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Study protocol to investigate the efficacy of confocal laser endomicroscopy-based selective single-elimination diet over standard fivefold elimination diet in patients with endomicroscopically proven food intolerance: app-assisted, monocentric, double-bli

Por: Hessler · N. · Kordowski · A. · Sasse · J. · Ahlemann · G. · Schulz · F. · Schröder · T. · Exner · A. · Jablonski · L. · Jappe · U. · Bischoff · S. C. · Grzegorzek · M. · König · I. R. · Sina · C.
Introduction

Imprecise nutritional recommendations due to a lack of diagnostic test accuracy are a frequent problem for individuals with adverse reactions to foods but no precise diagnosis. Consequently, patients follow very broad and strict elimination diets to avoid uncontrolled symptoms such as diarrhoea and abdominal pain. Dietary limitations and the uncertainty of developing gastrointestinal symptoms after the inadvertent ingestion of food have been demonstrated to reduce the quality of life (QoL) of affected individuals and subsequently might increase the risk of malnutrition and intestinal dysbiosis. This trial aims to investigate the effects of a tailored diet based on the confocal laser endoscopy (CLE) examination result to limit the side effects of unspecific and broad elimination diets and to increase the patient’s QoL.

Methods and analysis

The study is designed as a prospective, double-blind, monocentric, randomised and controlled trial conducted at the University Hospital of Schleswig-Holstein, Campus Lübeck, Germany. One hundred seventy-two patients with non-IgE-related food allergies and positive CLE results will be randomised to either a tailored diet or a standard fivefold elimination diet. The primary endpoints are the difference between the end and the start of the intervention in health-related QoL and the sum score of the severity of symptoms after 12 weeks. Key secondary endpoints are changes in the severity of symptoms, further QoL measurements, self-assessed state of health and number of days with a pathologically altered stool. Microbiome diversity and metabolome of stool, urine and blood will also be investigated. Safety endpoints are body composition, body mass index and adverse events.

Ethics and dissemination

The study protocol was accepted by the ethical committee of the University of Lübeck (AZ: 22-111) on 4 May2022. Results of the study will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number

German Clinical Trials Register (DRKS00029323).

Cohort profile: the U-BIRTH study on peripartum depression and child development in Sweden

Por: Tu · H.-F. · Fransson · E. · Kunovac Kallak · T. · Elofsson · U. · Ramklint · M. · Skalkidou · A.
Purpose

The current U-BIRTH cohort (Uppsala Birth Cohort) extends our previous cohort Biology, Affect, Stress, Imaging and Cognition (BASIC), assessing the development of children up to 11 years after birth. The U-BIRTH study aims to (1) assess the impact of exposure to peripartum mental illness on the children’s development taking into account biological and environmental factors during intrauterine life and childhood; (2) identify early predictors of child neurodevelopmental and psychological problems using biophysiological, psychosocial and environmental variables available during pregnancy and early post partum.

Participants

All mothers participating in the previous BASIC cohort are invited, and mother–child dyads recruited in the U-BIRTH study are consecutively invited to questionnaire assessments and biological sampling when the child is 18 months, 6 years and 11 years old. Data collection at 18 months (n=2882) has been completed. Consent for participation has been obtained from 1946 families of children having reached age 6 and from 698 families of children having reached age 11 years.

Findings to date

Based on the complete data from pregnancy to 18 months post partum, peripartum mental health was significantly associated with the development of attentional control and gaze-following behaviours, which are critical to cognitive and social learning later in life. Moreover, infants of depressed mothers had an elevated risk of difficult temperament and behavioural problems compared with infants of non-depressed mothers. Analyses of biological samples showed that peripartum depression and anxiety were related to DNA methylation differences in infants. However, there were no methylation differences in relation to infants’ behavioural problems at 18 months of age.

Future plans

Given that the data collection at 18 months is complete, analyses are now being undertaken. Currently, assessments for children reaching 6 and 11 years are ongoing.

Gender disparities, causes and predictors of immediate and short-term cardiovascular readmissions following COVID-19-related hospitalisations in the USA

Por: Vardar · U. · Shaka · H. · Kumi · D. · Gajjar · R. · Bess · O. · Kanemo · P. · Shaka · A. · Baskaran · N.
Objectives

In this study, we aimed to identify the causes, predictors and gender disparities of 30-day and 90-day cardiovascular readmissions after COVID-19-related hospitalisations using National Readmission Database (NRD) 2020.

Setting

We used the NRD from 2020 to identify hospitalised adults with a principal diagnosis of COVID-19 infection.

Participants

We included subjects who were readmitted within 30 days and 90 days after index admission. We excluded subjects with elective and traumatic admissions. We used a multivariate Cox regression model to identify independent predictors of readmission.

Primary and secondary outcomes measures

Our outcomes were inpatient mortality, 30-day and 90-day cardiovascular readmission rates following COVID-19 infection.

