Multicentre Randomised Research Articles

Study protocol on the efficacy of exergames-acceptance and commitment therapy program for the treatment of major depressive disorder: comparison with acceptance and commitment therapy alone and treatment-as-usual in a multicentre randomised controlled trial

BackgroundThe prevalence of major depressive disorder (MDD) is on the rise globally, and the use of antidepressant medications for its treatment does not usually result in full remission. However, the...

No Effect of Methylnaltrexone on Acute Pancreatitis Severity: A Multicenter Randomized Controlled Trial.

Opioids used to manage severe pain in acute pancreatitis (AP) might exacerbate the disease through effects on gastrointestinal and immune functions. Methylnaltrexone, a peripherally acting µ-opioid receptor antagonist, may counteract these effects without changing analgesia. This double-blind, randomized, placebo-controlled trial included adult patients with AP and systemic inflammatory response syndrome at 4 Danish centers. Patients were randomized to receive 5 days of continuous intravenous methylnaltrexone (0.15 mg/kg/d) or placebo added to the standard of care. The primary end point was the Pancreatitis Activity Scoring System score after 48 hours of treatment. Main secondary outcomes included pain scores, opioid use, disease severity, and mortality. In total, 105 patients (54% men) were randomized to methylnaltrexone (n = 51) or placebo (n = 54). After 48 hours, the Pancreatitis Activity Scoring System score was 134.3 points in the methylnaltrexone group and 130.5 points in the placebo group (difference 3.8, 95% confidence interval [CI] -40.1 to 47.6; P = 0.87). At 48 hours, we found no differences between the groups in pain severity (0.0, 95% CI -0.8 to 0.9; P = 0.94), pain interference (-0.3, 95% CI -1.4 to 0.8; P = 0.55), and morphine equivalent doses (6.5 mg, 95% CI -2.1 to 15.2; P = 0.14). Methylnaltrexone also did not affect the risk of severe disease (8%, 95% CI -11 to 28; P = 0.38) and mortality (6%, 95% CI -1 to 12; P = 0.11). The medication was well tolerated. Methylnaltrexone treatment did not achieve superiority over placebo for reducing the severity of AP.

Hybrid Versus Conventional Colorectal Endoscopic Submucosal Dissection: A Multicenter Randomized Controlled Trial (Short-Endoscopic Submucosal Dissection).

Hybrid endoscopic submucosal dissection (H-ESD), which utilizes ESD knife along with snare-based resection, has been developed to overcome the technical complexity of conventional ESD (C-ESD). The aim of this study was to compare the therapeutic outcomes of H-ESD vs C-ESD for nonpedunculated colorectal lesions ≥20 mm in size. We conducted a multicenter randomized controlled trial to compare H-ESD and C-ESD (Short-ESD trial). Patients with colorectal lesions between 20 and 50 mm in size were randomly assigned (1:1) to H-ESD or C-ESD. Primary outcome was procedure time/speed. Secondary outcomes were en bloc and complete (R0) resection rates and adverse event rates. A total of 89 patients (median age 63 years; 49.3% women) with the median polyp size of 30 mm underwent H-ESD (n = 40) and C-ESD (n = 49). The mean procedure time of H-ESD was significantly shorter than that of C-ESD (41.1 ± 16.3 vs 54.3 ± 28.2 minutes; P = 0.007). The en bloc and R0 resection rates trended lower in the H-ESD vs C-ESD groups (77.5% vs 87.8%; P = 0.26% and 72.5% vs 79.6%; P = 0.46) without reaching statistical significance. Adverse event rate was similar between H-ESD and C-ESD (10% vs 8.2%; P = 1.00). Both H-ESD and C-ESD were safe and effective for resection of large colorectal lesions. H-ESD was associated with a shorter procedure time. H-ESD may represent a viable alternative to C-ESD, with the main advantage being easy applicability of a snare-based technique for colorectal lesions. Future studies are needed to further define the most suitable lesions for H-ESD, as to optimize efficiency and safety without compromising resection outcomes. ClinicaTrials.gov NCT NCT05347446.

