Comparison of the clinical and functional outcomes of two immobilisation protocols after arthroscopic peripheral triangular fibrocartilage complex (TFCC) repair in adults: a single-centre, double-blinded randomised controlled trial protocol

Introduction
Injury to triangular fibrocartilage complex (TFCC) is a common cause of ulnar-sided wrist pain, of which peripheral TFCC tears are amenable to repair. The surgical approaches to treat TFCC tears are well-established, with arthroscopic or arthroscopic-assisted repair as the preferred method. However, the postoperative rehabilitation protocols significantly vary across different studies, ranging from 2 to 9 weeks, often without sufficient justification.

Methods and analysis
This research is designed to conduct a randomised controlled trial at a single centre with double-blinding to compare the clinical and functional results of two immobilisation protocols of 3 weeks and 6 weeks, following arthroscopic repair of peripheral TFCC tears (ie, Palmar 1B, 1C and 1D) in adults, considering the phase of ligament healing. The hypothesis that there will be no significant difference in outcomes between the two groups is considered. Adults aged 18–60 years of both genders who present with ulnar-sided wrist pain and satisfy the inclusion criteria are included in the study. Following the arthroscopic TFCC repair using the Polydioxanone Suture (PDS) inside-out suture technique, the patients will be immobilised in an above-elbow cast according to their assigned immobilisation groups, which will be determined by a computer-generated 1:1 block randomisation. In this study, each group will have at least 16 participants. The primary outcomes will be evaluated by the weight-bearing press test and the ballottement test. Secondary outcomes, including the Visual Analogue Scale (VAS) score, grip strength, pinch strength, foveal sign, Modified Mayo Wrist Score (MMWS), patient-rated wrist/hand evaluation (PRWHE) score and the range of movements in the wrist and forearm, will be assessed and compared across the groups at each point of assessment, with the results subsequently reported in a detailed manner. The study will be reported in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Ethics and dissemination
The Ethics Committee of Kasturba Medical College, Manipal, approved the trial (approval No. IEC1 – 386). The data from this trial will be presented at academic conferences and published in peer-reviewed international journals.

Trial registration number
This trial has been registered at the Clinical Trial Registry of India (registration number: CTRI/2023/03/050692).

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Determinants of Outcome After Endovascular Middle Cerebral Artery Occlusion in Rats in the SPAN Trial

Stroke, Ahead of Print. BACKGROUND:The SPAN (Stroke Preclinical Assessment Network) is a confirmatory trial platform to test the efficacy and safety of candidate cerebroprotective interventions in acute stroke. As the largest multicenter preclinical stroke trial to date, the SPAN1 trial (first SPAN) prospectively captured many biological and procedural variables, revealing a high degree of heterogeneity introduced by the multicenter approach that may impact stroke outcomes. Here, we examined the biological and procedural predictors of tissue and neurological outcomes after focal cerebral ischemic stroke in rats.METHODS:SPAN1 enrolled and randomized 698 rats to various active treatment arms or controls. Rats were subjected to transient middle cerebral artery occlusion for 60 (spontaneously hypertensive rats) or 120 minutes (young, healthy Sprague-Dawley rats) and followed for 1 month. Nine biological and procedural independent variables (sex, weight, strain, intervention arm, site, endovascular filament silicone tip coating characteristics, anesthesia duration, and intervention protocol) and 5 dependent outcome variables (weight loss, 4-point neuroscore, corner test, infarct volume, and mortality) were captured. Multivariable regression was used to identify independent predictors of each outcome readout and determine their effect sizes.RESULTS:Spontaneously hypertensive rats exhibited larger infarcts than Sprague-Dawley rats, particularly among females. Neuroscores were also worse in spontaneously hypertensive rats. Prolonged anesthesia exposure was associated with smaller cortical and hippocampal infarcts. Filament thickness and length showed a complex association with different regional infarct volumes, neuroscores, weight loss, and corner test outcomes. Mortality was worse among females. Bivariate analysis of dependent variables revealed moderate correlations among the tissue and neurological outcomes.CONCLUSIONS:Using the large and multicenter, prospective SPAN1 dataset, our multivariable analyses identified several predictors influencing rat middle cerebral artery occlusion outcomes and refuted others previously reported. Investigators should consider whether biological and procedural predictors identified herein should be standardized, accounted for, or stratified during subject allocation to decrease variability and avoid confounders in future multicenter preclinical trials.