Results

During the study period, there were 1 024 492 index hospitalisations with a primary diagnosis of COVID-19 infection in the 2020 NRD database, 644 903 (62.9%) were included for 30-day readmission analysis, and 418 122 (40.8%) were included for 90-day readmission analysis. Of patients involved in the 30-day analysis, 7140 (1.1%) patients had a readmission within 30 days; of patients involved in the 90-day analysis, 8379 (2.0%) had a readmission within 90 days due to primarily cardiovascular causes. Cox regression analysis revealed that the female sex (aHR 0.89; 95% CI 0.82 to 0.95; p=0.001) was associated with a lower hazard of 30-day cardiovascular readmissions; however, congestive heart failure (aHR 2.45; 95% CI 2.2 to 2.72; p

Conclusion

Our study demonstrates that male gender, heart failure, arrhythmias and valvular disease carry higher hazards of 30-day and 90-day cardiovascular readmissions. Identifying risk factors and common causes of readmission may assist with lowering the burden of cardiovascular disease in patients with COVID-19 infection.

Unveiling the effects of living standards on diabetes and hypertension with the mediating role of overweight and obesity: a cross-sectional study in Bangladesh

Por: Sen · K. K. · Jamee · A. R. · Islam · U. N. · Bari · W.
Objective

The purpose of the study was to ascertain how the standard of living is associated with the likelihood of developing diabetes and hypertension directly as well as indirectly through overweight and obesity.

Study design

The study used 2017–2018 Bangladesh Demographic and Health Survey data. It examined the household living standard (LSD) as the main factor, and body mass index (BMI) as a mediator. Outcomes included diabetes status, hypertension status and their co-occurrence. Structural equation modelling with logistic regression and bootstrapping were used for mediation analysis and computing bias-corrected SEs.

Setting

The research was carried out in Bangladesh and included both male and female adults.

Participants

The study encompassed a total of 11 961 adults (5124 males and 6837 females) aged 18 years or older.

Results

Among the participants, 10.3% had diabetes, 28.6% had hypertension and 4.9% had both conditions. The prevalence of diabetes, hypertension or both conditions was 18.5%, 33.5% and 9.7%, respectively, among those with a high LSD. Regression analysis demonstrated that individuals with high LSD had significantly elevated risks of these conditions compared with those with low LSD: 133% higher odds for diabetes (OR 2.22; 95% CI 1.97 to 2.76), 25% higher odds for hypertension (OR 1.25; 95% CI 1.10 to 1.42) and 148% higher odds for both conditions (OR 2.48; 95% CI 1.96 to 3.14). Moreover, the indirect effects of high LSD through obesity surpassed its direct effects for developing diabetes, hypertension or both conditions.

Conclusion

This study emphasises that with the enhancement of LSD, individuals often experience weight gain, resulting in elevated BMI levels. This cascade effect significantly amplifies the risks of diabetes, hypertension or both conditions. To counteract this concerning trajectory, policy interventions and targeted awareness campaigns are imperative. These efforts must prioritise the promotion of heightened physical activity and the mitigation of the overweight/obesity surge associated with rising LSD.

Salmonella Vaccine Study in Oxford (SALVO) trial: protocol for an observer-participant blind randomised placebo-controlled trial of the iNTS-GMMA vaccine within a European cohort

Por: Hanumunthadu · B. · Kanji · N. · Owino · N. · Ferreira Da Silva · C. · Robinson · H. · White · R. · Ferruzzi · P. · Nakakana · U. · Canals · R. · Pollard · A. J. · Ramasamy · M. · Vacc-iNTS Consortium · Agyapong · Breghi · Crump · Fiorino · Gordon · Jacobs · Kariuki · Malvolti · Mante
Introduction

Invasive non-typhoidal Salmonellosis (iNTS) is mainly caused by Salmonella enterica serovars Typhimurium and Enteritidis and is estimated to result in 77 500 deaths per year, disproportionately affecting children under 5 years of age in sub-Saharan Africa. Invasive non-typhoidal Salmonellae serovars are increasingly acquiring resistance to first-line antibiotics, thus an effective vaccine would be a valuable tool in reducing morbidity and mortality from infection. While NTS livestock vaccines are in wide use, no licensed vaccines exist for use in humans. Here, a first-in-human study of a novel vaccine (iNTS-GMMA) containing S. Typhimurium and S. Enteritidis Generalised Modules for Membrane Antigens (GMMA) outer membrane vesicles is presented.