First-line treatment for femoroacetabular impingement syndrome and hip-related quality of life: study protocol for a multicentre randomised controlled trial comparing a 6-month supervised strength exercise intervention to usual care (the Better Hip Trial)

IntroductionFemoroacetabular impingement syndrome (FAIS) is a motion-related and position-related clinical condition of the hip associated with pain, reduced physical function and hip-related quality of life (QoL). Interestingly, higher maximal muscle...

Effect of brewer’s yeast or beta-glucan on breast milk supply following preterm birth: the BLOOM study – protocol for a multicentre randomised controlled trial

BackgroundMany individuals who experience preterm birth struggle with early breast milk supply, which can translate into suboptimal longer-term breastfeeding outcomes. Further investigations into the potential role of early non-pharmacological and pharmacological interventions in improving breast milk production soon after birth is growing. While natural galactagogues, such as brewer’s yeast, are widely perceived by women to be safer than pharmaceutical galactagogues and are taken by many women, evidence to support their efficacy is largely absent. The BLOOM study has been designed to determine the efficacy and safety of brewer’s yeast and beta-glucans, derived from Saccharomyces cerevisiae, when administered soon after birth for increasing early breast milk supply in mothers who have delivered preterm.MethodsThe BLOOM study is a multicentre, double-blinded, randomised controlled trial that will assess if brewer’s yeast or beta-glucan can increase early breast milk production following preterm birth. Target population are mothers of preterm infants born at less than 34 weeks’ gestation who intend to provide breast milk for their infant, are less than 72 h following birth and able to give informed consent. Participants will be randomly allocated into three parallel groups at 1:1:1 ratio (n = 33 per group) to receive either brewer’s yeast, beta-glucan or placebo capsules for seven days. The primary outcome is total expressed breast milk volume over a 24-hour period on day 7 of intervention. Participants and their infants will be followed until the infant reaches term corrected age or is discharged home from the neonatal unit (whichever occurs first).DiscussionThe use of brewer’s yeast as a galactagogue to enhance milk production is extremely common amongst breastfeeding mothers, however, there are no trials evaluating its efficacy and safety. This will be the first randomised controlled trial to evaluate the efficacy and safety of two commonly used galactagogues, brewer’s yeast and beta-glucan, compared with placebo in improving maternal breast milk supply following preterm birth. The trial will also evaluate whether early intervention with galactagogues soon after a preterm birth improves longer-term breastfeeding outcomes.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12622000968774 (registered on 8 July 2022) and UTN U1111-1278-8827.

Pelvic Floor Rehabilitation After Rectal Cancer Surgery One-year follow-up of a Multicenter Randomized Clinical Trial (FORCE trial).

This study aims to evaluate the effects of pelvic floor rehabilitation (PFR) after low anterior resection (LAR) at one-year follow-up. After LAR, with restoration of bowel continuity, up to 90% of patients develop anorectal dysfunction, significantly impacting their quality of life. However, standardized treatment is currently unavailable. The FORCE trial demonstrated the beneficial effects of PFR after three months regarding specific domains of the Fecal Incontinence QoL (FIQL) questionnaire and urgency compared to usual care. The FORCE trial is a multicenter, two-arm, randomized clinical trial. All patients undergoing LAR were randomly assigned to receive either usual care or a standardized PFR program. The primary outcome measure is the Wexner incontinence score, and the secondary endpoints included the LARS score, the EORTC colorectal-specific QoL questionnaire, and health- and fecal incontinence-related QoL. Assessments were conducted at baseline before randomization, at three months and one-year follow-ups. A total of 86 patients were included (PFR: n=40, control: n=46). After one year, PFR did not significantly improve Wexner incontinence scores (PFR: -3.33, 95% CI -4.41 to -2.26, control: -2.54, 95% CI -3.54 to -1.54, P=0.30). Similar to the three-month follow-up, patients without near-complete incontinence at baseline showed sustained improvement in fecal incontinence (PFR: -2.82, 95% CI -3.86 to -1.76, control: -1.43, 95% CI -2.36 to -0.50, P=0.06). Significant improvement was reported in the FIQL domains Lifestyle (PFR: 0.51, control: -0.13, P=0.03) and Coping and Behavior (PFR: 0.40, control: -0.24, P=0.01). At one-year follow-up, no significant differences were found in fecal incontinence scores; however, PFR was associated with improved fecal incontinence related QoL compared to usual care.

