BACKGROUND: The purpose of this protocol is to investigate the risk factors, critical evaluation contents and preventive measures of high-output enterostomy.
METHODS: This scoping review will follow the Joanna Briggs Institute guidelines for scoping reviews. PubMed, EMBASE, CINAHL, the Chinese Biological Literature Database and the Cochrane Library will be searched for relevant literature published from January 2015 to January 2024. The Grading of Recommendations, Assessment, Development and Evaluation and the Risk Of Bias In Non-randomised Studies of Interventions will be used to assess the reliability of the evidence.
BACKGROUND: As this scoping review involves database searches for literature analysis, informed consent and ethical approval from patients will not be required. The findings will provide essential decision-making information for researchers, clinicians and ostomy nursing staff. The results of the review will be presented at a scientific conference and published in a peer-reviewed journal.

BACKGROUND: Coronary microcirculation dysfunction (CMD) is prevalent in patients with coronary artery disease (CAD). Current therapies for CMD are focused on pharmacotherapy, non-pharmacological treatments such as enhanced external counterpulsation (EECP) have shown favourable results in patients with CAD. However, whether EECP can improve CMD remains unknown. This study is designed to evaluate the effectiveness of EECP on CMD in patients with CAD, and to assess the feasibility of conducting a multicentre randomised controlled trial.
METHODS: This study is a single-centre, outcome-assessor-blinded, parallel randomised controlled trial. A total of 110 participants with CAD will be included and randomly assigned to either the intervention group (EECP plus optimal medical therapy (OMT)) or the control group (OMT alone). EECP will be administered by operators for 60 min, 5 times per week for 7 weeks (35 times in total). Outcomes include patients\' retention rates, the primary outcome and secondary outcomes. The primary outcome is the change in Myocardial Perfusion Reserve Index with cardiac MRI from baseline to the end of follow-up. The planned study duration is from 2024 to 2026.
BACKGROUND: Ethical approval was obtained from the Ethics Committee of the Eighth Affiliated Hospital, Sun Yat-sen University (ID: 2023-045-03). The findings will be disseminated in peer-reviewed publications.
BACKGROUND: ChiCTR2300076231.

BACKGROUND: Peripheral vasodilation causes a redistribution of body temperature from the core to the periphery, resulting in shivering and hypothermia. These are normal pathological and physiological processes during spinal anaesthesia. Two drugs, norepinephrine and phenylephrine, have peripheral vasoconstrictive effects. It is unclear the effects of norepinephrine and phenylephrine on shivering and hypothermia in patients undergoing caesarean section under spinal anaesthesia.
UNASSIGNED: 240 eligible parturients will be recruited for this randomised, double-blind, controlled trial and randomly assigned to either the norepinephrine or phenylephrine groups. The primary outcome will be the incidence of shivering while secondary outcomes will include the severity of shivering, rectal temperature, incidence of hypothermia and umbilical artery blood pH value.
BACKGROUND: The Institutional Ethics Committee of The Second People\'s Hospital of Hefei approved the trial protocol (ID: 2023-093). The results will be published in a compliant journal. The original data will be released in December 2029 on the ResMan original data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn).
BACKGROUND: ChiCTR2300077164.

BACKGROUND: The estimated prevalence of postpartum depression (PPD) worldwide, in China, and Shanghai is 17.2%, 18.0% and 23.2%, respectively. In 2021, Shanghai housed a population of 3.2 million childbearing-age migrant women, most of whom migrated to the city with their husbands for economic reasons. There is a general lack of help-seeking behaviour for mental disorders in China due to the perceived risk of social stigmatisation. In Shanghai, 70% of women did not seek professional help for perinatal mental health problems. We aim to gather information from multiple perspectives, such as the migrant women with PPD and perinatal depression (PND), their caregivers, health service providers and communities, to understand the help-seeking behaviour of postpartum migrant women with PPD or PND in China.
METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework for Scoping Reviews will guide this review. A bilingual research librarian developed a comprehensive search strategy to retrieve published and unpublished English and Chinese studies involving factors influencing women\'s PPD or PND help-seeking behaviour in China. This literature includes perceptions, views, patterns, acceptance and refusal, tendencies, probability, service accessibility and utilisation, and facts. We will search PubMed, Embase, Web of Science and CINAHL for English literature and CINKI for Chinese literature. Backward and forward snowball approaches will be used to identify additional relevant papers from the reference lists of selected papers. Two independent reviewers will screen the title and abstract and review the full text of selected papers to identify eligible articles for data extraction. We will build a Microsoft Access database to record the extracted data. The results will be presented in tables and a causal map to demonstrate the relationships between extracted variables and help-seeking behaviours for PPD and PND. A conceptual simulation model will be formulated based on the information from the literature to validate the logic of the relationships between variables, identify knowledge gaps and gain insights into potential intervention approaches. Experts and stakeholders will be invited to critique and comment on the results during group model building (GMB) workshops in Shanghai. These comments will be essential to validate the findings, receive feedback and obtain additional insights.
BACKGROUND: The literature review component of our study does not require ethical approval because the information and data collected will be obtained from publicly available sources and will not involve human subjects. Our collaborating research partner, International Peach Maternal Child Hospital, obtained the IRB approval (GKLW-A-2023-020-01) for screening and enrolling participants in GMB workshops. Stanford University received IRB approval under protocol number 67 419. The full review will be presented at a relevant conference and submitted to a peer-reviewed scientific journal for publication to report findings.

BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), currently marketed for type 2 diabetes and obesity, may offer novel mechanisms to delay or prevent neurotoxicity associated with Alzheimer\'s disease (AD). The impact of semaglutide in amyloid positivity (ISAP) trial is investigating whether the GLP-1 RA semaglutide reduces accumulation in the brain of cortical tau protein and neuroinflammation in individuals with preclinical/prodromal AD.
METHODS: ISAP is an investigator-led, randomised, double-blind, superiority trial of oral semaglutide compared with placebo. Up to 88 individuals aged ≥55 years with brain amyloid positivity as assessed by positron emission tomography (PET) or cerebrospinal fluid, and no or mild cognitive impairment, will be randomised. People with the low-affinity binding variant of the rs6971 allele of the Translocator Protein 18 kDa (TSPO) gene, which can interfere with interpreting TSPO PET scans (a measure of neuroinflammation), will be excluded.At baseline, participants undergo tau, TSPO PET and MRI scanning, and provide data on physical activity and cognition. Eligible individuals are randomised in a 1:1 ratio to once-daily oral semaglutide or placebo, starting at 3 mg and up-titrating to 14 mg over 8 weeks. They will attend safety visits and provide blood samples to measure AD biomarkers at weeks 4, 8, 26 and 39. All cognitive assessments are repeated at week 26. The last study visit will be at week 52, when all baseline measurements will be repeated. The primary end point is the 1-year change in tau PET signal.
BACKGROUND: The study was approved by the West Midlands-Edgbaston Research Ethics Committee (22/WM/0013). The results of the study will be disseminated through scientific presentations and peer-reviewed publications.
BACKGROUND: ISRCTN71283871.

BACKGROUND: The onset of cancer compels patients to grapple with existential questions. Enabling individuals with cancer, irrespective of the disease stage, to experience meaningful lives is of utmost importance in enhancing their overall quality of life. This study will synthesise qualitative research evidence to understand cancer patients\' perceptions and perspectives regarding their meaning in life. Such insights ultimately contribute to enhancing the profound experience of meaning throughout the life course of cancer patients.
METHODS: The English and Chinese databases we will search include the Cochrane Library, PubMed, MEDLINE, Web of Science, EMbase, CINAHL, PsycINFO, China National Knowledge Infrastructure, Wan Fang Data, Chinese Biomedical Literature Database and VIP Database for Chinese Technical Periodicals. Two independent reviewers will assess the quality of the included studies using the standard JBI Critical Appraisal Checklist for Qualitative Research and extract data using the standard JBI Data Extraction Tool for Qualitative Research. The JBI meta-aggregation approach will be employed to compare, analyse and summarise the original results. To enhance confidence in the synthesised results of the qualitative study, the final synthesised study results will be graded using the JBI ConQual approach.
BACKGROUND: External ethical approval is not necessary for this review since it involves a retrospective analysis of publicly available primary data through secondary analysis. The findings of the review will be disseminated by publishing them in a peer-reviewed journal.
UNASSIGNED: CRD42023447664.

BACKGROUND: Patients with liver cancer are susceptible to experiencing a decline in muscle mass and function, which can lead to physical frailty and have a negative impact on prognosis. However, there is currently a lack of physical activity interventions specifically tailored for these patients. Therefore, we have developed a modular multimodal hospital-home chain physical activity rehabilitation programme (3M2H-PARP) designed specifically for patients with liver cancer undergoing transarterial chemoembolisation (TACE). We aim to validate the effectiveness and feasibility of this programme through a randomised controlled trial (RCT).
METHODS: 3M2H-PARP RCT will compare a 12-week, modular, multimodal physical activity rehabilitation programme that includes supervised exercise in a hospital setting and self-management exercise at home. The programmes consist of aerobic, resistance, flexibility and balance exercise modules, and standard survivorship care in a cohort of liver cancer survivors who have undergone TACE. The control group will receive standard care. A total of 152 participants will be randomly assigned to either the 3M2H-PARP group or the control group. Assessments will be conducted at three time points: baseline, after completing the intervention and a 24-week follow-up visit. The following variables will be evaluated: liver frailty index, Functional Assessment of Cancer Therapy-Hepatobiliary subscale, Cancer Fatigue Scale, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale and physical activity level. After the completion of the training programme, semi-structured interviews will be conducted with participants from the 3M2H-PARP group to investigate the programme\'s impact on their overall well-being. SPSS V.26.0 software will be used for statistical analyses.
BACKGROUND: Ethical approval has been granted by the Jiangnan University School of Medicine Research Ethics Committee. The findings will be disseminated through publication in a peer-reviewed journal.
BACKGROUND: ChiCTR2300076800.

