bluuebunny/crossref_metadata_2025 huggingface dataset:
Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial
Authors: Kołodziej Maciej , Bebenek Dorota , Konarska Zofia , Szajewska Hania
Published: April 2023

Objective

To assess the efficacy of gelatine tannate (a complex of tannic acid with astringent and anti-inflammatory properties, and a protective gelatine) for the treatment of acute gastroenteritis (AGE) in children.

Design

Randomised, double-blind, placebo-controlled trial. Intention-to-treat analysis.

Setting

Two paediatric hospitals in Warsaw.

Participants

Children younger than 5 years of age with AGE, defined as a change in stool consistency to a loose or liquid form (according to the Bristol Stool Form Scale or Amsterdam Stool Form Scale) and/or an increase in the frequency of evacuations (≥3 in 24 hours), lasting for no longer than 5 days.

Interventions

Seventy-two children were assigned to receive gelatine tannate (n=36) or placebo (n=36) in addition to standard rehydration therapy. The gelatine tannate was administered at an age-dependent dose (250–500 mg), and both study products were taken four times per day for 5 days.

Primary and secondary outcome measures

The main outcome measure was duration of diarrhoea. Secondary outcomes included the need for intravenous rehydration, need for hospitalisation of outpatients, number of watery stools per day, vomiting, weight gain, adverse events, recurrence of diarrhoea, severity of diarrhoea according to the Vesikari Scale and use of concomitant medications.

Results

Sixty-four children (89%) completed the intervention and were included in the analysis. The duration of diarrhoea after randomisation was similar in the gelatine tannate and placebo groups (75.6±27.8 vs 75.5±29.0 hours, respectively, mean difference 0.1 hours, 95% CI −14.1 to 14.3 hours). There was no significant difference between groups in the number of watery stools per day throughout the study period. There were also no differences in any other secondary outcome measures between groups.

Conclusion

In children with AGE younger than 5 years of age, gelatine tannate was ineffective as an adjunct to rehydration therapy.

Trial registration number

NCT02280759.
Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol
Authors: Thamsborg Lise Holst , Andersen Berit , Larsen Lise Grupe , Christensen Jette , Johansen Tonje , Hariri Jalil , Christiansen Sanne , Rygaard Carsten , Lynge Elsebeth
Published: April 2023

Introduction

The first birth cohorts of women offered human papillomavirus (HPV) vaccination as girls are now entering cervical screening. However, there is no international consensus on how to screen HPV vaccinated women. These women are better protected against cervical cancer and could therefore be offered less intensive screening. Primary HPV testing is more sensitive than cytology, allowing for a longer screening interval. The aim of Trial23 is to investigate if primary HPV testing with cytology triage of HPV positive samples is a reasonable screening scheme for women offered HPV vaccination as girls.

Methods

Trial23 is a method study embedded in the existing cervical screening programme in four out of five Danish regions. Without affecting the screening programme, women born in 1994 are randomised to present screening with liquid-based cytology every third year (present programme arm) or present screening plus an HPV test (HPV arm). The study started 1 February 2017 and will run over three screening rounds corresponding to 7–8 years.

Analyses

The primary endpoint is cervical intraepithelial neoplasia grade 3 or above. The trial is undertaken as a non-inferiority study including intention-to-treat and per-protocol analyses. The potential effect of primary HPV screening with a 6-year interval will be calculated from the observed data.

Ethics and dissemination

The study protocol has been submitted to the ethical committee and deemed a method study. All women are screened according to routine guidelines. The study will contribute new evidence on the future screening of HPV vaccinated birth cohorts of women. All results will be published in open-access journal.

Trial registration

NCT03049553.
The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) retrospective heart failure study design
Authors: Yu Yuan , Zhang Hongzhao , Li Xi , Lu Yuan , Masoudi Frederick A , Krumholz Harlan M , Li Jing
Published: April 2023

Introduction

Heart failure (HF) is a leading cause of hospitalisation in China, which is experiencing a rapid increase in cardiovascular disease prevalence. Yet, little is known about current burden of disease, quality of care and treatment outcomes of HF in China. The objective of this paper is to describe the study methodology, data collection and abstraction, and progress to date of the China Patient-centered Evaluative Assessment of Cardiac Events 5 Retrospective Heart Failure Study (China PEACE 5r-HF).

Methods and analysis

The China PEACE 5r-HF Study will examine a nationally representative sample of more than 10 000 patient records hospitalised for HF in 2015 in China. The study is a retrospective cohort study. Patients have been selected using a two-stage sampling design stratified by economic–geographical regions. We will collect patient characteristics, diagnostic testing, treatments and in-hospital outcomes, including death and complications, and charges of hospitalisation. Data quality will be monitored by a central coordinating centre and will address case ascertainment, data abstraction and data management. As of October 2017, we have sampled 15 538 medical records from 189 hospitals, and have received 15 057 (96.9%) of these for data collection, and completed data abstraction and quality control on 7971.

