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Cohort profile: Worldwide Collaboration on OsteoArthritis prediCtion for the Hip (World COACH) - an international consortium of prospective cohort studies with individual participant data on hip osteoarthritis

Por: van Buuren · M. M. A. · Riedstra · N. S. · van den Berg · M. A. · Boel · F. D. E. M. · Ahedi · H. · Arbabi · V. · Arden · N. K. · Bierma-Zeinstra · S. M. A. · Boer · C. G. · Cicuttini · F. · Cootes · T. F. · Crossley · K. · Felson · D. · Gielis · W. P. · Heerey · J. · Jones · G. · Kluz
Purpose

Hip osteoarthritis (OA) is a major cause of pain and disability worldwide. Lack of effective therapies may reflect poor knowledge on its aetiology and risk factors, and result in the management of end-stage hip OA with costly joint replacement. The Worldwide Collaboration on OsteoArthritis prediCtion for the Hip (World COACH) consortium was established to pool and harmonise individual participant data from prospective cohort studies. The consortium aims to better understand determinants and risk factors for the development and progression of hip OA, to optimise and automate methods for (imaging) analysis, and to develop a personalised prediction model for hip OA.

Participants

World COACH aimed to include participants of prospective cohort studies with ≥200 participants, that have hip imaging data available from at least 2 time points at least 4 years apart. All individual participant data, including clinical data, imaging (data), biochemical markers, questionnaires and genetic data, were collected and pooled into a single, individual-level database.

Findings to date

World COACH currently consists of 9 cohorts, with 38 021 participants aged 18–80 years at baseline. Overall, 71% of the participants were women and mean baseline age was 65.3±8.6 years. Over 34 000 participants had baseline pelvic radiographs available, and over 22 000 had an additional pelvic radiograph after 8–12 years of follow-up. Even longer radiographic follow-up (15–25 years) is available for over 6000 of these participants.

Future plans

The World COACH consortium offers unique opportunities for studies on the relationship between determinants/risk factors and the development or progression of hip OA, by using harmonised data on clinical findings, imaging, biomarkers, genetics and lifestyle. This provides a unique opportunity to develop a personalised hip OA risk prediction model and to optimise methods for imaging analysis of the hip.

Scoping review of interventions to de-implement potentially harmful non-steroidal anti-inflammatory drugs (NSAIDs) in healthcare settings

Por: Rockwell · M. S. · Oyese · E. G. · Singh · E. · Vinson · M. · Yim · I. · Turner · J. K. · Epling · J. W.
Objectives

Potentially harmful non-steroidal anti-inflammatory drugs (NSAIDs) utilisation persists at undesirable rates worldwide. The purpose of this paper is to review the literature on interventions to de-implement potentially harmful NSAIDs in healthcare settings and to suggest directions for future research.

Design

Scoping review.

Data sources

PubMed, CINAHL, Embase, Cochrane Central and Google Scholar (1 January 2000 to 31 May 2022).

Study selection

Studies reporting on the effectiveness of interventions to systematically reduce potentially harmful NSAID utilisation in healthcare settings.

Data extraction

Using Covidence systematic review software, we extracted study and intervention characteristics, including the effectiveness of interventions in reducing NSAID utilisation.

Results

From 7818 articles initially identified, 68 were included in the review. Most studies took place in European countries (45.6%) or the USA (35.3%), with randomised controlled trial as the most common design (55.9%). Interventions were largely clinician-facing (76.2%) and delivered in primary care (60.2%) but were rarely (14.9%) guided by an implementation model, framework or theory. Academic detailing, clinical decision support or electronic medical record interventions, performance reports and pharmacist review were frequent approaches employed. NSAID use was most commonly classified as potentially harmful based on patients’ age (55.8%), history of gastrointestinal disorders (47.1%), or history of kidney disease (38.2%). Only 7.4% of interventions focused on over-the-counter (OTC) NSAIDs in addition to prescription. The majority of studies (76.2%) reported a reduction in the utilisation of potentially harmful NSAIDs. Few studies (5.9%) evaluated pain or quality of life following NSAIDs discontinuation.

Conclusion

Many varied interventions to de-implement potentially harmful NSAIDs have been applied in healthcare settings worldwide. Based on these findings and identified knowledge gaps, further efforts to comprehensively evaluate the effectiveness of interventions and the combination of intervention characteristics associated with effective de-implementation are needed. In addition, future work should be guided by de-implementation theory, focus on OTC NSAIDs and incorporate patient-focused strategies and outcomes, including the evaluation of unintended consequences of the intervention.

Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

Por: Liu · J. · Shen · L. · Nguyen-Hoang · L. · Zhou · Q. · Wang · C. C. · Lu · X. · Sahota · D. · Chong · K. C. · Ying · H. · Gu · W. · Zhou · R. · Yang · H. · Jiang · Y. · Chen · D. · Li · X. · Poon · L.
Introduction

Pre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal Medicine Foundation, which uses the Bayes theorem to combine maternal characteristics and medical history together with measurements of biomarkers, has been proven to be effective and has superior screening performance to that of the traditional risk factor-based approach for the prediction of PE. Prophylactic use of low-dose aspirin in women at risk for PE has resulted in a lower incidence of preterm-PE. However, there is no consensus on the preferred aspirin dosage for the prevention of preterm-PE. Evidence has also suggested that metformin has the potential benefit in preventing PE in pregnant women who are at high risk of the disorder.

Method and analysis

We present a protocol (V.2.0, date 17 March 2022) for the AVERT trial, which is a multicentre, double-blinded, 3-arm randomised controlled trial (RCT) that uses an effective PE screening programme to explore the optimal dosage of aspirin and the role of metformin for the prevention of PE among high-risk pregnant women in China. We intend to recruit 66 000 singleton pregnancies without treatment of low-dose aspirin and metformin at 11–13 weeks’ gestation and all eligible women attending for their first trimester routine scan will be invited to undergo screening for preterm-PE by the combination of maternal factors, mean arterial pressure and placental growth factor. Women found to be at high risk of developing preterm-PE will be invited to take part in the RCT. This study will compare the incidence of preterm-PE with delivery at

Ethics and dissemination

Ethical approval for the study was obtained from the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No. 2021.406) in Hong Kong and the Ethics Committee of each participating hospital in Mainland China. The study is registered at ClinicalTrials.gov. The results of the AVERT trial will be disseminated at international academic conferences and published in high-impact factor journals.

Trial registration number

NCT05580523.

Colchicine for the treatment of patients with COVID-19: an updated systematic review and meta-analysis of randomised controlled trials

Por: Cheema · H. A. · Jafar · U. · Shahid · A. · Masood · W. · Usman · M. · Hermis · A. H. · Naseem · M. A. · Sahra · S. · Sah · R. · Lee · K. Y.
Objectives

We conducted an updated systematic review and meta-analysis to investigate the effect of colchicine treatment on clinical outcomes in patients with COVID-19.

Design

Systematic review and meta-analysis.

Data sources

We searched PubMed, Embase, the Cochrane Library, medRxiv and ClinicalTrials.gov from inception to January 2023.

Eligibility criteria

All randomised controlled trials (RCTs) that investigated the efficacy of colchicine treatment in patients with COVID-19 as compared with placebo or standard of care were included. There were no language restrictions. Studies that used colchicine prophylactically were excluded.

Data extraction and synthesis

We extracted all information relating to the study characteristics, such as author names, location, study population, details of intervention and comparator groups, and our outcomes of interest. We conducted our meta-analysis by using RevMan V.5.4 with risk ratio (RR) and mean difference as the effect measures.

Results

We included 23 RCTs (28 249 participants) in this systematic review. Colchicine did not decrease the risk of mortality (RR 0.99; 95% CI 0.93 to 1.05; I2=0%; 20 RCTs, 25 824 participants), with the results being consistent among both hospitalised and non-hospitalised patients. There were no significant differences between the colchicine and control groups in other relevant clinical outcomes, including the incidence of mechanical ventilation (RR 0.75; 95% CI 0.48 to 1.18; p=0.22; I2=40%; 8 RCTs, 13 262 participants), intensive care unit admission (RR 0.77; 95% CI 0.49 to 1.22; p=0.27; I2=0%; 6 RCTs, 961 participants) and hospital admission (RR 0.74; 95% CI 0.48 to 1.16; p=0.19; I2=70%; 3 RCTs, 8572 participants).

Conclusions

The results of this meta-analysis do not support the use of colchicine as a treatment for reducing the risk of mortality or improving other relevant clinical outcomes in patients with COVID-19. However, RCTs investigating early treatment with colchicine (within 5 days of symptom onset or in patients with early-stage disease) are needed to fully elucidate the potential benefits of colchicine in this patient population.

