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Ayer — Mayo 14th 2024Tus fuentes RSS

Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study

Por: Meng · M. · Ge · B. · Lei · W. · Wu · Y. · Tian · M. · Lu · Y. · Shao · T. · Yang · Y. · Luo · X. · Luo · J. · Gao · Y. · Li · Q. · Chen · Y.
Objective

To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors.

Design

The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis.

Setting

A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020.

Results

We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians.

Conclusion

Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.

Perfusion outcomes with near-infrared indocyanine green imaging system in laparoscopic total mesorectal excision for mid-rectal or low-rectal cancer (POSTER): a study protocol

Por: Sun · L. · Gao · J. · Wu · G. · Meng · C. · Yang · Z. · Wei · P. · Yao · H. · Zhang · Z.
Introduction

Anastomotic leakage (AL) is defined as the failure of complete healing or disruption of the anastomosis subsequent to rectal cancer surgery, resulting in the extravasation of intestinal contents into the intra-abdominal or pelvic cavity. It is a serious complication of rectal cancer surgery, accounting for a considerable increase in morbidity and mortality. The use of fluorescence imaging technology in surgery allows surgeons to better evaluate blood perfusion. However, the conclusions of some existing studies are not consistent, so a consensus on whether the near-infrared indocyanine green (NIR–ICG) imaging system can reduce the incidence of AL is needed.

Methods

This POSTER trial is designed as a multicentre, prospective, randomised controlled clinical study adhering to the "population, interventions, comparisons, outcomes (PICO)" principles. It is scheduled to take place from August 2019 to December 2024 across eight esteemed hospitals in China. The target population consists of patients diagnosed with rectal cancer through pathological confirmation, with tumours located≤10 cm from the anal verge, eligible for laparoscopic surgery. Enrolled patients will be randomly assigned to either the intervention group or the control group. The intervention group will receive intravenous injections of ICG twice, with intraoperative assessment of anastomotic blood flow using the near-infrared NIR–ICG system during total mesorectal excision (TME) surgery. Conversely, the control group will undergo conventional TME surgery without the use of the NIR-ICG system. A 30-day follow-up period postoperation will be conducted to monitor and evaluate occurrences of AL. The primary endpoint of this study is the incidence of AL within 30 days postsurgery in both groups. The primary outcome investigators will be blinded to the application of ICG angiography. Based on prior literature, we hypothesise an AL rate of 10.3% in the control group and 3% in the experimental group for this study. With a planned ratio of 2:1 between the number of cases in the experimental and control groups, and an expected 20% lost-to-follow-up rate, the initial estimated sample size for this study is 712, comprising 474 in the experimental group and 238 in the control group.

Ethics and dissemination

This study has been approved by Ethics committee of Beijing Friendship Hospital, Capital Medical University (approval number: 2019-P2-055-02). The results will be disseminated in major international conferences and peer-reviewed journals.

Trial registration number

NCT04012645.

Do patients with nephrotic syndrome have an increased risk of osteoporosis? A nationwide population-based retrospective cohort study in Taiwan

Por: Liao · C.-Y. · Chung · C.-H. · Wei · K.-Y. · Tseng · M.-F. · Lin · F.-H. · Tsao · C.-H. · Chien · W.-C. · Chu · P. · Wu · C.-C.
Objectives

To evaluate whether nephrotic syndrome (NS) and further corticosteroid (CS) use increase the risk of osteoporosis in Asian population during the period January 2000–December 2010.

Design

Nationwide population-based retrospective cohort study.

Setting

All healthcare facilities in Taiwan.

Participants

A total of 28 772 individuals were enrolled.

Interventions

26 614 individuals with newly diagnosed NS between 2000 and 2010 were identified and included in out study. 26 614 individuals with no NS diagnosis prior to the index date were age matched as controls. Diagnosis of osteoporosis prior to the diagnosis of NS or the same index date was identified, age, sex and NS-associated comorbidities were adjusted.

Primary outcome measure

To identify risk differences in developing osteoporosis among patients with a medical history of NS.

Results

After adjusting for covariates, osteoporosis risk was found to be 3.279 times greater in the NS cohort than in the non-NS cohort, when measured over 11 years after NS diagnosis. Stratification revealed that age older than 18 years, congestive heart failure, hyperlipidaemia, chronic kidney disease, liver cirrhosis and NS-related disease including diabetes mellitus, hepatitis B infection, hepatitis C infection, lymphoma and hypothyroidism, increased the risk of osteoporosis in the NS cohort, compared with the non-NS cohort. Additionally, osteoporosis risk was significantly higher in NS patients with CS use (adjusted HR (aHR)=3.397). The risk of osteoporosis in NS patients was positively associated with risk of hip and vertebral fracture (aHR=2.130 and 2.268, respectively). A significant association exists between NS and subsequent risk for osteoporosis.

