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ObjectiveDiabetic foot ulcers (DFUs) present a significant global health challenge, resulting in high morbidity and economic costs. Current available treatments often fail to achieve satisfactory healing rates, highlighting the need for novel therapies. This study evaluated the safety and efficacy of a novel autologous whole blood clot (AWBC)-a blood-based, biodegradable provisional matrix-in conjunction with standard of care (SoC) when compared to SoC alone in the treatment of hard-to-heal DFUs.MethodA multicentre, prospective, blinded assessor, randomised controlled trial was conducted at 16 sites across the US, South Africa and Turkey. A cohort of patients with hard-to-heal DFUs was enrolled and randomised to either the AWBC group or the control group. The primary endpoint was complete wound closure at 12 weeks, while secondary endpoints included time to heal and percentage area reduction (PAR) at four and eight weeks. Data were analysed using both intention-to-treat (ITT) and per-protocol (PP) populations.ResultsThe cohort included 119 patients. AWBC treatment resulted in a significantly higher healing rate compared to the control in both ITT (41% versus 15%, respectively; p=0.002) and PP populations (51% versus 18%, respectively; p=0.0075). AWBC treatment also resulted in a shorter mean time to heal and higher durability of wound closure. Safety analysis showed a similar incidence of adverse events (AEs) between groups, with no device-related AEs.ConclusionThe AWBC system, by modulating the wound microenvironment and providing a functional extracellular matrix, offered a promising new approach to treating hard-to-heal DFUs, demonstrating superior healing outcomes compared to SoC alone in this study.

Summary The study aims to test the efficacy of a family‐centred healthy lifestyle program in primary care health centres among children with overweight or obesity, evaluating the results at 3, 6, and 9 months post‐intervention. A single‐blind, randomised controlled cluster study where participants will be blinded to group assignment to reduce bias will be followed. The intervention comprises a 6‐month program with intensive and maintenance behavioural therapies, including dietary modifications and guidelines for physical activity, administered by a multidisciplinary team. Participants will be assigned to an intervention group or a treatment‐as‐usual control group. Primary health centres in Seeb Wilayat, serving densely populated areas and willing to participate, will be included. Randomisation will be conducted at the cluster level to improve recruitment efficiency. A sample size calculation will ensure adequate power to detect significant differences. Ethical approval is granted and informed consent/assent will be obtained from all participants. The proposed study focusses on testing the efficacy of a family‐centred healthy lifestyle program in primary care centres through a controlled, randomised study. Successful outcomes could lead to informed interventions, improvements in the health system, policy recommendations, positive community impacts, information on behavioural therapies, and improved long‐term health outcomes for affected children and their families. This study will contribute to the literature by providing a culturally sensitive and evidence‐based solution to a pressing public health issue, which can be adapted to similar contexts in Oman and beyond. [ABSTRACT FROM AUTHOR]

Objectives: Despite growing interest, the cost-effectiveness of eHealth interventions for supporting quality of life of people with dementia and their caregivers remains unclear. This study evaluated the cost-effectiveness of the FindMyApps intervention, compared to digital care-as-usual. FindMyApps aims to help people with dementia and their caregivers find and learn to use tablet apps that may support social participation and self-management of people with dementia and sense of competence of caregivers. Method: A randomised controlled trial (Netherlands Trial Register NL8157) was conducted, including people with mild cognitive impairment (MCI) or mild dementia and their informal caregivers (FindMyApps n = 76, digital care-as-usual n = 74). Outcomes for people with MCI/dementia were Quality-Adjusted Life-Years (QALYs), calculated from EQ-5D-5L data and the Dutch tariff for utility scores, social participation (Maastricht Social Participation Profile) and quality of life (Adult Social Care Outcomes Toolkit), and for caregivers, QALYs and sense of competence (Short Sense of Competence Questionnaire). Societal costs were calculated using data collected with the RUD-lite instrument and the Dutch costing guideline. Multiple imputation was employed to fill in missing cost and effect data. Bootstrapped multilevel models were used to estimate incremental total societal costs and incremental effects between groups which were then used to calculate Incremental Cost-Effectiveness Ratios (ICERs). Cost-effectiveness acceptability curves were estimated. Results: In the FindMyApps group, caregiver SSCQ scores were significantly higher compared to care-as-usual, n = 150, mean difference = 0.75, 95% CI [0.14, 1.38]. Other outcomes did not significantly differ between groups. Total societal costs for people with dementia were not significantly different, n = 150, mean difference = €-774, 95%CI [–2.643,.,079]. Total societal costs for caregivers were significantly lower in the FindMyApps group compared to care-as-usual, n = 150, mean difference = € −392, 95% CI [−1.254, −26], largely due to lower supportive care costs, mean difference = €−252, 95% CI [−1.009, 42]. For all outcomes, the probability that FindMyApps was cost-effective at a willingness-to-pay threshold of €0 per point of improvement was 0.72 for people with dementia and 0.93 for caregivers. Conclusion: FindMyApps is a cost-effective intervention for supporting caregivers' sense of competence. Further implementation of FindMyApps is warranted. [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials (RCTs) are considered the gold standard for generating clinical evidence. The focus on high internal validity in RCTs challenges the external validity and generalisability of findings, potentially hindering their application in routine care. In neurorehabilitation, limited literature addresses conducting RCTs feasibly and efficiently. We investigated barriers and facilitators to conducting RCTs within routine care of neurorehabilitation centres from the perspective of stakeholders in neurorehabilitation in Germany and Austria. Methods: We conducted semi-structured interviews with stakeholders in neurorehabilitation from four centres in Germany and Austria, informed by the Theoretical Domains Framework (TDF) and the Capability, Opportunity, Motivation and Behaviour model (COM-B). Employing a hybrid approach, the interview analysis integrated both deductive, theory-driven analysis based on the TDF domains and COM-B model and inductive, reflexive thematic analysis. Results: Twelve stakeholders (4 physicians, 4 therapy managers, 4 therapists; 5 females, 7 males; with research experience spanning 0–40 years) were interviewed. Key barriers to conducting RCTs in neurological rehabilitation centres include limited financial, human, and time resources, high clinical workloads, and a lack of interest of some therapists. Ineffective leadership, perceived lack of research expertise, and communication issues were also significant barriers. Social influence factors such as lack of employer support and inadequate training access further contributed to the challenges. Additionally, barriers included insufficient research infrastructure, limited space, internal power struggles, and rigid cost bearer specifications. Key facilitators included physicians' and therapists' motivation to advance the field, contribute to knowledge, and to prioritise patient health. Support from supervisors, joint decision-making, and efficient organisation were crucial facilitators. Flexible therapy planning, mutual support, and interdisciplinary collaboration also played important roles. Conclusion: Our results suggest that increasing professional development and understanding, along with providing adequate financial, human, time, and spatial resources to support research endeavours, implementing effective communication strategies to enhance interdisciplinary collaboration and coordination among team members may contribute to increased motivation and facilitate RCTs within the setting of neurorehabilitation centres. Trial registration: This study was prospectively registered with the German Clinical Trials Register (08.04.2021 DRKSID DRKS00024982). [ABSTRACT FROM AUTHOR]

Background: Chronic diseases are a significant and growing problem of our time. They impair the ability to work and increase the risk of early retirement. To support the return to work, rehabilitation services can be applied for in Germany. Currently, the application system for rehabilitation allows only a limited degree of individualisation of the treatment and is associated with a lack of multidisciplinary communication. To facilitate rehabilitation care planning, we developed a complex intervention. A digital, platform-based case management approach (intervention) will ensure multidisciplinary communication and the tailored selection of medical treatments and/or non-medical support measures. The overall objective is to assess the effectiveness of the intervention compared to treatment as usual (control condition). The German Federal Ministry of Labour and Social Affairs (BMAS) funds the RehaPro-SERVE study (grant number: 661R0053K1). Methods: This is the protocol for an investigator-initiated, pragmatic, multicentre, randomised and controlled two-arm parallel-group superiority trial with embedded qualitative process evaluation. The study will be conducted in Hesse state, Germany. N = 59 primary care physicians will be recruited and tasked with the recruitment of six eligible patients each. Eligibility criteria: age 40–60; minimum of 4-week work disability due to musculoskeletal, oncologic or psychological conditions or the post-COVID-19 syndrome within the last 6 months; at high risk for early retirement. In total, n = 352 patients will be randomised with a 1:1 allocation to intervention or control group and stratified by primary care practice using permuted blocks. The primary outcome is the number of days of sick leave during a 12-month period after the assumed completion of treatments (t1 to t2). Secondary outcomes include the number of days of sick leave (self-report), work ability, and health-related quality of life, as well as data from the qualitative process evaluation. Discussion: The results of the study will inform the design of future care services and provide valuable information on multidisciplinary case management in the context of rehabilitation care planning. The results of the qualitative process evaluation will further contribute to the understanding of facilitating and hindering factors. Trial registration: DRKS-German Clinical Trials Register, DRKS0 00242 07. Registered on 22 March 2021. [ABSTRACT FROM AUTHOR]

AbstractPurposeMaterials and methodsResults\nIMPLICATIONS FOR REHABILITATIONCognitive functional therapy (CFT) is an individualised person-centred biopsychosocial intervention that demonstrated large and sustained clinically important improvements in people with chronic, disabling low back pain (LBP) in the RESTORE randomised controlled trial. This study aimed to explore physiotherapists’ experiences of delivering CFT in the RESTORE trial.Cross-sectional qualitative design using reflexive thematic analysis with interviews of 15 treating physiotherapists (3–25 years experience) across Perth and Sydney.The overarching theme was “Driving on P(probationary)-plates.” The probationary driver analogy encompassed feelings of being newly competent, gaining experience, and refining competencies. Four themes were developed: “Sharing the journey of transformational change,” “Refining new competencies,” “Navigating patient complexity,” and “Balancing patient care with trial-related processes.” Physiotherapists described the life-changing improvements and re-engagement with valued activities of their patients under the theme of “Sharing the journey of transformational change.” “Refining new competencies” described the continued enhancement of physiotherapists’ new competencies towards an individualised and collaborative approach.The experiences of physiotherapists trained to deliver individualised, person-centred biopsychosocial care within an RCT can be likened to being a probationary driver. Experiential learning, ongoing support, and opportunities to navigate challenges with complex patients were important aspects of the journey towards mastery.Physiotherapists have traditionally reported challenges addressing psychosocial barriers in people with chronic low back pain.People with disabling CLBP should be offered high-value person-centred biopsychosocial interventions, such as CFT, with a therapist who shares the journey with them.Ongoing peer and mentor support is a valuable extension to high-quality competency based training for physiotherapists delivering expanded scope biopsychosocial treatments like CFT.When treating patients with complex presentations, physiotherapists and their patients may benefit from integrated interdisciplinary input (e.g., from physicians, psychologists, and social workers).Physiotherapists have traditionally reported challenges addressing psychosocial barriers in people with chronic low back pain.People with disabling CLBP should be offered high-value person-centred biopsychosocial interventions, such as CFT, with a therapist who shares the journey with them.Ongoing peer and mentor support is a valuable extension to high-quality competency based training for physiotherapists delivering expanded scope biopsychosocial treatments like CFT.When treating patients with complex presentations, physiotherapists and their patients may benefit from integrated interdisciplinary input (e.g., from physicians, psychologists, and social workers). [ABSTRACT FROM AUTHOR]

