Pilot and Feasibility Studies

ObjectivesTo investigate the effectiveness of adding a brief vocational advice intervention to usual care in reducing the number of days absent from work over a period of 6 months in adults given a fit note by their general practice. DesignMulticentre, pragmatic, two parallel-arm, randomised controlled trial with health economic analyses and nested qualitative study. A computer-generated stratified block randomisation (ratio 1:1) was used to allocate arms. SettingParticipants will be recruited from general practices in the UK. Participants720 adults consulting in general practice, for any health condition, and receiving a fit note who have been absent from work for more than two-weeks but less than six months. InterventionsParticipants in the intervention arm will be offered usual care and vocational advice delivered by a Vocational Support Worker (VSW) remotely via phone or videoconferencing. Participants in the control arm will be offered usual care. Main outcome measureNumber of days off work over 6 months. Follow-up data collection is via questionnaires at 6 weeks and 6 months. ConclusionsThis paper presents the rationale, design and methods of the Work And Vocational advicE (WAVE) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for patients with work absence. Trial registration: Clinical Trials: NCT04543097 Protocol number: Version 5.1

Background Trials in occupational populations, such as surgeons, face feasibility challenges due to high workload, restricted availability, and clinical heterogeneity, which may compromise recruitment, adherence, and retention. Objective To prespecify the feasibility framework and progression criteria for an internal pilot phase embedded within a pragmatic randomized controlled trial (RCT) comparing Mechanical Diagnosis and Therapy with generalized exercise in surgeons with chronic spinal pain. Design Protocol for a prespecified internal pilot phase embedded within a pragmatic, two-arm, parallel-group RCT. Methods The internal pilot will include the first four months of recruitment and aims to randomize at least 12 participants. Feasibility will be assessed across predefined domains, i.e., recruitment, eligibility, consent, intervention uptake, adherence, retention, data completeness, and treatment fidelity. Each domain is operationally defined and linked to prespecified progression criteria to ensure interpretability and decision-making utility. Criteria will be interpreted collectively to guide trial continuation. A minimal qualitative process evaluation will be embedded. Ethics and dissemination The host trial has received ethical approval (N-20240046) and is registered at ClinicalTrials.gov (NCT07293130). The findings from the internal pilot will be reported in a separate feasibility manuscript.

Introduction Chronic musculoskeletal pain (CMSKP) in adolescence is associated with physical, psychological, social, and academic impairment and increased risk for chronic pain in adulthood. Although physical activity interventions are an evidence-based approach for managing pediatric chronic pain, many adolescents with CMSKP avoid physical activity due to fear of increased pain, low confidence in physical functioning, and other pain-avoidance behaviors. Resilience-focused interventions targeting self-efficacy, motivation, and mental flexibility may improve engagement in valued activities despite pain. This study describes the design and protocol of the Pain REsilience Promotion for Youth (PREP-Y) intervention, a resilience-focused physical activity intervention for adolescents with CMSKP. Methods and analysis This single-site, pilot phase 2, single-group, non-randomized clinical trial will enroll 40 adolescents aged 12-17 years with CMSKP from Nationwide Childrens Hospital in Columbus, Ohio, USA. Participants complete questionnaires, objective physical functioning assessments, and physical activity monitoring using activPAL devices as baseline measures. Participants then complete 4 virtual resilience-focused intervention sessions targeting pain resilience, self-efficacy, motivation, and adaptive coping related to physical activity. Garmin watches are used to track activity during the intervention period. Follow-up assessments occur post-intervention and at 3 months post-intervention. Primary outcomes include feasibility and acceptability, assessed through recruitment, retention, attendance, intervention fidelity, and completion of study measures. Exploratory outcomes include physical activity, sedentary behavior, pain-related functioning, pain catastrophizing, kinesiophobia, self-efficacy, and resilience-related constructs. Ethics and dissemination The study was approved by the Nationwide Childrens Hospital Institutional Review Board. Findings will inform a future randomized clinical trial. This manuscript reflects protocol version 5.0 dated 23 March 2026. Trial registration ClinicalTrials.gov: NCT06923891.

