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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. 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. 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. 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. • The COS includes seven core outcomes. • The use of this COS is recommended to improve data synthesis and promote evidence-based practice. • The outcome 'overall satisfaction' reflects the impact on a patient's daily life. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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 incomparability in outcomes makes it difficult to evaluate clinical trials in complex wound care in a uniform way. • Future research should investigate which outcomes are important to patients. • The development of a COS is a solution to the variety in outcome reporting across studies in complex wound care. [ABSTRACT FROM AUTHOR]

The Visual Analogue Scale applied by an observer (VASobs) is widely used to quantify pain but the evidence to support validity is poor. The aim of this study was to evaluate the psychometric and practical properties of the VASobs used to assess procedural pain in infants and young children. In an observational study, 26 clinicians applied the VASobs independently to video segments of 100 children aged six to 42 months undergoing a procedure to generate pain and distress scores. Each video segment was scored by four randomly selected reviewers. Reliability for pain scores was poor to fair (ICC 0.35 to 0.55) but higher for distress scores (ICC 0.6 to 0.89). At a cut-off score of 3, sensitivity and specificity were 84.7% and 95.0%, respectively for pain and 91.5% and 77.5% respectively for distress. Linear mixed modelling confirmed responsiveness. An increase in pain scores (regression slope 4.95) and distress scores (regression slope 5.52) across phases (baseline to procedure) was seen for painful procedures. The correlation between VASobs pain and FLACC scores was good (r = 0.74) and correlations between VASobs distress and FLACC scores were excellent (r = 0.89). VASobs was easily applied and preferred by clinicians. Despite evidence of sensitivity and responsiveness to pain, the reliability results were poor, and this scale cannot be recommended for use. The results of this study prevent recommending the VASobs for assessing procedural pain in infants and young children for clinical or research purposes. • VASobs scores were sensitive and responsive to procedural pain. • Clinicians were not confident about the clinical utility of the scores. • VASobs scores for procedural pain assessment show poor reliability. • VASobs scores did not distinguish adequately between pain and distress. • This scale cannot be recommended for research or clinical use. [ABSTRACT FROM AUTHOR]

The Face, Legs, Activity, Cry, and Consolability (FLACC) scale is one of the most commonly and widely used behavioral observation pain scales. The aim of this study was to test the psychometric and practical properties of the FLACC scale to quantify procedural pain in infants and young children. Twenty-six clinicians independently applied the FLACC scale to segments of video collected from 100 children aged 6 to 42 months undergoing a procedure. Video segments were scored by 4 reviewers. Inter- and intrarater reliability coefficients were high (.92 and .87, respectively). Linear mixed modeling confirmed scale responsiveness (differences in difference between FLACC scores across phases for painful versus nonpainful procedures was 4.2, 95% confidence interval = 3.67-4.81). Sensitivity and specificity were 94.9% and 73.5%, respectively, at a cutoff of 2. However, the mean difference across phases for children with baseline scores >3 was much lower than for children with scores <3, P = .0001. Correlations between FLACC and Visual Analog Scale observer pain and distress were good (r = .74 and r = .89, respectively). This study supports the reliability and sensitivity of the FLACC scale for procedural pain assessment. However, the circumstances of procedures interfered with application of the scale and the findings question the capacity of the scale to differentiate between pain- and nonpain-related distress.Perspective: This article provides evidence that the FLACC scale is reliable and sensitive to pain for procedural pain assessment. Concerns remain about specificity and scale design. Identification of a scale valid for this purpose is needed to provide a platform for improved procedural pain management in infants and young children. [ABSTRACT FROM AUTHOR]

