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Association between indoor air pollution and depression: a systematic review and meta-analysis of cohort studies

Por: Zhang · X. · Ding · L. · Yang · F. · Qiao · G. · Gao · X. · Xiong · Z. · Zhu · X.
Objectives

Incomplete combustion of solid fuel and exposure to secondhand smoke (SHS) are the primary causes of indoor air pollution (IAP), potentially leading to detrimental effects on individual mental health. However, current evidence regarding the association between IAP and depression remains inconclusive. This study aims to systematically investigate the evidence regarding the association between IAP and the risk of depression.

Design

Systematic review and meta-analysis of cohort studies.

Data sources

Two independent reviewers searched PubMed, the Cochrane Library, Web of Science and EMBASE for available studies published up to 13 January 2024.

Eligibility criteria

We included all cohort studies published in English that aimed to explore the relationship between IAP from solid fuel use and SHS exposure and the risk of depression.

Data extraction and synthesis

Two independent reviewers extracted data and assessed the risk of bias. The association between IAP and depression was calculated using pooled relative risk (RR) with 95% CIs. Heterogeneity was assessed using the I2 value, and the effect estimates were pooled using fixed-effects or random-effects models depending on the results of homogeneity analysis.

Results

We included 12 articles with data from 61 217 participants. The overall findings demonstrated a significant association between IAP exposure and depression (RR=1.22, 95% CI: 1.13 to 1.31), although with substantial heterogeneity (I2=75%). Subgroup analyses based on pollutant type revealed that IAP from solid fuel use was associated with a higher risk of depression (RR=1.20, 95% CI: 1.13 to 1.26; I2=62%; 5 studies, 36 768 participants) than that from SHS exposure (RR=1.11, 95% CI: 0.87 to 1.41; I2=80%; 7 studies, 24 449 participants). In terms of fuel use, the use of solid fuel for cooking (RR: 1.23, 95% CI: 1.16 to 1.31; I2=58%; 4 studies, 34 044 participants) and heating (RR 1.15, 95% CI: 1.04 to 1.27; I2=65%; 3 studies, 24 874 participants) was associated with increased depression risk.

Conclusions

The findings from this systematic review and meta-analysis of cohort studies indicated an association between exposure to IAP and depression.

PROSPERO registration number

CRD42022383285.

The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema - study protocol of a multicentre, randomised sham-controlled trial

Por: Kleeven · A. · Jonis · Y. M. J. · Tielemans · H. · van Kuijk · S. · Kimman · M. · van der Hulst · R. · Vasilic · D. · Hummelink · S. · Qiu · S. S.
Introduction

Cancer-related lymphoedema is one of the most debilitating side-effects of cancer treatment with an overall incidence of 15.5%. Patients may suffer from a variety of symptoms, possibly resulting in a diminished health-related quality of life (HRQoL). A microsurgical technique known as lymphaticovenous anastomosis (LVA) might be a promising treatment option. The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL.

Methods and analysis

A multicentre, double-blind, randomised sham-controlled trial conducted in three university hospitals in the Netherlands. The study population comprises 110 patients over the age of 18 years with unilateral, peripheral cancer-related lymphoedema, including 70 patients with upper limb lymphoedema and 40 patients with lower limb lymphoedema. A total of 55 patients will undergo the LVA operation, while the remaining 55 will undergo sham surgery. The follow-up will be at least 24 months. Patients are encouraged to complete the follow-up by explaining the importance of the study. Furthermore, patients may benefit from regular monitoring moments for their lymphoedema. The primary outcome is the HRQoL. The secondary outcomes are the limb circumference, excess limb volume, changes in conservative therapy, postoperative complications, patency of the LVA and incremental cost-effectiveness.

Ethics and dissemination

The study was approved by the Medical Ethical Committee of Maastricht University Medical Center on 20 September 2023 (NL84169.068.23). The results will be presented at scientific conferences and published in peer-reviewed medical journals.

Trial registration number

NCT06082349.

