bluuebunny/crossref_metadata_2025_split huggingface dataset:
How effective is community physical activity promotion in areas of deprivation for inactive adults with cardiovascular disease risk and/or mental health concerns? Study protocol for a pragmatic observational evaluation of the ’Active Herts' physical activity programme
Authors: Howlett Neil , Jones Andy , Bain Lucy , Chater Angel 
Published: May 2024

IntroductionThere is a high prevalence of inactive adults in the UK, and many suffer from conditions such as cardiovascular disease (CVD) or poor mental health. These coexist more frequently in areas of higher socioeconomic deprivation. There is a need to test the effectiveness, acceptability and sustainability of physical activity programmes. Active Herts uses novel evidence-based behaviour change techniques to target physical inactivity.Methods and analysisActive Herts is a community physical activity programme for inactive adults aged 16+ with one or more risk factors for CVD and/or a mild to moderate mental health condition. This evaluation will follow a mixed-methods longitudinal (baseline, and 3-month, 6-month and 12-month follow-ups) design. Pragmatic considerations mean delivery of the programme differs by locality. In two areas programme users will receive a behaviour change technique booklet, regular consultations, a booster phone call, motivational text messages and signposting to 12 weeks of exercise classes. In another two areas programme users will also receive 12 weeks of free tailored exercise classes, with optional exercise ‘buddies’ available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, well-being, psychological capability and reflective motivation as secondary outcomes. A process evaluation will explore the views of stakeholders, delivery staff and programme leads. Economic evaluation will examine the programme costs against the benefits gained in terms of reduced risk of morbidity.Ethics and disseminationThis study was been approved by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of East Anglia. Informed written consent will be obtained from programme users in the evaluation. Results will be published in peer-reviewed journals, presented at conferences, and shared through the study website and local community outlets.Trial registration numberClinicalTrials.gov ID number:NCT03153098.
How biomarkers reflect the prognosis and treatment of necrotising soft tissue infections and the effects of hyperbaric oxygen therapy: the protocol of the prospective cohort PROTREAT study conducted at a tertiary hospital in Copenhagen, Denmark
Authors: Polzik Peter , Johansson Pär I , Hyldegaard Ole 
Published: May 2024

IntroductionNot enough is known regarding the prognosis and treatment of necrotising soft tissue infections (NSTIs). Mortality has been shown to be 25%–35%, with survivors coping with amputations and prolonged rehabilitation. This study will evaluate soluble urokinase-type plasminogen activator receptor (suPAR) as a possible prognostic marker of NSTI severity and mortality, as well as whether hyperbaric oxygen therapy (HBOT) can modulate markers of endothelial damage during NSTI. We hypothesise that in patients with NSTI, suPAR can provide prognostic risk assessment on hospital admission and that HBOT can reduce the endothelial damage that these patients are exposed to.Methods and analysisThis is a prospective observational study. Biomarkers will be measured in 150 patients who have been diagnosed with NSTI. On admission, baseline blood samples will be obtained. Following surgery and HBOT, daily blood samples will be obtained in order to measure endothelial and prognostic biomarkers (soluble thrombomodulin, syndecan-1, sE-selectin, vascular endothelial (VE)-cadherin, protein C and suPAR levels). Clinical data will be acquired during the first 7 days of stay in the intensive care unit. The primary outcomes in studies I and II will be endothelial biomarker levels after HBOT, and in study III suPAR levels as a marker of disease prognosis and severity.Ethics and disseminationThe study has been approved by the Regional Scientific Ethical Committee of Copenhagen (H-16021845) and the Danish Data Protection Agency (RH-2016-199). Results will be presented at national and international conferences and published in peer-reviewed scientific journals.Trial registration numberClinicalTrials.gov IdentifierNCT03147352. (Pre-results)
Multicentre prospective randomised single-blind controlled study protocol of the effect of an additional parent-administered sensorimotor stimulation on neurological development of preterm infants: Primebrain
Authors: Pelc Karine , Daniel Irit , Wenderickx Bernard , Dan Bernard 
Published: May 2024

