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Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study)

Por: Kong · Y. · Chen · R. · Xu · M. · Zhang · J. · Chen · G. · Hong · Z. · Zhang · H. · Dai · X. · Ma · Y. · Zhao · X. · Peng · Y. · Zhang · C. · Xing · P. · Zhang · L.
Introduction

The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.

Objective

The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.

Methods and analysis

The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.

Trial registration number

NCT05790447.

Immunosuppressant medication behaviours in solid organ transplant recipients: a cross-sectional study from south-central China during COVID-19 reopening period

Por: Zhao · Q. · Dong · L. · Wang · L. · Zhao · H. · Zhu · X. · Zhang · Z. · Liu · J.
Objective

Medication non-adherence to immunosuppressants threatens allograft survival and function maintenance among solid organ transplant (SOT) recipients. This study aimed to investigate the prevalence of immunosuppressant medication non-adherence and associated factors during the COVID-19 reopening period among Chinese SOT recipients.

Design

Cross-sectional study.

Setting

South-central China.

Population

Adult patients who received SOT with functioning graft.

Methods

Sociodemographic questionnaire and scales to measure physical activity, depression and medication non-adherence were used to collect data. Logistic regression analysis was conducted to identify factors associated with medication non-adherence. Mediation and moderated mediation analyses were performed to examine the potential mechanisms influencing medication behaviour during the pandemic reopening period using SPSS PROCESS macro 4.3 software.

Results

A total of 1121 participants were recruited and the prevalence of medication non-adherence was 36.3% in this study. Recipients who were men, had a higher monthly income, lived alone, had received transplantation for a minimum of 3 years, had received COVID-19 vaccination and experienced depressive symptoms exhibited an increased risk of non-adherence. Contrarily, those who engaged in high-intensity physical activity exhibited a decreased risk. Physical activity was negatively associated with medication non-adherence (r=–0.124, p

Conclusion

This study investigated the prevalence of medication non-adherence among SOT recipients during the COVID-19 reopening period in China, its associated factors and a potential mechanism. Depression fully mediated the association between physical activity and medication non-adherence, and COVID-19 vaccination moderated the relationship between physical activity and depression. These findings provide some insights for managing medication behaviour when confronting public health emergencies. However, relationships displayed in the moderated mediation model should be tracked after returning to normal life and other potential relationships should be explored to deeply understand medication non-adherent behaviour.

Toxoplasma gondii seropositivity and cognitive functioning in older adults: an analysis of cross-sectional data of the National Health and Nutrition Examination Survey 2011-2014

Por: Song · G. · Zhao · Q. · Chen · H. · Li · M. · Zhang · Z. · Qu · Z. · Yang · C. · Lin · X. · Ma · W. · Standlee · C. R.
Objectives

This study sought to examine the relationship between Toxoplasma gondii seropositivity and cognitive function in older adults.

Design

An observational cross-sectional study.

Setting

The National Health and Nutrition Examination Survey (NHANES) study took place at participants’ homes and mobile examination centres.

Participants

A total of 2956 older adults aged 60 and above from the NHANES from 2011 to 2014 were included in the study. Exposure of interest: participants had serum Toxoplasma gondii antibody analysed in the laboratory. A value>33 IU/mL was categorised as seropositive for Toxoplasma gondii infection; Toxoplasma gondii infection.

Primary and secondary outcome measures

Cognitive tests included the Consortium to Establish a Registry for Alzheimer’s Disease Word Learning subtest (CERAD-WL) for immediate and delayed memory, the Animal Fluency Test (AFT), and the Digit Symbol Substitution Test (DSST).

Results

About half of the 2956 participants (mean age 70.0) were female (51.0%), non-Hispanic White (48.3%), and completed some college or above (48.3%). A total of 703 participants were positive for Toxoplasma gondii infection (23.8%). Adjusted linear regression showed that compared with participants with negative Toxoplasma gondii infection, those with positive Toxoplasma gondii infection had lower CERAD-WL immediate memory (beta (β) –0.16, 95% CI –0.25 to –0.07), CERAD-WL delayed memory (β –0.15, 95% CI –0.24 to –0.06), AFT (β –0.15, 95% CI –0.24 to –0.06), DSST (β –0.34, 95% CI –0.43 to –0.26), and global cognition (β –0.24, 95% CI –0.32 to –0.16) z-scores after controlling for the covariates.