PROSPERO registration number

CRD42022369850.

Outcomes after cancer diagnosis in children and adult patients with congenital heart disease in Sweden: a registry-based cohort study

Por: Karazisi · C. · Dellborg · M. · Mellgren · K. · Giang · K. W. · Skoglund · K. · Eriksson · P. · Mandalenakis · Z.
Objective

Patients with congenital heart disease (CHD) have an increased cancer risk. The aim of this study was to determine cancer-related mortality in CHD patients compared with non-CHD controls, compare ages at cancer diagnosis and death, and explore the most fatal cancer diagnoses.

Design

Registry-based cohort study.

Setting and participants

CHD patients born between 1970 and 2017 were identified using Swedish Health Registers. Each was matched by birth year and sex with 10 non-CHD controls. Included were those born in Sweden with a cancer diagnosis.

Results

Cancer developed in 758 out of 67814 CHD patients (1.1%), with 139 deaths (18.3%)—of which 41 deaths occurred in patients with genetic syndromes. Cancer was the cause of death in 71.9% of cases. Across all CHD patients, cancer accounted for 1.8% of deaths. Excluding patients with genetic syndromes and transplant recipients, mortality risk between CHD patients with cancer and controls showed no significant difference (adjusted HR 1.17; 95% CI 0.93 to 1.49). CHD patients had a lower median age at cancer diagnosis—13.0 years (IQR 2.9–30.0) in CHD versus 24.6 years (IQR 8.6–35.1) in controls. Median age at death was 15.1 years (IQR 3.6–30.7) in CHD patients versus 18.5 years (IQR 6.1–32.7) in controls. The top three fatal cancer diagnoses were ill-defined, secondary and unspecified, eye and central nervous system tumours and haematological malignancies.

Conclusions

Cancer-related deaths constituted 1.8% of all mortalities across all CHD patients. Among CHD patients with cancer, 18.3% died, with cancer being the cause in 71.9% of cases. Although CHD patients have an increased cancer risk, their mortality risk post-diagnosis does not significantly differ from non-CHD patients after adjustements and exclusion of patients with genetic syndromes and transplant recipients. However, CHD patients with genetic syndromes and concurrent cancer appear to be a vulnerable group.

Labour Care Guide implementation as a decision-making tool for monitoring labour among healthcare providers in Uganda: protocol for a mixed-methods study

Por: Mugyenyi · G. R. · Byamugisha · J. · Tumuhimbise · W. · Atukunda · E. · Yarine · F. T.
Introduction

The new WHO Labour Care Guide (LCG), also regarded as the ‘next-generation partograph’, is a core component of 2018 WHO consolidated guidelines on intrapartum care for positive childbirth experience. The Ugandan Ministry of Health is in the process of adopting the new WHO LCG with no local context-specific data to inform this transition. We will explore potential barriers and facilitators to healthcare providers’ (HCPs) sustained engagement in labour monitoring in Mbarara city, Southwestern Uganda, and use the data to refine the new WHO LCG and develop a suitable implementation strategy to effectively integrate LCG into routine maternity care in Uganda. We shall then assess effectiveness, validity and other preliminary implementation outcomes of using the new LCG in detecting prolonged labour.

Methods and analysis

The study will use a mixed-methods approach to identify key LCG user perspectives to refine and customise the WHO LCG among 120 HCPs and stakeholders involved in maternity care and labour monitoring within facilities in Southwestern Uganda. The refined prototype will be deployed and used to monitor labour in all 14 basic and comprehensive emergency obstetric and newborn care facilities in the study area. We will review labour outcomes of 520 patients monitored using the new LCG and compare these outcomes with a historical cohort of 520 patients monitored using the partograph. The main effectiveness outcome will be the proportion of women diagnosed with prolonged labour and/or obstructed labour.

Ethics and dissemination

Ethical approval was obtained from the Mbarara University of Science and Technology Research Ethics Committee (MUST-2023-808) and Uganda National Council for Science and Technology (HS2864ES). We shall obtain written informed consent from each participant. The results of this study will be published in international peer-reviewed journals and presented to the Ugandan Ministry of Health as policy briefs and at selected national/international conferences.

Trial registration number

NCT05979194.