The Modified Behavioral Pain Scale (MBPS) was designed to assess procedural pain in infants and is considered valid for assessing immunization pain. The aim of this study was to assess the practical and psychometric properties of the MBPS when applied to other commonly performed procedures. Twenty-six clinicians independently applied the MBPS scale to segments of video collected from 100 infants and children aged 6 to 42 months undergoing 1 of 4 procedures in the emergency department. Positive correlation between MBPS and Visual Analogue Scale observer applied (VASobs) pain (r = .74) was shown and inter- and intrarater reliability coefficients were high (.87 and .89, respectively). Construct validity was shown by scale responsiveness to painful stimuli (4.6 times increase in scores across phases) and the capacity of the scale to distinguish between painful versus nonpainful procedures (P < .001). However, mean baseline scores for procedures were not 0 (likely a function of item descriptors for a "0" score) and the mean difference increased across phases for children with baseline scores >3, which was much lower than for children with scores <3 (P = .0001). Finally, 28% of scores changed after the second viewing of a video segment. The MBPS appears reliable and sensitive to procedural pain when applied by clinicians. Results question the capacity of the scale to differentiate between pain- and nonpain-related distress, the feasibility of this scale, and the appropriateness of item descriptors for medical procedures.Perspective: This article presents the psychometric and practical properties of the MBPS applied to assess procedural pain. Identification of a suitable scale for this purpose will support improved pain management in infants and young children who undergo painful procedures. [ABSTRACT FROM AUTHOR]

Problem Clinicians and researchers require a valid way to assess procedural pain experienced by infants and children. The Modified Behavioral Pain Scale (MBPS) has been used to assess immunisation pain. However, it is unknown whether it is valid for this purpose and whether use can be extended to other procedures. The aim of this study was to rigorously assess evidence addressing the psychometric properties of this scale and to provide recommendations for its use. Eligibility criteria Psychometric evaluation studies reporting feasibility, reliability, validity, or utility data for the MBPS applied to children (birth to 18 years) and randomised controlled trials (RCT) using the MBPS were included. Sample Twenty-eight studies (8 psychometric and 20 RCTs) were included. Results Studies were of varying quality. Sufficient data was available to cautiously accept the MBPS as valid for assessing immunisation related pain in infants aged 2 to 22 months. There was insufficient data to support the psychometrics in other age groups or in circumstances other than immunisation. There is no data addressing the clinical utility of the MBPS. Conclusions It is not possible at this time to confidently accept the MBPS as suitable for assessing all procedural pain in young children. Implications Studies to evaluate the capacity of the MBPS to assess pain in a range of procedures and to distinguish between pain and non-pain related distress are needed if it is to be recommended. [ABSTRACT FROM AUTHOR]

Background High strain in soft tissues that overly bony prominences are considered a risk factor for pressure ulcers (PUs) following spinal cord impairment (SCI) and have been computed using Finite Element methods (FEM). The aim of this study was to translate a MRI protocol into ultrasound (US) and determine between-operator reliability of expert sonographers measuring diameter of the inferior curvature of the ischial tuberosity (IT) and the thickness of the overlying soft tissue layers on able-bodied (AB) and SCI using real-time ultrasound. Material and methods Part 1: Fourteen AB participants with a mean age of 36.7 ± 12.09 years with 7 males and 7 females had their 3 soft tissue layers in loaded and unloaded sitting measured independently by 2 sonographers: tendon/muscle, skin/fat and total soft tissue and the diameter of the IT in its short and long axis. Part 2: Nineteen participants with SCI were screened, three were excluded due to abnormal skin signs, and eight participants (42%) were excluded for abnormal US signs with normal skin. Eight SCI participants with a mean age of 31.6 ± 13.6 years and all male with 4 paraplegics and 4 tetraplegics were measured by the same sonographers for skin, fat, tendon, muscle and total. Skin/fat and tendon/muscle were computed. Results AB between-operator reliability was good (ICC = 0.81–0.90) for 3 soft tissues layers in unloaded and loaded sitting and poor for both IT short and long axis (ICC = −0.028 and −0.01). SCI between-operator reliability was good in unloaded and loaded for total, muscle, fat, skin/fat, tendon/muscle (ICC = 0.75–0.97) and poor for tendon (ICC = 0.26 unloaded and ICC = −0.71 loaded ) and skin (ICC = 0.37 unloaded and ICC = 0.10). Conclusion A MRI protocol was successfully adapted for a reliable 3 soft tissue layer model and could be used in a 2-D FEM model designed to estimate soft tissue strain as a novel risk factor for the development of a PU. [ABSTRACT FROM AUTHOR]

