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Background During the COVID‐19 pandemic, the first UK lockdown (March to May 2020) witnessed a dramatic reduction in children presenting to primary/emergency care, creating concern that fear of the virus was resulting in children presenting late. Methods An online survey was co‐developed with UK parents to understand the impact of the lockdown on parents' help‐seeking for, and care of, their sick/injured child(ren). The survey was advertised through social media and snowballing to parents whose children had been ill/injured during the lockdown. Analysis used descriptive statistics, SPSSv25 and thematic analysis. Results The survey was fully completed by 198 UK parents. The majority asked for help (144/198): from their family doctor (78), national helplines (48) or an Emergency Department (23). Most reported that their decision‐making had not changed, although how they sought help had changed. A few parents reported that the severity and duration of illness had increased because of uncertainty about and/or difficulty accessing services. Parents did not always report seeking help for symptoms rated red or amber by the Royal College of Paediatrics and Child Health. Parents reported accessing information through the internet or using information that they already had. Parent Contribution This was a collaboration with parents from survey development to dissemination, with two parents being integral members of our research team. Conclusions Our questionnaire was completed by parents who were not deterred from seeking help for their sick or injured children. Even for these parents, the lockdown changes to services created uncertainty about, and barriers to, accessing medical help for their children.

ObjectivesTo establish the feasibility of a definitive randomised controlled trial of Systemic Autism-related Family Enabling (SAFE), an intervention for families of children with autism.DesignA randomised, controlled, multicentred feasibility study.SettingParticipants were identified from three National Health Service (NHS) diagnosing centres in Plymouth and Cornwall and a community pathway.Participants34 families of a child with a diagnosis of autism severity level 1 or 2 between 3 and 16 years. Four families were lost to follow-up.InterventionsSAFE is a manualised five-session family therapy-based intervention delivered over 16 weeks and designed for families of children with autism. SAFE involves families attending five 3-hour sessions led by systemic practitioners.Primary and secondary outcome measuresThe proposed primary outcome measure was the Systemic CORE 15 (SCORE-15). Proposed secondary outcome measures: Patient Health Questionnaire-Somatic Anxiety Depressive Symptoms, the Coding of Attachment-Related Parenting for use with children with Autism, the Child Behaviour Checklist (CBCL), the Reflective Functioning Questionnaire (RFQ) and the Caregiving Helplessness Questionnaire. Outcome measures were collected at baseline and 24 weeks post randomisation.ResultsAll primary caregivers retained in the study completed the SCORE-15 at both time points. 34 of the target of 36 families were recruited and 88% of families were retained. Training for therapists was effective. Feedback revealed willingness to undergo randomisation. There was 100% attendance at appropriate sessions for core family members. The SCORE-15 showed reduction in scores for families receiving SAFE compared with controls suggesting positive change. Qualitative data also revealed that families found the study acceptable and families receiving SAFE experienced positive change. Feedback indicated that the SCORE-15 should be retained as a primary measure in a future trial, but secondary measures should be reduced.ConclusionsThis study indicates that a larger trial of SAFE is feasible. Findings suggest that SAFE can address current gaps in recommended care, can be confidently delivered by NHS staff and has potential as a beneficial treatment.Trial registration numbersISCTRN83964946 and IRAS213527.

