FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Impacts of income inequality and the mediation role of reporting delays on COVID-19 deaths during 2020 and 2021 in Hong Kong: an observational study

Por: Yuan · H.-Y. · Wong · W. H. · Khairunnasa · F. · Ho · H. C. · Chung · G. K.-K.
Objective

To estimate the impacts of demographic factors and income disparities on the case fatality rate (CFR) of COVID-19 in Hong Kong, taking into account the influence of reporting delays (ie, the duration between symptom onset and case confirmation).

Design

Retrospective observational longitudinal study.

Participants

A total of 7406 symptomatic patients with residence information reported between 23 January 2020 and 2 October 2021.

Main outcome measures

The study examined the disparity in COVID-19 deaths associated with the factors such as age (≥65 vs 0–64 years old groups), gender and the income level of districts (low income vs non-low income). The severe reporting delay (>10 days) was considered as the mediator for mediation analysis. A Cox proportional hazards regression model was constructed.

Results

We found that CFR was 3.07% in the low-income region, twofold higher than 1.34% in the other regions. Although the severe reporting delay was associated with a hazard ratio (HR) of about 1.9, its mediation effect was only weakly present for age, but not for gender or income level. Hence, high CFR in Hong Kong was largely attributed to the direct effects of the elderly (HR 25.967; 95% CI 14.254 to 47.306) and low income (HR 1.558; 95% CI 1.122 to 2.164).

Conclusion

The disparity in COVID-19 deaths between income regions is not due to reporting delays, but rather to health inequities in Hong Kong. These risks may persist after the discontinuation of test-and-trace measures and extend to other high-threat respiratory pathogens. Urgent actions are required to identify vulnerable groups in low-income regions and understand the underlying causes of health inequities.

Sarcopenia in systemic sclerosis: prevalence and impact--a systematic review and meta-analysis

Por: Tu · X. · Lin · T. · Ju · Y. · Shu · X. · Jiang · T. · Ge · N. · Yue · J.
Objective

This review aims to provide an estimate of sarcopenia prevalence and its impact on clinical characteristics in patients with systemic sclerosis (SSc).

Design

Systematic review and meta-analysis.

Data sources

Embase, Medline, Web of Science and the Cochrane Central Register of Controlled Trials were systemically searched from inception to 24 May 2023.

Eligibility criteria for selecting studies

We included observational studies that reported the prevalence of sarcopenia in patients with SSc.

Data extraction and synthesis

Two reviewers independently performed study selection and data extraction using standardised methods. Risk of bias was assessed using the Agency for Healthcare Research and Quality Scale and the Newcastle–Ottawa Scale. Meta-analysis was conducted using random effects models.

Results

A total of 4583 articles were screened and 9 studies with data from 815 patients were included in the analysis (8 cross-sectional studies and 1 retrospective cohort study). The overall prevalence of sarcopenia in patients with SSc was 22% (95% CI 17% to 28%). Patients with SSc with sarcopenia had a poorer quality of life (mean difference –12.02; 95% CI –19.11 to –4.93) and higher C reactive protein (CRP) levels (standardised mean difference 0.67; 95% CI 0.35 to 1.00).

Conclusions

Sarcopenia is common in patients with SSc. Patients with SSc with sarcopenia had a worse quality of life and higher CRP levels, based on our findings. Given the detrimental impact of sarcopenia on quality of life, future efforts aimed at early identification of sarcopenia in the clinical assessment of patients with SSc may have significance.

PROSPERO registration number

CRD42022368326.

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.

Knowledge, attitude and practice on ovarian reserve function among women of childbearing age: a prospective cross-sectional study in Chongqing and surrounding regions

Por: Yuan · Y. · Yang · L. · Hu · J. · Deng · Y. · Zhang · H.
Objectives

To evaluate the knowledge, attitudes and practice (KAP) on ovarian reserve function among women of childbearing age in Chongqing and surrounding regions, China.

Design

Cross-sectional study.

Setting

Chongqing and surrounding regions, China.

Participants

Women of childbearing age (18–48 years) by convenience sampling.

Primary and secondary outcome measures

The demographic characteristics of the respondents and their KAP on ovarian reserve function were collected by administering 38-item questionnaires.