Association between the triglyceride to high-density lipoprotein cholesterol ratio and mortality in Chinese maintenance haemodialysis patients: a retrospective cohort study

Por: Qi · L. · Zhang · A. · Zhang · Y. · Ren · Z. · Zhao · C. · Wang · Q. · Ren · K. · Bai · J. · Cao · N.
Objective

To investigate the relationship between the triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio and all-cause and cardiovascular (CV) mortality in Chinese haemodialysis (HD) patients.

Design

Retrospective cohort study.

Setting

Patients from June 2015 to September 2016 and followed through September 2021 were categorised into quartiles according to the follow-up averaged TG/HDL-C ratio. The association between TG/HDL-C and mortality was examined by univariate and multivariate time-varying Cox regression analyses. The C-index was used to assess the predictive accuracy of the Cox regression models.

Participants

A total of 534 maintenance HD patients were enrolled.

Primary and secondary outcome measures

The outcomes were all-cause death and CV mortality.

Results

During the median follow-up of 61 months, 207 patients died, with 94 (45.4%) classified as CV death. After adjusting for confounders, multivariate time-varying Cox regression analysis showed that the quartile 4 group (TG/HDL-C ≥2.64) was associated with decreased all-cause mortality (adjusted HR 0.51, 95% CI 0.33–0.77, p=0.001) and CV mortality (adjusted HR 0.31; 95% CI 0.16 to 0.62; p=0.001) in maintenance HD patients. Model 1 of all-cause mortality achieved a C-index of 0.72 (95% CI 0.68 to 0.75), and model 2 achieved a C-index of 0.77 (95% CI 0.73 to 0.82). The C-index for model 1 in CV mortality was 0.74 (95% CI 0.70 to 0.77), and the C-index for model 2 was 0.80 (95% CI 0.75 to 0.84).

Conclusions

High TG/HDL-C was associated with decreased all-cause and CV mortality in HD patients.

Real-world treatment patterns and clinical outcomes from a retrospective chart review study of patients with recurrent or advanced endometrial cancer who progressed following prior systemic therapy in Europe

Por: Zhang · J. · Kelkar · S. S. · Prabhu · V. S. · Qiao · Y. · Grall · V. · Miles · N. · Marth · C.
Objective

To evaluate real-world treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer patients who progressed following prior systemic therapy in clinical practice in Europe.

Design

Endometrial Cancer Health Outcomes-Europe (ECHO-EU) is a retrospective patient chart review study.

Setting

ECHO-EU is a multicentre study conducted in the UK, Germany, Italy, France and Spain.

Participants

Patients with recurrent/advanced endometrial cancer who progressed between 1 July 2016 and 30 June 2019 following prior first-line systemic therapy were eligible and data were collected until last available follow-up through November 2021.

Primary and secondary outcome measures

Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed since initiation of second-line therapy to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS) and overall survival (OS).

Results

A total of 475 patients were included from EU5 countries. Median age was 69 years at advanced endometrial cancer diagnosis, 78.7% had stage IIIB–IV disease, 45.9% had Eastern Cooperative Oncology Group status ≥2 at second-line therapy initiation. In second line, a majority of patients initiated either non-platinum-based chemotherapy (55.6%) or endocrine therapy (16.2%). Physician-reported real-world overall response rate (classified as complete or partial response) to second-line therapy was 34.5%, median rwPFS was 7.4 months (95% CI 6.2 to 8.0) and median OS was 11.0 months (95% CI 9.9 to 12.3).

Conclusions

Patients had poor clinical outcomes with a median OS of

Comparison of the effects of different functional exercise sequences on lymphedema in breast cancer: protocol for an exploratory randomised controlled cross-over trial

Por: Qiu · L. · Wu · J. · Huang · Y. · Ye · M. · Song · L. · Huang · H. · Jin · Y.
Introduction

Breast cancer-related lymphedema (BCRL) is a common postoperative complication of breast cancer. It develops in a chronic and vicious cycle. Once lymphedema occurs, it cannot be cured and bring serious physiological, psychological, social and economic burden to patients. Upper limb functional exercises are an effective and convenient intervention for managing lymphedema. However, the optimal exercise sequence remains unclear. Therefore, we aim to compare the effects of exercise sequences under the guidance of commonly used exercise sequences and lymphatic flow theory.