The role of serum interleukins in Cancer: A Multi-center Mendelian Randomization study

The occurrence of cancer is often accompanied by immune evasion and tumor-promoting inflammation, with interleukins (IL) playing a pivotal role in the immune-inflammatory mechanism. However, the precise contribution of serum interleukins in cancer remains elusive. We obtained GWAS summary data for 35 interleukins from eight independent large-scale serum proteome studies of European ancestry populations and for 23 common cancers from the FinnGen Consortium. We then conducted a multicenter Mendelian Randomization (MR) study to explore the relationship between systemic inflammatory status and cancers. 24 causal associations between interleukins and cancers were supported by multicenter data, 18 of which were reported for the first time. Our results indicated that IL-1α (Hodgkin lymphoma), IL-5 (bladder cancer), IL-7 (prostate cancer), IL-11 (bone malignant tumor), IL-16 (lung cancer), IL-17A (pancreatic cancer), IL-20 (bladder cancer), IL-22 (lymphocytic leukemia), IL-34 (breast cancer), IL-36β (prostate cancer), and IL-36γ (liver cancer) were risk factors for related cancers. Conversely, IL-9 (malignant neoplasms of the corpus uteri), IL-17C (liver cancer), and IL-31 (colorectal cancer, bladder cancer, pancreatic cancer, and cutaneous melanoma) exhibited protective effects against related cancers. Notably, the dual effects of serum interleukins were also observed. IL-18 acted as a risk factor for prostate cancer, however, was a protective factor against laryngeal cancer. Similarly, IL-19 promoted the development of lung cancer and myeloid leukemia, while conferring protection against Breast, cervical, and thyroid cancers. Our study confirmed the genetic association between multiple serum interleukins and cancers. Immune and anti-inflammatory strategies targeting these associations provide opportunities for prevention and treatment.

Early parent-child intervention with Dialogic Book-Sharing: effects on child communicative and socio-emotional development and on parenting. Study protocol for a multicentre randomised controlled trial in Italy

BackgroundResearch in the neurosciences has highlighted the importance of intersubjective relationships in promoting neuromental development of the child. Children’s learning in early childhood occurs mainly in a dyadic context of an interaction with their parents: from this perspective, good dialogic parent–child communication is required to be promoted also through good educational practices. Dialogic Book-Sharing (DBS), a dialogic form of parent–child communication through the use of wordless picture books, provides a privileged ‘intersubjective’ space and is highly effective in promoting communication, language, attention, behavioural development and the parent–child relationship. DBS programme, successfully previously trialled in South Africa and the UK, will be applied for the first time in Italy for research purposes in Italian health, educational and maternal-child centres.MethodsA multicentre randomised controlled trial is being conducted to evaluate DBS parenting intervention for children aged between 14 and 20 months. Parent–child dyads are randomly allocated to a book-sharing intervention group or to a wait-list control group. In the intervention, parents are trained in supportive book-sharing with their children by local staff of the centres. DBS intervention is carried out in small groups over a period of 4 weeks. Data are collected at baseline, post-intervention and at 6 months post-intervention with a questionnaire and video recording of parent–child interaction.DiscussionDBS programme in early childhood could enhance the educational resources offered by Italian health, educational and maternal-child centres, in support of child’s development and parenting. DBS represents a strategic opportunity for bringing about positive effects, also in terms of prevention of socio-emotional and cognitive difficulties. As such it represents a promising response to the new social, health and educational needs of the post-COVID-19 pandemic era caused by the social isolation measures. Furthermore, the application of the DBS methodology is a way to promote the use of books, and thereby counteract the excessive use of technological devices already present in early childhood.Trial registrationThe trial is registered on the International Standard Randomised Controlled Trial Number database, registration number ISRCTN11755019 Registered on 2 November 2023. This is version 1 of the protocol for the trial.