Using an ecological model of health behaviour to identify factors associated with smoking behaviour among Buddhist novices in Thailand: a cross-sectional digital survey

Por: Benjakul · S. · Nakju · S. · Thitavisiddho (Wongsai) · W. · Junjula · T.
Objective

Buddhist novices reside in Buddhist temples, which are legally designated as smoke-free areas. Nevertheless, similar to other men in their age group, they are susceptible to various risk factors that lead to smoking. This digital survey aimed to examine tobacco smoking and its associated factors among Buddhist novices in Thailand.

Design

A cross-sectional digital survey.

Setting

88 temple-based schools in Thailand.

Participants

A stratified two-stage cluster sampling method was employed to select 5371 novices. Data were collected between June and August 2022 using self-administered electronic questionnaires.

Measure

Descriptive statistics and multivariable logistic regression analysis were used to identify the associated factors.

Results

Overall, 32.8% of the respondents reported they had tried smoking, and the average age of initiation was 12.4 years. In the past 30 days, 25.7% had smoked any tobacco product. Multiple factors following the ecological model of health behaviour were found to be statistically associated with smoking by 37.3%. Among these were intrapersonal-level factors, such as age, living in the southern region and attempted smoking. Two were interpersonal-level factors: the smoking behaviour of close relatives, specifically parents, and their respected monks. Two were institutional-level factors: perceiving that temple-based schools are smoke-free areas and exposure to secondhand smoke. Three factors at the community and policy levels were noticed tobacco advertising at the point of sale, social media and tobacco promotion.

Conclusion

The findings of this study support the development of comprehensive intervention programmes that address the multiple factors to prevent Buddhist novices from smoking.

Systematic RADaR analysis of responses to the open-ended question in the Culture of Care Barometer survey of a Dutch hospital

Objectives

Systematically measuring the work environment of healthcare employees is key to continuously improving the quality of care and addressing staff shortages. In this study, we systematically analyse the responses to the one open-ended question posed in the Dutch version of the Culture of Care Barometer (CoCB-NL) to examine (1) if the responses offered new insights into healthcare employees’ perceptions of their work environment and (2) if the original CoCB had any themes missing.

Design

Retrospective text analysis using Rigorous and Accelerated Data Reduction technique.

Setting

University hospital in the Netherlands using the CoCB-NL as part of the annual employee survey.

Participants

All hospital employees were invited to participate in the study (N=14 671). In total, 2287 employees responded to the open-ended question.

Results

2287 comments were analysed. Comments that contained more than one topic were split according to topic, adding to the total (n=2915). Of this total, 372 comments were excluded because they lacked content or respondents indicated they had nothing to add. Subsequently, 2543 comments were allocated to 33 themes. Most comments (n=2113) addressed the 24 themes related to the close-ended questions in the CoCB-NL. The themes most commented on concerned questions on ‘organisational support’. The remaining 430 comments covered nine additional themes that addressed concerns about work environment factors (team connectedness, team effectiveness, corporate vision, administrative burden and performance pressure) and themes (diversity and inclusion, legal frameworks and collective bargaining, resilience and work–life balance, and personal matters).

Conclusions

Analysing responses to the open-ended question in the CoCB-NL led to new insights into relevant elements of the work environment and missing themes in the COCB-NL. Moreover, the analysis revealed important themes that not only require attention from healthcare organisations to ensure adequate improvements in their employees’ work environment but should also be considered to further develop the CoCB-NL.

Impact of health education on promoting influenza vaccination health literacy in primary school students: a cluster randomised controlled trial protocol

Por: Xie · W. · Xiao · J. · Chen · J. · Huang · H. · Huang · X. · He · S. · Xu · L.
Introduction

Influenza is a major public health threat, and vaccination is the most effective prevention method. However, vaccination coverage remains suboptimal. Low health literacy regarding influenza vaccination may contribute to vaccine hesitancy. This study aims to evaluate the effect of health education interventions on influenza vaccination rates and health literacy.

Methods and analysis

This cluster randomised controlled trial will enrol 3036 students in grades 4–5 from 20 primary schools in Dongguan City, China. Schools will be randomised to an intervention group receiving influenza vaccination health education or a control group receiving routine health education. The primary outcome is the influenza vaccination rate. Secondary outcomes include health literacy levels, influenza diagnosis rate, influenza-like illness incidence and vaccine protection rate. Data will be collected through questionnaires, influenza surveillance and self-reports at baseline and study conclusion.

Ethics and dissemination

Ethical approval has been sought from the Ethics Committee of the School of Public Health, Sun Yat-sen University. Findings from the study will be made accessible to both peer-reviewed journals and key stakeholders.

