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Do they stay, or do they go? Children presenting to five emergency departments across New South Wales, Australia with acute burn injuries: a retrospective review

Por: Phillips · W. · Southern · E. · Cattell · C. · Owens · P. · Jaques · M. · Melbourne · G. · Kezhekkekara · S. · Frost · S. A.
Objective

The overall objective of the study was to describe the disposition status of children presenting with a burn injury to five emergency departments (ED) across New South Wales (NSW), Australia.

Design

A retrospective study design was used to review routinely collected ED data.

Setting

Study sites included five acute hospitals across NSW, Australia.

Participants

During the 5-year study period between 1 January 2015 to 31 December 2020, there were 5213 paediatric burn injury presentations.

Results

The mean age of burn injury presentations was 24 months (Inter-Quartile-Range (IQR) 12–84), of which 57% (2951/5213) were males. The most common presentation time was between 16:00 and 23:59 hours (63%, 3297/5213), and the median time spent in the ED was 3 hours (IQR 1–4). The majority (80%, 4196/5213) of the burn injuries presentations did not require hospital admission. The most common principal diagnoses were ‘Burn body region unspecified’ (n=1916) and ‘Burn of wrist and hand’ (n=1060).

Conclusion

Most children who presented to the hospital with a burn injury were not admitted. Often the details of these burns were poorly recorded and a complete picture of the true burden of burn injury in children, especially the ongoing care given outside the acute hospital setting, is missing. This information is crucial, as it would inform future models of care as the paradigm shifts rapidly towards primary, ambulatory and outpatient models of care.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol

Por: Vahid · F. · Dessenne · C. · Tur · J. A. · Bouzas · C. · Devaux · Y. · Malisoux · L. · Monserrat-Mesquida · M. · Sureda · A. · Desai · M. S. · Turner · J. D. · Lamy · E. · Perez-Jimenez · M. · Ravn-Haren · G. · Andersen · R. · Forberger · S. · Nagrani · R. · Ouzzahra · Y. · Fontefrancesc
Introduction

Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers.

Methods and analysis

PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed.

Ethics and dissemination

Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

Feasibility of quality indicators on prehospital advanced airway management in a physician-staffed emergency medical service: survey-based assessment of the provider point of view

Por: Kottmann · A. · Pasquier · M. · Carron · P.-N. · Maudet · L. · Rouve · J.-D. · Suppan · L. · Caillet-Bois · D. · Riva · T. · Albrecht · R. · Krüger · A. · Sollid · S. J. M.
Objective

We aimed to determine the feasibility of quality indicators (QIs) for prehospital advanced airway management (PAAM) from a provider point of view.

Design

The study is a survey based feasibility assessment following field testing of QIs for PAAM.

Setting

The study was performed in two physician staffed emergency medical services in Switzerland.

Participants

42 of the 44 emergency physicians who completed at least one case report form (CRF) dedicated to the collection of the QIs on PAAM between 1 January 2019 and 31 December 2021 participated in the study.

Intervention

The data required to calculate the 17 QIs was systematically collected through a dedicated electronic CRF.

Primary and secondary outcome measures

Primary outcomes were provider-related feasibility criteria: relevance and acceptance of the QIs, as well as reliability of the data collection. Secondary outcomes were effort to collect specific data and to complete the CRF.

Results

Over the study period, 470 CRFs were completed, with a median of 11 per physician (IQR 4–17; range 1–48). The median time to complete the CRF was 7 min (IQR 3–16) and was considered reasonable by 95% of the physicians. Overall, 75% of the physicians assessed the set of QIs to be relevant, and 74% accepted that the set of QIs assessed the quality of PAAM. The reliability of data collection was rated as good or excellent for each of the 17 QIs, with the lowest rated for the following 3 QIs: duration of preoxygenation, duration of laryngoscopy and occurrence of desaturation during laryngoscopy.

Conclusions

Collection of QIs on PAAM appears feasible. Electronic medical records and technological solutions facilitating automatic collection of vital parameters and timing during the procedure could improve the reliability of data collection for some QIs. Studies in other services are needed to determine the external validity of our results.

Toxoplasma gondii seropositivity and cognitive functioning in older adults: an analysis of cross-sectional data of the National Health and Nutrition Examination Survey 2011-2014

Por: Song · G. · Zhao · Q. · Chen · H. · Li · M. · Zhang · Z. · Qu · Z. · Yang · C. · Lin · X. · Ma · W. · Standlee · C. R.
Objectives

This study sought to examine the relationship between Toxoplasma gondii seropositivity and cognitive function in older adults.

