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Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial)

Por: 't Hart · J. W. H. · Noordman · B. J. · Palsgraaf-Huisbrink · J. · Dunkelgrun · M. · Zengerink · H. F. · Birnie · E. · van Det · M. J. · Boerma · E.-J. G. · de Castro · S. M. M. · Hazebroek · E. J. · Langenhoff · B. S. · Verhoef · C. · Apers · J. A.
Introduction

By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery.

Method and analysis

This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs.

Ethics and dissemination

Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

NCT05464394

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

ISRCTN16299220.

Cohort profile: EFTER-COVID - a Danish nationwide cohort for assessing the long-term health effects of the COVID-19 pandemic

Por: Sorensen · A. I. V. · Bager · P. · Nielsen · N. M. · Koch · A. · Spiliopoulos · L. · Hviid · A. · Ethelberg · S.
Purpose

To follow SARS-CoV-2-infected persons up to 18 months after a positive test in order to assess the burden and nature of post acute symptoms and health problems.

Participants

Persons in Denmark above 15 years of age, who were tested positive for SARS-CoV-2 during 1 September 2020 to 21 February 2023 using a RT-PCR test. As a reference group, three test-negative individuals were selected for every two test-positive individuals by matching on test date.

Findings to date

In total, 2 427 913 invitations to baseline questionnaires have been sent out and 839 528 baseline questionnaires (34.5%) have been completed. Females, the age group 50–69 years, Danish-born and persons, who had received at least one SARS-CoV-2 vaccination booster dose were more likely to participate. Follow-up questionnaires were sent at 2, 4, 6, 9, 12 and 18 months after the test, with response rates at 42%–54%.

Future plans

New participants have been recruited on a daily basis from 1 August 2021 to 23 March 2023. Data collection will continue until the last follow-up questionnaires (at 18 months after test) have been distributed in August 2024.

Bacterial growth in patients with low back pain and Modic changes: protocol of a multicentre, case-control biopsy study

Por: Rolfsen · M. P. · Gammelsrud · K. W. · Espeland · A. · Braten · L. C. · Mjones · S. B. · Austevoll · I. · Dolatowski · F. C. · Arrestad · M. B. · Toppe · M. K. · Orlien · I. E. · Holberg-Petersen · M. · Fagerland · M. · Zwart · J.-A. · Storheim · K. · Hellum · C.
Introduction

Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.

Methods and analysis

This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.

Ethics and dissemination

The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.

Trial registration number

NCT03406624.

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial

Por: Little · R. B. · Carter · S. J. · Motl · R. W. · Hunter · G. · Cook · A. · Liu · N. · Krontiras · H. · Lefkowitz · E. J. · Turan · B. · Schleicher · E. · Rogers · L. Q.
Introduction

Breast cancer survivors have an increased risk for chronic fatigue and altered gut microbiota composition, both with negative health and quality of life affects. Exercise modestly improves fatigue and is linked to gut microbial diversity and production of beneficial metabolites. Studies suggest that gut microbiota composition is a potential mechanism underlying fatigue response to exercise. Randomised controlled trials testing the effects of exercise on the gut microbiome are limited and there is a scarcity of findings specific to breast cancer survivors. The objective of this study is to determine if fitness-related modifications to gut microbiota occur and, if so, mediate the effects of aerobic exercise on fatigue response.

Methods and analysis

The research is a randomised controlled trial among breast cancer survivors aged 18–74 with fatigue. The primary aim is to determine the effects of aerobic exercise training compared with an attention control on gut microbiota composition. The secondary study aims are to test if exercise training (1) affects the gut microbiota composition directly and/or indirectly through inflammation (serum cytokines), autonomic nervous system (heart rate variability) or hypothalamic-pituitary-adrenal axis mediators (hair cortisol assays), and (2) effects on fatigue are direct and/or indirect through changes in the gut microbiota composition. All participants receive a standardised controlled diet. Assessments occur at baseline, 5 weeks, 10 weeks and 15 weeks (5 weeks post intervention completion). Faecal samples collect the gut microbiome and 16S gene sequencing will identify the microbiome. Fatigue is measured by a 13-item multidimensional fatigue scale.