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Effect of Baduanjin on postoperative activity tolerance, lung function and negative emotions in patients with lung cancer: a protocol for systematic review and meta-analysis

Introduction
Patients who have undergone lung cancer surgery often experience reduced exercise tolerance, impaired lung function and increased negative emotions such as anxiety and depression. Baduanjin, a traditional Chinese mind-body exercise, has shown benefits in improving exercise tolerance and lung function in populations with chronic diseases. However, evidence on the effectiveness of Baduanjin for post-lung cancer surgery patients remains limited. This study aims to systematically assess the impact of Baduanjin on exercise tolerance, lung function and emotional well-being in these patients.

Methods and analysis
We will conduct a comprehensive search of PubMed, the Cochrane Library, China National Knowledge Infrastructure, Chinese Biomedical Literatures database, Wangfang database and China Science and Technology Journal Database (VIP) to identify randomised controlled trials (RCTs) assessing Baduanjin in postoperative lung cancer patients. The primary outcome measure will be the 6-minute walk test distance. We will assess the risk of bias in included RCTs using the bias risk assessment form from the Cochrane Collaboration Handbook. This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols 2015 guidelines.

Ethics and dissemination
Ethical approval is not required as no primary data are collected. The results will be presented at scientific conferences or submitted to a peer-reviewed scientific journal.

PROSPERO registration number
CRD42024570196.

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Patient experiences and expectations of faecal immunochemical testing for investigation of colorectal cancer symptoms: a cross-sectional qualitative interview study with patients and practitioners in the UK

Objectives
Faecal immunochemical testing (FIT) is now commonplace in the UK to prioritise symptomatic patients for urgent gastrointestinal investigation. The test requires a stool sample to be collected at home by the patient and returned for analysis. In this qualitative study, we sought to understand the feasibility and acceptability of FIT-based triage for patients.

Design
A cross-sectional, qualitative, experiential interview study.

Setting
Recruitment was through three participating UK NHS sites (Yorkshire, Midlands, North-East). Health professionals were also identified through membership of the BSG/ACPGBI Symptomatic FIT Guideline Development Group and snowball sampling.

Participants
We interviewed 21 patients who had completed FIT and been referred for colonoscopy and 30 primary and secondary care health professionals involved in symptomatic FIT delivery.

Results
Completion of FIT was unproblematic from the perspective of patients who returned the test. However, health professionals expressed concern over non-return. Among patients, understanding of the purpose of FIT and the meaning of results varied. Health professionals acknowledged that ensuring patient understanding of these can be challenging. Patients believed colonoscopy was less likely to miss cancer than FIT. Patients with a family or personal history of cancer were particularly anxious and wanted the reassurance of colonoscopy, even with a negative FIT result.

Conclusions
We found no major barriers to the use of FIT in prioritising symptomatic patients for urgent investigation. Improving communication might increase compliance and, possibly, acceptability of non-referral for colonoscopy in the case of a negative test result.

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Causal analysis of undernutrition among adolescents in the context of the agrarian community of North-West Ethiopia: a general structural equation modelling approach

Objective
This study was conducted to evaluate the causal analysis of undernutrition among adolescents in the context of the agrarian community of North-West Ethiopia.

Design
A community-based case-control study was conducted among 149 cases and 297 control adolescents.

Setting
Agrarian communities of North-West Ethiopia.

Participants
Adolescents aged 10–19 years, who reside in a randomly selected study setting.

Outcome measures
The stunting and thinness nutritional status of adolescents was determined using the WHO AnthroPlus 2010 software. A general structural equation modelling approach was used to determine a multicausal analysis of undernutrition. The Food Frequency Questionnaire was tested for internal reliability among 30 adolescents. The reliability test for the actual dietary tool was done using Cronbach’s alpha coefficient (α), which was 0.79. The model adequacy was tested using the Akaike information criterion and Bayesian information criterion. The significant direct and indirect determinants were identified with a value of p

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Study protocol of the multicentre, randomised, triple-blind, placebo-controlled MERCURI-2 trial: promoting effective renoprotection in cardiac surgery patients by inhibition of sodium glucose cotransporter (SGLT)-2

Introduction
Acute kidney injury (AKI) is a major complication after cardiac surgery and is associated with postoperative morbidity and mortality. Currently, no effective therapy exists to reduce the incidence of postoperative AKI. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are effective in reducing AKI in outpatient settings for patients with chronic kidney disease. We hypothesised that perioperative SGLT2 inhibition will also reduce AKI incidence after cardiac surgery according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria.

Methods and analysis
We designed a multicentre, randomised, placebo-controlled, triple-blinded, superiority trial. A total of 784 patients, aged above 18 years, undergoing cardiac surgery will be included with stratification for sex and type 2 diabetes in a 1:1 ratio. Patients will receive either dapagliflozin 10 mg or placebo from the day before until 2 days after surgery. Serum creatinine will be measured preoperatively and daily for the first 7 days after the operation, and urine output will be measured until the urinary catheter is removed. The primary outcome is the incidence of postoperative AKI according to the KDIGO criteria.