Conclusions

Toxoplasma gondii seropositivity is associated with worse immediate and delayed verbal learning, language proficiency, executive functioning, processing speed, sustained attention, working memory, as well as global cognition in older adults. Public health measures aiming at preventing Toxoplasma gondii infection may help preserve cognitive functioning in older adults.

Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial

Por: Yu · C. · Li · H. · Lei · C. · Wang · Y. · Chen · S. · Zhao · Y. · Zheng · Z.
Introduction

The prevalence of atrial fibrillation (AF) is increasing globally, and stroke prevention is the key to reduce the morbidity and mortality related to AF. Currently, direct oral anticoagulants (DOACs) are the primary options for stroke prevention, while it increases risk of bleeding. Left atrial appendage (LAA) is suspected as a vital source of cerebral emboli and may lead to ischaemic stroke, and thoracoscopic LAA clipping procedure provides an alternative option for stroke prevention in high-risk patients. However, high-quality evidence comparing LAA clipping to DOACs in terms of stroke prevention is lacking. This trial is designed to assess whether the efficacy of thoracoscopic LAA clipping is superior to DOACs for stroke prevention in AF patients at high risk of thrombosis (CHA2DS2-VASc≥2 in men and ≥3 in women)[CHA2DS2-VASc stands for "congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female)"].

Methods and analysis

This is a prospective, multicentre, open-labelled, randomised controlled study. This trial will randomly assign 290 patients with non-paroxysmal AF to thoracoscopic LAA clipping group or DOAC therapy group in a 1:1 randomisation. The primary endpoint is defined as a composite endpoint event consisting of stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant non-major bleeding events at 24 months after randomisation. The secondary endpoints consist of the components of the primary composite endpoint, surgery-related adverse events and minor bleeding events.

Ethics and dissemination

The central ethics committee at Fuwai Hospital approved the trial entitled "Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP trial)". The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations.

Trial registration number

NCT06021808.

Effects of opioid-free anaesthesia compared with balanced general anaesthesia on nausea and vomiting after video-assisted thoracoscopic surgery: a single-centre randomised controlled trial

Por: Bao · R. · Zhang · W.-s. · Zha · Y.-f. · Zhao · Z.-z. · Huang · J. · Li · J.-l. · Wang · T. · Guo · Y. · Bian · J.-j. · Wang · J.-f.
Objectives

Opioid-free anaesthesia (OFA) has emerged as a promising approach for mitigating the adverse effects associated with opioids. The objective of this study was to evaluate the impact of OFA on postoperative nausea and vomiting (PONV) following video-assisted thoracic surgery.

Design

Single-centre randomised controlled trial.

Setting

Tertiary hospital in Shanghai, China.

Participants

Patients undergoing video-assisted thoracic surgery were recruited from September 2021 to June 2022.

Intervention

Patients were randomly allocated to OFA or traditional general anaesthesia with a 1:1 allocation ratio.

Primary and secondary outcome measures

The primary outcome measure was the incidence of PONV within 48 hours post-surgery, and the secondary outcomes included PONV severity, postoperative pain, haemodynamic changes during anaesthesia, and length of stay (LOS) in the recovery ward and hospital.

Results

A total of 86 and 88 patients were included in the OFA and control groups, respectively. Two patients were excluded because of severe adverse events including extreme bradycardia and epilepsy-like convulsion. The incidence and severity of PONV did not significantly differ between the two groups (29 patients (33.0%) in the control group and 22 patients (25.6%) in the OFA group; relative risk 0.78, 95% CI 0.49 to 1.23; p=0.285). Notably, the OFA approach used was associated with an increase in heart rate (89±17 vs 77±15 beats/min, t-test: p

Conclusions

Our study findings suggest that the implementation of OFA does not effectively reduce the incidence of PONV following thoracic surgery when compared with traditional total intravenous anaesthesia. The opioid-free strategy used in our study may be associated with severe adverse cardiovascular events.

Trial registration number

ChiCTR2100050738.