Conclusion

NS patients, particularly those treated with CS, should be evaluated for subsequent risk of osteoporosis.

Status of the midwifery workforce and childbirth services and the impact of midwife staffing on birth outcomes in China: a multicentre cross-sectional study

Por: Zhu · W. · Zhu · C. · Min · H. · Li · L. · Wang · X. · Wu · J. · Zhu · X. · Gu · C.
Objective

To investigate the status of the midwifery workforce and childbirth services in China and to identify the association between midwife staffing and childbirth outcomes.

Design

A descriptive, multicentre cross-sectional survey.

Setting

Maternity hospitals from the eastern, central and western regions of China.

Participants

Stratified sampling of maternity hospitals between 1 July and 31 December 2021.

The sample hospitals received a package of questionnaires, and the head midwives from the participating hospitals were invited to fill in the questionnaires.

Results

A total of 180 hospitals were selected and investigated, staffed with 4159 midwives, 412 obstetric nurses and 1007 obstetricians at the labour and delivery units. The average efficiency index of annual midwifery services was 272 deliveries per midwife. In the sample hospitals, 44.9% of women had a caesarean delivery and 21.4% had an episiotomy. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery (adjusted β –0.032, 95% CI –0.115 to –0.012, p

Conclusion

The rates of childbirth interventions including the overall caesarean section in China and the episiotomy rate, especially in the central region, remain relatively high. Improved midwife staffing was associated with reduced rates of instrumental vaginal delivery and episiotomy, indicating that further investments in the midwifery workforce could produce better childbirth outcomes.

A survey of skin failure perceptions amongst pressure injury management staff in China: A cross‐sectional study

Abstract

This study sought to evaluate the perceptions of pressure injury (PI) management staff regarding skin failure (SF). Additionally, an analysis of influencing factors based on the collected data was conducted to establish a foundation for targeted SF training. A descriptive, cross-sectional survey was undertaken in October–November 2023, utilising a convenience sampling method involving selected management staff of PI from 16 provinces in China. A total of 501 nursing participants were included, exhibiting an overall perception level that was moderately low. Although the majority were aware of the possibility of SF (n = 417, 83.23%), only 60% reported an understanding of the fundamentals of SF, with the lowest level of comprehension observed in differentiating between SF and PI (n = 212, 42.31%). Overall attitudes were generally positive. Regarding behaviour, active learning was more prevalent (n = 340, 67.86%), but training is less (n = 287, 57.29%). Family education (n = 401, 80.04%) and nursing record monitoring (n = 426, 85.03%) demonstrated better behaviour. Further analysis revealed that training (t = 13.937, p < 0.001) and professional title (F = 4.681, p = 0.010) had a significant effect on participants' perceptions. These findings underscore that there remains a substantial lack of perception about SF amongst participants. Overall, participants exhibited a positive attitude towards SF, highlighting the need for future improvements in SF training.

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Incidence, prevalence, and medical costs of pressure injuries in Taiwan from 2001 to 2015: Results of a retrospective cohort study

Abstract

Aims and Objectives

This study aims to analyse the trends in the incidence, prevalence and medical costs of pressure injuries (PIs) among genders in Taiwan.

Background

The treatment of PIs is complex and costly, often leading to complications and increased mortality. This issue significantly impacts healthcare quality and incurs substantial medical and social costs, warranting attention.

Methods

A retrospective cohort study was conducted using data from Taiwan's National Health Insurance Database to obtain and calculate the incidence, prevalence, and medical costs of PIs in the country between 2001 and 2015 as well as to analyse high-risk groups and the medical care utilisation of patients following the STROBE reporting guidelines.

Results

Between 2001 and 2015, 15,327 incident case of PIs were diagnosed. During the study period, the prevalence rate of PIs per 100,000 population rose from 26.3 to 189.6, with approximately 11.5%–16.3% of patients undergoing surgical debridement. The PIs prevalence rate increased by 7.2-fold, and hospitalisation costs accounted for 91.7%–96.0% of the total medical costs. Patients with older age, comorbidities, poorer financial status and lower education levels were found to be likely to develop PIs. These predisposing factors differed between males and females. The prevalence of PIs was higher in patients ≥75 years old than in patients from other age groups. Moreover, PI-related medical expenses have been increasing annually.