Methods

An exploratory randomised controlled cross-over trial will be conducted. 32 patients with BCRL are randomly allocated into two groups (group A and group B). Group A patients will perform functional exercise from wrist joint to shoulder joint, and the exercise direction of group B is opposite to that of group A, that is, from shoulder joint to wrist joint end. Exercise time is once a day, each 20–30 min, for 2 weeks. After 2 weeks of washout period, A and B groups of exchange exercise sequences (exercise frequency and duration unchanged). The primary outcome is upper limb circumference, and secondary outcomes are upper limb function and lymphedema symptoms.

Ethics and dissemination

This study protocol is presented in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines. All participants will sign a written informed consent. The research ethics regional committee of Shanghai Seventh People’s Hospital has approved the study. Regardless of the outcome of this study, the results will be published in open-access journals to ensure public access.

Trial registration number

ChiCTR2200066463.

Telephone-based telepsychiatry consultations: a qualitative exploration of psychiatrists experiences in Oman

Por: Al-Mahrouqi · T. · Al-Alawi · K. · Al-Sabahi · F. · Al-Harrasi · A. · Al-Sinawi · H. · Al-Balushi · N. · Al-Shekaili · M. · Al-Alawi · M.
Objectives

The utilisation of tele-mental health services has the potential to address challenges in mental health services within the Eastern Mediterranean Region. However, the adoption of tele-mental health in Oman remains limited. Therefore, this study aimed to explore the experiences of psychiatrists with telephone consultations, offering valuable insights to advance the field of telepsychiatry.

Design

This is a qualitative exploratory study. The analysis of the data involved the application of manifest content analysis.

Setting

The semi-structured interviews were conducted with the psychiatrists at Al Masarra Hospital.

Participants

A total of 10 semi-structured interviews were conducted.

Results

The study reveals that psychiatrists encounter communication challenges in telephone consultations, such as the absence of visual cues, confirming patient identity, conducting comprehensive assessments and effectively communicating with younger patients who may lack developed social skills or patients with specific health conditions. Infrastructure limitations, such as outdated medical records, lack of electronic prescriptions and limited availability of child/adolescent psychiatric medications, further restrict the effectiveness of telepsychiatry consultations. In contrast, telephone appointments offer convenience and flexibility for psychiatrists, allowing them to manage non-clinical responsibilities and provide focused consultations tailored to individual needs. In addition, it benefits patients by improving appointment adherence, diminishing stigma and financial savings compared with in-person consultations.

Conclusions

Tele-mental health has emerged as a promising avenue for enhancing mental healthcare services in Oman. Addressing psychiatrists’ challenges is crucial to further developing and strengthening these services.

Risk factors for medical adhesive-related skin injury at the site of peripherally inserted central venous catheter placement in patients with cancer: a single-centre prospective study from China

Por: Qi · M. · Qin · Y. · Meng · S. · Feng · N. · Meng · Y.
Objectives

This study aims to explore the incidence of, and risk factors for medical adhesive-related skin injury (MARSI) at peripherally inserted central venous catheter (PICC) sites in patients with cancer.

Design

A prospective observational cohort study was conducted at a tertiary hospital in Shenzhen, China.

Setting

This was a single-centre study conducted in a tertiary hospital in Shenzhen, China.

Participants

A total of 340 patients with cancer and PICC placement from January 2022 to June 2023 were selected using a convenience sampling method.

Methods

Factors potentially associated with PICC-related MARSI (PICC-MARSI) were recorded, including patient demographics, and catheter placement and maintenance. Patients were divided into MARSI and non-MARSI groups. Univariate analysis was performed to screen for associated variables, and logistic regression analysis was used to identify independent risk factors for PICC-MARSI.

Results

Of all 340 patients enrolled, 33 (9.7%) developed PICC-MARSI, including skin tear (8, 24.2%), tension injury (5, 15.2%), irritant contact dermatitis (10, 30.3%), allergic dermatitis (7, 21.2%) and maceration (3, 9.1%). Multivariable analysis showed that age (OR=1.058, p=0.001, 95% CI 1.023–1.094), wet skin (OR=4.873, p=0.003, 95% CI 1.728–13.742), dry skin (OR=6.247, p

Conclusions

Proper catheter maintenance and appropriate dressing selection are crucial for the prevention of this condition.

Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol

Por: Wu · L. · Yan · H. · Qin · Y. · Huang · M. · Wang · T. · Jin · Q. · Wei · W.
Introduction

Curing locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ) with surgery alone is challenging. Neoadjuvant chemotherapy (NCT) has become the standard treatment for patients with locally advanced GC/GEJ, and SOX is the most common neoadjuvant regimen in China. The generally good tolerability in patients and fruquintinib’s low potential for drug–drug interaction suggest that it may be highly suitable for combinations with other antineoplastic therapies. A combination of fruquintinib, S-1 and oxaliplatin can be a promising neoadjuvant treatment for locally advanced GC/GEJ. In this phase II study, we aim to investigate the efficacy and toxicity of fruquintinib plus SOX as neoadjuvant treatment for locally advanced GC/GEJ.

Methods and analysis

The FRUTINEOGA trial is a prospective, multicentre, phase II, single-arm, open-label clinical trial that will enrol 54 patients. Eligible patients will be registered, enrolled and receive 2–4 cycles of fruquintinib plus SOX, after which surgery will be performed and tumour regression will be evaluated. The primary endpoint is the pathological remission rate, and the secondary endpoints are disease-free survival, overall survival, objective response rate, major pathological response rate and R0 resection rate.

Ethics and dissemination

Written informed consent will be required from all patients enrolled, and it will be provided by them. The study protocol received approval from the independent ethical review committee of Guangxi Medical University Cancer Hospital, Wuming Hospital of Guangxi Medical University and Wuzhou Red Cross Hospital, Wuzhou Gongren Hospital (approval number: CS2021(96)). We will submit the finalised paper for publication on completing the analyses. This study will provide valuable insights to clinicians regarding the safety and efficacy of incorporating fruquintinib into SOX as neoadjuvant treatment for locally advanced GC/GEJ. The findings have the potential to inform future research proposals and may guide the use of fruquintinib in the neoadjuvant setting for locally advanced GC/GEJ.

Trial registration number

NCT05122091.

Insight into Private General Physicians Practices: an Exploratory Qualitative Study in a Rural District of Pakistan

Por: Akber Pradhan · N. · Zaidi · T. W. · Siddiqi · S.
Objective

The study aimed to assess private general physicians’(GPs) healthcare practices, identifying perceived malpractices, the support they receive, and barriers they experience in providing healthcare services.

Design

Qualitative exploratory study.

Setting

Rural district, Thatta in Province of Sindh, Pakistan.

Participants

15 GPs.

Results

Our results include increased motivation among GPs for continued professional development, the high influence of pharmaceutical companies on providers’ prescribing practices, perceived malpractices by GPs, and the prevalence of quackery and ineffective regulatory mechanisms for private GPs in a rural district.

Conclusion

Our findings have implications for the capacity building of GPs by academic institutions, enforcement of regulatory measures by the authorities, and the introduction of measures to curb practices by unqualified practitioners. Finally, more research will be needed to further understand the perceptions of GPs, their needs and the service delivery interventions that will enhance the quality of care they provide.

Which aspects of patient experience are the 'moment of truth in the healthcare context: a multicentre cross-sectional study in China

Por: Chen · X. · Yuan · J. · Zhao · W. · Qin · W. · Gao · J. · Zhang · Y.
Objective

This study aimed to examine the differential magnitude of associations between specific dimensions of patient experience and overall patient satisfaction.

Design

A descriptive, cross-sectional design was used to collect patient experience and overall satisfaction data.

Setting

Participants were recruited at one tertiary general hospital, one tertiary specialised hospital, and one secondary hospital in Shanghai, China. These three institutes represent the main kinds of hospitals in the Chinese healthcare system.

Participants

1532 inpatients were recruited, and 1469 were included. The inclusion criteria were as follows: (1) having received inpatient service for at least 2 days; (2) able to understand the questions in the questionnaires; and (3) aged>18 years old. Patients who had impaired cognitive function and completed the questionnaires with missing information were excluded.