Ethics and dissemination

The Central Ethics Committee at the Chinese National Center for Cardiovascular Diseases approved the study. All collaborating hospitals accepted central ethics committee approval with the exception of 15 hospitals, which obtained local approval by internal ethics committees. Findings will be disseminated in future peer-reviewed papers and will serve as a foundation for improving the care for HF in China.

Trial registration number

NCT02877914.
Study protocol for a randomised controlled trial examining the association between physical activity and sleep quality in children with autism spectrum disorder based on the melatonin-mediated mechanism model
Authors: Tse Andy C Y , Lee Paul H , Zhang Jihui , Lai Elvis W H
Published: April 2023

Introduction

Sleep disturbance is commonly observed in children with autism spectrum disorders (ASD). Disturbed sleep may exacerbate the core symptoms of ASD. Behavioural interventions and supplemental melatonin medication are traditionally used to improve sleep quality, but poor sustainability of behavioural intervention effects and use of other medications that metabolise melatonin may degrade the effectiveness of these interventions. However, several studies have suggested that physical activity may provide an effective intervention for treating sleep disturbance in typically developing children. Thus, we designed a study to examine whether such an intervention is also effective in children with ASD. We present a protocol (4 December 2017) for a jogging intervention with a parallel and two-group randomised controlled trial design using objective actigraphic assessment and 6-sulfatoxymelatonin measurement to determine whether a 12-week physical activity intervention elicits changes in sleep quality or melatonin levels.

Methods and analysis

All eligible participants will be randomly allocated to either a jogging intervention group or a control group receiving standard care. Changes in sleep quality will be monitored through actigraphic assessment and parental sleep logs. All participants will also be instructed to collect a 24-hour urine sample. 6-sulfatoxymelatonin, a creatinine-adjusted morning urinary melatonin representative of the participant’s melatonin levels, will be measured from the sample. All assessments will be carried out before the intervention (T1), immediately after the 12-week intervention or regular treatment (T2), 6 weeks after the intervention (T3) and 12 weeks after the intervention (T4) to examine the sustainability of the intervention effects. The first enrolment began in February 2018.

Ethics and dissemination

Ethical approval was obtained through the Human Research Ethics Committee, Education University of Hong Kong. The results of this trial will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT03348982.
Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany
Authors: Krüger Klaus , Burmester Gerd R , Wassenberg Siegfried , Bohl-Bühler Martin , Thomas Matthias H
Published: April 2023

Objective

The Non Interventional Evaluation with Golumimab (GO-NICE) study aimed to document patient and treatment characteristics as well as clinical effectiveness and safety in adult patients newly treated with the tumour necrosis factor inhibitor golimumab (GLM).

Design

Prospective non-interventional study with 24-month observation per patient.

Setting

158 office-based and clinical-based physicians in Germany.

Intervention

GLM administered in the 50 mg dose subcutaneously in monthly intervals under real-life conditions.

Results

Of the 1613 included patients, 1458 patients were eligible for final analysis: 474 patients with rheumatoid arthritis (RA, 54.9±13.4 years, 72.8% women, 64.7% biologic-naïve), 501 with psoriatic arthritis (PsA, 50.5±12.1 years, 54.1% women, 56.5% biologic-naïve) and 483 with ankylosing spondylitis (AS, 43.6±12.3 years, 66.5% men, 61.0% biologic-naïve). 664 patients completed follow-up (2-year retention rate 45.5%). Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28-ESR) decreased from 5.0 to 2.9 after 24 months (p<0.0001) in patients with RA, and Bath Ankylosing Spondylitis Disease Index score decreased from 5.1 to 2.4 (p<0.0001) in patients with AS. Response rate calculated in patients with PsA by modified Psoriatic Arthritis Response Criteria was 67.9% after 24 months. Most adverse events were of mild or moderate nature, and no new safety signals were detected. According to the physicians’ clinical assessments, treatment with GLM was successful (no adverse drug reaction and a clear or moderate therapeutic effect in an individual patient) in 55.0%–56.6% of patients with RA, PsA and AS, respectively, at month 3, increasing from 74.5% to 76.1% at month 24.

Conclusions

GLM subcutaneously once monthly led to substantial improvements in clinical effectiveness in patients with various inflammatory rheumatic diseases who could be followed up in a real-life setting in Germany. The treatment was well tolerated, and the safety profile of GLM was consistent with that observed in the previous randomised controlled trials.