Conclusions

In Taiwan, the rising incidence of PIs is driving up medical costs. Effective care and prevention of PIs necessitate a comprehensive plan from the entire healthcare system.

Relevance to Clinical Practice

This research fills a gap in the available data on the incidence, prevalence, and medical costs of PIs in Taiwan and Asia.

Patient or Public Contribution

The findings can be used to help develop clinical guidelines for preventive education and treatment of PIs.

A bilateral filtering-based image enhancement for Alzheimer disease classification using CNN

by Nicodemus Songose Awarayi, Frimpong Twum, James Ben Hayfron-Acquah, Kwabena Owusu-Agyemang

This study aims to develop an optimally performing convolutional neural network to classify Alzheimer’s disease into mild cognitive impairment, normal controls, or Alzheimer’s disease classes using a magnetic resonance imaging dataset. To achieve this, we focused the study on addressing the challenge of image noise, which impacts the performance of deep learning models. The study introduced a scheme for enhancing images to improve the quality of the datasets. Specifically, an image enhancement algorithm based on histogram equalization and bilateral filtering techniques was deployed to reduce noise and enhance the quality of the images. Subsequently, a convolutional neural network model comprising four convolutional layers and two hidden layers was devised for classifying Alzheimer’s disease into three (3) distinct categories, namely mild cognitive impairment, Alzheimer’s disease, and normal controls. The model was trained and evaluated using a 10-fold cross-validation sampling approach with a learning rate of 0.001 and 200 training epochs at each instance. The proposed model yielded notable results, such as an accuracy of 93.45% and an area under the curve value of 0.99 when trained on the three classes. The model further showed superior results on binary classification compared with existing methods. The model recorded 94.39%, 94.92%, and 95.62% accuracies for Alzheimer’s disease versus normal controls, Alzheimer’s disease versus mild cognitive impairment, and mild cognitive impairment versus normal controls classes, respectively.

An in‐depth analysis of wound incidence and injury status among professional athletes: A comprehensive review

Abstract

This review aims to synthesize current knowledge on the incidence, characteristics and management of wounds and injuries among professional ice hockey athletes, with the specific focus on the emerging population of Chinese female players. An extensive literature search was conducted across several databases to gather data on injury patterns and wounds, causes, severity and prevention strategies in ice hockey. Special attention was given to studies involving female athletes and unique challenges faced by players in developing regions like China. The review also examined the impact of training modalities, protective equipment and medical interventions on injury rates. The findings reveal a significant seasonal fluctuation in wound incidence, with marked reduction following the preseason period. This trend underscores the effectiveness of adjusted training programmes and essential role of medical teams in injury prevention and rehabilitation. Analysis did not show significant difference in wound rates between technical and physical training sessions, suggesting that injuries are pervasive risk across all training activities. Skating, collisions and inadequate warm-ups were identified as the leading causes of wounds, highlighting areas for targeted preventive measures. The distribution of wounds across various body regions pointed to knee, lower back and wrist as the most vulnerable sites, necessitating focused protection and training adjustments. Ice hockey, particularly among female athletes in China, presents complex injury landscape characterized by the wide range of wounds. The study emphasizes the necessity of comprehensive, multidisciplinary approach to injury prevention that includes training modifications, enhanced protective gear and strategic medical oversight. By addressing the specific causes and patterns of injuries identified, stakeholders can better protect athletes from the inherent risks of the sport, promote safer play and extend career longevity.

Explore the effect of pressure and time of compression on the risk of intraoperatively acquired pressure injury based on theoretical framework: A prospective study