Combined MRI-TRUS fusion targeted and systematic biopsy versus systematic biopsy alone for the detection of prostate cancer: protocol for a prospective single-centre trial

Por: Liu · W. · Kadier · A. · Shen · D. · He · Y. · Dong · S. · Zhu · K. · Xu · G. · Zhao · B. · Mao · S. · Guo · C. · Yao · X. · Wei · Q. · Han · D. · Yang · B.
Introduction

The classic way of diagnosing prostate cancer (PCa) is by conducting the 12-core systematic biopsy (SB). However, it has a low detection rate for clinically significant PCa (csPCa) and can lead to the detection of clinically insignificant PCa (cisPCa). Although MRI-transrectal ultrasound (MRI-TRUS) fusion targeted biopsy (TB) can effectively improve the detection rate of csPCa, it may still miss some cases. Therefore, we propose using a combination of TB and SB methods to enhance the detection rate of csPCa while minimising the detection rate of cisPCa.

Methods and analysis

This study is a prospective, single-centre investigation that aims to assess and compare the detection rate of csPCa using MRI-TRUS fusion TB combined with SB versus TRUS 12-core SB alone. Biopsy-naïve men with suspected PCa will be subjected to multiparametric MRI. Patients with Prostate Imaging Reporting and Data System (V.2.1) score ≥3 will be enrolled in the TB-SB combination group. The sample size is established as 660 participants, considering a 10% drop-out rate. The primary outcome is the detection rate of csPCa in men without prior biopsy using MRI-TRUS fusion TB combined with the standard TRUS-guided 12-core SB method. CsPCa will be defined as International Society of Urological Pathology Grade ≥2.

Ethics and dissemination

This study has been approved by the Ethics Committee at the Shanghai Tenth People’s Hospital, an affiliated hospital of Tongji University School of Medicine. The research results will be published in a peer-reviewed international journal.

Trial registration number

ChiCTR2000036089.

Barriers and facilitators in implementing early essential newborn care of well‐born babies in low‐ and middle‐income countries: A mixed‐method systematic review

Abstract

Background

Evidences have demonstrated the effectiveness of early essential newborn care. However, the implementation of early essential newborn care is suboptimal. The aim is to identify and synthesise the barriers and facilitators impacting the implementation of early essential newborn care in low- and middle-income countries.

Data Sources

PubMed, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, CINAHL, CNKI, Wan Fang Data, SinoMed and Google Scholar.

Methods

Two authors independently screened, performed quality assessment using the Mixed Methods Appraisal Tool and extracted data. This review includes papers that reported the barriers and facilitators of implementing early essential newborn care in low- and middle-income countries from the view of healthcare providers. Barriers and facilitators were coded according to the consolidated framework for implementation research in a deductive way and then been inducted into five common themes. This review followed synthesis without meta-analysis reporting guideline.

Results

A total of 28 studies were included. Five inductive common themes influencing implementing early essential newborn care in low- and middle-income countries were system-level healthcare factors, healthcare providers’ knowledge and beliefs, the requirements of mothers or families, adapting to routine practice and the working climate of organisation.

Conclusion

The factors were from system level, facility level and individual level and were inducted into five themes. Based on this review, decision-makers could tailor implementing strategies to narrow the gap between the evidence and implementation.

Relevance to Clinical Practice

The study offers guidance for health professionals to identify barriers and facilitators in implementing early essential newborn care and make tailored strategies when implementing early essential newborn care.

Patient or Public Contribution

No patient or public contributions.

Is the risk of wound complications after total hip arthroplasty with suture closing the skin lower than closing the skin with staples?

Abstract

This is a study assessing the effectiveness of staples versus sutures for closing incisions after total hip arthroplasty (THA). We searched all relevant literature up to July 2023, and after reading through the full text, we finally included 5 for analysis, with a total of 1084 cases who underwent total hip arthroplasty, of which 548 were closed with staples and 536 with sutures, and evaluated the risk of bias with the Cochrane Risk of Bias Assessment Tool, using the ratio of ratios (OR) and 95% confidence intervals (CI) to compare the effectiveness of staples and sutures in wound closure in total hip arthroplasty. The study found that the suture group was superior to the staple group in terms of superficial infection and incisional exudate; superficial infection (OR = 3.04, 95% CI: 1.14–8.07; p = 0.03, I 2 = 0%), incisional exudate (OR = 3.22, 95% CI: 1.84–5.65; p < 0.001, I 2 = 0%) and suture staples were superior to suture group in terms of closure time (WMD = −231.8 95% CI: −429.55 to −34.05; p = 0.02, I 2 = 100%). There was no remarkable distinction between the two groups in terms of deep infection, postoperative hospital, HWES score and patient's satisfaction, deep infection (OR = 1.24, 95% CI: 0.35–4.35; p = 0.74, I 2 = 0%), postoperative hospital (WMD = 2.50 95% CI: −2.25 to 7.25; p = 0.30, I 2 = 100%), HWES score (WMD = −0.38 95% CI: −0.52 to −0.24; p < 0.01, I 2 = 72%) and patient's satisfaction (WMD = −0.23 95% CI: −1.43 to 0.96; p = 0.70, I 2 = 94%); however, due to the small sample sizes of several studies included in this study, caution must be exercised when addressing their value.