Trial registration number

NCT01313858.
Integrating culturally informed approaches into physiotherapy assessment and treatment of chronic pain: a pilot randomised controlled trial
Authors: Brady Bernadette , Veljanova Irena , Schabrun Siobhan , Chipchase Lucinda
Published: April 2023

Objective

To evaluate patient engagement with, and the feasibility of, a novel, culturally adapted physiotherapy pain management approach.

Design

A participant-blinded and assessor-blinded pilot randomised controlled trial.

Setting

Outpatient physiotherapy departments at two public hospitals and one district pain clinic.

Participants

Adults (n=48) with chronic musculoskeletal pain (daily pain >3 months), who self-identified as Mandaean, Assyrian or Vietnamese, were randomised to one of two physiotherapy treatment conditions.

Interventions

24 participants underwent combined group and individualised treatment described as ‘culturally adapted physiotherapy’, while 24 underwent evidence-informed ‘usual physiotherapy care’. Both treatment arms consisted of up to 10 sessions over a 3-month period.

Outcome measures

Patient engagement was measured via participant attendance, adherence and satisfaction data. Secondary outcomes included clinical measures of pain severity, interference and suffering, physical function and negative emotional state.

Results

96% of participants undergoing culturally adapted physiotherapy completed treatment, compared with 58% of the usual physiotherapy group. For the culturally adapted group attendance (87%±18%) and adherence (68%±32%) were higher relative to usual care (68%±32% and 55%±43%). Satisfaction was similar for the culturally adapted (82.7%±13.4%) and usual care (79.3±17.3) groups. For secondary outcomes, a significant between-group effect for pain-related suffering in favour of the culturally adapted group was observed with a medium effect size (partial η20.086, mean 3.56, 95% CI 0.11 to 7), while results for pain severity, interference, physical function and negative emotional state were similar.

Conclusions

Aligning treatment with the beliefs and values of culturally and linguistically diverse communities enhances patient engagement with physiotherapy. These results support the feasibility of a larger, multisite trial to determine if improved engagement with culturally adapted physiotherapy translates to improved clinical outcomes.

Trial registration number

NCT12616000857404
Multicentre randomised controlled trial protocol of urine CXCL10 monitoring strategy in kidney transplant recipients
Authors: Ho Julie , Sharma Atul , Kroeker Kristine , Carroll Robert , De Serres Sacha , Gibson Ian W , Hirt-Minkowski Patricia , Jevnikar Anthony , Kim S Joseph , Knoll Greg , Rush David N , Wiebe Chris , Nickerson Peter
Published: April 2023

Introduction

Subclinical inflammation is an important predictor of death-censored graft loss, and its treatment has been shown to improve graft outcomes. Urine CXCL10 outperforms standard post-transplant surveillance in observational studies, by detecting subclinical rejection and early clinical rejection before graft functional decline in kidney transplant recipients.

Methods and analysis

This is a phase ii/iii multicentre, international randomised controlled parallel group trial to determine if the early treatment of rejection, as detected by urine CXCL10, will improve kidney allograft outcomes. Incident adult kidney transplant patients (n~420) will be enrolled to undergo routine urine CXCL10 monitoring postkidney transplant. Patients at high risk of rejection, defined as confirmed elevated urine CXCL10 level, will be randomised 1:1 stratified by centre (n=250). The intervention arm (n=125) will undergo a study biopsy to check for subclinical rejection and biopsy-proven rejection will be treated per protocol. The control arm (n=125) will undergo routine post-transplant monitoring. The primary outcome at 12 months is a composite of death-censored graft loss, clinical biopsy-proven acute rejection, de novo donor-specific antibody, inflammation in areas of interstitial fibrosis and tubular atrophy (Banff i-IFTA, chronic active T-cell mediated rejection) and subclinical tubulitis on 12-month surveillance biopsy. The secondary outcomes include decline of graft function, microvascular inflammation at 12 months, development of IFTA at 12 months, days from transplantation to clinical biopsy-proven rejection, albuminuria, EuroQol five-dimension five-level instrument, cost-effectiveness analysis of the urine CXCL10 monitoring strategy and the urine CXCL10 kinetics in response to rejection therapy.

Ethics and dissemination

The study has been approved by the University of Manitoba Health Research Ethics Board (HS20861, B2017:076) and the local research ethics boards of participating centres. Recruitment commenced in March 2018 and results are expected to be published in 2023. De-identified data may be shared with other researchers according to international guidelines (International Committee of Medical Journal Editors [ICJME]).