Ethics and dissemination

The University of Alabama at Birmingham Institutional Review Board (IRB) approved this study on 15 May 2019, UAB IRB#30000320. A Data and Safety Monitoring Board convenes annually or more often if indicated. Findings will be disseminated in peer-reviewed journals and conference presentations.

Trial registration number

ClinicalTrials.gov, NCT04088708.

Impacts on paediatricians testifying in cases of child maltreatment: protocol for a systematic review

Por: Horstman · A. · Smith · J. A. S. · Bassed · R. B. · Bugeja · L.
Introduction

Paediatricians perform medical assessments for children in cases of suspected child maltreatment. Due to their role with statutory child protection agencies and police, paediatricians may be asked to testify in court about child protection and criminal justice matters. To the authors’ knowledge, there has been no previous systematic review of the literature synthesising the evidence on the impacts on paediatricians testifying in cases of child maltreatment.

Methods and analysis

A search strategy comprising indexed and key terms will be applied to six electronic reference databases from inception to May 2023: Medline, EMBASE, PsycINFO, CINAHL, Criminal Justice Abstracts and Cochrane Library. Two reviewers will independently screen titles and abstracts and full-text articles against predefined eligibility criteria to identify studies of interest. Conflicts will be independently adjudicated by a third reviewer.

Ethics and dissemination

Since the systematic review methodology aims at synthesising information from available publications, this study does not require ethical approval. An article reporting the results of the systematic review will be submitted for publication in a scientific journal, presented at relevant conferences and used in subsequent stakeholder consultations.

Effects of physiotherapy and home-based training in parkinsonian syndromes: protocol for a randomised controlled trial (MobilityAPP)

Por: Raccagni · C. · Sidoroff · V. · Paraschiv-Ionescu · A. · Roth · N. · Schönherr · G. · Eskofier · B. · Gassner · H. · Kluge · F. · Teatini · F. · Seppi · K. · Goebel · G. · Benninger · D. H. · Aminian · K. · Klucken · J. · Wenning · G.
Introduction

Gait and mobility impairment are pivotal signs of parkinsonism, and they are particularly severe in atypical parkinsonian disorders including multiple system atrophy (MSA) and progressive supranuclear palsy (PSP). A pilot study demonstrated a significant improvement of gait in patients with MSA of parkinsonian type (MSA-P) after physiotherapy and matching home-based exercise, as reflected by sensor-based gait parameters. In this study, we aim to investigate whether a gait-focused physiotherapy (GPT) and matching home-based exercise lead to a greater improvement of gait performance compared with a standard physiotherapy/home-based exercise programme (standard physiotherapy, SPT).

Methods and analysis

This protocol was deployed to evaluate the effects of a GPT versus an active control undergoing SPT and matching home-based exercise with regard to laboratory gait parameters, physical activity measures and clinical scales in patients with Parkinson’s disease (PD), MSA-P and PSP. The primary outcomes of the trial are sensor-based laboratory gait parameters, while the secondary outcome measures comprise real-world derived parameters, clinical rating scales and patient questionnaires. We aim to enrol 48 patients per disease group into this double-blind, randomised-controlled trial. The study starts with a 1 week wearable sensor-based monitoring of physical activity. After randomisation, patients undergo a 2 week daily inpatient physiotherapy, followed by 5 week matching unsupervised home-based training. A 1 week physical activity monitoring is repeated during the last week of intervention.

Ethics and dissemination

This study, registered as ‘Mobility in Atypical Parkinsonism: a Trial of Physiotherapy (Mobility_APP)’ at clinicaltrials.gov (NCT04608604), received ethics approval by local committees of the involved centres. The patient’s recruitment takes place at the Movement Disorders Units of Innsbruck (Austria), Erlangen (Germany), Lausanne (Switzerland), Luxembourg (Luxembourg) and Bolzano (Italy). The data resulting from this project will be submitted to peer-reviewed journals, presented at international congresses and made publicly available at the end of the trial.

Trial registration number

NCT04608604.

Chiropractic spinal manipulation and likelihood of tramadol prescription in adults with radicular low back pain: a retrospective cohort study using US data

Por: Trager · R. J. · Cupler · Z. A. · Srinivasan · R. · Casselberry · R. M. · Perez · J. A. · Dusek · J. A.
Objectives

Patients receiving chiropractic spinal manipulation (CSM) for low back pain (LBP) are less likely to receive any opioid prescription for subsequent pain management. However, the likelihood of specifically being prescribed tramadol, a less potent opioid, has not been explored. We hypothesised that adults receiving CSM for newly diagnosed radicular LBP would be less likely to receive a tramadol prescription over 1-year follow-up, compared with those receiving usual medical care.

