Economic evaluation of a trial exploring the effects of a web-based support tool for parents of children with juvenile idiopathic arthritis.

OBJECTIVE: To explore the cost-effectiveness of a web-based support tool for parents of children with Juvenile Idiopathic Arthritis. METHODS: A multi-centred randomised controlled trial was conducted in paediatric rheumatology centres in England. The WebParC intervention consisted of online information about JIA and its treatment and a toolkit using cognitive-behavioural therapy principles to support parents manage their child's JIA. An economic evaluation was performed alongside the trial involving 220 parents. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress, with two dimensions; difficulty and frequency. These measures along with costs were assessed post intervention at 4 months and 12 months. Costs were calculated for healthcare usage using a UK NHS economic perspective. Data was collected and analysed on the impact of caring costs on families. Uncertainty around cost effectiveness was explored using bootstrapping and cost-effectiveness acceptability curves. RESULTS: The intervention arm showed improved average Pediatric Inventory for Parents scores for the dimensions of frequency and difficulty, of 1.5 and 3.6 respectively at 4 months and. 0.35 and 0.39 at 12 months, representing improved PIP scores for the intervention arm. At both 4 and 12 month follow up the average total cost per case was higher in the control group when compared with the intervention arm with mean differences of £360 (95% CI £29.6 to £691) at 4 months and £203 (95% CI £16 to £390) at 12 months. The probability of the intervention being cost effective ranged between 49% and 54%. CONCLUSION: The WebParC intervention led to reductions in primary and secondary healthcare resource use and costs at 4 and 12 months. The intervention demonstrated particular savings for rheumatology services at both follow ups. Future economies of scale could be realised by health providers with increased opportunities for cost effectiveness over time. TRIAL REGISTRATION: ISRCTN, ISRCTN13159730.

Lactobacillus casei Shirota probiotic drinks reduce antibiotic associated diarrhoea in patients with spinal cord injuries who regularly consume proton pump inhibitors: a subgroup analysis of the ECLISP multicentre RCT.

STUDY DESIGN: This was a sub-group analysis of a multicentre, randomised, placebo-controlled, double-blind trial (ECLISP trial) OBJECTIVES: To assess the efficacy of a probiotic containing at least 6.5 × 109 live Lactobacillus casei Shirota (LcS) in preventing antibiotic associated diarrhoea (AAD) in patients with spinal cord injury (SCI) who consumed proton pump inhibitor (PPI) regularly. LcS or placebo was given once daily for the duration of an antibiotic course and continued for 7 days thereafter. The trial was registered with ISRCTN:13119162. SETTING: Three SCI centres (National Spinal Injuries Centre, Midland Centre for Spinal Injuries and Princess Royal Spinal Cord Injuries Centre) in the United Kingdom METHODS: Between November 2014, and November 2019, 95 eligible consenting SCI patients (median age: 57; IQ range: 43-69) were randomly allocated to receive LcS (n = 50) or placebo (n = 45). The primary outcome is the occurrence of AAD up to 30 days after finishing LcS/placebo. RESULTS: The LcS group had a significantly lower incidence of AAD at 30 days after finishing the antibiotic course (28.0 v 53.3%, RR: 95% CI: 0.53, 0.31-0.89; z = 2.5, p = 0.01). Multivariate logistic regression analysis identified that LcS can reduce the risk of AAD at 30 days (OR: 0.36, 95% CI 0.13, 0.99, p < 0.05). No intervention-related adverse events were reported during the study. CONCLUSIONS: LcS has the potential to prevent AAD in what could be considered a defined vulnerable group of SCI patients on regular PPI. A confirmatory, randomised, placebo-controlled study is needed to confirm this apparent therapeutic success to translate it into appropriate clinical outcomes. SPONSORSHIP: Yakult Honsha Co., Ltd.

A mixed model approach to estimate the survivor average causal effect in cluster-randomized trials.

In many medical studies, the outcome measure (such as quality of life, QOL) for some study participants becomes informatively truncated (censored, missing, or unobserved) due to death or other forms of dropout, creating a nonignorable missing data problem. In such cases, the use of a composite outcome or imputation methods that fill in unmeasurable QOL values for those who died rely on strong and untestable assumptions and may be conceptually unappealing to certain stakeholders when estimating a treatment effect. The survivor average causal effect (SACE) is an alternative causal estimand that surmounts some of these issues. While principal stratification has been applied to estimate the SACE in individually randomized trials, methods for estimating the SACE in cluster-randomized trials are currently limited. To address this gap, we develop a mixed model approach along with an expectation-maximization algorithm to estimate the SACE in cluster-randomized trials. We model the continuous outcome measure with a random intercept to account for intracluster correlations due to cluster-level randomization, and model the principal strata membership both with and without a random intercept. In simulations, we compare the performance of our approaches with an existing fixed-effects approach to illustrate the importance of accounting for clustering in cluster-randomized trials. The methodology is then illustrated using a cluster-randomized trial of telecare and assistive technology on health-related QOL in the elderly.