Trial registration number

NCT03206801; Pre-results.
Patient satisfaction in treatment of non-complex fractures and dislocations in general practice in the Netherlands: prospective cohort study protocol
Authors: Verbeek Tjitte , Arentsen Hans , Breet Evert Jan , Kuipers Machiel M , Lubbert Pieter H W , Burger Huibert
Published: April 2023

Introduction

Diagnosis and treatment of fractures and dislocations are mostly performed in hospital settings. However, equal care for patients with non-­complex fractures or dislocations (‘minor trauma care’) may be provided in general practice. While substitution of care from secondary to primary care settings is stimulated by governments and insurers, it is unknown what the effects are on patient satisfaction level. Therefore, our primary objective is to determine the effect of minor trauma care delivered in a general practice as compared with a hospital on patient satisfaction. Secondary objectives are to assess the effects on treatment outcomes, cost-effectiveness and time consumption.

Methods and analysis

In a prospective cohort study, we will include 200 patients aged 12 and over with an X-ray confirmed diagnosis of a non­-complex fracture or dislocation out of whom 100 treated in a general practice and 100 in a secondary care hospital, both located in the Netherlands. All treatment procedures and follow-up will be done in accordance to the hospital’s standards of trauma care. Study assessments will be performed pre-treatment, and 1, 6 and 12 weeks after treatment. Data collected include demographics, patient satisfaction and patient-reported outcomes including physical functioning, complications, pain scores and treatment-related costs. The primary outcome patient satisfaction measured at 12 weeks will be compared between the settings and additionally multivariable regression will be performed to assess potential confounding effects of unbalanced prognostic factors. Treatment outcomes and time consumption will be analysed following the same approach while cost-effectiveness will be assessed using an incremental cost-effectiveness ratio. Subsequently, results will be discussed using focus groups consisting of patients (n=15) and healthcare providers.

Ethics and dissemination

The Medical Ethics Committee from the University Medical Center Groningen reviewed this study protocol and granted exemption from ethical approval (METc UMCG 2017/277). Study results will be presented at (inter)national conferences and published in peer-reviewed journals.

Trial registration number

NCT03506958; Pre-results.
Protocol: randomised trial to compare nasoduodenal tube and nasogastric tube feeding in infants with bronchiolitis on high-flow nasal cannula; Bronchiolitis and High-flow nasal cannula with Enteral Tube feeding Randomised (BHETR) trial
Authors: Parlar-Chun Raymond , Lafferty-Prather Meaghan , Gonzalez Veronica , Pedroza Claudia , Gourishankar Anand
Published: April 2023

Introduction

High-flow nasal cannula (HFNC) is a non-invasive form of respiratory support used increasingly in bronchiolitis. HFNC provides a variable amount of positive pressure similar to continuous positive airway pressure (CPAP). The positive pressure in CPAP can distend and loosen oesophageal sphincter pressure leading to increased reflux. It is unclear if HFNC causes a similar action. Feeding tubes are used to provide nutrition and hydration to patients that are unable to safely take oral feedings. If there is increased reflux from HFNC, this would increase the risk of aspiration. Our institution places nasoduodenal tubes (NDT) to eliminate this risk. The purpose of the study is to infer if there is a difference between NDT and nasogastric tube (NGT) feeding with regard to length of respiratory support, number of emesis, number of chest X-rays and readmission/emergency room revisit rates.

Methods and analysis

Patients with bronchiolitis, on high-flow nasal cannula, and whose primary physicians have decided on feeding tube for nutrition/hydration will be approached for consent and enrolment. Patients will be randomised to NGT or NDT in variable block sizes and stratified into low- and high-risk groups. Outcomes will be analysed by both a frequentist and Bayesian statistical approach.

Ethics and dissemination

The trial was approved by local institutional review board. Every attempt will be made to reduce to an absolute minimum the interval between completion of data collection and release of study results through appropriate dissemination mediums including abstracts, poster presentations and journal publications.

Trial registration number

NCT03346850; Pre-results.
Prolong: a double-blind randomised placebo-controlled trial of broccoli sprout extract in women with early onset preeclampsia. A clinical trial protocol
Authors: Langston-Cox Annie G , Marshall Sarah A , Palmer Kirsten R , Wallace Euan M
Published: April 2023

Introduction

Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. There is a need for adjuvant, targeted therapies to improve outcomes. Broccoli sprout extract, rich in the antioxidant sulforaphane, reduces oxidative stress and placental secretion of the antiangiogenic factors that contribute to vascular dysfunction in preeclampsia. We propose a phase III trial investigating broccoli sprout extract. We will assess broccoli sprout extract in women with early onset (<34 weeks) preeclampsia, investigating (1) the interval between enrolment and delivery (days), (2) biomarkers of placental and endothelial function and (3) maternal and fetal outcomes.