Design

An observational cross-sectional study.

Setting

The National Health and Nutrition Examination Survey (NHANES) study took place at participants’ homes and mobile examination centres.

Participants

A total of 2956 older adults aged 60 and above from the NHANES from 2011 to 2014 were included in the study. Exposure of interest: participants had serum Toxoplasma gondii antibody analysed in the laboratory. A value>33 IU/mL was categorised as seropositive for Toxoplasma gondii infection; Toxoplasma gondii infection.

Primary and secondary outcome measures

Cognitive tests included the Consortium to Establish a Registry for Alzheimer’s Disease Word Learning subtest (CERAD-WL) for immediate and delayed memory, the Animal Fluency Test (AFT), and the Digit Symbol Substitution Test (DSST).

Results

About half of the 2956 participants (mean age 70.0) were female (51.0%), non-Hispanic White (48.3%), and completed some college or above (48.3%). A total of 703 participants were positive for Toxoplasma gondii infection (23.8%). Adjusted linear regression showed that compared with participants with negative Toxoplasma gondii infection, those with positive Toxoplasma gondii infection had lower CERAD-WL immediate memory (beta (β) –0.16, 95% CI –0.25 to –0.07), CERAD-WL delayed memory (β –0.15, 95% CI –0.24 to –0.06), AFT (β –0.15, 95% CI –0.24 to –0.06), DSST (β –0.34, 95% CI –0.43 to –0.26), and global cognition (β –0.24, 95% CI –0.32 to –0.16) z-scores after controlling for the covariates.

Conclusions

Toxoplasma gondii seropositivity is associated with worse immediate and delayed verbal learning, language proficiency, executive functioning, processing speed, sustained attention, working memory, as well as global cognition in older adults. Public health measures aiming at preventing Toxoplasma gondii infection may help preserve cognitive functioning in older adults.

University staff perspectives on determinants of high-quality health professions student placements in regional, rural and remote Australia: protocol for a mixed-method study

Por: Quilliam · C. · Green · E. · Rasiah · R. L. · Sheepway · L. · Seaton · C. · Moore · L. · Bailie · J. · Matthews · K. M. · Ferns · J. · Debenham · J. · Taylor · C. · Fitzgerald · K. · Ridd · M.
Introduction

In rural areas, work-integrated learning in the form of health student placements has several potential benefits, including contributing to student learning, enhancing rural health service capacity and attracting future rural health workforce. Understanding what constitutes a high-quality rural placement experience is important for enhancing these outcomes. There is no current standardised definition of quality in the context of rural health placements, nor is there understanding of how this can be achieved across different rural contexts. This study is guided by one broad research question: what do university staff believe are the determinants of high-quality health professions student placements in regional, rural and remote Australia?

Methods and analysis

This study will adopt a convergent mixed-method design with two components. Component A will use explanatory sequential mixed methods. The first phase of component A will use a survey to explore determinants that contribute to the development of high-quality health student placements from the perspective of university staff who are not employed in University Departments of Rural Health and are involved in the delivery of health student education. The second phase will use semistructured interviews with the same stakeholder group (non-University Department of Rural Health university staff) to identify the determinants of high-quality health student placements. Component B will use a case study Employing COnceptUal schema for policy and Translation Engagement in Research mind mapping method to capture determinants that contribute to the development of high-quality health student placements from the perspective of University Department of Rural Health university staff.

Ethics and dissemination

The University of Melbourne Human Ethics Committee approved the study (2022-23201-33373-5). Following this, seven other Australian university human research ethics committees provided external approval to conduct the study. The results of the study will be presented in several peer-review publications and summary reports to key stakeholder groups.

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.

Comparative effectiveness of biologics in patients with rheumatoid arthritis stratified by body mass index: a cohort study in a Swiss registry

Objectives

Obesity is associated with lower treatment response in patients with rheumatoid arthritis (RA). In patients with obesity, abatacept was suggested as a preferable option to tumour necrosis factor-alpha inhibitors. We aimed to assess the comparative effectiveness of etanercept, infliximab and abatacept, compared with adalimumab, in patients with RA with obesity. Secondarily, we also investigated this in patients with overweight and normal weight for completeness.

Design

Observational cohort study.

Setting

Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) registry (1997–2019).

Participants

Adult patients with RA from the SCQM registry who received etanercept, infliximab, abatacept or adalimumab as their first biological or targeted synthetic disease-modifying antirheumatic drug were classified based on their body mass index (BMI) at the start of that treatment in three cohorts: obese, overweight, normal weight. They were followed for a maximum of 1 year.

