Effectiveness of a Regenerative Epithelial Suspension (RES), on the pigmentation of split-thickness skin graft donor sites in children: the dRESsing pilot randomised controlled trial protocol.

BACKGROUND: Paediatric donor site wounds are often complicated by dyspigmentation following a split-thickness skin graft. These easily identifiable scars can potentially never return to normal pigmentation. A Regenerative Epidermal Suspension (RES) has been shown to improve pigmentation in patients with vitiligo, and in adult patients following a burn injury. Very little is known regarding the efficacy of RES for the management of donor site scars in children. METHODS AND ANALYSIS: A pilot randomised controlled trial of 40 children allocated to two groups (RES or no RES) standard dressing applied to donor site wounds will be conducted. All children aged 16 years or younger requiring a split thickness skin graft will be screened for eligibility. The primary outcome is donor site scar pigmentation 12 months after skin grafting. Secondary outcomes include re-epithelialisation time, pain, itch, dressing application ease, treatment satisfaction, scar thickness and health-related quality of life. Commencing 7 days after the skin graft, the dressing will be changed every 3-5 days until the donor site is ≥ 95% re-epithelialised. Data will be collected at each dressing change and 3, 6 and 12 months post skin graft. ETHICS AND DISSEMINATION: Ethics approval was confirmed on 11 February 2019 by the study site Human Research Ethics Committee (HREC) (HREC/18/QCHQ/45807). Study findings will be published in peer-reviewed journals and presented at national and international conferences. This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (available at https://anzctr.org.au/ACTRN12620000227998.aspx). TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry [Available at https://anzctr.org.au/ACTRN12620000227998.aspx].

Clinical Hypnosis for Procedural Pain and Distress in Children: A Scoping Review.

OBJECTIVE: Pain and distress are common in children undergoing medical procedures, exposing them to acute and chronic biopsychosocial impairments if inadequately treated. Clinical hypnosis has emerged as a potentially beneficial treatment for children's procedural pain and distress due to evidence of effectiveness and potential superiority to other psychological interventions. However, systematic reviews of clinical hypnosis for children's procedural pain and distress have been predominantly conducted in children undergoing oncology and needle procedures and are lacking in broader pediatric contexts. This scoping review maps the evidence of clinical hypnosis for children's procedural pain and distress across broad pediatric contexts while highlighting knowledge gaps and areas requiring further investigation. METHODS: Published databases (PubMed, Cochrane Library, PsycINFO, Embase, CINAHL, Scopus, and Web of Science) and grey literature were searched in addition to hand-searching reference lists and key journals (up to May 2022). Two independent reviewers screened the titles and abstracts of search results followed by a full-text review against eligibility criteria. Articles were included if they involved a clinical hypnosis intervention comprising an induction followed by therapeutic suggestions for pain and distress in children undergoing medical procedures. This review followed the Arksey and O'Malley (2005) methodology and incorporated additional scoping review recommendations by the Joanna Briggs Institute and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. RESULTS: A total of 38 eligible studies involving 2,205 children were included after 4,775 articles were screened. Research on clinical hypnosis for children's procedural pain and distress was marked by a lack of fidelity measures and qualitative data as well as by inadequate intervention reporting and high attrition rates. Evidence regarding the safety of clinical hypnosis, pain unpleasantness outcomes, factors influencing outcomes, as well as barriers and facilitators to implementing hypnosis and study procedures was also lacking. Clinical hypnosis has potential benefits for children's procedural pain and distress based on evidence of superiority to control conditions and nonpharmacological interventions (e.g., distraction, acupressure) with moderate to large effect sizes as reported in 76% of studies. However, heterogeneous interventions, contexts, study designs, and populations were identified, and the certainty of the evidence was not evaluated. CONCLUSIONS: The review suggests potential benefits of clinical hypnosis for children's procedural pain and distress and thus provides a precursor for further systematic reviews and trials investigating the effectiveness of clinical hypnosis. The review also indicates the need to further explore the feasibility, acceptability, implementation, and safety of clinical hypnosis in children undergoing painful procedures. Based on the review, researchers implementing clinical hypnosis should adequately report interventions or use treatment manuals, follow recommended research guidelines, and assess the fidelity of intervention delivery to promote replicating and comparing interventions. The review also highlights common methodological shortcomings of published trials to avoid, such as the lack of implementation frameworks, small sample sizes, inadequate reporting of standard care or control conditions, and limited evidence on pain unpleasantness outcomes.