Trial registration number

NCT06048406.

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Effect of transcranial direct current stimulation combined with transcutaneous auricular vagus nerve stimulation on poststroke cognitive impairment: a study protocol for a randomised controlled trial

Por: Liu · W. · Cheng · X. · Zhang · Y. · Liao · W.
Introduction

Poststroke cognitive impairment is a common complication in stroke survivors, seriously affecting their quality of life. Therefore, it is crucial to improve cognitive function of patients who had a stroke. Transcranial direct current stimulation (tDCS) and transcutaneous auricular vagus nerve stimulation (taVNS) are non-invasive, safe treatments with great potential to improve cognitive function in poststroke patients. However, further improvements are needed in the effectiveness of a single non-invasive brain stimulation technique for cognitive rehabilitation. This study protocol aims to investigate the effect and neural mechanism of the combination of tDCS and taVNS on cognitive function in patients who had a stroke.

Methods and analysis

In this single-centre, prospective, parallel, randomised controlled trial, a total of 66 patients with poststroke cognitive impairment will be recruited and randomly assigned (1:1:1) to the tDCS group, the taVNS group and the combination of tDCS and taVNS group. Each group will receive 30 min of treatment daily, five times weekly for 3 weeks. Primary clinical outcome is the Montreal Cognitive Assessment. Secondary clinical outcomes include the Mini-Mental State Examination, Stroop Colour Word Test, Trail Marking Test, Symbol Digit Modalities Test and Modified Barthel Index. All clinical outcomes, functional MRI and diffusion tensor imaging will be measured at preintervention and postintervention.

Ethics and dissemination

The trial has been approved by the Ethics Committee of the First Affiliated Hospital of Yangtze University (approval no: KY202390). The results will be submitted for publication in peer-reviewed journals or at scientific conferences.

Trial registration number

ChiCTR2300076632.

Reporting form and content of research priorities identified in knee osteoarthritis clinical practice guidelines: a methodological literature analysis

Por: Gao · Y. · Liu · Z. · Cao · R. · Feng · Y. · Tao · L. · Su · C. · Guan · X. · Fang · R. · Deng · Y. · Xiang · W. · Fei · Y.
Objectives

Clinical practice guideline (CPG) developers conduct systematic summaries of research evidence, providing them great capacity and ability to identify research priorities. We systematically analysed the reporting form and content of research priorities in CPGs related to knee osteoarthritis (KOA) to provide a valuable reference for guideline developers and clinicians.

Design

A methodological literature analysis was done and the characteristics of the reporting form and the content of the research priorities identified in KOA CPGs were summarised.

Data sources

Six databases (PubMed, Embase, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang and Chinese Biomedical Literature Database) were searched for CPGs published from 1 January 2017 to 4 December 2022. The official websites of 40 authoritative orthopaedic societies, rheumatology societies and guideline development organisations were additionally searched.

Eligibility criteria

We included all KOA CPGs published in English or Chinese from 1 January 2017 that included at least one recommendation for KOA. We excluded duplicate publications, older versions of CPGs as well as guidance documents for guideline development.

Data extraction and synthesis

Reviewers worked in pairs and independently screened and extracted the data. Descriptive statistics were used, and absolute frequencies and proportions of related items were calculated.

Results

187 research priorities reported in 41 KOA CPGs were identified. 24 CPGs reported research priorities, of which 17 (41.5%) presented overall research priorities for the entire guideline rather than for specific recommendations. 110 (58.8%) research priorities were put forward due to lack of evidence. Meanwhile, more than 70% of the research priorities reflected the P (population) and I (intervention) structural elements, with 135 (72.2%) and 146 (78.1%), respectively. More than half of the research priorities (118, 63.8%) revolved around evaluating the efficacy of interventions. Research priorities primarily focused on physical activity (32, 17.3%), physical therapy (30, 16.2%), surgical therapy (27, 14.6%) and pharmacological treatment (26, 14.1%).

Conclusions

Research priorities reported in KOA CPGs mainly focused on evaluating non-pharmacological interventions. There exists considerable room for improvement for a comprehensive and standardised generation and reporting of research priorities in KOA CPGs.

