bluuebunny/crossref_metadata_2025 huggingface dataset:
Can we design the next generation of digital health communication programs by leveraging the power of artificial intelligence to segment target audiences, bolster impact and deliver differentiated services? A machine learning analysis of survey data from rural India
Authors: Bashingwa Jean Juste Harrisson , Mohan Diwakar , Chamberlain Sara , Scott Kerry , Ummer Osama , Godfrey Anna , Mulder Nicola , Moodley Deshendran , LeFevre Amnesty Elizabeth
Published: May 2023

Objectives

Direct to beneficiary (D2B) mobile health communication programmes have been used to provide reproductive, maternal, neonatal and child health information to women and their families in a number of countries globally. Programmes to date have provided the same content, at the same frequency, using the same channel to large beneficiary populations. This manuscript presents a proof of concept approach that uses machine learning to segment populations of women with access to phones and their husbands into distinct clusters to support differential digital programme design and delivery.

Setting

Data used in this study were drawn from cross-sectional survey conducted in four districts of Madhya Pradesh, India.

Participants

Study participant included pregnant women with access to a phone (n=5095) and their husbands (n=3842)

Results

We used an iterative process involving K-Means clustering and Lasso regression to segment couples into three distinct clusters. Cluster 1 (n=1408) tended to be poorer, less educated men and women, with low levels of digital access and skills. Cluster 2 (n=666) had a mid-level of digital access and skills among men but not women. Cluster 3 (n=1410) had high digital access and skill among men and moderate access and skills among women. Exposure to the D2B programme ‘Kilkari’ showed the greatest difference in Cluster 2, including an 8% difference in use of reversible modern contraceptives, 7% in child immunisation at 10 weeks, 3% in child immunisation at 9 months and 4% in the timeliness of immunisation at 10 weeks and 9 months.

Conclusions

Findings suggest that segmenting populations into distinct clusters for differentiated programme design and delivery may serve to improve reach and impact.

Trial registration number

NCT03576157.
www.coronabambini.ch: Development and usage of an online decision support tool for paediatric COVID-19-testing in Switzerland: a cross-sectional analysis
Authors: Starvaggi Carl Alessandro , Travaglini Nicola , Aebi Christoph , Romano Fabrizio , Steiner Isabelle , Sauter Thomas Christian , Keitel Kristina
Published: May 2023

Objectives

To describe the development and usage ofwww.coronabambini.chas an example of a paediatric electronic public health application and to explore its potential and limitations in providing information on disease epidemiology and public health policy implementation.

Design

We developed and maintained a non-commercial online decision support tool,www.coronabambini.ch, to translate the Swiss Federal Office of Public Health (FOPH) paediatric (age 0–18 years) COVID-19 guidelines around testing and school/daycare attendance for caregivers, teachers and healthcare personnel. We analysed the online decision tool as well as a voluntary follow-up survey from October 2020 to September 2021 to explore its potential as a surveillance tool for public health policy and epidemiology.

Participants

68 269 users accessed and 52 726 filled out the complete online decision tool. 3% (1399/52 726) filled out a voluntary follow-up. 92% (18 797/20 330) of users were parents.

Results

Certain dynamics of the pandemic and changes in testing strategies were reflected in the data captured bywww.coronabambini.ch, for example, in terms of disease epidemiology, gastrointestinal symptoms were reported more frequently in younger age groups (13% (3308/26 180) in children 0–5 years vs 9% (3934/42 089) in children ≥6 years, χ2=184, p≤0.001). As a reflection of public health policy, the proportion of users consulting the tool for a positive contact without symptoms in children 6–12 years increased from 4% (1415/32 215) to 6% (636/9872) after the FOPH loosened testing criteria in this age group, χ2=69, p≤0.001. Adherence to the recommendation was generally high (84% (1131/1352)) but differed by the type of recommendation: 89% (344/385) for ‘stay at home and observe’, 75% (232/310) for ‘school attendance’.

Conclusions

Usage ofwww.coronabambini.chwas generally high in areas where it was developed and promoted. Certain patterns in epidemiology and adherence to public health policy could be depicted but selection bias was difficult to measure showing the potential and challenges of digital decision support as public health tools.
Social norms and goal-setting interventions to promote responsible gambling in low-to-moderate online gamblers: protocol for a four-arm randomised controlled feasibility study
Authors: Arden-Close Emily , Thomas Sarah , Bush-Evans Reece , Wang Ruijie , Bolat Elvira , Hodge Sarah , Phalp Keith , McAlaney John
Published: May 2023

Introduction

Gambling is increasingly recognised as an important public health issue. Problem gambling is associated with highly negative impacts on physical, psychological and social well-being, not only for those who gamble but also for those around them. There has been a rapid expansion of internet gambling and attributes such as continuous play and instant rewards, and enhanced privacy may lead to a greater likelihood of gambling-related harms. In this randomised controlled feasibility study, we are testing (1) the acceptability and feasibility of three online responsible gambling interventions targeting people with low-to-moderate risk of online problem gambling and (2) the feasibility of a future full-scale randomised controlled trial (RCT) to test their effectiveness and cost-effectiveness.