Analysis of pathogen distribution and associated risk factors for surgical site infections following laparoscopic urological surgeries

Abstract

Surgical site infections (SSIs) pose a significant complication following laparoscopic urological surgeries, impacting patient recovery and healthcare resources. Understanding the pathogen distribution and identifying associated risk factors for SSIs is critical for improving surgical outcomes. A retrospective analysis was performed on 90 patients, from March 2020 to June 2023, to investigate the risk factors and pathogen profiles in SSIs post-laparoscopic urological procedures. Patients with documented infections were compared to a control group without SSIs. Data on demographics, comorbidities and perioperative variables were collected. Pathogens were identified using the VITEK-2 Compact system. Statistical analyses included univariate and multivariate logistic regression models. Upon evaluation, demographic and clinical characteristics showed no significant variance in patients with SSIs compared to those without such infections. The predominant pathogen identified was Escherichia coli. Administration of prophylactic antibiotics correlated with a reduced incidence of SSIs, whereas an array of risk factors including surgery duration of 2 h or more, anaemia, white blood cell counts exceeding 10 × 109/L, a history of urinary tract infections, the presence of diabetes mellitus and incidences of urinary leakage post-surgery were identified as contributors to a heightened risk of SSIs. Prophylactic antibiotics serve as a protective factor against SSIs, whereas several modifiable risk factors, including operation duration, anaemia, elevated leukocytes, history of urinary infections, diabetes and urinary leakage, contribute to the increased risk.

Evaluation of diabetic foot care knowledge, determinants of self‐care practices and the efficacy of health education

Abstract

To evaluate the risk factors connected with diabetic foot care and investigate the impact of health education on promoting proper diabetic foot care practices. An explanatory and mixed-method study was performed. We administered a structured pretest questionnaire to patients diagnosed with Type 2 diabetes who frequented our health examination center and community health clinics. The survey encompassed patient demographics, basic knowledge concerning diabetic foot care, and self-care practices pertaining to diabetic foot care. Concurrent assessments and scoring were carried out. Following the survey, patients underwent health education sessions focusing on foot self-care behaviours. Their progress was reevaluated after 2 weeks to gauge its effectiveness. We identified educational attainment, diabetes duration, regular follow-up, and blood sugar control as critical factors influencing knowledge about foot care and self-care practices related to it. Pearson correlation analysis demonstrated a positive relationship between scores for diabetic foot care knowledge and scores for self-care behaviours (r = 0.32, p < 0.001). Health education led to a significant improvement in the self-care behaviours of diabetic patients. A variety of factors affect the occurrence of diabetic foot complications and the self-care behaviours associated with diabetic foot care. Health education proves to be an effective means of enhancing diabetic foot care behaviours.

Systematic review and network meta‐analysis of mesenchymal stem cells in treating diabetic skin ulcers in animal models

Abstract

Background

Diabetic cutaneous ulcers often pose considerable challenges in the healing process. These challenges stem from factors including inadequate perfusion of the ulcer's surrounding environment, persistent inflammation, tissue damage and microbial proliferation. The existing standard treatment modalities prove insufficient in fully addressing the complex pathogenesis of these ulcers. As a novel approach, researchers are exploring cellular therapies employing mesenchymal stem cells (MSCs) for the treatment of diabetic skin ulcers. MSCs are readily found in various tissues, including bone marrow, adipose tissue, placenta, amniotic membrane, amniotic fluid and umbilical cord. However, the optimal source of MSCs for effectively treating diabetic skin ulcers remains a topic of ongoing discussion.