Design

Retrospective cohort study.

Setting

US medical records-based dataset including >115 million patients attending academic health centres (TriNetX, Inc), queried 9 November 2023.

Participants

Opioid-naive adults aged 18–50 with a new diagnosis of radicular LBP were included. Patients with serious pathology and tramadol use contraindications were excluded. Variables associated with tramadol prescription were controlled via propensity matching.

Interventions

Patients were divided into two cohorts dependent on treatment received on the index date of radicular LBP diagnosis (CSM or usual medical care).

Primary and secondary outcome measures

Risk ratio (RR) for tramadol prescription (primary); markers of usual medical care utilisation (secondary).

Results

After propensity matching, there were 1171 patients per cohort (mean age 35 years). Tramadol prescription was significantly lower in the CSM cohort compared with the usual medical care cohort, with an RR (95% CI) of 0.32 (0.18 to 0.57; p

Conclusions

This study found that US adults initially receiving CSM for radicular LBP had a reduced likelihood of receiving a tramadol prescription over 1-year follow-up. These findings should be corroborated by a prospective study to minimise residual confounding.

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

Por: Ben · A. J. · van der Vaart · L. R. · E. Bosmans · J. · Roovers · J.-P. W. R. · Lagro-Janssen · A. L. M. · van der Vaart · C. H. · Vollebregt · A. · PEOPLE group · Milani · Bon · Bongers · Bos · Broekman · Dietz · van Eijndhoven · Hakvoort · Janszen · Kluivers · Link · Massop-Hel
Objective

To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.

Design

Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

Setting

21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

Participants

1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.

Interventions

Pessary therapy and surgery.

Primary and secondary outcome measures

The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of –10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.

Results

For the PGI-I, the mean difference between pessary therapy and surgery was –0.05 (95% CI –0.14; 0.03) and –0.03 (95% CI –0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=–1807, 95% CI –2172; –1446 and mean difference=–1850, 95% CI –2349; –1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between 0 and 20 000/QALY gained from both perspectives.

Conclusions

Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.

Trial registration number

NTR4883.

Is the QCI framework suited for monitoring outcomes and costs in a teaching hospital using value-based healthcare principles? A retrospective cohort study

Por: van Veghel · W. · van Dijk · S. C. · Klem · T. M. · Weel · A. E. · Bügel · J.-B. · Birnie · E.
Objectives

The objective is to develop a pragmatic framework, based on value-based healthcare principles, to monitor health outcomes per unit costs on an institutional level. Subsequently, we investigated the association between health outcomes and healthcare utilisation costs.

Design

This is a retrospective cohort study.

Setting

A teaching hospital in Rotterdam, The Netherlands.

Participants

The study was performed in two use cases. The bariatric population contained 856 patients of which 639 were diagnosed with morbid obesity body mass index (BMI)

Primary and secondary outcome measures

The quality cost indicator (QCI) was the primary measures and was defined as

QCI = (resulting outcome * 100)/average total costs (per thousand Euros)

where average total costs entail all healthcare utilisation costs with regard to the treatment of the primary diagnosis and follow-up care. Resulting outcome is the number of patients achieving textbook outcome (passing all health outcome indicators) divided by the total number of patients included in the care path.

Results

The breast cancer and bariatric population had the highest resulting outcome values in 2020 Q4, 0.93 and 0.73, respectively. The average total costs of the bariatric population remained stable (avg, 8833.55, min 8494.32, max 9164.26). The breast cancer population showed higher variance in costs (avg, 12 735.31 min 12 188.83, max 13 695.58). QCI values of both populations showed similar variance (0.3 and 0.8). Failing health outcome indicators was significantly related to higher hospital-based costs of care in both populations (p

Conclusions

The QCI framework is effective for monitoring changes in average total costs and relevant health outcomes on an institutional level. Health outcomes are associated with hospital-based costs of care.

