Barriers to integrating routine depression screening into community low vision rehabilitation services: a mixed methods study

Background:Undetected depression is common in people withlow vision and depression screening has beenrecommended. However, depression screening is a complex procedure for which low vision practitioners need training. Thisstudy examined the integration of routine depression screening, using two questions, and referral pathways into a nationallow vision service in Wales at 6 months following practitioner training, and identified key barriers to implementation.Methods:This pre-post single group study employed a convergent mixed methods design to collect quantitativequestionnaire and qualitative interview data on low vision practitioners’clinical practice and perceived barriers toimplementing depression screening. Forty practitioners completed questionnaires pre-, immediately post- and 6 monthspost-training and nine engaged in interviews 6 months post-training. Ordinal questionnaire scores were Rasch-transformedinto interval-level data before linear regression analyses were performed to determine the change in scores over time andthe association between perceived barriers and clinical practice. Thematic Analysis was applied to the interviews and thenarrative results merged withthe questionnaire findings.Results:Before training, only one third of practitioners (n= 15) identified depression in low vision patients, increasing toover 90% (n= 37) at 6 months post-training, with a corresponding increase in those using validated depression screeningquestions from 10% (n= 4) to 80% (n= 32). Six months post-training, practitioners reported taking significantly moreaction in response to suspected depression (difference in means = 2.77, 95% CI 1.93 to 3.61,p< 0.001) and perceived lessbarriers to addressing depression (difference in means =−0.95, 95% CI−1.32 to−0.59,p<0.001).However,thescreening questions were not used consistently. Some barriers to implementation remained, including perceived patientreluctance to discuss depression, time constraints and lack of confidence in addressing depression.Conclusions:The introduction of depression screening service guidelines and training successfully increased the numberof low vision practitioners identifying and addressing depression. However, standardized screening of all low visionattendees has not yet been achieved and several barriers remain. Healthcare services need to address these barriers whenconsidering mental health screening, and further research could focus on the process from the patients’perspective, todetermine the desire for and acceptability of screening

The development and validation of the CARe Burn Scale: Child Form: a parent-proxy-reported outcome measure assessing quality of life for children aged 8 years and under living with a burn injury

Purpose: Patient-reported outcome measures (PROMs) identify patient needs and therapeutic progress. This paper outlines the development and validation of the CARe Burn Scale: Child Form, a parent-proxy-reported outcome measure that assesses quality of life in children aged 8 and under living with a burn injury. Methods: A literature review and interviews with 12 parents of children with a burn and seven health professionals informed the development of a conceptual framework and draft PROM. Cognitive debriefing interviews with 18 parents and eight health professionals provided feedback to ascertain content validity, and 311 parents took part in field testing. Rasch and traditional psychometric analyses were conducted to create a shortened version. Further psychometric analyses with 133 parents tested the shortened CARe Burn Scale in relation to other parent-proxy measures. Results: The final conceptual framework included 5 domains: Social and Emotional Difficulties, Social and Emotional Well-Being, Wound/Scar Discomfort, Wound/Scar Treatment and Physical Abilities. Two scales fulfilled Rasch and traditional psychometric analyses, providing evidence of construct validity, acceptability, and reliability. Three scales did not fulfil the Rasch criteria and were retained as checklists. Compared to other parent-proxy measures, individual CARe Burn Scales correlated moderately with similar constructs and had low correlations with dissimilar constructs, indicating evidence of criterion validity (concurrent and discriminant). Conclusions: The CARe Burn Scale: Child Form can be used to measure children’s quality of life after having a burn injury which can inform rehabilitation and surgical decision-making

A study protocol to develop the domains of an observational well-being scale (WEBS) for non-verbal children and young people with cerebral palsy from using the Innowalk.

