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Zephanie Tyack - One of the best experts on this subject based on the ideXlab platform.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children a randomized controlled trial
    Clinical Rehabilitation, 2020
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Anne Dotta, Zephanie Tyack
    Abstract:

    Objective:To determine the effectiveness of silicone and Pressure Garments (alone and in combination) in children receiving scar management post-burn.Design:Multicentre, parallel-group, randomized ...

  • variability of Pressure at the Pressure Garment scar interface in children after burn a pilot longitudinal cohort study
    Burns, 2019
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Zephanie Tyack
    Abstract:

    Abstract Background Current consensus for the ideal Pressure range at the Pressure Garment to scar interface is 15–25 mmHg. Interface Pressure variability has been reported at new Pressure Garment fitting in children. Pressure reductions up to 25% have been recorded over one month in adults. Method A pilot longitudinal cohort study was completed with children aged less than 18 years receiving Pressure Garment therapy after burn. Interface Pressure was measured at first Pressure Garment fitting, one month and three months after fitting. Analysis was conducted using Linear Mixed Models. Results Thirty-four children were recruited to the study, 62% were male. Participants had a median (IQR) age of 3 (6) years. At the first Garment fitting, 32% of stationary and 25% of dynamic measurements were within 15–25 mmHg. Pressure variations were recorded at one and three months with scar location (p = 0.03) and %TBSA (p = 0.006) identified as predictors of stationary interface Pressure. No statistically significant predictors of dynamic Pressure were identified. Discussion Interface Pressure variability was recorded over time during children’s wear of the first Pressure Garment after burn. Further investigation of factors contributing to Pressure changes, subsequent impact on adherence and the effect of sub-optimal Pressure application on burn scar outcomes is indicated.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children study protocol for a randomised controlled trial
    Trials, 2017
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Zephanie Tyack
    Abstract:

    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.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children study protocol for a randomised controlled trial
    Trials, 2017
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Zephanie Tyack
    Abstract:

    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. 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. 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. Australian New Zealand Clinical Trials Registry, ACTRN12616001100482 . Registered on 5 August 2016.

Roy M Kimble - One of the best experts on this subject based on the ideXlab platform.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children a randomized controlled trial
    Clinical Rehabilitation, 2020
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Anne Dotta, Zephanie Tyack
    Abstract:

    Objective:To determine the effectiveness of silicone and Pressure Garments (alone and in combination) in children receiving scar management post-burn.Design:Multicentre, parallel-group, randomized ...

  • variability of Pressure at the Pressure Garment scar interface in children after burn a pilot longitudinal cohort study
    Burns, 2019
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Zephanie Tyack
    Abstract:

    Abstract Background Current consensus for the ideal Pressure range at the Pressure Garment to scar interface is 15–25 mmHg. Interface Pressure variability has been reported at new Pressure Garment fitting in children. Pressure reductions up to 25% have been recorded over one month in adults. Method A pilot longitudinal cohort study was completed with children aged less than 18 years receiving Pressure Garment therapy after burn. Interface Pressure was measured at first Pressure Garment fitting, one month and three months after fitting. Analysis was conducted using Linear Mixed Models. Results Thirty-four children were recruited to the study, 62% were male. Participants had a median (IQR) age of 3 (6) years. At the first Garment fitting, 32% of stationary and 25% of dynamic measurements were within 15–25 mmHg. Pressure variations were recorded at one and three months with scar location (p = 0.03) and %TBSA (p = 0.006) identified as predictors of stationary interface Pressure. No statistically significant predictors of dynamic Pressure were identified. Discussion Interface Pressure variability was recorded over time during children’s wear of the first Pressure Garment after burn. Further investigation of factors contributing to Pressure changes, subsequent impact on adherence and the effect of sub-optimal Pressure application on burn scar outcomes is indicated.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children study protocol for a randomised controlled trial
    Trials, 2017
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Zephanie Tyack
    Abstract:

    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.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children study protocol for a randomised controlled trial
    Trials, 2017
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Zephanie Tyack
    Abstract:

    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. 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. 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. Australian New Zealand Clinical Trials Registry, ACTRN12616001100482 . Registered on 5 August 2016.