IntroductionPreterm and very low birthweight infants are at increased risk for neurodevelopmental disorders, including cerebral palsy, sensory impairment and intellectual disability. Several early intervention approaches have been designed in the hope of optimising neurological development in this context. It seems important that the intervention takes into account parental mental health, focuses on parent–child interactions and lasts sufficiently long. This study aims to evaluate the effects of a stimulation programme administered by parents until 6 months post-term on motor and neurophysiological development of infants born preterm.Methods and analysisParticipants will be infants born <32 weeks’ gestation and/or with a birth weight <1500 g recruited prospectively from two tertiary neonatal intensive care units. They will be randomly assigned to receive nationally recommended follow-up only (control group) or also a stimulation programme between 37 weeks’ gestation and 6 months’ corrected age. Perinatal, clinical neurodevelopmental, socio-demographic and neuroimaging (ultrasonography or MRI) data will be collected. Bayley Scales of Infant Development will be used up to 24 months’ corrected age and Parental Stress Index at 6, 12, 18 and 24 months’ corrected age. High-density (64 or 128 electrodes) EEG, visual, somatosensory and long latency auditory evoked potentials will be recorded at term age, 3, 6, 12, 18 and 24 months’ corrected age. They will be analysed for spatiotemporal frequency bands contents and source localisation.Ethics and disseminationThe study was approved by the Ethics Committees of the Hôpital Universitaire des Enfants Reine Fabiola and CHU Saint-Pierre. Results dissemination will be made for stakeholders and families, reports will be written for parents, healthcare providers and policymakers, and scientific papers will be published.Trial registration numberNCT02159534; Pre-results.
Sensing interstitial glucose to nudge active lifestyles (SIGNAL): feasibility of combining novel self-monitoring technologies for persuasive behaviour change
Authors: Whelan Maxine E , Kingsnorth Andrew P , Orme Mark W , Sherar Lauren B , Esliger Dale W 
Published: May 2024

IntroductionIncreasing physical activity (PA) reduces the risk of developing diabetes, highlighting the role of preventive medicine approaches. Changing lifestyle behaviours is difficult and is often predicated on the assumption that individuals are willing to change their lifestyles today to reduce the risk of developing disease years or even decades later. The self-monitoring technologies tested in this study will present PA feedback in real time, parallel with acute physiological data. Presenting the immediate health benefits of being more physically active may help enact change by observing the immediate consequences of that behaviour. The present study aims to assess user engagement with the self-monitoring technologies in individuals at moderate-to-high risk of developing type 2 diabetes.Methods and analysis45 individuals with a moderate-to-high risk, aged ≥40 years old and using a compatible smartphone, will be invited to take part in a 7-week protocol. Following 1 week of baseline measurements, participants will be randomised into one of three groups: group 1— glucose feedback followed by biobehavioural feedback (glucose plus PA); group 2—PA feedback followed by biobehavioural feedback; group 3—biobehavioural feedback. A PA monitor and a flash glucose monitor will be deployed during the intervention. Participants will wear both devices throughout the intervention but blinded to feedback depending on group allocation. The primary outcome is the level of participant engagement and will be assessed by device use and smartphone usage. Feasibility will be assessed by the practicality of the technology and screening for diabetes risk. Semistructured interviews will be conducted to explore participant experiences using the technologies.Trial registration numberISRCTN17545949. Registered on 15/05/2017.
Association between secondhand smoke exposure and serum sex hormone concentrations among US female adults: a cross-sectional analysis using data from the National Health and Nutrition Examination Survey, 2013–2016
Authors: Li Shuna , Feng Aozi , Peng Yongjia , Li Li , Huang Liying , He Ningxia , Zeng Mengnan , Lyu Jun 
Published: May 2024

ObjectiveTo estimate the association between secondhand smoke (SHS) exposure and serum sex hormone concentrations in female adults (never smokers and former smokers).DesignCross-sectional analysis.SettingUS National Health and Nutrition Examination Survey, 2013–2016.Outcome measuresSerum sex hormone measures included total testosterone (TT) and oestradiol (E2), sex hormone-binding globulin (SHBG), the ratio of TT and E2 and free androgen index (FAI). Isotope dilution–liquid chromatography tandem mass spectrometry was used to measure serum TT and E2. SHBG was measured using immunoassay. The ratio of TT and E2 and FAI were calculated. SHS exposure was defined as serum cotinine concentration of 0.05–10 ng/mL.ParticipantsA total of 622 female participants aged ≥20 years were included in the analysis.ResultsFor never smokers, a doubling of serum cotinine concentration was associated with a 2.85% (95% CI 0.29% to 5.47%) increase in TT concentration and a 6.29% (95% CI 0.68% to 12.23%) increase in E2 in fully adjusted models. The never smokers in the highest quartile (Q4) of serum cotinine level exhibited a 10.30% (95% CI 0.78% to 20.72%) increase in TT concentration and a 27.75% (95% CI 5.17% to 55.17%) increase in E2 compared with those in the lowest quartile (Q1). For former smokers, SHBG was reduced by 4.36% (95% CI −8.47% to −0.07%, p for trend=0.049) when the serum cotinine level was doubled, and the SHBG of those in Q4 was reduced by 17.58% (95% CI −31.33% to −1.07%, p for trend=0.018) compared with those in Q1.ConclusionSHS was associated with serum sex hormone concentrations among female adults. In never smokers, SHS was associated with increased levels of TT and E2. In former smokers, SHS was associated with decreased SHBG levels.
The use and application of Lean Management methods to research processes—a scoping review protocol
Authors: Wraae Caroline Ariane Dahl , Opstrup Niels , Kyvik Kirsten Ohm , Brixen Kim , Wien Charlotte 
Published: May 2024

