The development of a core outcome set for clinical effectiveness studies of bordered foam dressings in the treatment of complex wounds.

AIM: The aim of this project was to develop a core outcome set (COS) for clinical effectiveness studies of bordered foam dressings in the treatment of complex wounds. METHODS: The research project followed the Core Outcome Measures in Effectiveness Trials (COMET) initiative and consisted of two phases. The first phase prepared the background and process, while the second phase had three steps: outcome list generation via systematic review and qualitative study, Delphi consensus study, and consensus meeting. The study has been registered in the Core Outcome Measures in Effectiveness Trials database. RESULTS: The systematic review resulted in 82 outcomes and 20 additional outcomes were obtained during the interviews. After refinement, 111 panellists from 23 countries rated a list of 51 outcomes. In the following consensus meeting, six outcomes were prioritized to be included in the core outcome set. After the consensus meeting, a patient-reported outcome was added to the core outcome set. CONCLUSION: The COS for evaluating the effectiveness of bordered foam dressings in treating complex wounds includes 7 outcomes: "ability to stay in place", "leakage", "pain", "dressing related periwound skin changes", "change in wound size over time", and "overall satisfaction". These identified outcomes are correlated with contemporary bioengineering testing and evaluation methods for dressing performance, which underpins the need for a close multidisciplinary collaboration to advance the field of wound dressings. The outcome 'overall satisfaction' reflects the impact of complex wounds and their treatment on a patient's daily life. The use of these outcomes is recommended to improve data synthesis and promote evidence-based practice. Future developments in COS development involve creating measurement instruments and relevant endpoints for these outcomes.

Swedish translation, cultural adaptation and psychometric evaluation of the pressure ulcer knowledge assessment tool for use in the operating room.

The aim of this study was to psychometrically evaluate the Swedish operating room version of PUKAT 2.0. In total, 284 Swedish operating room nurses completed the survey of whom 50 completed the retest. The item difficulty P-value of 14 items ranged between 0.38 and 0.96 (median 0.65). Three items were found to be too easy (0.90-0.96). The D-value of 14 items ranged between 0.00 and 0.42 (median 0.46). Three items had a D-value lower than 0.20 (0.11-0.16) and eight items scored higher than 0.40 (0.45-0.61). The quality of the response alternatives (a-value) ranged between 0.00 and 0.42. This showed that nurses with a master's degree had a higher knowledge than nurses with a professional degree (respectively 9.4/14 versus 8.6/14; t = -2.4, df = 199, P = 0.02). The ICC was 0.65 (95% CI 0.45-0.78). The ICCs for the domains varied from 0.12 (95% CI = -0.16-0.39) to 0.59 (95% CI = 0.38-0.75). Results indicated that 11 of the original items contributed to the overall validity. However, the low participation in the test-retest made the reliability of the instrument low. An extended evaluation with a larger sample should be considered in order to confirm aspects of the psychometric properties of this instrument.

Promoting and Maintaining Skin Integrity in End-of-Life Care: A Systematic Review.

OBJECTIVE: To systematically review recommendations for promoting and maintaining skin integrity in end-of-life care and their level of evidence. DATA SOURCES: MEDLINE (PubMed interface), CINAHL (Cumulative Index to Nursing and Allied Health Literature), EMBASE, and The Cochrane Library were systematically searched using a combination of key terms including end-of-life care , skin care , skin hygiene , and skin cleansing . STUDY SELECTION: Articles were included if they (1) described skin care recommendations, including but not limited to the use of skin care products and interventions such as cleansing procedures; and (2) included adult patients who were expected to die within 12 months. There were no restrictions on study design, study setting, or language. Articles with a publication date before 2000 were excluded. DATA EXTRACTION: Two data extraction forms were developed. The first included information about the author, publication year, type of evidence, study topic, sample, sample size, setting, limitations of the study, level of evidence, and quality of the study. The second included recommendations for promoting and maintaining skin integrity in patients at the end of life. DATA SYNTHESIS: Because of methodological heterogeneity, results were synthesized narratively, and no meta-analysis was performed. CONCLUSIONS: The information contained in the recommendations will assist nurses in promoting and maintaining skin integrity in patients at the end of life. More research is needed on end-of-life skin care, with an emphasis on patient-centered, holistic strategies that improve patient well-being and quality of life. In most current research, recommendations are limited to literature reviews and level V evidence. Skin care must balance the promotion and maintenance of skin integrity, wound prevention, and management while promoting patient dignity and quality of life.

