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Hoy — Mayo 14th 2024Tus fuentes RSS

Implementation of the WHO Safe Childbirth Checklist: a scoping review protocol

Introduction

The WHO Safe Childbirth Checklist (WHO SCC) was developed to accelerate adoption of essential practices that prevent maternal and neonatal morbidity and mortality during childbirth. This study aims to summarise the current landscape of organisations and facilities that have implemented the WHO SCC and compare the published strategies used to implement the WHO SCC implementation in both successful and unsuccessful efforts.

Methods and analysis

This scoping review protocol follows the guidelines of the Joanna Briggs Institute. Data will be collected and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews report. The search strategy will include publications from the databases Scopus, PubMed, Embase, CINAHL and Web of Science, in addition to a search in grey literature in The National Library of Australia’s Trobe, DART-Europe E-Theses Portal, Electronic Theses Online Service, Theses Canada, Google Scholar and Theses and dissertations from Latin America. Data extraction will include data on general information, study characteristics, organisations involved, sociodemographic context, implementation strategies, indicators of implementation process, frameworks used to design or evaluate the strategy, implementation outcomes and final considerations. Critical analysis of implementation strategies and outcomes will be performed with researchers with experience implementing the WHO SCC.

Ethics and dissemination

The study does not require an ethical review due to its design as a scoping review of the literature. The results will be submitted for publication to a scientific journal and all relevant data from this study will be made available in Dataverse.

Trial registration number

https://doi.org/10.17605/OSF.IO/RWY27.

Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial

Por: Gallagher · D. · Spyreli · E. · Anderson · A. S. · Bridges · S. · Cardwell · C. R. · Coulman · E. · Dombrowski · S. U. · Free · C. · Heaney · S. · Hoddinott · P. · Kee · F. · McDowell · C. · McIntosh · E. · Woodside · J. V. · McKinley · M. C.
Introduction

The reproductive years can increase women’s weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development.

Methods and analysis

Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost–utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants’ experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation.

Ethics and dissemination

Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences.

Trial registration number

ISRCTN16299220.

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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.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B trial): protocol for a mixed-methods process evaluation of a randomised controlled trial

Por: Aitken · L. M. · Emerson · L. M. · Kydonaki · K. · Blackwood · B. · Creagh-Brown · B. · Lone · N. I. · McKenzie · C. A. · Reade · M. C. · Weir · C. J. · Wise · M. P. · Walsh · T. S.
Introduction

An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes.

Methods and analysis

This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored.

Ethics and dissemination

All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement.

Trial registration number

NCT03653832.

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.

Metabolic dysfunction-associated profiles and subsequent site-specific risk of obesity-related cancers among Chinese patients with diabetes: a retrospective cohort study

Por: Yau · S. T. Y. · Leung · E. · Wong · M. C. S. · Hung · C. T. · Chong · K. C. · Lee · A. · Yeoh · E. K.
Objectives

To compare metabolic dysfunction-associated profiles between patients with diabetes who developed different obesity-related site-specific cancers and those who remained free of cancer during follow-up.

Design

Retrospective cohort study.

Setting

Public general outpatient clinics in Hong Kong.

Participants

Patients with diabetes without a history of malignancy (n=391 921).

Primary outcome measures

The outcomes of interest were diagnosis of site-specific cancers (colon and rectum, liver, pancreas, bladder, kidney and stomach) during follow-up. Cox proportional hazards regression was applied to assess the associations between metabolic dysfunction and other clinical factors with each site-specific cancer.

Results

Each 0.1 increase in waist-to-hip ratio was associated with an 11%–35% elevated risk of colorectal, bladder and liver cancers. Each 1% increase in glycated haemoglobin was linked to a 4%–9% higher risk of liver and pancreatic cancers. While low-density lipoprotein cholesterol and triglycerides were inversely associated with the risk of liver and pancreatic cancers, high-density lipoprotein cholesterol was negatively associated with pancreatic, gastric and kidney cancers, but positively associated with liver cancer. Furthermore, liver cirrhosis was linked to a 56% increased risk of pancreatic cancer. No significant association between hypertension and cancer risk was found.

Conclusions

Metabolic dysfunction-associated profiles contribute to different obesity-related cancer outcomes differentially among patients with diabetes. This study may provide evidence to help identify cancer prevention targets during routine diabetes care.

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.

