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Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study

Por: Morimoto · T. · Morikawa · T. · Imura · H. · Nezu · M. · Hamazaki · K. · Sakuma · M. · Chaumont · A. · Moitinho de Almeida · M. · Moreno · V. P. · Ho · Y. · Harrington · L. · Matsuki · T. · Nakamura · T.
Introduction

Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms.

Methods and analysis

We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients’ hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions.

Ethics and dissemination

The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings.

Trial registration number

NCT05913700.

Study protocol: improving response to malaria in the Amazon through identification of inter-community networks and human mobility in border regions of Ecuador, Peru and Brazil

Por: Janko · M. M. · Araujo · A. L. · Ascencio · E. J. · Guedes · G. R. · Vasco · L. E. · Santos · R. O. · Damasceno · C. P. · Medrano · P. G. · Chacon-Uscamaita · P. R. · Gunderson · A. K. · OMalley · S. · Kansara · P. H. · Narvaez · M. B. · Coombes · C. · Pizzitutti · F. · Salmon-Mulano
Introduction

Understanding human mobility’s role in malaria transmission is critical to successful control and elimination. However, common approaches to measuring mobility are ill-equipped for remote regions such as the Amazon. This study develops a network survey to quantify the effect of community connectivity and mobility on malaria transmission.

Methods

We measure community connectivity across the study area using a respondent driven sampling design among key informants who are at least 18 years of age. 45 initial communities will be selected: 10 in Brazil, 10 in Ecuador and 25 in Peru. Participants will be recruited in each initial node and administered a survey to obtain data on each community’s mobility patterns. Survey responses will be ranked and the 2–3 most connected communities will then be selected and surveyed. This process will be repeated for a third round of data collection. Community network matrices will be linked with each country’s malaria surveillance system to test the effects of mobility on disease risk.

Ethics and dissemination

This study protocol has been approved by the institutional review boards of Duke University (USA), Universidad San Francisco de Quito (Ecuador), Universidad Peruana Cayetano Heredia (Peru) and Universidade Federal Minas Gerais (Brazil). Results will be disseminated in communities by the end of the study.

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions

Por: Gumber · L. · Agbeleye · O. · Inskip · A. · Fairbairn · R. · Still · M. · Ouma · L. · Lozano-Kuehne · J. · Bardgett · M. · Isaacs · J. D. · Wason · J. M. · Craig · D. · Pratt · A. G.
Objective

International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.

Design

Systematic review.

Data sources

Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.

Eligibility criteria

All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.

Data extraction and synthesis

Search results were independently screened by at least two reviewers and data were extracted into a proforma.

Results

38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.

Conclusions

International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.

Open science framework registration number

osf-registrations-yvtjb-v1.

The impact of delayed diagnosis and treatment due to COVID-19 on Australian thyroid cancer patients: a qualitative interview study

Por: D'souza · B. · Glover · A. · Bavor · C. · Brown · B. · Dodd · R. H. · Lee · J. C. · Millar · J. · Miller · J. A. · Zalcberg · J. R. · Serpell · J. · Ioannou · L. J. · Nickel · B.
Objectives

The study aims to investigate the perceptions of patients with thyroid cancer on the potential impact of diagnosis and treatment delays during the COVID-19 pandemic.

Design

This study involved qualitative semi-structured telephone interviews. The interviews were transcribed verbatim, analysed using the thematic framework analysis method and reported using the Consolidated Criteria for Reporting Qualitative Research.

Setting

Participants in the study were treated and/or managed at hospital sites across New South Wales and Victoria, Australia.

Participants

17 patients with thyroid cancer were interviewed and included in the analysis (14 females and 3 males).

Results

The delays experienced by patients ranged from 12 months. The patients reported about delays to diagnostic tests, delays to surgery and radioactive iodine treatment, perceived disease progression and, for some, the financial burden of choosing to go through private treatment to minimise the delay. Most patients also reported not wanting to experience delays any longer than they did, due to unease and anxiety.

Conclusions

This study highlights an increased psychological burden in patients with thyroid cancer who experienced delayed diagnosis and/or treatment during COVID-19. The impacts experienced by patients during this time may be similar in the case of other unexpected delays and highlight the need for regular clinical review during delays to diagnosis or treatment.