Results

A total of 510 valid questionnaires were collected. The mean knowledge score of all respondents was 7.56±2.03 (possible range: 0–10), the mean attitude score was 29.12±3.98 (possible range: 8–40) and the mean practice score was 23.45±3.58 (possible range: 6–30). The multivariable analysis showed knowledge level (OR 1.175, 95% CI 1.049 to 1.317, p=0.002), attitude level (OR 1.249, 95% CI 1.167 to 1.337, p

Conclusions

The women living in Chongqing and surrounding regions had good knowledge, moderate attitude and good practice towards ovarian reserve function. The knowledge aspect can be further improved by education, which in turn might also improve practice among women of childbearing age.

Deep learning-based correction of cataract-induced influence on macular pigment optical density measurement by autofluorescence spectroscopy

by Akira Obana, Kibo Ote, Yuko Gohto, Hidenao Yamada, Fumio Hashimoto, Shigetoshi Okazaki, Ryo Asaoka

Purpose

Measurements of macular pigment optical density (MPOD) using the autofluorescence spectroscopy yield underestimations of actual values in eyes with cataracts. Previously, we proposed a correction method for this error using deep learning (DL); however, the correction performance was validated through internal cross-validation. This cross-sectional study aimed to validate this approach using an external validation dataset.

Methods

MPODs at 0.25°, 0.5°, 1°, and 2° eccentricities and macular pigment optical volume (MPOV) within 9° eccentricity were measured using SPECTRALIS (Heidelberg Engineering, Heidelberg, Germany) in 197 (training dataset inherited from our previous study) and 157 eyes (validating dataset) before and after cataract surgery. A DL model was trained to predict the corrected value from the pre-operative value using the training dataset, and we measured the discrepancy between the corrected value and the actual postoperative value. Subsequently, the prediction performance was validated using a validation dataset.

Results

Using the validation dataset, the mean absolute values of errors for MPOD and MPOV corrected using DL ranged from 8.2 to 12.4%, which were lower than values with no correction (P Conclusion

The usefulness of the DL correction method was validated. Deep learning reduced the error for a relatively good autofluorescence image quality. Poor-quality images were not corrected.

Caffeinated beverages intake and risk of deep vein thrombosis: A Mendelian randomization study

by Tong Lin, Haiyan Mao, Yuhong Jin

This study aimed to explore the potential link between coffee and tea consumption and the risk of deep vein thrombosis (DVT) through Mendelian randomization (MR) analysis. Employing the MR, we identified 33 single nucleotide polymorphisms (SNPs) as instrumental variables (IVs) for coffee intake and 38 SNPs for tea intake. The investigation employed the inverse-variance weighted (IVW) method to evaluate the causal impact of beverage consumption on DVT risk. Additionally, MR-Egger and MR-PRESSO tests were conducted to assess pleiotropy, while Cochran’s Q test gauged heterogeneity. Robustness analysis was performed through a leave-one-out approach. The MR analysis uncovered a significant association between coffee intake and an increased risk of DVT (odds ratio [OR] 1.008, 95% confidence interval [CI] = 1.001–1.015, P = 0.025). Conversely, no substantial causal effect of tea consumption on DVT was observed (OR 1.001, 95% CI = 0.995–1.007, P = 0.735). Importantly, no significant levels of heterogeneity, pleiotropy, or bias were detected in the instrumental variables used. In summary, our findings suggest a modestly heightened risk of DVT associated with coffee intake, while tea consumption did not exhibit a significant impact on DVT risk.

Downregulation of the CD151 protects the cardiac function by the crosstalk between the endothelial cells and cardiomyocytes via exosomes

by Luying Jiang, Jingbo Liu, Zhenjia Yang, Jianyu Wang, Wenkai Ke, Kaiyue Zhang, Chunran Zhang, Houjuan Zuo

Background

Heart failure (HF) is the last stage in the progression of various cardiovascular diseases. Although it is documented that CD151 contributes to regulate the myocardial infarction, the function of CD151 on HF and involved mechanisms are still unclear.