Methods

A double-blind, placebo-controlled randomised trial will be conducted at Monash Health, Melbourne, Australia. One hundred and eighty women (45 each arm of each stratum) with early onset preeclampsia (defined as per Society for Obstetric Medicine of Australia and New Zealand guidelines) will be recruited. Consenting women will be randomised to receive an oral dose of either broccoli sprout extract (24 mg of activated sulforaphane) or identical placebo, twice daily until delivery. Maternal blood will be collected antenatally for measurement of biomarkers of preeclampsia, including soluble fms-like tyrosine kinase 1 (sFlt-1), placental growth factor (PlGF), soluble endoglin (sEng) and activin A, as well as circulating sulforaphane metabolites. Maternal and perinatal outcomes will be monitored throughout. All clinical care decisions, including the timing of delivery, will be made by the treating team, blinded to treatment allocation. Participation in this trial will not affect routine care. At delivery, maternal and cord blood and placentae will be collected to measure sulforaphane metabolites and sFlt-1, PlGF, sEng and activin A.

Ethics and dissemination

Approval to conduct the trial has been granted by Monash Health Human Research and Ethics Committee (RES-18-0000-109A). Deidentified data will be published in peer-reviewed journals and presented at learnt society conferences, both nationally and internationally. This study has not yet commenced and is pre-results.

Trial registration number

NCT12618000216213
Colonisation of the proximal intestinal remnant in newborn infants with enterostomy: a longitudinal study protocol
Authors: Barreiros Mota Inês , Marques Cláudia , Faria Ana , Neto Maria Teresa , Cordeiro-Ferreira Gonçalo , Virella Daniel , Pita Ana , Pereira-da-Silva Luís , Calhau Conceição
Published: April 2023

Introduction

The gut microbiota plays a main role in the maintenance of host’s health. Exposure to different conditions in early life contributes to distinct ‘pioneer’ bacterial communities in the intestine, which shape the newborn infant development. Newborn infants with congenital malformations of the gastrointestinal tract (CMGIT), necrotising enterocolitis (NEC) and spontaneous intestinal perforation (SIP) commonly require abdominal surgery and enterostomy. The knowledge about the colonisation of these newborns’ intestine by microorganisms is scarce. This protocol is designed to explore the microbial colonisation over time of the proximal intestinal remnant in newborn infants who underwent surgery for CMGIT, NEC or SIP and require enterostomy.

Methods and analysis

The literature about microbiota colonisation in newborn infants with enterostomy was reviewed and an observational, longitudinal, prospective study was designed. The infants will be recruited at the Neonatal Intensive Care Unit of the Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central. Samples of the enterostomy effluent will be collected every 3 days, through 21 days after the first collection. The microorganisms colonising the proximal intestinal remnant will be identified using the 16S rRNA sequence analysis and a subset of microorganisms will be quantified using real-time PCR. This protocol may serve as basis for future observational and interventional studies on the modulation of the intestinal microbiota (eg, probiotics) on short and long-term outcomes in this population.

Ethics and dissemination

This study protocol was approved by the Ethics Committee of Centro Hospitalar Universitário de Lisboa Central (441/2017) and by the Ethics Committee of NOVA Medical School, Universidade Nova de Lisboa (n°50/2018/CEFCM). The results will be spread through peer-reviewed publications and presentations at international scientific meetings.

Trial registration number

NCT03340259.
Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial
Authors: Orkin Aaron , Campbell Douglas , Handford Curtis , Hopkins Shaun , Klaiman Michelle , Leece Pamela , Parsons Janet A , Shahin Rita , Strike Carol , Thorpe Kevin , Sellen Kate , Milos Geoffrey , Wright Amy , Charles Mercy , Sniderman Ruby , Morrison Laurie
Published: April 2023

Introduction

The surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants’ performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial.

Methods and analysis

Strategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2 weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered.

Ethics and dissemination

The study has been reviewed by ethics boards at St. Michael’s Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations.

Trial registration number

ClinicalTrials.gov registry (NCT03821649).
Cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of a Structured Health Intervention For Truckers (the SHIFT study): a study protocol
Authors: Clemes Stacy A , Varela Mato Verónica , Munir Fehmidah , Edwardson Charlotte L , Chen Yu-Ling , Hamer Mark , Gray Laura J , Bhupendra Jaicim Nishal , Richardson Gerry , Johnson Vicki , Troughton Jacqui , Yates Thomas , King James A
Published: April 2023

Introduction

Heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related comorbidities, in comparison to other occupational groups. Their working environments are not conducive to a healthy lifestyle, yet there has been limited attention to health promotion efforts. We have developed a Structured Health Intervention For Truckers (the SHIFT programme), a multicomponent, theory-driven, health-behaviour intervention targeting physical activity, diet and sitting in HGV drivers. This paper describes the protocol of a cluster randomised controlled trial designed to evaluate the effectiveness and cost-effectiveness of the SHIFT programme.

