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Objective: This study aims to systematically evaluate the efficacy of probiotics in treating minimum hepatic encephalopathy (MHE). Methods: 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. Results: 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). Conclusion: 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]

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]

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]

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]

Aim: To determine whether a strength‐based home‐visiting program enhances parent–child interaction during the first year at home for children born extremely preterm (gestational age < 28). Methods: A randomised controlled trial of 130 infants born extremely preterm 2018–2021 in Stockholm, allocated to either the Stockholm preterm interaction‐based intervention (SPIBI) (n = 66) or an extended follow‐up program (n = 64). The intervention group received ten home visits during the first year by a trained interventionist following SPIBI guidelines: an interaction‐based intervention supporting sensitive parental responses to infants' signals. The primary outcome of emotional availability was assessed at 12 months corrected age (CA) using the emotional availability scales (EAS). Results: At 1‐year CA, data were collected from 115/130 (89%) of the included children. There were no significant group differences in emotional availability at 12 months CA. A secondary analysis showed an effect modifier in families with mothers self‐rated as depressed at discharge, with the outcome favouring intervention in the EAS dimension of child involvement. Conclusion: The SPIBI had no significant main effect on emotional availability at 12 months CA. Children of self‐reported depressed mothers displayed superior involvement behaviour in the intervention group, prompting further research on risk groups and potential modifications of post‐discharge interventions. [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]

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]

Objective: This clinical trial aimed to evaluate the efficacy and safety of Jiandu granule, a Chinese herbal medicine formula, for preventing oral mucositis in patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy. Materials and Methods: A single‐centre, open‐label, randomised controlled trial was conducted, enrolling 138 patients with locally advanced nasopharyngeal carcinoma. Patients were randomly allocated to either the experimental group (n = 69) or the control group (n = 69). Both groups received concurrent chemoradiotherapy and standard care for oral mucositis, with the experimental group additionally receiving Jiandu granule intervention. The primary outcome was the incidence of severe oral mucositis (grade III to IV). Results: In the full‐analysis set, severe oral mucositis occurred in 14 of 69 (20.3%) patients in the experimental group and 31 of 69 (44.9%) patients in the control group (absolute risk reduction: 24.6%; relative risk reduction: 54.8%; p = 0.002; number needed to treat: 4). Jiandu granule was associated with mild/moderate gastrointestinal reactions, with an overall incidence of 5.9%. Conclusion: Jiandu granule reduced the incidence of severe oral mucositis in nasopharyngeal carcinoma patients during concurrent chemoradiotherapy and had an acceptable safety profile. [ABSTRACT FROM AUTHOR]

Objective: To explore how the use of the ProPep® Nerve Monitoring System (ProPep Surgical, Austin, TX, USA) for intraoperative specific sparing of the pudendal nerve fibres influences postoperative functional outcomes after unilateral nerve‐sparing (UNS) or non‐nerve‐sparing (NNS) robot‐assisted radical prostatectomy (RARP). Patients and methods: We randomised 100 men undergoing UNS or NNS RARP to ProPep nerve monitoring during RARP (intervention) or standard of care RARP (control). Functional outcomes were assessed at 3, 6, and 12 months using the International Consultation on Incontinence Questionnaire Short Form (ICIQ‐SF), the International Prostate Symptom Score, the Danish Prostate Symptom Score, the International Index of Erectile Function, the Erection Hardness Scale, and 24‐h pad tests. The primary outcome was the difference in ICIQ‐SF score between the groups at 12 months. Secondary outcomes included differences in the remaining outcome measures and continence rates at all time points. Continence was defined as the use of no pads and the answer 'Never' to the question: 'How often do you experience urinary incontinence?' or a urine loss of <8 g on the 24‐h pad test. Results: A total of 82 patients were included in the per‐protocol analysis at 12 months with 41 in each group. At 12 months the mean ICIQ‐SF scores were 5.37 (95% confidence interval [CI] 3.71–7.03) and 5.66 (95% CI 4.05–7.27) for the intervention and control groups, respectively (P = 0.8). There were no statistically significant differences in any of the remaining outcomes. However, the continence rate was higher in the intervention group at 6 months (63% vs 44%, P = 0.09). Conclusions: Intraoperative nerve monitoring did not result in better functional outcomes following UNS or NNS RARP. Larger studies are needed to explore if ProPep can reduce the time to continence after RARP. [ABSTRACT FROM AUTHOR]

Purpose: To compare the long‐term symptom resolution and use of resources of performing endoscopic dacryocystorhinostomy (enDCR) in acute or delayed phase in patients with acute dacryocystitis (AD). Methods: This prospective, randomised controlled trial was conducted in Helsinki University tertiary Eye and Ear, Nose and Throat (ENT) Hospitals between September 2013 and January 2019. Fifty patients aged 18 and above presenting with AD in the emergency care were randomised into acute and delayed enDCR surgery groups, performed in 1 week or 4 months from the diagnosis of AD. The follow‐up time was 18 months. Outcome measures were subjective epiphora, lacrimal symptoms and visual analogue scale (VAS) pain scores, the number of hospitalised and unhealthy days, use of medication and openness in lacrimal syringing and dye test. Results: EnDCR was performed on 24 patients in the acute and 19 in the delayed group. There were no significant differences between the groups in follow‐up lacrimal symptoms, syringing test, dye test or use of resources. At the 18 months' follow‐up, 21/23 (91.3%) in the acute group and 12/13 (92.3%) in the delayed group had no disturbing lacrimal symptoms. When reoperations and dropouts are considered, beneficial outcome was 22/24 (91.7%) in the acute and 12/16 (75%) (p = 0.195) in the delayed group. The acute group had significantly fewer pain medication days than the delayed group, 3 versus 10.5 (p = 0.03). Conclusion: Acute enDCR is associated with fewer pain medication days and equal resolution of lacrimal symptoms and use of resources. [ABSTRACT FROM AUTHOR]

Background: This study examined the effects of animal protein‐ and plant protein‐rich diets on postprandial phosphorus metabolism in healthy male subjects. Methods: The study was conducted by randomised parallel‐group comparison of healthy men aged 21–24 years. In Study 1, participants were divided into two groups and consumed either a 70% animal protein diet (AD, n = 6) or a 70% plant protein diet (PD, n = 6). In Study 2, participants were divided into three groups and consumed either AD (n = 10), PD (n = 10) or AD + DF, a 70% animal protein diet loaded with the same amount of fibre as PD (n = 9). The phosphorus contents of the diets used in this study were nearly equivalent (AD, 710.1 mg; PD, 709.7 mg; AD + DF, 708.9 mg). Blood and urine samples were collected before, and 2 and 4 h after the meal to measure phosphorus and calcium levels. Results: In Study 1, PD consumption resulted in lower blood and urinary phosphorus concentrations 2 h postprandially compared with AD (p < 0.05). In Study 2, blood phosphorus levels in AD + DF after the diet remained lower, but not significantly so compared with AD, and urinary phosphorus levels were significantly lower 2 h postprandially (p < 0.05). Conclusions: A plant protein‐rich diet reduced rapid postprandial increases in blood and urinary phosphorus concentrations compared with the animal protein‐rich diets, suggesting that dietary fibre may play a partial role in the postprandial decreases in blood and urinary phosphorus concentrations. Key points: The key points of this study are that a plant protein‐rich diet reduces the rapid increase in the blood and urinary phosphorus concentration after eating and that dietary fibre may contribute to this reduction. [ABSTRACT FROM AUTHOR]