Jodie Wiseman - One of the best experts on this subject based on the ideXlab platform.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children a randomized controlled trial
    Clinical Rehabilitation, 2020
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Anne Dotta, Zephanie Tyack
    Abstract:

    Objective:To determine the effectiveness of silicone and Pressure Garments (alone and in combination) in children receiving scar management post-burn.Design:Multicentre, parallel-group, randomized ...

  • variability of Pressure at the Pressure Garment scar interface in children after burn a pilot longitudinal cohort study
    Burns, 2019
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Zephanie Tyack
    Abstract:

    Abstract Background Current consensus for the ideal Pressure range at the Pressure Garment to scar interface is 15–25 mmHg. Interface Pressure variability has been reported at new Pressure Garment fitting in children. Pressure reductions up to 25% have been recorded over one month in adults. Method A pilot longitudinal cohort study was completed with children aged less than 18 years receiving Pressure Garment therapy after burn. Interface Pressure was measured at first Pressure Garment fitting, one month and three months after fitting. Analysis was conducted using Linear Mixed Models. Results Thirty-four children were recruited to the study, 62% were male. Participants had a median (IQR) age of 3 (6) years. At the first Garment fitting, 32% of stationary and 25% of dynamic measurements were within 15–25 mmHg. Pressure variations were recorded at one and three months with scar location (p = 0.03) and %TBSA (p = 0.006) identified as predictors of stationary interface Pressure. No statistically significant predictors of dynamic Pressure were identified. Discussion Interface Pressure variability was recorded over time during children’s wear of the first Pressure Garment after burn. Further investigation of factors contributing to Pressure changes, subsequent impact on adherence and the effect of sub-optimal Pressure application on burn scar outcomes is indicated.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children study protocol for a randomised controlled trial
    Trials, 2017
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Zephanie Tyack
    Abstract:

    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.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children study protocol for a randomised controlled trial
    Trials, 2017
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Zephanie Tyack
    Abstract:

    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. 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. 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. Australian New Zealand Clinical Trials Registry, ACTRN12616001100482 . Registered on 5 August 2016.

Megan Simons - One of the best experts on this subject based on the ideXlab platform.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children a randomized controlled trial
    Clinical Rehabilitation, 2020
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Anne Dotta, Zephanie Tyack
    Abstract:

    Objective:To determine the effectiveness of silicone and Pressure Garments (alone and in combination) in children receiving scar management post-burn.Design:Multicentre, parallel-group, randomized ...

  • variability of Pressure at the Pressure Garment scar interface in children after burn a pilot longitudinal cohort study
    Burns, 2019
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Zephanie Tyack
    Abstract:

    Abstract Background Current consensus for the ideal Pressure range at the Pressure Garment to scar interface is 15–25 mmHg. Interface Pressure variability has been reported at new Pressure Garment fitting in children. Pressure reductions up to 25% have been recorded over one month in adults. Method A pilot longitudinal cohort study was completed with children aged less than 18 years receiving Pressure Garment therapy after burn. Interface Pressure was measured at first Pressure Garment fitting, one month and three months after fitting. Analysis was conducted using Linear Mixed Models. Results Thirty-four children were recruited to the study, 62% were male. Participants had a median (IQR) age of 3 (6) years. At the first Garment fitting, 32% of stationary and 25% of dynamic measurements were within 15–25 mmHg. Pressure variations were recorded at one and three months with scar location (p = 0.03) and %TBSA (p = 0.006) identified as predictors of stationary interface Pressure. No statistically significant predictors of dynamic Pressure were identified. Discussion Interface Pressure variability was recorded over time during children’s wear of the first Pressure Garment after burn. Further investigation of factors contributing to Pressure changes, subsequent impact on adherence and the effect of sub-optimal Pressure application on burn scar outcomes is indicated.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children study protocol for a randomised controlled trial
    Trials, 2017
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Zephanie Tyack
    Abstract:

    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.