Exposure

The study exposure of interest was the patients’ first biological, particularly: etanercept, infliximab and abatacept, compared with adalimumab.

Primary and secondary outcome measures

The primary study outcome was remission within 12 months, defined as 28-joint Disease Activity Score (DAS28)

Results

The study included 443 obese, 829 overweight and 1243 normal weight patients with RA. There were no statistically significant differences in the odds of DAS28-remission at ≤12 months for etanercept, infliximab and abatacept, compared with adalimumab, in any of the BMI cohorts.

Conclusions

No differences in DAS28-remission were found between the study drugs and adalimumab as first biologic in patients with RA, independently of the BMI cohort. We did not find evidence that treatment with abatacept increased the likelihood of remission compared with adalimumab among obese patients with RA.

Treatment pathways, economic burden and clinical outcomes in new users of inhaled corticosteroid/long-acting B2-agonist dual therapy with chronic obstructive pulmonary disease in a primary care setting in England: a retrospective cohort study

Por: Czira · A. · Banks · V. · Requena · G. · Wood · R. · Tritton · T. · Wild · R. · Compton · C. · Ismaila · A.
Objective

Management of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) improves lung function and health status and reduces COPD exacerbation risk versus monotherapy. This study described treatment use, healthcare resource utilisation (HCRU), healthcare costs and outcomes following initiation of single-device ICS/LABA as initial maintenance therapy (IMT).

Design

Retrospective cohort study.

Setting

Primary care, England.

Data sources

Linked data from the Clinical Practice Research Datalink Aurum and Hospital Episode Statistics datasets.

Participants

Patients with COPD and ≥1 single-device ICS/LABA prescription between July 2015 and December 2018 were included.

Primary and secondary outcome measures

Treatment pathways, COPD-related HCRU and healthcare costs, COPD exacerbations, time to triple therapy, medication adherence (proportion of days covered ≥80%) and indexed treatment time to discontinuation. Data for patients without prior maintenance therapy history (IMT users) and non-triple users were assessed over a 12-month follow-up period.

Results

Of 13 451 new ICS/LABA users, 5162 were IMT users (budesonide/formoterol, n=1056; beclomethasone dipropionate/formoterol, n=2427; other ICS/LABA, n=1679), for whom at 3 and 12 months post-index, 45.6% and 39.4% were still receiving any ICS/LABA. At >6 to ≤12 months, the proportion of IMT users with ≥1 outpatient visit (10.1%) and proportion with ≥1 inpatient stay (12.6%) had increased from those at 3 months (9.0% and 7.4%, respectively). Inpatient stays contributed most to total COPD-related healthcare costs. For non-triple IMT users, at 3 and 12 months post-index, 4.5% and 13.7% had ≥1 moderate-to-severe COPD exacerbation. Time to triple therapy initiation and time to discontinuation of index medication ranged from 45.9 to 50.2 months and 2.3 to 2.8 months between treatments. Adherence was low across all time points (21.5–27.6%). Results were similar across indexed therapies.

Conclusions

In the year following treatment initiation, ICS/LABA adherence was poor and many patients discontinued or switched therapies, suggesting that more consideration and optimisation of treatment is required in England for patients initiating single-device ICS/LABA therapy.

Pivotal relationship between heavy metal, PM2.5 exposures and tuberculosis in Bangladeshi children: protocol paper of a case-control study

Por: Haque · R. · Hanson · M. · Shariful Islam · M. · Akter · N. · Moniruzzaman · M. · Alam · M. J. · Kamruzzaman · M. · Rahman · M. · Chisti · M. J. · Raqib · R. · Rahman · S. M.
Introduction

Air pollution is a global issue that poses a significant threat to public health. Children, due to their developing physiology, are particularly susceptible to the inhalation of environmental pollutants. Exposure can trigger immune modulation and organ damage, increasing susceptibility to respiratory diseases. Therefore, we aim to examine the association between heavy metal and particulate matter exposure with tuberculosis in children.

Methods and analysis

As a case–control study, we will include children diagnosed with pulmonary tuberculosis (n=60) and matched healthy controls (n=80) recruited from the same communities in Dhaka, Bangladesh. Exposure data for both cases and controls will be collected by a trained field team conducting home visits. They will administer an exposure questionnaire, measure child anthropometry, collect blood and household dust samples and instal 48-hour air quality monitors. The blood samples will be analysed by inductively coupled plasma mass spectrometry for serum heavy metal concentrations (lead, cadmium, arsenic, mercury and chromium), as a representative marker of exposure, and the presence of inflammatory biomarkers. Descriptive and inferential statistics, including independent samples t-tests, analysis of variance and conditional regression analysis, will be used to quantify heavy metal and particulate matter exposure status in tuberculosis cases compared with healthy controls, while accounting for potential confounders. Dust samples and air quality results will be analysed to understand household sources of heavy metal and particulate matter exposure. To test the study hypothesis, there is a positive association between exposure and tuberculosis diseases, we will also measure the accumulated effect of simultaneous exposures using Bayesian statistical modelling.