Identifying the top 10 research priorities for the school food system in the UK: a priority setting exercise

Por: Schliemann · D. · Spence · S. · OKane · N. · Chiang · C. C. · Olgacher · D. · McKinley · M. C. · Woodside · J. V. · on behalf of the GENIUS network · Schliemann · Spence · OKane · Chiang · Olgacher · McKinley · Woodside
Introduction

The school food system varies widely between schools and across the UK. There is a need to understand evidence gaps in school food research to allow the development, implementation and evaluation of policies and interventions to support children’s healthy eating at school. This study aimed to conduct a priority setting exercise to co-produce research priorities in relation to the UK school food system.

Methods

The James Lind Alliance process informed this priority setting exercise; all key steps engaged a wide range of UK school food stakeholders (including teachers, parents, principals, school governors, policymakers, caterers). An initial online stakeholder survey identified perceived research priorities. In a second survey, stakeholders were asked to rank these priorities. Lastly, an online priority setting workshop with stakeholders elicited the most important research priorities.

Results

In 2021, school food stakeholders (n=1280) completed the first survey, from which 136 research priorities were identified. In the second survey, participants (n=107) ranked these research priorities regarding their importance. Lastly, 30 workshop participants discussed and reached consensus on the research priorities. After final refinement by the research team, 18 priorities resulted, with the top 10 being related to the provision of free school meals (effectiveness of cost-effectiveness of different levels of eligibility, including universal provision), implementation of policy (including improving uptake) and food standards, issues around procurement, leadership, inequalities, social norms, the eating environment, food culture throughout the school setting and healthy eating.

Conclusion

The top 10 research priorities were elicited through a rigorous approach, including a wide range of stakeholders across the UK. These should be considered by policymakers, researchers and others to inform research, evidence-based policy development and, ultimately, improve the UK school food system.

Results from a cross-specialty consensus on optimal management of patients with chronic kidney disease (CKD): from screening to complications

Por: Arici · M. · Assaad-Khalil · S. H. · Bertoluci · M. C. · Choo · J. · Lee · Y.-J. · Madero · M. · Rosa Diez · G. J. · Sanchez Polo · V. · Chung · S. · Thanachayanont · T. · Pollock · C.
Background

Chronic kidney disease (CKD) affects around 10% of the global population and has been estimated to affect around 50% of individuals with type 2 diabetes and 50% of those with heart failure. The guideline-recommended approach is to manage with disease-modifying therapies, but real-world data suggest that prescribing rates do not reflect this in practice.

Objective

To develop a cross-specialty consensus on optimal management of the patient with CKD using a modified Delphi method.

Design

An international steering group of experts specialising in internal medicine, endocrinology/diabetology, nephrology and primary care medicine developed 42 statements on aspects of CKD management including identification and screening, risk factors, holistic management, guidelines, cross-specialty alignment and education. Consensus was determined by agreement using an online survey.

Participants

The survey was distributed to cardiologists, nephrologists, endocrinologists and primary care physicians across 11 countries.

Main outcomes and measures

The threshold for consensus agreement was established a priori by the steering group at 75%. Stopping criteria were defined as a target of 25 responses from each country (N=275), and a 4-week survey period.

Results

274 responses were received in December 2022, 25 responses from Argentina, Australia, Brazil, Guatemala, Mexico, Singapore, South Korea, Taiwan, Thailand, Turkey and 24 responses from Egypt. 53 responses were received from cardiologists, 52 from nephrologists, 55 from endocrinologists and 114 from primary care physicians. 37 statements attained very high agreement (≥90%) and 5 attained high agreement (≥75% and

Conclusions

There is a high degree of consensus regarding aspects of CKD management among healthcare professionals from 11 countries. Based on these strong levels of agreement, the steering group derived 12 key recommendations focused on diagnosis and management of CKD.

Common practices for sociodemographic data reporting in digital mental health intervention research: a scoping review

Por: Kirvin-Quamme · A. · Kissinger · J. · Quinlan · L. · Montgomery · R. · Chernenok · M. · Pirner · M. C. · Pajarito · S. · Rapoport · S. · Wicks · P. · Darcy · A. · Greene · C. J. · Robinson · A.
Background

The ability of digital mental health interventions (DMHIs) to reduce mental health disparities relies on the recruitment of research participants with diverse sociodemographic and self-identity characteristics. Despite its importance, sociodemographic reporting in research is often limited, and the state of reporting practices in DMHI research in particular has not been comprehensively reviewed.

Objectives

To characterise the state of sociodemographic data reported in randomised controlled trials (RCTs) of app-based DMHIs published globally from 2007 to 2022.