Cost-effectiveness of scar management post-burn: a trial-based economic evaluation of three intervention models.

Optimal burn scar management has the potential to markedly improve the lives of children, but can require substantial healthcare resources. The study aimed to examine the cost-effectiveness of three scar management interventions: pressure garment; topical silicone gel; combined pressure garment and topical silicone gel therapy, alongside a randomised controlled trial of these interventions. Participants were children (n = 153) referred for burn scar management following grafting, spontaneous healing after acute burn injury, or reconstructive surgery. Healthcare resource use was costed from a health service perspective (6-months post-burn time-horizon). The mean total scar management cost was lowest in the topical silicone gel group ($382.87 (95% CI $337.72, $443.29)) compared to the pressure garment ($1327.02 (95% CI $1081.46, $1659.95)) and combined intervention $1605.97 ($1077.65, $2694.23)) groups. There were no significant between-group differences in Quality Adjusted Life Year estimates. There was a 70% probability that topical silicone gel dominated pressure garment therapy (was cheaper and more effective), a 29% probability that pressure garment therapy dominated combined therapy, and a 63% probability that topical silicone gel dominated combined therapy. In conclusion, topical silicone gel was the cheaper intervention, and may be favoured in the absence of clear clinical effect favouring pressure garment therapy or a combination of these management approaches.Trial registration: ACTRN12616001100482 (prospectively registered).

Establishment of a core outcome set for burn care research: development and international consensus.

Objective: To develop a core outcome set for international burn research. Design: Development and international consensus, from April 2017 to November 2019. Methods: Candidate outcomes were identified from systematic reviews and stakeholder interviews. Through a Delphi survey, international clinicians, researchers, and UK patients prioritised outcomes. Anonymised feedback aimed to achieve consensus. Pre-defined criteria for retaining outcomes were agreed. A consensus meeting with voting was held to finalise the core outcome set. Results: Data source examination identified 1021 unique outcomes grouped into 88 candidate outcomes. Stakeholders in round 1 of the survey, included 668 health professionals from 77 countries (18% from low or low middle income countries) and 126 UK patients or carers. After round 1, one outcome was discarded, and 13 new outcomes added. After round 2, 69 items were discarded, leaving 31 outcomes for the consensus meeting. Outcome merging and voting, in two rounds, with prespecified thresholds agreed seven core outcomes: death, specified complications, ability to do daily tasks, wound healing, neuropathic pain and itch, psychological wellbeing, and return to school or work. Conclusions: This core outcome set caters for global burn research, and future trials are recommended to include measures of these outcomes.

Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE).

BACKGROUND: Intense and aggressive treatment regimens for most children's cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability. METHODS: A pragmatic hybrid II effectiveness-implementation controlled trial, using mixed methods, will be undertaken, advancing both knowledge of the effectiveness of the intervention and implementation factors. One-hundred and sixty children with cancer receiving active treatment will be recruited 1:1 to a non-randomised study involving two groups with an equal number of participants in each group. The intervention group (n = 80) will be prospectively recruited to receive the RESPONSE system intervention over eight weeks, versus the historical matched control group (n = 80) who will complete the ePROMs without access to the RESPONSE system. The primary outcome of the effectiveness trial is change between groups in total symptom burden. Secondary outcomes include child health-related quality-of-life and implementation outcomes. Trial data will be analysed using linear mixed-effects models. Formative implementation evaluation is informed by CFIR and ERIC frameworks and implementation outcomes will be mapped to the RE-AIM framework and include interviews, field notes, as well as administrative data to evaluate feasibility, acceptability, satisfaction and sustainability. TRIAL REGISTRATION NUMBER: ACTRN12621001084875 . Retrospectively Registered 16 August 2021.