Ethics and dissemination

This study has been approved by International Centre for Diarrhoeal Disease Research, Bangladesh’s Institutional Review Board (PR-22030). The study findings will be disseminated at conferences and published in peer-reviewed journals.

Evaluating the long-term impact of large-scale trainings: an exposure based cross-sectional study on female genital mutilation-related knowledge, attitudes and practices among Sudanese midwives in Khartoum State

Por: Ahmed · W. · Abdelrahim · M. · Gloyd · S. · Farquhar · C. · Puttkammer · N.
Objectives

To examine the long-term impact of large-scale training targeting midwives in a setting where they are the main female genital mutilation (FGM) practitioners. We hypothesised that trained midwives would have significantly higher knowledge, greater opposition to midwives’ involvement in this practice, and improved clinical practice in FGM prevention and care compared with non-trained midwives.

Design

We conducted an exposure based cross-sectional study, using closed-ended and open-ended questions during phone interviews.

Setting

Khartoum State in Sudan has a high prevalence of FGM (88%) mainly performed by midwives.

Participants

Midwives who received (n=127) and did not receive FGM training (n=55).

Primary and secondary outcome measures

We developed primary outcomes aligned to the three levels (reaction, learning and behaviour) of Kirkpatrick’s training evaluation model for descriptive and multivariable analyses in Stata.

Results

All the midwives interviewed were female, mostly village midwives (92%) and worked in health centres (89%). The mean age and midwifery experience was 51 years (SD=10) and 23 years (SD=12), respectively. Overall, most midwives (>90%) reported being supportive of FGM discontinuation. Midwives who had FGM training were more aware that performing FGM violates code of conduct (p=0.001) and reported to always counsel patients to abandon FGM (p

Conclusion

Though past trainings were associated with higher knowledge and greater opposition to midwives’ involvement in FGM, this was not translated into appropriate corrective clinical procedures among affected women during labour. The Sudan Ministry of Health invested heavily in training midwives and it would be important to investigate why trained midwives do not implement recommended FGM-related clinical management.

Use of removable support boot versus cast for early mobilisation after ankle fracture surgery: cost-effectiveness analysis and qualitative findings of the Ankle Recovery Trial (ART)

Por: Baji · P. · Barbosa · E. C. · Heaslip · V. · Sangar · B. · Tbaily · L. · Martin · R. · Docherty · S. · Allen · H. · Hayward · C. · Marques · E. M. R.
Objectives

To estimate the cost-effectiveness of using a removable boot versus a cast following ankle fracture from the National Health Service and Personal Social Services (NHS+PSS) payer and societal perspectives and explore the impact of both treatments on participants’ activities of daily living.

Design

Cost-effectiveness analyses and qualitative interviews performed alongside a pragmatic multicentre randomised controlled trial.

Setting

Eight UK NHS secondary care trusts.

Participants

243 participants (60.5% female, on average 48.2 years of age (SD 16.4)) with ankle fracture. Qualitative interviews with 16 participants. Interventions removable air boot versus plaster cast 2 weeks after surgery weight bearing as able with group-specific exercises.

Primary and secondary outcome measures

Quality-adjusted life years (QALYs) estimated from the EQ-5D-5L questionnaire, costs and incremental net monetary benefit statistics measured 12 weeks after surgery, for a society willing-to-pay £20 000 per QALY.

Results

Care in the boot group cost, on average, £88 (95% CI £22 to £155) per patient more than in the plaster group from the NHS+PSS perspective. When including all societal costs, the boot saved, on average, £676 per patient (95% CI –£337 to £1689). Although there was no evidence of a QALY difference between the groups (–0.0020 (95% CI –0.0067 to 0.0026)), the qualitative findings suggest participants felt the boot enhanced their quality of life. Patients in the boot felt more independent and empowered to take on family responsibilities and social activities.

Conclusions

While the removable boot is slightly more expensive than plaster cast for the NHS+PSS payer at 12 weeks after surgery, it reduces productivity losses and the need for informal care while empowering patients. Given that differences in QALYs and costs to the NHS are small, the decision to use a boot or plaster following ankle surgery could be left to patients’ and clinicians’ preferences.