Method and results

In the present study, we found that the recombinant adeno-associated virus (rAAV)-mediated endothelial cell-specific knockdown of CD151-transfected mice improved transverse aortic constriction (TAC)-induced cardiac function, attenuated myocardial hypertrophy and fibrosis, and increased coronary perfusion, whereas overexpression of the CD151 protein aggravated cardiac dysfunction and showed the opposite effects. In vitro, the cardiomyocytes hypertrophy induced by PE were significantly improved, while the proliferation and migration of cardiac fibroblasts (CFs) were significantly reduced, when co-cultured with the CD151-silenced endothelial cells (ECs). To further explore the mechanisms, the exosomes from the CD151-silenced ECs were taken by cardiomyocyte (CMs) and CFs, verified the intercellular communication. And the protective effects of CD151-silenced ECs were inhibited when exosome inhibitor (GW4869) was added. Additionally, a quantitative proteomics method was used to identify potential proteins in CD151-silenced EC exosomes. We found that the suppression of CD151 could regulate the PPAR signaling pathway via exosomes.

Conclusion

Our observations suggest that the downregulation of CD151 is an important positive regulator of cardiac function of heart failure, which can regulate exosome-stored proteins to play a role in the cellular interaction on the CMs and CFs. Modulating the exosome levels of ECs by reducing CD151 expression may offer novel therapeutic strategies and targets for HF treatment.

The application of flipped learning to a gross anatomy dissection course

by Eun-Kyung Chung, Heoncheol Yun, Kwang-Il Nam, Young-Suk Cho, Eui-Ryoung Han

We implemented flipped learning for a gross anatomy dissection course and compared its effects on students’ motivation and academic achievement with those of traditional dissection methods. We invited 142 first-year medical students at Chonnam National University Medical School to participate in this study. All participants engaged in traditional dissection methods in the first part of the study and flipped learning in the latter part. Medical students’ motivation to learn anatomy by cadaveric dissection was measured using the ARCS (Attention, Relevance, Confidence, and Satisfaction) model. Thereafter, all students completed a written examination consisting of 96 multiple-choice questions. The students’ mean motivational score regarding attention was significantly higher in association with flipped learning than with traditional learning. However, the students’ mean motivational scores regarding relevance, confidence, and satisfaction were not significantly different between the methods. Additionally, the mean anatomy practice test score was significantly higher in association with flipped learning than with traditional learning. The students’ motivational scores and anatomy practice test scores associated with flipped learning positively correlated with the extent of learning material completion. The students’ responses indicated that flipped learning helped enhance the learning process, improve time management, reduce confusion during practice, and promote independent practice. The application of flipped learning to a cadaveric dissection course increased individual learning motivation, which improved learning activities both in and out of class, as well as academic achievement.

Family resilience, patient‐reported symptoms in young stroke dyads: The effect of caregiver readiness and social support

Abstract

Aims and Objectives

To investigate empirically the direct effect and potential mechanism of family resilience on patient-reported outcomes among young stroke dyads in China.

Background

Young patients with stroke have been becoming an important public health issue. According to relevant theories and previous studies, we found that family resilience might play an important role in patient's symptoms. However, it is less clear about the specific relationship and potential mechanisms of these two variables.

Design

We used a prospective cross-sectional design.

Methods

A multi-item questionnaire was used to assess the constructs of interest. Researchers progressively constructed and validated conditional process models. The PROCESS macro was used to verify the research hypotheses.

Results

A total of 560 questionnaires were collected in this study. We found that family resilience of stroke patients and their spouses had a direct effect on the physical, psychological and social aspects of patient-reported symptoms. We further revealed that caregiver preparedness partially mediated the relationship between family resilience and patient's symptoms in stroke patient-spouse dyads, while perceived social support moderated the relationship between caregiver preparedness and patient's symptoms. Finally, we observed that the impact of caregiver readiness and social support on patients' symptoms predominantly manifested in physical and physiological outcomes.

Conclusions

Our research provides evidence about the positive impact of family resilience on patient-reported symptoms in young stroke dyads. Meanwhile, it further revealed how caregiver preparedness and perceived social support may play out in the relationship.

Practice Implications

Our research introduces a novel perspective and pathway to enhance short-term recovery outcomes for patients. It also furnishes clinicians and nurses with evidence to guide the implementation of interventions aimed at improving patient health outcomes and facilitating smoother transitions from the hospital to home.