Background: Chronic kidney disease (CKD) prevalence is steadily increasing, in part due to increased multimorbidity in our aging global population. When progression to kidney failure cannot be avoided, people need unbiased information to inform decisions about whether to start dialysis, if or when indicated, or continue with holistic person-centred care without dialysis (conservative kidney management). Comparisons suggest that while there may be some survival benefit from dialysis over conservative kidney management, in people aged 80 years and over, or with multiple health problems or frailty, this may be at the expense of quality of life, hospitalisations, symptom burden and preferred place of death. Prepare for Kidney Care aims to compare preparation for a renal dialysis pathway with preparation for a conservative kidney management pathway, in relation to quantity and quality of life in multimorbid, frail, older people with advanced CKD. Methods: This is a two-arm, superiority, parallel group, non-blinded, individual-level, multi-centre, pragmatic trial, set in United Kingdom National Health Service (NHS) kidney units. Patients with advanced CKD (estimated glomerular filtration rate < 15 mL/min/1.73 m2, not due to acute kidney injury) who are (a) 80 years of age and over regardless of frailty or multimorbidity, or (b) 65–79 years of age if they are frail or multimorbid, are randomised 1:1 to 'prepare for responsive management', a protocolised form of conservative kidney management, or 'prepare for renal dialysis'. An integrated QuinteT Recruitment Intervention is included. The primary outcome is mean total number of quality-adjusted life years during an average follow-up of 3 years. The primary analysis is a modified intention-to-treat including all participants contributing at least one quality of life measurement. Secondary outcomes include survival, patient-reported outcomes, physical functioning, relative/carer reported outcomes and qualitative assessments of treatment arm acceptability. Cost-effectiveness is estimated from (i) NHS and personal social services and (ii) societal perspectives. Discussion: This randomised study is designed to provide high-quality evidence for frail, multimorbid, older patients with advanced CKD choosing between preparing for dialysis or conservative kidney management, and healthcare professionals and policy makers planning the related services. Trial registration: ISRCTN, ISRCTN17133653 (https://doi.org/10.1186/ISRCTN17133653). Registered 31 May 2017. [ABSTRACT FROM AUTHOR]

Objectives:Methods:Results:Discussion:In experimental models, the prenatal diet influences gut microbiota composition in mothers and offspring; however, it is unclear whether this occurs in humans. We investigated the effects of a gut-focused perinatal dietary intervention on maternal and infant gut microbiota composition four weeks after birth.This randomised controlled trial randomised pregnant women to receive dietary advice as part of standard care, or additionally receive a dietary intervention focused on the Australian Dietary Guidelines and increasing prebiotic and probiotic/fermented food intakes (ACTRN12616000936426). Study assessments occurred from gestation week 26 (baseline) to four weeks postpartum (follow-up). Faecal samples, collected at baseline for mothers, and follow-up for mothers and infants, underwent 16SrRNA sequencing. The primary outcome was a between-group mean difference in infant faecal Shannon index. Secondary outcomes included between-group differences in other microbiota measures, including maternal change from baseline CLR-transformed Prevotella abundance.Forty-four women and 45 infants completed the study. The mean Shannon index of infants in the intervention group was −0.35 (95% CI: −0.64, −0.06, SD: 0.52) units lower than control group infants, corresponding to a medium effect size (Cohen’s D: −0.74, 95% CI: −1.34, −0.13). The findings were similar using other metrics of α-diversity. There were no between-group differences in β-diversity, nor any differentially abundant taxa in infants. The intervention increased abundances of the genus Prevotella in mothers compared to controls.This gut-focused perinatal dietary intervention was associated with differences in the maternal and infant gut microbiota composition. Larger studies are required to replicate and extend these findings. [ABSTRACT FROM AUTHOR]

Background: Suicide has become a first-order public health concern, especially following the negative impact of COVID-19 on the mental health of the general population. Few studies have analysed the effects of early psychotherapeutic interventions on subjects who have attempted suicide, and even fewer have focused on those hospitalized in non-psychiatric units after a Medically Serious Suicide Attempt (MSSA). The main aim of this study is to describe the protocol designed to evaluate the effectiveness of individual psychological treatment for patients hospitalized after an MSSA. The secondary objectives of the study are: (1) to evaluate the impact on quality of life and other psychosocial variables of patients with a recent MSSA who receive early psychological intervention; (2) to analyse the biological, psychological, and clinical impact of early psychotherapeutic treatment on subjects hospitalized after an MSSA. Methods: A longitudinal randomised controlled trial will be conducted with patients over 16 years of age admitted to two general hospitals. The case intervention group will enrol for 8-sessions of individual psychotherapy, Suicide Attempts Multi-component Intervention Treatment (SAMIT), combining Dialectical Behaviour Therapy (DBT), Mentalization-Based Therapy (MBT), and Narrative approaches, while the control group will receive a treatment-as-usual intervention (TAU). Longitudinal assessment will be conducted at baseline (before treatment), post-treatment, and 3, 6, and 12 months after. The main outcome variable will be re-attempting suicide during follow-up. Discussion: Some psychotherapeutic interventions, usually implemented in outpatient, have proven to be effective in preventing suicidal behaviours. The combination of some of these may be a powerful treatment for preventing future SA in patients hospitalised after an MSSA, which is the most severely suicidal subgroup. Moreover, assessment of the biological, clinical and psychometric impact of this new intervention on patients during the first year after the attempt may help understand some of the multi-level factors associated with the effectiveness of psychotherapeutic interventions in MSSAs. The prevalence of high suicide rates requires the design of effective psychological interventions for their prevention, and also in order to design new pharmacological and psychological treatments. Trial registration: ClinicalTrials.gov ID: NCT06238414. Date of registration: 1st February 2024, final update is protocol version 3.0, 19th March 2024. [ABSTRACT FROM AUTHOR]

Background: This paper reports the results from a feasibility trial of an early parent-delivered social communication intervention for young children with Down syndrome ('ASCEND'). The intervention focuses on developing children's early social communication skills, in particular responding to shared attention. The aim was to inform the feasibility of running a full-scale trial through National Health Service (NHS) Speech and Language Therapy (SaLT) services, to assess whether the intervention is effective in improving language skills before children with Down syndrome start school. Methods: This was a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site, comparing the intervention plus standard NHS SaLT provision with standard NHS SaLT alone. We recruited 20 children with Down syndrome aged between 11 and 36 months through 3 NHS SaLT services, 19 of whom were randomised (10 — intervention group, 9 —control group). Pre- and post-intervention and 6-month follow-up assessments included language, social communication skills, adaptive behaviour, quality of life (parents and children), parental anxiety and depression. The intervention was parent delivered with parents having access to SaLT services and the research team during the intervention. Data were collected on recruitment and retention, standard care, treatment fidelity, acceptability of the intervention by the parents and speech and language therapists, feasibility of collecting health economic measures and suitability of the primary outcome measure. Results: The sample was sufficient for a feasibility study. The intervention (manual, support, materials) was positively received by the participating parents. Speech and language therapists also evaluated the acceptability of the intervention positively. Treatment fidelity which was measured by completion of weekly parent diaries and two adherence phone call was acceptable as 100% of the parent diaries were returned, over 90% of the parental diaries were completed correctly and 100% of adherence phone calls were completed. Retention was acceptable at 84% overall. The preliminary health economic data suggest that this intervention will be low cost. The sample size calculation suggests that 290 participants would need to be recruited, with 228 having a complete data set, for a full RCT. Conclusion: Based on recruitment, retention and treatment fidelity, as well as the acceptability of the intervention to parents and speech and language therapists, a full-scale trial would be feasible in order to assess the effectiveness of the intervention. Trial registration: ISRCTN13902755, registered on 25th August 2020, http://www.isrctn.com/ISRCTN13902755 [ABSTRACT FROM AUTHOR]

Background: Loneliness is common among older adults in institutional settings. It leads to adverse effects on health and wellbeing, for which nature contact with peers in turn may have positive impact. However, the effects of nature engagement among older adults have not been studied in randomised controlled trials (RCT). The "Friends in Nature" (FIN) group intervention RCT for lonely older adults in Helsinki assisted living facilities (ALFs) aims to explore the effects of peer-related nature experiences on loneliness and health-related quality of life (HRQoL). In this study we aim describe the participants' baseline characteristics of the RCT, feasibility of FIN intervention and intervention participants' feedback on the FIN. Methods: Lonely participants were recruited from 22 ALFs in Helsinki area, Finland, and randomised into two groups: 1) nature-based social intervention once a week for nine weeks (n = 162) and 2) usual care (n = 157). Demographics, diagnoses and medication use were retrieved from medical records, and baseline cognition, functioning, HRQoL, loneliness and psychological wellbeing were assessed. Primary trial outcomes will be participants' loneliness (De Jong Giervald Loneliness Scale) and HRQoL (15D). Results: The mean age of participants was 83 years, 73% were female and mean Minimental State Examination of 21 points. The participants were living with multiple co-morbidities and/or disabilities. The intervention and control groups were comparable at baseline. The adherence with intervention was moderate, with a mean attendance of 6.8 out of the nine sessions. Of the participants, 14% refused, fell ill or were deceased, and therefore, participated three sessions or less. General subjective alleviation of loneliness was achieved in 57% of the intervention participants. Of the respondents, 96% would have recommended a respective group intervention to other older adults. Intervention participants appreciated their nature excursions and experiences. Conclusions: We have successfully randomised 319 lonely residents in assisted living facilities into a trial about the effects of nature experiences in a group-format. The feedback from participants was favourable. The trial will provide important information about possibilities of alleviating loneliness with peer-related nature-based experiences in frail residents. Trial registration: ClinicalTrials.gov, ID: NCT05507684. Registration 19/08/2022. [ABSTRACT FROM AUTHOR]

