bluuebunny/crossref_metadata_2025_split huggingface dataset:
Early initiation of antibiotic therapy and short-term outcomes in preterm infants: a single-centre retrospective cohort analysis
Authors: Köstlin-Gille Natascha , Serna-Higuita Lina Maria , Bubser Caren , Arand Joerg , Haag Laura , Schwarz Christoph E , Heideking Martin , Poets Christian F , Gille Christian 
Published: May 2023

BackgroundSepsis is one of the most important complications in preterm infants. For this reason, many such infants receive antibiotics during their hospital stay. However, early antibiotic therapy has also been associated with adverse outcome. It is yet largely unclear if the time of onset of antibiotic therapy influences the outcome. We here investigated whether the timing of initiation of antibiotic therapy plays a role in the association between antibiotic exposure and short-term outcome.MethodsRetrospective analysis of data from 1762 very low birthweight infants born in a German neonatal intensive care unit (NICU) between January 2004 and December 2021.ResultsAntibiotics were administered to 1214 of the 1762 (68.9%) infants. In 973 (55.2%) of the 1762 of infants, antibiotic therapy was initiated within the first two postnatal days. Only 548 (31.1%) infants did not have any antibiotic prescription during their stay in the NICU. Antibiotic exposure at every timepoint was associated with an increased risk of all short-term outcomes analysed in univariable analyses. In multivariable analyses, initiation of antibiotic therapy within the first two postnatal days and initiation between postnatal days 3 and 6 was independently associated with an increased risk of developing bronchopulmonary dysplasia (BPD) (OR 3.1 and 2.8), while later initiation of antibiotic therapy was not.ConclusionVery early initiation of antibiotic therapy was associated with an increased risk of BPD. Due to the study design, no conclusions on causality can be drawn. If confirmed, our data suggest that an improved identification of infants at low risk of early-onset sepsis is needed to reduce antibiotic exposure.
Evaluation of the impact of a smartphone application on adherence to home exercise program for people with chronic low back pain: research protocol for a pilot randomised controlled trial
Authors: Lechauve Jean-Baptiste , Dobija Lech , Pereira Bruno , Grolier Maxime , Goldstein Anna , Lanhers Charlotte , Coudeyre Emmanuel 
Published: May 2023

IntroductionMultidisciplinary rehabilitation programmes are highly recommended for individuals with the most disabling low back pain (LBP). However, the long-term adherence to regular home exercise is often poor. We aim to perform a prospective, controlled, pilot, randomised study that will evaluate the impact of a smartphone application on adherence to exercise programme for people with chronic LBP (CLBP).Methods and analysis120 participants with non-specific CLBP aged 18–65 years will be recruited and randomised in two groups: an experimental group benefitting from education in the application’s use in addition to a conventional multidisciplinary rehabilitation programme (exercises and self-management education) and a control group who will only participate in the multidisciplinary rehabilitation programme. Both groups will undergo the programme 5 days a week for 3 weeks. The primary outcome will be a change in patient’s adherence to physical exercise (Exercise Adherence Rating Scale) at 6 months. Secondary outcomes will be function (Oswestry Disability Index), beliefs concerning physical activity (Evaluation of Physical Activity Perception), pain (Numeric Rating Scale), and physical capacity and qualitative adherence (video).Statistical analyses will be performed according to intention to treat. A linear mixed model will be used to compare the primary endpoint between groups at 6 months post-randomisation.The study could demonstrate the impact of using a smartphone application on adherence to exercise programme in people with CLBP. We hypothesise that the application’s use will improve outcomes through improved exercise adherence.Ethics and disseminationThe study was approved by the medical ethics committee of Ile de France 3. The results of this study will be disseminated in peer-reviewed publications and presentations at international scientific meetings and will also be disseminated to the participants.Trial registration numberNCT04264949.
Protocol for a cohort study to evaluate the effectiveness and
cost-effectiveness of general population screening for cardiovascular
disease: the Viborg Screening Programme (VISP)
Authors: Høgh Annette , Lindholt Jes Sanddal , Søgaard Rikke , Refsgaard Jens , Svenstrup Dorte , Moeslund Niels-Jørgen , Bredsgaard Mette , Dahl Marie 
Published: May 2023