Methods and analysis

Four-arm randomised controlled feasibility study with qualitative substudy. One-hundred and forty UK residents with low-to-moderate risk of online gambling recruited via gambling operators and social media will be randomised (1:1:1:1) to either (1) goal setting, (2) descriptive norms messages (challenge perceptions of peer behaviours), (3) injunctive norms messages (challenge perceptions of peer attitudes) and (4) control (delayed intervention). Interventions will be delivered over 6 weeks and individually tailored. Outcomes, administered online, will be measured at baseline, 7 weeks, and 3 and 6 months post randomisation (including gambling risk behaviours and cognitions, anxiety and depression, quality of life, health use and productivity). Analyses will be descriptive, focusing on feasibility and acceptability of the interventions and study procedures. Telephone/online interviews, with a subsample of approximately 30 participants, will elicit experiences of participating in the study. Prespecified progression criteria will guide decisions around whether to progress to a definitive RCT.

Ethics and dissemination

Ethical approval obtained from Bournemouth University Research Ethics Committee (reference number 33247). Participants will be given a participant information sheet plus a ‘Key Facts’ summary and will provide informed online consent. Findings will be published in peer-reviewed journals and presented at conferences and public engagement events.

Trial registration number

ISRCTN37874344.
Do socioeconomic inequities arise during school-based physical activity interventions? An exploratory case study of the GoActive trial
Authors: Alliott Olivia , Fairbrother Hannah , Corder Kirsten , Wilkinson Paul , van Sluijs Esther
Published: May 2023

Objective

To investigate socioeconomic inequities in the intervention and evaluation process of the GoActive school-based physical activity intervention and demonstrate a novel approach to evaluating intervention-related inequalities.

Design

Exploratory post-hoc secondary data analysis of trial data.

Setting

The GoActive trial was run in secondary schools across Cambridgeshire and Essex (UK), between September 2016 and July 2018.

Participants

13–14 years old adolescents (n=2838, 16 schools).

Methods

Socioeconomic inequities across six stages in the intervention and evaluation process were evaluated: (1) provision of and access to resources; (2) intervention uptake; (3) intervention effectiveness (accelerometer-assessed moderate-to-vigorous physical activity (MVPA)); (4) long-term compliance; (5) response in evaluation; and (6) impact on health. Data from self-report and objective measures were analysed by individual-level and school-level socioeconomic position (SEP) using a combination of classical hypothesis tests and multilevel regression modelling.

Results

Stage: (1) There was no difference in the provision of physical activity resources by school-level SEP (eg, quality of facilities (0–3), low=2.6 (0.5); high=2.5 (0.4). (2) Students of low-SEP engaged significantly less with the intervention (eg, website access: low=37.2%; middle=45.4%; high=47.0%; p=0.001). (3) There was a positive intervention effect on MVPA in adolescents of low-SEP (3.13 min/day, 95% CI −1.27 to 7.54, but not middle/high (−1.49; 95% CI −6.54 to 3.57). (4) At 10 months post-intervention, this difference increased (low SEP: 4.90; 95% CI 0.09 to 9.70; middle/high SEP: −2.76; 95% CI −6.78 to 1.26). (5) There was greater non-compliance to evaluation measures among adolescents of low-SEP (eg, % accelerometer compliance (low vs high): baseline: 88.4 vs 92.5; post-intervention: 61.6 vs 69.2; follow-up: 54.5 vs 70.2. (6) The intervention effect on body mass index (BMI) z-score was more favourable in adolescents of low-SEP (low SEP: −0.10; 95% CI −0.19 to 0.00; middle/high: 0.03; 95% CI −0.05 to 0.12).

Conclusions

These analyses suggest the GoActive intervention had a more favourable positive effect on MVPA and BMI in adolescents of low-SEP, despite lower intervention engagement. However, differential response to evaluation measures may have biassed these conclusions. We demonstrate a novel way of evaluating inequities within young people’s physical activity intervention evaluations.

Trial registration number

ISRCTN31583496.
Psychometric evaluation of the NTDT-PRO questionnaire for assessing symptoms in patients with non-transfusion-dependent beta-thalassaemia
Authors: Taher Ali T , Musallam Khaled M , Viprakasit Vip , Kattamis Antonis , Lord-Bessen Jennifer , Yucel Aylin , Guo Shien , Pelligra Christopher , Shields Alan L , Shetty Jeevan K , Miteva Dimana , Bueno Luciana Moro , Cappellini Maria Domenica
Published: May 2023

Objectives

The non-transfusion-dependent beta-thalassaemia-patient-reported outcome (NTDT-PRO) questionnaire was developed for assessing anaemia-related tiredness/weakness (T/W) and shortness of breath (SoB) among patients with NTDT. Psychometric properties were evaluated using blinded data from the BEYOND trial (NCT03342404).

Design

Analysis of a phase 2, double-blind, randomised, placebo-controlled trial.

Setting

USA, Greece, Italy, Lebanon, Thailand and the UK.