Determinants of unmet need for modern contraceptives in Ethiopia

Por: Gebrekidan · H. · Alemayehu · M. · Debelew · G. T.
Objective

To identify the determinants of the unmet need for modern contraceptives in Ethiopia.

Design

Community-based cross-sectional study.

Setting

Ethiopia.

Participants

A group of 6636 women of reproductive age (15–49 years) who were sexually active were included in the study.

Outcome

Unmet need for modern contraceptives

Method

The study used data from the 2019 Performance Monitoring for Action-Ethiopia survey, which was community-based and cross-sectional. The sample consisted of women aged 15–49 from households randomly selected to be nationally representative. Multinomial logistic regression and spatial analysis were performed to determine the factors influencing unmet needs for modern contraceptives. The descriptive analysis incorporated svy commands to account for clustering.

Results

The proportion of unmet need for modern contraceptives was 19.7% (95% CI: 18% to 21.5%). Women with supportive norms towards family planning had a lower risk of unmet need for spacing (relative risk ratio (RRR)=0.92, 95% CI: 0.86 to 0.99). Older age lowered the risk of unmet need for spacing 40–44 (RRR=0.28, 95% CI: 0.13 to 0.59) and 45–49 (RRR=0.11, 95% CI: 0.04 to 0.31). Being married increased the unmet need for spacing (RRR=1.9, 95% CI: 1.36 to 2.7) and limiting (RRR=3.7, 95% CI: 1.86 to 7.4). Increasing parity increases the risk of unmet need for spacing (RRR=1.27, 95% CI: 1.16 to 1.38) and limiting (RRR=1.26, 95% CI: 1.15 to 1.4). Contrarily, older age increased the risk of unmet need for limiting 40–44 (RRR=10.2, 95% CI: 1.29 to 79.5), 45–49 (RRR=8.4, 95% CI: 1.03 to 67.4). A clustered spatial unmet need for modern contraceptives was observed (Global Moran’s I=0.715: Z-Score=3.8496, p

Conclusions

High levels of unmet need for modern contraceptives were observed in Ethiopia, showing geographical variations. It is essential to address the key factors affecting women and work towards reducing disparities in modern contraceptive unmet needs among different regions.

Cost analysis for initiating an integrated package of essential non-communicable disease interventions (PEN-Plus) in Kondoa District Hospital, Tanzania: a time-driven activity-based costing (TDABC) study protocol

Por: Ndumwa · H. P. · Mori · A. T. · Ruhago · G. M. · Willilo · R. · McBain · R. · Boudreaux · C. · Wroe · E. · Adler · A. J. · Bukhman · G. · Mayige · M. T. · Kaarboe · O.
Introduction

Non-communicable diseases (NCDs) constitute approximately 74% of global mortality, with 77% of these deaths occurring in low-income and middle-income countries. Tanzania exemplifies this situation, as the percentage of total disability-adjusted life years attributed to NCDs has doubled over the past 30 years, from 18% to 36%. To mitigate the escalating burden of severe NCDs, the Tanzanian government, in collaboration with local and international partners, seeks to extend the integrated package of essential interventions for severe NCDs (PEN-Plus) to district-level facilities, thereby improving accessibility. This study aims to estimate the cost of initiating PEN-Plus for rheumatic heart disease, sickle cell disease and type 1 diabetes at Kondoa district hospital in Tanzania.

Methods and analysis

We will employ time-driven activity-based costing (TDABC) to quantify the capacity cost rates (CCR), and capital and recurrent costs associated with the implementation of PEN-Plus. Data on resource consumption will be collected through direct observations and interviews with nurses, the medical officer in charge and the heads of laboratory and pharmacy units/departments. Data on contact times for targeted NCDs will be collected by observing a sample of patients as they move through the care delivery pathway. Data cleaning and analysis will be done using Microsoft Excel.

Ethics and dissemination

Ethical approval to conduct the study has been waived by the Norwegian Regional Ethics Committee and was granted by the Tanzanian National Health Research Ethics Committee NIMR/HQ/R.8a/Vol.IX/4475. A written informed consent will be provided to the study participants. This protocol has been disseminated in the Bergen Centre for Ethics and Priority Setting International Symposium, Norway and the 11th Muhimbili University of Health and Allied Sciences Scientific Conference, Tanzania in 2023. The findings will be published in peer-reviewed journals for use by the academic community, researchers and health practitioners.

Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance

Por: Ramboarina · S. · Crucitti · T. · Gill · K. · Bekker · L. G. · Harding-Esch · E. M. · van de Wijgert · J. H. H. M. · Huynh · B.-T. · Fortas · C. · Harimanana · A. · Mayouya Gamana · T. · Randremanana · R. V. · Mangahasimbola · R. · Dziva Chikwari · C. · Kranzer · K. · Mackworth-You
Introduction

A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test—called the Genital InFlammation Test (GIFT)—for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care.

Methods and analysis

We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical (‘diagnostic study’) and a qualitative, modelling and economic (‘an integration into care study’) part. The diagnostic study aims to evaluate GIFT’s performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms.

Ethics and dissemination

Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.

The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d’Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).

Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).

Trial registration number

NCT05723484.

Parents' Trigger Tool for Children with Medical Complexity – PAT‐CMC: Development of a recognition tool for clinical deterioration at home

Abstract

Aim

To develop a trigger tool for parents and lay caregivers of children with medical complexity (CMC) at home and to validate its content.

Design

This was a multi-method study, using qualitative data, a Delphi method and a concept mapping approach.

Methods

A three-round electronic Delphi was performed from December 2021 to April 2022 with a panel of 23 expert parents and 30 healthcare providers, supplemented by a preliminary qualitative exploration of children's signs of deterioration and three consensus meetings to develop the PArents' Trigger Tool for Children with Medical Complexity (PAT-CMC). Cognitive interviews with parents were performed to assess the comprehensiveness and comprehensibility of the tool. The COREQ checklist, the COSMIN guidelines and the CREDES guidelines guided the reporting respectively of the qualitative study, the development and content validity of the trigger tool and the Delphi study.

Results

The PAT-CMC was developed and its content validated to recognize clinical deterioration at home. The tool consists of 7 main clusters of items: Breathing, Heart, Devices, Behaviour, Neuro-Muscular, Nutrition/Hydration and Other Concerns. A total of 23 triggers of deterioration were included and related to two recommendations for escalation of care, using a traffic light coding system.

Conclusion

Priority indicators of clinical deterioration of CMC were identified and integrated into a validated trigger tool designed for parents or other lay caregivers at home, to recognize signs of acute severe illness and initiate healthcare interventions.

Impact

The PAT-CMC was developed to guide families in recognizing signs of deterioration in CMC and has potential for initiating an early escalation of care. This tool may also be useful to support education provided by healthcare providers to families before hospital discharge.

Patient or Public Contribution

Parents of CMC were directly involved in the selection of relevant indicators of children's clinical deterioration and the development of the trigger tool. They were not involved in the design, conducting, reporting or dissemination plans of this research.

Entangled in complexity: An ethnographic study of organizational adaptability and safe care transitions for patients with complex care needs

Abstract

Aim

The aim of this study was to visualize vulnerabilities and explore the dynamics of inter-professional collaboration and organizational adaptability in the context of care transitions for patients with complex care needs.

Design

An ethnographic design using multiple convergent data collection techniques.

Methods

Data collection involved document review, participant observations and interviews with healthcare and social care professionals (HSCPs). Narrative analysis was employed to construct two illustrative patient scenarios, which were then examined using the Functional Resonance Analysis Method (FRAM). Thematic analysis was subsequently applied to synthesize the findings.

Results

Inconsistencies in timing and precision during care transitions pose risks for patients with complex care needs as they force healthcare systems to prioritize structural constraints over individualized care, especially during unforeseen events outside regular hours. Such systemic inflexibility can compromise patient safety, increase the workload for HSCPs and strain resources. Organizational adaptability is crucial to managing the inherent variability of patient needs. Our proposed ‘safe care transition pathway’ addresses these issues, providing proactive strategies such as sharing knowledge and increasing patient participation, and strengthening the capacity of professionals to meet dynamic care needs, promoting safer care transitions.

Conclusion

To promote patient safety in care transitions, strategies must go beyond inter-professional collaboration, incorporating adaptability and flexible resource planning. The implementation of standardized safe care transition pathways, coupled with the active participation of patients and families, is crucial. These measures aim to create a resilient, person-centred approach that may effectively manage the complexities in care transitions.