Self-reported throat symptoms in Ehlers-Danlos syndromes and hypermobility spectrum disorders: A cross-sectional survey study.

Objectives: This study identified the frequency and severity of dysphagia, dysphonia, and laryngopharyngeal reflux symptoms in people with Ehlers-Danlos syndromes (EDS) or hypermobility spectrum disorders (HSD) and explored differences between diagnostic groups. Methods: Participants were recruited via non-probability convenience sampling. Information was gathered via online survey, including the Reflux Symptom Index (RSI; Belafsky et al., J Voice. 2002;16:274-277), the Eating and Drinking Assessment Tool (EAT-10; Belafsky et al., Ann Otol Rhinol Laryngol. 2008;117:919-924), and the Voice Handicap Index (VHI; Jacobson et al., Am J Speech Lang Pathol. 1997;6(3):66-70). These were analyzed using ANOVAs. Results: There were 1620 participants (96.6% female, 2.8% male) that met the inclusion criteria. The mean age was 38.09 (SD 12.22). 75.51% had hypermobile EDS (hEDS), 17.83% had HSD and 3.33% had classic EDS (cED). The cohort's mean scores were RSI = 22.95 (SD 9.01), EAT-10 = 11.91 (SD 9.66), and VHI score = 31.99 (SD 24.36). The hEDS group had significantly higher mean scores than the HSD group on RSI score and on some RSI items, on EAT-10 score and on all EAT-10 items, and on one VHI item. Conclusion: People with EDS/HSD experience symptoms of acid reflux, dysphagia, and dysphonia to varying degrees with significant differences between hEDS than HSD. Awareness of the impact of EDS/HSD on throat symptoms will enable health care professionals to anticipate throat symptoms more readily in this population, providing individualized and effective management plans. Level of Evidence: IV.

The impact of COVID-19 on Australian clinicians' decision making in line with the principles of Choosing Wisely.

AIM: To explore the perspectives of clinicians' decision-making processes and considerations in line with the Choosing Wisely principles during the first wave of the COVID-19 pandemic. DESIGN: An exploratory qualitative approach was used. METHODS: Data were collected via semi-structured interviews to encourage participants to discuss their own experience in making clinical decisions during the COVID-19 pandemic. A total of 12 clinicians from across disciplines were interviewed to reach data saturation. Interview data were analysed considering the Choosing Wisely principles. RESULTS: Five main themes as they relate to clinician decision-making emerged and included; prioritizing care and treatment, uncertainty regarding best practice as a result of rapidly changing guidelines, organizational challenges to clinical decision-making, the use of telehealth and enabling consumer engagement with health services. CONCLUSION: Despite the disruption caused by COVID-19, clinicians were mindful of necessary care and worked to ensure that core care was not compromised during the first wave of the pandemic. The need for clinicians to protect both their own safety and that of their colleagues arose as an additional factor that influenced clinicians' decision-making process during the COVID-19 pandemic.

Using the behaviour change wheel and person-based approach to develop a digital self-management intervention for patients with adrenal insufficiency: the Support AI study protocol.