Objective This study investigated the effectiveness of supramaximal high-intensity interval training (supramaximal HIT) on muscle capacities and physical function compared to moderate-intensity training (MIT) for older adults. Methods Sixty-eight older adults (66–79 years, 56% women), not engaged in regular exercise, were randomised to 3 months of twice-weekly supramaximal HIT (20 minutes including 10 × 6-second intervals) or MIT (40 minutes including 3 × 8-minute intervals). Both groups performed the training on stationary bicycles in a group setting. Target intensity was watt-controlled, with standardised cadence and individualised resistance. Outcomes analysed with linear-mixed models included leg power (Nottingham Power Rig), hand grip strength (Jamar dynamometer), static and dynamic balance (One leg stance, 30-second step test), chair stand (30-second chair stand), and anaerobic cycling performance (modified Borg Cycle Strength Test). Results Baseline values were (supramaximal HIT/MIT, mean ± SD) leg power 198 ± 60/189 ± 53 W, hand grip strength 4.2 ± 1.0/4.3 ± 1.1 N/kg, static balance 64 ± 41/62 ± 41 s, dynamic balance 39 ± 7/38 ± 5 steps, chair stands 22 ± 6/22 ± 6 and anaerobic cycling performance 224 ± 60/217 ± 55 W. At 3-month follow-up, a between-group difference in favour of supramaximal HIT [95% CI] was observed in anaerobic cycling performance of 19[3;35] W. Within-group mean changes for supramaximal HIT/MIT were for leg power 8.4[0.9;15.8]/6.0[−1.3;13.3] W, hand grip strength 0.14[0.00;0.27]/0.13[−0.01;0.26] N/kg, static balance 11[3;20]/10[1;18] s, dynamic balance 1.6[0.3;2.8]/2.3[1.1;3.6] steps, 2.1[1.1;3.1]/1.4[0.4;2.3] chair stands and anaerobic cycling performance 31.3[19.6;43.0]/12.0[0.4;23.5] W. Conclusion Supramaximal HIT showed superior effect on anaerobic cycling performance when compared to MIT. Additionally, the results indicate that supramaximal HIT is comparably beneficial as MIT in terms of effects on muscle capacity and physical function for older adults. [ABSTRACT FROM AUTHOR]

Objective: To assess the added value of caregiver-mediated exercises combined with telerehabilitation in addition to usual care compared to usual care alone on the self-reported mobility outcome after subacute stroke. Design: Multicentre, observer-blinded, parallel randomised controlled trial. An off-site researcher allocated treatments using minimisation. Setting: Four rehabilitation centres in the Netherlands. Participants: Forty-one patient–caregiver dyads within 3 months poststroke. Intervention: Eight-week blended care program with caregiver-mediated mobility exercises for 2.5 h per week supported by telerehabilitation and four face-to-face sessions in addition to usual care. Main measures: Self-reported mobility domain of the Stroke Impact Scale postintervention. Secondary outcomes were functional outcome, dyads' psychosocial wellbeing, care transition to the community postintervention and after 6 months. Results: Forty-one dyads (21 intervention, 20 control) were randomised, and 37 (N = 18; N = 19) were analysed following intention-to-treat. The Stroke Impact Scale mobility was not significantly different between groups postintervention (B 0.8, 95% CI –6.8–8.5, p = 0.826). The secondary outcomes, namely, (a) caregivers' quality of life postintervention (p = 0.013), (b) caregivers' symptoms of depression postintervention (p = 0.025), and (c) independence in leisurely activities at 6 months (p = 0.024), showed significant benefits in favour of caregiver-mediated exercises with telerehabilitation. A significant difference favouring controls was found in self-reported muscle strength at 6 months (p = 0.002). Conclusions: Caregiver-mediated exercises combined with telerehabilitation yielded no differential effect on our primary outcome self-reported mobility. Although the trial is underpowered, current findings are in line with previous trials. Future studies should further explore beneficial effects of caregiver involvement in stroke rehabilitation targeting psychosocial wellbeing. [ABSTRACT FROM AUTHOR]

Introduction: Affecting up to 67% of stroke patients, PSCI is a complication that predicts poor quality of life, decreased independence, and substantial economic burden. PSCI remains a major post-stroke complication with limited therapeutic options. Based on current understanding of PSCI's pathogenesis, Trigona honey makes an attractive therapeutic option, as it can act on numerous neuropathological substrates implicated in PSCI's pathogenesis via the action of multiple polyphenols. Materials and methods: The study was conducted following a unicentral, randomised, concurrent active treatment controlled, superiority trial with two parallel groups model. The interventional group included participants who were administered supplemental honey in addition to standard treatment regiments, while those in the control group solely continued the standard therapeutic protocol. Two honey sachets were administered for daily oral consumption for three months, with a total daily dose of 20 g. Demographic and clinical characteristics questionnaire, MoCA, and NIHSS were used to for data collection. Data collected was analysed using SPSS. Results: Difference in mean MoCA score gain between the two groups after three months was statistically significant (p<0.05), with the interventional group having greater gain by 3 points. No statistically significant relationship between demographic characteristics, clinical factors, stroke parameters, and the 3-month progression of PSCI was detected. The only exception was improved cognitive function in current smokers in the interventional group. Conclusion: Trigona honey supplements could be effective in halting progression of PSCI, and smoking can affect 3-month progression of PSCI. No association was detected between stroke severity, TOAST and OCSP classifications, and 3-month progression of PSCI. [ABSTRACT FROM AUTHOR]

Background: The ComEx3 community‐based extended maintenance pulmonary rehabilitation (PR) randomised controlled trial (RCT) aimed to determine the optimal strategy for maintaining the benefits of exercise for people with chronic obstructive pulmonary disease (COPD). We conducted a process evaluation of this RCT to determine if the trial was implemented per protocol, and to explore the barriers and facilitators of the trial, and mechanisms of impact. Methods: This was a mixed methods study consisting of analysis of PR class records, study diaries and interviews of those involved in the trial. We developed a reporting framework from available literature and performed a content analysis. Results: Eleven of the 12 participants in the intervention group attended ≥70% of available classes before the trial was terminated due to the COVID‐19 pandemic. Analysis of the study diaries found that adherence to the home exercise program was higher in the intervention than the control group. Analyses of interviews (n = 21) highlighted the complexity of standardising the processes across multiple sites, but revealed behaviour change amongst class physiotherapists who were able to conform with the required processes. Facilitators of participation included the desire to improve function and quality of life, while barriers included illnesses and lack of motivation. Mechanisms of impact included confidence in exercising and benefits from the education sessions. Conclusions: The ComEx3 RCT was implemented as planned largely due to commitment by the research team and the desire by patients to improve their quality of life by attending a PR program that they are familiar with. Successful implementation of PR RCTs requires good organisational skills, clear and consistent trial documentation, broad understanding of participant needs while being conscious of challenges experienced by people with COPD, and dedication by everyone involved in the RCT. So What?: This article shows the importance of running a process evaluation alongside an RCT. Although this RCT did not progress to completion, this process evaluation which was guided by a robust framework, will provide guidance for future interventions in this area. [ABSTRACT FROM AUTHOR]

Background: Tobacco smoking rates are higher in rural, regional, and remote (RRR) areas in Australia, and strategies to improve access to quit supports are required. This pilot study examined the feasibility of a smoking cessation intervention for people in RRR areas who smoke with the intention of using this data to design a powered effectiveness trial. Methods: A randomised controlled trial (RCT) of the feasibility of a 12‐week 'Outback Quit Pack' intervention consisting of mailout combination nicotine replacement therapy (NRT) and a proactive referral to Quitline, compared with a minimal support control (1‐page smoking cessation support information mailout) was conducted between January and October 2021. Participants recruited via mailed invitation or Facebook advertising, were adults who smoked tobacco (≥10 cigarettes/day) and resided in RRR areas of New South Wales, Australia. Participants completed baseline and 12‐week follow‐up telephone surveys. Outcomes were feasibility of trial procedures (recruitment method; retention; biochemical verification) and acceptability of intervention (engagement with Quitline; uptake and use of NRT). Results: Facebook advertising accounted for 97% of participant expressions of interest in the study (N = 100). Retention was similarly high among intervention (39/51) and control (36/49) participants. The intervention was highly acceptable: 80% of the intervention group had ≥1 completed call with Quitline, whilst Quitline made 3.7 outbound calls/participant (mean 14:05 mins duration). Most of the intervention group requested NRT refills (78%). No differences between groups in self‐reported cessation outcomes. Biochemical verification using expired air breath testing was not feasible in this study. Conclusion: The Outback Quit Pack intervention was feasible and acceptable. Alternative methods for remote biochemical verification need further study. So What?: A powered RCT to test the effectiveness of the intervention to improve access to evidence‐based smoking cessation support to people residing in RRR areas is warranted. [ABSTRACT FROM AUTHOR]

Summary: Insomnia is an emerging risk factor for the onset of mild cognitive impairment (MCI) and its progression to dementia. Impaired cognition and neuropsychiatric symptoms create challenges for persons with MCI to participate actively in non‐pharmacological interventions. This study examined the feasibility and preliminary effects of empowerment‐based cognitive‐behavioural therapy for insomnia (CBT‐I) on sleep, cognitive function, and health‐related quality of life (HRQoL) in persons with MCI and sleep problems. Sixty participants were randomly allocated to the intervention or control group to receive empowerment‐based CBT‐I or usual care, respectively. The 12 week intervention comprised all core CBT‐I techniques delivered through a group and individualised face‐to‐face approach. An empowerment approach with interactive teaching methods, goal setting, and action planning was used to deliver the intervention. Outcome measures included subjective and objective sleep quality and pattern, and a battery of neuropsychological tests and the 12‐item Short Form Survey were administered 3 months (T1) and 6 months post‐randomisation (T2). This intervention is feasible and highly acceptable for persons with MCI. The intervention group showed significant improvements in subjective and objective sleep‐related outcomes compared with the control group. Moreover, the intervention group showed greater improvements in global cognition, processing speed, attention, and mental flexibility than the control group at T1 and/or T2. No significant between‐group differences were observed in memory or HRQoL scores. The qualitative data converged with the quantitative data. In conclusion, empowerment‐based CBT‐I was well received by persons with MCI and had potential positive effects on improving sleep and cognition in this cohort. [ABSTRACT FROM AUTHOR]

Purpose: Agriculture and food production contribute to climate change. There is mounting pressure to transition to diets with less environmental impact while maintaining nutritional adequacy. MyPlanetDiet aimed to reduce diet-related greenhouse gas emissions (GHGE) in a safe, nutritionally adequate, and acceptable manner. This paper describes the trial protocol, development, and testing of personalised nutrition feedback in the MyPlanetDiet randomised controlled trial (RCT). Methods: MyPlanetDiet was a 12-week RCT that provided standardised personalised nutrition feedback to participants based on new sustainable healthy eating guidelines (intervention) or existing healthy eating guidelines (control) using decision trees and corresponding feedback messages. To test the personalised nutrition feedback, we modelled a sample of 20 of the MyPlanetDiet participants baseline diets. Diets were modelled to adhere to control and intervention decision trees and feedback messages. Modelled nutrient intakes and environmental metrics were compared using repeated measure one-way analysis of covariance. Results: Intervention diets had significantly lower (p < 0.001) diet-related GHGE per 2500 kilocalories (kcal) (4.7 kg CO2-eq) relative to control (6.6 kg CO2-eq) and baseline (7.1 kg CO2-eq). Modelled control and intervention diets had higher mean daily intakes of macronutrients (carbohydrates, fibre, and protein) and micronutrients (calcium, iron, zinc, and iodine). Modelled control and intervention diets had lower percent energy from fat and saturated fat relative to baseline. Conclusions: Adherence to the MyPlanetDiet personalised nutrition feedback would be expected to lead to better nutrient intakes and reduced diet-related GHGE. The MyPlanetDiet RCT will test the effectiveness and safety of personalised feedback for a more sustainable diet. Trial registration number and date of registration: Clinical trials registration number: NCT05253547, 23 February 2022 [ABSTRACT FROM AUTHOR]