Implications

The recommendations of this study span the spectrum from policy-level changes aimed at strategic resource allocation and fostering inter-professional collaboration to practical measures like effective communication, information technology integration, patient participation and family involvement. Together, the recommendations offer a holistic approach to enhance care transitions and, ultimately, patient outcomes.

Reporting Method

Findings are reported per the Consolidated Criteria for Reporting Qualitative research (COREQ).

Patient or Public Contribution

No patient or public contribution.

Protective and risk factors of workplace violence against nurses: A cross‐sectional study

Abstract

Aims

To describe how workplace violence (WPV) is experienced by nurses in hospitals and community services and identify protective and risk factors.

Methods

An online cross-sectional national study was conducted from January to April 2021 in Italy. Hospitals and community services were involved in the study. The survey combined the adapted and validated Italian version of the Violence in Emergency Nursing and Triage (VENT) questionnaire, which explores the episodes of WPV experienced during the previous 12 months, the Practice Environment Scale of the Nursing Work Index (PES-NWI) and some additional questions about staffing levels extracted from a previous RN4CAST study. Nurses working in all clinical settings and community services were invited to participate in the survey. Descriptive and inferential statistics were used for data analysis. We adhered to the STROBE reporting guidelines.

Results

A total of 6079 nurses completed the survey, 32.4% (n = 1969) had experienced WPV in the previous 12 months, and 46% (n = 920) reported WPV only in the previous week. The most significant protective factors were nurses' age, patients' use of illegal substances, attitude of individual nurses and considering effective the organization's procedures for preventing and managing episodes of violence. The most significant risk factors included workload, recognizing violence as an inevitable part of the job, patients' cultural aspects and patients' agitated behaviour. The frequency of WPV was significantly higher in certain areas, such as the emergency department and in mental health wards.

Conclusion

Workplace violence (WPV) against nurses is a very frequent and concerning issue, especially in hospitals and community services. Based on our findings, integrated and multimodal programmes for prevention and management of WPV are recommended. More attention and resources need to be allocated to reduce WPV by improving the quality of nurses' workplace environment and implementing violence-free policies for hospitals.

Implications for the Profession and/or Patient Care

Impact

Workplace verbal and physical violence is a widespread phenomenon, both in hospital and community settings, and even during COVID-19 pandemic. This problem is exacerbated by the lack of effective reporting systems, fear of retaliation and the tendency to consider violence as an inevitable part of the job. The characteristics of professionals, patients, work environment and organizational factors are involved in the spread of workplace violence, determining its multifactorial nature. Integrated and multimodal programmes to prevent and manage of workplace violence are probably the only way to effectively counteract workplace violence against nurses. Healthcare policymakers, managers of hospital and community services need to proactively prevent and effectively manage and monitor episodes of violence. Nurses need to feel protected and safeguarded against any form of verbal or physical violence, to provide high-quality care in a totally safe environment.

Patient or Public Contribution

No patient or public contribution.

Multiparameter immunoprofiling for the diagnosis and differentiation of progressive versus nonprogressive nontuberculous mycobacterial lung disease–A pilot study

by Paige K. Marty, Balaji Pathakumari, Thomas M. Cox, Virginia P. Van Keulen, Courtney L. Erskine, Maleeha Shah, Mounika Vadiyala, Pedro Arias-Sanchez, Snigdha Karnakoti, Kelly M. Pennington, Elitza S. Theel, Cecilia S. Lindestam Arlehamn, Tobias Peikert, Patricio Escalante

Clinical prediction of nontuberculous mycobacteria lung disease (NTM-LD) progression remains challenging. We aimed to evaluate antigen-specific immunoprofiling utilizing flow cytometry (FC) of activation-induced markers (AIM) and IFN-γ enzyme-linked immune absorbent spot assay (ELISpot) accurately identifies patients with NTM-LD, and differentiate those with progressive from nonprogressive NTM-LD. A Prospective, single-center, and laboratory technician-blinded pilot study was conducted to evaluate the FC and ELISpot based immunoprofiling in patients with NTM-LD (n = 18) and controls (n = 22). Among 18 NTM-LD patients, 10 NTM-LD patients were classified into nonprogressive, and 8 as progressive NTM-LD based on clinical and radiological features. Peripheral blood mononuclear cells were collected from patients with NTM-LD and control subjects with negative QuantiFERON results. After stimulation with purified protein derivative (PPD), mycobacteria-specific peptide pools (MTB300, RD1-peptides), and control antigens, we performed IFN-γ ELISpot and FC AIM assays to access their diagnostic accuracies by receiver operating curve (ROC) analysis across study groups. Patients with NTM-LD had significantly higher percentage of CD4+/CD8+ T-cells co-expressing CD25+CD134+ in response to PPD stimulation, differentiating between NTM-LD and controls. Among patients with NTM-LD, there was a significant difference in CD25+CD134+ co-expression in MTB300-stimulated CD8+ T-cells (p

