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Comparing nurses attending a specialised mental health programme with and without substance use disorder: a retrospective, observational study in Spain

Por: Braquehais · M. D. · Mozo · X. · Llavayol · E. · Gausachs · E. · Santiago · R. · Nieva · G. · Valero · S. · Grau-Lopez · L. · Ramos-Quiroga · J. A. · Bruguera · E.
Objectives

To analyse the differences between nurses with and without substance use disorders (SUDs) admitted to a specialised mental health programme.

Design

Retrospective, observational study.

Setting

Specialised mental health treatment programme for nurses in Catalonia, Spain.

Participants

1091 nurses admitted to the programme from 2000 to 2021.

Interventions

None.

Primary and secondary outcomes

Sociodemographic, occupational and clinical variables were analysed. Diagnoses followed Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision criteria.

Results

Most nurses admitted to the programme were women (88%, n=960) and came voluntarily (92.1%, n=1005). The mean age at admission was 45 (SD=10.4) years. The most common diagnoses were adjustment disorders (36.6%, n=399), unipolar mood disorders (25.8%, n=282), anxiety disorders (16.4%, n=179) and SUDs (13.8%, n=151). Only 19.2% (n=209) of the sample were hospitalised during their first treatment episode. After multivariate analysis, suffering from a SUD was significantly associated with being a man (OR=4.12; 95% CI 2.49 to 6.82), coming after a directed referral (OR=4.55; 95% CI 2.5 to 7.69), being on sick leave at admission (OR=2.21; 95% CI 1.42 to 3.45) and needing hospitalisation at the beginning of their treatment (OR=12.5; 95% CI 8.3 to 20).

Conclusions

Nurses with SUDs have greater resistance to voluntarily asking for help from specialised mental health treatment programmes and have greater clinical severity compared with those without addictions. SUDs are also more frequent among men. More actions are needed to help prevent and promote earlier help-seeking behaviours among nurses with this type of mental disorder.

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.

Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol

Por: Law · L. · Heerey · J. L. · Devlin · B. L. · Brukner · P. · Kemp · J. L. · Attanayake · A. · Hulett · M. D. · De Livera · A. · Mosler · A. B. · Morris · H. G. · White · N. P. · Culvenor · A. G.
Introduction

Chronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.

Methods and analysis

The eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.

Ethics and dissemination

The study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.

Trial registration number

ACTRN12622000440729.

Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV,

Por: Young · A. M. · Havens · J. R. · Cooper · H. L. F. · Fallin-Bennett · A. · Fanucchi · L. · Freeman · P. R. · Knudsen · H. · Livingston · M. D. · McCollister · K. E. · Stone · J. · Vickerman · P. · Freeman · E. · Jahangir · T. · Larimore · E. · White · C. R. · Cheatom · C. · Community S
Introduction

Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia.

Methods and analysis

KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness.

Ethics and dissemination

The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings.

Trial registration number

NCT05657106.

Non-pharmacological therapies for pain management in paediatric intensive care units: a protocol for a scoping review

Introduction

In critically ill children, pain management is complex owing to cognitive development and the nature of hospitalisation in paediatric intensive therapy units. Although there are many protocols and guidelines for pain control via pharmacological interventions, non-pharmacological practices should also be explored and disseminated for their potential benefit.

Methods and analysis

A systematic literature search will be performed using the following databases: Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Excerpta Medica Database, Virtual Health Library, Medical Literature Analysis and Retrieval System Online, ScienceDirect, Scopus, Web of Science Core Collection, Theses from Coordenacão de Aperfeicoamento de Pessoal de Nível Superior, Dart Europe, Open Access Theses and Dissertations and grey literature from Google Scholar. The research will consider quantitative and qualitative studies, mixed-method studies, systematic reviews, text articles, opinion articles, letters to editors and editorials in any language and from any database. The following will be eligible for inclusion: (1) newborns, infants, children and adolescents; and (2) non-pharmacological therapies used for pain in paediatric intensive care.