Participants

Adults (≥18 years) (N=145) with NTDT who had not received a red blood cell transfusion within 8 weeks prior to randomisation, with mean baseline haemoglobin level ≤100 g/L.

Measures

NTDT-PRO daily scores from baseline until week 24, and scores at select time points for the 36-Item Short Form Health Survey version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) and Patient Global Impression of Severity (PGI-S).

Results

Cronbach’s alpha at weeks 13–24 was 0.95 and 0.84 for the T/W and SoB domains, respectively, indicating acceptable internal consistency reliability. Among participants self-reporting no change in thalassaemia symptoms via the PGI-S between baseline and week 1, intraclass correlation coefficients were 0.94 and 0.92 for the T/W and SoB domains, respectively, indicating excellent test–retest reliability. In a known-groups validity analysis, least-squares mean T/W and SoB scores at weeks 13–24 were worse in participants with worse scores for the FACIT-F Fatigue Subscale (FS), SF-36v2 vitality or PGI-S. Indicating responsiveness, changes in T/W and SoB domain scores were moderately correlated with changes in haemoglobin levels, and strongly correlated with changes in SF-36v2 vitality, FACIT-F FS, select FACIT-F items and the PGI-S. Improvements in least-squares mean T/W and SoB scores were higher in participants with greater improvements in scores on other PROs measuring similar constructs.

Conclusions

The NTDT-PRO demonstrated adequate psychometric properties to assess anaemia-related symptoms in adults with NTDT and can be used to evaluate treatment efficacy in clinical trials.
Efficacy of mecobalamin (vitamin B12) in the treatment of long-term pain in women diagnosed with fibromyalgia: protocol for a randomised, placebo-controlled trial
Authors: Sall Hansson Karin , Lindqvist Gunilla , Stening Kent , Fohlman Jan , Wojanowski Anna , Ponten Moa , Jensen Karin , Gerdle Björn , Elmqvist Carina
Published: May 2023

Introduction

Fibromyalgia causes long-term pain. It affects at least 2% of the population, the majority being women. In addition, extended symptoms corresponding to vitamin B12deficiency occur. Findings from several studies have indicated that vitamin B12may be a possible treatment for pain in fibromyalgia. The aim of the proposed study is to evaluate whether vitamin B12decreases pain sensitivity and the experience of pain (ie, hyperalgesia and allodynia) in women with fibromyalgia.

Methods and analysis

The study is a randomised, placebo-controlled, single-blind, clinical trial with two parallel groups which are administered mecobalamin (vitamin B12) or placebo over 12 weeks. 40 Swedish women aged 20–70 years with an earlier recorded diagnosis of fibromyalgia are randomised into the placebo group or the treatment group, each consisting of 20 participants. Outcomes consist of questionnaires measured at baseline and after 12 weeks of treatment. A final re-evaluation will then follow 12 weeks after treatment ends. The primary outcome is tolerance time, maximised to 3 min, which is assessed using the cold pressor test. In order to broaden the understanding of the lived experience of participants, qualitative interviews will be conducted using a phenomenological approach on a lifeworld theoretical basis (reflective lifeworld research approach).

Ethics and dissemination

The protocol for the study is approved by the local ethical committee at Linkoping (EPM; 2018/294–31, appendices 2019–00347 and 2020–04482). The principles of the Helsinki Declaration are followed regarding oral and written consent to participate, confidentiality and the possibility to withdraw participation from the study at any time. The results will primarily be communicated through peer-reviewed journals and conferences.

Trial registration number

NCT05008042.
Development of a tool for objectively measuring somatic pain in the low back region based on a longitudinal diagnostic study conducted in Karachi, Pakistan
Authors: ul Hasanat Rasim , Syed Shahzad Ali , Rathore Farooq Azam , Iftikhar Sundus
Published: May 2023

Objectives

This study aimed at devising an objective method for quantifying pain in the low back region using pressure pain threshold (PPT) and demographic factors as predictive variables.

Methods

The research was conducted in two phases. Phase I was a longitudinal exploratory study conducted on 49 men aged 18–50 years with chronic low back pain (CLBP) recruited using non-probability purposive sampling. We used Visual Analogue Scale to record pain intensity and pain affect, and Disability Rating Index to record associated disability. PPT was measured on 12 different locations on the lower back using a manual algometer. These measurements were taken from each participant in 1 to 6-follow-up visits, depending on improvement in the individual’s symptoms. In phase II additional 33 subjects, both men and women with varying durations of low back pain were recruited using non-probability convenience sampling. Repeated measures ordinal regression and receiver’s operating characteristic curve analyses were performed to develop predictive models using STATA V.16.0 and R V.3.5.2 software. These models were given an interface using Microsoft Excel. A p value of <0.05 was considered statistically significant.

Results

Higher PPT scores, increased lean body mass, lean physique and a longer duration of CLBP were associated with a reduction in CLBP intensity, affect and disability. Advancing age was associated with an increase in these outcomes. Collectively, these factors were found to predict pain intensity, affect, and disability with 63%–65% diagnostic accuracy in phase I, however, this diagnostic accuracy increased to 65%–78% in phase II.