Methods and analysis

HGV drivers will be recruited from a logistics company in the UK. Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers). The 6-month SHIFT intervention includes a group-based interactive 6-hour education session, worksite champion support and equipment provision (including a Fitbit and resistance bands/balls to facilitate a ‘cab workout’). Objectively measured total daily physical activity (steps/day) will be the primary outcome. Secondary outcomes include: objectively measured light-intensity physical activity and moderate-to-vigorous physical activity, sitting time, sleep quality, markers of adiposity, blood pressure and capillary blood markers (glycated haemoglobin, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol). Self-report questionnaires will examine fruit and vegetable intake, psychosocial and work outcomes and mental health. Quality of life and resources used (eg, general practitioner visits) will also be assessed. Measures will be collected at baseline, 6 and 12 months and analysed according to a modified intention-to-treat principle. A full process evaluation and cost-effectiveness analysis will be conducted.

Ethics and dissemination

Ethical approval was obtained from the Loughborough University Ethics Approvals Sub-Committee (reference: R17-P063). Study findings will be disseminated through publications in research and professional journals, through conference presentations and to relevant regional and national stakeholders via online media and at dissemination events.

Trial registration number

NCT10483894.
Internet-delivered attentional bias modification training (iABMT) for the management of chronic musculoskeletal pain: a protocol for a randomised controlled trial
Authors: Liossi Christina , Georgallis Tsampikos , Zhang Jin , Hamilton Fiona , White Paul , Schoth Daniel Eric
Published: April 2023

Introduction

Chronic musculoskeletal pain is a complex medical condition that can significantly impact quality of life. Patients with chronic pain demonstrate attentional biases towards pain-related information. The therapeutic benefits of modifying attentional biases by implicitly training attention away from pain-related information towards neutral information have been supported in a small number of published studies. Limited research however has explored the efficacy of modifying pain-related biases via the internet. This protocol describes a randomised, double-blind, internet-delivered attentional bias modification intervention, aimed to evaluate the efficacy of the intervention on reducing pain interference. Secondary outcomes are pain intensity, state and trait anxiety, depression, pain-related fear, and sleep impairment. This study will also explore the effects of training intensity on these outcomes, along with participants’ perceptions about the therapy.

Methods and analysis

The study is a double-blind, randomised controlled trial with four arms exploring the efficacy of online attentional bias modification training versus placebo training theorised to offer no specific therapeutic benefit. Participants with chronic musculoskeletal pain will be randomised to one of four groups: (1) 10-session attentional modification group; (2) 10-session placebo training group; (3) 18-session attentional modification group; or (4) 18-session placebo training group. In the attentional modification groups, the probe-classification version of the visual-probe task will be used to implicitly train attention away from threatening information towards neutral information. Following the intervention, participants will complete a short interview exploring their perceptions about the online training. In addition, a subgroup analysis for participants aged 16–24 and 25–60 will be undertaken.

Ethics and dissemination

This study has been approved by the University of Southampton Research Ethics Committee. Results will be published in peer-reviewed journals, academic conferences, and in lay reports for pain charities and patient support groups.

Trial registration number

NCT02232100.
Fit for School Study protocol: early child growth, health behaviours, nutrition, cardiometabolic risk and developmental determinants of a child’s school readiness, a prospective cohort
Authors: Birken Catherine S , Omand Jessica A , Nurse Kim M , Borkhoff Cornelia M , Koroshegyi Christine , Lebovic Gerald , Maguire Jonathon L , Mamdani Muhammad , Parkin Patricia C , Randall Simpson Janis , Tremblay Mark S , Duku Eric , Reid-Westoby Caroline , Janus Magdalena
Published: April 2023

Introduction

School readiness is a multidimensional construct that includes cognitive, behavioural and emotional aspects of a child’s development. School readiness is strongly associated with a child’s future school success and well-being. The Early Development Instrument (EDI) is a reliable and valid teacher-completed tool for assessing school readiness in children at kindergarten age. A substantial knowledge gap exists in understanding how early child growth, health behaviours, nutrition, cardiometabolic risk and development impact school readiness. The primary objective was to determine if growth patterns, measured by body mass index trajectories in healthy children aged 0–5 years, are associated with school readiness at ages 4–6 years (kindergarten age). Secondary objectives were to determine if other health trajectories, including health behaviours, nutrition, cardiometabolic risk and development, are associated with school readiness at ages 4–6 years. This paper presents the Fit for School Study protocol.