Trial registration number

ISRCTN15497399, South Central—Hampshire A Research Ethics Committee (reference 14/SC/1409).

The economic burden associated with unmet surgical needs in Liberia: a retrospective macroeconomic analysis based on a nationwide enumeration of surgical procedures

Por: Adde · H. A. · Oghogho · M. D. · van Duinen · A. J. · Grimes · C. E. · Hampaye · T. C. · Quaife · M. · Bolkan · H. A.
Objectives

The economic consequences of untreated surgical disease are potentially large. The aim of this study was to estimate the economic burden associated with unmet surgical needs in Liberia.

Design

A nationwide enumeration of surgical procedures and providers was conducted in Liberia in 2018. We estimated the number of disability-adjusted life years (DALYs) saved by operative activities and converted these into economic losses averted using gross national income per capita and value of a statistical life (VSL) approaches. The total, the met and the unmet needs for surgery were determined, and economic losses caused by unmet surgical needs were estimated. Finally, we valued the economic losses avoided by various surgical provider groups.

Results

A total of 55 890 DALYs were averted by surgical activities in 2018; these activities prevented an economic loss of between US$35 and US$141 million. About half of these values were generated by the non-specialist physician workforce. Furthermore, a non-specialist physician working a full-time position for 1 year prevented an economic loss of US$717 069 using the VSL approach, while a specialist resident and a certified specialist saved US$726 606 and US$698 877, respectively. The burden of unmet surgical need was associated with productivity losses of between US$388 million and US$1.6 billion; these losses equate to 11% and 46% of the annual gross domestic product for Liberia.

Conclusion

The economic burden of untreated surgical disease is large in Liberia. There is a need to strengthen the surgical system to reduce ongoing economic losses; a framework where specialist and non-specialist physicians collaborate may result in better economic return than a narrower focus on training specialists alone.

Use of oxygen-ozone therapy to improve the effectiveness of antibiotic treatment on infected arthroplasty: protocol for a superiority, open-label, multicentre, randomised, parallel trial

Por: Cascini · F. · Franzini · M. · Andreoli · A. · Manzotti · A. · Cadeddu · C. · Quaranta · G. · Gentili · A. · Ricciardi · W.
Introduction

Surgical site infections still remain a major public health challenge and have become an increasing universal risk, especially for the implantation of orthopaedic devices.

Unfortunately, the discovery and increasingly widespread use (especially the misuse) of antibiotics have led to the rapid appearance of antibiotic-resistant strains today; more and more infections are caused by microorganisms that fail to respond to conventional treatments.

Oxygen-ozone therapy has been extensively used and studied for decades across various potential medical applications and has provided consistent effects with minimal side effects.

This study aims to determine the superiority of oxygen-ozone therapy in combination with oral antibiotic therapy in patients with wound infections after an orthopaedic device implantation when compared with antibiotic therapy alone.

Methods and analysis

This is an open-label, multicentre, randomised, parallel-group study that aims to assess the efficacy and safety of oxygen-ozone therapy in combination with oral antibiotic therapy to treat infections in patients (male or female aged ≥18 years) having undergone surgery for the implant of an orthopaedic device. Patients must have at least one (but no more than three) postoperative wounds in the site of surgery (ulcers, eschars and sores) and at least one symptom (pain, burning, redness and malodour) and at least one sign (erythema, local warmth, swelling and purulent secretion) of infection of at least moderate intensity (score ≥2) in the target lesion at the screening visit (patients with wounds without signs of localised infection or with undermining wounds will be excluded).

Patients (n=186) will be recruited from five Italian hospitals and studied for 7 weeks. All will be assigned to one of the two treatment groups according to a web-based, centralised randomisation procedure and placed into either the (1) intervention: oxygen-ozone therapy 2–3 times a week for 6 weeks (for a maximum of 15 sessions) simultaneously with an appropriate oral antibiotic therapy prescribed at baseline or (2) control: oral antibiotic therapy prescribed at baseline.

The primary outcome is the efficacy and superiority of the treatment (ozone and oral antibiotic therapies); secondary outcomes include the resolution of signs and symptoms, modifications in lesion size and the treatment’s safety and tolerability.

Ethics and dissemination

This study has been reviewed and approved by the responsible Independent Ethics Committee (IEC) of COMITATO ETICO CAMPANIA NORD, located at ‘Azienda Ospedaliera San Giuseppe Moscati di Avellino’.