Conclusion

We developed a new outcome tool ‘Pain Calculator’ that can objectively measure low back pain with sufficient statistical accuracy. With further refinement, this tool in the future can be configured to measure somatic pain in different regions as well, affording clinicians and researchers much-needed objectivity while recording pain levels.

Trial registration number

NCT04482075.
Understanding the role of physical activity on the pathway from intra-articular knee injury to post-traumatic osteoarthritis disease in young people: a scoping review protocol
Authors: Morgan Karl , Cowburn James , Farrow Matthew , Carter Josh , Cazzola Dario , Walhin Jean-Philippe , McKay Carly
Published: May 2023

Introduction

The prevalence of intra-articular knee injuries and reparative surgeries is increasing in many countries. Alarmingly, there is a risk of developing post-traumatic osteoarthritis (PTOA) after sustaining a serious intra-articular knee injury. Although physical inactivity is suggested as a risk factor contributing to the high prevalence of the condition, there is a paucity of research characterising the association between physical activity and joint health. Consequently, the primary aim of this review will be to identify and present available empirical evidence regarding the association between physical activity and joint degeneration after intra-articular knee injury and summarise the evidence using an adapted Grading of Recommendations Assessment, Development and Evaluations. The secondary aim will be to identify potential mechanistic pathways through which physical activity could influence PTOA pathogenesis. The tertiary aim will be to highlight gaps in current understanding of the association between physical activity and joint degeneration following joint injury.

Methods

A scoping review will be conducted using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist and best-practice recommendations. The review will be guided by the following research question: what is the role of physical activity in the trajectory from intra-articular knee injury to PTOA in young men and women? We will identify primary research studies and grey literature by searching the electronic databases Scopus, Embase: Elsevier, PubMed, Web of Science: all databases, and Google Scholar. Reviewing pairs will screen abstracts, full texts and will extract data. Data will be presented descriptively using charts, graphs, plots and tables.

Ethics and dissemination

This research does not require ethical approval due to the data being published and publicly available. This review will be submitted for publication in a peer-reviewed sports medicine journal irrespective of discoveries and disseminated through scientific conference presentations and social media.

Trial registration number

https://osf.io/84pnh/.
Engaging emergency medical services to improve postacute management of behavioural health emergency calls: a protocol of a scoping literature review
Authors: Ding Marissa L , Gerberi Danielle J , McCoy Rozalina G
Published: May 2023

Introduction

The public health crisis of escalating mental health, behavioural and substance-related emergencies has revealed the need to approach these complex events from a health perspective, rather than the traditional criminal justice standpoint. Despite law enforcement officers often being the first responders to emergency calls concerning self or bystander harm, they are not optimally equipped to manage these crises holistically or to connect affected individuals to necessary medical treatment and social support. Paramedics and other emergency medical services (EMS) providers are well positioned to deliver comprehensive medicosocial care during and in the immediate aftermath of these emergencies, moving beyond their traditional role in emergency evaluation, stabilisation and transport to a higher level of care. The role of EMS in bridging this gap and helping shift emphasis to mental and physical health needs in crisis situations has not been examined in prior reviews.

Methods and analysis

In this protocol, we delineate our approach to describing existing EMS programmes that focus specifically on supporting individuals and communities experiencing mental, behavioural and substance-related health crises. The databases to be searched are EBSCO CINAHL, Ovid Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid Medline, Ovid PsycINFO and Web of Science Core Collection, with search date limits being from database inception to 14 July 2022. A narrative synthesis will be completed to characterise populations and situations targeted by the programmes, describe programme staffing and composition, detail the interventions and identify collected outcomes.

Ethics and dissemination

All data in the review will be publicly accessible and published previously, so approval by a research ethics board is not needed. Our findings will be published in a peer-reviewed journal and shared with the public.

Trial registration number

https://doi.org/10.17605/OSF.IO/UYV4R
Evaluating a clinical ethics committee (CEC) implementation process in an oncological research hospital: protocol for a process evaluation study using normalisation process theory (EvaCEC)
Authors: Perin Marta , Magelssen Morten , Ghirotto Luca , De Panfilis Ludovica
Published: May 2023

Introduction

A Clinical Ethics Committee (CEC) is a multi-professional service whose aim is to support healthcare professionals (HPs) and healthcare organisations to deal with the ethical issues of clinical practice.

Although CEC are quite common worldwide, their successful implementation in a hospital setting presents many challenges.

EVAluating a Clinical Ethics Committee implementation process (EvaCEC) will evaluate the implementation of a CEC in a comprehensive cancer centre in Northern Italy 16 months after its establishment.

Methods and analysis

EvaCEC is a mixed-method study with a retrospective quantitative analysis and a prospective qualitative evaluation by a range of data collection tools to enable the triangulation of data sources and analysis. Quantitative data related to the amount of CEC activities will be collected using the CEC's internal databases. Data on the level of knowledge, use and perception of the CEC will be collected through a survey with closed-ended questions disseminated among all the HPs employed at the healthcare centre. Data will be analysed with descriptive statistics.

