Background Validated outcome measures are needed for vitiligo trials. Objectives To assess constr... more Background Validated outcome measures are needed for vitiligo trials. Objectives To assess construct validity, interpretability, reliability and acceptability of the Vitiligo Noticeability Scale (VNS). Methods We used images of vitiligo before and after treatment, plus outcome data, from the HI-Light Vitiligo trial. We compared outcome assessments made by trial participants with assessments of images by clinicians and people with vitiligo who were not trial participants [Patient and Public Involvement (PPI) panel]. Hypothesis testing assessed psychometric properties of the VNS, with κ statistics to assess agreement between outcomes. Three focus groups and two online discussion groups provided insight into the use of VNS by people with vitiligo. Results Our hypothesis of a positive association between VNS and participant-reported global treatment success was supported for trial participants (κ = 0·41 if VNS success was defined as ≥ 4; κ = 0·71 if VNS success was defined as ≥ 3), but ...
The aim of this study was to identify and assess all existing randomized studies on treatment int... more The aim of this study was to identify and assess all existing randomized studies on treatment interventions for hand fractures and joint injuries, to inform practice and plan future research. PubMed, Cochrane CENTRAL, MEDLINE and Embase were searched. We identified 78 randomized controlled trials published over 35 years, covering seven anatomical areas of the hand. We report on sources of bias, sample size, follow-up length and retention, outcome measures and reporting. In terms of interventions studied, the trials were extremely heterogeneous, so it is difficult to draw conclusions on individual treatments. The published randomized controlled clinical trial evidence for hand fractures and joint injuries is narrow in scope and of generally low methodological quality. Mapping provides a useful resource and stepping-stone for planning further research. There is a need for high-quality, collaborative research to guide management of a wider range of common hand injuries.
BackgroundCellulitis is a painful infection of the skin and underlying tissues, commonly affectin... more BackgroundCellulitis is a painful infection of the skin and underlying tissues, commonly affecting the lower leg. Approximately one-third of people experience recurrence. Patients’ ability to recover from cellulitis or prevent recurrence is likely to be influenced by their understanding of the condition.AimTo explore patients’ perceptions of cellulitis, and their information needs.Design and settingMixed-methods study comprising semi-structured, face-to-face interviews and a cross-sectional survey, recruiting through primary and secondary care, and advertising.MethodAdults aged ≥18 years with a history of cellulitis were invited to take part in a survey, qualitative interview, or both.ResultsIn all, 30 interviews were conducted between August 2016 and July 2017. Qualitative data highlighted a low awareness of cellulitis before the first episode, uncertainty about when it had been diagnosed, concern/surprise at the severity of cellulitis, and a perceived insufficient information prov...
Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management... more Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomised controlled trial (RCT) OBJECTIVES: To compare the cost-effectiveness of ciclosporin and prednisolone-initiated treatment for patients with PG. Quality-of-life (EuroQoL EQ-5D-3L) and resource data were collected as part of the STOP-GAP trial: a multicentre, parallel-group, observer-blind RCT. Within-trial analysis used bivariate regression of costs and QALYs, with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective. In the base case analysis, when compared with prednisolone, ciclosporin was cost-effective due to a reduction in costs (net cost: -£1160; 95%CI: (-2991 to 672) and improvement in quality of life (net QALYs: 0.055; 95%CI: 0.018 to 0.093). However, this findin...
Journal of the American Academy of Dermatology, Nov 10, 2016
Atopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardized methods ... more Atopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardized methods for capturing long-term control of AD. We sought to identify how long-term control has been captured in published randomized controlled trials (RCTs). Results will initiate consensus discussions on how best to measure long-term control in the core outcome set for AD. We conducted a systematic review of RCTs of AD treatments published between 2000 and 2013, with a follow-up period of 3 months or longer, at least 1 outcome measure recorded at 3 or more time points, full article available, and published in English. In all, 101 of 353 RCTs were eligible. Methods to capture long-term control included: repeated measurement of AD outcomes (92 RCTs; 91%), use of AD medication (29 RCTs; 28.7%), and AD flares/remissions (26 RCTs; 25.7%). Repeated measurements of AD outcomes were typically collected 3 to 5 times during a trial, but analysis methods often failed to make best use of the data. Time to...
Journal of the American Academy of Dermatology, Jan 5, 2016
Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. W... more Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. We sought to estimate the effectiveness of topical therapies in the treatment of patients with PG. This was a retrospective cohort study of UK secondary care patients with a clinical diagnosis of PG that was suitable for topical treatment (recruited between July 2009 and June 2012). Participants received topical therapy after normal clinical practice (primarily topical corticosteroids [classes I-III] and tacrolimus 0.03% or 0.1%). The primary outcome was speed of healing at 6 weeks. Secondary outcomes included the following: proportion healed by 6 months; time to healing; global assessment; inflammation; pain; quality of life; treatment failure; and recurrence. Sixty-six patients (22-85 years of age) were enrolled. Clobetasol propionate 0.05% was the most commonly prescribed therapy. Overall, 28 of 66 (43.8%) ulcers healed by 6 months. The median time to healing was 145 days (95% confiden...
Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of ... more Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigat...
Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a speci... more Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate ...