Ethics and dissemination
The medical ethics committee of the Amsterdam University Medical Centre (UMC) and the Dutch competent authority approved the study protocol (currently, version 9, 19 January 2024). This is an investigator-initiated study. The Amsterdam UMC, as sponsor, retains ownership of all data and publication rights. After completion of the trial, results will be disseminated to participants, patient societies and physicians via a network meeting and digital newsletter. Results will be submitted for publication in a peer-reviewed international medical journal and presented on (inter)national congresses.

Trial registration number
Clinicaltrials.gov identifier: NCT05590143.

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Sociodemographic factors associated with psychosocial consequences of false-positive colorectal cancer screening: a prospective cohort study

Objectives
Receiving a false positive in colorectal cancer screening is associated with psychosocial consequences, yet the reasons why some people are more affected than others remain unclear. This study examines the association between sociodemographic factors and psychosocial consequences among screening participants with false positives in colorectal cancer screening.

Design
Prospective cohort study.

Participants
1432 screening participants with positive faecal immunochemical test (FIT) screening with a follow-up colonoscopy with either no abnormalities or benign polyps (low or medium-high risk).

Outcome measures
We measured psychosocial consequences with the Consequences Of Screening – ColoRectal Cancer (COS-CRC) questionnaire, after the positive FIT but before the follow-up colonoscopy and again 1 year later. Sociodemographic factors were obtained from national registers and included sex, age, urbanicity, educational level, occupational status, income, assets, cohabitation status and Charlson Comorbidity Index. Psychosocial consequences were measured before colonoscopy (baseline) and 1 year after, and sociodemographic factors were assessed at baseline.

Results
We tested 19x2x3=114 associations between the sociodemographic factors and psychosocial consequences within the three groups of false positives and five associations were significant. We found that for participants with medium- and high-risk polyps, experiencing short-term psychosocial consequences was significantly associated with having a university degree compared with secondary school (OR=5.04 (1.38; 18.37), p=0.0142) and being unemployed compared with being employed (OR=5.61 (1.42; 22.14), p=0.0139). For participants with low-risk polyps, long-term consequences were significantly associated with the mid-income quartile (OR=2.32 (1.13; 4.76), p=0.0224) and the highest income quartile (OR=5.47 (1.13; 26.48), p=0.0349) compared with the lowest quartile. For participants with no abnormalities, there was an association between short-term psychosocial consequences and having comorbidities compared with none (OR=2.95 (1.13; 7.71), p=0.0277).

Conclusion
This study found few significant associations between psychosocial consequences and sociodemographic factors and with no apparent pattern in these. This suggests no strong evidence that specific sociodemographic groups should be especially vulnerable to experiencing psychosocial consequences after a false-positive result from colorectal cancer screening. Thus, there is currently weak evidence for identifying screening participants at higher risk for psychosocial consequences and developing targeted interventions to reduce psychosocial consequences.

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Comparing the efficacy of exertional oxygen delivery by continuous versus demand-based flow systems during 6-minute walk test in patients with fibrotic interstitial lung disease and COPD in a hospital setting (OXYCODE): a protocol for a randomised trial

Introduction
Fibrotic interstitial lung diseases (F-ILD) are severe and often progressive lung disorders that frequently lead to respiratory failure, with patients experiencing high symptom burdens, including severe dyspnoea. This is also evident in patients with severe chronic obstructive pulmonary disease (COPD). Many patients will eventually require ambulatory oxygen therapy (AOT) due to exertional desaturation. Although AOT has shown benefits like increased walking distance and improved quality of life, adherence remains a challenge due to practical issues. AOT can be given by oxygen bottles that provide continuous oxygen flow or as portable concentrators; however, there is a lack of studies comparing the different methods and assessing patient preferences. Data from the present study help guide the selection of patients for different AOTs and provide information on patient preferences.

Methods and analysis
The study design is a single-centre, randomised, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. Patients with COPD or F-ILD who, during a 6-minute walk test (6MWT), can walk at least 50 m and desaturate below 88% are eligible for inclusion in the study. The participants are randomised to perform the 6MWT with either oxygen bottles or portable concentrators first. The primary endpoint is the difference in the lowest oxygen saturation (SpO2) between the two systems. Secondary endpoints include, among others, the difference in percentage of time and number of minutes when SpO2 falls below 88%, mean and maximum pulse rate, and distance and time taken to recover during the 6MWT. Quality of life and patient preferences will be evaluated by scores from the COPD assessment test and the King’s Brief Interstitial Lung Disease health status questionnaire to help gain a better understanding of symptom impact during activity and limitations in daily life.

