Defining and measuring 'eczema control': an international qualitative study to explore the views of those living with and treating atopic eczema.

BACKGROUND: Atopic eczema (also known as eczema) is a chronic, inflammatory skin condition that often afflicts patients' health and well-being. The Harmonising Outcome Measures for Eczema (HOME) initiative recommends that 'long-term control of eczema' is measured in all clinical trials 3 months or longer in duration. However, little has been published on what eczema control means to those living with or treating atopic eczema. OBJECTIVES: To (i) develop understanding of what eczema control means to patients, carers and clinicians and (ii) explore the feasibility and acceptability of different ways of measuring eczema control in the long term. METHODS: Online focus groups explored patients/carers experiences in the UK, the United States, the Netherlands, France, Sweden and Japan, and an international online survey gathered views of clinicians. The framework method was used to analyse the focus groups, and thematic analysis was used to analyse survey data. All findings were integrated into a theoretical framework to create overarching themes that cut across these diverse groups. RESULTS: Eight focus groups with patients (16 years+) and eight groups with carers of children took place (N = 97). Sixty-two people took part in the survey. Eczema control was described as a multifaceted construct involving changes in disease activity, the treatment and management of the condition and psychological, social and physical functioning. Patient/carer measurement allows personal accounts and frequent measurement, whilst clinician measurement was deemed less subjective. The burden on patients/carers and issues for analysing and interpreting data should be considered. CONCLUSIONS: This study formed the basis of judging the content validity and feasibility of measurement instruments/methods to assess control of eczema in clinical trials. This online approach to an international qualitative study is an example of how core outcome set developers with limited resources can engage with multiple stakeholder groups on an international basis to inform consensus meeting discussions.

How should minimally important change scores for the Patient-Oriented Eczema Measure be interpreted? A validation using varied methods.

BACKGROUND: The Patient-Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the minimally important change (MIC) of the POEM is three points. Further assessment of the MIC of POEM in different populations, and using a variety of methods, will improve interpretability of the POEM in research and clinical practice. OBJECTIVES: To calculate the smallest detectable change in the POEM and estimate the MIC of the POEM using a variety of methods in a trial dataset of children with moderate-to-severe atopic eczema. METHODS: This study used distribution-based and anchor-based methods to calculate the MIC of the POEM in children with moderate-to-severe eczema. RESULTS: Data were collected from 300 children. The smallest detectable change was 2·13. The MIC estimates were 1·07 (using 0·2 SD of baseline POEM scores) and 2·68 (using 0·5 SD of baseline POEM scores) based on distribution-based methods; were 3·09-6·13 based on patient-/parent-reported anchor-based methods; and were 3·23-5·38 based on investigator-reported anchor-based methods. CONCLUSIONS: We recommend the following thresholds be used to interpret changes in POEM scores: ≤ 2, unlikely to be a change beyond measurement error; 2·1-2·9, a small change detected that is likely to be beyond measurement error but may not be clinically important; 3-3·9, probably a clinically important change; ≥ 4, very likely to be a clinically important change.

A systematic review of diagnostic criteria for psoriasis in adults and children: evidence from studies with a primary aim to develop or validate diagnostic criteria.

BACKGROUND: The diagnosis of psoriasis in adults and children is made clinically, for both patient management and the selection of participants in research. Diagnostic criteria provide a structure for clinical assessment, which in turn helps standardize patient recruitment into clinical trials and case definitions in observational studies. OBJECTIVES: The aim of this systematic review was to identify and critically appraise the published studies to date that had a primary research aim to develop or validate diagnostic criteria for psoriasis. METHODS: A search of Ovid MEDLINE and Ovid Embase was conducted in October 2016. The primary objective was to record the sensitivity and specificity of diagnostic criteria for psoriasis. Secondary objectives included diagnostic recommendations, applicability to children and study characteristics. Diagnostic accuracy studies were critically appraised for risk of bias using the QUADAS-2 tool. RESULTS: Twenty-three studies met the inclusion criteria. None detailed clinical examination-based diagnostic criteria. The included criteria varied from genetic and molecular diagnostic models to skin imaging, histopathology, and questionnaire-based, computer-aided and traditional Chinese medicine criteria. High sensitivity and specificity (> 90%) were reported in many studies. However, the study authors often did not specify how the criteria would be used clinically or in research. This review identified studies with varying risk of bias, and due to each study developing separate criteria meta-analysis was not possible. CONCLUSIONS: Clinical examination-based diagnostic criteria are currently lacking for psoriasis. Future research could follow an international collaborative approach and employ study designs allowing high-quality diagnostic accuracy testing. Existing and newly developed criteria require validation.

The prevalence of psychological comorbidity in people with vitiligo: a systematic review and meta-analysis.