BACKGROUND: With an increasing incidence and significant effects on patients, tinnitus has become a major disease burden. There is a dearth of therapies with established efficacy for tinnitus. Transcutaneous auricular vagus nerve stimulation (ta-VNS) is being investigated as a potential therapy for tinnitus, but the current body of evidence remains inconclusive due to conflicting results across different studies. As a result, this protocol aims to synthesise and update the evidence to clarify whether ta-VNS is effective and safe for alleviating tinnitus.
METHODS: To identify relevant randomised controlled trials (RCTs), seven representative bibliographical databases will be searched from their inception to December 2023: PubMed, Embase (via OVID), Cochrane Library, Chinese National Knowledge Infrastructure, Wangfang Database, Chinese BioMedical Literature Database, and Chongqing VIP Chinese Science and Technology Periodical Database. Publications in English or Chinese will be considered for inclusion. RCTs comparing ta-VNS with active treatments, no intervention, waitlist control or sham ta-VNS in adult patients with subjective tinnitus will be included. Studies on objective tinnitus will be excluded. Primary outcome is tinnitus symptom severity measured by validated scales. With all eligible trials included, when applicable, quantitative analysis via meta-analyses will be performed using RevMan V.5.4.1 software. Otherwise, a qualitative analysis will be conducted. The methodological quality of the included RCTs will be assessed using the Risk of Bias 2.0 tool. Sensitivity analyses, subgroup analysis and publication bias evaluation will also be performed. The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to grade the certainty of the evidence.
BACKGROUND: Ethical approval is not required for this systematic review, as no primary data will be collected. The results will be reported and disseminated through publication in a peer-reviewed journal.
UNASSIGNED: CRD42022351917.

BACKGROUND: Cardiopulmonary complications and cognitive impairment following craniotomy have a significantly impact on the general health of individuals with brain tumours. Observational research indicates that engaging in walking is linked to better prognosis in patient after surgery. This trial aims to explore whether walking exercise prior to craniotomy in brain tumour patients can reduce the incidence of cardiopulmonary complications and preserve patients\' cognitive function.
METHODS: In this randomised controlled trial, 160 participants with supratentorial brain tumours aged 18-65 years, with a preoperative waiting time of more than 3-4 weeks and without conditions that would interfere with the trial such as cognitive impairment, will be randomly assigned in a ratio of 1:1 to either receive traditional treatment or additional combined with a period of 3-4 weeks of walking exercise of 10 000-15 000 steps per day. Wearable pedometer devices will be used to record step counts. The researchers will evaluate participants at enrolment, baseline, 14 days preoperatively, 3 days prior to surgery and 1 week after surgery or discharge (select which occurs first). The primary outcomes include the incidence of postoperative cardiopulmonary complications and changes in cognitive function (gauged by the Montreal Cognitive Assessment test). Secondary outcomes include the average length of hospital stay, postoperative pain, participant contentment, healthcare-associated costs and incidence of other postoperative surgery-related complications. We anticipate that short-term preoperative walking exercises will reduce the incidence of surgery-related complications in the short term after craniotomy, protect patients\' cognitive function, aid patients\' postoperative recovery and reduce the financial cost of treatment.
BACKGROUND: The study protocol has been approved by Ethics Committee of Xiangya Hospital of Central South University (approval number: 202305117). The findings of the research will be shared via publications that have been reviewed by experts in the field and through presentations at conferences.
BACKGROUND: NCT05930288.

BACKGROUND: Subjective cognitive decline means a decline in the subjective perception of self-cognitive function, which is likely to evolve into mild cognitive impairment and dementia. The number of elderly with subjective cognitive decline has increased, bringing huge burdens and challenges to caregivers and society. With the increase in research on art therapies, some of them have gradually been proven to be effective for cognitive function. Therefore, this study aims to summarise the evidence and identify the best art therapy for elderly with subjective cognitive decline.
METHODS: We will include published randomised controlled trials written in English and Chinese if the intervention is one of the art therapies and applied in people aged 60 and above with subjective cognitive decline. Eight electronic databases, including the Cochrane Central Register of Controlled Trials, PubMed, Web of Science, Elsevier, China BioMedical Literature Database, China National Knowledge Infrastructure, VIP Database and Wanfang Database, will be searched from January 2013 to December 2023. Art therapies will mainly include music therapy, reminiscence therapy, painting therapy, dance therapy, reading therapy, horticultural therapy, museum therapy, calligraphy therapy and so on. The outcome will be cognitive function. Study selection, data extraction and quality assessment will be performed by two reviewers. The risk of bias will be evaluated according to the Cochrane Collaboration\'s risk-of-bias tool, and the evidence quality will be assessed with the Grading of Recommendations Assessment, Development and Evaluation. Standard pairwise meta-analysis and Bayesian network meta-analysis will be conducted. The probabilities of each art therapy will be ranked based on the surface under the cumulative ranking curve.
BACKGROUND: Ethical approval is not required for reviewing published studies. To provide important evidence for clinicians and guideline developers, the findings of this study will be submitted to a peer-reviewed journal.
UNASSIGNED: CRD42023443773.