Abstract

Surgery is a high risk factor for the occurrence of pressure injury (PI). On the basis of theoretical research, pressure and duration of pressure are key factors affecting PI. Pressure is affected by the individual pressure redistribution capacity. So our study aims to explore how the surgery time and pressure intensity affect the occurrence of PI and what are the risk factors. A prospective study. A total of 250 patients who underwent elective surgery in a grade-A general hospital from November 2021 to February 2023 were selected and divided into a group of 77 patients with IAPI (intraoperatively acquired pressure injury) and a group of 173 patients with no IAPI. Visual pressure inductive feedback system and body composition analysis technology were used to record the local pressure value and change of patients before and after anaesthesia. Relevant data of the patients were collected to explore the influencing factors. The maximum pressure and average pressure at the pressure site of the same patient changed before and after anaesthesia, and the pressure after anaesthesia was significantly higher than that before anaesthesia. There was no statistical difference in the average pressure after anaesthesia (p > 0.05), but the maximum pressure in the IAPI group was higher than that in the non-occurrence group (p < 0.05). The average pressure multiplied by the operation time in IAPI group is significantly higher than that in the non-IAPI group (p < 0.01). Multiple linear regression analysis (stepwise regression) showed that fat-free weight, age, waist circumference, body mass index (BMI) and gender were taken as independent variables into the regression model, affecting the maximum pressure. In addition, operation time ≥4 h may be a high risk factor for IAPI. In future studies, more objective research tools can be applied to improve the accuracy of predicting the risk of IAPI. In addition to gender and BMI, follow-up studies may consider including measures such as waist circumference and fat-free body weight in IAPI risk assessment to guide the clinical nursing work more scientifically.

Community perceptions, beliefs and factors determining family planning uptake among men and women in Ekiti State, Nigeria: finding from a descriptive exploratory study

Por: Ibikunle · O. O. · Ipinnimo · T. M. · Bakare · C. A. · Ibirongbe · D. O. · Akinwumi · A. F. · Ibikunle · A. I. · Ajidagba · E. B. · Olowoselu · O. O. · Abioye · O. O. · Alabi · A. K. · Seluwa · G. A. · Alabi · O. O. · Filani · O. · Adelekan · B.
Objectives

To examine family planning through the community’s perception, belief system and cultural impact; in addition to identifying the determining factors for family planning uptake.

Design

A descriptive exploratory study.

Setting

Three communities were selected from three local government areas, each in the three senatorial districts in Ekiti State.

Participants

The study was conducted among young unmarried women in the reproductive age group who were sexually active as well as married men and women in the reproductive age group who are currently living with their partners and were sexually active.

Main outcome measures

Eight focus group discussions were conducted in the community in 2019 with 28 male and 50 female participants. The audio recordings were transcribed, triangulated with notes and analysed using QSR NVivo V.8 software. Community perception, beliefs and perceptions of the utility of family planning, as well as cultural, religious and other factors determining family planning uptake were analysed.

Results

The majority of the participants had the perception that family planning helps married couple only. There were diverse beliefs about family planning and mixed reactions with respect to the impact of culture and religion on family planning uptake. Furthermore, a number of factors were identified in determining family planning uptake—intrapersonal, interpersonal and health system factors.

Conclusion

The study concluded that there are varied reactions to family planning uptake due to varied perception, cultural and religious beliefs and determining factors. It was recommended that more targeted male partner engagement in campaign would boost family planning uptake.

Association of maternal weight gain in early pregnancy with congenital heart disease in offspring: a China birth cohort study

Por: Wang · J. · Zhang · S. · Li · X. · Han · J. · Sun · L. · Wang · L. · Wu · Q.
Objectives

Little study has reported the association of maternal weight gain in early pregnancy with fetal congenital heart disease (CHD). We aimed to explore the potential relationship based on a China birth cohort while adjusting by multiple factors.

Design

Cohort study.

Setting

China birth cohort study conducted from 2017 to 2021.

Participants

The study finally included 114 672 singleton pregnancies in the 6–14 weeks of gestation, without missing data or outliers, loss to follow-up or abnormal conditions other than CHD. The proportion of CHD was 0.65% (749 cases).

Primary and secondary outcome measures

Association between maternal pre-pregnancy weight gain and CHD in the offspring were analysed by multivariate logistic regression, with the unadjusted, minimally adjusted and maximally adjusted methods, respectively.

Results

The first-trimester weight gain showed similar discrimination of fetal CHD to that period of maternal body mass index (BMI) change (DeLong tests: p=0.091). Compared with weight gain in the lowest quartile (the weight gain less than 0.0 kg), the highest quartile (over 2.0 kg) was associated with a higher risk of fetal CHD in unadjusted (OR 1.36, 95% CI: 1.08 to 1.72), minimally adjusted (adjusted OR (aOR) 1.29, 95% CI: 1.02 to 1.62) and maximally adjusted (aOR 1.29, 95% CI: 1.02 to 1.63) models. The association remains robust in pregnant women with morning sickness, normal pre-pregnancy BMI, moderate physical activity, college/university level, natural conception or with folic acid (FA) and/or multivitamin supplementation.