The Normalisation Process Theory (NPT) will be used for the qualitative evaluation to determine whether and how the CEC can be successfully integrated into clinical practice. We will perform one-to-one semistructured interviews and a second online survey with different groups of stakeholders who had different roles in the implementation process of the CEC. Based on NPT concepts, the interviews and the survey will assess the acceptability of the CEC within the local context and needs and expectations to further develop the service.

Ethics and dissemination

The protocol has been approved by the local ethics committee. The project is co-chaired by a PhD candidate and by a healthcare researcher with a doctorate in bioethics and expertise in research. Findings will be disseminated widely through peer-reviewed publications, conferences and workshops.

Trial registration number

NCT05466292.
Study design and methods of the Wells and Enteric disease Transmission (WET) Trial: a randomised controlled trial
Authors: Lee Debbie , Denno Donna , Tarr Phillip , Wu Jingwei , Stokdyk Joel P , Borchardt Mark , Murphy Heather M
Published: May 2023

Introduction

The burden of disease attributed to drinking water from private wells is not well characterised. The Wells and Enteric disease Transmission trial is the first randomised controlled trial to estimate the burden of disease that can be attributed to the consumption of untreated private well water. To estimate the attributable incidence of gastrointestinal illness (GI) associated with private well water, we will test if the household treatment of well water by ultraviolet light (active UV device) versus sham (inactive UV device) decreases the incidence of GI in children under 5 years of age.

Methods and analysis

The trial will enrol (on a rolling basis) 908 families in Pennsylvania, USA, that rely on private wells and have a child 3 years old or younger. Participating families are randomised to either an active whole-house UV device or a sham device. During follow-up, families will respond to weekly text messages to report the presence of signs and symptoms of gastrointestinal or respiratory illness and will be directed to an illness questionnaire when signs/symptoms are present. These data will be used to compare the incidence of waterborne illness between the two study groups. A randomly selected subcohort submits untreated well water samples and biological specimens (stool and saliva) from the participating child in both the presence and absence of signs/symptoms. Samples are analysed for the presence of common waterborne pathogens (stool and water) or immunoconversion to these pathogens (saliva).

Ethics

Approval has been obtained from Temple University’s Institutional Review Board (Protocol 25665). The results of the trial will be published in peer-reviewed journals.

Trial registration number

NCT04826991.
Early diagnostic BioMARKers in exacerbations of chronic obstructive pulmonary disease: protocol of the exploratory, prospective, longitudinal, single-centre, observational MARKED study
Authors: Waeijen-Smit Kiki , DiGiandomenico Antonio , Bonnell Jessica , Ostridge Kristoffer , Gehrmann Ulf , Sellman Bret R , Kenny Tara , van Kuijk Sander , Peerlings Daphne , Spruit Martijn A , Simons Sami O , Houben-Wilke Sarah , Franssen Frits M E
Published: May 2023

Introduction

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) play a pivotal role in the burden and progressive course of chronic obstructive pulmonary disease (COPD). As such, disease management is predominantly based on the prevention of these episodes of acute worsening of respiratory symptoms. However, to date, personalised prediction and early and accurate diagnosis of AECOPD remain unsuccessful. Therefore, the current study was designed to explore which frequently measured biomarkers can predict an AECOPD and/or respiratory infection in patients with COPD. Moreover, the study aims to increase our understanding of the heterogeneity of AECOPD as well as the role of microbial composition and hostmicrobiome interactions to elucidate new disease biology in COPD.

Methods and analysis

The ‘Early diagnostic BioMARKers in Exacerbations of COPD’ study is an exploratory, prospective, longitudinal, single-centre, observational study with 8-week follow-up enrolling up to 150 patients with COPD admitted to inpatient pulmonary rehabilitation at Ciro (Horn, the Netherlands). Respiratory symptoms, vitals, spirometry and nasopharyngeal, venous blood, spontaneous sputum and stool samples will be frequently collected for exploratory biomarker analysis, longitudinal characterisation of AECOPD (ie, clinical, functional and microbial) and to identify host–microbiome interactions. Genomic sequencing will be performed to identify mutations associated with increased risk of AECOPD and microbial infections. Predictors of time-to-first AECOPD will be modelled using Cox proportional hazards’ regression. Multiomic analyses will provide a novel integration tool to generate predictive models and testable hypotheses about disease causation and predictors of disease progression.

Ethics and dissemination

This protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, the Netherlands (NL71364.100.19).

Trial registration number

NCT05315674.
Role of single-dose intravenous iron therapy for the treatment of anaemia after orthopaedic trauma: protocol for a pilot randomised controlled trial
Authors: Peterson Danielle F , McKibben Natasha S , Hutchison Catherine E , Lancaster Karalynn , Yang Chih Jen , Dekeyser Graham J , Friess Darin M , Schreiber Martin A , Willett Nick J , Shatzel Joseph J , Aslan Joseph E , Working Zachary M
Published: May 2023

Introduction

Orthopaedic trauma and fracture care commonly cause perioperative anaemia and associated functional iron deficiency due to a systemic inflammatory state. Modern, strict transfusion thresholds leave many patients anaemic; managing this perioperative anaemia is an opportunity to impact outcomes in orthopaedic trauma surgery. The primary outcome of this pilot study is feasibility for a large randomised controlled trial (RCT) to evaluate intravenous iron therapy (IVIT) to improve patient well-being following orthopaedic injury. Measurements will include rate of participant enrolment, screening failure, follow-up, missing data, adverse events and protocol deviation.