Methods

We conducted a comprehensive search of Embase, PubMed and Web of Science databases, spanning from their inception to November 2022. Subsequently, we rigorously screened the literature following predetermined inclusion and exclusion criteria and evaluated the quality of the selected studies using the SYRCLE scale. Finally, the included literature underwent analysis, employing the Bayesian school of thought-based R language. To ensure transparency and accountability, we registered this study with PROSPERO's International Systematic Review Prospective Registry, with the Registration ID: CRD42023387421.

Results

We included a total of 11 articles in our analysis, all of which were randomized controlled studies involving 218 animal models. Among these studies, two utilized adipose-derived MSCs, six employed bone marrow-derived MSCs, one utilized amniotic membrane-derived MSCs and three utilized umbilical cord-derived MSCs. Our network meta-analysis results revealed that there were no statistically significant differences in the healing rates of diabetic skin ulcers among MSCs derived from amniotic membrane, adipose tissue, umbilical cord and bone marrow on days 7–8, 10–12 and 12–14. Notably, according to the probability ranking table, the most effective treatment for diabetic wounds was found to be amniotic membrane-derived MSCs.

Conclusion

There was no statistically significant difference in the efficacy of MSCs derived from amniotic membrane, adipose, umbilical cord and bone marrow in the treatment of diabetic skin ulcers during the short-term observation period, and the probability ranking graphs indicate that amniotic membrane-derived MSCs may be the best choice for the treatment of diabetic skin ulcers.

Effect of intra‐wound vancomycin on the surgical site wound infection after spinal surgery: A meta‐analysis

Abstract

The topical application of the vancomycin in spine surgery is an effective method of reducing the incidence of postsurgical infections. However, there are differences in the prophylactic strategies used for various spinal surgeries. Therefore, the primary aim of this meta-analysis was to evaluate the effectiveness of the application of the intra-wound vancomycin during spine surgery. For this purpose, 100 studies were identified through different databases and search engines with various search terms such as ‘intrawound vancomycin in surgery’, ‘intrawound applications of vancomycin’, ‘vancomycin in surgery’, ‘intraoperative vancomycin’, ‘vancomycin spinal surgeries’, ‘treating surgical site infections in spinal surgeries using vancomycin’, ‘spinal surgery’, ‘vancomycin in spinal surgery’, ‘spine surgery’, ‘topical vancomycin’ and ‘local vancomycin’. Furthermore, the identified studies were reviewed thoroughly and finally, 19 studies were selected for meta-analysis. The selected studies were included based on the inclusion criteria and data was extracted from the selected studies. The pool of the statistically significant studies was further analysed using the ‘meta’ package of R version 4.3.2. The analysed data resulted in statistically significant results with a p-value <0.001 and the heterogeneity at 50% suggesting that the meta-analysis results may be significant in supporting the application of vancomycin at surgical sites to reduce the surgical site infections and eventually improve the postoperative conditions by reducing the long hospital stays.

Trends of mean systolic and diastolic blood pressure among adults in Shenzhen, China, 1997-2018: findings from three rounds of the population-based survey

Por: Peng · K. · Cai · W. · Liu · X. · Liu · Y. · Ouyang · M. · Gong · J. · Wang · Z. · Wang · Y. · Hao · J. · Wang · W. · Zhao · H. · Lin · K. · Han · G. · Shi · Y. · Xie · Y. · Xie · Y. · Lei · L. · Si · L.
Objective

To quantify the trends in systolic and diastolic blood pressure (BP) among adults in Shenzhen from 1997 to 2018.

Design

Cross-sectional study.

Settings

The data were collected from all districts in Shenzhen, China in the years of 1997, 2009 and 2018 by multistage cluster sampling procedure.

Participants

Participants were residents aged 18–69 years in Shenzhen, China. A total of 26 621 people were included: 8266 people in 1997, 8599 people in 2009 and 9756 people in 2018.

Primary and secondary outcome measures

All participants were surveyed about their sociodemographic and lifestyle information. BP was measured by trained physicians using a mercury sphygmomanometer. Hypertension was defined as systolic BP of at least 140 mm Hg and diastolic BP of at least 90 mm Hg, self-reported use of antihypertensive medications or both. Hypertension control was defined as systolic BP values of less than 140 mm Hg and diastolic BP values of less than 90 mm Hg.