Aims: To assess the cost‐effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment‐resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. Methods: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ‐5D‐5L); cost of utilisation of health services (using the adult services utilization schedule, AD‐SUS) and of programme implementation and curriculum delivery were measured. A cost‐utility analysis was undertaken using quality‐adjusted life years (QALYs) as a measure of trial participant outcome and cost‐effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. Results: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: −£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post‐randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost‐effectiveness, with an 85% probability of correctly inferring an INB > 0. Conclusions: Addressing health cognitions in people with treatment‐resistant hypoglycaemia achieved cost‐effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost‐effective adjunct to educational and technological solutions for problematic hypoglycaemia. [ABSTRACT FROM AUTHOR]

Background: We investigated the effectiveness of Nurse‐Family Partnership (NFP), a prenatal‐to‐age‐two‐years home‐visiting programme, in British Columbia (BC), Canada. Methods: For this randomised controlled trial, we recruited participants from 26 public health settings who were: <25 years, nulliparous, <28 weeks gestation and experiencing socioeconomic disadvantage. We randomly allocated participants (one‐to‐one; computer‐generated) to intervention (NFP plus existing services) or comparison (existing services) groups. Prespecified outcomes were prenatal substance exposure (reported previously); child injuries (primary), language, cognition and mental health (problem behaviour) by age two years; and subsequent pregnancies by 24 months postpartum. Research interviewers were masked. We used intention‐to‐treat analyses. (ClinicalTrials.gov, NCT01672060.) Results: From 2013 to 2016 we enrolled 739 participants (368 NFP, 371 comparison) who had 737 children. Counts for child injury healthcare encounters [rate per 1,000 person‐years or RPY] were similar for NFP (223 [RPY 316.17]) and comparison (223 [RPY 305.43]; rate difference 10.74, 95% CI ‐46.96, 68.44; rate ratio 1.03, 95% CI 0.78, 1.38). Maternal‐reported language scores (mean, M [SD]) were statistically significantly higher for NFP (313.46 [195.96]) than comparison (282.77 [188.15]; mean difference [MD] 31.33, 95% CI 0.96, 61.71). Maternal‐reported problem‐behaviour scores (M [SD]) were statistically significantly lower for NFP (52.18 [9.19]) than comparison (54.42 [9.02]; MD ‐2.19, 95% CI −3.62, −0.75). Subsequent pregnancy counts were similar (NFP 115 [RPY 230.69] and comparison 117 [RPY 227.29]; rate difference 3.40, 95% CI ‐55.54, 62.34; hazard ratio 1.01, 95% CI 0.79, 1.29). We observed no unanticipated adverse events. Conclusions: NFP did not reduce child injuries or subsequent maternal pregnancies but did improve maternal‐reported child language and mental health (problem behaviour) at age two years. Follow‐up of long‐term outcomes is warranted given that further benefits may emerge across childhood and adolescence. [ABSTRACT FROM AUTHOR]

Issue Addressed: Interventions targeting health care professionals' behaviours are assumed to support them in learning how to give behavioural advice to patients, but such assumptions are rarely examined. This study investigated whether key assumptions were held regarding the design and delivery of physical activity interventions among health care professionals in applied health care settings. This study was part of the 'Physical Activity Tailored intervention in Hospital Staff' randomised controlled trial of three variants of a web‐based intervention. Methods: We used data‐prompted interviews to explore whether the interventions were delivered and operated as intended in health care professionals working in four hospitals in Western Australia (N = 25). Data were analysed using codebook thematic analysis. Results: Five themes were constructed: (1) health care professionals' perceived role in changing patients' health behaviours; (2) work‐related barriers to physical activity intervention adherence; (3) health care professionals' use of behaviour change techniques; (4) contamination between groups; and (5) perceptions of intervention tailoring. Conclusions: The intervention was not experienced by participants, nor did they implement the intervention guidance, in the way we expected. For example, not all health care professionals felt responsible for providing behaviour change advice, time and shift constraints were key barriers to intervention participation, and contamination effects were difficult to avoid. So What?: Our study challenges assumptions about how health care professionals respond to behaviour change advice and possible knock‐on benefits for patients. Applying our learnings may improve the implementation of health promotion interventions in health care settings. [ABSTRACT FROM AUTHOR]

Background: Placental cord drainage (PCD) after vaginal birth accelerates placental delivery by 2.85 minutes, but reduces blood loss by only 77 mL. Aims: To determine if PCD at elective caesarean section accelerates placental delivery, compared to delayed cord clamping (DCC). Materials and Methods: This randomised controlled trial randomised 100 women undergoing elective caesarean sections to receive either PCD for 60 sec after birth, or DCC for 60 sec. The primary outcome was time from birth until placental delivery. Secondary outcomes included estimated blood loss (EBL), postoperative haemoglobin drop, rates of postpartum haemorrhage (PPH), manual removal of placenta and blood transfusion. Results: There was no significant difference in timing of placental delivery (PCD 122 sec vs DCC 123.5 sec, P = 0.717). There were no significant differences in EBL (PCD 425 mL vs DCC 400 mL, P = 0.858), postoperative haemoglobin drop (PCD 12 g/L vs DCC 15 g/L, P = 0.297), PPH rate (PCD 45.8% vs DCC 44.4%, P = 0.893, relative risk (RR) 1.03, 95% confidence interval (CI) 0.66–1.62), manual removal rate (PCD 2.1% vs DCC 4.4%, P = 0.609, RR 0.47, 95% CI 0.04–4.99) or transfusion rate (PCD 4.2% vs DCC 0%, P = 0.495). Conclusions: PCD did not accelerate placental delivery at caesarean compared with DCC. Given that both PCD and DCC groups had faster placental deliveries than quoted in the literature at caesarean (200 sec), it could be postulated that DCC is mimicking the effect of PCD through passive transfusion to the neonate. This supports routine use of DCC at elective caesarean section. [ABSTRACT FROM AUTHOR]

