those with more experience made an initial clinical judgement and used PURPOSE-T as a safety net to ensure they hadn't missed anything. Nurses were concerned about demonstrating good documentation of assessment, care planning and delivery in order to underpin consistent communication about care and because they had an underlying fear of being blamed if things went wrong. There is an array of other contextual features that impact the planning and delivery of pressure area care that go beyond the use of PURPOSE-T alone, including systematic equipment provision, competing patient safety initiatives and rehabilitation requirements. CONCLUSION: The findings reinforce the assertion that PU-RAIs are complex interventions and could inform the development of a more integrated system of care which takes into account the contextual features associated with PU prevention in modern hospitals.

The theory and practice of pressure ulcer/injury risk assessment: a critical discussion.

Pressure ulcer/injury (PU) risk assessment is widely considered an essential component in clinical practice. It is a complex and broad concept that includes different approaches, such as clinical judgement, using standardised risk assessment instruments, skin assessments, or using devices to measure skin or tissue properties. A distinction between PU risk assessment and early detection is important. PU risk measures the individual's susceptibility to developing a PU under a specific exposure (primary prevention), and early detection includes the assessment of early (sub)clinical signs and symptoms to prevent progression and to support healing (secondary prevention). PU risk is measured using prognostic/risk factors or prognostic models. Every risk estimate is a probability statement containing varying degrees of uncertainty. It therefore follows that every clinical decision based on risk estimates also contains uncertainty. PU risk assessment and prevention is a complex intervention, where delivery contains several interacting components. There is a huge body of evidence indicating that risk assessment and its outcomes, the selection of preventive interventions and PU incidence are not well connected. Methods for prognostic model development and testing in PU risk research must be improved and follow state-of-the-art methodological standards. Despite these challenges, we do have substantial knowledge about PU risk factors that helps us to make better clinical decisions. An important next step in the development of PU risk prediction might be the combination of clinical and other predictors for more individualised care. Any prognostic test or procedure must lead to better prevention at an acceptable cost.

Feasibility of PURPOSE T in clinical practice and patient participation-A mixed-method study.

This study aimed to evaluate the feasibility of implementing an electronic version of PURPOSE T, a risk assessment instrument for pressure ulcers, in a Swedish hospital ward. A mixed-method was used. Nursing staff received training in PURPOSE T and a record review was performed (n = 30). PURPOSE T replaced the Modified Norton Scale, and after one month another record review was performed (n = 30). Individual interviews with patients (n = 15) and focus group interviews with nursing staff (n = 23) were performed after the implementation. The results of the record review and the focus group interviews showed good clinical feasibility of PURPOSE T. The record review showed that more patients were at risk of developing pressure ulcers and more nursing interventions were prescribed with PURPOSE T compared to the Modified Norton Scale. The focus group interviews showed that all nursing staff were satisfied with PURPOSE T. The instrument contributed to increased reflection and analysis as well as the opportunity for nursing staff to draw their own conclusions regarding patients´ risk status. The documentation encouraged the prescription of more preventive actions, and the nurses were more involved at bedside. However, almost all the patients expressed not receiving any information about pressure ulcers.

Using consensus methods to prioritize modifiable risk factors for development of manifestations of frailty in hospitalized older adults.

AIM: The aim of the study was to reach consensus on modifiable risk factors for a novel system of care to address Manifestations of Frailty in hospitalized older adults. DESIGN: Consensus study. METHOD: A modified nominal group technique, incorporating expert group face-to-face interaction, review of existing evidence and pre/post-meeting questionnaire completion was undertaken November 2019-February 2020. RESULTS: Seventy-one risk factors, within seven risk factor domains (pain, medication, fluid and nutrition intake, mobility, elimination, infection, additional patient factors) were considered. It was agreed that 44 risk factors incorporating patient, organizational and environmental risk factors were modifiable and should be included in a novel system of care.

Barriers and facilitators to reporting medical device-related pressure ulcers: A qualitative exploration of international practice.

