Kate Rumsby

Background: Acne is a common skin condition that is most prevalent in young people. It can have a substantial impact on the quality of life, which can be minimized with the appropriate use of topical treatments. Nonadherence to topical treatments for acne is common and often leads to treatment failure. Objective: The aim of this study is to develop a web-based behavioral intervention to support the self-management of acne and to assess the feasibility of recruitment, retention, and engagement of users with the intervention. Methods: The intervention was developed iteratively using the LifeGuide software and following the person-based approach for intervention development. The target behavior was appropriate use of topical treatments. Barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne in the past 6 months were invited to participate through mail-out from primary care practices in the South of England in a parallel, unblinded randomized trial. Participants were automatically randomized using a computer-generated algorithm to usual care or to usual care plus access to the web-based intervention. Usage data was collected, and a series of questionnaires, including the primary outcome measure for skin-specific quality of life (Skindex-16), were collected at baseline and at the 4- and 6-week follow-ups. Results: A total of 1193 participants were invited, and 53 young people with acne were randomized to usual care (27/53, 51%) or usual care plus intervention (26/53, 49%). The response rate for the primary outcome measure (Skindex-16) was 87% at 4 weeks, 6 weeks, and at both time points. The estimate of mean scores between groups (with 95% CI) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16) and secondary measures (Patient Health Questionnaire-4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed high uptake of the core module in the usual care plus web-based intervention group, with 88% (23/26) of participants completing the module. Uptake of the optional modules was low, with less than half visiting each (myth-busting quiz: 27%; living with spots or acne: 42%; oral antibiotics: 19%; what are spots or acne: 27%; other treatments: 27%; talking to your general practitioner: 12%). Conclusions: This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management in young people with acne. Additional work is needed before a full definitive trial, including enhancing engagement with the intervention, recruitment, and follow-up rates. Trial Registration: ISRCTN 78626638; https://tinyurl.com/n4wackrw

BACKGROUND Acne is a common skin condition that is most prevalent in young people. It can have a substantial impact on the quality of life, which can be minimized with the appropriate use of topical treatments. Nonadherence to topical treatments for acne is common and often leads to treatment failure. OBJECTIVE The aim of this study is to develop a web-based behavioral intervention to support the self-management of acne and to assess the feasibility of recruitment, retention, and engagement of users with the intervention. METHODS The intervention was developed iteratively using the LifeGuide software and following the person-based approach for intervention development. The target behavior was appropriate use of topical treatments. Barriers and facilitators identified from the qualitative research and evidence from the wider literature were used to identify techniques to improve and promote their use. Young people with acne aged 14-25 years who had received treatment for acne in the past 6 months were invited to participate through mail-out from primary care practices in the South of England in a parallel, unblinded randomized trial. Participants were automatically randomized using a computer-generated algorithm to usual care or to usual care plus access to the web-based intervention. Usage data was collected, and a series of questionnaires, including the primary outcome measure for skin-specific quality of life (Skindex-16), were collected at baseline and at the 4- and 6-week follow-ups. RESULTS A total of 1193 participants were invited, and 53 young people with acne were randomized to usual care (27/53, 51%) or usual care plus intervention (26/53, 49%). The response rate for the primary outcome measure (Skindex-16) was 87% at 4 weeks, 6 weeks, and at both time points. The estimate of mean scores between groups (with 95% CI) using linear regression showed a trend in the direction of benefit for the web-based intervention group in the primary outcome measure (Skindex-16) and secondary measures (Patient Health Questionnaire-4 and the Problematic Experiences of Therapy Scale). Intervention usage data showed high uptake of the core module in the usual care plus web-based intervention group, with 88% (23/26) of participants completing the module. Uptake of the optional modules was low, with less than half visiting each (myth-busting quiz: 27%; living with spots or acne: 42%; oral antibiotics: 19%; what are spots or acne: 27%; other treatments: 27%; talking to your general practitioner: 12%). CONCLUSIONS This study demonstrated the feasibility of delivering a trial of a web-based intervention to support self-management in young people with acne. Additional work is needed before a full definitive trial, including enhancing engagement with the intervention, recruitment, and follow-up rates. CLINICALTRIAL ISRCTN 78626638; https://tinyurl.com/n4wackrw