Background: There is a need for better implementation of patient‐centred (PC) communication and shared decision‐making (SDM) in routine cancer care. Objective: The aim of this study was to assess whether a programme to implement SDM in oncology had effects on PC communication in clinical encounters. Design: This study constitutes a secondary analysis of data derived from an implementation trial applying a stepped wedge design that, among other strategies, incorporated training and coaching to enhance the PC communication skills of physicians. Setting and Participants: We analysed audio recordings of clinical encounters collected in three departments of a comprehensive cancer centre in Germany before and after rolling out the implementation programme. Main Variables Studied: We assessed the PC communication skills of physicians. Main Outcome Measures: Each recording was rated by two researchers using the German version of the Four Habits Coding Scheme (4HCS), an observer‐based measure of PC communication. Interrater reliability of the outcome measure was acceptable but moderate. Demographic data of patients participating in audio recordings were analysed. Methods: Data were analysed using descriptive statistics and linear mixed‐effects models. Results: In total, 146 encounters, 74 before and 72 after implementation, were evaluated. The mean age of patients was 57.1 years (SD = 13.8), 70.3% were female, the largest portion of patients had medium formal education (32.4%) and were (self‐) employed (37.8%). No statistically significant effect of the implementation programme on the physicians' PC communication skills was found. Discussion: The results indicate that the investigated programme to implement SDM in oncology, including training and coaching, had no effects on PC communication in clinical encounters. These results are in contrast to other studies that report the effects of specific training or coaching on PC communication. Reasons for the lack of effect include the short duration of our training compared to other studies, limited reliability and moderate interrater reliability of the 4HCS scale, limited reach of the intervention programme as well as the inclusion of physicians regardless of their exposure to the interventions. Conclusion: Further research is needed to develop implementation strategies that improve physicians' PC communication skills. Patient Contribution: Data on patients and clinical encounters with patients and physicians were analysed. There was no other patient or public involvement. [ABSTRACT FROM AUTHOR]

Aims: Children and young people (CYP) with type 1 diabetes (T1D) are at increased risk of disordered eating. This study aimed to determine the feasibility and acceptability of a novel, theoretically informed, two‐session psychoeducational intervention for parents to prevent disordered eating in CYP with T1D. Methods: Parents of CYP aged 11–14 years with T1D were randomly allocated to the intervention or wait‐list control group. Self‐reported measures including the Diabetes Eating Problem Survey—Revised (DEPS‐R), Problem Areas in Diabetes Parent Revised (PAID‐PR), Child Eating Behaviour Questionnaire subscales (CEBQ), Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), clinical outcomes (e.g. HbA1c, BMI, medication and healthcare utilisation) and process variables, were collected at baseline, 1‐and 3‐month assessments. Acceptability data were collected from intervention participants via questionnaire. Results: Eighty‐nine parents were recruited, which exceeded recruitment targets, with high intervention engagement and acceptability (<80% across domains). A signal of efficacy was observed across outcome measures with moderate improvements in the CEBQ subscale satiety responsiveness (d = 0.55, 95% CI 0.01, 1.08) and child's BMI (d = −0.56, 95% CI −1.09, 0.00) at 3 months compared with controls. Trends in the anticipated direction were also observed with reductions in disordered eating (DEPS‐R) and diabetes distress (PAID‐PR) and improvements in wellbeing (WEMWBS). Conclusions: This is the first study to have co‐designed and evaluated a novel parenting intervention to prevent disordered eating in CYP with T1D. The intervention proved feasible and acceptable with encouraging effects. Preparatory work is required prior to definitive trial to ensure the most relevant primary outcome measure and ensure strategies for optimum outcome completion. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study is to show whether journals pay attention to double‐organ bias in studies on dacryocystorhinostomy (DCR) treatment. Most statistical tests are based on the assumption that each data entry is independent of the other. However, we wanted to understand whether the eye, which is a double organ in the human body, is a cause of bias and whether sufficient attention has been paid to it in published articles. Design: A PubMed search was conducted between November 1997 and November 2021 in the field of ophthalmology and otolaryngology with the terms 'dacryocystorhinostomy' and the limitations of 'people' and 'randomly controlled studies'. Publications containing DCR were searched. The publications published in the 15 journals with the highest impact were selected. The scope of the journal, the scope of the authors, the relevance of the articles, the presence of randomisation, the type of study (drug, endoscopic surgery, laser surgery and external surgery) and the statistical approach to bilateral organ bias were evaluated by two independent observers. Results and Main Outcome Measures: A total of 83 publications were found by Pubmed search. Fifty‐six publications were included in the study. Double‐organ bias was present in 41% (n = 23) of the cases. Of the 23 biased publications, 46.4% were found to be in the Quartile 1 group. Quartile 4 journals showed bias in only four journals. Conclusion: Double‐organ bias can also be seen in journals with high impact factors and published in recent years. Journals may need to pay more attention to double‐organ bias in the publication acceptance process. [ABSTRACT FROM AUTHOR]

Objective: We previously showed that intermittently scanned continuous glucose monitoring (isCGM) reduces HbA1c at 24 weeks compared with self‐monitoring of blood glucose with finger pricking (SMBG) in adults with type 1 diabetes and high HbA1c levels (58–97 mmol/mol [7.5%–11%]). We aim to assess the economic impact of isCGM compared with SMBG. Methods: Participant‐level baseline and follow‐up health status (EQ‐5D‐5L) and within‐trial healthcare resource‐use data were collected. Quality‐adjusted life‐years (QALYs) were derived at 24 weeks, adjusting for baseline EQ‐5D‐5L. Participant‐level costs were generated. Using the IQVIA CORE Diabetes Model, economic analysis was performed from the National Health Service perspective over a lifetime horizon, discounted at 3.5%. Results: Within‐trial EQ‐5D‐5L showed non‐significant adjusted incremental QALY gain of 0.006 (95% CI: −0.007 to 0.019) for isCGM compared with SMBG and an adjusted cost increase of £548 (95% CI: 381–714) per participant. The lifetime projected incremental cost (95% CI) of isCGM was £1954 (−5108 to 8904) with an incremental QALY (95% CI) gain of 0.436 (0.195–0.652) resulting in an incremental cost‐per‐QALY of £4477. In all subgroups, isCGM had an incremental cost‐per‐QALY better than £20,000 compared with SMBG; for people with baseline HbA1c >75 mmol/mol (9.0%), it was cost‐saving. Sensitivity analysis suggested that isCGM remains cost‐effective if its effectiveness lasts for at least 7 years. Conclusion: While isCGM is associated with increased short‐term costs, compared with SMBG, its benefits in lowering HbA1c will lead to sufficient long‐term health‐gains and cost‐savings to justify costs, so long as the effect lasts into the medium term. [ABSTRACT FROM AUTHOR]

Background: Conditioned pain modulation (CPM) is a potential predictor of treatment response that has not been studied in temporomandibular disorders (TMD). Objectives: We conducted a randomised, double‐blind, placebo‐controlled trial (RCT) of duloxetine in addition to self‐management (SM) strategies to investigate its efficacy to reduce pain intensity in painful TMD patients. Moreover, we investigated whether baseline CPM would predict the duloxetine efficacy to reduce TMD pain intensity. Methods: Eighty participants were randomised to duloxetine 60 mg or placebo for 12 weeks. The primary outcomes were the change in the pain intensity from baseline to week‐12 and CPM‐sequential paradigm at baseline. Safety, physical and emotional functioning outcomes were also evaluated. Results: Of 80 participants randomised, 78 were included in intention‐to‐treat analysis. Pain intensity decreased for SM‐duloxetine and SM‐placebo but did not differ between groups (p =.82). A more efficient CPM was associated with a greater pain intensity reduction regardless of the treatment group (p =.035). Physical and emotional functioning did not differ between groups, but adverse events (p =.014), sleep impairment (p =.003) and catastrophizing symptoms (p =.001) were more prevalent in SM‐duloxetine group. Conclusion: This study failed to provide evidence of a beneficial effect of adding duloxetine to SM strategies for treatment of painful TMD. Nonetheless, this RCT has shown the feasibility of applying pain modulation assessment to predict short‐term treatment response in painful TMD patients, which confirms previous finds that CPM evaluation may serve a step forward in individualising pain treatment. [ABSTRACT FROM AUTHOR]