IntroductionWaste in medical research is a relatively well-known issue. However, only a few initiatives exist to address this issue. Lean Management methods (Lean) were developed in industrial manufacturing and later applied within healthcare improvement. Overall, the results from studies of the application of Lean to healthcare appear to be positive in terms of greater efficiency regarding treatment outcomes and patient care. Nevertheless, the application of Lean to improve research processes is not well studied and, given that research alongside clinical practice and experiential knowledge provides the foundation for the treatment and care of patients, it is paramount to identify approaches and review the degree to which they increase efficiency within research procedures. Therefore, this review will scope the landscape of studies that investigated Lean and how to implement Lean in research processes, particularly regarding healthcare research.Methods and analysisOur approach follows the methodological framework of Arksey and O’Malley for conducting scoping reviews (PRISMA-ScR). The search strategy for this scoping review was developed using the PCC model. We will identify the relevant literature by searching four search databases: Scopus, Web of Science, Academic Search Premier and Business Source Complete. Next, we will use citation pearl growing to identify all relevant published literature. The data charting process will follow the PRISMA-ScR checklist and will be organised using NVivo. We will generate qualitative and quantitative assessments of the extracted data by using NVivo, RStudio and Excel. We will follow the PRISMA-ScR guideline when reporting the results.Ethics and disseminationThe review will comprise existing published studies and no primary data will be collected. Our findings will be shared through open access peer-reviewed journals, national and international conferences and emails to all relevant collaborative relationships. We plan to disseminate our findings via academic social media platforms, newspaper articles and blogposts.
Exploring the influence of health system factors on adaptive capacity in diverse hospital teams in Norway: a multiple case study approach
Authors: Fagerdal Birte , Lyng Hilda Bø , Guise Veslemøy , Anderson Janet E , Braithwaite Jeffrey , Wiig Siri 
Published: May 2024

ObjectivesUnderstanding flexibility and adaptive capacities in complex healthcare systems is a cornerstone of resilient healthcare. Health systems provide structures in the form of standards, rules and regulation to healthcare providers in defined settings such as hospitals. There is little knowledge of how hospital teams are affected by the rules and regulations imposed by multiple governmental bodies, and how health system factors influence adaptive capacity in hospital teams. The aim of this study is to explore the extent to which health system factors enable or constrain adaptive capacity in hospital teams.DesignA qualitative multiple case study using observation and semistructured interviews was conducted between November 2020 and June 2021. Data were analysed through qualitative content analysis with a combined inductive and deductive approach.SettingTwo hospitals situated in the same health region in Norway.ParticipantsMembers from 8 different hospital teams were observed during their workday (115 hours) and were subsequently interviewed about their work (n=30). The teams were categorised as structural, hybrid, coordinating and responsive teams.ResultsTwo main health system factors were found to enable adaptive capacity in the teams: (1) organisation according to regulatory requirements to ensure adaptive capacity, and (2) negotiation of various resources provided by the governing authorities to ensure adaptive capacity. Our results show that aligning to local context of these health system factors affected the team’s adaptive capacity.ConclusionsHealth system factors should create conditions for careful and safe care to emerge and provide conditions that allow for teams to develop both their professional expertise and systems and guidelines that are robust yet sufficiently flexible to fit their everyday work context.
Residents’ willingness towards first-contact with primary health care under uncertainty in healthcare: a cross-sectional study in rural China
Authors: Song Fei , Wei Ran , Wang Chenzhou , Zhang Yan 
Published: May 2024