ISO-101 is a novel wrist-worn device designed to deliver guided upper-limb isometric counter-manoeuvres via a retractable resistance tether with visual feedback. This proof-of-concept study evaluated feasibility, safety and preliminary efficacy in adults with orthostatic hypotension (OH). In a fixed-sequence, within-participant design, each participant completed three active-stand assessments: unassisted; device activation while supine immediately before standing; and device activation immediately after standing. The primary outcome was the proportion of responders, defined a priori as achieving, with device use versus the unassisted condition, [≥]10 mmHg improvement in any one of resting blood pressure, nadir standing blood pressure at 30- 60 s, or reduction in the orthostatic blood-pressure drop (systolic or diastolic). The study was powered to test the responder proportion against a 20% benchmark derived from standard non-pharmacological care. Seventeen participants were enrolled (mean age 72 years; 77% male) and fourteen completed all assessments. Six of fourteen (43%) met the responder definition, exceeding the benchmark (exact binomial p=0.012). When the device was used immediately after standing, responders showed mean (SD) increases of +22.13 (16.29) mmHg systolic and +19.52 (12.47) mmHg diastolic compared with the unassisted stand; pre-stand activation yielded smaller, non-significant changes. No adverse events occurred. Usability was high, with 88% rating the device easy to use and 69% indicating they would use it in daily life. ISO-101 produced clinically meaningful improvements in orthostatic blood pressure in a substantial subset of patients, supporting progression to larger, controlled evaluations. WHAT IS ALREADY KNOWNO_LIOrthostatic hypotension (OH) is common and clinically significant, yet counter-manoeuvres are often poorly implemented in practice. C_LIO_LIWearable assistance for standardised counter-manoeuvres has not previously been tested in OH. C_LI WHAT THIS STUDY ADDSO_LIIn this proof-of-concept study, ISO-101, a guided wrist-worn device, achieved a clinically meaningful and statistically significant responder rate, exceeding that typically observed with standard care. C_LIO_LIResponders demonstrated marked increases in postural blood pressure, the device was rated as highly usable, and no adverse events were reported. C_LI HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICYO_LIThese findings highlight the potential for wearable-assisted therapy in OH and support the need for further clinical evaluation. C_LI TRIAL REGISTRATION NUMBERClinicalTrials.gov: NCT06039410

IntroductionAssessing the fidelity of complex behavioural interventions and examining the contextual reasons why such interventions succeed, or fail are important activities but challenging and rarely reported. The Smoking Treatment Optimisation in Pharmacies (STOP) trial is a cluster randomised trial evaluating the effectiveness of a complex intervention to optimise the National Health Service (NHS) Stop Smoking Service delivered in community pharmacies. This complex intervention comprises a training package for pharmacy staff involving motivational interviewing and communication skills aimed at increasing smoking cessation knowledge and proactive client engagement. We report on a process evaluation which was planned alongside the trial to offer findings that will assist in the interpretation of the main trial results and help inform potential implementation in community pharmacy settings on a wider scale. Methods and analysisQuantitative data on recruitment and retention process of pharmacies, pharmacy staff and service users has been collected during the trial along with data on dose and fidelity of the intervention delivery from participating intervention arm pharmacies to identify potential implementation issues. Simulated client data on behaviour change skills and display of intervention materials from both control and intervention pharmacies is being assessed. These data will be combined with qualitative data; including adviser-smoker consultation recordings that provide a snapshot of behaviour skills delivery by stop smoking advisers and semi-structured interviews with pharmacy staff and services users from the intervention arm. DiscussionPublished protocols for process evaluations of complex health interventions are still rare despite increasing funding for this work to facilitate understanding of trial outcomes from an implementation perspective. This mixed methods protocol will contribute to the developing literature around the conduct of process evaluation and the value they add to health services research. Trial registration number ISRCTN16351033. Strengths and limitations of this studyO_LIA planned mixed methods process evaluation that draws together data from different sources to help explain the trial results and establish the feasibility of scaling this complex intervention up in community pharmacy settings. C_LIO_LIA strength is the use of a previously tested mystery shopping method to assess fidelity of skills performance at the pharmacy counter C_LIO_LIThe process evaluation relies on willing pharmacy staff and service users involved in the trial to collect some of the data, which may introduce bias. C_LIO_LIThis paper also provides a detailed example of how to use the MRC framework for process evaluation of complex interventions to design an extensive process evaluation within trial settings. C_LI