Background: Little is known about clinicians’ experiences of using a point-of-care test (POCT) to inform management of urinary tract infection (UTI) in general practice.Aim: To explore experiences of using the Flexicult test to inform management of UTI and views on requirements for an optimal POCT to inform successful implementation.Design & setting: Telephone interviews with 35 primary care clinicians and healthcare professionals in Wales, England, Spain, and the Netherlands, who had participated in a trial of the Flexicult POCT for UTI based on urine culture.Method: Thematic analysis of semi-structured interviews.Results: Most primary care clinicians interviewed agreed on the need for a POCT in UTI management, and that the Flexicult POCT delivered quicker results than laboratory results used in usual care, reassured patients, boosted their confidence in decision-making, and reminded them about antibiotic stewardship. However, clinicians also reported difficulties in interpreting results, limitations on when the Flexicult could be used, and concerns that testing all patients would strain care delivery and prolong patient discomfort when delaying decisions until a non-rapid POCT result was available. An optimal POCT would produce more rapid results, and be reliable and easy to use. Uptake into routine care would be enhanced by: clear guidance on which patients should be tested; training for interpreting ‘grey area’ results; reiterating that even ‘straightforward’ cases might be better managed with a test; clear messages about stopping unnecessary antibiotics versus completing a course; and better self-management strategies to accompany implementation of delayed, or non-prescription of, antibiotics.Conclusion: Primary care clinicians believe that POCT tests could play a useful role in the management of UTI and gave clear recommendations for successful implementation.

Patient-reported outcomes measures in clinical trials ensure that evaluations of effectiveness focus on outcomes that are important to patients. In relapsing-remitting conditions, such as eczema, repeated measurements may allow a more accurate reflection of disease burden and treatment effect than less frequent measurements. We asked parents/carers of children with eczema taking part in a trial of bath emollients to complete weekly questionnaires for 16 weeks. The objective of this study was to determine the acceptability and practicality of collecting weekly measures of eczema severity online for 16 weeks in children aged 1 to 11 years as part of the BATHE study. BATHE randomised patients to bath emollients plus standard eczema care or standard eczema care only. The primary outcome was eczema severity, measured by the seven-item Patient-Oriented Eczema Measure (POEM) repeated weekly for 16 weeks. Acceptability was explored through qualitative interviews with 10 participants. Interviews were audio-recorded, transcribed and analysed thematically. Practicality was assessed by exploring the completeness of the data and keeping a log of any problems. Four hundred and eighty-two participants were recruited to the trial and 429 opted to complete measures online (89.0%). Data were collected online for 83% of time points over the 16-week period and there was no association between socio-demographic characteristics and data completeness. Two hundred and six (48%) completed their weekly data every week for 16 weeks and 341 (79%) completed it at least 80% of the time. The mean number of weeks completed was 13.3 out of 16 (SD 4.2). Interviewees said that they understood the rationale behind weekly collection and some welcomed this as it helped them realise how their child’s eczema changed weekly. Whilst some interviewees spoke of weekly questionnaires as onerous, others said that they found them quick and easy. Reminders were welcomed. Parents/carers seemed happy to receive telephone reminders and it was sometimes useful for eliciting problems relating to obtaining trial medication or password problems for online data collection. Amongst this population, high levels of data completeness suggests that weekly completion of the online questionnaire appears to be acceptable and feasible over a 16-week period. ISRCTN84102309 . Registered on 9 December 2013.

Background: Childhood eczema is very common. Treatment often includes emollient bath additives, despite there being little evidence of their effectiveness.Objectives: To determine the clinical effectiveness and cost-effectiveness of emollient bath additives in the management of childhood eczema.Design: Pragmatic, randomised, open-label, multicentre superiority trial with two parallel groups.Setting: Ninety-six general practices in Wales, the west of England and southern England. Invitation by personal letter or opportunistically.Participants: Children aged between 12 months and 12 years fulfilling the UK Diagnostic Criteria for Atopic Eczema. Children with inactive or very mild eczema (a score of ≤ 5 on the Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once per week or whose parents/carers were not prepared to accept randomisation.Interventions: The intervention group were prescribed bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued standard eczema management, including regular leave-on emollients and topical corticosteroids (TCSs) when required.Main outcome measures: The primary outcome was eczema control measured by Patient Oriented Eczema Measure [POEM, 0 (clear) to 28 (severe)] weekly for 16 weeks. The secondary outcomes were eczema severity over 1 year (4-weekly POEM), number of eczema exacerbations, disease-specific quality of life (QoL) (Dermatitis Family Impact Questionnaire), generic QoL (Child Health Utility-9 Dimensions) and type and quantity of topical steroid/calcineurin inhibitors prescribed. Children were randomised (1 : 1) using online software to either bath additives plus standard eczema care or standard eczema care alone, stratified by recruiting centre, and there was open-label blinding.Results: From December 2014 to May 2016, 482 children were randomised: 51% were female, 84% were white and the mean age was 5 years (n = 264 in the intervention group,n = 218 in the control group). Reported adherence to randomised treatment allocation was > 92% in both groups, with 76.7% of participants completing at least 12 (80%) of the first 16 weekly questionnaires for the primary outcome. Baseline POEM score was 9.5 [standard deviation (SD) 5.7] in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. Average POEM score over the first 16 weeks was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group, with no statistically significant difference between the groups. After controlling for baseline severity and confounders (ethnicity, TCS use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% confidence interval –0.27 to 1.10), which is well below the published minimal clinically important difference of 3 points. There was no difference between groups in secondary outcomes or in adverse effects such as redness, stinging or slipping.Limitations: Simple randomisation resulted in an imbalance in baseline group size, although baseline characteristics were well balanced between groups.Conclusion: This trial found no evidence of clinical benefit of including emollient bath additives in the standard management of childhood eczema.Future work: Further research is required on optimal regimens of leave-on emollients and the use of emollients as soap substitutes.Trial registration: Current Controlled Trials ISRCTN84102309.Funding: This project was funded by the NIHR Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 57. See the NIHR Journals Library website for further project information.