Methods

A scoping review of RCTs of app-based DMHIs examined reporting frequency for 16 sociodemographic domains (eg, gender) and common category options within each domain (eg, woman). The search queried five electronic databases. 5079 records were screened and 299 articles were included.

Results

On average, studies reported 4.64 (SD=1.79; range 0–9) of 16 sociodemographic domains. The most common were age (97%) and education (67%). The least common were housing situation (6%), residency/location (5%), veteran status (4%), number of children (3%), sexual orientation (2%), disability status (2%) and food security (

Conclusions

This review describes the widespread underreporting of sociodemographic information in RCTs of app-based DMHIs published from 2007 to 2022. Reporting was often incomplete (eg, % female only), unclear (eg, the conflation of gender/sex) and limited (eg, only options representing majority groups were reported). Trends suggest reporting has somewhat improved in recent years. Diverse participant populations must be welcomed and described in DMHI research to broaden learning and the generalisability of results, a prerequisite of DMHI’s potential to reduce disparities in mental healthcare.

Use of drugs for hyperlipidaemia and diabetes and risk of primary and secondary brain tumours: nested case-control studies using the UK Clinical Practice Research Datalink (CPRD)

Por: Robinson · J. W. · Martin · R. · Ozawa · M. · Elwenspoek · M. M. C. · Redaniel · M. T. · Kurian · K. · Ben-Shlomo · Y.
Objectives

Previous studies have suggested that fibrates and glitazones may have a role in brain tumour prevention. We examined if there is support for these observations using primary care records from the UK Clinical Practice Research Datalink (CPRD).

Design

We conducted two nested case–control studies using primary and secondary brain tumours identified within CPRD between 2000 and 2016. We selected cases and controls among the population of individuals who had been treated with any anti-diabetic or anti-hyperlipidaemic medication to reduce confounding by indication.

Setting

Adults older than 18 years registered with a general practitioner in the UK contributing data to CPRD.

Results

We identified 7496 individuals with any brain tumour (4471 primary; 3025 secondary) in total. After restricting cases and controls to those prescribed any anti-diabetic or anti-hyperlipidaemic medication, there were 1950 cases and 7791 controls in the fibrate and 480 cases with 1920 controls in the glitazone analyses. Longer use of glitazones compared with all other anti-diabetic medications was associated with a reduced risk of primary (adjusted OR (aOR) 0.89 per year, 95% CI 0.80 to 0.98), secondary (aOR 0.87 per year, 95% CI 0.77 to 0.99) or combined brain tumours (aOR 0.88 per year, 95% CI 0.81 to 0.95). There was little evidence that fibrate exposure was associated with risk of either primary or secondary brain tumours.

Conclusions

Longer exposure to glitazones was associated with reduced primary and secondary brain tumour risk. Further basic science and population-based research should explore this finding in greater detail, in terms of replication and mechanistic studies.

Community health navigator-assisted transition of care from hospital to community: protocol for a randomised controlled trial

Por: Parker · S. M. · Aslani · P. · Harris-Roxas · B. · Wright · M. C. · Barr · M. · Doolan-Noble · F. · Javanparast · S. · Sharma · A. · Osborne · R. H. · Cullen · J. · Harris · E. · Haigh · F. · Harris · M.
Introduction

The objective of this parallel group, randomised controlled trial is to evaluate a community health navigator (CHN) intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes. Unplanned hospital readmissions are costly for the health system and negatively impact patients.

Methods and analysis

Patients are randomised post hospital discharge to the CHN intervention or usual care. A comparison of outcomes between intervention and control groups will use multivariate regression techniques that adjust for age, sex and any independent variables that are significantly different between the two groups, using multiple imputation for missing values. Time-to-event analysis will examine the relationship between seeing a CHN following discharge from the index hospitalisation and reduced rehospitalisations in the subsequent 60 days and 6 months. Secondary outcomes include medication adherence, health literacy, quality of life, experience of healthcare and health service use (including the cost of care). We will also conduct a qualitative assessment of the implementation of the navigator role from the viewpoint of stakeholders including patients, health professionals and the navigators themselves.

Ethics approval

Ethics approval was obtained from the Research Ethics and Governance Office, Sydney Local Health District, on 21 January 2022 (Protocol no. X21-0438 and 2021/ETH12171). The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations. Data will be deposited in an institutional data repository at the end of the trial. This is subject to Ethics Committee approval, and the metadata will be made available on request.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN 12622000659707).

Article Summary

The objective of this trial is to evaluate a CHN intervention provided to patients aged over 40 years and living with chronic health conditions to transition from hospital inpatient care to their homes.