Seasonal price variability for cereals is two to three times higher in Africa than on the international reference market. Seasonality is even more pronounced when access to appropriate storage and opportunities for price arbitrage are limited. As smallholder farmers typically sell their production after harvest, when prices are low, this leads to lower incomes as well as higher food insecurity during the lean season, when prices are high. One solution to reduce seasonal stress is the use of improved storage technologies. Using data from a randomised controlled trial, in a major maize‐growing region of Western Ethiopia, we study the impact of hermetic bags, a technology that protects stored grain against insect pests, so that the grain can be stored longer. Despite considerable price seasonality—maize prices in the lean season are 36% higher than after harvesting—we find no evidence that hermetic bags improve welfare, except that access to these bags allowed for a marginally longer storage period of maize intended for sale by 2 weeks. But this did not translate into measurable welfare gains as we found no changes in any of our welfare outcome indicators. This 'near‐null' effect is due to the fact that maize storage losses in our study region are relatively lower than previous studies suggested—around 10% of the quantity stored—likely because of the widespread use of an alternative to protect maize during storage, for example a cheap but highly toxic fumigant. These findings are important for policies that seek to promote improved storage technologies in these settings. [ABSTRACT FROM AUTHOR]

Summary: Rapid eye movement sleep fragmentation is hypothesised to be a reliable feature of insomnia, which may contribute to emotion dysregulation. Sleep restriction therapy, an effective intervention for insomnia, has the potential to reduce rapid eye movement sleep fragmentation through its manipulation of basic sleep–wake processes. We performed secondary data analysis of a randomised controlled trial to examine whether sleep restriction therapy reduces rapid eye movement sleep fragmentation in comparison to a matched control arm. Participants (n = 56; 39 female, mean age = 40.78 ± 9.08 years) were randomly allocated to 4 weeks of sleep restriction therapy or 4 weeks of time in bed regularisation. Ambulatory polysomnographic recordings were performed at baseline, week 1 and week 4. Arousals during rapid eye movement and non‐rapid eye movement sleep were scored blind to group allocation. The following rapid eye movement sleep fragmentation index was the primary outcome: index 1 = (rapid eye movement arousals + rapid eye movement awakenings + non‐rapid eye movement intrusions)/rapid eye movement duration in hours. Secondary outcomes were two further indices of rapid eye movement sleep fragmentation: index 2 = (rapid eye movement arousals + rapid eye movement awakenings)/rapid eye movement duration in hours; and index 3 = rapid eye movement arousals/rapid eye movement duration in hours. A non‐rapid eye movement fragmentation index was also calculated (non‐rapid eye movement arousals/non‐rapid eye movement duration in hours). Linear‐mixed models were fitted to assess between‐group differences. There was no significant group difference for the primary rapid eye movement fragmentation index at week 1 (p = 0.097, d = −0.31) or week 4 (p = 0.741, d = −0.06). There was some indication that secondary indices of rapid eye movement fragmentation decreased more in the sleep restriction therapy group relative to control at week 1 (index 2: p = 0.023, d = −0.46; index 3: p = 0.051, d = −0.39), but not at week 4 (d ≤ 0.13). No group effects were found for arousals during non‐rapid eye movement sleep. We did not find clear evidence that sleep restriction therapy modifies rapid eye movement sleep fragmentation. Small‐to‐medium effect sizes in the hypothesised direction, across several indices of rapid eye movement fragmentation during early treatment, demand further investigation in future studies. [ABSTRACT FROM AUTHOR]

Aim: We evaluated the effect on body mass index standard deviation score (BMI‐SDS) of a combined treatment (Web‐COP) for children with obesity, including a web‐based component targeting their parents. Methods: This randomised controlled trial recruited children 5–12 years of age with obesity (International Obesity Task Force BMI [IOTF‐BMI] ≥30 kg/m2) from school health care and outpatient paediatric clinics in in Northern Sweden from 1 June 2019 to 21 June 2020. The children were randomised to Web‐COP, an intervention with group sessions and a 12‐week web‐based component, or standard care. The primary outcome was the change in IOTF BMI‐SDS after 6 months. Results: In total, 75 children (33 girls), mean age 9.5 years, were randomised, and 65/75 (87%) children and their parents completed the study, 35/39 (90%) in the Web‐COP intervention and 30/36 (83%) in the standard care group. BMI‐SDS at 6 months was changed from 3.08 to 2.81 in the intervention group compared to an increase from 3.07 to 3.16 in the standard care group, representing a significant difference between groups (p < 0.001). In the intervention group, 14/30 (47%) reduced their BMI‐SDS ≥0.25, compared to none in the standard care group. Conclusion: The parent‐focused intervention significantly improved BMI‐SDS in children with obesity as compared to children in standard care. [ABSTRACT FROM AUTHOR]

Background: Mentalising and stress regulation pose challenges for adults with mild to borderline intellectual disabilities (MBID), emphasising the importance of an intervention program. The study examined the effectiveness and social validity of the serious game 'You & I' in enhancing mentalising and stress regulation among adults with MBID. Method: A randomised controlled superiority trial with experimental and waitlist‐control groups was conducted with 159 adults with MBID (Mage = 36) at baseline, post‐test, and follow‐up. Analyses investigated the effects on aspects of mentalising, stress regulation, and social validity. Results: The experimental group showed decreased stress from negative interpersonal relations, while the control group experienced increased stress (d = 0.26). There were no significant effects on mentalising, but positive user expectations and experiences were reported. Conclusions: This initial study on 'You & I' provides limited evidence of its effectiveness for people with MBID, warranting further examination of the potential of serious games. [ABSTRACT FROM AUTHOR]

Depression is a mental disorder that is associated with low quality of life, increased risk of suicide and a high economic cost for society. Meta‐analyses indicate that Meaning Centred Psychotherapies (MCP) are an efficacious psychotherapy to reduce depression in participants with chronic illness and cancer. However, to date, no systematic review has analysed the effectiveness of MCP in depressed participants who do not have a physical illness or cancer. The objective of this study was to carry out a systematic review to analyse the effectiveness of MCP in participants with depression and no physical illness. The search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines (PRISMA). Six studies (two randomised controlled trials and four quasi‐experimental studies) were included in the systematic review. The results indicate that MCP is more effective than a control group as waitlist (four studies), psychoeducation group (one study), and cognitive behavioural therapy (CBT, one study), in reducing depressive symptoms, improving meaning in life and reducing anxiety in participants without physical illness. MCP would be considered a probably efficacious treatment for depression. However, further research with better experimental designs will be necessary to confirm the effectiveness of MCP for depression. [ABSTRACT FROM AUTHOR]