Impact

What problem did the study address?

Families play a crucial role in a patient's recovery process from illness, with family resilience serving as an important force for families to overcome adversity. However, the impact on patient symptoms and the underlying mechanisms of this relationship are uncertain. Empirical research is required to validate these aspects.

What were the main findings?

Family resilience has a positive impact on the physical, psychological and social aspects of patient-reported symptoms in young stroke dyads. Both the actor effect and partner effect are supported. The impact of caregiver readiness and social support on patient-reported symptoms is primarily observed in physical and physiological outcomes.

Where and on whom will the research have an impact?

This study offers a novel approach to enhance the short-term recovery of stroke patients. The researchers believe that the findings of this study will play an even more significant role during patients' transition from the hospital to home.

Reporting Method

This study followed the STROBE statement of cross-sectional studies.

Patient or Public Contribution

The study was conducted by patients, their spouses, healthcare professionals and the research team.

Factors associated with the intrinsic capacity in older adults: A scoping review

Abstract

Introduction

In 2015, the term ‘intrinsic capacity’ (IC) was proposed by the World Health Organisation to promote healthy aging. However, the factors associated with IC are still discrepant and uncertain.

Aim

We aim to synthesise the factors connected with IC.

Methods

This scoping review followed the five-stage framework of Arksey and O'Malley and was reported using PRISMA-ScR guidelines.

Results

In all, 29 articles were included. IC of older adults is associated with demographic characteristics, socioeconomic factors, disease conditions, behavioural factors, and biomarkers. Age, sex, marital status, occupation status, education, income/wealth, chronic diseases, hypertension, diabetes, disability, smoking status, alcohol consumption, and physical activity were emerged as important factors related to the IC of older adults.

Conclusions

This review shows that IC is related to multiple factors. Understanding these factors can provide the healthcare personnel with the theoretical basis for intervening and managing IC in older adults.

Relevance to Clinical Practice

The influencing factors identified in the review help to guide older adults to maintain their own intrinsic capacity, thereby promoting their health and well-being. The modifiable factors also provide evidence for healthcare personnel to develop targeted intervention strategies to delay IC decline.

No Patient or Public Contribution

As this is a scoping review, no patient or public contributions are required.

Metabolism, fibrosis, and apoptosis: The effect of lipids and their derivatives on keloid formation

Abstract

Keloids, pathological scars resulting from skin trauma, have traditionally posed significant clinical management challenges due to their persistence and high recurrence rates. Our research elucidates the pivotal roles of lipids and their derivatives in keloid development, driven by underlying mechanisms of abnormal cell proliferation, apoptosis, and extracellular matrix deposition. Key findings suggest that abnormalities in arachidonic acid (AA) synthesis and non-essential fatty acid synthesis are integral to keloid formation. Further, a complex interplay exists between lipid derivatives, notably butyric acid (BA), prostaglandin E2 (PGE2), prostaglandin D2 (PGD2), and the regulation of hyperfibrosis. Additionally, combinations of docosahexaenoic acid (DHA) with BA and 15-deoxy-Δ12,14-Prostaglandin J2 have exhibited pronounced cytotoxic effects. Among sphingolipids, ceramide (Cer) displayed limited pro-apoptotic effects in keloid fibroblasts (KFBs), whereas sphingosine 1-phosphate (S1P) was found to promote keloid hyperfibrosis, with its analogue, FTY720, demonstrating contrasting benefits. Both Vitamin D and hexadecylphosphorylcholine (HePC) showed potential antifibrotic and antiproliferative properties, suggesting their utility in keloid management. While keloids remain a prevalent concern in clinical practice, this study underscores the promising potential of targeting specific lipid molecules for the advancement of keloid therapeutic strategies.