Result

Age-adjusted mean systolic BP increased from 117±16 mm Hg to 123±15 mm Hg (p

Conclusions

The mean systolic BP and diastolic BP among adults in Shenzhen increased from 1997 to 2018, and no improvements in hypertension awareness, treatment and control rates were found.

Fertility policy changes, maternal and foetal characteristics and birth timing patterns at a tertiary referral centre in Beijing: a ten-year retrospective study

Por: Wang · D. · Wei · T. · Zhao · F. · Huang · J.
Objective

This study aimed to explore the impacts of the changing national fertility policy on maternal and fetal characteristics, and birth timing patterns and provide a basis for the management of the obstetric and midwifery workforce.

Design

Retrospective cohort study.

Setting

Data from medical register of a tertiary referral centre in Beijing, China.

Participants

We included 20 334 births with a gestational age more than 28 weeks during January 2013–September 2023.

Main outcomes

The main outcomes included birth numbers, maternal age, parity, birth modes, premature rates, neonatal birth weight, and birth timings.

Results

The birth rates showed a general rising trend before 2016. Afterwards, the birth rates kept decreasing and reached the bottom level in 2022. The caesarean section rates showed a declining trend, while the assisted birth rates were progressively rising, especially among primiparous women. From 2013 to 2022, the proportions of multiparous women (increasing from 9.3% to 36.6%) and women with advanced maternal age (increasing from 11.4% to 34.5%) were on the rise, together with increasing rates of premature birth (increasing from 5.7% to 8.5%) and neonatal low birth weight (rising from 4.3% to 7.2%) in this population. This study found a significant peak of births between 14:00 and 15:00, which remained unchanged despite shifts in the fertility policy (p values close to 1, respectively).

Conclusion

The ‘three-child’ policy did not boost the birth rate further 2 years later after its enactment, and the proportion of multiparous women and women with advanced maternal age were on the rise, accompanied by an increase in rates of premature birth and low birth weight. Targeted training should be offered to healthcare professionals to empower them to deal with possible negative pregnancy outcomes and childbirth complications. Prepregnancy and antepartum education should be parity specific. Adequate midwifery staffing during this 14:00–15:00 is vital to promote a safe birth.

Reporting and influencing factors of patient-reported outcomes in acupuncture randomised controlled trials: a cross-sectional study protocol

Por: Duan · Y. · Zhao · P. · Liu · S. · Deng · Y. · Xu · Z. · Xiong · L. · Chen · Z. · Zhu · W. · Wu · S. · Yu · L.
Introduction

Patient-reported outcomes (PROs) are health reports that come directly from the patients themselves and represented the experience and insights of the patient’s perspective on the impact of the intervention. PROs were increasingly emphasised in acupuncture randomised controlled trials (RCTs). However, the reporting quality of PROs in acupuncture RCTs has not been investigated to date. Therefore, we constructed this study to reveal the basic characteristics and reporting quality of PROs in acupuncture RCTs, and explore the relationship between concealment, blinding and RROs. We hope our findings can provide guidance for the reporting standards and future development of PROs in acupuncture RCTs in reverse.

Methods and analysis

RCTs using acupuncture treatment as the intervention and PROs as primary outcomes or secondary outcomes will be systematically searched through seven databases MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP between 1 January 2012 and 15 October 2022. The basic characteristics, concealment, blinding design and the characteristics of PROs in included RCTs will be summarised. The reporting quality of PROs will be assessed based on the CONSORT PRO extension. Logistic analysis will be performed to identify the association between concealment, blinding and RROs.

Ethics and dissemination

Ethical approval is not required for this study. This protocol has been registered in Open Science Framework (OSF) Registries. The findings of this study will be submitted to a peer-reviewed academic journal.

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.