Conclusions and relevance

Although the association of maternal pre-pregnancy weight gain on fetal CHD is weak, the excessive weight gain may be a potential predictor of CHD in the offspring, especially in those with morning sickness and other conditions that are routine in the cohort, such as normal pre-pregnancy BMI, moderate physical activity, college/university level, natural conception or with FA and/or multivitamin supplementation.

The role of traditional Chinese medicine in postoperative wound complications of gastric cancer

Abstract

Due to the high risks of postoperative complications brought on by gastric cancer, traditional Chinese medicine (TCM) as a commonly used therapy, has exerted its vital role in postoperative recovery care. In this sense, this meta-analysis was conducted to explore the related documents about TCM's impact on gastric cancer postoperative recovery. During the research, we explored a total of 1549 results from databases PubMed, China National Knowledge Infrastructure (CNKI), Embase, Cochrane Library and Web of Science (WoS). Thirty-two clinical randomized trials (RCTs) were then selected and analysed for this meta-analysis by using the software RevMan 5.4 (under PRISMA 2020 regulations), with a population of 3178 patients. Data prove that TCM therapy reduced the risks for postoperative complications exposure by an estimated average of 19% (95% CI). Among the complications, TCM therapy suppressed the risks of wound infection and incisional infections by 53% and 48% respectively. Meanwhile, the patient's wound healing duration exhibited a significant reduction compared to those without TCM treatment, with a difference at around 0.74 days (95% CI). TCM also exerted its potential to strengthen the patient's immune and health conditions, leading to a significantly promoted gastrointestinal function in the patients with a shorter duration to release first exhaustion and defecation compared to those with no TCM therapy. In addition, similar promoted phenomena also exist in those patients with TCM therapy in terms of their immunity and nutritional conditions. These facts all indicate a positive impact of TCM therapy in clinical applications.

Effects of electromagnetic therapy in treating patients with venous leg ulcers: An overview of systematic reviews

Abstract

This study aims to evaluate the effects of electromagnetic therapy (EMT) on the treatment of venous leg ulcers (VLUs) by synthesising and appraising available meta-analyses (MAs) and systematic reviews (SRs). A comprehensive literature search was conducted across major databases up to 10 January 2024, focusing on SRs/MAs that investigated the use of EMT for VLUs. Selection criteria followed the PICO framework, and dual-author extraction was used for accuracy. Quality assessment tools included AMSTAR2, ROBIS, PRISMA, and GRADE. The search yielded five eligible studies. The reviews collectively presented moderate methodological quality and a low risk of bias in several domains. Reporting quality was high, albeit with inconsistencies in fulfilling certain PRISMA checklist items. The evidence quality, primarily downgraded due to small sample sizes, was rated as moderate. Whilst some studies suggest potential benefits of EMT in the treatment of VLUs, the overall evidence is inconclusive due to methodological limitations and limited sample sizes. This review underscores the need for future research with more rigorous methodologies and larger cohorts to provide clearer insights into the efficacy of EMT for VLUs.

Protocol for evaluating the effects of the Reducing Cardiometabolic Diseases Risk dietary pattern in the Chinese population with dyslipidaemia: a single-centre, open-label, dietary intervention study

Por: Wu · Q. · Zhang · L. · Cheng · C. · Chen · X. · Bian · S. · Huang · L. · Li · T. · Li · Z. · Liu · H. · Yan · J. · Du · Y. · Chen · Y. · Zhang · M. · Cao · L. · Li · W. · Ma · F. · Huang · G.
Introduction

Cardiometabolic disease (CMD) is the leading cause of mortality in China. A healthy diet plays an essential role in the occurrence and development of CMD. Although the Chinese heart-healthy diet is the first diet with cardiovascular benefits, a healthy dietary pattern that fits Chinese food culture that can effectively reduce the risk of CMD has not been found.

Methods/design

The study is a single-centre, open-label, randomised controlled trial aimed at evaluating the effect of the Reducing Cardiometabolic Diseases Risk (RCMDR) dietary pattern in reducing the risk of CMDs in people with dyslipidaemia and providing a reference basis for constructing a dietary pattern suitable for the prevention of CMDs in the Chinese population. Participants are men and women aged 35–45 years with dyslipidaemia in Tianjin. The target sample size is 100. After the run-in period, the participants will be randomised to the RCMDR dietary pattern intervention group or the general health education control group with a 1:1 ratio. The intervention phases will last 12 weeks, with a dietary intervention of 5 working days per week for participants in the intervention group. The primary outcome variable is the cardiometabolic risk score. The secondary outcome variables are blood lipid, blood pressure, blood glucose, body composition indices, insulin resistance and 10-year risk of cardiovascular diseases.