BACKGROUND: Vitiligo is a chronic disorder causing skin depigmentation with global prevalence varying from 0·2% to 1·8%. U.K. guidelines recommend assessment of psychological state during clinical evaluation of vitiligo. However, the prevalence of psychological comorbidity in people with vitiligo has not been described. OBJECTIVES: To establish the prevalence of psychological symptoms or disorders in people with vitiligo and describe the outcome measures used. METHODS: We performed a comprehensive search of MEDLINE, Embase, CINAHL and PsycINFO to identify observational studies assessing the prevalence of psychological symptoms or disorders (December 2016). DerSimonian and Lard random-effects models were used to estimate the overall pooled prevalence. RESULTS: We identified 29 studies with 2530 people with vitiligo. Most studies included a measure of either depression (n = 25) or anxiety (n = 13). The commonest tools were the Hospital Anxiety and Depression Scale and the Centre for Epidemiology Studies Depression Scale. Ten studies provided information on 13 other psychological outcomes. Pooled prevalence using depression-specific and anxiety-specific questionnaires was 0·29 [95% confidence interval (CI) 0·21-0·38] and 0·33 (95% CI 0·18-0·49), respectively. Prevalence was lower for clinically diagnosed depression (0·21, 95% CI 0·15-0·28) and anxiety (0·15, 95% CI 0·06-0·24). When nonspecific tools were used the prevalence remained similar for depression (0·27, 95% CI 0·08-0·46) but increased for anxiety (0·46, 95% CI 0·39-0·52). High heterogeneity was observed. CONCLUSIONS: A range of psychological outcomes are common in people with vitiligo. The prevalence of anxiety was influenced by type of screening tool, suggesting the need for validation of psychological outcome screening tools in the field of dermatology.

The epidemiology of childhood psoriasis: a scoping review.

Psoriasis is an inflammatory noncommunicable skin disease that affects both adults and children. At present, the epidemiology and natural history of psoriasis are not widely understood. This scoping review aimed to map the existing literature on the epidemiology of childhood psoriasis, identify research gaps for future studies and provide a comprehensive, clinically useful review. Search strategies were developed for Ovid Medline, Ovid Embase, Google Scholar and hand searching. In total, 131 articles met the inclusion criteria and were mapped; 107 articles were included for data extraction. Over the last 25 years there has been a dramatic increase in the volume of published observational epidemiological studies on childhood psoriasis. The majority were case series or cross-sectional studies, concentrated in Europe, Asia and North America. The prevalence of childhood psoriasis was found to be higher in European countries, older children and girls. Up to 48·8% of children had a family history of psoriasis in a first-degree relative. The most frequent subtype was plaque psoriasis and the most common initial sites of presentation were the scalp, limbs and trunk. Specific genetic differences have been found between child-onset and adult-onset populations. Case-control and cohort studies investigating risk factors for psoriasis onset, comorbidities and long-term health outcomes were extremely limited. The choice of study design and heterogeneity in methodology limit the validity and generalizability of the information, consistency of the results, and comparability of the studies. Well-designed epidemiological studies are needed to provide precise and consistent information about the frequency and clinical presentation, risk factors, associated diseases and long-term outcomes in childhood psoriasis.

Report from the kick-off meeting of the Cochrane Skin Group Core Outcome Set Initiative (CSG-COUSIN).

A major obstacle of evidence-based clinical decision making is the use of nonstandardized, partly untested outcome measurement instruments. Core Outcome Sets (COSs) are currently developed in different medical fields to standardize and improve the selection of outcomes and outcome measurement instruments in clinical trials, in order to pool results of trials or to allow indirect comparison between interventions. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The international, multidisciplinary Cochrane Skin Group Core Outcome Set Initiative (CSG-COUSIN) aims to develop and implement COSs in dermatology, thus making trial evidence comparable and, herewith, more useful for clinical decision making. The inaugural meeting of CSG-COUSIN was held on 17-18 March 2015 in Dresden, Germany, as the exclusive theme of the Annual Cochrane Skin Group Meeting. In total, 29 individuals representing a broad mix of different stakeholder groups, professions, skills and perspectives attended. This report provides a description of existing COS initiatives in dermatology, highlights current methodological challenges in COS development, and presents the concept, aims and structure of CSG-COUSIN.

Response rates to combination therapy for chronic HCV infection in a clinical setting and derivation of probability tables for individual patient management.

Evidence for efficacy of established treatment guidelines for chronic hepatitis C virus (HCV) disease is based on multinational randomized controlled trials (RCTs). Strategies for managing HCV, however, require an assessment of the effectiveness of intervention in routine clinical practice. We report the outcomes of combination therapy in a large cohort of HCV-infected individuals in the UK. A total of 347 (113 genotype 1, 234 genotype non-1) patients were treated with pegylated interferon and ribavirin according to current guidelines. Forty-two (37.2%) of those with genotype 1 infection and 164 (70.1%) with genotype non-1 infection achieved sustained viral response (SVR). Thirty-nine (11%) patients withdrew from treatment. In addition to viral genotype, factors predictive of a response to therapy were age at start of treatment and disease stage on pretreatment liver biopsy. Multivariate regression analysis demonstrated that the effects of age [odds ratio 0.5; 95% confidence interval (0.31-0.82) per 10-year increment (P = 0.006)] were confined to genotype 1 disease. In order to further inform the management of the individual patient, a multivariate logistic model was used to predict the probability of SVR for subgroups defined by disease stage, genotype and age at commencement of therapy. This model revealed striking differences in predicted response rates between subgroups and provided a strong rationale for early treatment, particularly for those with genotype 1 disease. Our study demonstrates that results comparable with those of RCTs can be achieved in clinical practice, and suggests that prediction of response rates based on probability modelling will provide a valuable adjunct to individual patient management.