Artificial intelligence-based prediction of diabetic retinopathy evolution (EviRed): protocol for a prospective cohort

Por: Tadayoni · R. · Massin · P. · Bonnin · S. · Magazzeni · S. · Lay · B. · Le Guilcher · A. · Vicaut · E. · Couturier · A. · Quellec · G. · Investigators · E.
Introduction

An important obstacle in the fight against diabetic retinopathy (DR) is the use of a classification system based on old imaging techniques and insufficient data to accurately predict its evolution. New imaging techniques generate new valuable data, but we lack an adapted classification based on these data. The main objective of the Evaluation Intelligente de la Rétinopathie Diabétique, Intelligent evaluation of DR (EviRed) project is to develop and validate a system assisting the ophthalmologist in decision-making during DR follow-up by improving the prediction of its evolution.

Methods and analysis

A cohort of up to 5000 patients with diabetes will be recruited from 18 diabetology departments and 14 ophthalmology departments, in public or private hospitals in France and followed for an average of 2 years. Each year, systemic health data as well as ophthalmological data will be collected. Both eyes will be imaged by using different imaging modalities including widefield photography, optical coherence tomography (OCT) and OCT-angiography. The EviRed cohort will be divided into two groups: one group will be randomly selected in each stratum during the inclusion period to be representative of the general diabetic population. Their data will be used for validating the algorithms (validation cohort). The data for the remaining patients (training cohort) will be used to train the algorithms.

Ethics and dissemination

The study protocol was approved by the French South-West and Overseas Ethics Committee 4 on 28 August 2020 (CPP2020-07-060b/2020-A01725-34/20.06.16.41433). Prior to the start of the study, each patient will provide a written informed consent documenting his or her agreement to participate in the clinical trial. Results of this research will be disseminated in peer-reviewed publications and conference presentations. The database will also be available for further study or development that could benefit patients.

Trial registration number

NCT04624737

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.

SARS-CoV-2 infection by trimester of pregnancy and adverse perinatal outcomes: a Mexican retrospective cohort study

Por: Ghosh · R. · Gutierrez · J. P. · de Jesus Ascencio-Montiel · I. · Juarez-Flores · A. · Bertozzi · S. M.
Objective

Conflicting evidence for the association between COVID-19 and adverse perinatal outcomes exists. This study examined the associations between maternal COVID-19 during pregnancy and adverse perinatal outcomes including preterm birth (PTB), low birth weight (LBW), small-for-gestational age (SGA), large-for-gestational age (LGA) and fetal death; as well as whether the associations differ by trimester of infection.

Design and setting

The study used a retrospective Mexican birth cohort from the Instituto Mexicano del Seguro Social (IMSS), Mexico, between January 2020 and November 2021.

Participants

We used the social security administrative dataset from IMSS that had COVID-19 information and linked it with the IMSS routine hospitalisation dataset, to identify deliveries in the study period with a test for SARS-CoV-2 during pregnancy.

Outcome measures

PTB, LBW, SGA, LGA and fetal death. We used targeted maximum likelihood estimators, to quantify associations (risk ratio, RR) and CIs. We fit models for the overall COVID-19 sample, and separately for those with mild or severe disease, and by trimester of infection. Additionally, we investigated potential bias induced by missing non-tested pregnancies.

Results

The overall sample comprised 17 340 singleton pregnancies, of which 30% tested positive. We found that those with mild COVID-19 had an RR of 0.89 (95% CI 0.80 to 0.99) for PTB and those with severe COVID-19 had an RR of 1.53 (95% CI 1.07 to 2.19) for LGA. COVID-19 in the first trimester was associated with fetal death, RR=2.36 (95% CI 1.04, 5.36). Results also demonstrate that missing non-tested pregnancies might induce bias in the associations.

Conclusions

In the overall sample, there was no evidence of an association between COVID-19 and adverse perinatal outcomes. However, the findings suggest that severe COVID-19 may increase the risk of some perinatal outcomes, with the first trimester potentially being a high-risk period.