Psychometric properties of the living with long term conditions scale in an English-speaking population living with long term conditions in the UK

Por: Ambrosio · L. · Hislop-Lennie · K. · Serrano-Fuentes · N. · Driessens · C. · Portillo · M. C.
Objective

To present the psychometric properties of the living with long-term condition (LwLTCs) scale in an English-speaking population of people with different LTCs.

Design

An observational and cross-sectional study, with retest was conducted. Psychometric properties including feasibility, internal consistency, confirmatory factor analysis, reproducibility and content validity were tested.

Setting

The study took place across the UK via primary care surgeries and voluntary organisations, between December 2021 and June 2022.

Participants

The study included 577 patients living with different LTCs, as chronic obstructive pulmonary disease, arthritis, chronic heart failure, Parkinson’s disease, chronic kidney disease and type 2 diabetes mellitus. Inclusion criteria included: (a) having been diagnosed with one or more of the conditions; (b) being able to read, understand and answer written questionnaires; (c) being fluent in English and (d) being able to provide written informed consent. Patients were involved in the design and pilot study of the scale.

Results

A total sample of 577 people with an age range of 37–97 years (98±9.65) were recruited. Internal consistency of the total 26-item LwLTCs scale score was excellent (ordinal alpha=0.90) but confirmatory factor analysis showed better fit indices (Normed Fit Index=0.96; standardised root mean square residual=0.051; Goodness of Fit Index=0.98) for a 20-item LwLTCs scale.

Conclusions

A shorter version of the LwLTCs scale, with just 20 items and with excellent psychometric properties, is recommended. Having a short scale is key when considering the implementation of the scale in clinical practice to develop person-centred pathways and more comprehensive care plans.

The Tuberculosis Sentinel Research Network (TB-SRN) of the International epidemiology Databases to Evaluate AIDS (IeDEA): protocol for a prospective cohort study in Africa, Southeast Asia and Latin America

Por: Enane · L. A. · Duda · S. N. · Chanyachukul · T. · Bolton-Moore · C. · Navuluri · N. · Messou · E. · Mbonze · N. · McDade · L. R. · Figueiredo · M. C. · Ross · J. · Evans · D. · Diero · L. · Akpata · R. · Zotova · N. · Freeman · A. · Pierre · M. F. · Rupasinghe · D. · Ballif · M. · Byakwag
Introduction

Tuberculosis (TB) is a leading infectious cause of death globally. It is the most common opportunistic infection in people living with HIV, and the most common cause of their morbidity and mortality. Following TB treatment, surviving individuals may be at risk for post-TB lung disease. The TB Sentinel Research Network (TB-SRN) provides a platform for coordinated observational TB research within the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium.

Methods and analysis

This prospective, observational cohort study will assess treatment and post-treatment outcomes of pulmonary TB (microbiologically confirmed or clinically diagnosed) among 2600 people aged ≥15 years, with and without HIV coinfection, consecutively enrolled at 16 sites in 11 countries, across 6 of IeDEA’s global regions. Data regarding clinical and sociodemographic factors, mental health, health-related quality of life, pulmonary function, and laboratory and radiographic findings will be collected using standardised questionnaires and data collection tools, beginning from the initiation of TB treatment and through 12 months after the end of treatment. Data will be aggregated for proposed analyses.

Ethics and dissemination

Ethics approval was obtained at all implementing study sites, including the Vanderbilt University Medical Center Human Research Protections Programme. Participants will provide informed consent; for minors, this includes both adolescent assent and the consent of their parent or primary caregiver. Protections for vulnerable groups are included, in alignment with local standards and considerations at sites. Procedures for requesting use and analysis of TB-SRN data are publicly available. Findings from TB-SRN analyses will be shared with national TB programmes to inform TB programming and policy, and disseminated at regional and global conferences and other venues.

Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial

Por: Li · M. C. M. · Cheng · Y. K. · Cui · C. · Chow · S. K. H. · Wong · R. M. Y. · Kwok · T. C. · Siu · P. M. · Yang · M. · Tian · M. · Rubin · C. · Welch · A. A. · Qin · L. · Law · S. W. · Cheung · W. H.
Introduction

Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.

Methods and analysis

In this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.

Ethics and dissemination

This study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.

Trial registration number

NCT05525039.