Ethics and dissemination

The study complies with the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings and the Declaration of Helsinki. Signed informed consent will be obtained from all participants. The study has been approved by the Medical Ethics Committee of the Second Hospital of Tianjin Medical University (approval number: KY2023020). The results from the study will be disseminated through publications in a peer-reviewed journal.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2300072472).

Preoperative pancreatic stent placement before the enucleation of insulinoma located in the head and neck of the pancreas in proximity to the main pancreatic duct: study protocol for a multicentre randomised clinical trial in Chinese tertiary medical cent

Por: Gao · R. · Yin · B. · Jin · J. · Tian · X. · Zhang · Y. · Wei · J. · Cao · F. · Wang · Z. · Ma · Z. · Wang · M. · Gou · S. · Cong · L. · Xu · Q. · Wu · W. · Zhao · Y.
Introduction

The surgical intervention approach to insulinomas in proximity to the main pancreatic duct remains controversial. Standard pancreatic resection is recommended by several guidelines; however, enucleation (EN) still attracts surgeons with less risk of late exocrine/endocrine insufficiency, despite a higher postoperative pancreatic fistula (POPF) rate. Recently, the efficacy and safety of preoperative pancreatic stent placement before the EN have been demonstrated. Thus, a multicentre open-label study is being conducted to evaluate the efficacy and safety of stent placement in improving the outcome of EN of insulinomas in proximity to the main pancreatic duct.

Methods and analysis

This is a prospective, randomised, open-label, superiority clinical trial conducted at multiple tertiary centres in China. The major eligibility criterion is the presence of insulinoma located in the head and neck of the pancreas in proximity (≤2 mm) to the main pancreatic duct. Blocked randomisation will be performed to allocate patients into the stent EN group and the direct EN group. Patients in the stent EN group will go through stent placement by the endoscopist within 24 hours before the EN surgery, whereas other patients will receive EN surgery directly. The primary outcome is the assessment of the superiority of stent placement in reducing POPF rate measured by the International Study Group of Pancreatic Surgery standard. Both interventions will be performed in an inpatient setting and regular follow-up will be performed. The primary outcome (POPF rate) will be tested for superiority with the X2 test. The difference in secondary outcomes between the two groups will be analysed using appropriate tests.

Ethics and dissemination

The study has been approved by the Peking Union Medical College Hospital Institutional Review Board (K23C0195), Ruijin Hospital Ethics Committee (2023-314), Peking University First Hospital Ethics Committee (2024033-001), Institutional Review Board of Xuanwu Hospital of Capital Medical University (2023223-002), Ethics Committee of the First Affiliated Hospital of Xi’an Jiaotong University (XJTU1AF2023LSK-473), Institutional Review Board of Tongji Medical College Tongji Hospital (TJ-IRB202402059), Ethics Committee of Tongji Medical College Union Hospital (2023-0929) and Shanghai Cancer Center Institutional Review Board (2309282-16). The results of the study will be published in an international peer-reviewed journal.

Trial registration number

NCT05523778.

Supplements for cognitive ability in patients with mild cognitive impairment or Alzheimers disease: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Zhang · X.-Y. · Li · Y.-Q. · Yin · Z.-H. · Bao · Q.-N. · Xia · M.-Z. · Chen · Z.-H. · Zhong · W.-Q. · Wu · K.-X. · Yao · J. · Liang · F.-R.
Introduction

Considering the increasing incidence of Alzheimer’s disease (AD) and mild cognitive impairment (MCI) worldwide, there is an urgent need to identify efficacious, safe and convenient treatments. Numerous investigations have been conducted on the use of supplements in this domain, with oral supplementation emerging as a viable therapeutic approach for AD or MCI. Nevertheless, given the multitude of available supplements, it becomes imperative to identify the optimal treatment regimen.

Methods and analysis

Eight academic databases and three clinical trial registries will be searched from their inception to 1 June 2023. To identify randomised controlled trials investigating the effects of supplements on patients with AD or MCI, two independent reviewers (X-YZ and Y-QL) will extract relevant information from eligible articles, while the risk of bias in the included studies will be assessed using the Rob 2.0 tool developed by the Cochrane Collaboration. The primary outcome of interest is the overall cognitive function. Pair-wise meta-analysis will be conducted using RevMan V.5.3, while network meta-analysis will be carried out using Stata 17.0 and ADDIS 1.16.8. Heterogeneity test, data synthesis and subgroup analysis will be performed if necessary. The GRADE system will be employed to assess the quality of evidence. This study is scheduled to commence on 1 June 2023 and conclude on 1 October 2023.