Introduction
The prevalence of cardiovascular disease (CVD) is increasing.
Furthermore, asymptomatic individuals may not receive timely preventive
initiatives to minimise the risk of further CVD events. Paradoxically,
80% of CVD events are preventable by early detection, followed by
prophylactic initiatives. Consequently, we introduced the
population-based Viborg Screening Programme (VISP) for subclinical and
manifest CVD, focusing on commonly occurring, mainly asymptomatic
conditions, followed by prophylactic initiatives.
The aim of the VISP was to evaluate the health benefits, harms and
cost-effectiveness of the VISP from a healthcare sector perspective.
Furthermore, we explored the participants’ perspectives.

Methods and analysis
From August 2014 and currently ongoing, approximately 1100 men and
women from the Viborg municipality, Denmark, are annually invited to
screening for abdominal aortic aneurysm, peripheral arterial disease,
carotid plaque, hypertension, diabetes mellitus and cardiac arrhythmia
on their 67th birthday. A population from the surrounding municipalities
without access to the VISP acts as a control. The VISP invitees and the
controls are followed on the individual level by nationwide registries.
The primary outcome is all-cause mortality, while costs,
hospitalisations and deaths from CVD are the secondary
endpoints.
Interim evaluations of effectiveness and cost-effectiveness are
planned every 5 years using propensity score matching followed by a Cox
proportional hazards regression analysis by the ‘intention-to-treat’
principle. Furthermore, censoring-adjusted incremental costs, life-years
and quality-adjusted life-years are estimated. Finally, the
participants’ perspectives are explored by semistructured face-to-face
interviews, with participant selection representing participants with
both negative and positive screening results.

Ethics and dissemination
The VISP is not an interventional trial. Therefore, approval from a
regional scientific ethical committee is not needed. Data collection
from national registries was approved by the Regional Data Protection
Agency (record no. 1-16-02-232-15). We ensure patient and public
involvement in evaluating the acceptability of VISP by adopting an
interviewing approach in the study.

Trial registration number
NCT03395509.
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

ObjectivesDirect 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.SettingData used in this study were drawn from cross-sectional survey conducted in four districts of Madhya Pradesh, India.ParticipantsStudy participant included pregnant women with access to a phone (n=5095) and their husbands (n=3842)ResultsWe 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.ConclusionsFindings suggest that segmenting populations into distinct clusters for differentiated programme design and delivery may serve to improve reach and impact.Trial registration numberNCT03576157.
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

ObjectivesTo 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.DesignWe 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.Participants68 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.ResultsCertain 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’.ConclusionsUsage 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

IntroductionGambling 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 analysisFour-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 disseminationEthical 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 numberISRCTN37874344.
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

ObjectiveTo 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.DesignExploratory post-hoc secondary data analysis of trial data.SettingThe GoActive trial was run in secondary schools across Cambridgeshire and Essex (UK), between September 2016 and July 2018.Participants13–14 years old adolescents (n=2838, 16 schools).MethodsSocioeconomic 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.ResultsStage: (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).ConclusionsThese 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 numberISRCTN31583496.
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

ObjectivesThe 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).DesignAnalysis of a phase 2, double-blind, randomised, placebo-controlled trial.SettingUSA, Greece, Italy, Lebanon, Thailand and the UK.ParticipantsAdults (≥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.MeasuresNTDT-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).ResultsCronbach’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.ConclusionsThe 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

IntroductionFibromyalgia 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 analysisThe 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 disseminationThe 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 numberNCT05008042.
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

ObjectivesThis 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.MethodsThe 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.ResultsHigher 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.ConclusionWe 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 numberNCT04482075.