Objectives: To determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children.Design: Pragmatic randomised open label superiority trial with two parallel groups.Setting: 96 general practices in Wales and western and southern England.Participants: 483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded.Interventions: Participants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants.Main outcome measures: The primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed.Results: 483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean baseline POEM score was 9.5 (SD 5.7) in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. The mean POEM score over the 16 week period was 7.5 (SD. 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group. No statistically significant difference was found in weekly POEM scores between groups over 16 weeks. After controlling for baseline severity and confounders (ethnicity, topical corticosteroid use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additives group were 0.41 points higher than in the bath additives group (95% confidence interval −0.27 to 1.10), below the published minimal clinically important difference for POEM of 3 points. The groups did not differ in secondary outcomes, economic outcomes, or adverse effects.Conclusions: This trial found no evidence of clinical benefit from including emollient bath additives in the standard management of eczema in children. Further research is needed into optimal regimens for leave-on emollient and soap substitutes.Trial registration: Current Controlled Trials ISRCTN84102309.

Background: The effectiveness of using point-of-care (POC) urine culture in primary care on appropriate antibiotic use is unknown.Aim: To assess whether use of the Flexicult^™ SSI-Urinary Kit, which quantifies bacterial growth and determines antibiotic susceptibility at the point of care, achieves antibiotic use that is more often concordant with laboratory culture results, when compared with standard care.Design and setting: Individually randomised trial of females with uncomplicated urinary tract infection (UTI) in primary care research networks (PCRNs) in England, the Netherlands, Spain, and Wales.Method: Multilevel regression compared outcomes between the two groups while controlling for clustering.Results: In total, 329 participants were randomised to POC testing (POCT) and 325 to standard care, and 324 and 319 analysed. Fewer females randomised to the POCT arm than those who received standard care were prescribed antibiotics at the initial consultation (267/324 [82.4%] versus 282/319 [88.4%], odds ratio [OR] 0.56, 95% confidence interval [CI] = 0.35 to 0.88). Clinicians indicated the POCT result changed their management for 190/301 (63.1%). Despite this, there was no statistically significant difference between study arms in antibiotic use that was concordant with laboratory culture results (primary outcome) at day 3 (39.3% POCT versus 44.1% standard care, OR 0.84, 95% CI = 0.58 to 1.20), and there was no evidence of any differences in recovery, patient enablement, UTI recurrences, re-consultation, antibiotic resistance, and hospitalisations at follow-up. POCT culture was not cost-effective.Conclusion: Point-of-care urine culture was not effective when used mainly to adjust immediate antibiotic prescriptions. Further research should evaluate use of the test to guide initiation of ‘delayed antibiotics’.

PURPOSE Up to 50% of urinary tract infections (UTIs) in young children are missed in primary care. Urine culture is essential for diagnosis, but urine collection is often difficult. Our aim was to derive and internally validate a 2-step clinical rule using (1) symptoms and signs to select children for urine collection; and (2) symptoms, signs, and dipstick testing to guide antibiotic treatment. METHODS We recruited acutely unwell children aged under 5 years from 233 primary care sites across England and Wales. Index tests were parent-reported symptoms, clinician-reported signs, urine dipstick results, and clinician opinion of UTI likelihood (clinical diagnosis before dipstick and culture). The reference standard was microbiologically confirmed UTI cultured from a clean-catch urine sample. We calculated sensitivity, specificity, and area under the receiver operator characteristic (AUROC) curve of coefficient-based (graded severity) and points-based (dichotomized) symptom/sign logistic regression models, and we then internally validated the AUROC using bootstrapping. RESULTS Three thousand thirty-six children provided urine samples, and culture results were available for 2,740 (90%). Of these results, 60 (2.2%) were positive: the clinical diagnosis was 46.6% sensitive, with an AUROC of 0.77. Previous UTI, increasing pain/crying on passing urine, increasingly smelly urine, absence of severe cough, increasing clinician impression of severe illness, abdominal tenderness on examination, and normal findings on ear examination were associated with UTI. The validated coefficient- and points-based model AUROCs were 0.87 and 0.86, respectively, increasing to 0.90 and 0.90, respectively, by adding dipstick nitrites, leukocytes, and blood. CONCLUSIONS A clinical rule based on symptoms and signs is superior to clinician diagnosis and performs well for identifying young children for noninvasive urine sampling. Dipstick results add further diagnostic value for empiric antibiotic treatment.