Clinical research on the use of bordered foam dressings in the treatment of complex wounds: A systematic review of reported outcomes and applied measurement instruments.

OBJECTIVE: The aim of this review article was to identify reported outcomes and measurement instruments used in clinical research on bordered foam dressings in the treatment of complex wounds. METHODS: MEDLINE (PubMed interface), Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, and The Cochrane Library were systematically searched using a combination of key terms including; wounds, bordered foam dressing, and treatment. Studies were included if they (1) targeted an adult population, (2) addressed the treatment of complex wounds with a bordered foam dressing as the primary wound dressing, (3) were retrieved from original research, and (4) were published between 2000 and 2022. There were no restrictions on language or study design. Studies that focused primarily on the prevention of complex wounds were excluded. Data extraction included outcome domains, outcomes, instruments, time points, and outcome measures. The OMERACT Filter 2.0 was used as a conceptual framework for the extraction of outcomes. RESULTS: A total of 24 outcome domains and 82 outcomes were identified. The outcomes were categorised into five core areas: (1) impact on life, (2) dressing performance, (3) pathophysiological manifestations, (4) resource use, and (5) adverse events. Thirtynine outcomes (47.0%) were measured at more than one time point. The most frequently reported time point was 'at the end of treatment' (62.7%). Outcomes were measured using self-report instruments, clinical observations, and bio-physiological instruments. CONCLUSION: This systematic review identified reported outcomes and measurement instruments in research on bordered foam dressings in the treatment of complex wounds. The variety and lack of consistency in terms of instruments, time points and outcome measurements made it difficult to compare data directly across different reported studies. A solution to the variety in outcome reporting across studies in complex wound care, and moreover for the treatment with bordered foam dressings, is the development of a Core Outcome Set (COS). The outcomes in this review article will inform the next steps of developing a COS, where patients, clinicians and researchers will be involved to decide on the final outcomes included in a COS for the treatment of complex wounds with bordered foam dressings.

The Swedish version of the attitude towards pressure ulcer prevention instrument for use in an operating room context (APUP-OR): A nationwide psychometric evaluation.

INTRODUCTION: To assess operating room (OR) nurses' attitudes towards pressure ulcer prevention, the Attitude towards Pressure Ulcer Prevention (APuP) instrument was developed. AIM: The aim of this study was to psychometrically evaluate the Attitude towards Pressure Ulcer Prevention (APuP) instrument in a Swedish OR context. MATERIALS AND METHODS: A psychometric evaluation study was conducted, using a convenience sample, between February and August 2020. Validity (content, construct, discriminatory power) and reliability (stability and internal consistency) were evaluated. RESULTS: The first survey (test) was completed by 284 Swedish OR nurses, of whom n = 50 (17.6%) completed the second survey (retest). A Principal Component Analysis was conducted for the 13-item instrument. The KMO value for this model was 0.62. Bartlett's test for sphericity was statistically significant (p 0.001). Five factors were identified which accounted for 56% of the variance in responses related to attitudes toward pressure ulcer prevention. The Cronbach's α for the instrument "attitude towards Pressure Ulcer Prevention" was 0.66. The intraclass correlation coefficient was 0.49 (95% CI = 0.25-0.67). CONCLUSION: This Swedish version of the APuP- OR is the first step in the development of an instrument to measure OR nurses' attitudes towards PU prevention in a Swedish OR context. The reliability of the instrument was low and the validity moderate. A larger sample and the revision or addition of items related to the context of the operating room should be considered in order to confirm aspects of the psychometric properties.

Integrating Sensor Technology in Disposable Body-Worn Absorbent Products: A Qualitative Study to Define User Profile, (Technical) Criteria, Conditions, and Potential Benefits.