Primary and secondary outcome measure

Patient experience was measured using the Inpatient Experience with Nursing Care Scale, which is widely used in the China. The overall patient satisfaction was measured with 10-point response option.

Results

The LASSO (least absolute shrinkage and selection operator) regression results showed that as the penalty factor () = 0.0162, age, marriage status, financial status, length of hospital stay and numbers of previous of hospitalisation and six dimensions of nursing care remained in the model. As increases to 0.1862, only four patient experience variables, potentially the most influential on patient satisfaction, remained in the model. Patient experience with emotional support was the most significant dimension explaining patient satisfaction (β=0.1564), the second most significant dimension was admission and discharge management (β=0.1562), and the third was monitoring and coping with the progress of diseases (β=0.0613).

Conclusion

Patient experience with emotional support, admission and discharge management, monitoring and coping with the progress of diseases, and information and education are the most significant dimensions explaining patient satisfaction.

Study protocol for a prediction model for mild cognitive impairment in older adults with diabetes mellitus and construction of a nurse-led screening system: a prospective observational study

Por: Miao · W. · Lu · Y. · Xv · H. · Zheng · C. · Yang · W. · Qian · X. · Chen · J. · Geng · G.
Introduction

With an increasing number of older adults in China, the number of people with cognitive impairment is also increasing. To decrease the risk of dementia, it is necessary to timely detect mild cognitive impairment (MCI), which is the preliminary stage of dementia. The prevalence of MCI is relatively high among older adults with diabetes mellitus (DM); however, no effective screening strategy has been designed for this population. This study will construct a nurse-led screening system to detect MCI in community-dwelling older adults with DM in a timely manner.

Methods and analysis

A total of 642 participants with DM will be recruited (n=449 for development, n=193 for validation). The participants will be divided into MCI and none-MCI groups. The candidate predictors will include demographic variables, lifestyle factors, history of diseases, physical examinations, laboratory tests and neuropsychological tests. Univariate analysis, least absolute shrinkage and selection operator regression screening, and multivariate logistic regression analysis will be conducted to identify the outcome indicators. Based on the multivariate logistic regression equation, we will develop a traditional model as a comparison criterion for the machine learning models. The Hosmer-Lemeshow goodness-of-fit test and calibration curve will be used to evaluate the calibration. Sensitivity, specificity, area under the curves and clinical decision curve analysis will be performed for all models. We will report the sensitivity, specificity, area under the curve and decision curve analysis of the validation dataset. A prediction model with better performance will be adopted to form the nurse-led screening system.

Ethics and dissemination

This prospective study has received institutional approval of the Medical Ethics Committee of Qidong Hospital of TCM (QDSZYY-LL-20220621). Study results will be disseminated through conference presentations, Chinese Clinical Trial Registry and publication.

Trial registration number

ChiCTR2200062855.

Quantitative assessments of retinal macular structure among rural-dwelling older adults in China: a population-based, cross-sectional, optical coherence tomography study

Por: Zhang · Q. · Zhang · C. · Wang · Y. · Cong · L. · Liu · K. · Xu · Z. · Jiang · C. · Zhou · W. · Zhang · C. · Dong · Y. · Feng · J. · Qiu · C. · Du · Y.
Objectives

To quantitatively assess and compare retinal macular structures of rural-dwelling older adults in China using two different optical coherence tomography (OCT) scanners and to examine their associations with demographic, lifestyle, clinical and ocular factors.

Design, setting and participants

This population-based, cross-sectional study included 971 participants (age ≥60 years) derived from the Multimodal Interventions to Delay Dementia and Disability in Rural China study. We collected data on demographics, lifestyle factors, clinical conditions (eg, cardiovascular disease (CVD)) and ocular factors (eg, visual acuity and spherical equivalent). We used two models of spectral-domain OCT to measure macular parameters in nine Early Treatment Diabetic Retinopathy Study subfields. Data were analysed using the multiple general linear models.

Results

Spectralis OCT demonstrated higher macular thickness but a lower macular volume than Primus 200 OCT (p

Conclusions

Macular thickness and volume assessed by Spectralis and Primus 200 OCT scanners differ. Older age and female sex are associated with lower macular thickness and volume. Macular parameters are associated with education, CVD and spherical equivalent.