Methods and analysis

This single-centre, pilot, double-blind RCT investigates the use of IVIT for acute blood loss anaemia in traumatically injured orthopaedic patients. Patients are randomised to receive either a single dose infusion of low-molecular weight iron dextran (1000 mg) or placebo (normal saline) postoperatively during their hospital stay for trauma management. Eligible subjects include adult patients admitted for lower extremity or pelvis operative fracture care with a haemoglobin of 7–11 g/dL within 7 days postoperatively during inpatient care. Exclusion criteria include history of intolerance to intravenous iron supplementation, active haemorrhage requiring ongoing blood product resuscitation, multiple planned procedures, pre-existing haematologic disorders or chronic inflammatory states, iron overload on screening or vulnerable populations. We follow patients for 3 months to measure the effect of iron supplementation on clinical outcomes (resolution of anaemia and functional iron deficiency), patient-reported outcomes (fatigue, physical function, depression and quality of life) and translational measures of immune cell function.

Ethics and dissemination

This study has ethics approval (Oregon Health & Science University Institutional Review Board, STUDY00022441). We will disseminate the findings through peer-reviewed publications and conference presentations.

Trial registration number

NCT05292001; ClinicalTrials.gov.
Effects of physical, psychosocial and dual-career loads on injuries and illnesses among elite handball players: protocol of prospective cohort study
Authors: Drole Kristina , Paravlic Armin , Steffen Kathrin , Doupona Mojca
Published: May 2023

Introduction

Health problems in sport cause a major burden on several pillars: sport clubs, health and insurance system and mostly the individual athlete. There is limited knowledge in supporting dual-career athletes firmed on evidence-based research in injury/illness prevention, load and stress management. The main goal of this research approach is to determine how specific physical, psychosocial and dual-career loads affect the occurrence of injuries and illnesses in elite handball players and how much of a variation in the athlete’s load leads to an occurrence of an injury/illness. A secondary aim is to determine the association between objective and subjective measures of stress as well as examine the benefits of certain biomarkers to monitor stress, load and injury/illness occurrence in athletes.

Methods and analysis

This prospective cohort study, as part of a PhD project, will be carried out on 200 elite handball players of first men's handball league in Slovenia during an entire handball season, lasting from July 2022 to June 2023. Primary outcomes, including health problems, loads and stress, will be assessed weekly on a player level. Other player-related outcomes will include anthropometry, life event survey and blood biomarkers (cortisol, free testosterone and Ig-A), which will be taken three to five times across the observation period according to the players’ training cycle.

Ethics and dissemination

The project was approved by the National Medical Ethics Committee of Slovenia (number: 0120-109/2022/3) and will be conducted in compliance with the most recent version of Helsinki Declaration. The study results will be published as peer-reviewed articles, congress presentations and as a Doctoral thesis. The results will not only be of importance for the medical and sports community for development of new injury prevention and rehabilitation strategies but also for structuring the correct policy recommendations for athletes’ general health.

Trial registration number

NCT0547129.
Telehealth use in primary healthcare collaborative interprofessional practice: protocol for a scoping review
Authors: Belber Gisele Silvestre , Vasconcelos Raíssa Ottes , Agreli Heloise Lima Fernandes , Haddad Ana Estela , Peduzzi Marina , Leonello Valéria Marli
Published: May 2023

Introduction

Telehealth is a growing topic, with potential to improve access to primary healthcare. However, there is a lack of knowledge regarding how telehealth could facilitate interprofessional collaboration that is recommended to strengthen the comprehensive approach of primary healthcare. The objective is to identify the characteristics and applications of telehealth services related to the interprofessional collaborative practice of primary healthcare professionals.

Methods and analysis

This review will cover studies including as target population those health professionals who work in telehealth services; as concept, telehealth in relation to collaborative interprofessional practice; and as context, primary healthcare. A scoping review will be carried out according to the Joanna Briggs Institute methodology. Databases to be searched include MEDLINE, CINAHL, Embase, Eric, Scopus, LILACS and Web of Science. All identified records will be grouped, duplicates will be removed, titles and abstracts will be selected by two independent reviewers, and the full text of selected articles will be evaluated in detail. A data extraction tool developed by the reviewers will be used for data extraction. The results will be presented in data map format in a logical way, in a diagram or in a tabular format, accompanied by a descriptive summary.

Ethics and dissemination

No ethical approval is required for this study. A manuscript based on this scoping review will be submitted to a journal and we hope it will contribute to scientific knowledge on the interprofessional field and key research findings will be sent to key events on interprofessional practice and education.