Background and Aims: Potentially harmful polypharmacy is a growing public health concern. This article aims to evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) framework. Methods: We recruited patients at metropolitan hospitals for a randomised controlled trial with 12 months of follow‐up. The intervention included a comprehensive medicines history, multidisciplinary meeting and medicines review prior to discharge, with engagement with the participants' general practitioner extending after discharge. The primary outcome was the change in the number of regular medicines used at 12 months from baseline. A cost consequence was performed to estimate costs per participant during the study period. Results: There were 98 participants enrolled in the study. The number of regular medicines was significantly reduced from baseline in both groups (−1.7 ± 4.3, t = 2.38, P = 0.02 in the control group vs −2.7 ± 3.6, t = 4.48, P = 0.0001 in the intervention group), although there was no statistical difference detected between the two groups (1.0 (SE 0.9), t = 1.03, P = 0.31). The intervention was estimated to cost AU$644.17 and was associated with cost savings of AU$552.53 per participant in sustained reduced medicines cost. Health outcomes and healthcare costs were similar in both groups. Discussion: Medicines were significantly reduced in both groups, with a trend to a larger reduction in medicines at 12 months in the intervention group. The intervention cost was approximately offset by sustained reduced medicines cost, although these results should be regarded cautiously because of the absence of significance in the differences in outcomes between groups. [ABSTRACT FROM AUTHOR]

Background: Tackling poor mental health in university students has been identified as a priority in higher education. However, there are few evidence-based prevention initiatives designed for students. Repetitive Negative Thought (RNT, e.g. worry, rumination) is elevated in university students and is a well-established vulnerability factor for anxiety and depression. Furthermore, there are now evidence-based cognitive-behavioural interventions to tackle RNT. A mobile self-help cognitive-behavioural app targeting RNT, adapted for students may therefore be an effective, scalable, and acceptable way to improve prevention in students. Methods: An online single blind, two-arm parallel-group Randomised Controlled Trial (RCT) to examine the incidence of major depression and symptoms of anxiety and depression across 12 months in university students aged over 16 who screen into the study with self-reported high levels of worry and/or rumination and no current diagnosis of major depression. Eligible participants will be randomised to the active intervention arm (usual practice plus using a self-guided mobile app targeting RNT) or to the control arm (usual practice). In total, 648 participants aged over 16, with no current major depression, bipolar disorder or psychosis will be recruited from UK universities. Assessments will take place at baseline (pre-randomisation), 3 months and 12 months post- randomisation. Primary endpoint and outcome is incidence of major depression as determined by self-reported diagnostic criteria at 12-month follow-up. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and academic outcomes are secondary outcomes. Compliance, adverse events, and potentially mediating variables will be carefully monitored. Discussion: The trial aims to provide a better understanding of the causal role of tackling RNT (worry, rumination) using a self-help mobile app with respect to preventing depression in university students. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective mobile-health public health strategies for preventing common mental health problems. Trial registration: https://www.isrctn.com/ISRCTN86795807 Date of registration: 27 October 2022 [ABSTRACT FROM AUTHOR]

The science of pilot trials is evolving, and understanding of their role in medical research is increasing. Perioperative randomised controlled trials often test interventions that are inherently multidisciplinary and complex; therefore, there might be compelling reasons to conduct pilot studies to assess feasibility and inform trial design. As pilot studies themselves require resources, investigators should not squander this opportunity; they should design them so that they properly address the sources of uncertainty regarding the success of the definitive trial. [ABSTRACT FROM AUTHOR]

Prolonged sitting is associated with an increased risk of musculoskeletal pain, especially in nightshift workers. However, research investigating effects of breaking up sitting on musculoskeletal pain during nightshifts is lacking. This study evaluated effects of prolonged sitting or breaking up sitting with short bouts of light-intensity physical activity on pain in healthy adults during simulated nightshifts. An in-laboratory randomised controlled trial was undertaken with 52 healthy adults completing five simulated nightshifts. Participants were randomised to prolonged sitting (Sit9; n = 26) or breaking up prolonged sitting (Break9; n = 26). Break9 group completed 3-min walking every 30 min during nightshifts, while Sit9 group remained seated. Musculoskeletal pain intensity and sensory/affective pain experiences were assessed. Linear mixed models examined pain within nights (pre-to post-shift) and across nights (pre-shift-night-1 to pre-shift-night-5). Musculoskeletal pain intensity increased within nights for both Sit9 (mean change [95%CI] points: 0.14 [0.05, 0.24]) and Break9 (0.09 [0.001, 0.19], but not across nights (Sit9: −0.13 [-0.33, 0.08]; Break9: 0.07 [-0.14, 0.29]). Sensory-pain experience improved across nights for Sit9 (−3.08 [-4.72, −1.45]), but not within nights (0.77 [-0.004, 1.55]). There was no change in affective-pain experience in either group. Between-group difference was observed favouring Sit9 for improving sensory-pain across nights (β: 3.71 [1.42, 5.99]). No other between-group difference was observed. Both prolonged sitting and breaking up sitting were associated with a within-night increase in musculoskeletal pain intensity. Compared to prolonged sitting, breaking up sitting did not induce benefits on pain in healthy adults working simulated nightshifts. ACTRN12619001516178. • Prolonged sitting during nightshifts associated with increase in musculoskeletal pain. • Breaking up sitting with 3-min walking every 30 min was insufficient to reduce musculoskeletal pain. • Findings would inform appropriate designs of workplace interventions. [ABSTRACT FROM AUTHOR]

Do five baseline moderators identify patients with chronic low back pain who respond best to cognitive functional therapy (CFT) when compared with usual care? Secondary analysis of the RESTORE randomised controlled trial. A total of 492 adults with low back pain for > 3 months with at least moderate pain-related activity limitation. Participants were allocated to CFT alone or CFT plus biofeedback; these two groups were combined for this secondary analysis. The control group was usual care. The outcome was activity limitation measured using the Roland Morris Disability Questionnaire (RMDQ) at 3, 6, 13, 26, 40 and 52 weeks. Investigated effect modifiers were baseline measures of activity limitation, cognitive flexibility, pain intensity, self-efficacy and catastrophising. Baseline levels of activity limitation and, potentially, cognitive flexibility were associated with different effects of CFT treatment, while pain intensity, self-efficacy and catastrophising were not. Patients who had higher baseline activity limitation had greater treatment effects at 13 and 52 weeks. A person with a baseline RMDQ score of 18 (90th percentile) would on average be 6.1 (95% CI 4.8 to 7.4) points better at 13 weeks if they received CFT compared with usual care. However, a person with a baseline score of 7 (10th percentile) would on average be 3.6 (95% CI 2.6 to 4.6) points better at 13 weeks. The finding that CFT is most effective among patients who are most disabled and incur the greatest burden strongly suggests that CFT should be considered as a treatment for this group of patients. ACTRN12618001396213. [ABSTRACT FROM AUTHOR]

Malnutrition is prevalent among hospitalised patients, and increases the morbidity, mortality, and medical costs; yet nutritional assessments on admission are not routine. This study assessed the clinical and economic benefits of using an artificial intelligence (AI)-based rapid nutritional diagnostic system for routine nutritional screening of hospitalised patients. A nationwide multicentre randomised controlled trial was conducted at 11 centres in 10 provinces. Hospitalised patients were randomised to either receive an assessment using an AI-based rapid nutritional diagnostic system as part of routine care (experimental group), or not (control group). The overall medical resource costs were calculated for each participant and a decision-tree was generated based on an intention-to-treat analysis to analyse the cost-effectiveness of various treatment modalities. Subgroup analyses were performed according to clinical characteristics and a probabilistic sensitivity analysis was performed to evaluate the influence of parameter variations on the incremental cost-effectiveness ratio (ICER). In total, 5763 patients participated in the study, 2830 in the experimental arm and 2933 in the control arm. The experimental arm had a significantly higher cure rate than the control arm (23.24% versus 20.18%; p = 0.005). The experimental arm incurred an incremental cost of 276.52 CNY, leading to an additional 3.06 cures, yielding an ICER of 90.37 CNY. Sensitivity analysis revealed that the decision-tree model was relatively stable. The integration of the AI-based rapid nutritional diagnostic system into routine inpatient care substantially enhanced the cure rate among hospitalised patients and was cost-effective. NCT04776070 (https://clinicaltrials.gov/study/NCT04776070). [ABSTRACT FROM AUTHOR]

Background: Telenursing comprises a set of tools and interventions enabling nurses to provide remote care. This study aims to assess the impact of telenursing interventions on the supportive care needs of patients with melanoma and lung cancer who are receiving targeted therapies. Methods: This six-month monocentric, double-arm, randomised, controlled trial study protocol will assess the effect of telenursing on the supportive care needs (primary outcome) in 40 patients (20 in each group) after one month. The secondary outcomes will be monitored at baseline, one, three and six months: supportive care needs (at three and six months), therapeutic adherence, quality of life, usability and satisfaction, performance status, patient-reported outcomes and main adverse events. The SPIRIT guidelines will be used for the reporting. Results: The results from this trial will assess the impact of a telenursing intervention on cancer care. Conclusions: This trial could be a starting point for more extensive studies on telenursing interventions to promote nurses' skills, as well as the quality and safety of care in patients with cancer, highlighting the impact of more outstanding nursing contributions on cancer care. Trial and Protocol Registration: The study protocol was approved by the relevant Italian Ethics Committee Lazio Area 5 (RS1851/23, 2773; 6 September 2023) and was registered on ClinicalTrials.gov (trial registry number NCT06254196). [ABSTRACT FROM AUTHOR]