Remote symptom monitoring with patient-reported outcome measures in outpatients with chronic kidney disease (PROKID): a multicentre randomised controlled non-inferiority study.

The increasing incidence of chronic kidney disease (CKD) is straining the capacity of outpatient clinics. Remote healthcare delivery might improve CKD follow-up compared with conventional face-to-face follow-up. Patient-reported outcomes (PROs) are used to empower remote follow-up and patient engagement. The consequences of shifting from face-to-face follow-up to remote outpatient follow-up on kidney function, health resource utilisation and quality of life remain unknown. We conducted a multicentre pragmatic non-inferiority trial at three outpatient clinics in the Central Denmark Region. A total of 152 incident outpatients with CKD were randomised (1:1:1) to either PRO-based, PRO-telephone follow-up or standard of care (SoC). The primary outcome was the annual change in kidney function measured by the slope of the estimated glomerular filtration rate (eGFR). The non-inferiority margin was an eGFR of 2.85ml/min/1.73m2/year. Mean differences were estimated using intention-to-treat (ITT), per protocol and random coefficient models. Mean eGFR slope differences between PRO-based and SoC were -0.97ml/min/1.73m2/year [95% confidence interval (CI) -3.00-1.07] and -1.06ml/min/1.73m2/year (95% CI -3.02-0.89) between PRO-telephone and SoC. Non-inferiority was only established in the per-protocol analysis due to CIs exceeding the margin in the ITT group. Both intervention groups had fewer outpatient visits: -4.95 (95% CI -5.82 to -4.08) for the PRO-based group and -5.21 (95% CI -5.95 to -4.46) for the PRO-telephone group. We found no significant differences in quality of life, illness perception or satisfaction. Differences in the eGFR slope between groups were non-significant and results on non-inferiority were inconclusive. Thus, transitioning to remote PRO-based follow-up requires close monitoring of kidney function. Reducing patients' attendance in the outpatient clinic was possible without decreasing either quality of life or illness perception.ClinicalTrials.gov identifier: NCT03847766.

73-OR: The Plant-Based Substance Totum-63 (T63) Reduces Fasting Plasma Glucose and HbA1c in People with Prediabetes or Type 2 Diabetes (T2D)—A 24-Week Multicenter Randomized Controlled Trial (REVERSE-IT)

73-OR: The Plant-Based Substance Totum-63 (T63) Reduces Fasting Plasma Glucose and HbA1c in People with Prediabetes or Type 2 Diabetes (T2D)—A 24-Week Multicenter Randomized Controlled Trial (REVERSE-IT)

16-OR: Preadministration of SGLT2 Inhibitor Reduces Frequency of Anti-VEGF Agent Administration in Patients with Mild Diabetic Macular Edema—A Multicenter Randomized Controlled Open-Label Trial

16-OR: Preadministration of SGLT2 Inhibitor Reduces Frequency of Anti-VEGF Agent Administration in Patients with Mild Diabetic Macular Edema—A Multicenter Randomized Controlled Open-Label Trial

MANCAN2: A multicentre randomised controlled trial of self-help cognitive behavioural therapy (CBT) to manage hot flush and night sweats (HFNS) symptoms in patients with prostate cancer receiving androgen deprivation therapy (ADT).