ObjectivesAcute gastroenteritis is a leading cause of pediatric emergency department (ED) visits. While ondansetron reduces vomiting, intravenous rehydration, and hospital admissions, its efficacy when initiated at triage remains unclear. We aimed to evaluate whether triage nurse-initiated administration of ondansetron in children with suspected gastroenteritis reduces the proportion of patients requiring observation following initial physician assessment. MethodsWe conducted a randomized, double-blind, placebo-controlled trial in a tertiary pediatric ED in Canada. Children aged 6 months to 17 years presenting with morae than 3 episodes of vomiting in the preceding 24 hours (including 1 within 2 hours of arrival), were eligible. At triage, we randomized participants to receive liquid ondansetron or a color- and taste-matched placebo. The primary outcome was the proportion of patients requiring observation after the first physician evaluation. Secondary outcomes included post-intervention vomiting, ED length of stay, patient comfort, and 48-hour return visits. The trial was registered at ClinicalTrials.gov (NCT03052361). ResultsRecruitment was stopped prematurely due to the COVID-19 pandemic. Ninety-one participants were randomized to ondansetron (n= 44) or placebo (n= 47). Overall, 40 patients (45%) were discharged immediately after the initial physician assessment, with no difference between the ondansetron and placebo groups (44% vs. 45%; absolute difference -1%, 95% CI: -20% to 19%). No significant differences were observed in all secondary outcomes. ConclusionIn this trial, triage nurse-initiated ondansetron administration did not reduce the need for ED observation in children with presumed gastroenteritis. While being underpowered, this study could inform researchers planning larger clinical trials.

Procedures carried out in acute care settings, such as emergency departments (EDs), are among the most common sources of acute pain experienced by children. Such procedures may include intravenous insertions (IVs), venipuncture, and wound irrigation and repair. Inadequately managed procedural pain can cause negative short-term and long-term implications for children, ranging from anxiety to aversion to healthcare. Parents have repeatedly expressed that they do not have the necessary tools to comfort or distract their child during uncomfortable medical procedures. As such, the purpose of this study was to work with parents to develop and evaluate two digital tools for pediatric procedural pain. A whiteboard animation video and interactive infographic were developed following a systematic review and interview with parents. Prototypes were tested in five ED waiting rooms in two Canadian provinces. Sites included those in urban, rural, and remote settings. Overall, parents rated the tools highly, suggesting that engaging with parents to develop arts-based digital tools is a highly effective method in ensuring that parents can understand and utilize complex health information. Author ContributionsThis study was conducted under the supervision of Drs. Shannon D. Scott (SDS) and Lisa Hartling (LH), PIs for translation Evidence in Child Health to enhance Outcomes (ECHO) Research and the Alberta Research Centre for Health Evidence (ARCHE), respectively. Both PIs designed the research study and obtained research funding through Translating Emergency Knowledge for Kids (TREKK) Networks of Centres of Excellence of Canada (NCE). SDS designed and supervised all aspects of tool development and evaluation. LH co-designed and supervised the qualitative study involving interviews with parents and systematic review of parent experiences and information needs. Tony An developed the infographic. Kassi Shave conducted and analyzed qualitative interviews with parents. Anne Le (AL) conducted usability testing. AL analyzed usability data. All authors contributed to the writing of this technical report and provided substantial feedback. This work was funded by: Networks of Centres of ExcellenceO_LIKlassen, T., Hartling, L., Jabbour, M., Johnson, D., & Scott, S.D. (2015). Translating emergency knowledge for kids (TREKK). Networks of Centres of Excellence of Canada Knowledge Mobilization Renewal ($1,200,000). January 2016 - December 2019. C_LI Women and Childrens Health Research Institute (WCHRI)O_LIScott, S.D & Hartling L. (2016). Translating Emergency Knowledge for Kids renewal. Women and Childrens Health Research Institute (matched dollars, $150,000). April 2016 - December 2019. C_LI This report should be cited asLe, A., Hartling, L., Scott, S.D. (2021). The development and usability testing of two arts-based knowledge translation tools for pediatric procedural pain. Technical Report. ECHO Research, University of Alberta. Available at: http://www.echokt.ca/research/technical-reports/