Shanghai Community-Based Schizophrenia Cohort (SCS): a protocol for establishing a longitudinal cohort and research database of patients with schizophrenia receiving community-based mental health treatment

Por: Zhu · Y. · He · S. · Liu · Y. · Chen · C. · Ge · X. · Zhang · W. · Zhu · Y. · Zhou · Q. · Jiang · Y. · Zhang · Y. · Xu · W. · Wang · N. · Cai · J. · Xie · B.
Introduction

Drivers for remission, relapse and violence-related behaviour among patients with schizophrenia are the most complicated issue.

Methods and analysis

This study aims to recruit a longitudinal cohort of patients with schizophrenia. Two suburban districts and two urban districts were randomly selected according to health service facilities, population, geographical region and socioeconomic status. Individuals (>18 years old) who received a diagnosis of schizophrenia following the International Classification of Diseases (10th edition) criteria within the past 3 years will be invited as participants. Assessments will be carried out in local community health centres. Data will be used to (1) establish a community-based schizophrenia cohort and biobank, (2) prospectively determine the course of multidimensional functional outcomes of patients with schizophrenia who are receiving community-based mental health treatment, and (3) map the trajectories of patients with schizophrenia and prospectively determine the course of multidimensional outcomes based on the differential impact of potentially modifiable moderators.

Ethics and dissemination

The study has been reviewed and approved by the Human Research Ethics Committee of Shanghai Mental Health Center (2021-67). Results of the study will be disseminated through peer-reviewed journals. If effective, related educational materials will be released to the public.

Predicting pressure injury risk in hospitalised patients using machine learning with electronic health records: a US multilevel cohort study

Por: Padula · W. V. · Armstrong · D. G. · Pronovost · P. J. · Saria · S.
Objective

To predict the risk of hospital-acquired pressure injury using machine learning compared with standard care.

Design

We obtained electronic health records (EHRs) to structure a multilevel cohort of hospitalised patients at risk for pressure injury and then calibrate a machine learning model to predict future pressure injury risk. Optimisation methods combined with multilevel logistic regression were used to develop a predictive algorithm of patient-specific shifts in risk over time. Machine learning methods were tested, including random forests, to identify predictive features for the algorithm. We reported the results of the regression approach as well as the area under the receiver operating characteristics (ROC) curve for predictive models.

Setting

Hospitalised inpatients.

Participants

EHRs of 35 001 hospitalisations over 5 years across 2 academic hospitals.

Main outcome measure

Longitudinal shifts in pressure injury risk.

Results

The predictive algorithm with features generated by machine learning achieved significantly improved prediction of pressure injury risk (p

Conclusions

These data could help hospitals conserve resources within a critical period of patient vulnerability of hospital-acquired pressure injury which is not reimbursed by US Medicare; thus, conserving between 30 000 and 90 000 labour-hours per year in an average 500-bed hospital. Hospitals can use this predictive algorithm to initiate a quality improvement programme for pressure injury prevention and further customise the algorithm to patient-specific variation by facility.

Spatial variation and associated factors of inadequate counselling regarding pregnancy danger signs during antenatal care visits among pregnant women in Ethiopia: a Geographically Weighted Regression Model

Por: Alemayehu · M. A. · Derseh · N. M. · Tesfie · T. K. · Abuhay · H. W. · Yismaw · G. A. · Agimas · M. C.
Introduction

Inadequate counselling of pregnant women regarding pregnancy danger signs contributes to a delay in deciding to seek care, which causes up to 77% of all maternal deaths in developing countries. However, its spatial variation and region-specific predictors have not been studied in Ethiopia. Hence, the current study aimed to model its predictors using geographically weighted regression analysis.

Methods

The 2019 Ethiopian Mini Demographic and Health Survey data were used. A total weighted sample of 2922 women from 283 clusters was included in the final analysis. The analysis was performed using ArcGIS Pro, STATA V.14.2 and SaTScan V.10.1 software. The spatial variation of inadequate counselling was examined using hotspot analysis. Ordinary least squares regression was used to identify factors for geographical variations. Geographically weighted regression was used to explore the spatial heterogeneity of selected variables to predict inadequate counselling.

Results

Significant hotspots of inadequate counselling regarding pregnancy danger signs were found in Gambella region, the border between Amhara and Afar regions, Somali region and parts of Oromia region. Antenatal care provided by health extension workers, late first antenatal care initiation and antenatal care follow-up at health centres were spatially varying predictors. The geographically weighted regression model explained about 66% of the variation in the model.