In the last decades, Housing First model has become a feasible alternative to the traditional "staircase" systems in caring for the most vulnerable homeless people. The analysis that we present in this work is referred to Hábitat, a pioneering HF programme in Spain, which has been evaluated attending to both costs and outcomes. A randomised controlled trial was carried out and the collected data was explored through a Cost‐Effectiveness Analysis (CEA), including the estimation of Incremental Cost‐Effectiveness Ratios (ICER) and acceptability thresholds of the programme's spending. The results highlight the capacity of the programme to significantly improve the participants' life satisfaction levels, reduce the number of homeless nights, and increase the rate of institutional coverage. Even though the programme involves significant short‐term expenditure on accommodation, positive effects in net terms are demonstrated supporting the usefulness and viability of HF model. [ABSTRACT FROM AUTHOR]

Objectives: To compare University of Southern California (USC) Institute of Urology pentafecta and trifecta achievement comparing open radical cystectomy (ORC) vs robot‐assisted RC (RARC) with totally intracorporeal urinary diversion (iUD) from a randomised controlled trial (RCT). Patients and Methods: Patients were eligible for randomisation if they had a diagnostic transurethral resection of bladder tumour with clinical T stage (cT)2–4, cN0, cM0, or recurrent high‐grade non‐muscle‐invasive bladder cancer and no anaesthesia contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomisation process based on the following variables: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, planned UD, neoadjuvant chemotherapy, and cT stage. USC pentafecta was defined as the combination at 1 year after surgery of: negative soft tissue surgical margins, ≥16 lymph node (LN) yield, absence of major (Clavien–Dindo Grade ≥III) complications at 90 days, absence of UD‐related long‐term sequalae, and absence of clinical recurrence. Trifecta was defined as the coexistence of daytime urinary continence, absence of major complications and recurrence‐free status, all assessed at 1 year. Continuous and categorical variables were compared using Student's t‐test and chi‐square test, respectively. Univariable logistic regression analysis was performed to assess the role of USC pentafecta and trifecta achievement on health‐related quality of life (HRQoL). Results: There was no statistically significant difference in USC pentafecta and trifecta achievement between groups. Among secondary outcomes, univariable logistic regression analysis was performed and both 1‐year USC pentafecta and trifecta achievement were predictors of 2‐year unmodified global HRQoL. Conclusions: This study supports equivalence of RARC‐iUD and ORC with regard to surgical quality as described by the USC pentafecta and trifecta. We described a significant impact of USC pentafecta and trifecta achievement on global health status/HRQoL, providing a strict correlation between objective evaluation of surgical outcomes and self‐reported HRQoL. [ABSTRACT FROM AUTHOR]

Purpose: To determine if a consumer co‐designed infographic increased knowledge of physical activity and self‐efficacy for exercise after total knee joint replacement surgery. Methods: Forty‐four adults with primary knee joint replacement surgery were recruited from a public and a private hospital in Melbourne, Australia. Participants were randomly allocated to an experimental or control group. The experimental group received a consumer co‐designed infographic. All participants received usual care. Primary outcome measures were knowledge of physical activity and self‐efficacy for exercise. Outcomes were administered at baseline, week 1 and week 6. Semi‐structured interviews with experimental group participants explored the acceptability, implementation and efficacy of the infographic. Results: There were no between‐group differences for knowledge of physical activity at week 1 (MD −0.02 units, 95% CI −0.9 to 0.9) or week 6 (MD 0.01 units, 95% CI −0.9 to 0.9). Self‐efficacy for exercise increased at week 1 (MD 14.2 units, 95% CI 2.9–25.4) but was not sustained. Qualitative data showed that the infographic was embraced by some participants but not by others. Conclusions: A consumer co‐designed infographic did not improve knowledge of physical activity but may have had a short‐term positive effect on self‐efficacy for exercise after knee joint replacement. Trial registration ACTRN12621000910808. [ABSTRACT FROM AUTHOR]

Introduction: Persistent musculoskeletal (MSK) pain is associated with physical inactivity in older people. While walking is an acceptable form of physical activity, the effectiveness of walking interventions in this population has yet to be established. Objectives: To assess the acceptability and feasibility of conducting a randomised controlled trial (RCT) to test the effectiveness of a healthcare assistant‐led walking intervention for older people with persistent MSK pain (iPOPP) in primary care. Methods: A mixed method, three arm pilot RCT was conducted in four general practices and recruited patients aged ≥65 years with persistent MSK pain. Participants were randomised in a 1:1:1 ratio to: (i) usual care, (ii) usual care plus a pedometer intervention, or (iii) usual care plus the iPOPP walking intervention. Descriptive statistics were used in an exploratory analysis of the quantitative data. Qualitative data were analysed using thematic analysis. A triangulation protocol was used to integrate the analyses from the mixed methods. Results: All pre‐specified success criteria were achieved in terms of feasibility (recruitment, follow‐up and iPOPP intervention adherence) and acceptability. Triangulation of the data identified the need, in the future, to make the iPOPP training (for intervention deliverers) more patient‐centred to better support already active patients and the use of individualised goal setting and improve accelerometry data collection processes to increase the amount of valid data. Conclusions: This pilot trial suggests that the iPOPP intervention and a future full‐scale RCT are both acceptable and feasible. The use of a triangulation protocol enabled more robust conclusions about acceptability and feasibility to be drawn. [ABSTRACT FROM AUTHOR]

Introduction: Knee osteoarthritis (OA) negatively impacts the health outcomes and equity, social and employment participation, and socio‐economic wellbeing of those affected. Little community‐based support is offered to people with knee OA in Aotearoa New Zealand. Identifying Māori and non‐Māori with knee OA in community pharmacy and providing co‐ordinated, evidence‐ and community‐based care may be a scalable, sustainable, equitable, effective and cost‐effective approach to improve health and wellbeing. Aim: Assess whether the Knee Care for Arthritis through Pharmacy Service (KneeCAPS) intervention improves knee‐related physical function and pain (co‐primary outcomes). Secondary aims assess impacts on health‐related quality of life, employment participation, medication use, secondary health care utilisation, and relative effectiveness for Māori. Methods and analysis: A pragmatic randomised controlled trial will compare the KneeCAPS intervention to the Pharmaceutical Society of New Zealand Arthritis Fact Sheet and usual care (active control) at 12 months for Māori and non‐Māori who have knee OA. Participants will be recruited in community pharmacies. Knee‐related physical function will be measured using the function subscale of the Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index. Knee‐related pain will be measured using an 11‐point numeric pain rating scale. Primary outcome analyses will be conducted on an intention‐to‐treat basis using linear mixed models. Parallel within‐trial health economic analysis and process evaluation will also be conducted. Ethics and trial dissemination: Ethical approval was obtained from the Central Health and Ethics Committee (2022‐EXP‐11725). The trial is registered with ANZCTR (ACTRN12622000469718). Findings will be submitted for publication and shared with participants. [ABSTRACT FROM AUTHOR]