Comparative effectiveness of pericapsular nerve group block versus fascia iliac compartment block on postoperative wound pain management in patients undergoing hip fracture surgery: A systematic review and meta‐analysis

Abstract

Hip fracture surgeries are challenging, with postoperative pain management being a critical component of patient care. This systematic review and meta-analysis aimed to compare the effectiveness of Pericapsular nerve group block (PENGB) and fascia iliac compartment block (FICB) in postoperative wound pain management for patients undergoing hip fracture surgery. The study followed the PRISMA guidelines and was structured around the PICO framework. Comprehensive searches were conducted across PubMed, Embase, Web of Science, and the Cochrane Library. Inclusion criteria were limited to RCTs comparing the effectiveness of PENGB and FICB in adult patients undergoing hip fracture surgery. Key outcomes included pain control effectiveness, safety, and complication incidence. The quality of studies was assessed using the Cochrane Collaboration's risk of bias tool. Statistical heterogeneity was evaluated using I 2 statistics, and meta-analysis effect values were calculated using random-effects or fixed-effect models, depending on the degree of heterogeneity. The search identified 1095 articles, with 5 studies meeting inclusion criteria. The meta-analysis revealed that PENGB and FICB were comparable in managing postoperative pain and opioid consumption. However, PENGB significantly reduced the incidence of quadriceps muscle weakness (RR = 0.12, p < 0.05) and did not increase the risk of PONV (RR = 1.36, p = 0.51), suggesting its advantage in maintaining motor function without adding to PONV complications. No significant publication bias was detected. PENGB is comparable to FICB in pain and opioid consumption management after hip fracture surgeries. Its significant benefit lies in reducing the incidence of quadriceps muscle weakness, facilitating better postoperative mobility. Additionally, PENGB does not increase the risk of postoperative nausea and vomiting, underlining its suitability for comprehensive postoperative care in hip fracture patients.

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.

The impact of cognitive behavioural therapy‐based psychological intervention on emotional improvement in elderly patients with extensive burns

Abstract

To evaluate the efficacy of cognitive behavioural therapy (CBT) as a psychological intervention for elderly patients with extensive burns, focusing on its impact on emotional well-being, self-efficacy and quality of life. A prospective, randomized study involving 200 elderly burn patients was conducted from November 2021 to January 2023. The patients were randomly assigned to receive either standard care (control group) or burn care based on cognitive behavioural therapy (CBT-B) (study group), with 100 patients in each group. Outcome measures included the Visual Analog Scale (VAS) for pain assessment, 36-item Short Form Survey (SF-36) for quality of life, General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES). The study revealed that CBT-based intervention significantly reduced anxiety and depression scores compared with standard care (p < 0.05). Additionally, patients in the CBT group exhibited improved self-efficacy, self-esteem and quality of life (p < 0.05). CBT proves to be a valuable intervention for elderly burn patients, effectively addressing emotional distress and enhancing their psychological well-being. By modifying negative cognitive patterns, providing coping mechanisms and fostering problem-solving skills, CBT-based care contributes to a more positive recovery experience and improved quality of life.

Good School Toolkit-Secondary Schools to prevent violence against students: protocol for a pilot cluster randomised controlled trial

Por: Devries · K. · Tanton · C. · Knight · L. · Nakuti · J. · Nanyunja · B. · Laruni · Y. · Amollo · M. · Apota · J. · Opobo · T. · Pearlman · J. · Allen · E. · Bonell · C. · Naker · D.
Introduction

No whole-school interventions which seek to reduce physical, sexual and emotional violence from peers, intimate partners and teachers have been trialled with adolescents. Here, we report a protocol for a pilot trial of the Good School Toolkit-Secondary Schools intervention, to be tested in Ugandan secondary schools. Our main objectives are to (1) refine the intervention, (2) to understand feasibility of delivery of the intervention and (3) to explore design parameters for a subsequent phase III trial.

Methods and analysis

We will conduct a pilot cluster randomised controlled trial, with two arms and parallel assignment. Eight schools will be randomly selected from a stratified list of all eligible schools in Kampala and Wakiso Districts. We will conduct a baseline survey and endline survey 18 months after the baseline, with 960 adolescents and 200 teachers. Qualitative data and mixed methods process data collection will be conducted throughout the intervention. Proportion of staff and students reporting acceptability, understanding and implementing with fidelity will be tabulated at endline for intervention schools. Proportions of schools consenting to participation, randomisation and proportions of schools and individual participants completing the baseline and endline surveys will be described in a Consolidated Standards of Reporting Trials diagram.