Introduction: Most patients with Adrenal insufficiency (AI) require lifelong glucocorticoid replacement. They need to increase glucocorticoids during physical illness or major stressful situations and require parenteral hydrocortisone in the event of an adrenal crisis. Patients with AI have impaired quality of life and high mortality; approximately 1 in 6-12 patients are hospitalised at least once/year from a potentially preventable adrenal crisis. Adoption of self-management behaviours are crucial; these include adherence to medication, following "sick day rules" and associated behaviours that aid prevention and treatment of adrenal crisis such as symptom monitoring, having extra tablets, carrying a medical-alert ID and injection kit, and self-injecting when necessary. Current patient education is ineffective at supporting self-management behaviour change or reducing adrenal crisis-related hospitalisations. This research study aims to gain an in-depth understanding of the barriers and enablers to self-management for patients with AI and to develop an evidence-based digital self-management behaviour change intervention. Methods: The study is conducted in accordance with the MRC Framework for developing complex interventions. Underpinned by the Behaviour Change Wheel (BCW), the Theoretical Domains Framework (TDF), and the Person-Based Approach, this research will be conducted in two phases: Phase 1 will involve a sequential qualitative/quantitative mixed-methods study involving focus group interviews followed by a cross-sectional survey with patients with AI recruited from patient advocacy groups and endocrine clinics in the UK. Phase 2 will develop the Support AI, a website-based digital behaviour change intervention (DBCI) informed by Phase 1 findings to support self-management for patients with AI. The most appropriate behaviour change techniques (BCTs) will be selected utilising a nominal group technique with an Expert Panel of 10-15 key stakeholders. The design of the Support AI website will be guided by the Person-Based Approach using an Agile iterative "think-aloud" technique with 12-15 participants over 3 usability testing iterations. Conclusion: A theory- and evidence-based digital behaviour change intervention will be developed which will be tested in a feasibility randomised trial following completion of this study. The projected benefit includes cost-effective health care service (reduced hospitalisations and demand for specialist services) and improved health outcomes and quality of life for patients with AI.

The impact of chemotherapy on cognitive performance post-surgery in patients with colorectal cancer: A prospective cohort study.

OBJECTIVES: Subjective reports of cognitive impairment following chemotherapy are frequent in cancer patients. Objective cognitive impairment has been observed in cancer patients regardless of treatment regimen suggesting the relationship between cognitive impairment and chemotherapy is not clear cut. Little research has explored the effects of chemotherapy on cognition following surgery in colorectal cancer (CRC). The present study explored the effects of chemotherapy on cognitive performance in a sample of CRC patients. METHODS: 136 participants were recruited into a prospective cohort study: 78 CRC patients undergoing surgery and adjuvant chemotherapy, 58 CRC patients undergoing surgery only. A battery of neuropsychological tests was administered to participants 4 weeks post-surgery (T1), 12 weeks after first chemotherapy (T2) and 3 months after last chemotherapy (T3) or equivalent time-points. RESULTS: Using the criterion of scoring at least two standard-deviations below the group norm on at least one neuropsychological test, 45%-55% of all CRC patients showed cognitive deficits 10 months after surgery (T3) and 14% on at least 3 tests. However, cognition did not significantly differ between patients who had chemotherapy and those who did not. A time by group interaction effect was found on the composite cognition score using multi-level modelling suggesting a greater improvement in cognition in the surgery only group over time (p < 0.05). CONCLUSIONS: CRC patients display cognitive impairment 10 months after surgery. Chemotherapy did not worsen cognitive impairment but did appear to slow cognitive recovery relative to those undergoing surgery only. The findings demonstrate a clear need for supportive cognitive interventions for all CRC patients following treatment.

Artificial intelligence education for radiographers, an evaluation of a UK postgraduate educational intervention using participatory action research: a pilot study.

BACKGROUND: Artificial intelligence (AI)-enabled applications are increasingly being used in providing healthcare services, such as medical imaging support. Sufficient and appropriate education for medical imaging professionals is required for successful AI adoption. Although, currently, there are AI training programmes for radiologists, formal AI education for radiographers is lacking. Therefore, this study aimed to evaluate and discuss a postgraduate-level module on AI developed in the UK for radiographers. METHODOLOGY: A participatory action research methodology was applied, with participants recruited from the first cohort of students enrolled in this module and faculty members. Data were collected using online, semi-structured, individual interviews and focus group discussions. Textual data were processed using data-driven thematic analysis. RESULTS: Seven students and six faculty members participated in this evaluation. Results can be summarised in the following four themes: a. participants' professional and educational backgrounds influenced their experiences, b. participants found the learning experience meaningful concerning module design, organisation, and pedagogical approaches, c. some module design and delivery aspects were identified as barriers to learning, and d. participants suggested how the ideal AI course could look like based on their experiences. CONCLUSIONS: The findings of our work show that an AI module can assist educators/academics in developing similar AI education provisions for radiographers and other medical imaging and radiation sciences professionals. A blended learning delivery format, combined with customisable and contextualised content, using an interprofessional faculty approach is recommended for future similar courses.

A Bayesian Approach for Estimating the Survivor Average Causal Effect When Outcomes Are Truncated by Death in Cluster-Randomized Trials.