Assessment of the prevalence and associated factors of lower back pain (LBP) among three different professionals in Bangladesh: Findings from a face-to-face survey

Por: Nasim · A. S. M. · Siddique · A. B. · Devnath · N. · Zeba · Z.
Objectives

This study aims to evaluate the prevalence and associated factors of lower back pain (LBP) among farmers, rickshaw pullers and office workers in Bangladesh, while also investigating potential contributors within these occupational groups.

Design

This cross-sectional study aimed to determine the prevalence of LBP, associated factors and management procedures among farmers, rickshaw pullers and office workers in Bangladesh through face-to-face interviews.

Setting

The study was conducted in different parts of the Bogura district in Bangladesh.

Participants

A total of 396 participants were included in the final analysis, all the participants were men and adult in age.

Main outcome measurements

Data were collected using a semi-structured questionnaire based on previous research. Bivariate and multivariable logistic regression analyses were performed to identify significant associations.

Results

The prevalence of LBP was found to be 42.7% among the participants. Farmers and rickshaw pullers had approximately four-times and three-times higher odds of experiencing LBP compared with office workers. Other significant factors associated with LBP included living in a nuclear family, having a normal body weight, lacking professional training, having a chronic disease, having a family history of LBP and experiencing numbness in the legs or feet. The majority of respondents sought medical attention and took medication for their LBP.

Conclusion

The study underscores occupational differences in LBP prevalence, emphasising the necessity for tailored interventions and occupational health policies. Identifying specific risk factors and management practices in these professions can aid in developing effective prevention strategies and enhancing healthcare services.

Multicomponent processes to identify and prioritise low-value care in hospital settings: a scoping review

Por: Tyack · Z. · Carter · H. · Allen · M. · Senanayake · S. · Warhurst · K. · Naicker · S. · Abell · B. · McPhail · S. M.
Objectives

This scoping review mapped and synthesised original research that identified low-value care in hospital settings as part of multicomponent processes.

Design

Scoping review.

Data sources

Electronic databases (EMBASE, PubMed, CINAHL, PsycINFO and Cochrane CENTRAL) and grey literature were last searched 11 July and 3 June 2022, respectively, with no language or date restrictions.

Eligibility criteria

We included original research targeting the identification and prioritisation of low-value care as part of a multicomponent process in hospital settings.

Data extraction and synthesis

Screening was conducted in duplicate. Data were extracted by one of six authors and checked by another author. A framework synthesis was conducted using seven areas of focus for the review and an overuse framework.

Results

Twenty-seven records were included (21 original studies, 4 abstracts and 2 reviews), originating from high-income countries. Benefit or value (11 records), risk or harm (10 records) were common concepts referred to in records that explicitly defined low-value care (25 records). Evidence of contextualisation including barriers and enablers of low-value care identification processes were identified (25 records). Common components of these processes included initial consensus, consultation, ranking exercise or list development (16 records), and reviews of evidence (16 records). Two records involved engagement of patients and three evaluated the outcomes of multicomponent processes. Five records referenced a theory, model or framework.

Conclusions

Gaps identified included applying systematic efforts to contextualise the identification of low-value care, involving people with lived experience of hospital care and initiatives in resource poor contexts. Insights were obtained regarding the theories, models and frameworks used to guide initiatives and ways in which the concept ‘low-value care’ had been used and reported. A priority for further research is evaluating the effect of initiatives that identify low-value care using contextualisation as part of multicomponent processes.

Evidence related to a vegetarian diet and metabolic dysfunction-associated steatotic liver disease: protocol for a scoping review

Por: Moss · K. · Gitman · V. · Pinto Sanchez · M. I. · Oczkowski · S. · Armstrong · D. · Jayakumar · S. · Karvellas · C. J. · Selzner · N. · Dionne · J.
Introduction

Metabolic dysfunction-associated fatty liver disease (MASLD) is the hepatic manifestation of metabolic syndrome and the leading cause of chronic liver disease worldwide. Given that there is no pharmacological treatment for MASLD, it is imperative to understand whether lifestyle modifications may improve biochemical and pathological outcomes. One commonly proposed dietary modification is the Mediterranean diet; however, vegetarianism may also be a promising intervention. Vegetarianism has been shown to be associated with reduced morbidity and mortality in metabolic syndrome outcomes in coronary artery disease and diabetes; however, the relationship between vegetarian diet and MASLD is less clear. In this scoping review, we will provide a comprehensive overview of the current body of evidence related to a vegetarian diet and MASLD.