BackgroundFalls are the leading cause of injury-related mortality and hospitalization among adults aged [≥] 65 years. An important modifiable fall-risk factor is use of fall-risk increasing drugs (FRIDs). However, deprescribing is not always attempted or performed successfully. The ADFICE_IT trial evaluates the combined use of a clinical decision support system (CDSS) and a patient portal for optimizing the deprescribing of FRIDs in older fallers. The intervention aims to optimize and enhance shared decision making (SDM) and consequently prevent injurious falls and reduce healthcare-related costs. MethodsA multicenter, cluster-randomized controlled trial with process evaluation will be conducted among hospitals in the Netherlands. We aim to include 856 individuals aged [≥] 65 years that visit the falls clinic due to a fall. The intervention comprises the combined use of a CDSS and a patient portal. The CDSS provides guideline-based advice with regard to deprescribing and an individual fall-risk estimation, as calculated by an embedded prediction model. The patient portal provides educational information and a summary of the patients consultation. Hospitals in the control arm will provide care-as-usual. Fall-calendars will be used for measuring the time to first injurious fall (primary outcome) and secondary fall outcomes during one year. Other measurements will be conducted at baseline, 3, 6, and 12 months and include quality of life, cost-effectiveness, feasibility, and shared decision-making measures. Data will be analyzed according to the intention-to-treat principle. Difference in time to injurious fall between the intervention and control group will be analyzed using multilevel Cox regression. DiscussionThe findings of this study will add valuable insights about how digital health informatics tools that target physicians and older adults can optimize deprescribing and support SDM. We expect the CDSS and patient portal to aid in deprescribing of FRIDs, resulting in a reduction in falls and related injuries. Trial registrationClinicalTrials.gov NCT05449470 (7-7-2022) Participant recruitment7 July 2022-ongoing * * Results of this study have not yet been published or submitted to any journal. Protocol version1 Trial sponsorAmsterdam UMC, Meibergdreef 9, 1105 AZ Amsterdam

ObjectiveThe overall objective of our research is to determine in children with septic shock whether use of a fluid-sparing strategy results in improved clinical outcomes without an increased risk of adverse events compared to usual care. The specific objective of this pilot randomized controlled trial was to evaluate the feasibility of a definitive multicenter trial to answer our research question. DesignPragmatic, 2-arm, parallel group, open label, prospective pilot randomized controlled trial including a nested biosample-based translational study. SettingPediatric tertiary care centre PatientsChildren aged 29 days to <18 years of age presenting to the Emergency Department or admitted to an in-patient ward (including the PICU) with suspected or confirmed septic shock and a need for ongoing resuscitation. InterventionsFluid-sparing vs. usual care resuscitation strategy continued until shock reversal. The fluid-sparing intervention comprised instructions to restrict fluid bolus therapy in conjunction with early initiation and/or preferential use of vasoactive medication support as a strategy to spare fluid while targeting the hemodynamic goals specified in the American College of Critical Care Medicine Surviving Sepsis Guidelines. The usual care strategy did not limit use of fluid bolus therapy. Measurements and Main Results53 were randomized to usual care (n=27) or fluid-sparing (n=26). Fifty-one participants were available for primary outcome analysis. Primary feasibility outcomes related to participant enrolment and protocol adherence. Enrolment rate was 1.8 (51/29); 95% confidence interval [CI]: 1.3-2.3 participants/month. Study procedures were implemented in 49/51 (96.1%), 95% CI: 86.5-99.5% participants within 1 hour of randomization in a median (quartile range [IQR]) of 8 (5, 15) minutes. The protocol required use of an exception to consent process and consent for ongoing participation was 48/51 (94.1%), 95% CI: 83.8-98.8%. There were no serious adverse events. ConclusionsWe concluded the large multicenter SQUEEZE Trial feasible to conduct. Trial Registration: ClinicalTrials.gov [NCT01973907]

IntroductionCompared with the general population, people with serious mental illness (SMI) are 2-3 times more likely to develop type 2 diabetes, have poorer outcomes, and die 15 to 20 years younger, often as a result of long-term physical health conditions. Standard diabetes care does not meet the needs of people with SMI and they are frequently excluded from research, missing out on innovation. As diabetes care increasingly uses technology like continuous glucose monitoring (CGM) it is important to consider the views of people with SMI when new interventions are developed. This is a study protocol to identify candidate components of a structured CGM intervention for people with SMI, including the co-design of a logic model and programme theory. MethodsDrawing on experience-based co-design (EBCD) methods, we propose to collaborate with service-users, carers, and healthcare professionals to undertake early-phase development work for a novel intervention that maximises the potential of CGM to facilitate behaviour change. Fifteen participants will be recruited through existing cohorts and networks in England. The co-design will be informed by existing evidence and based on links between mechanisms of action and behaviour change techniques. Through a series of events (discovery sessions, co-design workshop, celebration event), we will identify candidate components for a prototype intervention ready for further development and testing. A logic model and programme theory will be developed and refined iteratively. DiscussionThe main output of this study will be a logic model and programme theory for a novel prototype intervention, ready for further testing following best practice intervention development, such as the Medical Research Council guidance for the development and evaluation of complex interventions. An intervention that makes CGM accessible for people with SMI has the potential to make a considerable contribution to reducing the profound health inequalities experienced by this population.