BACKGROUND: Pressure ulcers are a complex healthcare issue. Hospital-acquired pressure ulcers are used as proxy measurements for the quality and safety of nursing care. Medical device-related pressure ulcers are mostly facility acquired, but their reporting has only recently been widely adopted. Consequently, we do not yet know what factors impact their reporting by registered nurses. OBJECTIVES: To identify and systematically report determinants of the practice of medical device-related pressure ulcers reporting using the Tailored Implementation for Chronic Diseases checklist. DESIGN: Descriptive, explorative design using semi-structured interviews to explore barriers and facilitators to reporting medical device-related pressure ulcers. SETTING: We undertook online, telephone, and face-to-face interviews with participants from 11 different countries. PARTICIPANTS: We interviewed 17 participants who represented acute care (Adult, Paediatrics), academia, and industry. Eleven participants were healthcare professionals with more than 10 years' experience in wound care. METHODS: The interview recordings were transcribed and coded by the lead researcher. Data were analysed thematically using the codebook approach, and themes were developed inductively and deductively. RESULTS: Participants identified determinants of practice which clustered around four domains of the Tailored Implementation for Chronic Diseases checklist i) individual health professional factors, ii) professional interactions, iii) incentives and resources, and iv) capacity for organisational change. Knowledge, attitudes, workload, time, staffing, and perception of consequences, including financial, were identified as the main barriers to reporting. Factors supporting the practice were education, openness, and teamwork. Device procurement could take on characteristics of a barrier or facilitator depending on the organisation. CONCLUSIONS: Reporting medical device-related pressure ulcers has been adopted in healthcare institutions worldwide. Understanding what drives the reporting practice enables improvements in incident reporting, which consequently can lead to improvements in the quality of nursing care and patient safety.

Core outcomes for pressure ulcer prevention trials: results of an international consensus study: Classification: Outcomes and qualitative research.

BACKGROUND: There is substantial heterogeneity between trial outcomes in pressure ulcer prevention research. The development of core outcome sets is one strategy to improve comparability between trial results and thus increase the quality of evidence. OBJECTIVES: To identify core outcomes for pressure ulcer prevention trials. METHODS: A workshop was held with service users to discuss their views and understanding of the outcomes identified by a scoping review and to identify any missing outcomes. In a next step, a Delphi survey comprising three rounds was conducted to evaluate a compiled list of outcomes by their importance. Afterwards the preselection from the Delphi survey was discussed in a virtual consensus meeting with the aim of agreeing on a final set of core outcomes. Individuals who had completed all three rounds of the Delphi survey were eligible to participate in this meeting. Participants included practitioners, service users, researchers and industry representatives. The OUTPUTs project is registered in the COMET database and is part of the Cochrane Skin Core Outcome Set Initiative. RESULTS: The workshop did not reveal any missing outcomes, but highlighted the need for further efforts to make lay people understand what an outcome is in a study setting. The Delphi survey took place between December 2020 and June 2021. After the three rounds, 18 out of 37 presented outcomes were rated to be critically important. In the following consensus meeting, six outcomes were prioritized to be included in the core outcome set for pressure ulcer prevention trials: (i) pressure ulcer occurrence; (ii) pressure ulcer precursor signs and symptoms; (iii) mobility; (iv) acceptability and comfort of intervention; (v) adherence/compliance; and (vi) adverse events/safety. CONCLUSIONS: Based on a comprehensive list of outcomes in pressure ulcer prevention research, there was clear agreement on the six identified core outcomes in three international Delphi rounds and in the consensus meeting. Although outcome measurement instruments need to be identified next, the six identified core outcomes should already be considered in future trials, as service users, practitioners, researchers and industry representatives have agreed that they are critically important. What is already known about this topic? There are numerous trials on pressure ulcer prevention, but evidence on the effectiveness of preventive measures is limited due to heterogeneity between trial outcomes. The development of a core outcome set is one strategy to improve comparability between trial results. What does this study add? A service user workshop, a three-round Delphi survey and an online consensus meeting with practitioners, service users, researchers and industry representatives were conducted to identify core outcomes for pressure ulcer prevention trials. Six core outcomes were defined: (i) pressure ulcer occurrence, (ii) pressure ulcer precursor signs and symptoms, (iii) mobility, (iv) acceptability and comfort of intervention, (v) adherence/compliance and (vi) adverse events/safety. What are the clinical implications of this work? Better evidence of interventions for pressure ulcer prevention will help health professionals and service users to decide which interventions are most appropriate and effective. Better evidence may contribute to better pressure ulcer prevention.

Risk factors for manifestations of frailty in hospitalized older adults: A qualitative study.