Methods and analysis

This is an ongoing prospective cohort study. Parents of children enrolled in the The Applied Health Research Group for Kids (TARGet Kids!) practice-based research network are invited to participate in the Fit for School Study. Child growth, health behaviours, nutrition, cardiometabolic risk and development data are collected annually at health supervision visits and linked to EDI data collected by schools. The primary and secondary analyses will use a two-stage process: (1) latent class growth models will be used to first determine trajectory groups, and (2) generalised linear mixed models will be used to examine the relationship between exposures and EDI results.

Ethics and dissemination

The research ethics boards at The Hospital for Sick Children, Unity Health Toronto and McMaster University approved this study, and research ethics approval was obtained from each school board with a student participating in the study. The findings will be presented locally, nationally and internationally and will be published in peer-reviewed journals.

Trial registration number

NCT01869530
.
Update on the prevalence of persistent post-traumatic headache in adult civilian traumatic brain injury: protocol for a systematic review and meta-analysis
Authors: Arbour Caroline , Bouferguene Yasmine , Beauregard Roxanne , Lavigne Gilles , Herrero Babiloni Alberto
Published: April 2023

Introduction

Traumatic brain injury (TBI) is a major public health concern. Persistent post-traumatic headache (PTH) is a common consequence of TBI affecting productivity and quality of life. The only review providing information about headache prevalence after TBI was published in 2008, combined data from civilian and military TBI, and was strictly derived from Medline database. Due to recent changes in TBI diagnosis and trauma epidemiology, the aim of the current study is to perform a systematic review and meta-analysis to derive updated prevalence estimates of persistent PTH in adult civilian TBI.

Methods and analysis

The methods have been defined following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies published from 2008 to 2019 will be identified searching the electronic databases Medline, Embase, Cochrane, Google Scholar, Directory of Open Access Journals and Web of Science. Retrieved records will be independently screened by two authors and relevant data will be extracted from studies reporting data on persistent PTH prevalence among civilian TBI individuals (≥16 years). The pooled prevalence estimates of any form of headache will be computed applying random-effects meta-analysis. Heterogeneity will be assessed using the I2statistic and explored through subgroup analyses considering TBI severity (mild vs moderate/severe). Estimations of risk of bias will be performed using the Risk of Bias Tool for Prevalence Studies.

Ethics and dissemination

The result of this systematic review will be published in a peer-reviewed journal and disseminated at relevant conferences presentations. Formal ethical approval is not required because we will search and evaluate only existing sources of literature. By focusing on studies conducted in the last decade, this review will provide the most up-to-date information about the global prevalence of persistent PTH after TBI. Considering the economical and social burden of persistent PTH after TBI, accurate estimates of this problematic disorder is of utmost importance for planning, implementing and evaluating prevention interventions.

PROSPERO registration number

NCT42018094138
Development of a system based on artificial intelligence to identify visual problems in children: study protocol of the TrackAI project
Authors: Pueyo Victoria , Pérez-Roche Teresa , Prieto Esther , Castillo Olimpia , Gonzalez Inmaculada , Alejandre Adrian , Pan Xian , Fanlo-Zarazaga Alvaro , Pinilla Juan , Echevarria Jose Ignacio , Gutierrez Diego , Altemir Irene , Romero-Sanz María , Cipres Marta , Ortin Marta , Masia Belen
Published: April 2023

Introduction

Around 70% to 80% of the 19 million visually disabled children in the world are due to a preventable or curable disease, if detected early enough. Vision screening in childhood is an evidence-based and cost-effective way to detect visual disorders. However, current screening programmes face several limitations: training required to perform them efficiently, lack of accurate screening tools and poor collaboration from young children.

Some of these limitations can be overcome by new digital tools. Implementing a system based on artificial intelligence systems avoid the challenge of interpreting visual outcomes.

The objective of the TrackAI Project is to develop a system to identify children with visual disorders. The system will have two main components: a novel visual test implemented in a digital device, DIVE (Device for an Integral Visual Examination); and artificial intelligence algorithms that will run on a smartphone to analyse automatically the visual data gathered by DIVE.

Methods and analysis

This is a multicentre study, with at least five centres located in five geographically diverse study sites participating in the recruitment, covering Europe, USA and Asia.

The study will include children aged between 6 months and 14 years, both with normal or abnormal visual development.

The project will be divided in two consecutive phases: design and training of an artificial intelligence (AI) algorithm to identify visual problems, and system development and validation. The study protocol will consist of a comprehensive ophthalmological examination, performed by an experienced paediatric ophthalmologist, and an exam of the visual function using a DIVE.