There is a strong association between total hip bone mineral density (THBMD) changes after 24 mo of treatment and reduced fracture risk. We examined whether changes in THBMD after 12 and 18 mo of treatment are also associated with fracture risk reduction. We used individual patient data (n = 122 235 participants) from 22 randomized, placebo-controlled, double-blind trials of osteoporosis medications. We calculated the difference in mean percent change in THBMD (active-placebo) at 12, 18, and 24 mo using data available for each trial. We determined the treatment-related fracture reductions for the entire follow-up period, using logistic regression for radiologic vertebral fractures and Cox regression for hip, non-vertebral, "all" (combination of non-vertebral, clinical vertebral, and radiologic vertebral) fractures and all clinical fractures (combination of non-vertebral and clinical vertebral). We performed meta-regression to estimate the study-level association (r2 and 95% confidence interval) between treatment-related differences in THBMD changes for each BMD measurement interval and fracture risk reduction. The meta-regression revealed that for vertebral fractures, the r2 (95% confidence interval) was 0.59 (0.19, 0.75), 0.69 (0.32, 0.82), and 0.73 (0.33, 0.84) for 12, 18, and 24 mo, respectively. Similar patterns were observed for hip: r2 = 0.27 (0.00, 0.54), 0.39 (0.02, 0.63), and 0.41 (0.02, 0.65); non-vertebral: r2 = 0.27 (0.01, 0.52), 0.49 (0.10, 0.69), and 0.53 (0.11, 0.72); all fractures: r2 = 0.44 (0.10, 0.64), 0.63 (0.24, 0.77), and 0.66 (0.25, 0.80); and all clinical fractures: r2 = 0.46 (0.11, 0.65), 0.64 (0.26, 0.78), and 0.71 (0.32, 0.83), for 12-, 18-, and 24-mo changes in THBMD, respectively. These findings demonstrate that treatment-related THBMD changes at 12, 18, and 24 mo are associated with fracture risk reductions across trials. We conclude that BMD measurement intervals as short as 12 mo could be used to assess fracture efficacy, but the association is stronger with longer BMD measurement intervals. Lay Summary: In this study, we looked at how changes in hip bone density over time relate to the risk of fractures in people taking osteoporosis medications. We analysed data from over 122 000 participants across 22 different clinical trials. We found that the increase in bone density measured after 12, 18, and 24 mo of treatment was linked to the risk of fractures. Specifically, greater improvements in bone density were associated with fewer fractures in the spine, hips, and other bones. Using statistical methods, we calculated the strength of this association. We discovered that the later, we measured BMD in people taking the medication, the stronger the link between improved bone density and reduced fracture risk became. Our findings suggest that bone density measurements after 12 mo of treatment could help predict how well a medication will prevent fractures. However, the best predictions came from bone density changes measured over longer periods. Graphical Abstract [ABSTRACT FROM AUTHOR]

Background: Azithromycin has been shown to be beneficial in preventing infectious diseases, including malaria, infectious diarrhoea and pneumonia. A cluster randomised control trial on azithromycin MDA in children in Niger, Malawi and Tanzania found a reduction in all-cause under-five (U5) mortality in communities who received azithromycin compared to placebo. However, the reduction was largest and statistically significant only in Niger. The purpose of this trial is to evaluate the impact of azithromycin plus intermittent preventive treatment in infants (IPTi), recently renamed by the World Health Organisation as perennial malaria chemoprevention (PMC), with sulfadoxine-pyrimethamine (SP) on all-cause mortality up to 18 months of age in children living in areas of high mortality burden through the Expanded Program on Immunisation (EPI) in Sierra Leone. Methods: The Improving Care through Azithromycin Research for Infants in Africa (ICARIA) trial is a phase III two-arm, individually randomised, double-blinded, placebo-controlled trial administering oral AZI (20 mg/kg bodyweight) at three time points to children attending EPI visits in Sierra Leone. A total of 20,560 infants attending the first EPI contact at around 6 weeks of age are recruited and randomised to AZI or placebo in a 1:1 ratio. The second and third AZI/placebo doses are given at 9 and 15 months of age. The primary outcome of the trial is all-cause mortality rate at 18 months of age assessed through mortality surveillance. Other trial outcomes include the impact on antimicrobial resistance, and on the immune response to certain key routine EPI immunisations, the safety of the intervention, the prevalence of SP resistance markers and the feasibility, and acceptability of adding AZI to the EPI programme. Discussion: The trial will provide the evidence needed to inform policy regarding the adoption and large-scale implementation of AZI in areas of high-mortality burden in sub-Saharan Africa. Trial registration: ClinicalTrials.gov NCT04235816. Registered on 22 January 2020. Pan-African Clinical Trials Registry PACTR202004540256535. Registered on 14 April 2020. [ABSTRACT FROM AUTHOR]

Background: Reusable surgical drapes have a lower lifetime environmental impact than disposable drapes in most cases. There is limited evidence regarding whether drape choice impacts patient outcomes including post-operative wound complications. The aim of this study is to compare wound complication rates following routine neutering surgeries in cats and dogs when reusable drapes are used as compared with disposable drapes. Methods: The trial will be conducted as a pragmatic, multi-centre, parallel group randomised controlled trial in the UK. Dogs and cats undergoing routine neutering will be randomised to disposable or reusable drapes with all other aspects of care occurring as they usually would at the practice. The required sample size is 2,850, with 4750 animals to be recruited from up to ten practices to allow for a 40% loss to follow-up. Demographic data and details on peri-operative care will be collected at the time of surgery. Post-operative wound complications will be assessed and recorded as usual at each practice using clinical codes. The post-operative wound clinical codes and any antibiotic use within 30 days of surgery will be retrieved from the practice management software. The primary outcome that will be compared between the two groups is the rate of post-operative wound complications within 30 days of surgery which will be analysed by multivariable logistic regression with a binary outcome of wound complication (yes/no). Secondary outcomes are the prevalence of different types of complications and antibiotic use within 30 days of surgery which will be compared between the two groups by chi square analysis. Discussion: Our hypothesis is that there will be no difference in post-operative wound complication rates between disposable and reusable drapes. If the likely rate of post-surgical wound complications with reusable drapes is similar to that with disposable drapes, then veterinary clinical teams can choose the more sustainable option, confident that their patients will not be impacted by this choice. Trial registration: We have retrospectively registered the protocol on the Open Science Framework on 14 Nov 2023 (Trial registration entry: https://doi.org/10.17605/OSF.IO/72HMA). [ABSTRACT FROM AUTHOR]

Background: Urinary incontinence (UI) is the most prevalent pelvic floor disorder following treatment for gynaecological cancer with a distressing impact on quality-of-life in survivors. Physiotherapist-supervised pelvic floor muscle (PFM) training is recommended as the first-line intervention for UI in community-dwelling women. However, it is not known if this intervention is effective in women following treatment for gynaecological cancer, nor whether PFM training can be delivered entirely remotely. The primary aim of this study is to investigate if a telehealth-delivered PFM training program incorporating a novel biofeedback device reduces UI compared with usual care, following gynaecological cancer. Methods: This is a pragmatic, two-arm parallel-group, stratified superiority randomised controlled trial recruiting 72 participants (ACTRN12622000580774). Recruitment sites include gynaecology-oncology outpatient clinics, supplemented by advertisements through community foundations/social media/care groups. Participants must have completed primary cancer treatment at least 6 months prior or adjuvant therapy at least 3 months prior, for Stage I, II or III uterine, cervical, fallopian tube, primary peritoneal or ovarian cancer or borderline ovarian tumour, and have UI occurring at least weekly. Participants randomised to the usual care group will receive bladder and bowel advice handouts and one audio telehealth physiotherapist consultation to answer any queries about the handouts. Participants randomised to the intervention group will receive the same handouts plus eight video telehealth physiotherapist consultations for PFM training with a biofeedback device (femfit®), alongside a home-based program over 16 weeks. The primary outcome measure is a patient-reported outcome of UI frequency, amount and interference with everyday life (measured using the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form), immediately post-intervention compared with baseline. Secondary outcomes include quality-of-life measures, bother of pelvic floor symptoms, leakage episodes, use of continence pads and global impression of change. We will also investigate if the intervention improves intra-vaginal resting and squeeze pressure in women in the intervention arm, using data from the biofeedback device. Discussion: If clinical effectiveness of telehealth-delivered physiotherapist-supervised PFM training, supplemented with home biofeedback is shown, this will allow this therapy to enter pathways of care, and provide an evidence-based option for treatment of post-cancer UI not currently available. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR), ID 12622000580774. Registered 20 April 2022. [ABSTRACT FROM AUTHOR]

Background: An adaptive design allows modifying the design based on accumulated data while maintaining trial validity and integrity. The final sample size may be unknown when designing an adaptive trial. It is therefore important to consider what sample size is used in the planning of the study and how that is communicated to add transparency to the understanding of the trial design and facilitate robust planning. In this paper, we reviewed trial protocols and grant applications on the sample size reporting for randomised adaptive trials. Method: We searched protocols of randomised trials with comparative objectives on ClinicalTrials.gov (01/01/2010 to 31/12/2022). Contemporary eligible grant applications accessed from UK publicly funded researchers were also included. Suitable records of adaptive designs were reviewed, and key information was extracted and descriptively analysed. Results: We identified 439 records, and 265 trials were eligible. Of these, 164 (61.9%) and 101 (38.1%) were sponsored by industry and public sectors, respectively, with 169 (63.8%) of all trials using a group sequential design although trial adaptations used were diverse. The maximum and minimum sample sizes were the most reported or directly inferred (n = 199, 75.1%). The sample size assuming no adaptation would be triggered was usually set as the estimated target sample size in the protocol. However, of the 152 completed trials, 15 (9.9%) and 33 (21.7%) had their sample size increased or reduced triggered by trial adaptations, respectively. The sample size calculation process was generally well reported in most cases (n = 216, 81.5%); however, the justification for the sample size calculation parameters was missing in 116 (43.8%) trials. Less than half gave sufficient information on the study design operating characteristics (n = 119, 44.9%). Conclusion: Although the reporting of sample sizes varied, the maximum and minimum sample sizes were usually reported. Most of the trials were planned for estimated enrolment assuming no adaptation would be triggered. This is despite the fact a third of reported trials changed their sample size. The sample size calculation was generally well reported, but the justification of sample size calculation parameters and the reporting of the statistical behaviour of the adaptive design could still be improved. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Design Methods Results Conclusions Implications for the Profession Impact Reporting Method Patient or Public Contribution Clinical Trials To evaluate the effect of dignity therapy on dignity, anxiety, depression and overall quality of life for people with burns.A single‐blind, double‐arm, parallel randomised controlled study.The Patient Dignity Scale, Hospital Anxiety and Depression Scale, and Burn‐Specific Health Scale‐Short were employed to assess the dignity, anxiety, depression and overall quality of life for people with burns. These outcome indicators were measured and analysed at baseline, 2‐, 4‐ and 8‐week follow‐up. The generalised estimating equations were used to analyse the effect of the intervention during each time point.A total of 99 participants were recruited (50 in the intervention group and 49 in the control group), with a high retention rate of 97 participants (94.95%) completing the 8‐week follow‐up. All outcome measurement tools met the feasibility criteria related to completeness and responsiveness over time. Dignity was the primary outcome measure, with anxiety, depression and quality of life serving as secondary outcome measures. At the 8‐week post‐intervention, participants in the intervention group demonstrated a statistically significant decrease in dignity and anxiety and depression, and a statistically significant increase in burn‐specific health.Dignity therapy can effectively reduce the loss of dignity, anxiety and depression, and improve the quality of life for people with burns. This study has a positive impact on burn dignity nursing practice and provides healthcare professionals with a novel approach to help people with burns return to normal social life with dignity.It is important to develop patient‐centred care for burns with dignity. Focusing on developing a rational understanding of non‐discriminatory dignity care practices among clinical providers and to develop dignity‐oriented clinical care practices on the wards.This study validated the feasibility of implementing dignity therapy for people with burns. Dignity therapy is effective in reducing the degree of dignity impairment, reducing anxiety and depressive symptoms, and enhancing the quality of life for people with burns. Our findings can help healthcare professionals to provide personalised dignity care throughout the patient's journey to facilitate a dignified reintegration into society and life for people with burns.This randomised controlled trial used the CONSORT guidelines.No patients or members of the public participated in the study design, data analysis or interpretation.This study has been registered in the Chinese Clinical Trial Registry registration number: ChiCTR2200065145, 29 October 2022. [ABSTRACT FROM AUTHOR]