Ethics and dissemination

The ethical requirements of our project are complex. Full approvals have been received from the Mildmay Ethics Committee (0407-2019), the Uganda National Council for Science and Technology (SS 6020) and the London School of Hygiene & Tropical Medicine (16212). Results of this study will be published in peer-reviewed academic journals, and shared with public bodies, policy makers, study participants and the general public in Uganda.

Trial registration number

PACTR202009826515511.

Impact of intraosseous regional administration of tranexamic acid in total knee arthroplasty on perioperative blood loss: a protocol for a randomised controlled trial

Por: Wei · Z. · Yu · M. · Xu · Y. · Weng · X. · Feng · B.
Introduction

Total knee arthroplasty (TKA) is a common surgical intervention to treat joint diseases. However, TKA is associated with significant blood loss. Tranexamic acid (TXA) has been used to reduce perioperative bleeding and postoperative blood transfusion. This study aims to explore the effectiveness and safety of intraosseous regional administration (IORA) of TXA in TKA and compare differences in perioperative blood loss between IORA of TXA, intravenous infusion of TXA, and combined IORA and intravenous infusion of TXA.

Methods and analysis

This randomised controlled trial will enrol 105 patients with osteoarthritis who meet the inclusion criteria for unilateral TKA. Patients were randomly divided into three groups using the random number table method. Group A received 1.0 g of TXA via IORA, group B received 1.0 g of TXA via intravenous infusion 15 min prior to the tourniquet release, and group C received both IORA of 1.0 g of TXA and intravenous infusion of 1.0 g of TXA. The primary outcome measure is perioperative total blood loss. Secondary outcomes include bleeding events, venous thromboembolism events, inflammation reactions, other complications and knee function assessments.

Ethics and dissemination

This study has been approved by the Ethics Committee of Peking Union Medical College Hospital and registered in the Chinese Clinical Trial Registry. Informed consent will be obtained from all the patients before enrolment. The trial will be conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The results of this study will be disseminated through peer-reviewed publications, conference presentations and social media platforms. The findings will provide valuable insights into the use of IORA of TXA in TKA and may lead to the development of new strategies for perioperative blood management in joint replacement surgery.

Trial registration number

The Ethics Committee of Peking Union Medical College Hospital (approval number: K2371); Chinese Clinical Trial Registry (trial registration number: ChiCTR2200066293).

Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in the Elderly with Alzheimer’s Disease (D-PRESCRIBE-AD): Trial protocol and rationale of an open-label pragmatic, prospective randomized controlled

by Sonal Singh, Noelle M. Cocoros, Xiaojuan Li, Kathleen M. Mazor, Mary T. Antonelli, Lauren Parlett, Mark Paullin, Thomas P. Harkins, Yunping Zhou, Paula A. Rochon, Richard Platt, Inna Dashevsky, Carly Massino, Cassandra Saphirak, Sybil L. Crawford, Jerry H. Gurwitz

Context

Potentially inappropriate prescribing of medications in older adults, particular those with dementia, can lead to adverse drug events including falls and fractures, worsening cognitive impairment, emergency department visits, and hospitalizations. Educational mailings from health plans to patients and their providers to encourage deprescribing conversations may represent an effective, low-cost, “light touch”, approach to reducing the burden of potentially inappropriate prescription use in older adults with dementia.

Objectives

The objective of the Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer’s Disease (D-PRESCRIBE-AD) trial is to evaluate the effect of a health plan based multi-faceted educational outreach intervention to community dwelling patients with dementia who are currently prescribed sedative/hypnotics, antipsychotics, or strong anticholinergics.

Methods

The D-PRESCRIBE-AD is an open-label pragmatic, prospective randomized controlled trial (RCT) comparing three arms: 1) educational mailing to both the health plan patient and their prescribing physician (patient plus physician arm, n = 4814); 2) educational mailing to prescribing physician only (physician only arm, n = 4814); and 3) usual care (n = 4814) among patients with dementia enrolled in two large United States based health plans. The primary outcome is the absence of any dispensing of the targeted potentially inappropriate prescription during the 6-month study observation period after a 3-month black out period following the mailing. Secondary outcomes include dose-reduction, polypharmacy, healthcare utilization, mortality and therapeutic switching within targeted drug classes.