PURPOSE: The purpose of this study was to define the user profile, (technical) criteria, conditions, and potential benefits of the integration of sensor technology in disposable body-worn incontinence materials. DESIGN: Qualitative study using a framework method. SUBJECT AND SETTING: The sample included residents with incontinence, nurses, and decision-makers in a selection of Flemish nursing homes (Belgium). METHODS: Semistructured interviews were performed between June and August 2020. The interviews with nurses included open-ended questions focusing on the user profile, (technical) criteria, conditions, and potential benefits of the integration of sensor technology in disposable body-worn incontinence materials. The interviews with decision-makers were supplemented with questions about purchase cost and other economic criteria (such as reimbursement). Interviews with residents included questions about wearing comfort. Interviews were tape-recorded and transcribed verbatim. Data were analyzed using a framework method. RESULTS: The user profile was defined as (1) residents with cognitive impairment and (2) residents who are bedridden or are severely limited in mobility. The following (technical) criteria emerged from the analyses: a small, thin, and oval/circular sensor, an adaptable or in front attachment of the sensor on the absorbent product, a real-time indication of the absorbent product's saturation, leakage detection, liquid stool detection, the automatic recording of incontinence-related data, a durable sensor easy to disinfect, and receiving notifications on a wearable device. Conditions included a stable connection between the wearable device and the sensor, accurate measurements, user-friendly system, comprehensible training, affordability, and data protection. Potential benefits included workload reduction, increased comfort for residents and staff, more person-centered care, increased quality of care, less skin damage and economic (eg, less costs due to less excessive absorbent product changes), and/or environmental (e.g. less waste) gains. CONCLUSION: Study findings identified the user profile, (technical) criteria, conditions, and potential benefits of the integration of sensor technology in disposable body-worn incontinence materials. Respondents reported problems with changing routines and skepticism about the sensor's accuracy. Based on findings from this study, we recommend involving representatives of all relevant stakeholders in the design of sensor technology to ensure users' needs and increase the use of sensor technology. Comprehensive education is recommended to inform nurses, residents, and their family members on the importance and benefits of the technology and to aid overcoming barriers to use (skepticism, resistance to new technologies, and changing care routines). Study findings also indicate that the sensor technology cannot replace the existing voiding programs; rather it should be an addition to routine continence care.

A Fully Automated Pulsating Support System for Pressure Injury Prevention and Treatment in 10 Belgium Nursing Homes: An Observational Study.

PURPOSE: We studied pressure injury (PI) stage II-IV cumulative incidence and the change of PI status in the sacral area of nursing home residents associated with the use of a fully automated pulsating support system air mattress in use for 30 days. We also assessed caregivers', residents', and their family members' experiences and perceptions of mattress comfort and other factors such as pain. DESIGN: Multicenter cohort study. SUBJECT AND SETTING: A convenience sample of 40 residents residing in 10 Belgian nursing homes was recruited. METHODS: Pressure injury classification was confirmed using the European Pressure Ulcer Advisory Panel classification system. The Pressure Ulcer Scale for Healing (PUSH) tool was used to assess and measure PI status change. A comfort assessment was performed at end of the study. Cumulative PI incidence of stages II-IV was calculated, and frequencies and percentages were used to describe the results of the comfort assessments. RESULTS: Residents were allocated to the prevention group (n = 22) and to the treatment group (n = 18). The cumulative PI incidence was 4.5% (n = 1/22) in the prevention group. In the treatment group, the mean score on the PUSH tool decreased from 9.36 to 7.70 during the observation period, indicating an overall improvement. Four of the existing PIs healed, 17 PIs remained stable, and 1 PI deteriorated. The comfort questionnaires were completed by 76 nursing home caregivers, 21 family members, and 11 residents in the 10 participating nursing homes; the mattress comfort was perceived as very good, and pain was noted to decrease. CONCLUSIONS: Low cumulative PI incidence findings were observed with use of the mattress for the prevention of PIs and resulted in improvements in existing PIs, results which are consistent with several existing studies. The majority of the caregivers, residents, and family members evaluated the mattress as comfortable. Future research is needed to corroborate findings in larger randomized clinical trials.

Management of incontinence-associated dermatitis: A systematic review of monetary data.

The objective was to systematically review monetary data related to management of incontinence-associated dermatitis (IAD) in an adult population. Six electronic databases were searched: MEDLINE, CINAHL, Web of Science, EMBASE, The Cochrane Library and EconLit. The search string combined index terms and text words related to IAD and monetary data. The quality of the articles was assessed using the consensus on Health Economic Criteria. Results were synthesised narratively because of methodological heterogeneity. Nine studies were included. Only direct medical costs were reported. The product cost per application for prevention ranged between $0.05 and $0.52, and for treatment between $0.20 and $0.35. The product cost per patient/day for prevention ranged between $0.23 and $20.17. The product cost of IAD prevention and treatment per patient/day ranged between $0.57 and $1.08. The cost to treat IAD did not consider the treatment of secondary infection. The calculation of labour cost and total cost differed considerably between studies. Summarising monetary data is a challenge because of heterogeneity in currencies, settings, samples, time horizons, health- and cost outcome valuation, IAD definition and measurements, and included costs. Procedures for health economic evaluations are to be clarified to guarantee valid interpretation and comparison with other studies.