BackgroundA study of premature babies, less than 32 weeks gestation, found that the median number of medicines per patient at discharge was 2.5 (range 2 to 7), with 28% of babies discharged on more than 3 medicines (1). Medication administration to infants can cause anxiety and concern for parents/carers who worry about making mistakes. A systematic review of carers for all ages has estimated the administration error rate at home to be between 2 and 33% (2) while a rate of 66.3% was recorded in medication administered to premature infants where parents were responsible for administration (3). It has also been reported that up to 90% of carers will administer a medicine incorrectly at some point (2). The aim of this study is to work with healthcare professionals (HCPs) and parents/carers to co-design resources aimed at improving medication safety and reducing parental anxiety for those giving medications to neonates at home. MethodsWork Package 1: Project management and co-ordination phase: preparation of protocols and survey material and ethics approval applications. Work Package 2: Stakeholder engagement phase, e-surveys and focus groups: An electronic-survey (e-survey) will be developed by a multi-disciplinary study management group (SMG). This will be circulated to HCPs involved in the care of neonates and parents/carers whose babies had recently been discharged from hospital. A small number of parents/carers will be invited to take part in focus groups. Work Package 3: Co-design of resources and quantitative evaluation: Parents/carers willing to co-design educational and information resources to support safe administration of medicines to neonates following discharge will be recruited. A quantitative evaluation of the effect of the resource will be conducted with a new group of caregivers to measure specific outcome(s). DiscussionThis study aims to co-develop, with healthcare professionals (HCPs) and parents/carers, resources aimed at improving medication safety and reducing parental anxiety for those giving medications to neonates at home. Co-development of resources with HCPs and parents, ensures that the project outcomes are relevant and useful, leading to a reduction in parental anxiety. Trial registrationISRCTN registry Ref 17332620

BackgroundThe World Health Organisations Medication Without Harm campaign aims to reduce severe avoidable medication related harm by 50%. This systematic review explored the characteristics of interventions that provide visual and longitudinal feedback on prescribing, or interactive dashboards, in general practice and the effect of these interventions on prescribing-related outcome measures. MethodsThis systematic review was registered prospectively and reported in line with PRISMA guidelines. Multiple databases and grey literature were searched in November 2023 to identify interventional studies that explored the effect of interactive dashboards on prescribing-related outcomes in general practice. Two independent researchers conducted screening, data extraction, and risk of bias assessment. Interventions were described narratively, and a random-effects meta-analysis was performed for comparable studies. ResultsEight randomised controlled trials, one controlled before-and-after study and three interrupted time series were included. Six studies reported a significant positive effect on prescribing-related outcomes, with an effect seen more often for studies focusing on potentially inappropriate prescribing (PIP) (four out of six). Two of the six studies that focused on antibiotic prescribing demonstrated a significant effect. A meta-analysis of three RCTs involving 160 general practices and 198,135 patients demonstrated the overall odds of PIP was 0.91 (95%CI: 0.77-1.06 I2=71.8%) in the intervention compared to control group. ConclusionInteractive dashboards show promise for supporting safe and effective prescribing in general practice. Future research should focus on developing core outcome sets to facilitate future meta-analyses of effectiveness as well as optimising their implementation and understanding how to sustain user engagement. Lay summaryThe World Health Organizations "Medication Without Harm" campaign aims to reduce preventable medication-related harm by 50%. One way to support safe prescribing is by giving prescribers ongoing feedback on their prescribing habits using interactive dashboards. These dashboards provide visual and long-term data to help guide safer and more effective prescribing. This research looked at how interactive dashboards have been used in general practice and whether their use improves prescribing. Researchers systematically searched the published literature and identified 12 relevant studies. Some studies involved randomly assigning doctors or practices to either use the dashboards or continue usual care. Others compared prescribing practices before and after introducing dashboards or looked at practices that used dashboards compared to those that did not. Six of the studies showed improvements in prescribing, especially when focused on reducing high-risk prescriptions. The data for three studies that looked at high-risk prescribing involving 160 general practices and 198,135 patients showed that interactive dashboards may reduce the chance of unsafe prescribing by 8.8%. However, this result was not statistically significant, and the difference in results between studies means the true effect remains uncertain. The findings highlight the potential of interactive dashboards to support safer prescribing in general practice, though further research is needed.