The effect of placing drains and no drains after caesarean section in obese patients on patients' post‐operative wound complications: A meta‐analysis

Abstract

The purpose of this research is to investigate the influence of placement of drainage channels and non-drainage channels in obese women on post-caesarean delivery. Documents were retrieved from four databases, such as PubMed and Embase. This study was not limited in time, language, or geography. This trial was conducted using either a cohort or a randomized, controlled study to compare the efficacy of placement of drain in caesarean delivery channel in obese women with or without drain for post-operative wound complications. The study excluded those who were restricted to those who were not overweight. The main results were the wound infection, the bleeding of the wound and the dehiscence. The risk of bias was evaluated by two authors with a risk-of-bias tool for nonrandomized intervention trials. The meta-analyses only included those that were considered to have a low-to-medium risk of bias. The data were pooled with a random-effects model to determine the relative risk and 95% confidence interval (CI). The quality of the evidence in the selection of results was evaluated. Of 329 related trials, eight were eligible for inclusion. There were 1868 cases of obesity who received C-section. Among them, there were 451 cases of drain and 1417 cases of non-drain. No statistical significance was found in the rate of post-operation infection of the post-operation between non-drain or drain treatment of obesity patients (OR, 0.8; 95% CI: 0.48–1.33; p = 0.39). Compared with those with non-drain, there was a reduction in the risk of haematoma after drain (OR, 0.34; 95% CI: 0.20–0.58; p < 0.0001). The results showed that there were no significant differences in the influence of drainage and non-drainage on the post-operative dehiscence of the patients with obesity (OR, 0.84; 95% CI: 0.15–4.70; p = 0.85). The results showed that there were no statistically different effects on the rate of post-operation wound infection and dehiscence after operation, but the rate of haematoma during drain operation was lower.

Global burden and trends of disability‐adjusted life years and mortality for decubitus ulcer: A systematic analysis

Abstract

The management of chronic wounds has presented a significant dilemma, which is evident not only in clinical treatment but also in the substantial burden it places on medical resources. The global COVID-19 pandemic in 2020 is likely to further exacerbate this trend. Therefore, it is imperative to delve deeper into the impact of chronic wound on disease burden across different regions and populations. In this study, we focused on decubitus ulcers (DU) as representative chronic wounds and utilized data from the Global Burden of Disease (GBD) 2019 database (http://ghdx.healthdata.org/gbd-results-tool) pertaining to age, gender, region, year and socio-demographic index (SDI) group. Disability-adjusted life years (DALYs) and mortality were utilized as indicators to assess the burden of DU. The analysis and visualization were performed using R software (version 4.2.3). A decrease in the global ASRs of DALYs and mortality for DU was observed across most regions between 1990 and 2019. The reduction in burden was particularly significant in regions characterized by a high SDI, while regions with a high-middle SDI experienced an increase. The burden of DU increased with age for both males and females, with males generally experiencing a higher burden compared to females. Strengthening population-based data on the prevalence of DU and implementing dynamic monitoring at the public health level will enable policymakers to develop evidence-based strategies for efficient allocation of healthcare resources.

Multicentre, parallel, open-label, two-arm, randomised controlled trial on the prognosis of electrical impedance tomography-guided versus low PEEP/FiO2 table-guided PEEP setting: a trial protocol

Por: Wong · H. · Chi · Y. · Zhang · R. · Yin · C. · Jia · J. · Wang · B. · Liu · Y. · Shang · Y. · Wang · R. · Long · Y. · Zhao · Z. · He · H.
Introduction

Previous studies suggested that electrical impedance tomography (EIT) has the potential to guide positive end-expiratory pressure (PEEP) titration via quantifying the alveolar collapse and overdistension. The aim of this trial is to compare the effect of EIT-guided PEEP and acute respiratory distress syndrome (ARDS) network low PEEP/fraction of inspired oxygen (FiO2) table strategy on mortality and other clinical outcomes in patients with ARDS.

Methods

This is a parallel, two-arm, multicentre, randomised, controlled trial, conducted in China. All patients with ARDS under mechanical ventilation admitted to the intensive care unit will be screened for eligibility. The enrolled patients are stratified by the aetiology (pulmonary/extrapulmonary) and partial pressure of arterial oxygen/FiO2 (≥150 mm Hg or 2 table proposed by the ARDS Network. The primary outcome is 28-day survival.

Analysis

Qualitative data will be analysed using the 2 test or Fisher’s exact test, quantitative data will be analysed using independent samples t-test or Mann-Whitney U test. Kaplan-Meier analysis with log-rank test will be used to evaluate the 28-day survival rate between two groups. All outcomes will be analysed based on the intention-to-treat principle.

Ethics and dissemination

The trial is approved by the Institutional Research and Ethics Committee of the Peking Union Medical College Hospital. Data will be published in peer-reviewed journals.

Trial registration number

NCT05307913.

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