Ethics and dissemination

This study does not require ethical approval. The results of this research will be disseminated through social media channels and podcasts about pain in children.

Trial registration number

This protocol has been registered with the Open Science Framework (DOI 10.17605/OSF.IO/DZHKT).

Physician and nurse well-being, patient safety and recommendations for interventions: cross-sectional survey in hospitals in six European countries

Por: Aiken · L. H. · Sermeus · W. · McKee · M. · Lasater · K. B. · Sloane · D. · Pogue · C. A. · Kohnen · D. · Dello · S. · Maier · C. B. B. · Drennan · J. · McHugh · M. D. · For the Magnet4Europe Consortium · Sermeus · Bruyneel · Witte · Schaufeli · Dello · Kohnen · Aiken · McHugh · Smith
Objectives

To determine the well-being of physicians and nurses in hospital practice in Europe, and to identify interventions that hold promise for reducing adverse clinician outcomes and improving patient safety.

Design

Baseline cross-sectional survey of 2187 physicians and 6643 nurses practicing in 64 hospitals in six European countries participating in the EU-funded Magnet4Europe intervention to improve clinicians’ well-being.

Setting

Acute general hospitals with 150 or more beds in six European countries: Belgium, England, Germany, Ireland, Sweden and Norway.

Participants

Physicians and nurses with direct patient contact working in adult medical and surgical inpatient units, including intensive care and emergency departments.

Main outcome measures

Burnout, job dissatisfaction, physical and mental health, intent to leave job, quality of care and patient safety and interventions clinicians believe would improve their well-being.

Results

Poor work/life balance (57% physicians, 40% nurses), intent to leave (29% physicians, 33% nurses) and high burnout (25% physicians, 26% nurses) were prevalent. Rates varied by hospitals within countries and between countries. Better work environments and staffing were associated with lower percentages of clinicians reporting unfavourable health indicators, quality of care and patient safety. The effect of a 1 IQR improvement in work environments was associated with 7.2% fewer physicians and 5.3% fewer nurses reporting high burnout, and 14.2% fewer physicians and 8.6% fewer nurses giving their hospital an unfavourable rating of quality of care. Improving nurse staffing levels (79% nurses) and reducing bureaucracy and red tape (44% physicians) were interventions clinicians reported would be most effective in improving their own well-being, whereas individual mental health interventions were less frequently prioritised.

Conclusions

Burnout, mental health morbidities, job dissatisfaction and concerns about patient safety and care quality are prevalent among European hospital physicians and nurses. Interventions to improve hospital work environments and staffing are more important to clinicians than mental health interventions to improve personal resilience.

Protocol of a scoping review of outcome domains in dermatology

Por: Nadir · U. · Ahmed · A. · Yi · M. D. · Hisham · F. I. · Dave · L. · Kottner · J. · Ezzedine · K. · Garg · A. · Ingram · J. R. · Jemec · G. B. E. · Spuls · P. I. · Kirkham · J. J. · Cahn · B. · Alam · M.
Introduction

Core outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide, the number of COSs is increasing and there might be conceptual overlaps of domains (subdomains) and instruments within disciplines. The aim of this scoping review is to map and to classify all outcomes identified with COS projects relating to skin diseases.

Methods and analysis

We will conduct a scoping review of outcomes of skin disease-related COS initiatives to identify all concepts and their definitions. We will search PubMed, Embase and Cochrane library. The search dates will be 1 January 2010 (the point at which Core Outcome Measures in Effectiveness Trials (COMET) was established) to 1 January 2024. We will also review the COMET database and C3 website to identify parts of COSs (domains and/or instruments) that are being developed and published. This review will be supplemented by querying relevant stakeholders from COS organisations, dermatology organisations and patient organisations for additional COSs that were developed. The resulting long lists of outcomes will then be mapped into conceptually similar concepts.