After completion of the study, the project coordinator will prepare a draft manuscript containing the final results of the study on the basis of the statistical analysis. The manuscript will be derived by the co-authors for comments, and after revision, it will be sent to a major scientific journal. Findings will be disseminated via online and print media, events and peer-reviewed journals.

Trial registration number

NCT04787575.

Adverse outcomes of cannabis use in Canada, before and after legalisation of non-medical cannabis: cross-sectional analysis of the International Cannabis Policy Study

Por: Marquette · A. · Iraniparast · M. · Hammond · D.
Objectives

To date, there is little evidence on the extent to which cannabis legalisation affects the prevalence of adverse events from cannabis at the population level. The current study examined trends in the prevalence of adverse events among people who consumed cannabis before and after Canada’s legalisation of recreational cannabis.

Design

Data come from the first four survey waves of the International Cannabis Policy Study, which were conducted online annually immediately prior to non-medical cannabis legalisation in Canada in October 2018, and in the three following years (2019–2021).

Participants

The current analysis included 18 285 Canadian respondents aged 16–65 who reported cannabis use in the past 12 months.

Outcome measures

Primary outcomes included types of adverse events experienced from cannabis use, medical help-seeking and the types of products used. Weighted logistic regression models examined differences in help-seeking, emergency room usage and the experience of cannabinoid hyperemesis syndrome across survey years.

Results

Approximately one-third of people who consume cannabis reported experiencing at least one adverse event within the past 12 months, including 5% of consumers who sought medical help for an adverse event, most commonly for panic attacks, feeling faint/dizzy/passing out, heart/blood pressure problems and nausea/vomiting. The prevalence of seeking help and the types of adverse events were similar before (2018) and after legalisation (2019–2021); however, the proportion of consumers seeking help from emergency rooms increased postlegalisation (F=2.77, p=0.041). Adverse events were associated with various product types, with dried flower and oral oils accounting for the largest proportion of events. Help-seeking associated with cannabis edibles significantly decreased after legalisation (p=0.001).

Conclusions

Substantial proportions of people who consume cannabis report adverse events, suggesting widespread difficulty in ‘dosing’. Few changes were observed in the prevalence of adverse events reported by consumers since legalisation; however, the location of medical help-seeking and associated products used have changed postlegalisation.

Impact of COVID-19 pandemic on characteristics, extent and trends in child maltreatment in 34 Euro-CAN COST Action countries: a scoping review protocol

Por: Cankardas · S. · Tagiyeva-Milne · N. · Loiseau · M. · Naughton · A. · Grylli · C. · Sammut - Scerri · C. · Pivoriene · J. · Schöggl · J. · Pantazidou · A. · Quantin · C. · Mora-Theuer · E. A.
Introduction

While the factors commonly associated with an increased risk of child maltreatment (CM) were found to be increased during COVID-19, reports of actual maltreatment showed varying trends. Similarly, evidence regarding the impact of COVID-19 on CM within the European Cooperation on Science and Technology and Network Collaborative (COST) Action countries remains inconsistent. This scoping review aims to explore the extent and nature of evidence pertaining to CM within the countries affiliated with the Child Abuse and Neglect in Europe Action Network (Euro-CAN), funded by the COST.

Methods and analysis

Key electronic databases were searched to identify eligible papers, reports and other material published between January 2020 and April 2023: PubMed, EMBASE, PsycINFO, Social Policy and Practice, Scopus and Web of Science. To cover the breadth of evidence, a systematic and broad search strategy was applied using a combination of keywords and controlled vocabulary for four concepts: children, maltreatment, COVID-19 and Euro-CAN countries, without restrictions on study design or language. Grey literature was searched in OpenGrey and Google Scholar. Two reviewers will independently screen full-text publications for eligibility and undertake data extraction, using a customised grid. The screening criteria and data charting will be piloted by the research team.

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension for scoping reviews will be followed to present the results. Results will be summarised in a tabular form and narratively.

Ethics and dissemination

This review will identify and summarise publicly available data, without requiring ethical approval. The findings will be disseminated to the Euro-CAN Network and reported to the COST Association. They will also be published in a peer-reviewed journal. This protocol is registered on Open Science Framework.

Excess mortality during the COVID-19 pandemic in low-income and lower middle-income countries: protocol for a systematic review and meta-analysis

Por: Gmanyami · J. M. · Jarynowski · A. · Belik · V. · Lambert · O. · Amuasi · J. · Quentin · W.
Introduction

The COVID-19 pandemic has been marked by a massive death toll. However, the overall effect of the pandemic, including potential unintended negative impacts of some control measures, on mortality remains poorly understood in low-income and lower middle-income countries (LLMICs). This review aims to summarise the available literature on excess mortality in LLMICs, focusing on the methods and data sources used in estimating excess mortality and the drivers of excess mortality.