Objective: Fear of Cancer Recurrence (FCR) is highly prevalent among cancer survivors and leads to decreased quality of life and increased healthcare costs. We assessed the effectiveness of a guided online primary care intervention for FCR, compared to waiting list. Methods: In this RCT, participants were recruited online and randomised 1:1. All adults who finished successful curative cancer treatment between 3 months and 10 years ago, wanted support for FCR, and had sufficient Dutch skills were eligible. The intervention consisted of a 10‐week online programme and three to five video calling sessions with a trained mental health worker. After 6 months, the control group received the same intervention. The primary outcome was the difference between the groups in the change in FCR severity from baseline (T0) to 6 months (T2), measured online with the short form of the Fear of Cancer Recurrence Inventory. Results: One hundred and seventy‐three participants were enroled and randomised to the intervention (n = 86) or control group (n = 87). FCR severity dropped 2.1 points more in the intervention group than in the control group (2.7 points (SD = 3.9) versus 0.6 points (SD = 3.6), t(154) = 3.4, p = 0.0007). General mental well‐being also improved significantly in the intervention group and remained stable in the control group. These improvements remained at 10 months follow up. Conclusions: This easily accessible and relatively inexpensive intervention effectively reduces FCR and has potential to replace or precede existing more intensive psychological treatments, improving patients' access to care. Trial registration: The trial was prospectively registered in the Netherlands Trial Register on 25‐02‐2019 with number NL7573. [ABSTRACT FROM AUTHOR]

Aim: The LeoDOR trial explored the efficacy and safety of intermittent levosimendan therapy in the vulnerable phase following a hospitalization for acute heart failure (HF). Methods and results: In this prospective multicentre, double‐blind, two‐armed trial, patients with advanced HF were randomized 2:1 at the end of an index hospitalization for acute HF to intermittent levosimendan therapy or matching placebo for 12 weeks. All patients had left ventricular ejection fraction (LVEF) ≤30% during index hospitalization. Levosimendan was administered according to centre preference either as 6 h infusion at a rate of 0.2 μg/kg/min every 2 weeks, or as 24 h infusion at a rate of 0.1 μg/kg/min every 3 weeks. The primary efficacy assessment after 14 weeks was based on a global rank score consisting of three hierarchical groups. Secondary clinical endpoints included the composite risk of tiers 1 and 2 at 14 and 26 weeks, respectively. Due to the COVID‐19 pandemic, the planned number of patients could not be recruited. The final modified intention‐to‐treat analysis included 145 patients (93 in the combined levosimendan arm, 52 in the placebo arm), which reduced the statistical power to detect a 20% risk reduction in the primary endpoint to 60%. Compared with placebo, intermittent levosimendan had no significant effect on the primary endpoint: the mean rank score was 72.55 for the levosimendan group versus 73.81 for the placebo group (p = 0.863). However, there was a signal towards a higher incidence of the individual clinical components of the primary endpoint in the levosimendan group versus the placebo group both after 14 weeks (hazard ratio [HR] 2.94, 95% confidence interval [CI] 1.12–7.68; p = 0.021) and 26 weeks (HR 1.64, 95% CI 0.87–3.11; p = 0.122). Conclusions: Among patients recently hospitalized with HF and reduced LVEF, intermittent levosimendan therapy did not improve post‐hospitalization clinical stability. [ABSTRACT FROM AUTHOR]

Aim: The aim was to determine whether specialist‐led habit training using Habit Training with Biofeedback (HTBF) is more effective than specialist‐led habit training alone (HT) for chronic constipation and whether outcomes of interventions are improved by stratification to HTBF or HT based on diagnosis (functional defaecation disorder vs. no functional defaecation disorder) by radio‐physiological investigations (INVEST). Method: This was a parallel three‐arm randomized single‐blinded controlled trial, permitting two randomized comparisons: HTBF versus HT alone; INVEST‐ versus no‐INVEST‐guided intervention. The inclusion criteria were age 18–70 years; attending specialist hospitals in England; self‐reported constipation for >6 months; refractory to basic treatment. The main exclusions were secondary constipation and previous experience of the trial interventions. The primary outcome was the mean change in Patient Assessment of Constipation Quality of Life score at 6 months on intention to treat. The secondary outcomes were validated disease‐specific and psychological questionnaires and cost‐effectiveness (based on EQ‐5D‐5L). Results: In all, 182 patients were randomized 3:3:2 (target 384): HT n = 68; HTBF n = 68; INVEST‐guided treatment n = 46. All interventions had similar reductions (improvement) in the primary outcome at 6 months (approximately −0.8 points of a 4‐point scale) with no statistically significant difference between HT and HTBF (−0.03 points; 95% CI −0.33 to 0.27; P = 0.85) or INVEST versus no‐INVEST (0.22; −0.11 to 0.55; P = 0.19). Secondary outcomes showed a benefit for all interventions with no evidence of greater cost‐effectiveness of HTBF or INVEST compared with HT. Conclusion: The results of the study at 6 months were inconclusive. However, with the caveat of under‐recruitment and further attrition at 6 months, a simple, cheaper approach to intervention may be as clinically effective and more cost‐effective than more complex and invasive approaches. [ABSTRACT FROM AUTHOR]

Emotion dysregulation (ED) is a key target for change among empirically supported treatments for emotional disorders, including dialectical behaviour therapy skills training (DBT‐ST), yet how treatments improve ED is poorly understood. Using data from a randomised trial of DBT‐ST versus supportive group therapy for transdiagnostic ED, we tested whether three mechanistic variables—behavioural skills use, mindfulness, and perceived control—explain variability in ED within people over time. We additionally explored the mediating roles of these variables between conditions. Adults with transdiagnostic ED (N = 44) participated in weekly groups for 4 months, with assessments at pre‐, mid‐ and post‐treatment and at 2‐month follow‐up. As hypothesised, multilevel models disaggregating within‐ and between‐person effects indicated that skills use, mindfulness, and perceived control each had significant total and unique within‐person associations with ED at concurrent time points, net the effect of time. Unexpectedly, these within‐person relations were not significant for mechanistic variables predicting ED 2 months later. Further, unique between‐person variability in skills use, mindfulness, and perceived control did not significantly mediate the relationship between condition and ED improvements. The present study is an important step in clarifying ED mechanisms of change, both within and between persons. [ABSTRACT FROM AUTHOR]

Pressure injuries affect 13.1% to 45.5% of patients in the intensive care unit and lead to pain and discomfort for patients, burden on healthcare providers, and unnecessary cost to the health system. Turning and positioning systems offer improvements on usual care devices, however the evidence of the effectiveness of such systems is still emerging. We conducted an investigator initiated, prospective, single centre, two group, non‐blinded, randomised controlled trial to determine the effectiveness of a system for turning and positioning intensive care unit patients, when compared to usual care turning and positioning devices, for preventing PIs. The trial was prematurely discontinued after enrolment of 78 participants due to COVID‐19 pandemic related challenges and lower than expected enrolment rate. The study groups were comparable on baseline characteristics and adherence to the interventions was high. Four participants developed a PI (in the sacral, ischial tuberosity or buttock region), n = 2 each in the intervention and control group. Each participant developed one PI. As the trial is underpowered, these findings do not provide an indication of the clinical effectiveness of the interventions. There was no participant drop‐out or withdrawal and there were no adverse events, device deficiencies, or adverse device effects identified or reported. The results of our study (in particular those pertaining to enrolment, intervention adherence and safety) provide considerations for future trials that seek to investigate how to prevent PIs among ICU patients. [ABSTRACT FROM AUTHOR]