Method and analysis

The Salmonella Vaccine Study in Oxford is a randomised placebo-controlled participant-observer blind phase I study of the iNTS-GMMA vaccine. Healthy adult volunteers will be randomised to receive three intramuscular injections of the iNTS-GMMA vaccine, containing equal quantities of S. Typhimurium and S. Enteritidis GMMA particles adsorbed on Alhydrogel, or an Alhydrogel placebo at 0, 2 and 6 months. Participants will be sequentially enrolled into three groups: group 1, 1:1 randomisation to low dose iNTS-GMMA vaccine or placebo; group 2, 1:1 randomisation to full dose iNTS-GMMA vaccine or placebo; group 3, 2:1 randomisation to full dose or lower dose (dependant on DSMC reviews of groups 1 and 2) iNTS-GMMA vaccine or placebo.

The primary objective is safety and tolerability of the vaccine. The secondary objective is immunogenicity as measured by O-antigen based ELISA. Further exploratory objectives will characterise the expanded human immune profile.

Ethics and dissemination

Ethical approval for this study has been obtained from the South Central—Oxford A Research Ethics Committee (Ethics REF:22/SC/0059). Appropriate documentation and regulatory approvals have been acquired. Results will be disseminated via peer-reviewed articles and conferences.

Trial registration number

EudraCT Number: 2020-000510-14.

What are the perceptions and concerns of people living with diabetes and National Health Service staff around the potential implementation of AI-assisted screening for diabetic eye disease? Development and validation of a survey for use in a secondary car

Por: Willis · K. · Chaudhry · U. A. R. · Chandrasekaran · L. · Wahlich · C. · Olvera-Barrios · A. · Chambers · R. · Bolter · L. · Anderson · J. · Barman · S. A. · Fajtl · J. · Welikala · R. · Egan · C. · Tufail · A. · Owen · C. G. · Rudnicka · A. · On behalf of the ARIAS Research Group · S
Introduction

The English National Health Service (NHS) Diabetic Eye Screening Programme (DESP) performs around 2.3 million eye screening appointments annually, generating approximately 13 million retinal images that are graded by humans for the presence or severity of diabetic retinopathy. Previous research has shown that automated retinal image analysis systems, including artificial intelligence (AI), can identify images with no disease from those with diabetic retinopathy as safely and effectively as human graders, and could significantly reduce the workload for human graders. Some algorithms can also determine the level of severity of the retinopathy with similar performance to humans. There is a need to examine perceptions and concerns surrounding AI-assisted eye-screening among people living with diabetes and NHS staff, if AI was to be introduced into the DESP, to identify factors that may influence acceptance of this technology.

Methods and analysis

People living with diabetes and staff from the North East London (NEL) NHS DESP were invited to participate in two respective focus groups to codesign two online surveys exploring their perceptions and concerns around the potential introduction of AI-assisted screening.

Focus group participants were representative of the local population in terms of ages and ethnicity. Participants’ feedback was taken into consideration to update surveys which were circulated for further feedback. Surveys will be piloted at the NEL DESP and followed by semistructured interviews to assess accessibility, usability and to validate the surveys.

Validated surveys will be distributed by other NHS DESP sites, and also via patient groups on social media, relevant charities and the British Association of Retinal Screeners. Post-survey evaluative interviews will be undertaken among those who consent to participate in further research.

Ethics and dissemination

Ethical approval has been obtained by the NHS Research Ethics Committee (IRAS ID: 316631). Survey results will be shared and discussed with focus groups to facilitate preparation of findings for publication and to inform codesign of outreach activities to address concerns and perceptions identified.

Effectiveness and cost-effectiveness of Assets-based feeding help Before and After birth (ABA-feed) for improving breastfeeding initiation and continuation: protocol for a multicentre randomised controlled trial (Version 3.0)

Por: Clarke · J. · Dombrowski · S. U. · Gkini · E. · Hoddinott · P. · Ingram · J. · MacArthur · C. · Moss · N. · Ocansey · L. · Roberts · T. · Thomson · G. · Sanders · J. · Sitch · A. J. · Stubbs · C. · Taylor · B. · Tearne · S. · Woolley · R. · Jolly · K.
Introduction

Breastfeeding has health benefits for infants and mothers, yet the UK has low rates with marked social inequalities. The Assets-based feeding help Before and After birth (ABA) feasibility study demonstrated the acceptability of a proactive, assets-based, woman-centred peer support intervention, inclusive of all feeding types, to mothers, peer supporters and maternity services. The ABA-feed study aims to assess the clinical and cost-effectiveness of the ABA-feed intervention compared with usual care in first-time mothers in a full trial.