LBA5004 Background: Up to 80% of patients receiving ADT suffer HFNS which impacts quality of life (QOL) and potentially ADT compliance. Mitigation options are limited. Prior research has found self-help CBT, with minimal guidance, reduced HFNS due to ADT at 6 weeks. We tested the longer term impact of self-help CBT, guided and delivered by prostate Cancer Nurse Specialist (CNS) teams. Methods: MANCAN2 is a multicentre randomised controlled trial and process evaluation within UK prostate cancer units. Eligibility: localised/advanced prostate cancer; on ADT with ≥ 6 months further planned; HFNS Problem Rating Scale ≥ 2. Patients were randomised (1:1) in groups of 6 to 8 to treatment as usual (TAU) or CBT + TAU, by permuted block, stratified by site, cohort and treatment intent. CBT was a 4-week self-help intervention (booklet and relaxation audio) with pre- and post-intervention group workshops by the prostate CNS team. Primary objective: does adding CBT to TAU reduce 6 month HFNS Problem Rating Scale versus baseline (mixed linear regression). Secondary endpoints: 6 week HFNS Problem Rating Scale, HFNS frequency, HFNS beliefs and behaviours, QOL (EORTC QLQ-C30, symptoms (rating scales for anxiety, depression, mood and sleep) by mixed logistic regression), ADT compliance (chi-squared test). A 6 month mean HFNS Problem Rating Scale difference of ≥ 1.5 points was deemed clinically relevant, and required data from 111 patients (90% power, 5% type 1 error, 6 to 8 patients per group, intra-class correlation 0.01, anticipating 26% patient loss). Results: 162 patients were randomly assigned (81/arm) and 117 returned 6 month HFNS Problem Rating Scale data. Baseline characteristics were balanced. Mean CBT delivery adherence was 85%. 6 month mean HFNS Problem Rating Scale score was not significantly different for the TAU alone versus CBT + TAU (mean 4.08 vs 4.04, 95% CI for difference: -0.89, 0.80; p=0.97), although a difference was observed at 6 weeks (mean 4.47 vs 3.79, 95% CI: -1.26, -0.09; p=0.03). At 6 weeks, CBT patients had higher weekly HFNS frequency (median 54.2 vs 59.4, 95% CI: 0.22, 10.19; p=0.04), lower depression score (median 7.19 vs 6.19, 95% CI: -1.88, -0.12; p=0.03) and lower anxiety score (median 4.25 vs 3.39, 95% CI: -1.64, -0.08; p=0.03). CBT patients had more positive beliefs about openness and humour scores at 6 months (median 4.92 vs 4.59, 95% CI: -0.63, -0.03; p=0.03). There was no significant difference for other measures of HFNS beliefs and behaviours, quality of life, anxiety, mood, sleep quality and treatment compliance. Conclusions: Adding CBT to TAU in prostate cancer patients receiving ADT improved short-term HFNS severity but was not maintained at 6 months. Future research should investigate whether initial CBT benefit could be made sustainable in this setting. Clinical trial information: 58720120.

Ultrasound-derived rates of muscle wasting in the intensive care unit and in the post-intensive care ward for patients with critical illness: Post hoc analysis of an international, multicentre randomised controlled trial of early rehabilitation

Background and aimsMuscle wasting results in weakness for patients with critical illness. We aim to explore ultrasound-derived rates of change in skeletal muscle in the intensive care unit (ICU) and following discharge to the post-ICU ward. DesignPost hoc analysis of a multicentre randomised controlled trial of functional–electrical stimulated cycling, recumbent cycling, and usual care delivered in intensive care. MethodParticipants underwent ultrasound assessment of rectus femoris at ICU admission, weekly in the ICU, upon awakening, ICU discharge, and hospital discharge. The primary outcome was rate of change in rectus femoris cross-sectional area (ΔRFCSA) in mm2/day in the ICU (enrolment to ICU discharge) and in the post-ICU ward (ICU discharge to hospital discharge). Secondary outcomes included rate of change in echo intensity (ΔEI), standard deviation of echo intensity (ΔEISD), and the intervention effect on ultrasound measures. Echo intensity is a quantitative assessment of muscle quality. Elevated echo intensity may indicate fluid infiltration, adipose tissue, and reduced muscle quality. Results154 participants were included (mean age: 58 ± 15 years, 34% female). Rectus femoris cross-sectional area declined in the ICU (−4 mm2/day [95% confidence interval {CI}: −9 to 1]) and declined further in the ward (−9 mm2/day [95% CI: −14 to −3]) with a mean difference between ICU and ward of −5 mm2/day ([95% CI: −2, to 11]; p = 0.1396). There was a nonsignificant difference in ΔEI between in-ICU and the post-ICU ward of 1.2 ([95% CI: −0.1 to 2.6]; p = 0.0755), a statistically significant difference in ΔEISD between in-ICU and in the post-ICU ward of 1.0 ([95% CI, 0.5 to 1.5]; p = 0.0003), and no difference in rate of change in rectus femoris cross-sectional area between groups in intensive care (p = 0.411) or at hospital discharge (p = 0.1309). ConclusionsMuscle wasting occurs in critical illness throughout the hospital admission. The average rate of loss in muscle cross-sectional area does not slow after ICU discharge, even with active rehabilitation.