Change of refractive state and eye size in children of birth weight less than 1701 g.

AIMS: To determine the refractive status and ocular dimensions of a cohort of children at age 10-12 years with birth weight below 1701 g, and also the relation between the neonatal ophthalmic findings and subsequent refractive state. METHODS: 293 low birthweight children who had been examined in the neonatal period were assessed at 10-12 years of age. The examination consisted of autorefraction, keratometry, and A-scan. Results of right eyes were compared with published normative data. RESULTS: 293 of the birth cohort of 572 children consented to participate. The average mean spherical equivalent (MSE) in the low birthweight cohort was +0.691 dioptre, significantly higher than the control data (+0.30D, p = 0.02). The average change in MSE over the 10-12 year period was -1.00 dioptre (n = 256), but only 62.1% of cases showed a shift in refractive error of the appropriate magnitude and direction. The presence of any retinopathy of prematurity (ROP) increases the risk of developing anisometropia sixfold. CONCLUSIONS: Low birth weight and ROP both significantly impact the refractive state in the long term. At age 10-12 years children born preterm have an increased prevalence of all refractive errors. In low birthweight children refractive state is relatively stable over the first decade of life with a shift towards myopia of 1 dioptre.

Education for people with progressive neurological conditions can have negative effects: evidence from a randomized controlled trial.

OBJECTIVES: To test the effects of a home-based educational intervention in reducing the incidence and the risk of falls and pressure sores in adults with progressive neurological conditions. DESIGN: Randomized controlled trial with 12 months follow-up. SETTING: Participants' homes in the City of Nottingham. PARTICIPANTS: One hundred and fourteen people with progressive neurological conditions recruited from general practices in Nottingham, including 53 with Parkinson's disease and 45 with multiple sclerosis. INTERVENTIONS: In the education group (EG), baseline data were reviewed by an expert panel which advised on actions most likely to promote each individual's physical, social and psychological well-being. An occupational therapist (OT) then visited EG participants to provide education and information and to discuss a personalized 12-month health action plan. The comparison group (CoG) received standardized printed information delivered to their home. MAIN MEASURES: Numbers of participants reporting falls and skin sores at two-monthly phone calls during the follow-up period of 12 months. RESULTS: The EG reported significantly more falls during the follow-up period and at 12 months (adjusted odds ratio 2.83 (95% CI 1.07-7.47), p=0.036) and significantly more skin sores (adjusted odds ratio 12.74 (95% CI 1.14-142.6), p =0.039) than the CoG. There was no difference between CoG and EG in the Nottingham Extended Activities of Daily Living score, but EG patients showed a significant rise in this score over the study period of 1.62 (95% CI 0.69-2.55, p=0.002). CONCLUSIONS: Our findings provide evidence that education for people with progressive neurological conditions can have negative effects.

Visual function in low birthweight children.

AIM: To determine the visual functions, at age 10-12 years, of a geographically based cohort of children of birth weight less than 1701 g. The results were compared to a group of children born at full term. METHODS: 572 low birthweight (LBW) "low birthweight cohort" children who had been examined in the neonatal period were invited for review at 10-12 years of age. 169 11 year old schoolchildren born at full term were also recruited, "school cohort." Visual acuity (at distance and near), contrast sensitivity, colour vision, and visual fields were measured. RESULTS: 293 of the original 572 participants consented to a further examination. Compared to the school cohort of children born at term the low birthweight cohort showed significantly lower near and distance acuities and contrast sensitivity (p<0.001 for all uniocular and binocular measures). Retinopathy of prematurity (ROP) was a very poor predictor of outcome and multivariate analysis did not identify any key neonatal factors as predictors of long term visual outcome. CONCLUSIONS: Low birthweight children have a small but statistically significant deficit in both visual acuity and contrast sensitivity. Low birth weight and ROP both impact on long term visual functions.

A comparison of findings on parents' and teachers' questionnaires, and detailed ophthalmic and psychological assessments.

BACKGROUND: Questionnaires are important tools used to gain information about health and level of function in different domains. AIMS AND METHODS: To determine the degree of agreement between questionnaires, administered to parents and teachers, and ophthalmic and psychological examinations in a cohort of 309 low birth weight children (<1701 g) at age 10-13 years. RESULTS: A total of 90.9% of cases showed agreement between the question on distance vision and clinical assessment, and agreement for the near vision question was 83%. However, the correlation on an individual basis was only fair (kappa = 0.46, distance vision) to poor (kappa = 0.2, near vision). The overall agreement for the questions on cognitive ability was better than the correlation, whereas the questions on reading and mathematical ability showed low agreement and low correlation. CONCLUSION: Questionnaire assessment of vision and cognitive ability is more suitable for studying the outcome of a large population than for identifying deficits in individuals.