Ethics and dissemination

Ethics approval is not required for systematic review and network meta-analysis. The results will be submitted to a peer-reviewed journal or at a conference.

Trial registration number

PROSPERO (CRD42023414700).

Association of prepregnancy body mass index and gestational weight gain trajectory with adverse pregnancy outcomes--a prospective cohort study in Shanghai

Por: Ma · Z. · Chu · L. · Zhang · Z. · Hu · Y. · Zhu · Y. · Wu · F. · Zhang · Y.
Objectives

The objective was to investigate the associations of maternal prepregnancy body mass index (BMI) and gestational weight gain (GWG) trajectories with adverse pregnancy outcomes (APOs).

Design

This was a prospective cohort study.

Setting

This study was conducted in Shanghai Pudong New Area Health Care Hospital for Women and Children, Shanghai, China.

Primary and secondary outcome measures

A cohort study involving a total of 2174 pregnant women was conducted. Each participant was followed to record weekly weight gain and pregnancy outcomes. The Institute of Medicine classification was used to categorise prepregnancy BMI, and four GWG trajectories were identified using a latent class growth model.

Results

The adjusted ORs for the risks of large for gestational age (LGA), macrosomia, gestational diabetes mellitus (GDM) and hypertensive disorders of pregnancy (HDP) were significantly greater for women with prepregnancy overweight/obesity (OR=1.77, 2.13, 1.95 and 4.24; 95% CI 1.3 to 2.42, 1.32 to 3.46, 1.43 to 2.66 and 2.01 to 8.93, respectively) and lower for those who were underweight than for those with normal weight (excluding HDP) (OR=0.35, 0.27 and 0.59; 95% CI 0.22 to 0.53, 0.11 to 0.66 and 0.36 to 0.89, respectively). The risk of small for gestational age (SGA) and low birth weight (LBW) was significantly increased in the underweight group (OR=3.11, 2.20; 95% CI 1.63 to 5.92, 1.10 to 4.41; respectively) compared with the normal-weight group; however, the risk did not decrease in the overweight/obese group (p=0.942, 0.697, respectively). GWG was divided into four trajectories, accounting for 16.6%, 41.4%, 31.7% and 10.3% of the participants, respectively. After adjustment for confounding factors, the risk of LGA was 1.54 times greater for women in the slow GWG trajectory group than for those in the extremely slow GWG trajectory group (95% CI 1.07 to 2.21); the risk of SGA and LBW was 0.37 times and 0.46 times lower for women in the moderate GWG trajectory group and 0.14 times and 0.15 times lower for women in the rapid GWG trajectory group, respectively; the risk of macrosomia and LGA was 2.65 times and 2.70 times greater for women in the moderate GWG trajectory group and 3.53 times and 4.36 times greater for women in the rapid GWG trajectory group, respectively; and the women in the other three trajectory groups had a lower risk of GDM than did those in the extremely slow GWG trajectory group, but there was not much variation in the ORs. Notably, different GWG trajectories did not affect the risk of HDP.

Conclusions

As independent risk factors, excessively high and low prepregnancy BMI and GWG can increase the risk of APOs.

Comparative analysis of pressure ulcer development in stroke patients within and outside healthcare facilities: A systematic review and meta‐analysis

Abstract

The risk of pressure ulcers in stroke patients is a significant concern, impacting their recovery and quality of life. This systematic review and meta-analysis investigate the prevalence and risk factors of pressure ulcers in stroke patients, comparing those in healthcare facilities with those in home-based or non-clinical environments. The study aims to elucidate how different care settings affect the development of pressure ulcers, serving as a crucial indicator of patient care quality and management across diverse healthcare contexts. Following PRISMA guidelines, a comprehensive search was conducted across PubMed, Embase, Web of Science and the Cochrane Library. Inclusion criteria encompassed studies on stroke patients in various settings, reporting on the incidence or prevalence of pressure ulcers. Exclusion criteria included non-stroke patients, non-original research and studies with incomplete data. The Newcastle–Ottawa scale was used for quality assessment, and statistical analyses involved both fixed-effect and random-effects models, depending on the heterogeneity observed. A total of 1542 articles were initially identified, with 11 studies meeting the inclusion criteria. The studies exhibited significant heterogeneity, necessitating the use of a random-effects model. The pooled prevalence of pressure injuries was 9.53% in patients without family medical services and 2.64% in patients with medical services. Sensitivity analysis confirmed the stability of these results, and no significant publication bias was detected through funnel plot analysis and Egger's linear regression test. The meta-analysis underscores the heightened risk of pressure injuries in stroke patients, especially post-discharge. It calls for concerted efforts among healthcare providers, policymakers and caregivers to implement targeted strategies tailored to the specific needs of different care environments. Future research should focus on developing and evaluating interventions to effectively integrate into routine care and reduce the incidence of pressure injuries in stroke patients.