Abstract Pressure ulcers are caused by sustained mechanical loading and deformation of the skin and subcutaneous layers between internal stiff anatomical structures and external surfaces or devices. In addition, the skin microclimate (temperature, humidity and airflow next to the skin surface) is an indirect pressure ulcer risk factor. Temperature and humidity affect the structure and function of the skin increasing or lowering possible damage thresholds for the skin and underlying soft tissues. From a pressure ulcer prevention research perspective, the effects of humidity and temperature next to the skin surface are inextricably linked to concurrent soft tissue deformation. Direct clinical evidence supporting the association between microclimate and pressure ulceration is sparse and of high risk of bias. Currently, it is recommended to keep the skin dry and cool and/or to allow recovery periods between phases of occlusion. The stratum corneum must be prevented from becoming overhydrated or from drying out but exact ranges of an acceptable microclimate are unknown. Therefore, vague terms like 'microclimate management' should be avoided but product and microclimate characteristics should be explicitly stated to allow an informed decision making. Pressure ulcer prevention interventions like repositioning, the use of special support surfaces, cushions, and prophylactic dressings are effective only if they reduce sustained deformations in soft tissues. This mode of action outweighs possible undesirable microclimate properties. As long as uncertainty exists efforts must be taken to use as less occlusive materials as possible. There seems to be individual intrinsic characteristics making patients more vulnerable to microclimate effects. Highlights • An object on the skin surface provides an impedance to convective heat loss. • An object on the skin surface provides an impedance to evaporative moisture loss. • Microclimate is an effect-modifier or an indirect risk factor for pressure ulcer development. • Effects of 'microclimate interventions' on pressure ulcer prevention are unclear. • The term 'microclimate management' should not be used. [ABSTRACT FROM AUTHOR]

Background: Respiratory rate is an important sign that is commonly either not recorded or recorded incorrectly. Mobile phone ownership is increasing even in resource-poor settings. Phone applications may improve the accuracy and ease of counting of respiratory rates. Objectives: The study assessed the reliability and initial users' impressions of four mobile phone respiratory timer approaches, compared to a 60-second count by the same participants. Methods: Three mobile applications (applying four different counting approaches plus a standard 60-second count) were created using the Java Mobile Edition and tested on Nokia C1-01 phones. Apart from the 60-second timer application, the others included a counter based on the time for ten breaths, and three based on the time interval between breaths ('Once-per-Breath', in which the user presses for each breath and the application calculates the rate after 10 or 20 breaths, or after 60s). Nursing and physiotherapy students used the applications to count respiratory rates in a set of brief video recordings of children with different respiratory illnesses. Limits of agreement (compared to the same participant's standard 60-second count), intra-class correlation coefficients and standard errors of measurement were calculated to compare the reliability of the four approaches, and a usability questionnaire was completed by the participants. Results. There was considerable variation in the counts, with large components of the variation related to the participants and the videos, as well as the methods. None of the methods was entirely reliable, with no limits of agreement better than -10 to +9 breaths/min. Some of the methods were superior to the others, with ICCs from 0.24 to 0.92. By ICC the Once-per-Breath 60-second count and the Once-per-Breath 20-breath count were the most consistent, better even than the 60-second count by the participants. The 10-breath approaches performed least well. Users' initial impressions were positive, with little difference between the applications found. Conclusions: This study provides evidence that applications running on simple phones can be used to count respiratory rates in children. The Once-per-Breath methods are the most reliable, outperforming the 60-second count. For children with raised respiratory rates the 20-breath version of the Once-per-Breath method is faster, so it is a more suitable option where health workers are under time pressure. [ABSTRACT FROM AUTHOR]