  • effectiveness of topical silicone gel and Pressure Garment therapy for burn scar prevention and management in children study protocol for a randomised controlled trial
    Trials, 2017
    Co-Authors: Jodie Wiseman, Megan Simons, Roy M Kimble, Robert S Ware, Steven M Mcphail, Zephanie Tyack
    Abstract:

    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. 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. 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. Australian New Zealand Clinical Trials Registry, ACTRN12616001100482 . Registered on 5 August 2016.

Jonathan Mathers - One of the best experts on this subject based on the ideXlab platform.

  • Pressure Garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study
    NIHR Journals Library, 2018
    Co-Authors: Naiem Moiemen, Jonathan Mathers, Laura Jones, Jonathan Bishop, Philip Kinghorn, Mark Monahan, Melanie Calvert, Gemma Slinn, Fay Gardiner, Amy Bamford
    Abstract:

    Background: Eleven million people suffer a fire-related injury worldwide every year, and 71% have significant scarring. Pressure Garment therapy (PGT) is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness. Objective: To identify the barriers to, and the facilitators of, conducting a randomised controlled trial (RCT) of burn scar management with and without PGT and test whether or not such a trial is feasible. Design: Web-based surveys, semistructured individual interviews, a pilot RCT including a health economic evaluation and embedded process evaluation. Setting: UK NHS burns services. Interviews and the pilot trial were run in seven burns services. Participants: Thirty NHS burns services and 245 staff provided survey responses and 15 staff participated in individual interviews. Face-to-face interviews were held with 24 adult patients and 16 parents of paediatric patients who had undergone PGT. The pilot trial recruited 88 participants (57 adults and 31 children) who were at risk of hypertrophic scarring and were considered suitable for scar management therapy. Interviews were held with 34 participants soon after recruitment, with 23 participants at 12 months and with eight staff from six sites at the end of the trial. Interventions: The intervention was standard care with Pressure Garments. The control was standard care comprising scar management techniques involving demonstration and recommendations to undertake massage three or four times per day with moisturiser, silicone treatment, stretching and other exercises. Main outcome measures: Feasibility was assessed by eligibility rates, consent rates, retention in allocated arms, adherence with treatment and follow-up and completion of outcome assessments. The outcomes from interview-based studies were core outcome domains and barriers to, and facilitators of, trial participation and delivery. Results: NHS burns services treat 2845 patients per annum (1476 paediatric and 1369 adult) and use Pressure Garments for 6–18 months, costing £2,171,184. The majority of staff perceived a need for a RCT of PGT, but often lacked equipoise around the research question and PGT as a treatment. Strong views about the use of PGT have the potential to influence the conduct of a full-scale RCT. A range of outcome domains was identified as important via the qualitative research: perceptions of appearance, specific scar characteristics, function, pain and itch, broader psychosocial outcomes and treatment burden. The outcome tools evaluated in the pilot trial did not cover all of these domains. The planned 88 participants were recruited: the eligibility rate was 88% [95% confidence interval (CI) 83% to 92%], the consent rate was 47% (95% CI 40% to 55%). Five (6%) participants withdrew, 14 (16%) were lost to follow-up and 8 (9%) crossed over. Adherence was as in clinical practice. Completion of outcomes was high for adult patients but poorer from parents of paediatric patients, particularly for quality of life. Sections on range of movement and willingness to pay were found to be challenging and poorly completed. Limitations: The Brisbane Burn Scar Impact Profile appears more suitable in terms of conceptual coverage than the outcome scales that were used in the trial but was not available at the time of the study. Conclusions: A definitive RCT of PGT in burn scar management appears feasible. However, staff attitudes to the use of Pressure Garments may lead to biases, and the provision of training and support to sites and an ongoing assessment of trial processes are required. Future work: We recommend that any future trial include an in-depth mixed-methods recruitment investigation and a process evaluation to account for this. Trial registration: Current Controlled Trials ISRCTN34483199. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 36. See the NIHR Journals Library website for further project informatio