Background Hepatic steatosis (HS) increases morbidity and mortality associated with liver surgery (LS). Furthermore, patients with HS are more likely to require a blood transfusion, which is associated with worse short and long-term outcomes. Patients with HS requiring LS receive no specific dietary treatment or advice. A very low-calorie diet (VLCD) is commonly used before gallbladder and bariatric surgery to reduce liver volumes and associated intraoperative morbidity. These diets typically provide 800–1200 kcal/day over a 2–4-week period. Limited evidence suggests that a VLCD in patients with LS may result in better outcomes. Methods This study aims to test the feasibility of delivering a multi-centre randomised clinical trial to compare a dietary intervention (VLCD plus motivational instructions) versus treatment as usual (TAU) in people with HS having LS. This study will provide high-quality data to estimate screening rates, recruitment, randomisation, retention, and intervention adherence. The study will also determine the definitive trial’s most clinically relevant primary outcome. The study will also estimate resource use and costs associated with the delivery of the intervention. Seventy-two adults ≥ 18 who are scheduled to undergo elective LS and have a magnetic resonance imaging (MRI) identified HS will be recruited. Acceptability to the dietary intervention will be evaluated with food diaries and focus groups. Clinical and patient-reported outcomes will be collected at baseline, pre- and post-surgery, day of discharge, plus 30- and 90-day follow-up. Discussion This feasibility study will provide data on the acceptability and feasibility of a dietary intervention for patients with HS having LS. The intervention has been developed based on scientific evidence from other clinical areas and patient experience; therefore, it is safe for this patient group. Patients with experience of LS and VLCDs have advised throughout the development of the study protocol. The findings will inform the design of a future definitive study. Trial registration ISRCTN Number 19701345. Date registered: 20/03/2023. URL: https://www.isrctn.com/ISRCTN19701345 .

ObjectiveTo assess the impact of the COVID-19 lockdown on parents’ health-seeking behaviour and care for a sick or injured child in the Netherlands.Design and settingAn online survey on parents’ experiences with a sick or injured child during the COVID-19 lockdown periods was disseminated through social media.ParticipantsParents living in the Netherlands with a sick or injured child during the lockdown periods from March to June 2020 and from December 2020 to February 2021 were eligible to participate.Outcome measuresDescriptive statistics and thematic analysis were used to analyse family and children’s characteristics, parents’ response to a sick or injured child, and the perceived impact of the lockdown on child’s severity of illness and treatment reported by parents. Analyses were stratified for children with and without chronic conditions.ResultsOf the 105 parents who completed the survey, 83% reported they would have sought medical help before lockdown compared with 88% who did seek help during lockdown for the same specific medical problem. Parents reported that changes in health services affected their child’s severity of illness (31%) and their treatment (39%), especially for children with chronic conditions. These changes included less availability of healthcare services and long waiting lists, which mostly led to worsening of the child’s illness. During lockdown, there was no change in health-seeking behaviour by parents of children with a chronic condition (N=51) compared with parents of children without a chronic condition.ConclusionParents in the Netherlands who completed the survey were not deterred from seeking medical help for their sick or injured child during the COVID-19 lockdown periods. However, changes in health services affected child’s severity of illness and treatment, especially for children with chronic conditions.