Ethics and dissemination
The study has been approved by the Central Denmark Region Committees on Health Research Ethics (1-10-72-115-24). The results of this trial will be submitted for publication in an international peer-reviewed journal.

Trial registration number
NCT06767904.

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Intravenous acetaminophen for postoperative delirium in older patients recovering from major non-cardiac surgery: a randomised-controlled study protocol

Introduction
Delirium is a common complication in elderly patients after major surgeries and can lead to poor outcomes such as neurocognitive decline. Acetaminophen is one of the most widely used adjuvants for perioperative multimodal analgesia. Previous studies showed that it can effectively alleviate postoperative pain, promote opioid sparing and exert anti-neuroinflammatory response, showing strong potential for preventing postoperative delirium. We, thus, propose to test the primary hypothesis that postoperative intravenous acetaminophen would reduce delirium over 5 postoperative days in older patients following major non-cardiac surgery.

Methods and analysis
We propose a multicentre, randomised, placebo-controlled, parallel-group trial in patients aged >65 years old scheduled for non-cardiac major surgery with general anaesthesia expected to last at least 2 hours. A total of 1930 elderly patients will be enrolled and randomised at 1:1 ratio to acetaminophen or saline placebo groups, stratified by age, education level and trial site with randomsised blocking. Acetaminophen or saline will be given when the surgical suture begins at the end of surgery and, thereafter, a total of seven doses within 48 hours after surgery. Our primary outcome will be the incidence of delirium, assessed two times per day, through the fifth postoperative day. Secondary and exploratory outcomes will include pain scores with movement, total opioid consumption, severity of delirium, intensive care unit and hospital lengths of stay.

Ethics and dissemination
This study has been approved by the Ethics Committee of Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine (LY2023-239-C) and approved by each participating centre. This report follows the Consolidated Standards of Reporting Trials reporting guideline for randomised studies. The findings will be shared in academic meetings and peer-reviewed academic journals.

Trial registration number
NCT06653465.

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Prevalence of common mental disorders and sleep disorder among adolescents and young adults with HIV: a systematic review and meta-analysis

Objective
Adolescents and young adults (AYA) with HIV are a population at high risk of experiencing mental issues and sleep disorder. We aim to summarise the global prevalence and risks of depression, anxiety, post-traumatic stress disorder (PTSD) and sleep disorder among AYA with HIV.

Design
Systematic review and meta-analysis.

Data sources
PubMed, Web of Science, Embase and PsycINFO were searched from inception to 3 August 2024.

Eligibility criteria
Observational studies reporting the prevalence of depression, anxiety, PTSD or sleep disorder among AYA with HIV and published in English were included. Reviews, case reports, conference papers, notes, editorials and non-observational research were excluded.

Data extraction and synthesis
Titles, abstracts and full texts were reviewed and screened, and data were independently extracted. A modified Newcastle-Ottawa Quality Assessment Scale (NOS) was used to evaluate study quality. Heterogeneity was assessed by I2 statistics, and subgroup analysis was performed to identify the source of heterogeneity. The pooled prevalence and the risks of depression, anxiety, PTSD and sleep disorder by comparison with HIV-uninfected peers were measured with random-effects and fixed-effects models. Publication bias was examined using Egger’s correlation tests and funnel plot. The Grading of Recommendations Assessment, Development and Evaluation was used to assess the certainty of evidence.

Results
56 articles were included in the final analysis. According to the modified NOS, 13 (23.2%) studies were considered good, 38 (67.9%) were satisfactory and 5 (8.9%) were unsatisfactory. 51 studies including 21 735 AYA with HIV contributed data for the pooled prevalence of depression (28%, 95% CI 24% to 32%, I2=98.68%; low certainty evidence); 21 studies including 8021 cases contributed data for the pooled prevalence of anxiety (22%, 95% CI 17% to 27%, I2=98.35%; low certainty evidence); 9 studies including 3691 cases contributed data for the pooled prevalence of PTSD (12%, 95% CI 8% to 17%, I2=95.60%; low certainty evidence); and 4 studies including 1909 cases contributed data for the pooled prevalence of sleep disorder (51%, 95% CI 31% to 70%, I2=98.37%; low certainty evidence). Compared with AYA without HIV, those with HIV had a higher risk of depression (OR=2.67, 95% CI 1.63 to 5.90, I2=84.0%), anxiety (OR=1.89, 95% CI 1.32 to 2.69, I2=50.3%), PTSD (OR=1.58, 95% CI 1.23 to 2.04, I2=40.1%) and sleep disorder (OR=2.11, 95% CI 1.51 to 2.95, I2=0.0%). A subgroup analysis found that studies conducted in Asia had a lower prevalence of depression (21.7% vs 29.6%, p

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