Background: The aim of this study is to evaluate the efficacy and safety of faecal microbiota transplantation (FMT) for the treatment of irritable bowel syndrome (IBS). Methods: We searched four databases for randomised controlled trials (RCTs) that compared FMT with a control intervention in patients with IBS. The revised Cochrane risk-of-bias (RoB) tool was chosen for appraisal. Meta-analysis with trial sequential analysis (TSA) was conducted. Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence (CoE). Results: We included 12 RCTs with a total of 615 participants. Meta-analyses showed no significant difference between the FMT and control groups in terms of clinical responses (relative risk [RR] = 1.44, 95% confidence interval [CI] 0.88–2.33) and changes in IBS Severity Scoring System (IBS-SSS) scores (standardised mean difference [SMD] = − 0.31, 95% CI − 0.72 to 0.09) and IBS Quality of Life (IBS-QOL) scores (SMD = 0.30, 95% CI − 0.09 to 0.69). Subgroup analysis revealed that in studies with low RoB and using endoscopy, nasojejunal tube and rectal enema delivery, FMT led to a significant improvement in clinical responses and changes in IBS-SSS and IBS-QOL scores. TSA suggested that the current evidence is inconclusive and that the CoE is very low. Conclusion: This study suggests that patients with IBS may benefit from FMT especially when it is administered via endoscopy, nasojejunal tube or rectal enema. However, the certainty of evidence is very low. Further research is needed to confirm the efficacy and safety of FMT for IBS treatment. Trial Registration: PROSPERO registration number CRD42020211002. [ABSTRACT FROM AUTHOR]

Background: Prematurity remains one of the main causes of neonatal morbidity and mortality. Approximately two thirds of preterm births are spontaneous, i.e. secondary to preterm labour, preterm prelabour rupture of membranes (PPROM) or cervical insufficiency. Etiologically, the vaginal microbiome plays an important role in spontaneous preterm birth (sPTB). Vaginal dysbiosis and bacterial vaginosis are well-known risk factors for ascending lower genital tract infections and sPTB, while a Lactobacillus crispatus-dominated vaginal microbiome is associated with term deliveries. Synbiotics may help to achieve and/or maintain a normal, Lactobacillus-dominated vaginal microbiome. Methods: We will perform a multi-centre, double-blind, randomised, placebo-controlled trial. Women aged 18 years or older with a singleton pregnancy are eligible for inclusion at 80/7–106/7 weeks gestational age if they have one or more of the following risk factors for sPTB: previous sPTB at 240/7–356/7 weeks, prior PPROM before 360/7 weeks, or spontaneous pregnancy loss at 140/7–236/7 weeks of gestation. Exclusion criteria are multiple gestation, cervix conisation, inflammatory bowel disease, uterine anomaly, and the use of pro-/pre-/synbiotics. Patients will be randomised to oral synbiotics or placebo, starting before 11 weeks of gestation until delivery. The oral synbiotic consists of eight Lactobacillus species (including L. crispatus) and prebiotics. The primary outcome is the gestational age at delivery. Vaginal microbiome analysis once per trimester (at approximately 9, 20, and 30 weeks) and delivery will be performed using metataxonomic sequencing (16S rRNA gene) and microbial culture. Secondary outcomes include PPROM, the use of antibiotics, antenatal admission information, and neonatal outcomes. Discussion: This study will evaluate the effect of oral synbiotics on the vaginal microbiome during pregnancy in a high-risk population and correlate the microbial changes with the gestational age at delivery and relevant pregnancy outcomes. Trial registration: ClinicalTrials.gov, NCT05966649. Registered on April 5, 2024. [ABSTRACT FROM AUTHOR]

Background: Mental health settings are increasingly using co-facilitation of educational group interventions in collaboration with patient partners and service users. However, despite promising results, limited information is available regarding the feasibility and satisfaction levels of these programmes among adults newly diagnosed with attention-deficit hyperactivity/impulsivity disorder (ADHD). Hence, this study aimed to determine the feasibility, acceptability, and preliminary effects of a user co-facilitated psychoeducational group programme for adults diagnosed with ADHD. Methods: This feasibility proof-of-concept randomised controlled trial recruited outpatients from a Norwegian community mental health centre. Outpatients randomised to the intervention group (IG) received a psychoeducational programme supplementing Treatment As Usual (TAU), while the control group received TAU. Feasibility was determined by the acceptance rate, adherence rate, and dropout rate. Acceptability was measured with the Client Satisfaction Questionnaire and a 3-item scale measuring satisfaction with the received information. To test the preliminary effects, self-efficacy, symptom severity, and quality of life were measured at baseline and pre- and post-intervention. Results: Feasibility was demonstrated; most of the patients were willing to enrol, participants attended 82% of the psychoeducational programme, and only 13% dropped out of the study. The between-group analyses revealed that the IG reported significantly greater mean satisfaction than the CG. Moreover, the intervention group was more satisfied with the information they received during the psychoeducational programme. Concerning the preliminary effects, the linear mixed model showed improvement in quality of life (the subscale relationship); however, other patient-reported outcomes did not show improvements. Conclusions: This proof-of-concept randomised controlled trial supports the feasibility and acceptability of the user co-facilitated psychoeducational programme for patients newly diagnosed with ADHD in an outpatient setting. While preliminary findings indicate promise in enhancing patient-reported outcomes, a larger study is warranted to assess the intervention's effectiveness rigorously. Trial registration: NCT03425, 09/11/2017. [ABSTRACT FROM AUTHOR]

Background: Experimental studies of wound healing often use survival analysis and time to event outcomes or differences in wound area at a specific time point. However, these methods do not use a potentially large number of observations made over the course of a trial and may be inefficient. A model-based approach can leverage all trial data, but there is little guidance on appropriate models and functional forms to describe wound healing. Methods: We derive a general statistical model and review a wide range of plausible mathematical models to describe wound healing. We identify a range of possible derived estimands and their derivation from the models. Using data from a trial of an intervention to promote ulcer healing in patients affected by leprosy that included three measurement methods repeated across the course of the study, we compare the goodness-of-fit of the models using a range of methods and estimate treatment effects and healing rate functions with the best-fitting models. Results: Overall, we included 5,581 ulcer measurements of 1,578 unique images from 130 patients. We examined the performance of a range of models. The square root, log square root, and log quadratic models were the best fitting models across all outcome measurement methods. The estimated treatment effects magnitude and sign varied by time post-randomisation, model type, and outcome type, but across all models there was little evidence of effectiveness. The estimated effects were significantly more precise than non-parametric alternatives. For example, estimated differences from the three outcome measurements at 42-days post-randomisation were − 0.01 cm2 (-0.77, 0.74), -0.44 cm2 (-1.64, 0.76), and 0.11 cm2 (-0.87, 1.08) using a non-parametric method versus − 0.03 cm2 (-0.14, 0.06), 0.06 cm2 (-0.05, 0.17), and 0.03 cm2 (-0.07, 0.17) using a square-root model. Conclusions: Model-based analyses can dramatically improve the precision of estimates but care must be taken to carefully compare and select the best fitting models. The (log) square-root model is strongly recommended reflecting advice from a century ago. [ABSTRACT FROM AUTHOR]

ABSTRACT Aim Design Methods Results Conclusions Impact Reporting Method Patient or Public Contribution Trial Registration To develop an evidence‐driven, behaviour change focused strategy to maximise implementation and uptake of HIRAID (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, communication and reassessment) in 30 Australian rural, regional and metropolitan emergency departments.An embedded, mixed‐methods study.This study is the first phase of a step‐wedge cluster randomised control trial of HIRAID involving over 1300 emergency nurses. Concurrent quantitative and qualitative data were collected via an electronic survey sent to all nurses to identify preliminary barriers and enablers to HIRAID implementation. The survey was informed by the Theoretical Domains Framework, which is a synthesis of behavioural change theories that applies the science of intervention implementation in health care to effect change. Quantitative data were analysed using descriptive statistics and qualitative data with inductive content analysis. Data were then integrated to generate barriers and enablers to HIRAID implementation which were mapped to the Theoretical Domains Framework. Corresponding intervention functions and Behaviour Change techniques were selected and an overarching implementation strategy was developed through stakeholder consultation and application of the APEASE criteria (Affordability, Practicability, Effectiveness and cost‐effectiveness, Acceptability, Side‐effects/safety and Equity).Six barriers to HIRAID implementation were identified by 670 respondents (response rate ~58%) representing all 30 sites: (i) lack of knowledge about HIRAID; (ii) high workload, (iii) lack of belief anything would change; (iv) not suitable for workplace; (v), uncertainty about what to do and (vi) lack of support or time for education. The three enablers were as follows: (i) willingness to learn and adopt something new; (ii) recognition of the need for something new and (iii) wanting to do what is best for patient care. The 10 corresponding domains were mapped to seven intervention functions, 21 behaviour change techniques and 45 mechanisms. The major components of the implementation strategy were a scaffolded education programme, clinical support and environmental modifications.A systematic process guided by the behaviour change wheel resulted in the generation of a multifaceted implementation strategy to implement HIRAID across rural, regional and metropolitan emergency departments. Implementation fidelity, reach and impact now require evaluation. HIRAID emergency nursing assessment framework reduced clinical deterioration relating to emergency care and improved self‐confidence and documentation in emergency departments in pilot studies. Successful implementation of any intervention in the emergency department is notoriously difficult due to workload unpredictability, the undifferentiated nature of patients and high staff turnover. Key barriers and enablers were identified, and a successful implementation strategy was developed. This study uses theoretical frameworks to identify barriers and enablers to develop a data‐driven, behavioural‐focused implementation strategy to optimise the uptake of HIRAID in geographically diverse emergency departments which can be used to inform future implementation efforts involving emergency nurses. The CROSS reporting method (Supporting Information S3) was used to adhere to EQUATOR guidelines.No Patient or Public Contribution.Australian New Zealand; Clinical Trials Registry (ANZCTR) number: ACTRN12621001456842, registered 25/10/2021 [ABSTRACT FROM AUTHOR]