Background Validated outcome measures are needed for vitiligo trials. Objectives To assess constr... more Background Validated outcome measures are needed for vitiligo trials. Objectives To assess construct validity, interpretability, reliability and acceptability of the Vitiligo Noticeability Scale (VNS). Methods We used images of vitiligo before and after treatment, plus outcome data, from the HI-Light Vitiligo trial. We compared outcome assessments made by trial participants with assessments of images by clinicians and people with vitiligo who were not trial participants [Patient and Public Involvement (PPI) panel]. Hypothesis testing assessed psychometric properties of the VNS, with κ statistics to assess agreement between outcomes. Three focus groups and two online discussion groups provided insight into the use of VNS by people with vitiligo. Results Our hypothesis of a positive association between VNS and participant-reported global treatment success was supported for trial participants (κ = 0·41 if VNS success was defined as ≥ 4; κ = 0·71 if VNS success was defined as ≥ 3), but ...
The aim of this study was to identify and assess all existing randomized studies on treatment int... more The aim of this study was to identify and assess all existing randomized studies on treatment interventions for hand fractures and joint injuries, to inform practice and plan future research. PubMed, Cochrane CENTRAL, MEDLINE and Embase were searched. We identified 78 randomized controlled trials published over 35 years, covering seven anatomical areas of the hand. We report on sources of bias, sample size, follow-up length and retention, outcome measures and reporting. In terms of interventions studied, the trials were extremely heterogeneous, so it is difficult to draw conclusions on individual treatments. The published randomized controlled clinical trial evidence for hand fractures and joint injuries is narrow in scope and of generally low methodological quality. Mapping provides a useful resource and stepping-stone for planning further research. There is a need for high-quality, collaborative research to guide management of a wider range of common hand injuries.
BackgroundCellulitis is a painful infection of the skin and underlying tissues, commonly affectin... more BackgroundCellulitis is a painful infection of the skin and underlying tissues, commonly affecting the lower leg. Approximately one-third of people experience recurrence. Patients’ ability to recover from cellulitis or prevent recurrence is likely to be influenced by their understanding of the condition.AimTo explore patients’ perceptions of cellulitis, and their information needs.Design and settingMixed-methods study comprising semi-structured, face-to-face interviews and a cross-sectional survey, recruiting through primary and secondary care, and advertising.MethodAdults aged ≥18 years with a history of cellulitis were invited to take part in a survey, qualitative interview, or both.ResultsIn all, 30 interviews were conducted between August 2016 and July 2017. Qualitative data highlighted a low awareness of cellulitis before the first episode, uncertainty about when it had been diagnosed, concern/surprise at the severity of cellulitis, and a perceived insufficient information prov...
Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management... more Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomised controlled trial (RCT) OBJECTIVES: To compare the cost-effectiveness of ciclosporin and prednisolone-initiated treatment for patients with PG. Quality-of-life (EuroQoL EQ-5D-3L) and resource data were collected as part of the STOP-GAP trial: a multicentre, parallel-group, observer-blind RCT. Within-trial analysis used bivariate regression of costs and QALYs, with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective. In the base case analysis, when compared with prednisolone, ciclosporin was cost-effective due to a reduction in costs (net cost: -£1160; 95%CI: (-2991 to 672) and improvement in quality of life (net QALYs: 0.055; 95%CI: 0.018 to 0.093). However, this findin...
Journal of the American Academy of Dermatology, Nov 10, 2016
Atopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardized methods ... more Atopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardized methods for capturing long-term control of AD. We sought to identify how long-term control has been captured in published randomized controlled trials (RCTs). Results will initiate consensus discussions on how best to measure long-term control in the core outcome set for AD. We conducted a systematic review of RCTs of AD treatments published between 2000 and 2013, with a follow-up period of 3 months or longer, at least 1 outcome measure recorded at 3 or more time points, full article available, and published in English. In all, 101 of 353 RCTs were eligible. Methods to capture long-term control included: repeated measurement of AD outcomes (92 RCTs; 91%), use of AD medication (29 RCTs; 28.7%), and AD flares/remissions (26 RCTs; 25.7%). Repeated measurements of AD outcomes were typically collected 3 to 5 times during a trial, but analysis methods often failed to make best use of the data. Time to...
Journal of the American Academy of Dermatology, Jan 5, 2016
Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. W... more Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. We sought to estimate the effectiveness of topical therapies in the treatment of patients with PG. This was a retrospective cohort study of UK secondary care patients with a clinical diagnosis of PG that was suitable for topical treatment (recruited between July 2009 and June 2012). Participants received topical therapy after normal clinical practice (primarily topical corticosteroids [classes I-III] and tacrolimus 0.03% or 0.1%). The primary outcome was speed of healing at 6 weeks. Secondary outcomes included the following: proportion healed by 6 months; time to healing; global assessment; inflammation; pain; quality of life; treatment failure; and recurrence. Sixty-six patients (22-85 years of age) were enrolled. Clobetasol propionate 0.05% was the most commonly prescribed therapy. Overall, 28 of 66 (43.8%) ulcers healed by 6 months. The median time to healing was 145 days (95% confiden...
Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of ... more Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigat...
Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a speci... more Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate ...
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