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Protocol for development of a checklist and guideline for transparent reporting of cluster analyses (TRoCA)

Por: Lisik · D. · Shah · S. A. · Basna · R. · Dinh · T. · Browne · R. P. · Andrews · J. L. · Wallace · M. · Ezugwu · A. · Marusic · A. · Tran · D. · Torres-Sospedra · J. · Dam · H.-C. · Fournier-Viger · P. · Hennig · C. · Timmerman · M. · Warrens · M. J. · Ceulemans · E. · Nwaru · B. I. · Herna
Introduction

Cluster analysis, a machine learning-based and data-driven technique for identifying groups in data, has demonstrated its potential in a wide range of contexts. However, critical appraisal and reproducibility are often limited by insufficient reporting, ultimately hampering the interpretation and trust of key stakeholders. The present paper describes the protocol that will guide the development of a reporting guideline and checklist for studies incorporating cluster analyses—Transparent Reporting of Cluster Analyses.

Methods and analysis

Following the recommended steps for developing reporting guidelines outlined by the Enhancing the QUAlity and Transparency Of health Research Network, the work will be divided into six stages. Stage 1: literature review to guide development of initial checklist. Stage 2: drafting of the initial checklist. Stage 3: internal revision of checklist. Stage 4: Delphi study in a global sample of researchers from varying fields (n=) to derive consensus regarding items in the checklist and piloting of the checklist. Stage 5: consensus meeting to consolidate checklist. Stage 6: production of statement paper and explanation and elaboration paper. Stage 7: dissemination via journals, conferences, social media and a dedicated web platform.

Ethics and dissemination

Due to local regulations, the planned study is exempt from the requirement of ethical review. The findings will be disseminated through peer-reviewed publications. The checklist with explanations will also be made available freely on a dedicated web platform (troca-statement.org) and in a repository.

Effect of music listening on delirium after hip fracture operations (MLDHFO) in a regional hospital in Taiwan: a randomised controlled trial protocol

Por: Chao · L.-Y. · Lin · C.-C. · Wang · L. · Lu · H.-J. · Chen · J.-L. · Ku · H.-C.
Introduction

Postoperative delirium is a serious complication occurring in 10.09%–51.28% of geriatric patients undergoing surgery for hip fractures. Delirium has resulted in poorer functional recovery, increased readmission rates, repeat surgeries and elevated mortality. Perioperative music listening is a promising non-pharmacological intervention with beneficial effects on delirium. This trial aims to evaluate the effect of perioperative music listening on postoperative delirium in patients with femur fracture undergoing surgery.

Methods and analysis

The music listening on clinical outcome after hip fracture operations study is an investigator-initiated, randomised controlled, clinical trial. 102 patients with femur fracture meeting eligibility criteria will be randomised to the music listening intervention or control group with concealed allocation. The perioperative music intervention consists of preselected lists totalling 4 hours of music (classical, jazz and pop). The primary outcome is postoperative delirium rate. Secondary outcome measures include pain score and opioid medication requirement, postoperative complications, hospital length of stay, 14-day readmission rate and 30-day mortality. A 90-day follow-up will be performed in order to assess readmission rate and mortality rate. Data will be analysed according to an intention-to-treat principle.

Ethics and dissemination

The study protocol was approved by the Research Ethics Committee of Ditmanson Medical Foundation of Chia-Yi Christian Hospital (IRB2023084). The trial will be carried out following the Declaration of Helsinki principles and Good Clinical Practice guidelines. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal and presented at scientific conferences. Data availability statement: data generated by this study will be made available on reasonable request. A data sharing plan has been submitted to ClinicalTrials.gov in compliance with ICMJE (International Committee of Medical Journal Editors) and BMJ Open data policies.

Trial registration number

NCT06209788.

Effectiveness of electroacupuncture for the treatment of refractory overactive bladder disease in women: study protocol for a randomised controlled clinical trial

Por: Wang · H.-Y. · Ji · Y. · Zhang · S. · Zhao · H.-C. · Ding · Y.
Introduction

Overactive bladder (OAB) is a common condition, affecting approximately one-fifth to one-sixth of the world’s population. The American Urological Association and the Society of Urodynamics, Female Pelvic Medicine and Genitourinary Reconstruction guidelines recommend sacral neuromodulation (SNM) as third-line treatment. Although SNM can relieve the symptoms of refractory OAB, several factors, including high cost and the high incidence of adverse effects, limit its large-scale clinical use. Moreover, patient acceptance is low. Acupuncture is an alternative approach for treating OAB that is minimally invasive and has few side effects. Clinical studies have shown that it can reduce the number of episodes of urination and urgent urination within 24 hours and improve the quality of life. However, clinical evidence on the effectiveness of electroacupuncture for treating refractory OAB is limited.

The primary objective of this study

Is to assess the short-term effectiveness of electroacupuncture for improving the symptoms and quality of life of women with refractory OAB and to observe its long-term effects. A secondary objective is to assess whether electroacupuncture is more effective than conventional acupuncture for treating patients with refractory OAB.

Methods and analysis

The study is designed as a two-arm, parallel, participant-blinded randomised controlled trial (RCT). A total of 60 women between the ages of 18 years and 60 years who are experiencing refractory OAB will be randomly assigned to two groups: one receiving electroacupuncture and the other receiving conventional acupuncture. Each participant will undergo a treatment regimen lasting 4 weeks. During the initial 2 weeks, participants will receive five sessions of either electroacupuncture or conventional acupuncture per week, followed by three sessions per week during the subsequent 2 weeks. In total, each individual will receive 16 treatment sessions throughout the course of the study. The primary outcome measure will be the change in OAB Symptom Score (OABSS) over time between groups. The secondary outcome measures will include the OABSS, the Patient-Perceived Bladder Symptom Grading Scale, the Overactive Bladder Questionnaire, the Self-Rating Anxiety Scale and the Self-Rating Depression Scale during the treatment and follow-up periods. Blinding and safety will also be assessed. Two-sided p values

Ethics and dissemination

The study protocol was approved by the Institutional Review Board of Beijing Fengtai Hospital of Integrated Traditional and Western Medicine on 5 February 2024 (Approval No. 2024020101). The results will be disseminated through presentations at scientific conferences and peer-reviewed publications.

Trial registration number

ChiCTR2400081448.

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