Objective Methods Results Conclusion This study aims to systematically evaluate the efficacy of probiotics in treating minimum hepatic encephalopathy (MHE).A systematic search was conducted across three major databases: PubMed, China National Knowledge Infrastructure and Wanfang. The search period spanned from the inception of each database to 9 March 2023. The objective was to identify all randomised controlled trials (RCTs) examining the efficacy of probiotic preparations in treating MHE. The search terms included ‘probiotics’ along with other clinically relevant terms to comprehensively capture all pertinent studies.A total of 18 RCTs were included. The meta‐analysis showed that probiotic treatment outperformed control groups in reducing blood ammonia levels (standard mean difference [MD] = −2.68, 95% confidence interval [CI]: −3.90 to −1.46, p < .0001), improving the remission rate of MHE (risk ratio [RR] = 2.79, 95% CI: 1.23–6.35, p = .01) and lowering alanine aminotransferase levels (MD = −11.10, 95% CI: −16.17 to −6.03, p < .0001). It also significantly reduced the Model for End‐Stage Liver Disease scores (MD = −2.55, 95% CI: −3.56 to −1.54, p < .00001) and the incidence of MHE (RR = .18, 95% CI: .09–.34, p < .00001).Our study demonstrates that probiotics effectively improve blood ammonia levels, liver function and cognitive function in patients with MHE. They significantly enhance the remission rate of MHE and effectively reduce its incidence, providing solid new evidence for treating MHE with probiotics. [ABSTRACT FROM AUTHOR]

ABSTRACT Aim Design Methods Results Conclusions Implications for the Profession and/or Patient Care Impact Patient or Public Contribution Reporting Method To assess the impact of digital picture books on preoperative anxiety, pain and sleep quality in young children undergoing cardiac catheterisation and the anxiety of their family caregivers.A randomised, single‐blinded, two‐arm, parallel‐group controlled trial.Participants are young children aged 2–7 years with congenital heart disease scheduled for cardiac catheterisation and their family caregivers. They were enrolled at Fujian Medical University Union Hospital between September 2022 and July 2023. They were randomised to either a control group receiving usual care or an intervention group receiving digital picture book sessions. Anxiety and pain levels were assessed using standardised scales, and sleep quality was measured using actigraphy.The study included 64 pairs of young children and family caregivers. Digital picture books significantly reduced preoperative anxiety and bandage removal pain in children and anxiety in family caregivers. However, there was no statistical difference in sleep quality between the intervention group and the control group.Digital picture books prove to be an effective intervention for reducing anxiety and pain in paediatric cardiac catheterisation patients and anxiety of their family caregivers. The intervention did not affect sleep quality, suggesting the need for additional strategies to address this aspect of the hospital experience.This study demonstrated the effectiveness of digitally illustrated books in reducing preoperative anxiety and pain in young children and anxiety in family caregivers. Digital picture books offer a creative and engaging way to help children and their families cope with the stress and anxiety associated with medical procedures. Further research in this area may lead to the development of more innovative and effective interventions for paediatric patients and their family caregivers.The study's impact lies in its innovative approach to addressing the psychological and emotional challenges faced by young children and their family caregivers during the stressful experience of cardiac catheterisation. By demonstrating the efficacy of digital picture books in significantly reducing preoperative anxiety and postoperative pain, the research presents a non‐pharmacological, accessible and engaging intervention that can be seamlessly integrated into existing healthcare practices. The findings have the potential to transform paediatric care by offering a safe, developmentally appropriate and cost‐effective method to support the emotional well‐being of children and their families, thereby enhancing the overall patient experience and clinical outcomes. Moreover, the study's emphasis on family caregiver involvement underscores the importance of a holistic approach to care that considers the needs of both the patient and their support system.Children and their family caregivers were invited to provide valuable input which has been critical to the development of the intervention. The participant information sheet and consent form, as well as the consent/recruitment process, were reviewed by a consumer advisor advocate from the pilot study.CONSORT.Trial Registration: Chinese clinical trial registry: ChiCTR2200063973. Registered on 22 September 2022, https://www.chictr.org.cn/showproj.html?proj=132833 [ABSTRACT FROM AUTHOR]

Background: The World Health Organization's (WHO) Mental Health Gap Action Programme (mhGAP) is a validated intervention that can be provided by non-specialised healthcare workers to individuals with unhealthy alcohol use. However, it typically requires several in-person sessions at a health facility, which may limit its feasibility and effectiveness in remote settings. This trial compares mhGAP-Standard, a 4 to 6 in-person session intervention, to mhGAP-Remote, a 1 in-person session intervention followed by 8 week of short message service (SMS) in Lesotho. We hypothesise that mhGAP-Remote is superior to mhGAP-Standard in reducing alcohol use (as detailed by the primary and secondary outcomes below). Methods: This is a two-arm randomised open-label multicentre superiority trial. Participants allocated to mhGAP-Standard receive 4 in-person sessions using motivational interviewing, identifying triggers, and alternative behaviours, with the option of two additional booster sessions. Participants in the mhGAP-Remote arm receive 1 in-person session covering the same content, followed by standardised SMSs over 8 weeks that reinforce intervention content. Non-specialist providers deliver the intervention and receive weekly supervision. Adults (Nplanned = 248) attending participating health facilities for any reason and who meet criteria for unhealthy alcohol use based on the Alcohol Use Disorders Identification Test ([AUDIT] score ≥ 6 for women, ≥ 8 for men) are individually randomised to the two arms (1:1 allocation, stratified by participant sex and age (≥ 50 vs < 50 years old). Follow-up assessments occur at 8, 20, and 32 weeks post-randomisation. The primary outcome is change in self-reported alcohol use (continuous AUDIT score), from baseline to 8 weeks follow-up. Change in the AUDIT from baseline to 20 and 32 weeks follow-up is a secondary outcome. Change in the biomarker phosphatidylethanol (secondary), liver enzyme values in serum (exploratory), and HIV viral load (for people with HIV only; exploratory) are also evaluated from baseline throughout the entire follow-up period. A linear regression model will be conducted for the primary analysis, adjusted for the stratification factors. Three a priori sensitivity analyses for the primary outcome are planned based on per protocol treatment attendance, recovery from unhealthy alcohol use, and clinically significant and reliable change. Discussion: This trial will provide insight into feasibility and effectiveness of a shortened and primarily SMS supported version of mhGAP, which is especially relevant for settings where regular clinic attendance is a major barrier. Trial registration: clinicaltrials.gov NCT05925270. Approved on June 29th, 2023. [ABSTRACT FROM AUTHOR]

SUMMARY: Diabetes and depression have a bidirectional relationship, but some antidepressants (such as the tricyclics) may have detrimental effects in diabetes that are exacerbated by behavioural changes associated with depression. This month's Cochrane Review evaluated the efficacy of psychological and pharmacological treatments of comorbid depression in diabetes and found that such interventions have a moderate and clinically significant effect on depression outcomes in people with diabetes. However, conclusions were limited by significant heterogeneity within examined populations and interventions, and significant risk of bias within trials. This commentary critically appraises the review and aims to contextualise its findings. [ABSTRACT FROM AUTHOR]

Australian Governments are increasingly understanding the impacts of early adversity, evidenced by ongoing policy and investment in two of the most widely implemented early interventions: nurse home visiting (NHV) and early childhood education and care (ECEC). Neither intervention fully redresses the developmental inequities engendered by early adversity, yet their synergistic impacts ("dynamic complementarity") are unknown. In this research, we aimed to (1) inform evaluation of policy implementation by (2) experimentally testing the dynamic complementarity of NHV and ECEC. We capitalised on an opportunity afforded by the Australian "right@home" randomised trial, which involved 722 pregnant women experiencing adversity, randomised to receive NHV or usual care to child age 2 years. Detailed data describing family‐accessed ECEC were collected from parents at 3–4 years, and "quality ECEC" was categorised according to meeting quality recommendations defined by Australian policy and provision. Children's developmental outcomes (language, executive functioning, behaviour and well‐being) were parent‐reported or assessed directly at 4 years. At 4 years, 33 per cent of families had received neither intervention; 40 per cent NHV only; 14 per cent quality ECEC only; and 13 per cent had received both. We used linear regression to estimate differences in mean outcomes between exposure groups, including interaction between NHV and ECEC. Unadjusted analyses indicated modest effects of the combination of NHV and ECEC, which attenuated after adjustment for socioeconomic confounders. We present the design and preliminary findings as an approach that could be used to evaluate equitable implementation at scale and enable policymakers to determine the most effective evidence‐based policy. [ABSTRACT FROM AUTHOR]

Introduction: Midfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high‐quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA. Methods: This will be a parallel‐group randomised controlled superiority trial. One‐hundred and forty community‐dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7 days on an 11‐point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester–Oxford Foot Questionnaire), participants' perception of overall treatment effect (self‐reported global rating of change on a 15‐point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health‐related quality of life (Short Form‐12 Version® 2.0), use of co‐interventions and adverse events. Discussion: This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health‐related quality of life in people with midfoot OA. The findings will provide high‐quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA. Trial registration: Australian and New Zealand Clinical Trial Registry (ACTRN12623000953639). [ABSTRACT FROM AUTHOR]

Purpose: The objective of the trial was to compare the regression rate of atypical endometrial hyperplasia (AEH) in patients treated with megestrol acetate (MA) vs. levonorgestrel-intrauterine device (LNG-IUS). We also aimed to assess the fertility and pregnancy outcomes in these patients. Methods: The study was a phase II multi-centre randomised controlled trial on the use of MA compared to LNG-IUS in the treatment of AEH conducted from January 2020 to January 2024 in Singapore. Women who were diagnosed with AEH and between 21 and 40 years old were included. The patients were randomised to receive either MA (160 mg orally daily) or LNG-IUS. The primary outcomes assessed were the regression rates at 3 months, 6 months and 9 months of treatment. The secondary outcomes assessed were the side effects, patient acceptability and fertility outcomes. Results: Thirty-six patients completed the trial. The overall regression rate was 88.9% by 9 months. There was no statistically significant difference in the 9-month complete regression rate between MA vs. LNG-IUS. There was also no significant difference in side effects and weight change between both arms. Nineteen patients were actively pursuing fertility after complete regression. There were 8 pregnancies achieved, with resultant 4 live births and 4 miscarriages. Conclusion: Our study confirms a high regression rate of AH with medical treatment. LNG-IUS is a non-inferior treatment compared to megestrol acetate. Successful pregnancy outcomes can be achieved after regression of AEH. Long-term studies of sufficient sample-size are needed to assess for fertility and pregnancy outcomes, risk of recurrence and long-term risk of malignancy. Trial registration number: The study was registered with the Health Science Authority (HSA) (License No.: CTA1900087) on September 5, 2019: https://eservice.hsa.gov.sg/prism/ct%5fr/enquiry.do?action=loadSpecificDetail. The trial was registered retrospectively on ClinicalTrials.gov (ID: NCT05492487) on April 7, 2022: https://clinicaltrials.gov/study/NCT05492487. [ABSTRACT FROM AUTHOR]