Background and aims: Behavioural smoking cessation trials have used comparators that vary considerably between trials. Although some previous meta‐analyses made attempts to account for variability in comparators, these relied on subsets of trials and incomplete data on comparators. This study aimed to estimate the relative effectiveness of (individual) smoking cessation interventions while accounting for variability in comparators using comprehensive data on experimental and comparator interventions. Methods: A systematic review and meta‐regression was conducted including 172 randomised controlled trials with at least 6 months follow‐up and biochemically verified smoking cessation. Authors were contacted to obtain unpublished information. This information was coded in terms of active content and attributes of the study population and methods. Meta‐regression was used to create a model predicting smoking cessation outcomes. This model was used to re‐estimate intervention effects, as if all interventions have been evaluated against the same comparators. Outcome measures included log odds of smoking cessation for the meta‐regression models and smoking cessation differences and ratios to compare relative effectiveness. Results: The meta‐regression model predicted smoking cessation rates well (pseudo R2 = 0.44). Standardising the comparator had substantial impact on conclusions regarding the (relative) effectiveness of trials and types of intervention. Compared with a 'no support comparator', self‐help was 1.33 times (95% CI = 1.16–1.49), brief physician advice 1.61 times (95% CI = 1.31–1.90), nurse individual counselling 1.76 times (95% CI = 1.62–1.90), psychologist individual counselling 2.04 times (95% CI = 1.95–2.15) and group psychologist interventions 2.06 times (95% CI = 1.92–2.20) more effective. Notably, more elaborate experimental interventions (e.g. psychologist counselling) were typically compared with more elaborate comparators, masking their effectiveness. Conclusions: Comparator variability and underreporting of comparators obscures the interpretation, comparison and generalisability of behavioural smoking cessation trials. Comparator variability should, therefore, be taken into account when interpreting and synthesising evidence from trials. Otherwise, policymakers, practitioners and researchers may draw incorrect conclusions about the (cost) effectiveness of smoking cessation interventions and their constituent components. [ABSTRACT FROM AUTHOR]

The article discusses the challenges in conducting evidence-based research on pilonidal sinus disease due to the lack of large multicenter trials and standardized outcome measures. It highlights the need for stratification of disease severity, clear definitions of outcomes, and patient-reported outcome measures. The author suggests a template for future research that includes studies of appropriate size, classification of disease severity, and patient-relevant outcomes, aiming for methodologically robust and clinically meaningful research in the field. [Extracted from the article]

Background: The traditional cancer follow‐up (FU) model for cancer survivors is by scheduled clinic appointments; however, this is not tailored to patient needs and is becoming unsustainable. Patient‐initiated follow‐up (PIFU) may be a more effective and flexible alternative. This systematic review aims to analyse all existing evidence from randomised controlled trials (RCTs) on the effectiveness of PIFU compared with other FU models that include routinely scheduled appointments in adults who have been treated with curative intent for any type of cancer. Methods: Standard systematic review methodology aimed at limiting bias was used for study identification, selection and data extraction. MEDLINE, Embase, CINAHL, the Cochrane Database of Systematic Reviews and Epistemonikos were searched for systematic reviews to March 2022, and Cochrane CENTRAL was searched for RCTs from 2018 (April 2023). Ongoing trial registers were searched (WHO ICTRP, ClinicalTrials.gov, April 2023). Eligible studies were randomised controlled trials comparing PIFU with an alternative FU model in adult cancer survivors. Risk of bias assessment was via the Cochrane risk of bias tool‐2. Meta‐analysis was precluded by clinical heterogeneity and results were reported narratively. Results: Ten RCTs were included (six breast, two colorectal, one endometrial cancer and one melanoma, total n = 1754); all studies had risk of bias concerns, particularly relating to how missing data were handled, and populations were unlikely to be representative. Limited findings in breast cancer suggested that type of FU does not affect recurrence detection or patient‐related outcomes, while PIFU may reduce the number of clinic visits. Adding patient‐led surveillance to routine FU may increase melanoma detection. Evidence for other types of cancer is too limited to draw firm conclusions. Conclusions: PIFU may be a viable FU model in breast cancer, but further research is needed for other types of cancer and on long‐term outcomes. A protocol was registered with PROSPERO (CRD42020181424). [ABSTRACT FROM AUTHOR]

Objectives: The primary aim was to investigate the effect of prefabricated foot orthoses on pain and function in people with chronic nonspecific low back pain (LBP). Secondary aims were to report on the recruitment rate, adherence to and safety of these interventions, and the relationship between physical activity and pain and function. Design: A two‐arm parallel group (intervention vs. control) randomised (1:1) controlled trial. Subjects: Forty‐one participants with chronic nonspecific LBP. Intervention: Twenty participants were randomised to the intervention group (prefabricated foot orthotic and The Back Book) and 21 to the control group (The Back Book). The primary outcomes for this study were change in pain and function from baseline to 12 weeks. Results: No statistically significant difference in pain was found between the intervention and control group (adjusted mean difference −0.84, 95% CI: −2.09 to 0.41, p = 0.18) at the 12‐week follow‐up. No statistically significant difference in function was found between the intervention and control group (adjusted mean difference −1.47, 95% CI: −5.51 to 2.57, p = 0.47) at the 12‐week follow‐up. Conclusion: This study found no evidence of a significant beneficial effect of prefabricated foot orthoses for chronic nonspecific LBP. This study demonstrated that the rate of recruitment, intervention adherence and safety, and participant retention is acceptable and supportive of conducting a larger randomised controlled trial. Australian and New Zealand Clinical Trials Registry (ACTRN12618001298202). [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to conduct a feasibility pilot of the Dementia Lifestyle Coach program; an individual coaching and counselling program for people recently diagnosed with dementia, to help them to adjust to the diagnosis and live well. Methods: A randomised controlled pilot trial (n = 11) with wait‐list control group was undertaken over 12 months. Intervention group participants received immediate personalised counselling from a registered psychologist and monthly support (face‐to‐face or by telephone) from a trained peer mentor living with dementia. The wait‐listed control group commenced treatment 6 months after baseline. Results: Recruitment and delivery of the Dementia Lifestyle Coach program was highly feasible. The program was acceptable, with nine of the 11 participants describing benefits including informational and emotional support, improving their outlook and mood, and family relationships. The planned program was adapted to participants' individual needs. Conclusions: This small pilot showed that it is feasible to recruit for and deliver a counselling and peer mentoring program for people recently diagnosed with dementia. A larger hybrid implementation randomised control trial should be conducted to evaluate efficacy and effectiveness. [ABSTRACT FROM AUTHOR]