Methods and analysis

A multicentre randomised controlled trial with economic evaluation to explore clinical and cost-effectiveness, and embedded process evaluation to explore differences in implementation between sites. We aim to recruit 2730 primiparous women, regardless of feeding intention. Women will be recruited at 17 sites from antenatal clinics and various remote methods including social media and invitations from midwives and health visitors. Women will be randomised at a ratio of 1.43:1 to receive either ABA-feed intervention or usual care. A train the trainer model will be used to train local Infant Feeding Coordinators to train existing peer supporters to become ‘infant feeding helpers’ in the ABA-feed intervention. Infant feeding outcomes will be collected at 3 days, and 8, 16 and 24 weeks postbirth. The primary outcome will be any breastfeeding at 8 weeks postbirth. Secondary outcomes will include breastfeeding initiation, any and exclusive breastfeeding, formula feeding practices, anxiety, social support and healthcare utilisation. All analyses will be based on the intention-to-treat principle.

Ethics and dissemination

The study protocol has been approved by the East of Scotland Research Ethics Committee. Trial results will be available through open-access publication in a peer-reviewed journal and presented at relevant meetings and conferences.

Trial registration number

ISRCTN17395671.

Patterns, prevalence and risk factors of intimate partner violence and its association with mental health status during COVID-19: a cross-sectional study on early married female adolescents in Khulna district, Bangladesh

Por: Nishat · J. F. · Khan · U. S. · Shovo · T.-E.-A. · Ahammed · B. · Rahman · M. M. · Hossain · M. T.
Objectives

This study was designed to identify the patterns, prevalence and risk factors of intimate partner violence (IPV) against female adolescents and its association with mental health problems.

Design

Cross-sectional survey.

Settings

Dumuria Upazila (subdistrict) under the Khulna district of Bangladesh.

Participants

A total of 304 participants were selected purposively based on some specifications: they must be female adolescents, residents of Dumuria Upazila and married during the COVID-19 pandemic when under 18 years of age.

Outcome measures

By administering a semi-structured interview schedule, data were collected regarding IPV using 12 five-point Likert scale items; a higher score from the summation reflects frequent violence.

Results

The findings suggest that the prevalence of physical, sexual and emotional IPV among the 304 participants, who had an average age of 17.1 years (SD=1.42), was 89.5%, 87.8% and 93.7%, respectively, whereas 12.2% of the participants experienced severe physical IPV, 9.9% experienced severe sexual IPV and 10.5% experienced severe emotional IPV. Stepwise regression models identified age at marriage (p=0.001), number of miscarriages (p=0.005), education of spouse (p=0.001), income of spouse (p=0.016), age gap between spouses (p=0.008), marital adjustment (p

Conclusion

During the COVID-19 pandemic, an increase in IPV and mental health problems among early married adolescents was documented. To reduce physical and mental harm and to assure their well-being, preventive and rehabilitative measures should be devised.

Are pharmacists on the front lines of the opioid epidemic? A cross-sectional study of the practices and competencies of community and hospital pharmacists in Punjab, Pakistan

Por: Mubarak · N. · Zahid · T. · Rana · F. R. · Ijaz · U.-E.-B. · Shabbir · A. · Manzoor · M. · Khan · N. · Arif · M. · Naeem · M. M. · Kanwal · S. · Saif-ur-Rehman · N. · Zin · C. S. · Mahmood · K. · Asgher · J. · Elnaem · M. H.
Introduction

Countries are grappling with a rapidly worsening upsurge in the opioid-related overdose deaths, misuse and abuse. There is a dearth of data in Pakistan regarding the practices and competencies of pharmacists in handling opioid-related issues.

Study design

A cross-sectional study, conducted across Punjab, Pakistan.

Method

The study deployed a validated survey to evaluate the competencies and practices of the community and hospital pharmacists.

Results

504 community pharmacists and 279 hospital pharmacists participated in the survey with an overall response rate of 85.5%. Almost half of the respondents ‘never’ or ‘sometimes’ made clinical notes in a journal or dispensing software to monitor ongoing opioid use. Generally, pharmacists were reluctant to collaborate with physicians or notify police regarding the abuse/misuse of opioids. Hospital pharmacists achieved significantly higher mean competency scores than chain and independent community pharmacists (p

Conclusion

Both community and hospital pharmacists hold significant positions and potential to contribute meaningfully to the mitigation of harms and risks associated with opioids. Nevertheless, this study underscores notable deficiencies in the competence of pharmacists, whether in hospital or community settings in Punjab, concerning various aspects related to the dispensing and utilisation of opioids. It also highlights the pressing need for the development of strategies aimed at improving several practice areas including the documentation, the quality of patient counselling, the effectiveness of reporting mechanisms for opioid abuse and the stringent enforcement of regulatory policies to curtail opioid misuse. Thus, to mitigate the opioid epidemic in Pakistan, it is imperative to institute opioid stewardship initiatives aimed at rectifying the competency and procedural deficiencies within the pharmacist workforce.