Anaphylaxis, or anaphylactic reactions, are a severe allergic reaction with a rapid onset and can be fatal. Children are disproportionately at risk for hospitalization and emergency department visits due to anaphylaxis. A previously conducted mixed studies systematic review and qualitative descriptive study found that parents lacked confidence in recognizing and treating an anaphylactic reaction in their child, and were unsure of when to bring their child to the emergency department. This demonstrates that more effective knowledge translation (KT) tools are needed to satisfy parent information needs. The purpose of this research was to work with parents to develop and test the usability of an animated video and an interactive infographic about anaphylactic reactions in children. These tools merge the best available research evidence with narratives of parent experiences to respond to their information needs. Prototypes were evaluated by parents (video n=31; infographic n=30) through usability testing in an urban emergency department waiting room in Alberta. Parents viewed the tools on an iPad and answered questions via an electronic survey. The usability survey consisted of 9, 5-point Likert items, which assessed: 1) usefulness, 2) aesthetics, 3) length, 4) relevance, and 5) future use. Parents were also asked to provide their positive and negative opinions of the tool via two free text boxes. Overall, results were positive and the tools were highly rated across most usability items. Mean scores across usability items were 4.26 to 4.71 for the video and 3.83 to 4.43 for the infographic. The scores from the usability testing suggest arts-based digital tools are useful in sharing complex health information with parents about managing an anaphylactic reaction in their child and provide meaningful guidance on how to improve KT tools to better reflect the needs of parents.

Background Occupational exoskeletons are used to reduce physical workload and prevent work-related musculoskeletal disorders in physically demanding jobs. Although laboratory studies demonstrate reduced muscle load during simulated manual work tasks, evidence from long-term, real-world implementations remains very limited. The RELAX project aims to investigate the long-term effects of a passive back-support exoskeleton (BSE) during manual order-picking work in a Danish warehouse, focusing on health and socio-economic outcomes. Methods This 18-month controlled in-field intervention study compares outcomes at two warehouse departments: one where workers use a passive BSE and a control group where workers perform work tasks as usual. Approximately 90 full-time workers will be followed during the intervention period with questionnaires, interviews and company-registered performance indicators. Primary outcomes include perceived work intensity and musculoskeletal discomfort, while secondary outcomes include sickness absence, employee turnover, productivity and cost effectiveness. Furthermore, a process evaluation will be conducted based on questionnaires, focus-group interviews, and reported exoskeleton use. Quantitative effects will be analysed using difference-in-difference analysis with generalized linear mixed models to account for repeated measures over time. Employee turnover will be analysed using time-to-event analysis, and qualitative focus-group interviews will be analysed using reflexive thematic analysis to explore implementation processes and contextual factors. Cost-effectiveness and return on investment will be assessed by comparing the investment with potential savings in costs and resource use. Discussion By combining longitudinal quantitative outcomes with qualitative process evaluation, the study seeks to provide ecologically valid evidence on the effectiveness, feasibility and sustainability of occupational exoskeleton implementation. This approach will help clarify whether long-term exoskeleton use improves worker health without compromising productivity and may inform future workplace guidelines and large-scale adoption strategies.

BackgroundWheezing in the pre-school aged group (under 5 years) is a common presentation and significant healthcare burden. It is a heterogenous presentation representing a spectrum of phenotypes and although the causes may be multifactorial, viral infection is the most common trigger, with rhinovirus and Respiratory Syncytial Virus (RSV) being the most commonly detected. Rigorous evidence-based guidance for the acute management of preschool wheeze (PW) with respect to which children likely to benefit from oral corticosteroid therapy (OCS), is lacking. RCTs of OCS use in PW have not adequately assessed the impact of respiratory virus testing in the management of PW. To address the hypothesis that OCS response may be determined by the specific virus, the feasibility of performing POC respiratory virus tests prior to randomisation in an acute paediatric ED setting needs to be ascertained. MethodsThe PRECISE Study will be a single centre, randomised, open-label, feasibility trial. Children aged 24-59 months with acute wheeze will be eligible if the clinician is uncertain if there is a role for oral corticosteroid therapy or not. At enrolment, participants will undergo a nasal swab for rapid respiratory virus testing. Children will be randomised in a 1:1 ratio to receive oral dexamethasone or not, based on their RSV result. Participants will continue to be managed by the clinician according to local guidance. They will be invited for clinical review at 72 hours where a repeat nasal swab may be performed. There will be a telephone follow up at one month and parents will be invited for extended telephone interviews within a further month. Comprehensive screening logs will address the primary outcome of recruitment and timeliness until enrolment. Remaining timeliness and adherence outcomes will be recorded in individual participant records and described using CONSORT diagrams. Acceptability will be measured using a mixed method qualitative approach based on the theory of acceptability framework. DiscussionThis pragmatically designed trial will address key feasibility points needed to inform a future, definitive multi-centre RCT prospectively testing the role of respiratory virus testing to randomise children with PW to receive oral corticosteroids or not. Trial registrationNCT06580600 (clinicaltrials.gov)