Many studies encounter clustering due to multicenter enrollment and nonmortality outcomes, such as quality of life, that are truncated due to death-that is, missing not at random and nonignorable. Traditional missing-data methods and target causal estimands are suboptimal for statistical inference in the presence of these combined issues, which are especially common in multicenter studies and cluster-randomized trials (CRTs) carried out among the elderly or seriously ill. Using principal stratification, we developed a Bayesian estimator that jointly identifies the always-survivor principal stratum in a clustered/hierarchical data setting and estimates the average treatment effect among them (i.e., the survivor average causal effect (SACE)). In simulations, we observed low bias and good coverage with our method. In a motivating CRT, the SACE and the estimate from complete-case analysis differed in magnitude, but both were small, and neither was incompatible with a null effect. However, the SACE estimate has a clear causal interpretation. The option to assess the rigorously defined SACE estimand in studies with informative truncation and clustering can provide additional insight into an important subset of study participants. Based on the simulation study and CRT reanalysis, we provide practical recommendations for using the SACE in CRTs and software code to support future research.

Prevalence of vitamin D deficiency in patients with spinal cord injury at admission: a single-centred study in the UK.

Vitamin D deficiency is prevalent in patients with chronic spinal cord injury (SCI) and has been implicated as an aetiologic factor of osteoporosis and various skeletal and extra-skeletal issues in SCI patients. Few data were available regarding vitamin D status in patients with acute SCI or immediately assessed at hospital admission. This retrospective cross-sectional study evaluated vitamin D status in SCI patients at admission to a UK SCI centre in January-December 2017. A total of 196 eligible patients with serum 25(OH)D concentration records at admission were recruited. The results found that 24 % were vitamin D deficient (serum 25(OH)D < 25 nmol/l), 57 % of the patients had serum 25(OH)D < 50 nmol/l. The male patients, patients admitted in the winter-spring time (December-May), and patients with serum sodium < 135 mmol/l or with non-traumatic causes had a significant higher prevalence of vitamin D deficiency than their counterparts (28 % males v. 11⋅8 % females, P = 0⋅02; 30⋅2 % in winter-spring v. 12⋅9 % in summer-autumn, P = 0⋅007; 32⋅1 % non-traumatic v. 17⋅6 % traumatic SCI, P = 0⋅03; 38⋅9 % low serum sodium v. 18⋅8 % normal serum sodium, P = 0⋅010). There was a significant inverse association of serum 25(OH)D concentration with body mass index (BMI) (r = -0⋅311, P = 0⋅002), serum total cholesterol (r = -0⋅168, P = 0⋅04) and creatinine concentrations (r = -0⋅162, P = 0⋅02) that were also significant predictors of serum 25(OH)D concentration. Strategies for systematic screening and efficacy of vitamin D supplementation in SCI patients need to be implemented and further investigated to prevent the vitamin D deficiency-related chronic complications.

Psychosocial Risk Factors for Health-Related Quality of Life in Adult Congenital Heart Disease.

BACKGROUND: There is variability in the impact of adult congenital heart disease (ACHD) on health-related quality of life (HRQoL). A greater insight into the impact of ACHD may be gained from investigating HRQoL in various diagnostic groups and considering the importance of psychosocial risk factors for poor HRQoL. OBJECTIVE: We compared the HRQoL of people with ACHD with normative data from the general population and among 4 diagnostic groups and identified risk factors for poor HRQoL in ACHD from a comprehensive set of sociodemographic, clinical, and psychosocial factors. METHODS: We conducted a cross-sectional study with 303 participants from 4 diagnostic groups Simple, Tetralogy of Fallot, Transposition of the Great Arteries, Single Ventricle who completed measures of illness perceptions, coping, social support, mood, and generic and disease-specific HRQoL. Data were analyzed using 1-sample t tests, analysis of variance, and hierarchical multiple regressions. RESULTS: There was diminished psychosocial HRQoL in the Simple group compared with the general population. Consistently significant risk factors for poor HRQoL included younger age, a perception of more severe symptoms due to ACHD, depression, and anxiety. Clinical factors were poor predictors of HRQoL. CONCLUSIONS: The findings highlight the need to develop intervention studies aiming to improve HRQoL in people with ACHD and the routine assessment of illness perceptions and mood problems during key periods in people's lives. This will help address patient misconceptions that could be tackled by clinicians or specialist nurses during routine outpatient appointments and identify people in need of psychological support.

Healthcare professionals' perceived barriers and facilitators of implementing clinical practice guidelines for stroke rehabilitation: A systematic review.