NSAID prescribing and adverse outcomes in common infections: a population-based cohort study

Por: Stuart · B. · Venekamp · R. · Hounkpatin · H. · Wilding · S. · Moore · M. · Little · P. · Gulliford · M. C.
Objectives

Infections in primary care are often treated with non-steroidal anti-inflammatory drugs (NSAIDs). This study evaluates whether NSAID prescribing is associated with adverse outcomes for respiratory (RTIs) or urinary track (UTI) infections.

Objectives

To determine whether there is an association between NSAID prescribing and the rate of adverse outcomes for infections for individual consulting in primary care.

Design

Cohort study of electronic health records.

Setting

87 general practices in the UK Clinical Practice Research Datalink GOLD.

Participants

142 925 patients consulting with RTI or UTI.

Primary and secondary outcome measures

Repeat consultations, hospitalisation or death within 30 days of the initial consultation for RTI or UTI. Poisson models estimated the associations between NSAID exposure and outcome. Rate ratios were adjusted for gender, age, ethnicity, deprivation, antibiotic use, seasonal influenza vaccination status, comorbidities and general practice. Since prescribing variations by practice are not explained by case mix—hence, less impacted by confounding by indication—both individual-level and practice-level analyses are included.

Results

There was an increase in hospital admission/death for acute NSAID prescriptions (RR 2.73, 95% CI 2.10 to 3.56) and repeated NSAID prescriptions (6.47, 4.46–9.39) in RTI patients, and for acute NSAID prescriptions for UTI (RR 3.03; 1.92 to 4.76). Practice-level analysis, controlling for practice population characteristics, found that for each percentage point increase in NSAID prescription, the percentages of hospital admission/death within 30 days increased by 0.32 percentage points (95% CI 0.16 to 0.47).

Conclusions

In this non-randomised study, prescription of NSAIDs at consultations for RTI or UTIs in primary care is infrequent but may be associated with increased risk of hospital admission. This supports other observational and limited trial data that NSAID prescribing might be associated with worse outcomes following acute infection and should be prescribed with caution.

Correlational study of ergonomic knowledge and level of MSK discomfort during online classes of 1st-4th year UST-CRS physical therapy students: a cross-sectional study

Por: Siy · W. · Sicat · Z. M. · Bautista · T. M. · Formalejo · A. · Gatdula · M. E. · Ico · A. A. · Julian · C. J. · Pabion · M. C. · Reyes · J. L. · Santander · N. M.
Introduction

The abrupt transition of the mode of learning due to the COVID-19 pandemic resulted in an increase in complaints of musculoskeletal (MSK) discomfort among students in Higher Education Institutions (HEI). Inadequate physical space and equipment are one major cause of these complaints. Among HEIs, physical therapy (PT) students have sufficient background in managing MSK discomforts. However, this does not prevent them from experiencing pain and discomfort during online classes. This analytical cross-sectional study aims to determine the correlation between ergonomic knowledge and MSK discomfort among first-year to fourth-year PT students.

Methods and analysis

The study will use two questionnaires, the Ergonomic Knowledge Questionnaire, and the Cornell Musculoskeletal Discomfort Questionnaire, that determine the level of ergonomic knowledge and MSK discomfort, respectively. This will be disseminated to 144 students through google forms. Results will then be analysed using Pearson Correlation Test. The study anticipates a correlation between the level of ergonomic knowledge and MSK discomfort among the participants.

Ethics and dissemination

The study has been approved by the University of Santo Tomas-College of Rehabilitation Sciences Ethics Review Committee. The participants will receive the results prior to publication in a peer-reviewed scientific journal.

Trial registration number

Philippine Health Research Registry with registry ID PHRR230216-005443.

Recurrent bacterial meningitis in children in the Netherlands: a nationwide surveillance study

Por: Snoek · L. · van Kassel · M. N. · Koelman · D. L. H. · van der Ende · A. · van Sorge · N. M. · Brouwer · M. C. · van de Beek · D. · Bijlsma · M. W.
Objectives

This study aimed to estimate the recurrence rate of culture-positive bacterial meningitis in children in the Netherlands.

Design

Nationwide surveillance study, using the database of the Netherlands Reference Laboratory for Bacterial Meningitis to identify patients with culture-positive bacterial meningitis during childhood.

Setting

The study was based in the Netherlands.

Participants

A total of 9731 children with a first bacterial meningitis episode between 1 July 1987 and 30 June 2019 were identified.

Primary and secondary outcome measures

Recurrence was defined as a subsequent episode >28 days, or caused by a different pathogen. Annual incidence and incidence rate ratios (IRRs) comparing the periods 1988–2003 and 2004–2019 were calculated. Predictors of recurrent meningitis were assessed using Cox proportional hazards regression.