Methods and analysis

The aim of this scoping review is to describe and summarise the current body of evidence related to MASLD and a vegetarian diet. This review will be conducted using Arksey and O’Malley’s framework. The literature review will be conducted using the following databases: SCOPUS, Web of Science, CINAHL-Plus, Cochrane Library and Medline. No restriction will be made on publication date. Included studies will encompass clinical trials and observational designs that examine effects or association of vegetarian diet in adults (≥16 years) and report on the incidence, prevalence or progression of MASLD. Grey literature, non-human studies and articles focusing on changes in a specific food or nutraceutical will be excluded. Articles must have an English-language abstract available to be considered for inclusion. Screening and data extraction will be conducted by two independent reviewers. The findings will be summarised with descriptive statistics.

Ethics and dissemination

Approval from a medical ethics committee is not required for this review. Once the review is complete, the findings will be submitted to a peer-reviewed journal.

Design considerations for the migration from paper to screen-based media in current health education for older adults: a scoping review

Por: Ferraz · L. T. · Santos · A. J. T. · Lorenzi · L. J. · Frohlich · D. M. · Barley · E. · Castro · P. C.
Objectives

To map the current use of paper-based and/or screen-based media for health education aimed at older people.

Design

A scoping review was reported following the Preferred Reporting Items of Systematic Reviews and Meta-analyses for Scoping Reviews checklist.

Data sources

The search was carried out in seven databases (Scopus, Web of Science, Embase, Medline, CINAHL, ACM Guide to Computing Literature, PsycINFO), with studies available from 2012 to the date of the search in 2022, in English, Portuguese, Italian or Spanish. In addition, Google Scholar was searched to check the grey literature. The terms used in the search strategy were older adults, health education, paper and screen-based media, preferences, intervention and other related terms.

Eligibility criteria

Studies included were those that carried out health education interventions for older individuals using paper and/or screen-based media and that described barriers and/or facilitators to using these media.

Data extraction and synthesis

The selection of studies was carried out by two reviewers. A data extraction form was developed with the aim of extracting and recording the main information from the studies. Data were analysed descriptively using Bardin’s content analysis.

Results

The review included 21 studies that carried out health education interventions with different purposes, the main ones being promotion of physical activity, hypertension prevention and psychological health. All 21 interventions involved screen-based media on computers, tablets, smartphones and laptops, while only 4 involved paper-based media such as booklets, brochures, diaries, flyers and drawings. This appears to reflect a transition from paper to screen-based media for health education for the older population, in research if not in practice. However, analysis of facilitators and barriers to using both media revealed 10 design factors that could improve or reduce their use, and complementarity in their application to each media type. For example, screen-based media could have multimedia content, additional functionality and interactivity through good interaction design, but have low accessibility and require additional learning due to complex interface design. Conversely, paper-based media had static content and low functionality but high accessibility and availability and a low learning cost.

Conclusions

We recommend having improved screen-based media design, continued use of paper-based media and the possible combination of both media through the new augmented paper technology.

Registration number

Open Science Framework (DOI: 10.17605/OSF.IO/GKEAH).

Conceptual framework for establishing twins prevention and continuous health promotion programme: a qualitative study

Por: Abtahi · H. · Khoshnam-Rad · N. · Gholamzadeh · M. · Daraie · M. · Sabouri · F.
Background

Twin registries and cohorts face numerous challenges, including significant resource allocation, twins’ recruitment and retention. This study aimed to assess expert feedback on a proposed pragmatic idea for launching a continuous health promotion and prevention programme (HPPP) to establish and maintain twin cohorts.

Design

A qualitative study incorporating an inductive thematic analysis.

Setting

Tehran University of Medical Sciences.

Participants

Researchers with expertise in twin studies participated in our study.

Analysis and design

Expert opinions were gathered through focus group discussions (FGDs). Thematic analysis was employed to analyse the findings and develop a model for designing a comprehensive, long-term health promotion programme using ATLAS.ti software. Additionally, a standardised framework was developed to represent the conceptual model of the twin HPPP.