OBJECTIVE: To identify healthcare professionals' perceived barriers and facilitators to clinical practice guideline implementation within stroke rehabilitation. DATA SOURCES: CINAHL, MEDLINE, EMBASE, AMED, Cochrane library, Academic Search Complete and Scopus. Additional papers were identified through hand searching. REVIEW METHODS: The review followed the Preferred Reporting Item for Systematic Reviews and Meta-Analysis Protocols systematic review approach. Any empirical research that provided qualitative data on healthcare professionals' perceived factors influencing clinical guideline implementation in stroke rehabilitation was included. One reviewer screened all titles and abstract reviews (n = 669). Another two reviewers independently screened 30% of title and abstract reviews, followed by full-text reviews (n = 61). Study quality was assessed using the mixed-method appraisal tool. RESULTS: Data from 10 qualitative, six quantitative and six mixed-method studies published between 2000 and 2022, involving 1576 participants in total, were analysed and synthesised using modified thematic synthesis approach. The majority of participants were therapists n = 1297 (occupational therapists, physiotherapists, speech and language therapists). Organisational factors (time constraints, resources) alongside healthcare professionals' lack of knowledge and skills were the most cited barriers to guideline implementation. Contradictory attitudes and beliefs towards stroke guidelines applicability to real-life clinical practice and their evidence base were reported. Organisational support in the form of training, local protocols, performance monitoring and leadership were reported as perceived facilitators. CONCLUSION: Barriers and facilitators are multifactorial and were identified at guideline, individual, team and organisational levels. There is a need to translate perceived barriers and facilitators into implementation interventions especially addressing organisational-level barriers.

Voice Related Coping in Professional Voice Users-A Systematic Review.

OBJECTIVES: This systematic review explored coping with voice problems in professional voice users. The objectives were to: 1) evaluate how voice-related coping is assessed in professional voice users 2) investigate how they cope with voice problems, and 3) identify factors associated with voice-related coping. DESIGN: Systematic review. METHODS: A systematic literature search of ten electronic databases using both EBSCOhost and OVID online platforms was conducted following the Preferred Reporting Items for Systematic Reviews (PRISMA) guidelines. Only peer-reviewed articles which assessed coping in the context of voice problems in professional voice users were included. Methodological quality was assessed using Johanna-Briggs Institute Critical Appraisal checklists. Data analysis was conducted using narrative synthesis. RESULTS: Following deduplication, abstract and full-text screening, seven articles were included in the review. All participants (n=2484) were teachers; no other professional voice users were covered. 98% of the cases studied were females. The tools used to assess voice-related coping were Utrecht Coping List (UCL) and Voice Disability Coping Questionnaire (VDCQ). Studies which used UCL reported a passive coping pattern in teachers with high vocal handicap whereas VDCQ showed increased use of social support. Factors associated with coping were not examined by any of the studies. CONCLUSION: Seeking social support was highlighted as a frequently used coping strategy across studies and measures. Teachers with high vocal handicap used a passive coping pattern and active coping styles were not significantly used. Current evidence does not sufficiently specify factors affecting coping in professional voice users. More research on voice-related coping involving all professional voice users is warranted to identify associated factors and further ascertain its influence on vocal health.

Acceptability and Impact of an Educational App (iCare) for Informal Carers Looking After People at Risk of Pressure Ulceration: Mixed Methods Pilot Study.

BACKGROUND: Pressure ulcers are areas of skin damage resulting from sustained pressure. Informal carers play a central role in preventing pressure ulcers among older and disabled people living at home. Studies highlight the paucity of pressure ulcer training for informal carers and suggest that pressure ulcer risk is linked to high levels of carer burden. OBJECTIVE: This pilot study evaluated a smartphone app with a specific focus on pressure ulcer prevention education for informal carers. The app was developed based on the principles of microlearning. The study aimed to explore carer perspectives on the acceptability of the app and determine whether the app increased knowledge and confidence in their caring role. METHODS: In this concurrent mixed methods study, participants completed quantitative questionnaires at baseline and at the end of weeks 2 and 6, which examined caregiving self-efficacy, preparedness for caregiving, caregiver strain, pressure ulcer knowledge, and app acceptability and usability. A subsample of participants participated in a "think aloud" interview in week 1 and semistructured interviews at the end of weeks 2 and 6. RESULTS: Of the 32 participants, 23 (72%) participants completed the week 2 and 16 (50%) completed the week 6 questionnaires; 66% (21/32) of carers participated in qualitative "think aloud" interviews, and 18 (56%) also participated in semistructured interviews at week 2, and 13 (41%) at week 6. Pressure ulcer knowledge scores significantly changed (F1,6.112=21.624; P=.001) from baseline (mean 37.5; SE 2.926) to the second follow-up (mean 59.72, SE 3.985). Regarding the qualitative data, the theme "I'm more careful now and would react to signs of redness" captured participants' reflections on the new knowledge they had acquired, the changes they had made to their caring routines, their increased vigilance for signs of skin damage, and their intentions toward the app going forward. There were no significant results pertaining to improved preparedness for caregiving or caregiving self-efficacy or related to the Caregiver Strain Index. Participants reported above average usability scores on a scale of 0 to 100 (mean 69.94, SD 18.108). The app functionality and information quality were also rated relatively high on a scale of 0 to 5 (mean 3.84, SD 0.704 and mean 4.13, SD 0.452, respectively). Overall, 2 themes pertaining to acceptability and usability were identified: "When you're not used to these things, they take time to get the hang of" and "It's not a fun app but it is informative." All participants (n=32, 100%) liked the microlearning approach. CONCLUSIONS: The iCare app offers a promising way to improve informal carers' pressure ulcer knowledge. However, to better support carers, the findings may reflect the need for future iterations of the app to use more interactive elements and the introduction of gamification and customization based on user preferences.