Effectiveness of computerised decision aids for patients with chronic diseases in shared decision‐making: A systematic review and meta‐analysis

Abstract

Aims

To synthesise the composition and effectiveness of computer-based patient decision aid (PDAs) in interventions for patients with chronic diseases.

Design

A systematic review with meta-analysis.

Methods

Five databases were searched, and only randomised controlled trials (RCTs)were included. This review was conducted with the PRISMA guidelines. The JBI Appraisal Tools for randomised trials were used to assess the risk of bias. We used the random-effects model to conduct meta-analyses. Evidence from RCTs was synthesised using standardised mean differences or mean differences. The GRADE system was employed to assess the certainty of evidence and recommendations. This study was registered on PROSPERO (number: CRD42022369340).

Data Sources

PubMed, Embase, Web of Science, CINAHL and Cochrane Library were searched for studies published before October 2022.

Results

The review included 22 studies, and most computer-based PDAs reported information on the disease, treatment options, pros and cons and risk comparison and value clarification. The use of computer-based PDAs showed a significant effect on decision conflict and knowledge, but not on decision regret, satisfaction, self-efficacy, anxiety and quality of life. The overall GRADE certainty of evidence was low.

Conclusion

Although the quality of evidence was low, however, using computer-based PDAs could reduce decision conflict and enhance knowledge when making medical decisions. More research is needed to support the contention above.

Relevance to Clinical Practice

Computer-based PDAs could assist health-care providers and patients in the shared decision-making process and improving the quality of decision-making.

Reporting Method

This study adhered to PRISMA guidelines.

No Patient or Public Contribution

The effectiveness of non‐pharmacological interventions on reducing pain in patients undergoing bone marrow aspiration and biopsy: A systematic review and meta‐analysis of randomized controlled trials

Abstract

Background

Patients often consider bone marrow aspiration and biopsy to be one of the most painful medical procedures. The effectiveness of non-pharmacological interventions to reduce pain during bone marrow aspiration and biopsy remains unclear.

Aim

To synthesize existing evidence regarding the effectiveness of non-pharmacological interventions in mitigating procedural pain among patients undergoing bone marrow aspiration and biopsy.

Design

A systematic review and meta-analysis of randomized controlled trials.

Methods

Six electronic databases, including PubMed, EMBASE, CINAHL, PsycINFO, Cochrane Library and Web of Science were searched from inception to July 15, 2023. The risk of bias was assessed using the Cochrane Risk of Bias Tool Version 2.0. Meta-analysis was conducted using STATA 16. The certainty of the evidence was assessed by the GRADE approach.

Results

This meta-analysis included 18 studies derived from 17 articles involving a total of 1017 participants. The pooled results revealed statistically significant pain reduction effects using distraction (SMD: −.845, 95% CI: −1.344 to −.346, p < .001), powered bone marrow biopsy system (SMD: −.266, 95% CI: −.529 to −.003, p = .048), and acupoint stimulation (SMD: −1.016, 95% CI: −1.995 to −.037, p = .042) among patients undergoing bone marrow aspiration and biopsy. However, the pooled results on hypnosis (SMD: −1.228, 95% CI: −4.091 to 1.515, p = .368) showed no significant impact on pain reduction. Additionally, the pooled results for distraction did not demonstrate a significant effect on operative anxiety (MD: −2.942, 95% CI: −7.650 to 1.767, p = .221).

Conclusions

Distraction, powered bone marrow biopsy system and acupoint stimulation are effective in reducing pain among patients undergoing bone marrow aspiration and biopsy.

Patient or Public Contribution

Not applicable.

Relevance to Clinical Practice

This meta-analysis highlights the effectiveness of distraction, powered bone marrow biopsy system and acupoint stimulation for reducing pain in patients undergoing bone marrow biopsy. Healthcare professionals should consider integrating these interventions into pain management practices for these patients.

Registration

(PROSPERO): CRD42023422854.

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