Pressure ulcers often become chronic wounds that are difficult to treat and that tend to recur after healing. In China, convincing data from randomised trials have demonstrated that the pharmaceutical preparations of Periplaneta americana (KangFuXin Liquid, KFX) have a significant efficacy for pressure ulcers. To provide more reference to the clinicians and experts, we conducted a meta‐analysis based on the existing randomised controlled trials (RCTs). We searched the RCTs about KFX for the treatment of pressure ulcers published up to July 2022 in major English and Chinese databases with no language restriction, including PubMed, EMBASE, Web of Science (WOS), Cochrane Central Register of Controlled Trials (CENTRAL), China Network Knowledge Infrastructure (CNKI), Chinese Biomedicine (CBM), Chinese Scientific Journals Database (VIP), and WanFang database. Cochrane Handbook guidelines were used to assess the risk of bias and to evaluate the methodological quality of included RCTs. Estimates of the intervention's effects are expressed as the risk ratio (RR) (95% CI) for binary outcomes and mean difference or standardised mean difference (95% CI) for continuous outcomes. We applied fixed or random effects models, and all analyses were performed using Review Manager version 5.4 and Stata/SE version 12.0. We included 22 studies with a total of 1575 participants. Compared with controls, KFX combined with basic wound care or KFX combined with basic wound care and another topical drug or physical treatment significantly increase clinical efficacy (RR: 1.17; 95% CI, 1.06‐1.28; P = 0.001; I2 = 81%) and shorten the complete healing time (MD = −5.11; 95% CI [−8.19, −2.02]; P = 0.001) for pressure ulcers. Subgroup analysis showed a significant difference in the total clinical effect rate between KFX combined with basic wound care and controls. (n = 1018, RR 1.21, 95% CI [1.07, 1.36], I2 = 82%, P = 0.003). No difference was found in the total clinical effective rate between patients using KFX combined with basic wound care and another topical drug or physical treatment with controls (KFX combined with basic wound care and topical physical treatment: n = 267, RR 1.15, 95% CI [0.86, 1.52], I2 = 87%, P = 0.34; KFX combined with basic wound care and topical drug: n = 290, RR 1.05, 95% CI [0.80, 1.37], I2 = 86%, P = 0.71). Based on treatment duration, subgroup analysis indicated that increasing treatment duration increased the total clinical effective rate when treatment duration was not long. (treatment duration: 14 days: n = 158, OR 5.48, 95% CI [1.47, 20.43], I2 = 0%, P = 0.01; 21 days: n = 132, OR 5.93, 95% CI [1.86, 18.91], I2 = 65%, P = 0.003). When treatment duration was 28 days or 30 days, the results showed that there was no significant difference in total clinical effective rate between interventions and controls (treatment duration: 28 days: n = 107, OR 3.04, 95% CI [0.25, 37.32], I2 = 50%, P = 0.38; 30 days: n = 256, OR 0.58, 95% CI [0.11, 3.15], I2 = 65%, P = 0.53). No data on side effects were reported in any of the 22 studies. The conclusion is that the combination of KFX and basic wound care is effective in increasing the total clinical effectiveness and shortening the complete healing time of pressure ulcers. [ABSTRACT FROM AUTHOR]

Summary: Anaemia is common and associated with poor outcomes during and after critical illness. The use of erythropoietin to treat such anaemia is controversial with older studies showing mixed results. In this study, we aimed to evaluate the feasibility of performing a large multicentre randomised controlled trial of erythropoietin in this setting. We randomly allocated patients staying in the ICU for ≥ 72 h with haemoglobin ≤ 120 g.l‐1 to either a weekly injection of erythropoietin (40,000 iu, maximum of five injections) or placebo (saline). The primary endpoint was feasibility (as measured by recruitment, randomisation and follow‐up rates, and protocol compliance). Secondary endpoints included biological efficacy and clinical outcomes. Forty‐two participants were recruited and randomly allocated, all participants received the allocated intervention, but one withdrew their consent and refused the use of their data, leaving 20 in the erythropoietin group and 21 in placebo group. Follow‐up was completed for all patients who survived. The overall recruitment rate was 73.7% with 8.4 participants recruited on average per month. The last haemoglobin measured before hospital discharge (or death) was similar between the groups with a mean (SD) haemoglobin of 107 (21) vs. 95 (25) g.l‐1, mean difference (95%CI) 11 (‐4–26), g.l‐1, p = 0.154. A large, multicentre randomised controlled trial of erythropoietin to treat anaemia in ICU patients is feasible and necessary to determine effects of erythropoietin on mortality in ICU anaemic patients. [ABSTRACT FROM AUTHOR]

Summary: Extended wakefulness, or sleep deprivation, impairs cognitive performance and brain glucose metabolism. A ketogenic diet (KD) provides an alternative fuel source, ketone bodies, that could elicit a metabolic benefit during sleep deprivation. A randomised, cross‐over trial was conducted with seven male military personnel. Participants ingested an iso‐energetic ketogenic diet or carbohydrate‐based diet for 14 days, immediately followed by 36 h of extended wakefulness and separated by a 12 day washout. Cognitive performance, mood, subjective sleepiness, capillary blood glucose, and D‐β‐hydroxybutyrate concentrations were measured every 2 h during extended wakefulness. Linear mixed models were used to analyse data. D‐β‐hydroxybutyrate was higher (p < 0.001) and glucose was lower (p < 0.01) on the KD compared with the carbohydrate‐based diet. The KD improved psychomotor vigilance task performance (number of lapses, mean reciprocal response time, mean fastest 10% response time (RT), and mean slowest 10% RT; all p < 0.05), running memory continuous performance test performance (RT and number of correct responses per minute; both p < 0.01), and vigour, fatigue, and sleepiness (all, p ≤ 0.001) compared with the carbohydrate‐based diet. In conclusion, a KD demonstrated beneficial effects on cognitive performance, mood, and sleepiness during 36 h of extended wakefulness compared with a carbohydrate‐based diet. [ABSTRACT FROM AUTHOR]

Does proactively asking about allergens before ordering improve customer outcomes? There were improvements on all the secondary outcomes: customer satisfaction, customer trust in the business and whether the customer would recommend the business to a friend or family member. Staff proactively asking about allergens increased customer satisfaction, on three different customer satisfaction metrics. [Extracted from the article]

Objectives: Reduced progression of atherosclerosis can decrease the risk of cardiovascular disease (CVD). This study aimed at evaluating the effect of a pictorial intervention showing atherosclerotic severity on the progression of carotid atherosclerosis. Methods: A prospective randomised open‐label blinded end‐point trial with participants aged 40–60 years enroled from a routine CVD prevention programme. The intervention group (n: 1575) and their treating physicians received an image based presentation of subclinical atherosclerotic severity measured by carotid ultrasound. The control group (n: 1579) did not receive any information about ultrasound results. Carotid ultrasound at baseline and at 3‐year follow‐up contained plaque detection and measurements of carotid intima media thickness (cIMT). The left, right and bilateral‐mean‐cIMT, plaque prevalence and total plaque area (TPA) at 3‐year follow‐up were compared between groups. Significance level was set to p = 0.01 to adjust for multiple comparisons. Results: The intervention group revealed reduced cIMT progression in the left‐mean‐cIMT of −0.011 mm (p = 0.001) compared with the control group. The intervention effect on cIMT progression was most prominent in individuals with increased cIMT and plaque prevalence at baseline (−0.021 mm, p = 0.005). There were no differences in progression between groups for the right‐and bilateral‐mean‐cIMT (−0.005 mm, p = 0.223 and −0.005 mm, p = 0.036, respectively), nor any differences between groups for plaque prevalence or TPA (odds ratio 0.88, p = 0.09 and 0.89, p = 0.21, respectively). Conclusion: Pictorial presentation of subclinical atherosclerotic severity sent to both the individual and their treating physician resulted in significantly reduced left cIMT progression. Pictorial presentation has the potential to increase adherence in CVD prevention. [ABSTRACT FROM AUTHOR]