Systematic review registration

This scoping review was registered in the Open Science Framework (https://doi.org/10.17605/OSF.IO/2BV8D).
Effectiveness of a targeted brief intervention for recent suicide attempt survivors: a randomised controlled trial protocol
Authors: Pisani Anthony , Connor Kenneth , Van Orden Kimberly , Jordan Neil , Landes Sara , Curran Geoffrey , McDermott Michael , Ertefaie Ashkan , Kelberman Caroline , Ramanathan Seethalakshmi , Carruthers Jay , Mossgraber Kristina , Goldston David
Published: May 2023

Introduction

Effective, brief, low-cost interventions for suicide attempt survivors are essential to saving lives and achieving the goals of the National Strategy for Suicide Prevention and Zero Suicide. This study aims to examine the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP) in averting suicide reattempts in the United States healthcare system, its psychological mechanisms as predicted by the Interpersonal Theory of Suicide, and the potential implementation costs, barriers and facilitators for delivering it.

Methods and analysis

This study is a hybrid type 1 effectiveness–implementation randomised controlled trial (RCT). ASSIP is delivered at three outpatient mental healthcare clinics in New York State. Participant referral sites include three local hospitals with inpatient and comprehensive psychiatric emergency services, and outpatient mental health clinics. Participants include 400 adults who have had a recent suicide attempt. All are randomised to ‘Zero Suicide-Usual Care plus ASSIP’ or ‘Zero Suicide-Usual Care’. Randomisation is stratified by sex and whether the index attempt is a first suicide attempt or not. Participants complete assessments at baseline, 6 weeks, and 3, 6, 12 and, 18 months. The primary outcome is the time from randomisation to the first suicide reattempt. Prior to the RCT, a 23-person open trial took place, in which 13 participants received ‘Zero Suicide-Usual Care plus ASSIP’ and 14 completed the first follow-up time point.

Ethics and dissemination

This study is overseen by the University of Rochester, with single Institutional Review Board (#3353) reliance agreements from Nathan Kline Institute (#1561697) and SUNY Upstate Medical University (#1647538). It has an established Data and Safety Monitoring Board. Results will be published in peer-reviewed academic journals, presented at scientific conferences, and communicated to referral organisations. Clinics considering ASSIP may use a stakeholder report generated by this study, including incremental cost-effectiveness data from the provider point of view.

Trial registration number

NCT03894462.
Gender-affirming care in undergraduate nursing education: a scoping review protocol
Authors: Crawford Jess , Schultz Annette S H , Linton Janice , Kramer Marnie , Ristock Janice
Published: May 2023

Introduction

Transgender and gender-diverse (TGD) people face a multitude of barriers to safe, accessible healthcare. One way to overcome access inequities is through the provision of gender-affirming care. Gender-affirming care is culturally safe and engaged care that values TGD identities and is focused on depathologising TGD people. Additionally, gender-affirming care encompasses awareness and support of TGD individuals as unique beings, including supporting gender-affirming medical goals for those who are interested. The discipline of nursing is well situated to advocate for gender-affirming care, however, receives little undergraduate education in the subject. Undergraduate schools of nursing (including faculty and curriculum) are in a crucial position to implement gender-affirming care, though how they have done this is not widely known. Our scoping review aims to understand how Canadian and US undergraduate schools of nursing teach and integrate gender-affirming education.

Methods and analysis

Our scoping review will follow the six stages by Arksey and O’Malley and the advancements by Levacet al, reported on as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. The review will be completed in 2023, with the database searches carried out in spring 2023, followed by screening and analysis.

Ethics and dissemination

Ethics approval is not required for this protocol. To aid in knowledge translation, a visual representation of the findings will be created. Results from the final scoping review will be published in a peer-reviewed journal, promoted on social media to schools of nursing, and presented at conferences and seminars.

Protocol registration number

Open Science Framework (https://doi.org/10.17605/OSF.IO/Q68BD).
Hyperuricaemia: prevalence and association with mortality in an elderly Finnish population
Authors: Timsans Janis , Kauppi Jenni Emilia , Kerola Anne Mirjam , Lehto Tiina Maarit , Kautiainen Hannu , Kauppi Markku Jaakko
Published: May 2023

Objective

To establish the prevalence of hyperuricaemia in an elderly Finnish cohort and to assess its association with comorbidities and mortality.

Design

Prospective cohort study.

Setting

Good Ageing in Lahti Region study, Finland 2002–2012 (mortality data analysed until 2018).

Participants

2673 participants (mean age 64 years; 47% men).

Primary and secondary outcome measures

Prevalence of hyperuricaemia in the study population was detected. Associations between hyperuricaemia and mortality were assessed using multivariable adjusted Cox proportional hazards models.

Methods

Data from a prospective, population-based study of elderly people (52–76 years) in the Lahti region, Finland, were used. Information on serum uric acid (SUA) levels as well as several other laboratory variables, comorbidities, lifestyle habits and socioeconomic factors was collected, and the association between SUA level and mortality in a 15-year follow-up period was analysed.