Conclusion

Inadequate counselling service regarding pregnancy danger signs in Ethiopia varies across regions and there exists within country inequality in the service provision and utilisation. Prioritisation and extra efforts should be made by concerned actors for those underprivileged areas and communities (as shown in the maps), and health extension workers, as they are found in the study.

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).

Quality of childbirth care and its determinants along the continuum of care among pregnant women who gave birth vaginally in Gondar town public health facility, Northwest Ethiopia, 2022: generalised structural equation modelling

Por: Abebaw · W. A. · Wolde · H. F. · Tilahun · W. M. · Gebreegziabher · Z. A. · Teshome · D. F.
Objective

To assess the quality of childbirth care and its determinants along the continuum of care in Gondar town public health facility in Ethiopia.

Design

An institution-based, cross-sectional study was employed. Completed data were imported to Stata V.16 for cleaning and analysis. A generalised structural equation model was employed to examine the relationships along the continuum of childbirth care and to determine the factors affecting the quality of childbirth care.

Setting and participants

This study was conducted among a total of 865 women who delivered in the public health facility of Gondar, Ethiopia, from 19 May to 30 June 2022.

Results

The study revealed the proportion of good-quality childbirth care during admission, intrapartum and immediate postpartum period was 59% (95% CI 55.7, 62.4), 76.8% (95% CI 73.8, 79.5) and 45% (95% CI 41.7, 48.5), respectively. Postsecondary educational status of mothers (β=0.60, 95% CI 0.16, 1.04) and maternal age of 25–35 (β=0.68, 95% CI 0.33, 1.02) were predictors of quality of care at admission. Referral hospital (β=0.43, 95% CI 0.10, 0.76), presence of guidelines (β=1.36, 95% CI 0.72, 1.99) and provider age of 25–35 (β=0.61, 95% CI 0.12, 1.10) affected the quality of care during the intrapartum period. Urban residence (β=0.52, 95% CI 0.12, 0.93), skilled birth attendant experience (β=0.19, 95% CI 0.11, 0.28) and number of delivery couches (β=–0.29, 95% CI –0.44, –0.13) had significant associations with the quality of childbirth care during the immediate postpartum period.

Conclusions

Although our study found improvements in the quality of childbirth care along the continuum compared with previous studies, more workers are needed to alleviate the problem of poor-quality service. Different maternal, provider and facility factors were found to be predictors of the quality of childbirth care.

Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials

Por: Holzer · K. J. · Bartosiak · K. A. · Calfee · R. P. · Hammill · C. W. · Haroutounian · S. · Kozower · B. D. · Cordner · T. A. · Lenard · E. M. · Freedland · K. E. · Tellor Pennington · B. R. · Wolfe · R. C. · Miller · J. P. · Politi · M. C. · Zhang · Y. · Yingling · M. D. · Baumann
Introduction

Preoperative anxiety and depression symptoms among older surgical patients are associated with poor postoperative outcomes, yet evidence-based interventions for anxiety and depression have not been applied within this setting. We present a protocol for randomised controlled trials (RCTs) in three surgical cohorts: cardiac, oncological and orthopaedic, investigating whether a perioperative mental health intervention, with psychological and pharmacological components, reduces perioperative symptoms of depression and anxiety in older surgical patients.

Methods and analysis

Adults ≥60 years undergoing cardiac, orthopaedic or oncological surgery will be enrolled in one of three-linked type 1 hybrid effectiveness/implementation RCTs that will be conducted in tandem with similar methods. In each trial, 100 participants will be randomised to a remotely delivered perioperative behavioural treatment incorporating principles of behavioural activation, compassion and care coordination, and medication optimisation, or enhanced usual care with mental health-related resources for this population. The primary outcome is change in depression and anxiety symptoms assessed with the Patient Health Questionnaire-Anxiety Depression Scale from baseline to 3 months post surgery. Other outcomes include quality of life, delirium, length of stay, falls, rehospitalisation, pain and implementation outcomes, including study and intervention reach, acceptability, feasibility and appropriateness, and patient experience with the intervention.

Ethics and dissemination

The trials have received ethics approval from the Washington University School of Medicine Institutional Review Board. Informed consent is required for participation in the trials. The results will be submitted for publication in peer-reviewed journals, presented at clinical research conferences and disseminated via the Center for Perioperative Mental Health website.

Trial registration numbers

NCT05575128, NCT05685511, NCT05697835, pre-results.