Background: It is not clear which young children presenting acutely unwell to primary care should be investigated for urinary tract infection (UTI) and whether or not dipstick testing should be used to inform antibiotic treatment.Objectives: To develop algorithms to accurately identify pre-school children in whom urine should be obtained; assess whether or not dipstick urinalysis provides additional diagnostic information; and model algorithm cost-effectiveness.Design: Multicentre, prospective diagnostic cohort study.Setting and participants: Children < 5 years old presenting to primary care with an acute illness and/or new urinary symptoms.Methods: One hundred and seven clinical characteristics (index tests) were recorded from the child’s past medical history, symptoms, physical examination signs and urine dipstick test. Prior to dipstick results clinician opinion of UTI likelihood (‘clinical diagnosis’) and urine sampling and treatment intentions (‘clinical judgement’) were recorded. All index tests were measured blind to the reference standard, defined as a pure or predominant uropathogen cultured at ≥ 10⁵colony-forming units (CFU)/ml in a single research laboratory. Urine was collected by clean catch (preferred) or nappy pad. Index tests were sequentially evaluated in two groups, stratified by urine collection method: parent-reported symptoms with clinician-reported signs, and urine dipstick results. Diagnostic accuracy was quantified using area under receiver operating characteristic curve (AUROC) with 95% confidence interval (CI) and bootstrap-validated AUROC, and compared with the ‘clinician diagnosis’ AUROC. Decision-analytic models were used to identify optimal urine sampling strategy compared with ‘clinical judgement’.Results: A total of 7163 children were recruited, of whom 50% were female and 49% were < 2 years old. Culture results were available for 5017 (70%); 2740 children provided clean-catch samples, 94% of whom were ≥ 2 years old, with 2.2% meeting the UTI definition. Among these, ‘clinical diagnosis’ correctly identified 46.6% of positive cultures, with 94.7% specificity and an AUROC of 0.77 (95% CI 0.71 to 0.83). Four symptoms, three signs and three dipstick results were independently associated with UTI with an AUROC (95% CI; bootstrap-validated AUROC) of 0.89 (0.85 to 0.95; validated 0.88) for symptoms and signs, increasing to 0.93 (0.90 to 0.97; validated 0.90) with dipstick results. Nappy pad samples were provided from the other 2277 children, of whom 82% were < 2 years old and 1.3% met the UTI definition. ‘Clinical diagnosis’ correctly identified 13.3% positive cultures, with 98.5% specificity and an AUROC of 0.63 (95% CI 0.53 to 0.72). Four symptoms and two dipstick results were independently associated with UTI, with an AUROC of 0.81 (0.72 to 0.90; validated 0.78) for symptoms, increasing to 0.87 (0.80 to 0.94; validated 0.82) with the dipstick findings. A high specificity threshold for the clean-catch model was more accurate and less costly than, and as effective as, clinical judgement. The additional diagnostic utility of dipstick testing was offset by its costs. The cost-effectiveness of the nappy pad model was not clear-cut.Conclusions: Clinicians should prioritise the use of clean-catch sampling as symptoms and signs can cost-effectively improve the identification of UTI in young children where clean catch is possible. Dipstick testing can improve targeting of antibiotic treatment, but at a higher cost than waiting for a laboratory result. Future research is needed to distinguish pathogens from contaminants, assess the impact of the clean-catch algorithm on patient outcomes, and the cost-effectiveness of presumptive versus dipstick versus laboratory-guided antibiotic treatment.Funding: The National Institute for Health Research Health Technology Assessment programme.

Background The added diagnostic utility of nappy pad urine samples and the proportion that are contaminated is unknown. Aim To develop a clinical prediction rule for the diagnosis of urinary tract infection (UTI) based on sampling using the nappy pad method. Design and setting Acutely unwell children P<0.001). Conclusion Nappy pad urine culture results, with features that can be reported by parents and dipstick tests, can be clinically useful, but are less accurate and more often contaminated compared with clean-catch urine culture.