  • outcomes important to burns patients during scar management and how they compare to the concepts captured in burn specific patient reported outcome measures
    Burns, 2017
    Co-Authors: Laura Jones, Naiem Moiemen, Jonathan Bishop, Philip Kinghorn, Melanie Calvert, Jonathan J Deeks, Jonathan Mathers
    Abstract:

    Abstract Background Pressure Garment therapy (PGT) is an established treatment for the prevention and treatment of hypertrophic scarring; however, there is limited evidence for its effectiveness. Burn survivors often experience multiple issues many of which are not adequately captured in current PGT trial measures. To assess the effectiveness of PGT it is important to understand what outcomes matter to patients and to consider whether patient-reported outcome measures (PROMs) can be used to ascertain the effect of treatments on patients’ health-related quality of life. This study aimed to (a) understand the priorities and perspectives of adult burns patients and the parents of burns patients who have experienced PGT via in-depth qualitative data, and (b) compare these with the concepts captured within burn-specific PROMs. Methods We undertook 40 semi-structured interviews with adults and parents of paediatric and adolescent burns patients who had experienced PGT to explore their priorities and perspectives on scar management. Interviews were audio-recorded, transcribed and thematically analysed. The outcomes interpreted within the interview data were then mapped against the concepts captured within burn-specific PROMs currently in the literature. Results Eight core outcome domains were identified as important to adult patients and parents: (1) scar characteristics and appearance, (2) movement and function, (3) scar sensation, (4) psychological distress, adjustments and a sense of normality, (5) body image and confidence, (6) engagement in activities, (7) impact on relationships, and (8) treatment burden. Conclusions The outcome domains presented reflect a complex holistic patient experience of scar management and treatments such as PGT. Some currently available PROMs do capture the concepts described here, although none assess psychological adjustments and attainment of a sense of normality following burn injury. The routine use of PROMs that represent patient experience and their relative contribution to trial outcome assessment versus clinical measures is now a matter for further research and debate.

  • below the surface parents views on the factors that influence treatment adherence in paediatric burn scar management a qualitative study
    Burns, 2017
    Co-Authors: Nicole Andrews, Naiem Moiemen, Laura Jones, Jonathan Bishop, Philip Kinghorn, Melanie Calvert, Jonathan J Deeks, Ian Litchfield, Jonathan Mathers
    Abstract:

    Abstract Introduction Parents have a crucial role to play in burn scar management for their children at a time that is extremely stressful for them and their child. Scar management treatments such as Pressure Garment therapy (PGT) require high levels of adherence. There has been a lack of research into the factors that may influence adherence in paediatric burn scar management. This qualitative research study has investigated parents’ experiences of scar management and their attempts to adhere to treatment at home. The aim of this paper is to outline parents’ views on the factors that influence adherence. Methods 25 parents of paediatric and adolescent burn patients took part in semi-structured interviews. Participants were recruited from three UK burns services. Interviews were conducted in a participant-focussed manner and topics for discussion included parents’ accounts of treatment and their experience of PGT. A thematic analysis was undertaken. Results Four overarching themes describe parents’ views and experiences of scar management and adherence. These are the transition from hospital to home; the practical realities of treatment; the emotional labour involved in treatment and; negotiating treatment and regime. The transition from hospital to home is a significant event for parents. They may be apprehensive about this at the same time as they desire that they and their child return to some sense of normality following the burn injury. Parents are required to adopt the role of therapeutic caregiver upon transition from hospital to home. Adherence to scar management is influenced by the practical realities of maintaining treatment (routine, division of care labour, hospital appointments) and the emotional labour involved in doing so. The latter demands that parents manage their own and their children’s emotions. Approaches to adherence were often described as flexible in response to these influences. Conclusions Some parents negotiate the realities and demands of scar management successfully, whereas others do not. The emotional labour experienced by parents and their ability to cope with this is often a strong influence on their views regarding adherence to scar management. Further research is needed to explore how burns services and staff manage this at present, and whether simple interventions can help with the key practical and emotional influences on treatment adherence.