Ethics and dissemination

This study was supported by departmental research funds from the Department of Dermatology at Northwestern University. An ethics committee review was waived since this protocol was done by staff researchers with no involvement of patient care. Conflicts of interests, if any, will be addressed by replacing participants with relevant conflicts or reassigning them. The results will be disseminated through publication in peer-reviewed journals, social media posts and promotion by COS organisations.

Predictive factors for the treatment success of peri-implantitis: a protocol for a prospective cohort study

Por: Zhu · Y. · Lu · H. · Yang · S. · Liu · Y. · Zhu · P. · Li · P. · Waal · Y. C. M. D. · Visser · A. · Tjakkes · G.-H. E. · Li · A. · Xu · S.
Introduction

Peri-implantitis, a common biological complication of dental implant, has attracted considerable attention due to its increasing prevalence and limited treatment efficacy. Previous studies have reported several risk factors associated with the onset of peri-implantitis (eg, history of periodontitis, poor plaque control and smoking). However, inadequate data are available on the association between these risk factors and successful outcome after peri-implantitis therapy. This prospective cohort study aims to identify the local and systemic predictive factors for the treatment success of peri-implantitis.

Methods and analysis

A single-centre cohort study will be conducted by recruiting 275 patients diagnosed with peri-implantitis. Sociodemographic variables, healthy lifestyles and systemic disorders will be obtained using questionnaires. In addition, clinical and radiographic examinations will be conducted at baseline and follow-up visits. Treatment success is defined as no bleeding on probing on more than one point, no suppuration, no further marginal bone loss (≥0.5 mm) and probing pocket depth ≤5 mm at the 12-month follow-up interval. After adjustment for age, sex and socioeconomic status, potential prognostic factors related to treatment success will be identified using multivariable logistic regression models.

Ethics and dissemination

This cohort study in its current version (2.0, 15 July 2022) is in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of Stomatological Hospital, Southern Medical University (EC-CT-(2022)34). The publication will be on behalf of the study site.

Trial registration number

ChiCTR2200066262.

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.

Meeting high-risk patient pain care needs through intensive primary care: a secondary analysis

Por: Giannitrapani · K. F. · Holliday · J. R. · McCaa · M. D. · Stockdale · S. · Bergman · A. A. · Katz · M. L. · Zulman · D. M. · Rubenstein · L. V. · Chang · E. T.
Objective

Chronic pain disproportionately affects medically and psychosocially complex patients, many of whom are at high risk of hospitalisation. Pain prevalence among high-risk patients, however, is unknown, and pain is seldom a focus for improving high-risk patient outcomes. Our objective is to (1) evaluate pain frequency in a high-risk patient population and (2) identify intensive management (IM) programme features that patients and providers perceive as important for promoting patient-centred pain care within primary care (PC)-based IM.

Design

Secondary observational analysis of quantitative and qualitative evaluation data from a multisite randomised PC-based IM programme for high-risk patients.

Setting

Five integrated local Veterans Affairs (VA) healthcare systems within distinct VA administrative regions.

Participants

Staff and high-risk PC patients in the VA.

Intervention

A multisite randomised PC-based IM programme for high-risk patients.

Outcome measures

(a) Pain prevalence based on VA electronic administrative data and (b) transcripts of interviews with IM staff and patients that mentioned pain.

Results

Most (70%, 2593/3723) high-risk patients had at least moderate pain. Over one-third (38%, 40/104) of the interviewees mentioned pain or pain care. There were 89 pain-related comments addressing IM impacts on pain care within the 40 interview transcripts. Patient-identified themes were that IM improved communication and responsiveness to pain. PC provider-identified themes were that IM improved workload and access to expertise. IM team member-identified themes were that IM improved pain care coordination, facilitated non-opioid pain management options and mitigated provider compassion fatigue. No negative IM impacts on pain care were mentioned.

Conclusions

Pain is common among high-risk patients. Future IM evaluations should consider including a focus on pain and pain care, with attention to impacts on patients, PC providers and IM teams.

Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial

Por: Mandetta · A. R. H. · Bortoletto · C. C. · Sobral · A. P. T. · Goncalves · M. L. L. · Motta · L. J. · Horliana · A. C. R. T. · Ferrari · R. A. M. · Prates · R. A. · Deana · A. M. · Cordeiro · R. d. C. L. · Pinto · L. A. M. d. S. · Fernandes · K. P. S. · Bussadori · S. K.
Introduction

Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.

Methods and analysis

Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the 2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

Ethics and dissemination

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.

Trial registration number

NCT05443035.

Latin American Cerebral Palsy Register (LATAM-CPR): study protocol to develop a collaborative register with surveillance of children with cerebral palsy in Latin American countries

Por: Ruiz Brunner · M. d. l. M. · Jahan · I. · Cuestas · E. · Cieri · M. E. · Escobar Zuluaga · J. · Condinanzi · A. L. · Sanchez · F. · McIntyre · S. · Smithers-Sheedy · H. · Muhit · M. · Badawi · N. · Diaz · R. · Diaz · A. · Carranza · J. · Duran · C. · Quintero Valencia · C. A. · Melarag
Introduction

Cerebral palsy (CP) is one of the leading causes of childhood disability globally with a high burden in low-income and middle-income countries (LMICs). Preliminary findings from the global LMIC CP Register (GLM CPR) suggest that the majority of CP in LMICs are due to potentially preventable causes. Such data are lacking in the Latin American region. Generating comparable epidemiological data on CP from this region could enable translational research and services towards early diagnosis and early intervention. We aim to establish a Latin American multicountry network and online data repository of CP called Latin American Cerebral Palsy Register (LATAM-CPR).

Methods and analysis

The LATAM-CPR will be modelled after the GLM CPR and will support new and emerging Latin American CP registers following a harmonised protocol adapted from the GLM CPR and piloted in Argentina (ie, Argentine Register of Cerebral Palsy). Both population-based and institution-based surveillance mechanisms will be adopted for registration of children with CP aged less than 18 years to the participating CP registers. The data collection form of the LATAM-CPR will include risk factors, clinical profile, rehabilitation, socioeconomical status of children with CP. Descriptive data on the epidemiology of CP from each participating country will be reported, country-specific and regional data will be compared.

Ethics and dissemination

Individual CP registers have applied ethics approval from respective national human research ethics committees (HREC) and/or institutional review boards prior to the establishment and inclusion into the LATAM-CPR. Ethical approval for LATAM-CPR has already been obtained from the HREC in the two countries that started (Argentina and Mexico). Findings will be disseminated and will be made publicly available through peer-reviewed publications, conference presentations and social media communications.

Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study

Por: Bolou · A. · Drymoussi · Z. · Lanz · D. · Amaefule · C. E. · Gonzalez Carreras · F. J. · Pardo Llorente · M. d. C. · Dodds · J. · Pizzo · E. · Thomas · A. · Heighway · J. · Harden · A. · Sanghi · A. · Hitman · G. · Zamora · J. · Perez · T. · Huda · M. S. B. · Thangaratinam · S.
Objective

To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.

Design

A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.

Setting

Three inner-city UK National Health Service hospitals in London.

Participants

Pregnant women with gestational diabetes treated with medication.

Interventions

2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.

Primary outcome measures

Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.

Secondary outcome measures

Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.

Results

Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.

Conclusions

It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.

Trial registration number

ISRCTN20930880.

Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia

Por: Weber · A. M. · Barbazza · S. · Fauzi · M. D. · Rachmadewi · A. · Zuhrina · R. · Putri · F. K. · Campos Ponce · M. · Hoeven · M. v. d. · Rimbawan · R. · Nasution · Z. · Giriwono · P. E. · Wieringa · F. T. · Soekarjo · D. D. · Ryan · E. P.
Introduction

Current formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota metabolism and mucosal barrier functions. Heat-stabilised rice bran contains essential nutrients, prebiotics, vitamins and unique phytochemicals that have demonstrated favourable bioactivity to modulate gut microbiota composition and mucosal immunity. This study seeks to examine the impact of RUTF with rice bran on the microbiota during SAM treatment, recovery and post-treatment growth outcomes in Jember, Indonesia. Findings are expected to provide insights into rice bran as a novel food ingredient to improve SAM treatment outcomes.

Methods and analysis

A total of 200 children aged 6–59 months with uncomplicated SAM (weight-for-height z-scores (WHZ)

Ethics and dissemination

The findings of this trial will be submitted to peer-reviewed journals and will be presented at relevant conferences. Ethics approval obtained from the Medical and Health Research Ethical Committee at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Madain Yogyakarta Ref. No.: KE/FK/0546/EC/2022 and KE/FK/0703/EC/2023 and from Colorado State University IRB#1823, OHRP FWA00000647.

Trial registration number

NCT05319717.

Stratification of risk for emergent intracranial abnormalities in children with headaches: a Pediatric Emergency Care Applied Research Network (PECARN) study protocol

Por: Tsze · D. S. · Kuppermann · N. · Casper · T. C. · Barney · B. J. · Richer · L. P. · Liberman · D. B. · Okada · P. J. · Morris · C. R. · Myers · S. R. · Soung · J. K. · Mistry · R. D. · Babcock · L. · Spencer · S. P. · Johnson · M. D. · Klein · E. J. · Quayle · K. S. · Steele · D. W. · Cr
Introduction

Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.

Methods and analysis

Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score

Ethics and dissemination

Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.

What is the aetiology of dysnatraemia in COVID-19 and how is this related to outcomes in patients admitted during earlier and later COVID-19 waves? A multicentre, retrospective observational study in 11 Dutch hospitals

Por: de Haan · L. · ten Wolde · M. · Beudel · M. · Olde Engberink · R. H. G. · Appelman · B. · Haspels-Hogervorst · E. K. · Rusch · D. · Gritters van den Oever · N. C. · Simsek · S. · Paternotte · N. · van den Bergh · J. P. · Wyers · C. E. · de Kruif · M. D. · Dormans · T. · Moeniralam
Objectives

To evaluate the relationship among dysnatraemia at hospital presentation and duration of admission, risk of intensive care unit (ICU) admission and all-cause mortality and to assess the underlying pathophysiological mechanism of hyponatraemia in patients with COVID-19. Our hypothesis is that both hyponatraemia and hypernatraemia at presentation are associated with adverse outcomes.

Design

Observational study.

Setting

Secondary care; 11 Dutch hospitals (2 university and 9 general hospitals).

Participants

An analysis was performed within the retrospective multicentre cohort study COVIDPredict. 7811 patients were included (60% men, 40% women) between 24 February 2020 and 9 August 2022. Patients who were ≥18 years with PCR-confirmed COVID-19 or CT with COVID-19 reporting and data system score≥4 and alternative diagnosis were included. Patients were excluded when serum sodium levels at presentation were not registered in the database or when they had been transferred from another participating hospital.

Outcome measures

We studied demographics, medical history, symptoms and outcomes. Patients were stratified according to serum sodium concentration and urinary sodium excretion.

Results

Hyponatraemia was present in 2677 (34.2%) patients and hypernatraemia in 126 (1.6%) patients. Patients with hyponatraemia presented more frequently with diarrhoea, lower blood pressure and tachycardia. Hyponatraemia was, despite a higher risk for ICU admission (OR 1.27 (1.11–1.46; p

Conclusions

Hypernatraemia at presentation was associated with adverse outcomes in patients with COVID-19. Hypovolaemic hyponatraemia was found to be the most common aetiology of hyponatraemia. Hyponatraemia of unknown aetiology was associated with a higher risk for ICU admission and intubation and longer duration of admission.

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