Results

Of 2673 elderly Finnish persons included in the study 1197 (48%) were hyperuricaemic. Hyperuricaemia was extremely prevalent in men (60%). There was an association between elevated SUA and mortality which remained after adjustment for potential confounding factors (age, gender, education, smoking status, body mass index, hypertension and dyslipidaemia). The adjusted HR for all-cause mortality among clearly hyperuricaemic individuals with SUA≥420 µmol/L compared with normouricaemic individuals (SUA<360 µmol/L) was 1.32 (95% CI 1.05 to 1.60) in women and 1.29 (95% CI 1.05 to 1.60) in men. In slightly hyperuricaemic individuals (SUA 360–420 µmol/L) the corresponding HRs were 1.03 (95% CI 0.78 to 1.35) and 1.11 (95% CI 0.89 to 1.39).

Conclusions

Hyperuricaemia is very prevalent in the elderly Finnish population and is independently associated with increased mortality.
Gut microbiome modulates the effects of a personalised postprandial-targeting (PPT) diet on cardiometabolic markers: a diet intervention in pre-diabetes
Authors: Ben-Yacov Orly , Godneva Anastasia , Rein Michal , Shilo Smadar , Lotan-Pompan Maya , Weinberger Adina , Segal Eran
Published: May 2023

Objective

To explore the interplay between dietary modifications, microbiome composition and host metabolic responses in a dietary intervention setting of a personalised postprandial-targeting (PPT) diet versus a Mediterranean (MED) diet in pre-diabetes.

Design

In a 6-month dietary intervention, adults with pre-diabetes were randomly assigned to follow an MED or PPT diet (based on a machine-learning algorithm for predicting postprandial glucose responses). Data collected at baseline and 6 months from 200 participants who completed the intervention included: dietary data from self-recorded logging using a smartphone application, gut microbiome data from shotgun metagenomics sequencing of faecal samples, and clinical data from continuous glucose monitoring, blood biomarkers and anthropometrics.

Results

PPT diet induced more prominent changes to the gut microbiome composition, compared with MED diet, consistent with overall greater dietary modifications observed. Particularly, microbiome alpha-diversity increased significantly in PPT (p=0.007) but not in MED arm (p=0.18). Post hoc analysis of changes in multiple dietary features, including food-categories, nutrients and PPT-adherence score across the cohort, demonstrated significant associations between specific dietary changes and species-level changes in microbiome composition. Furthermore, using causal mediation analysis we detect nine microbial species that partially mediate the association between specific dietary changes and clinical outcomes, including three species (fromBacteroidales,Lachnospiraceae,Oscillospiralesorders) that mediate the association between PPT-adherence score and clinical outcomes of hemoglobin A1c (HbA1c), high-density lipoprotein cholesterol (HDL-C) and triglycerides. Finally, using machine-learning models trained on dietary changes and baseline clinical data, we predict personalised metabolic responses to dietary modifications and assess features importance for clinical improvement in cardiometabolic markers of blood lipids, glycaemic control and body weight.

Conclusions

Our findings support the role of gut microbiome in modulating the effects of dietary modifications on cardiometabolic outcomes, and advance the concept of precision nutrition strategies for reducing comorbidities in pre-diabetes.

Trial registration number

NCT03222791.
Association of beta-blockers beyond 1 year after myocardial infarction and cardiovascular outcomes
Authors: Ishak Divan , Aktaa Suleman , Lindhagen Lars , Alfredsson Joakim , Dondo Tatendashe Bernadette , Held Claes , Jernberg Tomas , Yndigegn Troels , Gale Chris P , Batra Gorav
Published: May 2023

Objective

Beta-blockers (BB) are an established treatment following myocardial infarction (MI). However, there is uncertainty as to whether BB beyond the first year of MI have a role in patients without heart failure or left ventricular systolic dysfunction (LVSD).

Methods

A nationwide cohort study was conducted including 43 618 patients with MI between 2005 and 2016 in the Swedish register for coronary heart disease. Follow-up started 1 year after hospitalisation (index date). Patients with heart failure or LVSD up until the index date were excluded. Patients were allocated into two groups according to BB treatment. Primary outcome was a composite of all-cause mortality, MI, unscheduled revascularisation and hospitalisation for heart failure. Outcomes were analysed using Cox and Fine–Grey regression models after inverse propensity score weighting.

Results

Overall, 34 253 (78.5%) patients received BB and 9365 (21.5%) did not at the index date 1 year following MI. The median age was 64 years and 25.5% were female. In the intention-to-treat analysis, the unadjusted rate of primary outcome was lower among patients who received versus not received BB (3.8 vs 4.9 events/100 person-years) (HR 0.76; 95% CI 0.73 to 1.04). Following inverse propensity score weighting and multivariable adjustment, the risk of the primary outcome was not different according to BB treatment (HR 0.99; 95% CI 0.93 to 1.04). Similar findings were observed when censoring for BB discontinuation or treatment switch during follow-up.

Conclusion

Evidence from this nationwide cohort study suggests that BB treatment beyond 1 year of MI for patients without heart failure or LVSD was not associated with improved cardiovascular outcomes.