For the first part of the study, diagnostic labels will be given to each DIVE exam to train the neural network. For the validation, diagnosis provided by ophthalmologists will be compared with AI system outcomes.

Ethics and dissemination

The study will be conducted in accordance with the principles of Good Clinical Practice. This protocol was approved by the Clinical Research Ethics Committee of Aragón, CEICA, on January 2019 (Code PI18/346).

Results will be published in peer-reviewed journals and disseminated in scientific meetings.

Trial registration number

NCT17316993.
Longitudinal team training programme in a Norwegian surgical ward: a qualitative study of nurses’ and physicians’ experiences with teamwork skills
Authors: Ballangrud Randi , Aase Karina , Vifladt Anne
Published: April 2023

Objectives

Teamwork and interprofessional team training are fundamental to ensuring the continuity of care and high-quality outcomes for patients in a complex clinical environment. Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an evidence-based team training programme intended to facilitate healthcare professionals’ teamwork skills. The aim of this study is to describe healthcare professionals’ experiences with teamwork in a surgical ward before and during the implementation of a longitudinal interprofessional team training programme.

Design

A qualitative descriptive study based on follow-up focus group interviews.

Setting

A combined gastrointestinal surgery and urology ward at a hospital division in a Norwegian hospital trust.

Participants

A convenience sample of 11 healthcare professionals divided into three professionally based focus groups comprising physicians (n=4), registered nurses (n=4) and certified nursing assistants (n=3).

Interventions

The TeamSTEPPS programme was implemented in the surgical ward from May 2016 to June 2017. The team training programme included the three phases: (1) assessment and planning, (2) training and implementation and (3) sustainment.

Results

Before implementing the team training programme, healthcare professionals were essentially satisfied with the teamwork skills within the ward. During the implementation of the programme, they experienced that team training led to greater awareness and knowledge of their common teamwork skills. Improved teamwork skills were described in relation to a more systematic interprofessional information exchange, consciousness of leadership-balancing activities and resources, the use of situational monitoring tools and a shared understanding of accountability and transparency.

Conclusions

This study suggests that the team training programme provides healthcare professionals with a set of tools and terminology that promotes a common understanding of teamwork, hence affecting behaviour and communication in their daily clinical practice at the surgical ward.

Trial registration number

NCT13997367.
Quasiexperimental intervention study protocol to optimise the use of new antibiotics in Spain: the NEW_SAFE project
Authors: Palacios-Baena Zaira R , Valiente de Santis Lucia , Maldonado Natalia , Rosso-Fernández Clara M , Borreguero Irene , Herrero-Rodríguez Carmen , López-Cárdenas Salvador , Martínez-Marcos Franciso J , Martín-Aspas Andrés , Jiménez-Aguilar Patricia , Castón Juan J , Anguita-Santos Francisco , Ojeda-Burgos Guillermo , Aznarte-Padial M Pilar , Praena-Segovia Julia , Corzo-Delgado Juan E , Esteban-Moreno M Ángeles , Rodríguez-Baño Jesús , Retamar Pilar
Published: April 2023

Introduction

Ceftaroline, tedizolid, dalbavancin, ceftazidime-avibactam and ceftolozane-tazobactam are novel antibiotics used to treat infections caused by multidrug-resistant pathogens (MDR). Their use should be supervised and monitored as part of an antimicrobial stewardship programme (ASP). Appropriate use of the new antibiotics will be improved by including consensual indications for their use in local antibiotic guidelines, together with educational interventions providing advice to prescribers to ensure that the recommendations are clearly understood.

Methods and analysis

This study will be implemented in two phases. First, a preliminary historical cohort (2017–2019) of patients from 13 Andalusian hospitals treated with novel antibiotics will be analysed. Second, a quasiexperimental intervention study will be developed with an interrupted time-series analysis (2020–2021). The intervention will consist of an educational interview between prescribers and ASP leaders at each hospital to reinforce the proper use of novel antibiotics. The educational intervention will be based on a consensus guideline designed and disseminated by leaders after the retrospective cohort data have been analysed. The outcomes will be acceptance of the intervention and appropriateness of prescription. Incidence of infection and colonisation with MDR organisms as well as incidence ofClostridioides difficileinfection will also be analysed. Changes in prescription quality between periods and the safety profile of the antibiotics in terms of mortality rate and readmissions will also be measured.

Ethics and dissemination

Ethical approval will be obtained from the Andalusian Coordinating Institutional Review Board. The study is being conducted in compliance with the protocol and regulatory requirements consistent with International Council of Harmonisation E6 Good Clinical Practice and the ethical principles of the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and disseminated at national and international conferences.

Trial registration number

NCT03941951.