Results

Sixty-three (0.6%) of the 9731 children with a first bacterial meningitis episode contracted recurrent meningitis. Neisseria meningitidis was the leading pathogen for first meningitis episodes (52%) and Streptococcus pneumoniae for recurrent episodes (52%). The median annual incidence of first episodes per 100 000 children decreased from 11.81 (IQR 11.26–17.60) in 1988–2003 to 2.60 (IQR 2.37–4.07) in 2004–2019 (IRR 0.25, 95% CI 0.23 to 0.26). The incidence of recurrences did not change: 0.06 (IQR 0.02–0.11) in 1988–2003 to 0.03 (IQR 0.00–0.06) in 2004–2019 (IRR 0.65, 95% CI 0.39 to 1.1). Age above 5 years (OR 3.6 (95% CI 1.5 to 8.3)) and a first episode due to Escherichia coli (OR 25.7 (95% CI 7.2 to 92.0)) were associated with higher risks of recurrence.

Conclusion

The recurrence rate of childhood bacterial meningitis in the Netherlands was 0.6%. While the incidence rate of first episodes decreased substantially, this was not the case for recurrent episodes. Older age and a first episode due to E. coli were associated with higher recurrence risks.

Assessing the feasibility of a randomised controlled trial examining the effect of hearing aids on cognitive decline in elderly individuals: a study protocol

Por: Fuchten · D. · Smit · A. L. · Huenges Wajer · I. M. C. · Rhebergen · K. S. · Stegeman · I.
Introduction

Hearing loss is one of the leading potentially modifiable risk factors for dementia. There is growing evidence suggesting that treating hearing loss with hearing aids could be a relatively low-cost intervention in reducing cognitive decline and the risk of dementia in the long term. However, given the current constraints of the limited evidence, it is premature to draw definitive conclusions about the effect of hearing aids on cognitive functioning. More long-term randomised studies examining this effect would be recommended. Prior to embarking on large-scale lengthy randomised controlled trials (RCTs), it is imperative to determine the viability of such studies. Therefore, the purpose of the current study is to assess the feasibility of a RCT that investigates the effect of hearing aids on cognitive functioning in elderly hearing impaired individuals.

Methods and analysis

In this randomised controlled feasibility trial, 24 individuals aged 65 years or older with mild to moderate hearing loss (≥35–

Ethics and dissemination

This research protocol was approved by the Institutional Review Board of the University Medical Centre Utrecht (NL80594.041.22, V.3, January 2023). The trial results will be made accessible to the public in a peer-reviewed journal.

Trial registration number

ISRCTN84550071.

Influence of perioperative step volume on complication rate and length of hospital stay after colorectal cancer surgery (IPOS trial): study protocol for a randomised controlled single-centre trial at a German university hospital

Por: Anthuber · L. · Sommer · F. · Wolf · S. · Vlasenko · D. · Hoffmann · M. · Arndt · T. T. · Schiele · S. · Anthuber · M. · Schrempf · M. C.
Background

Perioperative mobilisation and physical activity are critical components of postoperative rehabilitation. Physical inactivity is a significant risk factor for complications and prolonged hospitalisation. However, specific recommendations for preoperative and postoperative physical activity levels are currently lacking. Evidence suggests that daily step count before and after surgery may impact the length of hospital stay and complication rate.

The goal of this study is to determine the effectiveness of perioperative step volume recommendations, measured by pedometers, in reducing the length of hospital stay and complication rate for patients undergoing colorectal cancer surgery.

Methods

This study is a single-centre randomised controlled trial with two arms, allocated at a 1:1 ratio. The trial includes individuals undergoing colorectal surgery for either suspected or confirmed colorectal malignancy. A total of 222 patients will be randomly assigned to either an intervention or a control group. Step counts will be measured using a pedometer. Patients assigned to the intervention group will be given a predetermined preoperative and postoperative step count goal. The analysis will be conducted on preoperative and postoperative physical activity, quality of life, health, duration of hospitalisation, complication rate and bowel function, among other factors.

Ethics and dissemination

The trial was approved by the ethics committee of the Ludwig-Maximilians-University of Munich, Germany (reference number: 22-0758, protocol version 2022.02). Results will be published in peer-reviewed journals and shared at academic conferences. After the publication of the results, a fully anonymised data set and the statistical code can be made available on justified scientific request and after ethical approval has been granted.

Trial registration number

DRKS00030017.

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