Background Postpartum pelvic girdle pain (PGP), experienced by approximately 10% of women, is typically refractory to conservative management. Customised dynamic elastomeric fabric orthoses (DEFOs) are one novel option to address this. We assessed the feasibility and acceptability of a randomised controlled trial comparing a DEFO plus standardised advice/exercises (intervention) versus standardised advice/exercise alone (control). Methods A multicentre randomised controlled feasibility trial with embedded qualitative study and economic evaluation. Participants were randomised to either intervention or control group. All received two remote physiotherapy sessions via videoconferencing separated by 14 days. Primary feasibility outcomes were related to the feasibility and acceptability of methods and interventions, recruitment, intervention fidelity, outcome measure performance and completion. The proposed primary outcome measure for the definitive trial was the Numerical Pain Rating Scale (NPRS) which assessed pain intensity fortnightly over 24 weeks. Secondary outcome measures assessed kinesiophobia, continence, function, health-related quality of life, depression and health/care resource use at baseline, 12 and 24 weeks. Adverse events were recorded. Pre-defined progression criteria were set to decide whether, and how, to proceed with a future definitive trial: (1) Target sample size (60 from 3 centres over a 7-month recruitment period), (2) outcome measure completion (> 60% at 24 weeks), (3) orthosis wear-time compliance (> 70% for 6 h/day) as measured by the Orthotimer, and (4) evidence suggesting efficacy. Results Of 180 participants sent information sheets, 40 were screened and 24 randomised. At 24 weeks, 95% completed NPRS and 89–95% the secondary outcome measures. Wear-time adherence appeared below the set target of 42 h per week. Outcomes were broadly comparable between groups. Recruitment was insufficient to estimate a signal of efficacy with confidence. Two intervention participants experienced Candida infections, considered possibly due to the DEFO. Conclusions Trial procedures and interventions were acceptable to participants. Technical Orthotimer issues are resolvable through modification of recording parameters. Recruitment of participants was a major challenge. Work to understand how best to engage women in this research is needed before moving to a definitive trial. Trial registration ISCRTN, ISRCTN67232113. Registered 08/05/2021, https://www.isrctn.com/ISRCTN67232113 . Key messages • What uncertainties existed regarding the feasibility? ➣ There is uncertainty regarding the feasibility of recruiting participants at a rate conducive to a definitive trial. • What are the key feasibility findings? ➣ Twenty-four participants were recruited over 7 months. Retention and complete NPRS data were available for analysis at final follow-up for 18 participants (75%). ➣ Overall, the trial procedures and interventions were perceived as acceptable by participants and clinicians. ➣ Overall recruitment was insufficient to estimate a signal of efficacy with confidence. ➣ Technical issues with the Orthotimer significantly impacted on adherence data collection. ➣ Progression criteria indicate that progression to a definitive trial in its current format is not recommended. • What are the implications of the feasibility findings for the design of the main study? ➣ Further research is required to best understand how to recruit women to a future study. ➣ A hybrid approach to intervention delivery may be preferable. ➣ Orthotimer reading intervals for capturing orthosis wear-time adherence require careful consideration. ➣ An internal pilot within a future definitive multicentre randomised controlled trial would add value.

IntroductionSmoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods.Methods and analysisA pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months.Ethics and disseminationApproved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers.Trial registration numberISRCTN47776579; Pre-results.

Long COVID (LC) affects around two million people in the UK and over 65 million people globally. Antiviral medications have shown positive effects in reducing the risk of progression to severe disease in high-risk patients during an acute SARS-CoV-2 infection and have improved outcomes in those living with LC. Research testing the feasibility and efficacy of antiviral medications is ongoing, and clinical trials should determine the use of Remdesivir and its impact on LC symptoms, patient-reported outcomes, quality of life and functional status. Seventy-two patients ≥ 18 years of age who have a confirmed LC diagnosis will be recruited across two sites to trial Remdesivir treatment delivered via intravenous infusion over 5 days. This feasibility study will provide high-quality data to estimate screening rates, recruitment through different pathways, retention and treatment adherence. The study will also determine the definitive trial's most clinically relevant primary outcome. After a detailed screening process, patient-reported and clinical outcome measures (including EQ-5D-5L, Symptom Burden Questionnaire™ for LC (SBQ™), cardiopulmonary exercise tests (CPET), lung function, biomarkers and inflammatory profiles) will be collected to determine symptoms and impact of their condition, which will be repeated post-treatment. A subset of 20 participants will undergo whole-body parametric Fluorodeoxyglucose (FDG) PET/CT to measure multi-organ metabolic activity. Due to the established physical, cognitive and clinical impairment impacts of LC, patient involvement has been extensively embedded within the design and implementation of all study processes to increase patient safety and delivery. This study will provide data on the feasibility of a trial of 5-day intravenous treatment with Remdesivir for patients with LC. The treatment is already effective in the treatment of patients with acute severe cases of SARS-CoV-2. Remdesivir has an established safety profile and carries no higher risk to patients than standard medical care. The findings will inform the design of a future definitive study. ISRCTN Number: 72940450. Date registered: 07/06/2024. URL: https://www.isrctn.com/ISRCTN72940450. gov Number: NCT05911906.