Results

Eight FGDs were conducted, involving 16 experts. Thematic analysis identified eight themes and seven subthemes that encompassed the critical aspects of a continuous monitoring programme for twin health. Based on these identified themes, a conceptual framework was developed for the implementation of an HPPP tailored for twins.

Conclusion

This study presented the initial endeavour to establish a comprehensive and practical solution in the form of a continuous HPPP designed to tackle the obstacles of twins’ cohorts.

Cohort profile: the PERSIAN Dena Cohort Study (PDCS) of non-communicable diseases in Southwest Iran

Por: Harooni · J. · Joukar · F. · Goujani · R. · Sikaroudi · M. K. · Hatami · A. · Zolghadrpour · M.-A. · Hejazi · M. · Karimi · Z. · Rahmanpour · F. · Askari Shahid · S. · Jowshan · M.-R.
Purpose

This study conducted in Dena County is a population-based cohort study as part of the Prospective Epidemiological Research Studies in Iran (PERSIAN). The specific objectives of this study were to estimate the prevalence of region-specific modifiable risk factors and their associations with the incidence of major non-communicable diseases (NCDs).

Participants

This PERSIAN Dena Cohort Study (PDCS) was conducted on 1561 men and 2069 women aged 35–70 years from October 2016 in Dena County, Kohgiluyeh and Boyer-Ahmad Province, Southwest Iran. The overall participation rate was 82.7%.

Findings to date

Out of 3630 participants, the mean age was 50.16 years, 2069 (56.9%) were women and 2092 (57.6%) were rural residents. Females exhibited higher prevalence rates of diabetes, hypertension, fatty liver, psychiatric disorders, thyroiditis, kidney stones, gallstones, rheumatic disease, chronic lung disease, depression and osteoporosis compared with males (p126 mg/dL, low-density lipoprotein >100 mg/dL and haematuria, respectively; most of them were female and urban people (p

Future plans

PDCS will be planned to re-evaluate NCD-related incidence, all-cause and cause-specific mortality every 5 years, along with annual follow-up for 15 years. Some examples of additional planned studies are evaluation of genetic, environmental risk, spirometry and ECG tests.

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.

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

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

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

Design

Retrospective cohort study.

Setting

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

Participants

A total of 534 maintenance HD patients were enrolled.

Primary and secondary outcome measures

The outcomes were all-cause death and CV mortality.

Results

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

Conclusions

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

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.

Protocol for the Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study in Khulna, Bangladesh: A Prospective cohort to quantify the influence of menstrual health on adolescent girls health and education outcomes.

Por: Hennegan · J. · Hasan · M. T. · Jabbar · A. · Jalil · T. · Kennedy · E. · Hunter · E. · Kaiser · A. · Akter · S. · Zaman · A. · Rahman · M.-u. · Dunstan · L. · Head · A. · Scott · N. · Weiss · H. A. · Win · T. M. · Melendez-Torres · G. J. · Than · K. K. · Hughes · C. L. · Grover · S. · Hasan
Background

Menstrual health is essential for gender equity and the well-being of women and girls. Qualitative research has described the burden of poor menstrual health on health and education; however, these impacts have not been quantified, curtailing investment. The Adolescent Menstrual Experiences and Health Cohort (AMEHC) Study aims to describe menstrual health and its trajectories across adolescence, and quantify the relationships between menstrual health and girls’ health and education in Khulna, Bangladesh.

Methods and analysis

AMEHC is a prospective longitudinal cohort of 2016 adolescent girls recruited at the commencement of class 6 (secondary school, mean age=12) across 101 schools selected through a proportional random sampling approach. Each year, the cohort will be asked to complete a survey capturing (1) girls’ menstrual health and experiences, (2) support for menstrual health, and (3) health and education outcomes. Survey questions were refined through qualitative research, cognitive interviews and pilot survey in the year preceding the cohort. Girls’ guardians will be surveyed at baseline and wave 2 to capture their perspectives and household demographics. Annual assessments will capture schools’ water, sanitation and hygiene, and support for menstruation and collect data on participants’ education, including school attendance and performance (in maths, literacy). Cohort enrolment and baseline survey commenced in February 2023. Follow-up waves are scheduled for 2024, 2025 and 2026, with plans for extension. A nested subcohort will follow 406 post-menarche girls at 2-month intervals throughout 2023 (May, August, October) to describe changes across menstrual periods. This protocol outlines a priori hypotheses regarding the impacts of menstrual health to be tested through the cohort.