Cerebral palsy (CP) is a group of permanent disorders of the development of movement and posture often accompanied by disturbances of communication and behaviour. For those with more severe physical disabilities, their ability to participate in physical activities is limited, which includes those with walking limitations. It is known that adults with CP are prone to early development of chronic diseases such as a cardiovascular disease. Increasing physical activity levels improves well-being across the general population, including children without disabilities. Whether this is so for those children who have mobility limitations and cannot communicate their feelings is currently unknown. It is also unknown whether and how their well-being and quality of life can be influenced. Well-being in this context refers to how children with CP are able to indicate they are enjoying life in their environments-‘thriving or surviving’ which directly impacts upon their perceived quality of life. This research will observe children using the Innowalk, a robotic device as one context for them to indicate their well-being. The National Institute for Health and Care Excellence (2017) guidelines for the management of CP included recommendations to use validated measures to monitor their mental health and well-being, however available questionnaires are problematic for those who cannot communicate verbally or have a learning disability and experience epilepsy, fatigue or pain. Additionally, Mpundu-Kaambwa et al (2018) did not find a valid and reliable measure of well-being for those with complex disabilities. However, a recent development by Oliver et al (2020), the Be-Well checklist for children with profound disabilities, has informed this study. Profound disabilities refer to those children with severe learning disabilities and complex needs. Other existing well-being measures will be reviewed in a co-productive way with children and their parents, to develop the domains for this new observational well-being scale for children with CP. This research will use the context of the Innowalk to observe well-being indicators in the children’s responses. Problem: The lack of a valid and reliable measurement scale for the well-being of children and young people with complex CP. Interest: Developing and testing a new scale by observing the well-being of non-ambulant and non-verbal children and young people with CP when using the Innowalk. Context: Special School setting for children and young people with CP Outcome: The domains established will enable the content validity to be evaluated in larger funded study to test the psychometric properties of the WEBS

Oral fumaric acid esters for psoriasis: abridged Cochrane systematic review including GRADE assessments

Fumaric acid esters (FAE) are licensed for the treatment of moderate to severe psoriasis in Germany but are also used off-label in many other countries. We conducted this systematic review to synthesize the highest quality evidence for the benefits and risks of FAE for psoriasis. Our primary outcomes were change in PASI score and drop-out rates due to adverse effects. Randomised controlled trials (RCTs) of FAE or dimethyl fumarate were included, with no restriction on age or psoriasis subtype. We searched The Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library, MEDLINE, EMBASE, LILACS, five trials registers and handsearched six conference proceedings. Six RCTs with 544 participants were included, four of which were published only as abstracts or brief reports, limiting study reporting. Five RCTs compared FAE with placebo and all demonstrated benefit in favour of FAE but meta-analysis was only possible for PASI 50 after 12-16 weeks, which was achieved by 64% of participants on FAE compared to 14% on placebo (risk ratio (RR) 4.55; 95% CI 2.80 to 7.40; 2 studies; 247 participants; low quality evidence). There was no difference in drop-out rates due to adverse effects (RR 5.36, 95% CI 0.28 to 102.12; 1 study; 27 participants; very low-quality evidence and wide confidence interval). More participants experienced nuisance adverse effects with FAE (76%) compared to placebo (16%) (RR 4.72, 95% CI 2.45 to 9.08; 1 study; 99 participants; moderate-quality evidence), mainly abdominal pain, diarrhoea and flushing. One head-to-head study of very low quality evidence comparing FAE with methotrexate reported comparable efficacy and drop-out rates, although FAE caused more flushing. The evidence in this review was limited and must be interpreted with caution; better designed and reported studies are needed

Testing the responsiveness of and defining minimal important difference (MID) values for the CARe burn scales: patient-reported outcome measures to assess quality of life for children and young people affected by burn injuries, and their parents/caregivers

The CARe Burn Scales are a portfolio of burn-specific PROMs for people affected by burns, including a Child Form (for children < 8 years (parent-proxy)), a Young Person Form (for young people aged 8–17 years), an Adult Form, and a Parent Form (for parents/carers of children aged 0–17 years). This study aimed to determine the responsiveness and minimal important difference (MID) values of the three scales developed for use in paediatric burn services and research. Participants were recruited by 15 UK Burn Services. Participants completed the appropriate CARe Burn Scale and a set of appropriate comparison validated measures, at three time points: 4 weeks (T1), 3 months (T2) and 6 months (T3) post-burn injury. Spearman’s correlation analysis and effect sizes based on Cohen’s d thresholds were reported and MID values were calculated. At baseline, 250 participants completed the Child Form, 69 completed the Young Person Form, and 320 completed the Parent Form. A total of 85–92% of participants were retained at follow up. The tested CARe Burn Scales were all responsive to change over time. MID values were created for all subscales and ranged from 2 to 11 for the Child Form, 3 to 14 for the Young Person Form and 3 to 10 for the Parent Form. The CARe Burn Scales for children, young people and parents are responsive to change over time. The scales are freely available for clinical and research use

Training results in increased practitioner confidence and identification of depression in people with low vision: a mixed methods study