Methods and analysis

We will review the available literature and report results in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis. Searches will be conducted in PubMed, Embase, Web of Science, Cochrane Library, Google Scholar and Scopus. All published studies that report on the estimates of excess mortality in populations of LLMICs will be included. This will include those with a publication date from 2019 onwards and those with at least a 1-year non-COVID-19 period as the comparator in the estimation of excess mortality during the pandemic. There will be no language restrictions on the search. The meta-analysis will include studies with extractable data on excess mortality, methods, population size, and observed and expected deaths. We will use the Mantel-Haenszel method to estimate the pooled risk ratio with 95% CIs.

Ethics and dissemination

As there is no primary data collection, there is no requirement for ethical review. The results will be disseminated through peer-reviewed journal publication and conference presentations.

PROSPERO registration number

CRD42022378267.

Analysis of cardiovascular risk factors for the viability of cornea donors: a case-control study

Objective

The main objective of the study was to evaluate the influence of arterial hypertension, diabetes, dyslipidaemia, smoking, alcoholism and COPD (chronic obstructive pulmonary disease) on the viability of the extracted tissue as well as the donor.

Design

Observational case–control study.

Setting

Regional hospital in Northern Spain.

Participants

1517 corneas were registered.

Interventions

Patients’ medical history was reviewed after corneal donation and evaluation. Previous medical information (age, sex and cardiovascular risk factors (CVRFs)) and data related to the donor (type of donor), the corneal tissue and its evaluation, and the viability of the implant were collected.

Results

A total of 1517 corneas were registered and 81.5% of the donors presented at least one CVRF. In relation to the viability of the donor, it was observed that having suffered from COPD reduced the viability of the donor (no COPD: 93.8% vs COPD: 88%; OR=0.49; 95% CI: 0.28 to 0.84) while alcohol consumption increased it (drinker or ex-drinker: 95.8% vs non-drinker: 92.5%; OR=1.84; 95% CI: 1.01 to 3.33). Regarding tissue viability, decreased viability was observed in the presence of COPD (no COPD: 72.5% vs COPD: 64; OR=0.67; 95% CI: 0.47 to 0.96) and diabetes mellitus (no diabetes: 72.9% vs diabetes: 67.2%; OR=0.76; 95% CI: 0.58 to 0.99). As regards the viability of the implant, a total of 1039 corneas (68.9%) were suitable, observing decreased viability when suffering from COPD (no COPD: 69.8% vs COPD: 60.7%; OR=0.67; 95% CI: 0.47 to 0.94) and increased when having an active smoking habit (no habit: 65.3% vs habit: 74.1%; OR=1.52; 95% CI: 1.21 to 1.91).

Conclusions

Through this study, it can be concluded that in the absence of absolute exclusion criteria for donors, the assessment of how CVRF, alcoholism and COPD may affect the donor provides details about the quality of the tissue to be obtained.

From intentions to practices: what drove people to get the COVID-19 vaccine? Findings from the French longitudinal socioepidemiological cohort survey

Por: Spire · A. · Sireyjol · A. · Bajos · N. · for the EpiCoV study group · for the EpiCov study group · Bajos · Warszawski · Baghein · Counil · Jusot · Lydie · Martin · Meyer · Raynaud · Rouquette · Pailhe · Pousson · Rahib · Sillard · Spire
Objective

In many countries, before COVID-19 vaccines became available, reluctance to get vaccinated was particularly prevalent among women, the most disadvantaged social groups and ethnoracial minorities, known to be at higher risk for the virus. Using a longitudinal perspective, we analyse the social determinants that are associated with the transition from attitudes towards vaccination to actual vaccination practices.

Design

Representative population-based prospective cohort.

Settings

From November 2020 to July 2021.

Participants

Adults included in the Epidemiology and Living Conditions (EpiCoV) cohort (n=86 701).

Main outcome measures

Attitudes towards vaccination in November 2020 before COVID-19 vaccines were available in France (in January 2021) and vaccination practices in July 2021.

Results

Among those who were initially reluctant in November 2020, the youngest, the poorest 10% (OR=0.68, 0.59–0.77), non-European immigrants (OR=0.72, 0.59–0.88) and descendants of non-European immigrants (OR=0.72, 0.61–0.86) were less likely to be vaccinated in July 2021, irrespective of trust in government and scientists. The same social factors were associated with non-vaccination among those who initially were undecided or who favoured vaccination.