Objective: To assess the effectiveness of pre‐ and postoperative supervised pelvic floor muscle training (PFMT) on the recovery of continence and pelvic floor muscle (PFM) function after robot‐assisted laparoscopic radical prostatectomy (RARP). Patients and Methods: We carried out a single‐blind randomised controlled trial involving 54 male patients scheduled to undergo RARP. The intervention group started supervised PFMT 2 months before RARP and continued for 12 months after surgery with a physiotherapist. The control group was given verbal instructions, a brochure about PFMT, and lifestyle advice. The primary outcome was 24‐h pad weight (g) at 3 months after RARP. The secondary outcomes were continence status (assessed by pad use), PFM function, and the Expanded Prostate Cancer Index Composite (EPIC) score. Results: Patients who participated in supervised PFMT showed significantly improved postoperative urinary incontinence (UI) compared with the control group (5.0 [0.0–908.0] g vs 21.0 [0.0–750.0] g; effect size: 0.34, P = 0.022) at 3 months after RARP based on 24‐h pad weight. A significant improvement was seen in the intervention compared with the control group (65.2% continence [no pad use] vs 31.6% continence, respectively) at 12 months after surgery (effect size: 0.34, P = 0.030). Peak pressure during a maximum voluntary contraction was higher in the intervention group immediately after catheter removal and at 6 months, and a longer duration of sustained contraction was found in the intervention group compared with the control group. We were unable to demonstrate a difference between groups in EPIC scores. Conclusion: Supervised PFMT can improve postoperative UI and PFM function after RARP. Further studies are needed to confirm whether intra‐anal pressure reflects PFM function and affects continence status in UI in men who have undergone RARP. [ABSTRACT FROM AUTHOR]

Objectives: To comprehensively compare quality‐of‐life (QoL) outcomes between open partial nephrectomy (OPN) and robot‐assisted PN (RAPN) from the randomised ROBOtic‐assisted versus Conventional Open Partial nephrectomy (ROBOCOP) II trial, as QoL data comparing OPN and RAPN are virtually non‐existent, especially not from randomised controlled trials (RCTs). Patients and Methods: The ROBOCOP II was a single‐centre, open‐label RCT between OPN and RAPN. The pre‐planned analyses of QoL outcomes are presented. Data were analysed descriptively in a modified intention‐to‐treat population. Results: A total of 50 patients underwent surgery. At postoperative Day 90 (POD90), there was no significant difference for the Kidney Disease Quality of Life‐Short Form questionnaire score (mean [sd] OPN 72 [20] vs RAPN 76 [15], P = 0.850), while there were advantages for RAPN in the subdomains of 'Pain' (P = 0.006) and 'Physical functioning' (P = 0.011) immediately after surgery. For the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30‐item core there were overall advantages directly after surgery (mean [sd] score OPN 63 [20] vs RAPN 75 [17], P = 0.031), as well as for the subdomains 'Fatigue' (P = 0.026), 'Pain' (P = 0.002) and 'Constipation' (P = 0.045) but no differences at POD90. There were no differences for the EuroQoL five Dimensions five Levels questionnaire at POD90 (mean [sd] score OPN 70 [22] vs RAPN 72 [17], P = 1.0) or at any other time point. Finally, no significant differences were found for the overall Convalescence and Recovery Evaluation questionnaire score at POD90 (mean [sd] OPN 84 [13] vs RAPN 86 [10], P = 0.818) but less pain in the RAPN group (P = 0.017) directly after surgery. Conclusions: Pain and physical functioning as subdomains of QoL are improved after RAPN compared to OPN in the early postoperative course, while there are no differences anymore after 3 months. [ABSTRACT FROM AUTHOR]

Background: Stepping Stones Triple P (SSTP) is a complex parent‐mediated intervention aimed to reduce behaviours that challenge in children with moderate to severe intellectual disabilities, aged 30–59 months. Methods: To formulate a comprehensive understanding of SSTP implementation in the UK, we conducted a process evaluation collecting stakeholder views and considering intervention fidelity, dose, reach, delivery adaptations, and acceptability. Results: Fidelity and quality of delivery ratings were high. Parents perceived SSTP as valuable, reporting increased parental confidence and understanding of the child's behaviours. However, only 30% of families received an adequate dose of the intervention. Parents who only received treatment as usual described feeling abandoned by current services. Service managers emphasised the importance of availability of resources and therapist training for successful intervention delivery. Conclusions: SSTP supports effective management of early‐onset behaviours that challenge. Further work is needed to ensure equitable access to the intervention across health and social care services. Trial Registration: NCT03086876 – https://www.clinicaltrials.gov/ct2/show/NCT03086876?term=Hassiotis+Angela&draw=1&rank=1. [ABSTRACT FROM AUTHOR]

Objectives: To investigate whether intensified cooperation between general practitioner (GP), care manager and rehabilitation coordinator (RC) for patients sick-listed for stress-related mental disorder, combined with a person-centred dialogue meeting with employer, could reduce sick-leave days compared with usual care manager contact. Design: Pragmatic cluster-randomised controlled trial, randomisation at primary care centre (PCC) level. Setting: PCCs in Region Västra Götaland, Sweden, with care manager organisation. Participants: Of 30 invited PCCs, 28 (93%) accepted the invitation and recruited 258 patients newly sick-listed due to stress-related mental disorder (n = 142 intervention, n = 116 control PCCs). Intervention: Cooperation between GP, care manager and rehabilitation coordinator from start of illness notification plus a person-centred dialogue meeting between patient and employer within 3 months. Regular contact with care manager was continued at the control PCCs. Main outcome measures: 12-months net and gross number of sick-leave days. Secondary outcomes: Symptoms of stress, depression, anxiety; work ability and health related quality of life (EQ-5D) over 12 months. Results: There were no significant differences between intervention and control groups after 12 months: days on sick-leave (12-months net sick-leave days, intervention, mean = 110.7 days (95% confidence interval (CI) 82.6 − 138.8); control, mean = 99.1 days (95% CI 73.9 − 124.3)), stress, depression, or anxiety symptoms, work ability or EQ-5D. There were no significant differences between intervention and control groups concerning proportion on sick-leave after 3, 6, 12 months. At 3 months 64.8% were on sick-leave in intervention group vs 54.3% in control group; 6 months 38% vs 32.8%, and12 months 16.9% vs 15.5%. Conclusion: Increased cooperation at the PCC between GP, care manager and RC for stress-related mental disorder coupled with an early workplace contact in the form of a person-centred dialogue meeting does not reduce days of sick-leave or speed up rehabilitation. Trial registration: ClinicalTrials.gov Identifier: NCT03250026 CO-WORK-CARE First Posted: August 15, 2017. Recruitment of PCCs: September 2017. Inclusion of patients from December 2017 [ABSTRACT FROM AUTHOR]

Postoperative delirium remains prevalent despite extensive research through randomised trials aimed at reducing its incidence. Understanding trial characteristics associated with interventions' effectiveness facilitates data interpretation. Trial characteristics were extracted from eligible trials identified through two systematic literature searches. Multivariable meta-regression was used to investigate trial characteristics associated with effectiveness estimated using odds ratios. Meta-analysis was used to investigate pooled effectiveness. We identified 201 eligible trials. Compared with China, trials from the USA/Canada (ratio of odds ratio, 1.89; 95% confidence interval, 1.45–2.45) and Europe/Australia/New Zealand (1.67; 1.29–2.18) had an 89% and 67% higher odds ratio, respectively, suggesting reduced effectiveness. The effectiveness was enhanced when the incidence of postoperative delirium increased (0.85; 0.79–0.92, per 10% increase). Trials with concerns related to deviations from intended interventions reported increased effectiveness compared with those at low risk (0.69; 0.53–0.90). Compared with usual care, certain interventions appeared to have reduced the incidence of postoperative delirium in low-risk trials with low-to-moderate certainty of evidence. However, these findings should be considered inconclusive because of challenges in grouping heterogeneous interventions, the limited number of eligible trials, the prevalence of small-scale studies, and potential publication bias. The effectiveness of postoperative delirium trials varied based on the region of trial origin, the incidence of delirium, and the risk of bias. The limitations caution against drawing definitive conclusions from different bodies of evidence. These findings highlight the imperative need to improve the quality of research on a global scale. PROSPERO (CRD42023413984). [ABSTRACT FROM AUTHOR]

• This study worked with a case management program involving a multidimensional assessment and development of individualized care plan according to the identified falls risk. • There were trends indicating lower fall and fracture rates in the intervention group at both the 16-week and 12-month time-points. • There was a difference statistically significant between groups for injurious fall rates at 12 months - IRR=0.18 (95 % CI = 0.04 to 0.74). • A remotely-delivered case-management program was feasible to implement among older people with a history of falls. The present study aimed to determine whether a remotely delivered intervention, based on an individual case management, can reduce falls and their consequences in community-dwelling older people with a history of multiple falls. In this randomized controlled trial, 32 participants were randomized to the intervention group, which comprised a 16-week case management program involving a multidimensional assessment, targeted interventions according to the identified fall risk factors, and development of individualized care plans. The intervention was performed by trained gerontologists, under weekly supervision of professionals with experience in falls. The control group (n = 30) received usual care. Falls were monitored over 12 months with monthly falls calendars and telephone calls. Remotely delivered case management presented an 82 % uptake of recommendations. There was a trend toward a reduced fall incidence in the intervention vs control group, with lower fall, fall injury and fracture rates in the intervention group compared with the control group at both the 16-week and 12-month time-points, with the difference statistically significant for injurious fall rates at 12 months - IRR=0.18 (95 % CI = 0.04 to 0.74). [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of bone anchored maxillary protraction (BAMP) in the management of class III skeletal malocclusion in children aged 11–14 years compared with an untreated control group in terms of perceived need for orthognathic surgery, skeletal and dental change, and psychological impact. Design: A multicentre two-armed parallel randomised controlled trial. Setting: Six UK hospital orthodontic units. Methods: A total of 57 patients were randomly allocated into either the BAMP group (BAMPG) (n = 28) or a no treatment control group (CG) (n = 29). Outcomes: Data collection occurred at registration (DC1),18 months (DC2) and 3 years (DC3), where skeletal and dental changes were measured from lateral cephalograms and study models. Oral Aesthetic Subjective Impact Score (OASIS) and Oral Quality of Life (OHQOL) questionnaires were used to assess the psychological impact of treatment. Results: The mean age was 12.9 ± 0.7 years and 12.6 ± 0.9 years in the BAMPG and CG, respectively. At DC2, the BAMPG achieved a class III ANB improvement of +0.6° compared with −0.7° in the CG (P = 0.004). The overjet improvement was +1.4 mm for the BAMPG and −0.2 mm for the CG (P = 0.002). There was no evidence of any other group differences for the other skeletal or dental cephalometric outcomes (P > 0.05) or the questionnaire data (OASIS P = 0.10, OHQOL P = 0.75). At DC2, the 18-month follow-up, 22% of the BAMPG achieved a positive overjet. At the 3-year follow-up (DC3), fewer participants in the BAMPG were perceived to need orthognathic surgery (48%) compared with 75% of participants in the CG (P = 0.04), with an odds ratio of 0.31 (95% confidence interval = 0.10–0.95). Conclusion: The BAMP technique did not show any social or psychological benefits; however, the skeletal class III improvement in ANB and the overjet change were sufficient to reduce the perceived need for orthognathic surgery by 27% compared with the CG. [ABSTRACT FROM AUTHOR]