AIMS: To explore the experiences of older people and ward staff to identify modifiable factors (risk factors) which have the potential to reduce development or exacerbation of manifestations of frailty during hospitalization. To develop a theoretical framework of modifiable risk factors. DESIGN: Qualitative descriptive study. METHODS: Qualitative interviews with recently discharged older people (n = 18) and focus groups with ward staff (n = 22) were undertaken between July and October 2019. Data were analysed using directed content analysis. RESULTS: Themes identified related to attitude to risk, communication and, loss of routine, stimulation and confidence. Using findings from this study and previously identified literature, we developed a theoretical framework including 67 modifiable risk factors. Risk factors are grouped by patient risk factor domains (pain, medication, nutritional/fluid intake, mobility, elimination, infection, additional patient risk factors) and linked care management sub-domains (including risk factors relating to the ward environment, process of care, ward culture or broader organizational set up). Many of the additional 36 risk factors identified by this study were related to care management sub-domains. CONCLUSION: A co-ordinated approach is needed to address modifiable risk factors which lead to the development or exacerbation of manifestations of frailty in hospitalized older people. Risk assessment and management practices should not be duplicative and, should recognize and address modifiable risk factors which occur at the ward and organizational level. IMPACT: Some older people leave hospital more dependent than when they come in and this is, in part, due to the environment and process of care and not just the severity of their presenting illness. Many of the risk factors identified need to be addressed at an organizational rather than individual level. Findings will inform a programme of research to develop and test a novel system of care aimed at preventing loss of independence in hospitalized older people.

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

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.

Reporting of pressure ulcers and medical device related pressure ulcers in policy and practice: A narrative literature review.

Pressure ulcers (PUs) occur in a range of care settings, resulting in reduced quality of life for the individual. There has been a growing awareness that medical devices can cause PUs, although reporting has been limited. There is a need to evaluate PU reporting practice and identify whether standards exist for medical device-related pressure ulcers (MDRPUs). AIM: To synthesize academic and grey literature relevant to reporting of PUs and MDRPUs in healthcare settings. METHODS: A systematic search of multiple scientific and grey literature databases was undertaken. Key search terms and Boolean operators were used to identify relevant literature. All sources of evidence discussing reporting practices were included in a synthesis. Primary topics are discussed in the corresponding analysis. RESULTS: Thirty-one evidence sources met the inclusion criteria, including 16 journal articles and 15 policy and guidance documents. The results revealed a variation in reporting practices. MDRPUs were often not identified as a separate category in local and national systems. Policies for related patient safety reporting varied across all organisational levels, with more serious categories of PUs reported more consistently. Reporting to medical device regulatory bodies was not mandatory. CONCLUSION: This narrative review identified inconsistencies in local and national reporting of PUs and MDRPUs, prohibiting meaningful comparisons and improvements in patient safety. Lack of specific medical device data and low levels of voluntary reporting to regulatory bodies is likely to result in an under-reporting, with little evidence of specific devices which may be a patient safety concern.

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

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.

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

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.

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

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.

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, 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.

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

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 (n = 1016) or HSFM (n = 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 p-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; p = 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; p-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; p = 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; p = 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 Health Technology Assessment; Vol. 23, No. 52. See the NIHR Journals Library website for further project information.

Pressure ulcers (PUs) are patches of damaged skin, mainly caused by sitting/lying in one position. PUs are graded based on how serious they are, ranging from red patches (category 1) through small skin breaks/blisters (category 2) to serious wounds (category 4). Special mattresses are used to help prevent PUs. This study compared alternating pressure mattresses (APMs) with high-specification foam mattresses (HSFMs), to see which is better at preventing PUs. The study included adults admitted to hospital for acute illness who were at a high risk of developing PUs. Patients were randomly allocated to HSFM or APM. Nurses checked patients' skin and recorded changes. A total of 132 patients developed at least one new PU of category ≥ 2 before the end of treatment (60 days maximum). Of these, 53 patients were allocated to the APM arm and 79 to the HSFM arm, a difference of 2.6%. This is a small but significant difference. Nurses looked at patients' skin again 30 days after the patient had stopped using a trial mattress. At this point, 160 patients had at least one new PU (of category ≥ 2). Of these, 70 patients were allocated to the APM arm and 90 to the HSFM arm, a very small difference of 2.0%. Some patients asked to change mattresses; this happened more in the APM group. This study focused on high-risk patients; however, only a small number of people developed PUs, suggesting that prevention is possible with either mattress. Results also suggest that certain groups of patients may benefit more from APMs, for example people who cannot give consent or who have skin redness. When planning prevention and choosing mattresses, professionals and patients need to consider a number of factors, such as comfort, existing PUs and people's ability to self-care. Further research is recommended to understand what sort of prevention works, for whom and in what circumstances.

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.

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.

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

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.

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

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.

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

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.

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

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.