Conclusion

This large pragmatic RCT will contribute to the evidence base on promoting deprescribing of potentially inappropriate medications among older adults with dementia. If successful, such light touch, inexpensive and highly scalable interventions have the potential to reduce the burden of potentially inappropriate prescribing for patients with dementia.ClinicalTrials.gov Identifier: NCT05147428.

Adequacy of cancer-related pain management using the Pain Management Index among patients with cancer in the Northwest oncology centres of Ethiopia: an institutional-based cross-sectional study

Por: Mihiretie · E. A. · Siyum · T. S. · Tamene · F. B.
Objective

The aim of this study was to assess the adequacy of cancer-related pain (CRP) management and associated factors among patients with cancer in the Northwest oncology centres of Ethiopia.

Design and setting

An institutional-based multicentre cross-sectional study was conducted among patients with cancer in the Northwest oncology centres of Ethiopia from May to July 2022.

Participants

All oncology patients at selected hospitals who fulfilled the inclusion criteria during the data collection period were the study population.

Main outcome measures

The main outcome of this study was the adequacy of CRP management, which was measured by the Pain Management Index (PMI). A systematic random sampling technique was used to select representatives from each study area. Data entry and analysis were done using EpiData V.4.6.1 and SPSS V.26, respectively. Binary logistic regression was conducted to determine independent predictors of the adequacy of CRP management. A p value of

Results

From a total of 422 included respondents, about 67.5% of the participants had adequate CRP management (95% CI 62.8 to 72). Good performance status (adjusted OR (AOR)=0.44; 95% CI 0.24 to 0.80), presence of comorbidity (AOR=3.28; 95% CI 1.68 to 6.38) and pain history (AOR=0.33; 95% CI 0.01 to 0.11) were significantly associated with the adequacy of cancer pain management.

Conclusion

Using PMI status in the Northwest oncology centre of Ethiopia, more than two-thirds of patients with CRP obtained adequate pain management. The adequacy of CRP management was found to be influenced by factors like comorbidity, past pain history and Eastern cooperative oncology group performance status.

Left atrial appendage occlusion for patients with valvular diseases without atrial fibrillation (the OPINION Study): study protocol for a multicentre, randomised controlled trial

Por: Ju · F. · Yuan · X. · Sun · H.
Introduction

Atrial fibrillation (AF) is a significant cause of perioperative stroke in aortic and mitral valve surgeries. Although several large studies have evaluated surgical left atrial appendage occlusion (SLAAO) during cardiac surgeries, their retrospective nature and an uncontrolled broad spectrum of conditions leave them subject to potential residual confounding. This trial aims to test the hypothesis that opportunistic SLAAO can prevent long-term stroke after cardiac surgery in patients receiving mitral or aortic valve surgeries without a history of AF and with a CHA2DS2-VASc score of 2 or higher.

Methods and design

This study is a single-blinded, multicentre, randomised controlled trial. A total of 2118 patients planning to undergo aortic or mitral surgery without AF will be recruited and equally randomised into intervention or control arms at a 1:1 ratio. In the intervention arm, suture excision of the left atrial appendage (LAA) will be performed during the operation in addition to the original surgery plan. In the control arm, the operation will be performed according to the surgery plan without any intervention on the LAA. The primary outcome is a composite of newly occurred ischaemic stroke or transient ischaemic attack and cardiovascular mortality during a 1-year follow-up. Secondary outcomes include postoperative AF, cardiovascular mortality, newly occurred ischaemic stroke, newly occurred transient ischaemic attack, newly occurred haemorrhagic stroke, bleeding events, and AF-associated health utilisation.

Ethics and dissemination

The Ethics Committee in Fuwai Hospital approved this study. Patients will give informed consent to the study. An information leaflet will be provided to participating patients to introduce the SLAAO procedure. Patients and the public will not get involved in developing the research hypothesis, study design or any other part of this protocol. We plan to publish several papers in peer-reviewed journals about the current research and these will include a description of the study’s development and the main findings of the study.

Trial registration number

ChiCTR2100042238.

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.

❌