Childhood obesity levels continue to rise, with significant impact on individuals and the NHS. The Complications of Excess Weight (CEW) clinics provide support to young people with complications of their weight. Our objective was to co-develop, with young people, a new intervention; AIM2Change, to enable young people to develop their intrinsic motivation to manage weight, using Acceptance and Commitment Therapy (ACT), with a person-centred approach. Young people from the Care of Childhood Obesity (CoCO) clinic in Bristol, UK, were recruited to co-develop this intervention. The study was registered on ISRCTN (ISRCTN16607863). The seven-session, ACT-based intervention was delivered one-to-one, securely online. Qualitative interviews were conducted after each intervention session was delivered. Qualitative data were coded and reviewed regularly to make iterative changes to individual sessions and the overall programme. Fourteen co-developers were recruited, of whom nine completed the co-development process (female=4; median age (IQR)=15(1.5); 4 with a parent; Indices of Multiple Deprivation (IMD) median = 3.5, range=1-10). Iterative changes made during co-development included introducing an earlier focus on eating behaviour and body image, with more practical activities to increase engagement. Thematic analysis of co-developer feedback identified four themes: theoretical understanding; delivery and receipt of therapy; view of strategies and engagement; real world benefits of co-development process. Framework analysis was conducted to map data pertaining to these themes into matrices according to each participant and session. Insights from the co-development process have shaped AIM2Change to optimise the interventions value, relevance and acceptability. Findings suggest that AIM2Change meets an unmet need in delivery of current childhood weight management services.

Introduction Diabetes distress describes the psychological and emotional burden of living with diabetes and is associated with reduced self-management and adverse diabetes outcomes. Clinical guidelines recommend routine assessment and management of diabetes distress, but this is not always implemented. Therefore, there is a need to develop approaches to deliver emotional health support in routine clinical care more effectively. We describe here the protocol for a study to I) assess the feasibility of implementation of the D-stress Pathway, comprising Enhanced Usual Care (EUC) and an online, group-based, psychological diabetes distress reduction intervention called REDUCE, ii) evaluate the feasibility of the study protocol iii) detect an effect signal of diabetes distress score and Interstitial Glucose Time in Range and iv) refine initial programme theories of how both interventions (EUC and REDUCE) work, for whom, and under what circumstances. Methods This feasibility study includes a multicentre trial within a cohort design (TWICs) where sites have a staggered exposure to the interventions alongside a realist process evaluation. Four UK NHS diabetes services will recruit 80 adults with type 1 diabetes ([&ge;]1 year) using continuous glucose monitoring (CGM) ([&ge;]3 months). All participants will receive EUC and provide monthly data over 7 months on diabetes distress (measured by the Type 1 Diabetes Distress Assessment System (T1DDAS) and interstitial glucose measured by using continuous glucose monitoring. Participants with elevated diabetes distress, will be offered the six-week, group-based, online REDUCE intervention plus EUC, compared to EUC alone. Up to twenty participants with type 1 diabetes, ten family members/friends, sixteen healthcare professionals delivering EUC and five REDUCE facilitators will be interviewed to explore their experience of receiving training and delivering the D-stress Pathway. Up to 20 EUC consultations and REDUCE sessions will be observed. Analysis Feasibility will be assessed against pre-specified progression criteria and analysed descriptively using summary statistics. Primary outcomes include baseline level of diabetes distress, recruitment rate, intervention uptake, and data completeness, which will be analysed descriptively. Qualitative data will be analysed using framework analysis guided by realist programme theories developed for this study. Ethics Ethics approval has been granted by NHS Research Ethics Committee (REC) (Bromley REC: 25/LO/0469) and Health Research Authority obtained. All participants will provide informed consent. Trial registration no: Registered at ClinicalTrials.gov number NCT07193446 on 26/11/2025. Protocol and statistical analysis plan: The trial protocol and statistical analysis plan can be accessed at ClinicalTrials.gov.