What to measure in biliary atresia research: study protocol for developing a core outcome set.

AIM: Extrahepatic biliary atresia is a rare disorder. This creates challenges in the quality and quantity of research conducted. This issue is exacerbated by the potential heterogeneity in the reported outcomes in research examining the management of biliary atresia. A core outcome set is required to standardise reporting on the management of biliary atresia in research, facilitate systematic reviews that include outcomes of greatest importance to patients and clinicians, and to evaluate the quality of the existing evidence base on the management of biliary atresia. METHODS: A list of all potential outcomes will be developed through a systematic review of the literature. This list will be refined through a three-stage Delphi approach, involving key stakeholders in the management of biliary atresia. This will include patients and their parents, clinicians, nurses and allied health professionals. In this way, outcomes will be prioritised into a set of consensus core outcomes. CONCLUSION: The development of a core outcome set in biliary atresia management is needed to guide future research and assist in evaluating the quality of existing research. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC), Ref: HREC/20/QCHQ/62448. Results of the study will be published in an open access format.

Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children 12-months postburn: A parallel group randomised controlled trial.

OBJECTIVE: The longer-term effectiveness of silicone and pressure burn scar interventions was evaluated at 12-months postburn. DESIGN: Parallel group, randomised trial. SETTING: Hospital outpatient clinics, research centre. PARTICIPANTS: Children referred for burn scar management following grafted or spontaneously healed acute burn injuries or scar reconstruction surgery. INTERVENTIONS: Participants were randomised to: (1) topical silicone gel only, (2) pressure garment only, or (3) combined topical silicone gel and pressure garment. MAIN MEASURES: Primary outcomes were scar thickness (blinded ultrasound measurement) and itch intensity (caregiver proxy-report, numeric rating scale). RESULTS: Of 153 participants randomised who received the interventions (silicone n = 51, pressure garment n = 49, combined n = 53), 86 were followed-up at 12-months postburn (n = 34, n = 28, n = 24). No differences were identified for the primary outcomes using intention-to-treat analysis. Scar thickness mean difference (95% confidence interval) = 0.00 cm (-0.04, 0.05); -0.03 cm (-0.07, 0.02); 0.03 cm (-0.02, 0.08) and scar itch = 0.09 (-0.88, 1.06); -0.21 (-1.21, 0.79); 0.30 (-0.73, 1.32) for silicone vs pressure; silicone vs combined and combined vs pressure respectively. No serious adverse effects occurred. CONCLUSION: Similar to short-term results, the combined intervention offered no statistically or clinically significant benefit for improving the primary outcomes compared to each intervention alone. No differences in the primary outcomes were identified between the silicone and pressure alone groups.

Hypnotherapy for Procedural Pain and Distress in Children: A Scoping Review Protocol.

OBJECTIVE: Inadequately treated pain and distress elicited by medical procedures can put children at higher risk of acute and chronic biopsychosocial sequelae. Children can benefit from hypnotherapy, a psychologically tailored intervention, as an adjunct to pharmacological agents to address the multiple components of pain and distress. Despite providing evidence on the effectiveness and potential superiority of hypnotherapy to other psychological interventions, research on hypnotherapy for pediatric procedural pain and distress has been predominantly limited to oncology and needle procedures. Plus, there is a lack of reporting of intervention manuals, factors influencing hypnotic responding, pain unpleasantness outcomes, theoretical frameworks, adverse events, as well as barriers and facilitators to the feasibility of delivering the intervention and study procedures. The proposed review aims to map the range and nature of the evidence on hypnotherapy for procedural pain and distress in children to identify gaps in literature and areas requiring further investigation. METHODS: This review will follow the Arksey and O'Malley (2005) methodology and incorporate additional scoping review recommendations by the Joanna Briggs Institute and Preferred Reporting Items for Systematic reviews and Meta-Analyses. Relevant studies will be identified through searching published literature databases (PubMed, Cochrane Library, PsycINFO, Embase, CINAHL, Scopus and Web of Science) and grey literature in addition to hand-searching of reference lists and key journals. Two authors will independently screen titles and abstracts of search results followed by full-texts review against eligibility criteria. CONCLUSION: Findings are anticipated to guide future research and inform the development of tailored hypnotic interventions in children.