CINDERELLA clinical trial: Using artificial intelligence–driven healthcare to enhance breast cancer locoregional treatment decisions.

TPS621 Background: Breast cancer treatments often pose challenges in balancing efficacy with quality of life. The CINDERELLA Project pioneers an artificial intelligence (AI)-driven approach (CINDERELLA APP) for shared decision-making process, aiming to harmonise locoregional therapeutic interventions with breast cancer patients' expectations about aesthetic outcomes. The CINDERELLA clinical trial aims to establish a new standard in patient-centred care by bridging the gap between clinical treatment options and patient expectations through innovative technology. The trial focuses on evaluating the effectiveness of the CINDERELLA APP in improving patient satisfaction regarding locoregional treatment aesthetic outcomes, aligning patient expectations with real-world results, and assessing its impact on overall quality of life and psychological well-being. Methods: Trial design and statistical methods: This international multicentric interventional randomised controlled open-label clinical trial will recruit and randomise patients into two groups: one receiving standard treatment information and the other using the AI-powered CINDERELLA APP. The primary objective is to assess the levels of agreement among patients' expectations regarding the aesthetic outcome before and 12 months after locoregional treatment. The trial will also evaluate the aesthetic outcome level of agreement between the AI evaluation tool and self-evaluation. The impact of the intervention on aligning expectations with outcomes will be evaluated using the Wilcoxon signed-rank test. The improvement in classification of aesthetic results post-intervention will be measured by calculating the Weighted Cohen's kappa. Outcomes across different groups will be compared using statistical tests and bootstrap methods. CANKADO functions as the base system, allowing doctors to supervise APP content for patients and handle data gathering, while upholding principles of privacy, data security, and ethical AI practices. Intervention planned: Using the CINDERELLA APP, the patient will have access to supervised medical information approved by breast cancer experts, and the AI system will match patient's information to pictures showing the potential aesthetic outcome (spectrum of good-poor) according to different locoregional approach. Major eligibility criteria: Non-metastatic breast cancer patients eligible for either breast-conserving surgery or mastectomy with immediate reconstruction. Current enrollment: Recruitment is currently open at six study sites. The recruitment started on 8 August 2023, aiming to enroll at least 515 patients/arm. As of January 26, 2024, clinical study sites have successfully randomised 177 patients. Clinical trial information: NCT05196269 .

Improving diagnostic of cervical dysplasia among postmenopausal women aged ≥50 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study)

IntroductionColposcopy is the most important diagnostic tool to detect cervical precancerous lesions and thereby prevention of cervical cancer. Due to age-dependent changes of the cervix, colposcopy is challenging in postmenopausal...

A Multicenter Randomized Controlled Trial of Measurement-Based Care for Major Depressive Disorder in Pakistan

A Multicenter Randomized Controlled Trial of Measurement-Based Care for Major Depressive Disorder in Pakistan

Standard-definition White-light, High-definition White-light versus Narrow-band Imaging Endoscopy for Detecting Colorectal Adenomas: A Multicenter Randomized Controlled Trial.