Blood transfusion in haematology: A qualitative exploration of patients' and healthcare professionals' perceptions.

OBJECTIVES: Repeated blood transfusions are indicated for the management of patients with cancer or blood disorders. Patients' perceptions about transfusions may be associated with decision-making and coping, which has been under-explored in the haematology context. This study therefore aimed to explore haematology transfusion patients' and HCPs' perceptions of blood transfusion, drawing on theory and previously identified themes of transfusion perceptions. DESIGN: Semi-structured interview study with 14 adult blood transfusion patients and 14 HCPs (consultants, registrars, nurses) at two UK haematology units. METHODS: Patient- and HCP-tailored topic guides were developed based on themes of blood transfusion perceptions identified in a systematic review: 'Health benefits', 'Safety/risk', 'Negative emotions', 'Alternatives' 'Decision making' and 'Necessity'. Transcripts were analysed using deductive and thematic analysis. Patient and HCP themes were compared using triangulation methods. Conceptual models (one for patients, one for HCPs) specific to haematology portraying the association between themes were developed. RESULTS: Findings for patients and HCPs converged with transfusion reported as beneficial for patients, who were largely involved in the decision-making. Both groups also reported concerns about transfusion, including iron-overload, allergic reactions and challenges to deliver transfusions in time-pressurized services. Themes in the conceptual models included patient 'Burden' of receiving repeated transfusions and 'Supportive relationships', reflective of patients' positive interactions with other patients and HCPs in the haematology unit. CONCLUSION: Despite the challenges for patients receiving repeated transfusions, convergent perceptions suggest a shared understanding of patients' transfusion experiences. Identified challenges could inform ways to improve transfusion services and patients' experiences.

The Effects of a Web-Based Tool for Parents of Children With Juvenile Idiopathic Arthritis: Randomized Controlled Trial.

BACKGROUND: Juvenile idiopathic arthritis (JIA) is a group of autoinflammatory diseases that cause pain and disability if not controlled by treatment. Parenting a child with JIA is stressful for parents, who express concerns about their child's treatment and may experience anxiety and powerlessness concerning their child's illness. Parenting stress is greater in parents of children with chronic illness than in those with healthy children and is related to poorer psychological adjustment in both parents and children. It is therefore important to develop interventions to support parents. This paper reports the evaluation of a web-based tool that provides information and practical skills to help increase parents' confidence in managing their child's illness and reduce parenting stress. OBJECTIVE: The aim of this study is to evaluate the benefits of a web-based tool (WebParC) for parents of children with recently diagnosed JIA. METHODS: A multicentered randomized controlled trial was conducted at pediatric rheumatology centers in England. We recruited parents of children aged ≤12 years who had been diagnosed with JIA within the previous 6 months. They were randomized to the intervention (WebParC access plus standard care) or the control (standard care alone) and followed up 4 months and 12 months after randomization. Where both parents participated, they were randomized by household to the same trial arm. The WebParC intervention consists of information about JIA and its treatment plus a toolkit, based on cognitive behavioral therapy, to help parents develop skills to manage JIA-related issues. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress. The secondary outcomes were parental mood, self-efficacy, coping, effectiveness of participation in their child's health care, satisfaction with health care, and child's health-related quality of life. RESULTS: A total of 203 households comprising 220 parents were randomized to the intervention (100/203, 49.3%) or control (103/203, 50.7%) arm. Follow-up assessments were completed by 65.5% (133/203) of the households at 4 months (intervention 60/100, 60%, and control 73/103, 70.9%) and 61.1% (124/203) of the households at 12 months (intervention 58/100, 58%, and control 66/103, 64.1%). A main effect of the trial arm was found on the Pediatric Inventory for Parents: the intervention participants reported less frequency (subscales communication F1,120627=5.37; P=.02, and role function F1,27203=5.40; P=.02) and difficulty (subscales communication F1,2237=7.43; P=.006, medical care F1,2907=4.04; P=.04, and role function F1,821=4.37, P=.04) regarding illness-related stressful events than the control participants. CONCLUSIONS: The WebParC website for parents of children with JIA reduced illness-related parenting stress. This web-based intervention offers a feasible preventive approach for parents of children with JIA and potentially could be adapted and evaluated for parents of children with other chronic illnesses. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 13159730; http://www.isrctn.com/ISRCTN13159730.