Clinical staging across eating disorders: a scoping review protocol

Por: Hyam · L. E. · Phillips · M. · Gracie · L. · Allen · K. · Schmidt · U.
Introduction

Clinical staging models in psychiatry assert that there are earlier, less severe or more malleable forms of illness that are distinguishable from later, more chronic forms of illness, and that these stages may have different prognostic and treatment implications. Previous reviews on clinical staging in eating disorders (EDs) suggest a staging heuristic could be useful for anorexia nervosa, but less research is available on how this applies to other EDs. An up-to-date review is required to synthesise new and heterogenous avenues of research. This scoping review aims to explore the extent and types of evidence in relation to illness staging for EDs and how these concepts are associated with treatment response and outcomes.

Methods and analysis

This protocol was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol extension for Scoping Reviews checklist and the Joanna Briggs Institute Reviewer’s Manual. We will consider any documents providing evidence for clinical staging such as those which describe full or partial staging models, for all EDs, across various domains of assessment and functioning. Participants will include clinical or non-clinical population samples with full-syndrome EDs or disordered eating behaviour. PubMed, PsycINFO, MEDLINE and Web of Science databases will be systematically searched for relevant literature. Two authors will export documents and screen titles, abstracts and full texts. Data will be extracted into a charting form drafted by the authors. A narrative summary of the documents will be conducted in line with the study aims. Finally, clinical and research recommendations will be outlined.

Ethics and dissemination

Ethical approval will not be required to synthesise published and unpublished literature. The study will be published in a peer-reviewed journal and shared at conferences, via social media, and in other communications.

Implementation and the effects of a Parkinson Network Therapy (PaNTher) on activities of daily living and health-related quality of life in Parkinsons disease patients: study protocol of an mixed-method observational cohort study in outpatient care

Por: Loidl · V. · Ziegler · K. · Hoppmann · D. · Wagner · C. · Fietzek · U. M. · Ceballos-Baumann · A. O. · Grill · E.
Introduction

Parkinson’s disease (PD) represents the fastest growing neurodegenerative disease with an increasing prevalence worldwide. It is characterised by complex motor and non-motor symptoms that lead to considerable disability. Specialised physiotherapy has been shown to benefit patients with PD. The Parkinson Netzwerk Therapie (PaNTher) was created to improve access to specialised physiotherapy tailored to care priorities of PD patients. This study aims to evaluate the effectiveness, acceptability and needs of the PaNTher network by neurologists and physiotherapists involved in the network in outpatient care.

Methods and analysis

This is a mixed-method, prospective, pragmatic non-randomised cohort study of parallel groups, with data collection taking place in Bavaria, Germany, between 2020 and 2024. Patients with PD insured by the Allgemeine Ortskrankenkasse Bayern (AOK Bayern) living in Bavaria will be recruited for study participation by network partners. Patients in the intervention group must reside in Munich or the surrounding area to ensure provision of specialised physiotherapy in close proximity to their place of residence. Controls receive care as usual. Six and 12 months after baseline, all patients receive a follow-up questionnaire. Mixed-effect regression models will be used to examine changes in impairment of activities of daily living and quality of life of patients with PD enrolled in the programme over time compared with usual care. Qualitative interviews will investigate the implementation processes and acceptability of the PaNTher network among neurologists and physiotherapists. The study is expected to show that the PaNTher network with an integrative care approach will improve the quality and effectiveness of the management and treatment of patients with PD.

Ethics and dissemination

The study has been approved by the ethics committee at the medical faculty of the Ludwig-Maximilians-University Munich (20-318). Results will be published in scientific, peer-reviewed journals and presented at national and international conferences.

Hidden sodium in effervescent-tablet dietary supplements and over-the-counter drugs: a comparative cross-sectional study

Por: Kunz · M. · Götzinger · F. · Jacobs · C. M. · Lauder · L. · Ukena · C. · Meyer · M. R. · Laufs · U. · Schulz · M. · Böhm · M. · Mahfoud · F.
Objective

Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA.

Design

Comparative cross-sectional study.

Setting and methods

The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health’s Dietary Supplement Label Database).

Results

The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p

Conclusion

Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.

Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocol

Por: De Oliveira Ascef · B. · Gabriel · F. C. · Suzumura · E. A. · Maia · F. H. d. A. · Bortoluzzi · A. F. R. · Farias · N. S. · Jahn · B. · Siebert · U. · De Soarez · P. C.
Background

Benefit–risk assessment (BRA) is used in multiple phases along the health technology’s life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA’s application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.

Methods and analysis

This scoping review protocol was developed following the framework proposed by Arksey and O’Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.

Ethics and dissemination

This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.

Trial registration number

Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).