This study aimed to compare the performance of standard-definition white-light endoscopy (SD-WL), high-definition white-light endoscopy (HD-WL), and high-definition narrow-band imaging (HD-NBI) in detecting colorectal lesions in the Chinese population. This was a multicenter, single-blind, randomized, controlled trial with a non-inferiority design. Patients undergoing endoscopy for physical examination, screening, and surveillance were enrolled from July 2017 to December 2020. The primary outcome measure was the adenoma detection rate (ADR), defined as the proportion of patients with at least one adenoma detected. The associated factors for detecting adenomas were assessed using univariate and multivariate logistic regression. Out of 653 eligible patients enrolled, data from 596 patients were analyzed. The ADRs were 34.5% in the SD-WL group, 33.5% in the HD-WL group, and 37.5% in the HD-NBI group (P=0.72). The advanced neoplasm detection rates (ANDRs) in the three arms were 17.1%, 15.5%, and 10.4% (P=0.17). No significant differences were found between the SD group and HD group regarding ADR or ANDR (ADR: 34.5% vs. 35.6%, P=0.79; ANDR: 17.1% vs. 13.0%, P=0.16, respectively). Similar results were observed between the HD-WL group and HD-NBI group (ADR: 33.5% vs. 37.7%, P=0.45; ANDR: 15.5% vs. 10.4%, P=0.18, respectively). In the univariate and multivariate logistic regression analyses, neither HD-WL nor HD-NBI led to a significant difference in overall adenoma detection compared to SD-WL (HD-WL: OR 0.91, P=0.69; HD-NBI: OR 1.15, P=0.80). HD-NBI and HD-WL are comparable to SD-WL for overall adenoma detection among Chinese outpatients. It can be concluded that HD-NBI or HD-WL is not superior to SD-WL, but more effective instruction may be needed to guide the selection of different endoscopic methods in the future. Our study's conclusions may aid in the efficient allocation and utilization of limited colonoscopy resources, especially advanced imaging technologies.

Effect of Weighted Blanket Versus Traditional Practices on Anxiety and Pain in Patients Undergoing Elective Surgery: A Multicenter Randomized Controlled Trial.

Perioperative anxiety is common in surgical patients and linked to poor outcomes. This multicenter randomized controlled trial assessed the effect of the use of a warm weighted blanket on presurgical anxiety and pain, as well as postsurgical restlessness, nausea, and vomiting. Levels of anxiety and pain were measured in adult patients using a 100-point visual analog scale before elective surgery. Patients received either a warm weighted blanket (n=74) or a traditional sheet or nonweighted blanket (n=74). Patients in the intervention group had significantly lower preoperative anxiety scores (mean [SD]=26.28 [25.75]) compared to the control group (mean [SD]=38.73 [30.55], P=.008). However, the intervention had no significant effect on presurgical pain or postsurgical nausea, vomiting, or restlessness. These results suggest that weighted blankets reduce preoperative anxiety in adult patients.

Efficacy and cost-effectiveness of a digital guided self-management intervention to support transition from intensive care to community care in anorexia nervosa (TRIANGLE): pragmatic multicentre randomised controlled trial and economic evaluation