Ethics and dissemination

AMEHC has ethical approval from the Alfred Hospital Ethics Committee (369/22) and BRAC James P Grant School of Public Health Institutional Review Board (IRB-06 July 22-024). Study materials and outputs will be available open access through peer-reviewed publication and study web pages.

Ultrasound measurement of traumatic scar and skin thickness: a scoping review of evidence across the translational pipeline of research-to-practice

Por: Meikle · B. · Simons · M. · Mahoney · T. · Reddan · T. · Dai · B. · Kimble · R. M. · Tyack · Z.
Objectives

To identify the ultrasound methods used in the literature to measure traumatic scar thickness, and map gaps in the translation of these methods using evidence across the research-to-practice pipeline.

Design

Scoping review.

Data sources

Electronic database searches of Ovid MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature and Web of Science. Grey literature searches were conducted in Google. Searches were conducted from inception (date last searched 27 May 2022).

Data extraction

Records using brightness mode (B-mode) ultrasound to measure scar and skin thickness across the research-to-practice pipeline of evidence were included. Data were extracted from included records pertaining to: methods used; reliability and measurement error; clinical, health service, implementation and feasibility outcomes; factors influencing measurement methods; strengths and limitations; and use of measurement guidelines and/or frameworks.

Results

Of the 9309 records identified, 118 were analysed (n=82 articles, n=36 abstracts) encompassing 5213 participants. Reporting of methods used was poor. B-mode, including high-frequency (ie, >20 MHz) ultrasound was the most common type of ultrasound used (n=72 records; 61% of records), and measurement of the combined epidermal and dermal thickness (n=28; 24%) was more commonly measured than the epidermis or dermis alone (n=7, 6%). Reliability of ultrasound measurement was poorly reported (n=14; 12%). The scar characteristics most commonly reported to be measured were epidermal oedema, dermal fibrosis and hair follicle density. Most records analysed (n=115; 97%) pertained to the early stages of the research-to-practice pipeline, as part of research initiatives.

Conclusions

The lack of evaluation of measurement initiatives in routine clinical practice was identified as an evidence gap. Diverse methods used in the literature identified the need for greater standardisation of ultrasound thickness measurements. Findings have been used to develop nine methodological considerations for practitioners to guide methods and reporting.

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.

Side effects of COVID-19 vaccines in paediatric patients: a review systematic and meta-analysis protocol

Por: Freitas · C. L. · Sarmento · A. C. A. · Serquiz · N. · Nobre · M. L. · Costa · A. P. F. · Medeiros · K. S. · Goncalves · A. K.
Introduction

The paediatric population represents a quarter of the world’s population, and like adult patients, they have also suffered immeasurably from the SARS-CoV-2 pandemic. Immunisation is an effective strategy for reducing the number of COVID-19 cases. With the advancements in vaccination for younger age groups, parents or guardians have raised doubts and questions about adverse effects and the number of doses required. Therefore, systematic reviews focusing on this population are needed to consolidate evidence that can help in decision-making and clinical practice. This protocol aims to assess the safety of COVID-19 vaccines in paediatric patients and evaluate the correlation between the number of vaccine doses and side effects.

Methods and analysis

We will search the PubMed, ClinicalTrials.gov, Web of Science, Embase, CINAHL, Latin American and Caribbean Health Sciences Literature, Scopus and Cochrane databases for randomised and quasi-randomised clinical trials that list the adverse effects of the COVID-19 vaccine and assess its correlation with the number of doses, without any language restrictions. Two reviewers will select the studies according to the inclusion and exclusion criteria, extract data and asses for risk of bias using the Cochrane risk-of-bias tool. The Review Software Manager (RevMan V.5.4.1) will be used to synthesise the data. We will use the Working Group’s Grading of Recommendations Assessment, Development and Evaluations to grade the strength of the evidence of the results.

Ethics and dissemination

Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication.

PROSPERO registration number

CRD42023390077.

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