Cohort profile: the Pregnancy Risk Infant Surveillance and Measurement Alliance (PRISMA) - Pakistan

Por: Naz · S. · Jaffar · A. · Yazdani · N. · Kashif · M. · Hussain · Z. · Khan · U. · Farooq · F. · Nisar · M. I. · Jehan · F. · Smith · E. · Hoodbhoy · Z.
Purpose

Pakistan has disproportionately high maternal and neonatal morbidity and mortality. There is a lack of detailed, population-representative data to provide evidence for risk factors, morbidities and mortality among pregnant women and their newborns. The Pregnancy Risk, Infant Surveillance and Measurement Alliance (PRISMA) is a multicountry open cohort that aims to collect high-dimensional, standardised data across five South Asian and African countries for estimating risk and developing innovative strategies to optimise pregnancy outcomes for mothers and their newborns. This study presents the baseline maternal and neonatal characteristics of the Pakistan site occurring prior to the launch of a multisite, harmonised protocol.

Participants

PRISMA Pakistan study is being conducted at two periurban field sites in Karachi, Pakistan. These sites have primary healthcare clinics where pregnant women and their newborns are followed during the antenatal, intrapartum and postnatal periods up to 1 year after delivery. All encounters are captured electronically through a custom-built Android application. A total of 3731 pregnant women with a mean age of 26.6±5.8 years at the time of pregnancy with neonatal outcomes between January 2021 and August 2022 serve as a baseline for the PRISMA Pakistan study.

Findings to date

In this cohort, live births accounted for the majority of pregnancy outcomes (92%, n=3478), followed by miscarriages/abortions (5.5%, n=205) and stillbirths (2.6%, n=98). Twenty-two per cent of women (n=786) delivered at home. One out of every four neonates was low birth weight (

Future plans

The PRISMA cohort will provide data-driven insights to prioritise and design interventions to improve maternal and neonatal outcomes in low-resource regions.

Trial registration number

NCT05904145.

Consensus building on definitions and types of child maltreatment to improve recording and surveillance in Europe: protocol for a multi-sectoral, European, electronic Delphi study

Por: Nurmatov · U. · Cowley · L. E. · Rodrigues · L. B. · Naughton · A. · Debelle · G. · Alfandari · R. · Lamela · D. · Otterman · G. · Jud · A. · Ntinapogias · A. · Laajasalo · T. · Soldino · V. · Stancheva · V. · Caenazzo · L. · Vaughan · R. · Christian · C. W. · Drabarek · K. · Kemp · A. M.
Introduction

Child maltreatment (CM) is a complex global public health issue with potentially devastating effects on individuals’ physical and mental health and well-being throughout the life course. A lack of uniform definitions hinders attempts to identify, measure, respond to, and prevent CM. The aim of this electronic Delphi (e-Delphi) study is to build consensus on definitions and types of CM for use in surveillance and multi-sectoral research in the 34 countries in the Euro-CAN (Multi-Sectoral Responses to Child Abuse and Neglect in Europe) project (COST Action CA19106).

Methods and analysis

The e-Delphi study will consist of a maximum of three rounds conducted using an online data collection platform. A multi-disciplinary expert panel consisting of researchers, child protection professionals (health and social care), police, legal professionals and adult survivors of CM will be purposefully recruited. We will approach approximately 100 experts, with between 50 and 60 of these anticipated to take part. Participants will rate their agreement with a range of statements relating to operational definitions and types of CM, and free-text comments on each of the statements to give further detail about their responses and areas of uncertainty. Consensus has been defined a priori as ≥70% of the panel agreeing or disagreeing with the statement after the final round. The responses to the open-ended questions will be analysed using a ‘codebook’ approach to thematic analysis, and used to refine the statements between rounds where no consensus is reached.

Ethics and dissemination

Ethical approval has been granted from the Cardiff University School of Medicine ethics committee (reference number SMREC22/96). Results will be submitted for publication in a peer-reviewed journal and presented at workshops (including for the participants) and international academic conferences. The Euro-CAN network will also be used to disseminate the results, with results briefings and presentations to key public health and other relevant organisations in the field.

Suicidality Treatment Occurring in Paediatrics (STOP) Medication Suicidality Side Effects Scale in young people in two cohorts across Europe

Por: Santosh · P. · Sala · R. · Lievesley · K. · Singh · J. · Arango · C. · Buitelaar · J. K. · Castro-Fornieles · J. · Coghill · D. · Dittmann · R. W. · Flamarique · I. · Hoekstra · P. J. · Llorente · C. · Purper-Ouakil · D. · Schulze · U. · Zuddas · A. · Parnell · N. · Mohan · M. · Fiori · F
Objectives

As part of the ‘Suicidality: Treatment Occurring in Paediatrics (STOP)’ study, we developed and performed psychometric validation of an electronic-clinical-outcome-assessment (eCOA), which included a patient-reported-outcome (ePRO), an observer-rated-outcome (eObsRO) for parents/carers and a clinician-reported-outcome (eClinRO) that allows identification and monitoring of medication-related suicidality (MRS) in adolescents.

Design

STOP: Prospective study: A two phase validation study to assess the impact of medication on suicidal ideations.