Descriptive study of causes of death and COVID-19-associated morbidities from the New York City electronic death record: first wave of the pandemic March-July 2020

Por: Maduro · G. · Li · W. · Huynh · M. · Bernard-Davila · B. · Gould · L. H. · Van Wye · G.
Objective

Assessing excess deaths from benchmarks across causes of death during the first wave of the COVID-19 pandemic and identifying morbidities most frequently mentioned alongside COVID-19 deaths in the death record.

Methods

Descriptive study of death records between 11 March 2020 and 27 July 2020, from the New York City Bureau of Vital Statistics. Mortality counts and percentages were compared with the average for the same calendar period of the previous 2 years. Distributions of morbidities from among forty categories of conditions were generated citywide and by sex, race/ethnicity and four age groups. Causes of death were assumed to follow Poisson processes for Z-score construction.

Results

Within the study period, 46 563 all-cause deaths were reported; 132.9% higher than the average for the same period of the previous 2 years (19 989). Of those 46 563 records, 19 789 (42.5%) report COVID-19 as underlying cause of death. COVID-19 was the most prevalent cause across all demographics, with respiratory conditions (prominently pneumonia), hypertension and diabetes frequently mentioned morbidities. Black non-Hispanics had greater proportions of mentions of pneumonia, hypertension, and diabetes. Hispanics had the largest proportion of COVID-19 deaths (52.9%). Non-COVID-19 excess deaths relative to the previous 2-year averages were widely reported.

Conclusion

Mortality directly due to COVID-19 was accompanied by significant increases across most other causes from their reference averages, potentially suggesting a sizable COVID-19 death undercount. Indirect effects due to COVID-19 may partially account for some increases, but findings are hardly dispositive. Unavailability of vaccines for the time period precludes any impact over excess deaths. Respiratory and cardiometabolic-related conditions were most frequently reported among COVID-19 deaths across demographic characteristics.

Success in vaccination programming through community health workers: a qualitative analysis of interviews and focus group discussions from Nepal, Senegal and Zambia

Por: Ogutu · E. A. · Ellis · A. S. · Hester · K. A. · Rodriguez · K. · Sakas · Z. · Jaishwal · C. · Yang · C. · Dixit · S. · Bose · A. S. · Sarr · M. · Kilembe · W. · Bednarczyk · R. · Freeman · M. C.
Objectives

Community health workers are essential to front-line health outreach throughout low-income and middle-income countries, including programming for early childhood immunisation. Understanding how community health workers are engaged for successful early childhood vaccination among countries who showed success in immunisation coverage would support evidence-based policy guidance across contexts.

Design

We employed a multiple case study design using qualitative research methods.

Setting

We conducted research in Nepal, Senegal and Zambia.

Participants

We conducted 207 interviews and 71 focus group discussions with 678 participants at the national, regional, district, health facility and community levels of the health systems of Nepal, Senegal and Zambia, from October 2019 to April 2021. We used thematic analysis to investigate contributing factors of community health worker programming that supported early childhood immunisation within each country and across contexts.

Results

Implementation of vaccination programming relied principally on the (1) organisation, (2) motivation and (3) trust of community health workers. Organisation was accomplished by expanding cadres of community health workers to carry out their roles and responsibilities related to vaccination. Motivation was supported by intrinsic and extrinsic incentives. Trust was expressed by communities due to community health worker respect and value placed on their work.

Conclusion

Improvements in immunisation coverage was facilitated by community health worker organisation, motivation and trust. With the continued projection of health worker shortages, especially in low-income countries, community health workers bridged the equity gap in access to vaccination services by enabling wider reach to underserved populations. Although improvements in vaccination programming were seen in all three countries—including government commitment to addressing human resource deficits, training and remuneration; workload, inconsistency in compensation, training duration and scope, and supervision remain major challenges to immunisation programming. Health decision-makers should consider organisation, motivation and trust of community health workers to improve the implementation of immunisation programming.

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial

Por: Zhuang · R. · Xiong · Z. · Yan · S. · Zhang · H. · Dong · Q. · Liu · W. · Miao · J. · Zhuo · Y. · Fan · X. · Zhang · W. · Wang · X. · Liu · L. · Cao · J. · Zhang · T. · Hao · C. · Huang · X. · Jiang · L.
Introduction

Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes.

Methods and analysis

This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population.

Ethics and dissemination

The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal.

Trial registration number

ChiCTR2200061408.

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