Purpose The prevalence of depression in people with low vision is high and often goes undiagnosed. There is the potential for those who provide low vision services to perform concurrent depression screening. However, prior training in depression identification and suitable referral pathways is required. The aims of this study were: (1) to assess the impact of a training programme on practitioners’ confidence and behaviour in addressing depression in patients with low vision, and (2) to review the training programme and identify areas for further development. Methods A convergent mixed methods approach was used. Questionnaires were completed by practitioners pre‐, immediately post‐ and 6 months post‐ training (n = 40) to assess practitioner confidence in approaching depression in patients with low vision. Qualitative interviews were performed with a subset of practitioners 6 months post‐training (n = 9). Additionally, routine data from the Low Vision Service Wales (LVSW) database was used to determine the change in the number of practitioners identifying depression in patients, and the change in the number of patients identified at risk of depression 6 months post‐training. Results Of the 148 practitioners who completed low vision assessments pre‐ and post‐training, 28 (18.9%) documented risk of depression in their patients pre‐training, which increased substantially to 65 (43.9%) post‐training (p < 0.0001). Mixed methods analysis confirmed increased documentation of depressive symptoms by practitioners. Practitioner confidence increased following training, with 92.3% feeling more confident to approach emotional issues with patients and 92.2% intending to use the recommended screening tool to identify depression. Interviews provided insight into areas where confidence was still lacking. Quantitative questionnaires revealed that training content was considered appropriate by 91% of participants. Interviews confirmed these findings while expanding upon possibilities for programme improvement. Conclusions Training for depression screening was found to be time‐efficient and acceptable for LVSW practitioners and shown to increase practitioner confidence in the identification of depression. Additionally, the programme changed behaviour, resulting in an increase in the identification of depression in patients with low vision. However, this is a complex topic and ongoing development is required to embed depression screening as an integral part of low vision services

The CARe Burn Scale—Adult Form: Identifying the responsiveness and Minimal Important Difference (MID) values of a Patient Reported Outcome Measure (PROM) to assess quality of life for adults with a burn injury

The CARe Burn Scales are a suite of burn-specific PROMs for adults, children, young people, and parents affected by burns. This study aimed to determine the responsiveness and minimal important difference (MID) values of the Adult Form for use in adult burn care and research. Participants were recruited by 11 UK Burn Services. They completed online or paper versions of the CARe Burn Scale –Adult Form and a set of appropriate comparison validated measures and anchor questions at baseline (T1, up to 4 weeks post-burn), 3 months (T2), and 6 months post-burn (T3). A total of 269 participants took part at baseline and 226 (84%) were retained at the 6-month follow-up. Spearman’s correlation analysis and effect sizes based on Cohen’s d thresholds were reported and MID values calculated. MID values were created for all subscales and ranged from 4–15. The CARe Burn Scale–Adult Form is responsive to change over time and can therefore be used to reliably inform the management of adults’ burn injury treatment and recovery. It is freely available for clinical and research use

AZTEC—azithromycin therapy for prevention of chronic lung disease of prematurity: a statistical analysis plan for clinical outcomes

Background: The AZTEC trial is a multi-centre, randomised, placebo-controlled trial of azithromycin to improve survival without development of chronic lung disease of prematurity (CLD) in preterm infants. The statistical analysis plan for the clinical outcomes of the AZTEC trial is described. Methods and design: A double-blind, randomised, placebo-controlled trial of a 10-day course of intravenous azithromycin (20 mg/kg for 3 days; 10 mg/kg for 7 days) administered to preterm infants born at < 30 weeks’ gestational age across UK tertiary neonatal units. Following parental consent, infants are randomly allocated to azithromycin or placebo, with allocated treatment starting within 72 h of birth. The primary outcome is survival without moderate/severe CLD at 36 weeks’ postmenstrual age (PMA). Serial respiratory fluid and stool samples are being collected up to 21 days of life. The target sample size is 796 infants, which is based on detecting a 12% absolute difference in survival without moderate/severe CLD at 36 weeks’ PMA (90% power, two-sided alpha of 0.05) and includes 10% loss to follow-up. Results: Baseline demographic and clinical characteristics will be summarised by treatment arm and in total. Categorical data will be summarised by numbers and percentages. Continuous data will be summarised by mean, standard deviation, if data are normal, or median, interquartile range, if data are skewed. Tests of statistical significance will not be undertaken for baseline characteristics. The primary analysis, on the intention to treat (ITT) population, will be analysed using multilevel logistic regression, within a multiple imputation framework. Adjusted odds ratios, 95% confidence intervals, and p-values will be presented. For all other analyses, the analysis population will be based on the complete case population, which is a modified ITT population. All analyses will be adjusted for gestational age and treatment arm and account for any clustering by centre and/or multiple births as a random effect. Conclusion: We describe the statistical analysis plan for the AZTEC trial, including the analysis principles, definitions of the key clinical outcomes, methods for primary analysis, pre-specified subgroup analysis, sensitivity analysis, and secondary analysis. The plan has been finalised prior to the completion of recruitment. Trial registration: ISRCTN registry ISRCTN11650227. Registered on 31 July 2018