Investigating the feasibility of MePlusMe, an online intervention to support mental health, well-being, and study skills in higher education students.

INTRODUCTION: While there are several web-based mental health interventions, few target higher education (HE) students. Importantly, more research is needed to establish their effectiveness. Here, we provide a pragmatic evaluation of an online intervention (MePlusMe) specifically designed to improve the mental health, well-being, and study skills of HE students. METHODS: In accordance with the published protocol for a feasibility study, we recruited a convenience sample of 137 HE students to participate in an eight-week intervention, with 26 participants retained at week 8. Validated measures of mood (depression and anxiety), well-being, and self-efficacy were collected at baseline, 2, 4, and 8 weeks, alongside two feedback forms assessing design and functionality (baseline) and engagement (week 4 and 8). RESULTS: We observed significant reductions in levels of anxiety and depression as well as increases in well-being, but no changes in self-efficacy. Participants rated the system design and functionality positively and qualitative findings indicated high levels of satisfaction with MePlusMe. DISCUSSION: Findings support both the acceptability and the effectiveness of MePlusMe. Nonetheless, modest retention rates limit the precision and generalisability of these findings. Further investigation should ascertain optimal duration of engagement, most acceptable means of outcome assessment, and further detail about obstacles to utilisation.

A patient-initiated treatment model for blepharospasm and hemifacial spasm: a randomized controlled trial.

BACKGROUND: To test, in a two-arm, single center, superiority, randomized controlled trial, the effectiveness of and costs associated with a patient-initiated treatment model for people with hemifacial spasm (HFS) and blepharospasm (BEB) in comparison to usual care. METHODS: One hundred and thirty patients with HFS or BEB, aged 18 years or over, were recruited from a nurse-led botulinum toxin type A clinic at an eye hospital in the United Kingdom (UK), completed baseline measures and were randomized (1:1). The intervention group determined their own botulinum toxin type A (BoNT/A) treatment schedule during the trial period (9 months) and received an information leaflet with a "hotline" number to book an appointment. Usual care appointments were scheduled by treating clinicians. Data analysts were blind to study group. The primary outcomes were disease severity and functional disability, as measured by the Jankovic Rating Scale and Blepharospasm Disability Index, respectively. Secondary outcomes included quality of life, anxiety and depression, satisfaction with care, confidence in the service, economic costs and employment days lost. RESULTS: Sixty-five patients were randomized to each group. The intervention demonstrated no statistically significant difference to usual care for any of primary outcomes. On secondary outcomes the levels of anxiety differed significantly (F2, 142.39 = 1.65, p = 0.02), with the intervention arm exhibiting a decrease and the control arm an increase (Hedges' g = - 0.26 [99% CI -0.83, 0.32]). No other statistically significant differences were found for secondary outcomes. Overall healthcare costs and costs to the patient were on average £198.95 less (95% CI -£256.76, £654.67; p = 0.10) per participant for those in the intervention compared to usual care, although this finding was not significant. CONCLUSIONS: We did not observe differences between the patient-initiated treatment model and usual care for people with BEB or HFS, on any primary outcome measure, quality of life, or depression. The patient-initiated treatment model may, however, have the potential to save healthcare costs and reduce anxiety. Patients using this new model were also equally as satisfied in the service and confident in their care as those receiving treatment as usual. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT02577224 , 16th October 2015.

Is an individually tailored programme of intense leg resistance and dynamic exercise acceptable to adults with an acute lateral patellar dislocation? A feasibility study.