Setting

Six participating countries: Netherlands, UK, Germany, France, Spain and Italy that were part of the Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 261411.

Participants

Cohort 1 consisted of 41 adolescent-completions, 50 parent-completions and 56 clinician-completions. Cohort 2 consisted of 244 adolescent-completions, 198 parent-completions and 240 clinician-completions from across the six countries. The scale was administered only to participants who have screened positive for the STOP-Suicidality Assessment Scale (STOP-SAS).

Results

A total of 24 items for the development of the STOP-Medication Suicidality Side Effects Scale (STOP-MS3) were identified and three versions (for patients, parents and clinicians) of the STOP-MS3 were developed and validated in two separate study cohorts comprising of adolescents, their parents and clinicians. Cronbach’s α coefficients were above 0.85 for all domains. The inter-rater reliability of the STOP-MS3 was good and significant for the adolescent (ePRO), clinician (eClinRO) (r=0.613), parent (eObsRO) versions of the scale (r=0.394) and parent and clinician (r=0.347). Exploratory factor analysis identified a 3-factor model across 24 items for the adolescent and parent version of the scale: (1) Emotional Dysregulation, (2) Somatic Dysregulation and (3) Behavioural Dysregulation. For the clinician version, a 4-factor model defined the scale structure: (1) Somatic Dysregulation, (2) Emotional Dysregulation, (3) Behavioural Dysregulation and (4) Mood Dysregulation.

Conclusion

These findings suggest that the STOP-MS3 scale, a web-based eCOA, allows identification and monitoring of MRS in the adolescent population and shows good reliability and validity.

Perceptions of academic staff and students of senior high school in implementing game-based exercises in physical education classes--a research protocol for a qualitative descriptive study

Por: Manlapaz · D. · Vergara · J. A. · Alpuerto · K. M. B. · De Los Santos · I. K. S. · Enriquez · M. U. · Manicio · Z. Z. · Mendres · J. E. F. · Tolosa · C. G. S. · Vilela · Z. G. D. · Zabat · Z. E. G. A.
Background

The COVID-19 pandemic has taken a toll on both physical activity and fitness as several pursuits and activities have been restricted. Coupled with this, increased food intake and sedentary lifestyles have produced poor physical health outcomes. Online physical education classes have been more difficult to conduct given the limitations of the setup. As such, exergaming has been identified as a possible educational tool that could improve students’ motivation, participation and fitness levels and reduce negative behaviours in class while contributing to the current curriculum.

Objectives

The study explores the perspectives of both the physical education academic staff and senior high school students from the University of Santo Tomas on the implementation of exergaming to determine the feasibility of exergaming as an educational tool in the Philippines’ physical education curriculum.

Methodology

A descriptive qualitative design will be used and participants will be selected through criterion sampling. The authors will conduct a process of question development and pilot FGDs beforehand to ensure smooth proceedings. Once done, they will undergo FGDs conducted through Google Meet. Data will be coded and analysed via thematic analysis using manual coding and NVivo V.12 software to summarise central themes and perceptions.

Ethics and dissemination

This study will abide by the Nuremberg Code, Declaration of Helsinki, Belmont Report, Data Privacy Act of 2012 and National Ethical Guidelines (for health-related research) of 2017. The study has received approval from the University of Santo Tomas (UST)-College of Rehabilitation Sciences (CRS) Ethics Review Committee. All participant data will be labelled according to random two-digit computer generated codes to preserve anonymity and stored in password-protected laptops and Google Drive folders to preserve confidentiality. Results will be made available to individual UST physical education academic staff and senior high school students prior to publication in peer-reviewed journal.

Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial

Por: Wijk · I. · Amsberg · S. · Johansson · U.-B. · Livheim · F. · Toft · E. · Anderbro · T.
Objective

To evaluate the impact of an Acceptance and Commitment Therapy (ACT) programme, tailored for people living with type 1 diabetes, on glycated haemoglobin (HbA1c), self-management and psychosocial factors among individuals with HbA1c>60 mmol/mol compared with treatment as usual (TAU).

Setting

An endocrinologic clinic in Sweden.

Participants

In this randomised controlled trial, 81 individuals with type 1 diabetes, aged 18–70 years with HbA1c>60 mmol/mol, were randomly assigned to either an ACT group intervention or TAU. Exclusion criteria were: unable to speak Swedish, untreated or severe psychiatric disease, cortisone treatment, untreated thyroid disease and newly started insulin pump therapy. At the 2-year follow-up, HbA1c was measured in 26 individuals.

Intervention

The ACT programme comprised seven 2-hour sessions held over 14 weeks and focused on acceptance of stressful thoughts and emotions, and to promote value-based committed action.

Outcomes

The primary outcome was HbA1c, and the secondary outcomes were measures of depression, anxiety, general stress, fear of hypoglycaemia, diabetes distress, self-care activities, psychological flexibility (general and related to diabetes) and quality of life. The primary endpoint was HbA1c 2 years after the intervention programme. Linear mixed models were used to test for an interaction effect between measurement time and group.