Trial registeration number

MIND-China study (ChiCTR1800017758).

Pivotal relationship between heavy metal, PM2.5 exposures and tuberculosis in Bangladeshi children: protocol paper of a case-control study

Por: Haque · R. · Hanson · M. · Shariful Islam · M. · Akter · N. · Moniruzzaman · M. · Alam · M. J. · Kamruzzaman · M. · Rahman · M. · Chisti · M. J. · Raqib · R. · Rahman · S. M.
Introduction

Air pollution is a global issue that poses a significant threat to public health. Children, due to their developing physiology, are particularly susceptible to the inhalation of environmental pollutants. Exposure can trigger immune modulation and organ damage, increasing susceptibility to respiratory diseases. Therefore, we aim to examine the association between heavy metal and particulate matter exposure with tuberculosis in children.

Methods and analysis

As a case–control study, we will include children diagnosed with pulmonary tuberculosis (n=60) and matched healthy controls (n=80) recruited from the same communities in Dhaka, Bangladesh. Exposure data for both cases and controls will be collected by a trained field team conducting home visits. They will administer an exposure questionnaire, measure child anthropometry, collect blood and household dust samples and instal 48-hour air quality monitors. The blood samples will be analysed by inductively coupled plasma mass spectrometry for serum heavy metal concentrations (lead, cadmium, arsenic, mercury and chromium), as a representative marker of exposure, and the presence of inflammatory biomarkers. Descriptive and inferential statistics, including independent samples t-tests, analysis of variance and conditional regression analysis, will be used to quantify heavy metal and particulate matter exposure status in tuberculosis cases compared with healthy controls, while accounting for potential confounders. Dust samples and air quality results will be analysed to understand household sources of heavy metal and particulate matter exposure. To test the study hypothesis, there is a positive association between exposure and tuberculosis diseases, we will also measure the accumulated effect of simultaneous exposures using Bayesian statistical modelling.

Ethics and dissemination

This study has been approved by International Centre for Diarrhoeal Disease Research, Bangladesh’s Institutional Review Board (PR-22030). The study findings will be disseminated at conferences and published in peer-reviewed journals.

Effect of methylene blue on outcomes in patients with distributive shock: a meta-analysis of randomised controlled trials

Por: Huang · X. · Yan · W. · Chen · Z. · Qian · Y.
Objective

This meta-analysis aimed to demonstrate the effect of methylene blue (MB) in patients with distributive shock.

Design

Meta-analysis.

Methods

According to the Prospective International Register of Systematic Reviews (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched the relevant randomised controlled trials (RCTs) via PubMed, Embase and Cochrane Library from the date of database inception to 19 April 2023. The primary outcome was mortality during follow-up, and secondary outcomes included mean arterial pressure (mm Hg), mechanical ventilation time (hours), intensive care unit (ICU) length of stay (LOS) (days), hospital LOS (days) and heart rate (times/min).

Results

This study included six RCTs with 265 participants. The study showed no significant difference in mortality between the MB and placebo groups (ORs: 0.59; 95% CI 0.32 to –1.06). However, MB reduced the duration of mechanical ventilation (mean difference (MD): –0.68; 95% CI –1.23 to –0.14), ICU LOS (MD: –1.54; 95% CI –2.61 to –0.48) and hospital LOS (MD: –1.97; 95% CI –3.92 to –0.11).

Conclusions

The use of MB may not reduce mortality in patients with distributive shock, but may shorten the duration of mechanical ventilation, ICU LOS and hospital LOS. More clinical studies are needed to confirm these findings in the future.

Trial registration number

CRD42023415938.

Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial

Por: Zhang · W. · Deng · L. · Yang · F. · Liu · J. · Chen · S. · You · X. · Gou · J. · Zi · D. · Li · Y. · Qi · X. · Wang · Y. · Zheng · Y.
Introduction

Hysterectomy is the most common surgical procedure in the field of gynaecology. The traditional multiport laparoscopy, transumbilical laparoendoscopic single-site surgery (TU-LESS) and transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy approaches have been implemented to varying degrees in clinical practice. At present, although their feasibility has been proven, there are no large randomised controlled studies on postoperative rehabilitation. This study aims to evaluate postoperative recovery and assess the safety and effectiveness of these three surgical approaches for total laparoscopic hysterectomy.