BACKGROUND: Lateral patellar dislocations mainly affect active teenagers and young adults. To help people recover, non-surgical exercise-based treatment is often recommended but the optimal exercise-based treatment is unknown. Currently, treatment outcomes after this injury are variable. Common problems include recurrent dislocation, reduced activity levels, and later surgery. A programme of intense leg resistance exercises, and dynamic exercises related to participants' activity-related goals, has rationale, but has not been previously reported. In line with the Medical Research Council guidance, this study aimed to assess the acceptability of a novel evidence-based exercise programme for adults after acute lateral patellar dislocation and the feasibility of future research evaluating this treatment. METHODS: A single-group prospective study was conducted at the John Radcliffe Hospital, Oxford, UK. Participants were 16 years or older with an acute first-time or recurrent lateral patellar dislocation. Participants received up to six face-to-face, one-to-one, physiotherapy sessions, over a maximum of 3 months, and performed intensive home exercises independently at least three times per week. Strategies to increase exercise adherence were used. Primary objectives were to determine the number of eligible patients, the recruitment rate (proportion of eligible patients that provided written informed consent), participant adherence to scheduled physiotherapy sessions and self-reported adherence to prescribed exercise, and intervention acceptability to participants measured by attrition and a study-specific questionnaire. Data were analysed using descriptive statistics. RESULTS: Fifteen of 22 (68%) patients with a lateral patellar dislocation were eligible. All eligible (100%) were recruited. Two of 15 (13%) participants provided no outcome data, 2/15 (13%) provided partial outcome data, and 11/15 (73%) provided all outcome data. Questionnaire responses demonstrated high intervention acceptability to participants. Participants attended 56/66 (85%) physiotherapy sessions and 10/11 (91%) participants reported they 'always' or 'often' completed the prescribed exercise. One participant redislocated their patella; another experienced knee pain or swelling lasting more than one week after home exercise on three occasions. CONCLUSION: The intervention appeared acceptable to adults after acute lateral patellar dislocation, and a future randomised pilot trial is feasible. This future pilot trial should estimate attrition with increased precision over a longer duration and assess participants' willingness to be randomised to different treatments across multiple centres. TRIAL REGISTRATION: ClinicalTrials.gov NCT03798483 , registered on January 10, 2019.

A study into the effect of Lactobacillus casei Shirota in preventing antibiotic associated diarrhoea including Clostridioides difficile infection in patients with spinal cord injuries: a multicentre randomised, double-blind, placebo-controlled trial.

BACKGROUND: Antibiotic Associated Diarrhoea (AAD) and Clostridioides Difficile Infection (CDI) are of major concern in spinal cord injury (SCI) rehabilitation. METHODS: A multi-centre, randomized, double-blind, placebo-controlled (the ECLISP) trial, was conducted in three tertiary spinal cord injury centre in the UK to assess the efficacy of consuming a probiotic beverage containing at least 6.5 × 109 live Lactobacillus casei Shirota (LcS) in preventing AAD and CDI and in patients with SCI and to determine whether proton pump inhibitors (PPI) and under nutrition-risk are risk factors for AAD/CDI. LcS or placebo was given once daily for the duration of an antibiotic course and continued for 7 days thereafter. Follow up was set at 7 and 30 days after the antibiotic course finished. The primary outcome was occurrence of AAD up to 30 days after finishing LcS/placebo. This trial is completed and registered (ISRCTN:13119162). FINDINGS: Between November 2014, and November 2019, 359 consenting adult SCI patients (median age: 53.3; range: 18-88 years), from 3 SCI centres responsible for providing approximate 45-50% of UK SCI service, with a requirement for antibiotics due to infection were randomly allocated to receive LcS (n = 181) or placebo (n = 178). Overall, no statistical difference was seen in occurrence of the primary outcomes of AAD at 30 days follow up (45% v 42.1%, RR: 1.071, 0.8-1.4, p = 0.639). In the secondary analyses LcS was associated with a lower risk of AAD at 7 (19% v 35.7%, RR: 0.53, 0.29-0.99, p = 0.040) and 30 days follow up (28% v 52.2%, RR: 0.54, 0.32-0.91, p = 0.015) in the participants who took PPI regularly. Under nutrition-risk was associated with an increased risk of AAD at 7 (RR: 1.76, 1.28-2.44) and 30 days follow up (RR: 1.69, 1.30-2.0). No intervention-related adverse events were reported during the study. INTERPRETATION: The present study indicates that LcS could not prevent AAD/CDI in unselected SCI patients. LcS might have the potential to prevent AAD in the higher risk group of patients on regular PPI. Confirmatory studies are needed to allow translation of this apparent therapeutic success into improved clinical outcomes. FUNDING: Yakult Honsha Co., Ltd.