BackgroundDiabetic foot ulcers (DFUs) are a leading cause of limb loss globally, and DFU-related amputation rates are increasing in the United States. Multidisciplinary care improves DFU healing and prevents amputations. This strategy encompasses 4 key pillars: optimizing glycemic control, managing wounds, treating vascular disease, and addressing infections. However, the implementation of these pillars is fraught with fragmented and delayed care impeding effective wound healing and leading to amputations. Patient navigation improves chronic disease outcomes, including diabetes, but have not been tested for DFU care. Methods/DesignThe Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav) is a multicomponent patient navigator program tailored to address individual and structural obstacles to would healing. Adults hospitalized with a DFU (n=270) will be randomized 1:1 to receive the CARE-D-Foot-Nav intervention or usual care. The primary outcome is complete DFU healing at 20-weeks post-hospital discharge adjudicated by independent reviewers blinded to treatment assignment. Secondary outcomes include patient-reported measures and economic outcomes. DiscussionCARE-D-Foot-Nav is the first randomized controlled trial to evaluate patient navigation for DFU care. If the patient navigator program improves outcomes, it could transform care delivery for people with DFUs and reduce preventable limb loss. Trial registrationClinicalTrials.gov NCT07223268

Pediatric functional constipation (FC) is a common childhood problem that involves difficult or painful defecation and can be caused by a variety of different factors. In children, FC is often unrecognized and poorly treated, and has potential to cause abdominal pain, appetite suppression, loss of control over defecation, and family disruption. A recent interpretive description qualitative study found that parents who care for children with FC often experience a myriad of negative sentiments, including isolation and self-doubt. Furthermore, parents often have unanswered questions about the condition, particularly regarding the cause, symptoms, and treatment options. As such, more effective knowledge translation (KT) tools are needed to satisfy parental information needs. The purpose of this research was to collaborate with parents to develop and test the usability of two animated KT tools (video and interactive infographic) on FC in children. Prototypes were co-developed with parents, and then evaluated by parents through usability testing in a large Alberta emergency department waiting room. Usability was assessed based on nine items with responses on a five-point Likert scale from 1=strongly disagree to 5=strongly agree. Overall, results were positive and the tools were highly rated across most usability items. Mean scores across usability items were 4.20 to 4.59 for the video and 3.73 to 4.30 for the infographic. The scores from the usability testing suggest arts-based digital tools are useful in sharing complex health information with parents about FC and provide meaningful guidance on how to improve KT tools to better reflect the needs of parents of children with FC.

IntroductionLifestyle behavior modification interventions, delivered using telehealth, have been shown to be effective in reducing weight. However, limited data exists on the benefits of lifestyle behavior change delivered using telehealth and web-based applications on blood pressure (BP). MethodsWe conducted a 2-site randomized controlled trial in the Geisinger Health System (January 2019 to March 2021) to compare the efficacy of a self-guided vs. a dietitian telehealth approach using web-based applications in 187 participants with 24-hour systolic BP 120-160 mmHg and body mass index [&ge;] 25 kg/m2. Both arms received recommendations to improve diet based on a web-based food frequency questionnaire, and access to an online weight management program. The telehealth arm received weekly telephone calls with a dietitian who used motivational interviewing. The primary outcome was 12-week change in 24-hour systolic BP. Secondary outcomes included changes in sleep/awake systolic BP and diastolic BP, self-reported physical activity, healthy eating index (HEI)-2015 score, and weight. ResultsA total of 187 participants (mean age 54.6 [SD 13.2] years, 52% female, 23% on BP medications, mean body mass index 34.5 [6.5] kg/m2, mean HEI-2015 score 60.8 [11.1] units) were randomized with 156 (83.4%) completing the trial. Mean 24-hour systolic BP improved from baseline to 12 weeks similarly in the dietitian (-6.73 mmHg, 95% CI: -8.64, -4.82) and the self-directed arm (-4.92, 95% CI: -7.01, -2.77; p comparing groups=0.2). The dietitian telehealth arm had greater 12-week improvements in sleep systolic BP (mean -6.92 vs. -1.45; p=0.004), sleep diastolic BP (-3.31 vs. 0.73; p=0.001), and self-reported physical activity (866 vs. -243 metabolic equivalent of task minutes/week; p=0.01). The dietitian telehealth arm also tended to have greater 12-week improvements in weight loss (-5.11 vs. -3.89 kg; p=0.1) and HEI-2015 score (9.23 vs. 6.43 units; p=0.09), though these differences were not statistically significant. ConclusionsDietitian-led telehealth supported by web-based applications resulted in a similar reduction in 24-hour systolic BP as a self-directed approach, with secondary improvements in sleep BP and physical activity. Trial registration numberClinicalTrials.gov Identifier NCT03700710