Method and analysis

This is a multicentre, randomised, single-blind, three-arm, parallel-group, interventional clinical trial. Recruitment will be carried out in five tertiary hospitals in China. Patients diagnosed with benign uterine disease or precancerous lesions will be assigned to the vNOTES group, TU-LESS group and conventional laparoscopy group at a 1:1:1 ratio. The achievement rate of comprehensive indices of enhanced recovery after surgery (ERAS) within 24 hours postoperatively will be considered the primary outcome (the comprehensive indicators of ERAS include fluid intake, passing flatus, urination after catheter removal, ambulation and a Visual Analogue Scale score ≤3.) This study will use a non-inferiority test, with a power (1–ß) of 80% and a margin of –0.15, at a one-sided α of 0.0125. The sample size will be 480 patients (including an assumed 15% dropout rate), calculated according to the primary outcome.

Ethics and dissemination

This study was approved on 25 April 2022 by the Medical Ethics Committee of West China Second University Hospital (2022(057)), Sichuan University, Chengdu, China. All participants will be required to provide informed consent before their participation in the study. The results of the trial will be submitted for publication in a peer-reviewed journal and presented at international conferences.

Protocol version

V.3.0, 31 August 2023.

Trial registration number

ChiCTR2200057405.

Scope, range and effectiveness of interventions to address social norms to prevent and delay child marriage and empower adolescent girls: a systematic review

Por: Greene · M. E. · Edmeades · J. · Siddiqi · M.
Objectives

Harmful gender and social norms prescribe divergent opportunities for girls and boys and drive child marriage. This systematic review examines the scope, range and effectiveness of interventions to change social norms and delay child marriage.

Design

We systematically assess the contributions made by interventions that work to shift norms to prevent child marriage or to limit its harmful consequences. Our analysis classifies each study’s quality in evaluation and implementation design regarding shifting norms.

Data sources

We conducted a search of electronic databases (PubMed, PsycINFO, Embase, CINAHL Plus, Popline, Web of Science and Cochrane Library) and grey literature (targeted hand-searches of 15 key organisations and Google Scholar).

Eligibility criteria

Included interventions sought to change norms related to child marriage, were evaluated in experimental or quasi-experimental evaluations, collected data on age at marriage and norms/attitudes, and were published in English from January 2000 to September 2021.

Data extraction and synthesis

We used a standardised form to extract data from all eligible studies, and double-screened to validate coding and reporting. We classified the studies by low, medium and high quality for evaluation and risk of bias, and separately by the extent to which they addressed social norms.

Results

Our assessment of the 12 eligible studies identified revealed little evidence of a systematic relationship between social norms related to marriage and changes in child marriage behaviours. We found stronger evidence of programme effect on child marriage outcomes than on social norms, though only a minority of studies found an effect for either. Studies that appeared effective in changing child marriage norms varied greatly in scale and extent of programming, and few attempted to identify the appropriate reference groups for measuring social norms.

Conclusion

The studies evaluated by our review provide only weak evidence on the impact of interventions on norms, and on the link between shifts in norms and marriage behaviour.

Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial

Por: Li · M. C. M. · Cheng · Y. K. · Cui · C. · Chow · S. K. H. · Wong · R. M. Y. · Kwok · T. C. · Siu · P. M. · Yang · M. · Tian · M. · Rubin · C. · Welch · A. A. · Qin · L. · Law · S. W. · Cheung · W. H.
Introduction

Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.

Methods and analysis

In this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.

Ethics and dissemination

This study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.

Trial registration number

NCT05525039.

Incidence of community-acquired pneumonia among children under 5 years in Suzhou, China: a hospital-based cohort study

Por: Qian · C. · Chen · Q. · Lin · W. · Li · Z. · Zhu · J. · Zhang · J. · Luan · L. · Zheng · B. · Zhao · G. · Tian · J. · Zhang · T.
Objectives

To depict the seasonality and age variations of community-acquired pneumonia (CAP) incidence in the context of the COVID-19 impact.