There is uncertainty regarding how best to support patients with anorexia nervosa following inpatient or day care treatment. This study evaluated the impact of augmenting intensive treatment with a digital, guided, self-management intervention (ECHOMANTRA) for patients with anorexia nervosa and their carers. In this pragmatic multicentre randomised controlled trial and economic evaluation, patients with a diagnosis of anorexia nervosa or atypical anorexia nervosa, aged 16+ and attending one of the 31 inpatient or day-patient services in the UK were randomised with one of their carers to receive ECHOMANTRA plus treatment as usual (TAU), or TAU alone. ECHOMANTRA was hosted on a digital platform and included a workbook, recovery-oriented video-clips and online facilitated groups (patients only, carers only, joint patient-carer). Participants were randomised on a 1:1 ratio using a minimisation algorithm to stratify by site (N=31) and severity (defined by BMI <15 and≥15kg/m2 at baseline). The primary outcome was patient depression, anxiety, and stress at 12months. Primary and secondary outcomes were compared between trial arms on an intention-to-treat basis (ITT). This trial is registered with the ISRSTN registry, ISRCTN14644379. Between July 01, 2017 and July 20, 2020, 371 patient-carer dyads were enrolled and randomly assigned to ECHOMANTRA+TAU (N=185) or TAU alone (N=186). There were no significant differences between trial arms with regards to the primary outcome (completed by N=143 patients in the TAU group, Mean=61.7, SD=29.4 and N=109 patients in the ECHOMANTRA+TAU group, Mean=58.3, SD=26.9; estimated mean difference 0.48 points; 95% CI-5.36 to 6.33; p=0.87). Differences on secondary outcomes were small and non-significant (standardised effect size estimates ≤0.25). Five patients died (2 from suicide and 3 from physical complications) over the course of the trial, and this was unrelated to their participation in the study. ECHOMANTRA added to TAU was not superior to TAU alone in reducing patient depression, anxiety, and stress symptoms. This may be explained by limited engagement with the intervention materials and changes in usual care practices since the beginning of the trial. National Institute for Health Research (NIHR), under its Health Technology Assessment Programme (HTA) Programme (Grant Reference Number 14/68/09). NIHR Maudsley Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust and Institute of Psychiatry, Psychology and Neuroscience, and King's College London. NIHR Applied Research Collaboration South London (NIHR ARC South London) at King's College Hospital NHS Foundation Trust.

Myopia Control Effect of Repeated Low-Level Red-Light Therapy Combined with Orthokeratology: A Multicenter Randomized Controlled Trial

To investigate the efficacy and safety of repeated low-level red-light(RLRL) therapy combined with orthokeratology(Ortho-k) among the children who, despite undergoing Ortho-k treatment, exhibited an axial elongation of at least 0.50mm over 1 year. Multicenter, randomized, parallel-group, single-blind clinical trial (ClinicaTrials.gov,NCT04722874). Eligible children were aged 8-13 years with a cycloplegic spherical equivalent refraction of -1.00 to -5.00 diopters in the initial Ortho-k fitting examination and had annual axial length (AL) elongation ≥ 0.50 mm despite undergoing Ortho-k for 1 year. A total of 48 children were enrolled from March 2021 to January 2022, and the final follow-up was completed in March 2023. Children were randomly assigned to the RLRL combined with Ortho-k(RCO) or the Ortho-k group in a 2:1 ratio. The Ortho-k group wore Ortho-k at least 8 hours per night, while the RCO group received daily RLRL therapy twice a day for 3 minutes in addition to Ortho-k wearing. The primary outcome was AL change measured at 12 months relative to baseline. The primary analysis was conducted in children who received the assigned intervention and completed at least 1 post-randomization follow-up using the modified intention-to-treat principle. A total of 47(97.9%) children were included in the analysis (30 in the RCO group and 17 in the Ortho-k group). The mean axial elongation rate before the trial was 0.60mm/year in the RCO group and 0.61mm/year in the Ortho-k group. After 12 months following the intended intervention, the adjusted mean AL changes were -0.02mm(95% CI, -0.08 to +0.03 mm) in the RCO group and 0.27mm(0.19-0.34 mm) in the Ortho-k group. The adjusted mean difference in AL change was -0.29mm(-0.44 to -0.14mm) between the RCO and Ortho-k groups. The percentage of children achieving an uncorrected visual acuity greater than 20/25 was similar in the RCO (64.3%) and Ortho-k (65.5%) groups (Chi2 test, P=0.937). Combining RLRL therapy with Ortho-k may offer a promising approach to optimize axial elongation control among myopic children. This approach also potentially allows children to achieve satisfactory visual acuity, reducing the daytime dependence on corrective eyewear.