Systematic Review on the Content of Outcome Measurement Instruments on Scar Quality.

Measurements of scar quality are essential to evaluate the effectiveness of scar treatments and to monitor scars. A large number of scar scales and measurement devices have been developed, which makes instrument selection challenging. The aim of this study was to provide an overview of the content (ie, included items) of all outcome measurement instruments that measure scar quality in different types of scars (burn, surgical, keloid, and necrotizing fasciitis), and the frequency at which the instruments and included items are used. METHODS: A systematic search was performed in PubMed and Embase.com up to October 31, 2018. All original studies reporting on instruments that measured at least 1 characteristic of scar quality were included and the instrument's content was extracted. RESULTS: We included 440 studies for data extraction. Included instruments (N = 909) were clinician-reported scales (41%), measurement devices (30%), patient-reported scales (26%), and combined clinician- and patient-reported scales (3%). The Observer scale of the Patient and Observer Scar Assessment Scale, the Cutometer, the Patient Scale of the Patient and Observer Scar Assessment Scale, and the modified Vancouver Scar Scale were the most often used instrument in each of these categories, respectively. The most frequent assessed items were thickness, vascularity, pigmentation, pliability, pain, and itch. CONCLUSION: The results of this study lay the foundation for our future research, which includes an international Delphi study among many scar experts, and an international focus group study among scar patients, aiming to elucidate how scar quality must be defined and measured from both professional and patient perspectives.

Effectiveness of interventions for optimising adherence to treatments for the prevention and management of scars: protocol for a systematic review and meta-analysis.

INTRODUCTION: Treatments used in the management of scarring following wounds of the skin can be complex and time consuming, and patients may experience difficulties adhering to these treatments. Therefore, the aim of this systematic review is to identify the types of interventions that have been used to optimise adherence to treatment for preventing or reducing skin scars in adults and children and to determine the effectiveness of these interventions. METHODS AND ANALYSIS: Databases (PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Web of Science and OTSeeker) will be searched using the developed search strategy to identify eligible randomised trials. Adults and children using scar treatments to prevent or manage scarring as a result of a dermal wound (which may occur following burn injury, surgery, lacerations, piercings, vaccinations, acne and other conditions affecting the skin) will be included. Any intervention with the potential to effect adherence will be included. Titles and abstracts located through searching will be screened by two independent reviewers. Full text of studies will also be screened to determine eligibility for final inclusion. Two reviewers will assess the quality of included studies using the Cochrane 'risk of bias' tool. Data extraction forms will be developed and two reviewers will extract the data. A third reviewer will be used at each stage to ensure consensus is achieved. Meta-analysis and meta-regression will be completed if appropriate, otherwise a narrative synthesis of results will be undertaken. ETHICS AND DISSEMINATION: No ethical approval is necessary for this systematic review as no patients will be directly involved. Results of this systematic review will be disseminated through journal publications and relevant conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018095082.

Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial.

BACKGROUND: Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar prevention and management techniques include silicone therapy, pressure garment therapy, or a combination of both. Currently, no definitive, high-quality evidence is available for the effectiveness of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Thus, this study aims to determine the effectiveness of these treatments in children. METHODS: A randomised controlled trial will be conducted at a large tertiary metropolitan children's hospital in Australia. Participants will be randomised to one of three groups: Strataderm® topical silicone gel only, pressure garment therapy only, or combined Strataderm® topical silicone gel and pressure garment therapy. Participants will include 135 children (45 per group) up to 16 years of age who are referred for scar management for a new burn. Children up to 18 years of age will also be recruited following surgery for burn scar reconstruction. Primary outcomes are scar itch intensity and scar thickness. Secondary outcomes include scar characteristics (e.g. colour, pigmentation, pliability, pain), the patient's, caregiver's and therapist's overall opinion of the scar, health service costs, adherence, health-related quality of life, treatment satisfaction and adverse effects. Measures will be completed on up to two sites per person at baseline and 1 week post scar management commencement, 3 months and 6 months post burn, or post burn scar reconstruction. Data will be analysed using descriptive statistics and univariate and multivariate regression analyses. DISCUSSION: Results of this study will determine the effectiveness of three noninvasive scar interventions in children at risk of, and with, scarring post burn or post reconstruction. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616001100482 . Registered on 5 August 2016.

Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial.

BACKGROUND: Burns and the associated wound care procedures can be extremely painful and anxiety-provoking for children. Burn injured children and adolescents are therefore at greater risk of experiencing a range of psychological reactions, in particular posttraumatic stress disorder, which can persist for months to years after the injury. Non-pharmacological intervention is critical for comprehensive pain and anxiety management and is used alongside pharmacological analgesia and anxiolysis. However, effective non-pharmacological pain and anxiety management during pediatric burn procedures is an area still needing improvement. Medical hypnosis has received support as a technique for effectively decreasing pain and anxiety levels in adults undergoing burn wound care and in children during a variety of painful medical procedures (e.g., bone marrow aspirations, lumbar punctures, voiding cystourethrograms, and post-surgical pain). Pain reduction during burn wound care procedures is linked with improved wound healing rates. To date, no randomized controlled trials have investigated the use of medical hypnosis in pediatric burn populations. Therefore this study aims to determine if medical hypnosis decreases pain, anxiety, and biological stress markers during wound care procedures; improves wound healing times; and decreases rates of traumatic stress reactions in pediatric burn patients. METHODS/DESIGN: This is a single-center, superiority, parallel-group, prospective randomized controlled trial. Children (4 to 16 years, inclusive) with acute burn injuries presenting for their first dressing application or change are randomly assigned to either the (1) intervention group (medical hypnosis) or (2) control group (standard care). A minimum of 33 participants are recruited for each treatment group. Repeated measures of pain, anxiety, stress, and wound healing are taken at every dressing change until ≥95 % wound re-epithelialization. Further data collection assesses impact on posttraumatic stress symptomatology, speed of wound healing, and parent perception of how easy the dressing change is for their child. DISCUSSION: Study results will elucidate whether the disease process can be changed by using medical hypnosis with children to decrease pain, anxiety, and stress in the context of acute burn wounds. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000419561.

The sociodemographic and health-related characteristics of a regional population with chronic disease at an interprofessional student-assisted clinic in Queensland Capricornia Allied Health Partnership.

OBJECTIVE: This paper describes the sociodemographic and health-related characteristics of people with chronic disease attending an interprofessional student-assisted clinic in regional Queensland. DESIGN: A retrospective review of data collected during the first 10 months of operation of the clinic was conducted. SETTING, PARTICIPANTS AND OUTCOME MEASURES: Data was collected on up to 378 patients during an intake appointment at the Capricornia Allied Health Partnership (CAHP) community-based clinic and compared with normative reference groups where available. Sociodemographic characteristics included age, gender and education level; health-related characteristics included body mass index and hospitalisations in the previous 12 months; and risk factors included prescribed medications, smoking status and general practitioner-diagnosed medical conditions. RESULTS: Patients attending the CAHP clinic had a mean number of chronic conditions of 4.9 ± 2.1 per patient, and 97% of patients had multimorbidities. A high level of socioeconomic disadvantage was found in comparison with normative comparison groups based on employment, highest level of schooling completed and the index of social disadvantage. Patients predominantly lived in inner regional areas (76.7%). The most common diagnoses of patients attending the clinic for the first time were hypertension, osteoarthritis, high cholesterol, diabetes and chronic back pain. CONCLUSIONS: The CAHP clinic offers a unique student-assisted service model for interprofessional management of patients who are socioeconomically disadvantaged, have multimorbid chronic disease and live in regional areas. The description of baseline data in this paper is important to refine clinic services, to guide other chronic disease clinics and to inform future research study designs.