Conclusion

Despite the fact that COVID-19 vaccines were relatively available and free of charge in France in July 2021, social inequalities in vaccination against the virus remained the same than those observed in vaccination reluctance in November 2020, before vaccines were available. While adjusting for trust, migration background, younger age and lower income were associated with lower vaccination uptake irrespective of initial intention. By neglecting to genuinely target specific groups that were initially reluctant to be vaccinated, vaccination policies contributed to strengthening pre-existing social inequalities around COVID-19 burden.

Factors affecting the implementation of calcium supplementation strategies during pregnancy to prevent pre-eclampsia: a mixed-methods systematic review

Por: Cormick · G. · Moraa · H. · Zahroh · R. I. · Allotey · J. · Rocha · T. · Pena-Rosas · J. P. · Qureshi · Z. P. · Hofmeyr · G. J. · Mistry · H. · Smits · L. · Vogel · J. P. · Palacios · A. · Gwako · G. N. · Abalos · E. · Larbi · K. K. · Carroli · G. · Riley · R. · Snell · K. I. · Thorson · A.
Objectives

Daily calcium supplements are recommended for pregnant women from 20 weeks’ gestation to prevent pre-eclampsia in populations with low dietary calcium intake. We aimed to improve understanding of barriers and facilitators for calcium supplement intake during pregnancy to prevent pre-eclampsia.

Design

Mixed-method systematic review, with confidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative research approach.

Data sources

MEDLINE and EMBASE (via Ovid), CINAHL and Global Health (via EBSCO) and grey literature databases were searched up to 17 September 2022.

Eligibility criteria

We included primary qualitative, quantitative and mixed-methods studies reporting implementation or use of calcium supplements during pregnancy, excluding calcium fortification and non-primary studies. No restrictions were imposed on settings, language or publication date.

Data extraction and synthesis

Two independent reviewers extracted data and assessed risk of bias. We analysed the qualitative data using thematic synthesis, and quantitative findings were thematically mapped to qualitative findings. We then mapped the results to behavioural change frameworks to identify barriers and facilitators.

Results

Eighteen reports from nine studies were included in this review. Women reported barriers to consuming calcium supplements included limited knowledge about calcium supplements and pre-eclampsia, fears and experiences of side effects, varying preferences for tablets, dosing, working schedules, being away from home and taking other supplements. Receiving information regarding pre-eclampsia and safety of calcium supplement use from reliable sources, alternative dosing options, supplement reminders, early antenatal care, free supplements and support from families and communities were reported as facilitators. Healthcare providers felt that consistent messaging about benefits and risks of calcium, training, and ensuring adequate staffing and calcium supply is available would be able to help them in promoting calcium.

Conclusion

Relevant stakeholders should consider the identified barriers and facilitators when formulating interventions and policies on calcium supplement use. These review findings can inform implementation to ensure effective and equitable provision and scale-up of calcium interventions.

PROSPERO registration number

CRD42021239143.

Lived experience of recurrent miscarriage: women and their partners experience of subsequent pregnancy and support within an NHS specialist clinic - a qualitative study

Por: Hawkes · A. · Shields · R. C. · Quenby · S. · Bick · D. · Parsons · J. · Harris · B.
Objective

This study aims to describe the lived experiences of couples with a history of recurrent miscarriage in subsequent pregnancies and their perception of clinic support and cytogenetic investigations.

Design

A qualitative interview study with a phenomenological approach. Semistructured interviews were conducted using video conferencing software. Two researchers coded the transcripts and developed themes.

Setting

A National Health Service (NHS) hospital in central England between May 2021 and July 2021, during the COVID-19 pandemic.

Participants

Patients attending a specialist recurrent miscarriage clinic and their partners. This clinic accepts referrals from all over the UK for couples who have suffered two or more miscarriages.

Results

Seventeen participants were interviewed: 14 women and 3 male partners. Six main themes were identified from the data. Three related to the women’s lived experience of recurrent miscarriage (emotions in pregnancy, confidence in their bodies, expectations and coping strategies) and three related to the clinical support offered by the NHS service (impact of early pregnancy scanning, effect of the COVID-19 pandemic and cytogenetic investigations).

Conclusions

Pregnancy following recurrent miscarriage is extremely difficult. Recurrent miscarriage specialist services can provide couples with support and access to early pregnancy scanning, which can make the first trimester of pregnancy manageable. Partners should not be excluded from the clinic as it can result in a feeling of disconnect. Cytogenetic testing of pregnancy tissue can offer couples with recurrent miscarriage closure after pregnancy loss and is a desired investigation.

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