Results

Likelihood ratio test of nested models demonstrated no statistically significant interaction effect (2=0.49, p=0.485) between measurement time and group regarding HbA1c. However, a statistically significant interaction effect (likelihood ratio test 2=12.63, p

Conclusions

No statistically significant difference was found between the groups regarding the primary outcome measure, HbA1c. However, the ACT programme showed a persistent beneficial impact on psychological flexibility in the intervention group. The dropout rate was higher than expected, which may indicate a challenge in this type of study.

Trial registration number

NCT02914496.

Self-Management Analysis in Chronic Conditions (SMACC) checklist: an international consensus-based tool to develop, compare and evaluate self-management support programmes

Por: Moreels · T. · Cruyt · E. · De Baets · S. · Andries · L. · Arts-Tielemans · M. · Rodriguez-Bailon · M. · Bergström · A. · Boete · K. · Bormans · I. · Costa · U. · Declercq · H. · Dekelver · S. · Dekyvere · V. · Delooz · E. · Engels · C. · Helderweirt · S. · Jarrey · M. · Lenaerts · A.
Objectives

The Self-Management Analysis in Chronic Conditions (SMACC) checklist was developed as a guidance tool to support the development, comparison and evaluation of self-management support programmes for persons with a chronic condition. The checklist was based on a previously performed concept analysis of self-management. The aim of this study was to validate its content using an international Delphi study and to deliver a final version.

Design

A two-round Delphi study was conducted between October 2022 and January 2023. Using the researchers’ networks, professionals with research or clinical expertise in self-management support and chronic conditions were recruited via online purposive snowball sampling. Participants were asked to score each item of the checklist (16 items total) on 3 content validity indicators: (1) clarity and comprehensibility, (2) relevance and importance and (3) degree of alignment with the overall goal of the checklist to promote adequate and comprehensive self-management support programmes. A consensus threshold of 75% agreement was used. The participants were also asked general questions about the checklist as a whole and were asked to provide feedback considering its refinement.

Results

Fifty-four professionals with an average 14.5 years of experience participated in round 1, 48 with an average 12.5 years of experience participated in round 2. The majority of professionals were from Western Europe. For the majority of items consensus was reached after round 1. In round 2, 3 of the 4 remaining items reached consensus, 1 last item was retained based on highly recurring feedback.

Conclusions

The SMACC checklist was considered a valid and comprehensive tool to aid the development, evaluation and comparison of self-management support programmes. It was acknowledged as a useful instrument to supplement existing frameworks and was seen as feasible to implement in both research and clinical settings. Further validation in the field, with input from patients and peer experts, will be valuable.

Acceptance of COVID-19 vaccine and associated factors among healthcare workers in Katsina state: a cross-sectional study in Northwest Nigeria

Por: Abubakar · A. T. · Suleiman · K. · Ahmad · S. I. · Yahaya · S. S. · Bello · U. I. · Suleiman · B. A. · Haladu · S. A. · Al-Mustapha · A. I. · Abubakar · M. I.
Objectives

Healthcare workers were prioritised to receive the COVID-19 vaccine in Nigeria. Administration of COVID-19 vaccination in Nigeria was challenging because of a lack of trust in vaccine safety and vaccine effectiveness among healthcare workers, who are expected to provide reliable information about vaccines and vaccine-preventable diseases in the communities. Hence, their acceptance and attitudes towards COVID-19 preventive practices could influence the acceptance of the vaccine by the local population. This cross-sectional study assessed the acceptance of the COVID-19 vaccine among healthcare workers in Katsina State. We predicted the variables that increased the vaccine acceptance using logistic regression analysis.

Setting

This hospital-based study was conducted at primary, secondary and tertiary healthcare facilities in Nigeria.

Participants

A total of 793 healthcare workers were included in this study. Of these, 65.4% (n=519) were male.

Outcome measures

To assess acceptance of COVID-19 vaccine measures, and factors increasing acceptance among healthcare workers.

Results

Of the healthcare workers, 80% (638) were tested for the SARS-CoV-2, of whom 10.8% (n=65) tested positive. Approximately 97% (n=765) of them believed that the COVID-19 vaccine was safe, and 90% (n=714) received the first dose of the vaccine. Healthcare workers between 30 and 39 years were more likely to accept the vaccine (aOR: 7.06; 95% CI 2.36 to 21.07; p

Conclusions

Our findings showed that the age and prior COVID-19 testing were the main factors influencing the acceptance of the COVID-19 vaccine. There was high acceptance of the COVID-19 vaccine among healthcare workers in Katsina State, Nigeria. Future studies should focus on the completion of doses and serological testing for immunity.

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