Design

Retrospective cohort study.

Participants

The observational cohort study was conducted at Soochow University Affiliated Children’s Hospital from January 2017 to June 2021 and involved 132 797 children born in 2017 or 2018. They were followed and identified CAP episodes by screening on the Health Information Systems of outpatients and inpatients in the same hospital.

Outcome

The CAP episodes were defined when the diagnoses coded as J09–J18 or J20–J22. The incidence of CAP was estimated stratified by age, sex, birth year, health status group, season and month, and the rate ratio was calculated and adjusted by a quasi-Poisson regression model. Stratified analysis of incidence of CAP by birth month was conducted to understand the age and seasonal variation.

Results

The overall incidence of CAP among children aged ≤5 years was 130.08 per 1000 person years. Children aged ≤24 months have a higher CAP incidence than those aged >24 months (176.84 vs 72.04 per 1000 person years, p

Conclusions

The burden of CAP among children is considerable. The incidence of CAP among children ≤5 years varied by age and season and decreased during COVID-19 lockdown.

Risk factors for cognitive impairment in middle-aged type 2 diabetic patients: a cross-sectional study

Por: Li · Y.-S. · Li · J.-B. · Wang · J.-J. · Wang · X.-H. · Jiang · W.-R. · Qiu · H.-N. · Xia · L.-F. · Wu · F. · Lin · C.-Y. · Liu · Y.-L. · Lin · J.-N.
Objective

The aim of this study was to investigate risk factors for cognitive impairment (CI) and explore the relationship between obesity and cognition in hospitalised middle-aged patients with type 2 diabetes (T2DM).

Methods

Subjects were divided into normal cognitive function (NCF) (n=320) and CI (n=204) groups based on the results of the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). The risk factors for CI were determined by logistic regression analysis and generalised linear modelling. The associations between obesity parameters (body mass index (BMI) and waist circumference (WC)) and cognitive ability were studied with the use of linear regression analysis, piecewise regression modelling and interaction analysis. The receiver operating characteristic curve analysis was used to examine the diagnostic value of influencing factors for cc

Results

The prevalence of CI was 38.9% in hospitalised middle-aged T2DM patients (median age, 58 years). Age, WC, hypoglycaemic episode within past 3 months and cerebrovascular disease (CVD) were identified as independent risk factors for CI, while the independent protective factors were education, diabetic dietary pattern, overweight and obesity. BMI was a protective factor for the MoCA score within a certain range, whereas WC was a risk factor for the MMSE and MoCA scores. The area under the curve for the combination of BMI and WC was 0.754 (p

Conclusion

Age, education, diabetic dietary pattern, WC, overweight, obesity, hypoglycaemic episode in 3 months and CVD may be potential influencing factors for the occurrence of CI in hospitalised middle-aged population with T2DM. The combination of BMI and WC may represent a good predictor for early screening of CI in this population. Nevertheless, more relevant prospective studies are still needed.

Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China

Por: Qin · G. · Chen · J. · Hu · L. · Qi · Y. · Xu · L. · He · W. · Yu · S. · Pazo · E. E. · He · X.
Introduction

Assessment of near work-induced transient myopia (NITM) is important for permanent myopia development and progression. Atropine eye drop has been reported to be beneficial in reducing initial NITM and slowing down myopic progression. This study aimed to investigate the efficacy of 0.01% atropine in treating NITM and its possible association with the progression of refractive change in Chinese myopic children.

Methods and analysis

The study is designed as a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial conducted at He Eye Specialist Hospital in Shenyang, China. One hundred fifty participants will be randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for 1 year. Initial NITM, cycloplegic refraction, axial length, best-corrected visual acuity, intraocular pressure and pupil diameter will be measured at baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks. Visual Function Questionnaire will be administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit.

Ethics and dissemination

A parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression registered on 10 September 2023. Ethics approval number: IRB (2023) K025.01. The study’s findings will be shared regardless of the effect’s direction.

Trial registration number

NCT06034366.

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