Knowledge, attitudes, and practices about HIV and other sexually transmitted infections among High School students in Southern Italy: A cross-sectional survey

by Francesco Di Gennaro, Francesco Vladimiro Segala, Giacomo Guido, Mariacristina Poliseno, Laura De Santis, Alessandra Belati, Carmen Rita Santoro, Irene Francesca Bottalico, Carmen Pellegrino, Roberta Novara, Luisa Frallonardo, Mariangela Cormio, Michele Camporeale, Sergio Cotugno, Vincenzo Giliberti, Stefano Di Gregorio, Valentina Totaro, Nicola Catucci, Anna De Giosa, Roberta Giusto, Ilaria Viviana Lanera, Gioacchino Angarano, Sergio Lo Caputo, Annalisa Saracino

High School students, recognized as a high-risk group for sexually transmitted infections (STIs), were the focal point of an educational campaign in Southern Italy to share information and good practices about STIs and HIV/AIDS. A baseline survey comprising 76 items was conducted via the REDCap platform to assess students’ initial knowledge, attitudes, and practices (KAP) related to STIs and HIV/AIDS. Sociodemographic variables were also investigated. The association between variables and KAP score was assessed by Kruskal-Wallis’ or Spearman’s test, as appropriate. An ordinal regression model was built to estimate the effect size, reported as odds ratio (OR) with a 95% confidence interval (CI), for achieving higher KAP scores among students features. On a scale of 0 to 29, 1702 participants achieved a median KAP score of 14 points. Higher scores were predominantly reported by students from classical High Schools (OR 3.19, 95% C.I. 1.60–6.33, p

Effects of (2<i>R</i>,6<i>R</i>)-hydroxynorketamine in assays of acute pain-stimulated and pain-depressed behaviors in mice

by Todd M. Hillhouse, Kaitlyn J. Partridge, Patrick I. Garrett, Sarah C. Honeycutt, Joseph H. Porter

Ketamine has been shown to produce analgesia in various acute and chronic pain states; however, abuse liability concerns have limited its utility. The ketamine metabolite (2R,6R)-hydroxynorketamine (HNK) has been shown to produce antidepressant-like effects similar to ketamine without abuse liability concerns. (2R,6R)-HNK produces sustained analgesia in models of chronic pain, but has yet to be evaluated in models of acute pain. The present study evaluated the efficacy of acute (2R,6R)-HNK administration (one injection) in assays of pain-stimulated (52- and 56-degree hot plate test and acetic acid writhing) and pain-depressed behavior (locomotor activity and rearing) in male and female C57BL/6 mice. In assays of pain-stimulated behaviors, (2R,6R)-HNK (1–32 mg/kg) failed to produce antinociception in the 52- and 56-degree hot plate and acetic acid writhing assays. In assays of pain-depressed behaviors, 0.56% acetic acid produced a robust depression of locomotor activity and rearing that was not blocked by pretreatment of (2R,6R)-HNK (3.2–32 mg/kg). The positive controls morphine (hot plate test) and ketoprofen (acetic acid writhing, locomotor activity, and rearing) blocked pain-stimulated and pain-depressed behaviors. Finally, the effects of intermittent (2R,6R)-HNK administration were evaluated in 52-degree hot plate and pain-depressed locomotor activity and rearing. Intermittent administration of (2R,6R)-HNK also did not produce antinociceptive effects in the hot plate or pain-depressed locomotor activity assays. These results suggest that (2R,6R)-HNK is unlikely to have efficacy in treating acute pain; however, the efficacy of (2R,6R)-HNK in chronic pain states should continue to be evaluated.
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