ObjectiveTo estimate Chinese rural residents’ willingness degree of initially contacting primary healthcare (PHC) under uncertainty in healthcare and to explore its influencing factors.SettingThis study collected primary data from rural residents in Dangyang, Hubei Province in China.ParticipantsThe study investigated 782 residents and 701 finished the survey. The response rate was 89.64%. A further 27 residents failed the internal consistency test, so the effective sample size was 674.DesignIn this cross-sectional study, residents’ willingness was reflected by the threshold of disease severity for PHC (TDSP), the individual maximal disease scope for considering PHC based on residents’ decision-making framework. TDSP was measured through scenario tests. Univariate analysis and unordered multiple logistic regression were used to explore the influencing factors of three-level TDSP: low, general, and high.ResultsOnly 28.2% of respondents had high TDSP and high willingness towards PHC. Compared with general TDSP, respondents who were younger than 40 (OR 7.344, 95% CI 2.463 to 21.894), rich (OR 1.913, 95% CI 1.083 to 3.379), highly risk-averse (OR 1.958, 95% CI 1.016 to 3.774), had substitute medical decision-maker (OR value of parent/child was 2.738, 95% CI 1.386 to 5.411) and had no visits to PHC in the last 6 months (OR 2.098, 95% CI 1.316 to 3.346) tended to have low TDSP and low willingness towards PHC. Compared with general TDSP, no factors were found to significantly influence respondents’ high TDSP.ConclusionsTDSP can be a good indicator of residents’ willingness. TDSP results demonstrate rural residents’ generally low willingness towards first-contact with PHC that some residents refuse to consider PHC even for mild diseases. This study provides practical significance for elaborating the underutilisation of PHC from resident decision-making and offers advice to policymakers and researchers for future modifications.
Knowledge, attitude and practice of poststroke depression among patients with poststroke depression and their family members in Heilongjiang Province, China: a cross-sectional study
Authors: Zhao Bin , Wang Yujue , Xu Ning , Xu Jiaben , Yang Keqin 
Published: May 2024

ObjectiveThis study aimed to investigate the knowledge, attitude and practice (KAP) of poststroke depression (PSD) among patients with PSD and their family members.DesignWeb-based cross-sectional study.SettingThis study was conducted in Heilongjiang Province between October 2022 and April 2023.ParticipantsPatients with PSD and their family members.Primary and secondary outcome measuresKAP scores.MethodThe self-administered questionnaire comprised demographic characteristics, knowledge dimension, attitude dimension and practice dimensions.ResultsA total of 489 valid questionnaires were collected, with the average age of the subjects was 54.68±13.80 years, and including 258 (53.09%) patients who had a stroke. The mean scores for KAP were 6.36±2.66 (possible range: 0–10), 29.07±5.18 (possible range: 8–40) and 37.50±8.49 (possible range: 10–50), respectively. Concerning KAP scores, no differences were found between patients with PSD and their family members. Multivariate logistic regression analysis showed that retirement (OR=0.29, 95% CI 0.11 to 0.77, p=0.012) and monthly income less than ¥2000 (OR=0.46, 95% CI 0.27, 0.79, p=0.005) were independently associated with adequate knowledge. Knowledge (OR=2.12, 95% CI 1.44 to 3.14, p<0.001) was independently associated with positive attitude. Knowledge (OR=3.85, 95% CI 2.53 to 5.86, p<0.001) and attitude (OR=1.62, 95% CI 1.06 to 2.47, p=0.024) were independently associated with proactive practice.ConclusionPatients and their family members had insufficient knowledge, positive attitude and moderate practice towards PSD. Retirement and low monthly income were associated with insufficient knowledge, while knowledge was associated with positive attitude and proactive practice.
Protocol for the Chinese Real-World Evidence for Acute Spinal Cord Injury (ChiRES) study: a prospective, observational, multicentre cohort study of acute spinal cord injury
Authors: Yuan Wenjian , Sun Jiuxiao , Li Qingyang , Zheng Ruiyuan , Guan Bin , Chen Zhuo , Ding Jiaming , Sun Qingyu , Fu Runhan , Wang Wei , Fan Yuxuan , Kang Yi , Sun Chao , Li Ang , Wu Dongjin , Wang Dachuan , Qi Lei , Chen Lingxiao , Feng Shiqing , Zhou Hengxing 
Published: May 2024

IntroductionSpinal cord injury (SCI) is a catastrophic event with devastating physical, social and occupational consequences for patients and their families. The number of patients with acute SCI in China continues to grow rapidly, but there have been no large prospective cohort studies of patients with acute SCI. This proposed study aims to establish a multicentre, extensive sample cohort of clinical data and biological samples of patients in China, which would aid the systematisation and standardisation of clinical research and treatment of acute SCI, thus reducing the heavy burden of acute SCI on patients and society.Methods and analysisThe Chinese Real-World Evidence for Acute Spinal Cord Injury (ChiRES) study is an observational, multicentre cohort study of patients with acute SCI admitted to the Qilu Hospital of Shandong University and other participating centres with prospective collection of their clinical data and biological samples. We aim to recruit 2097 patients in this study. Demographics, disease history, emergency intervention information, motor and sensory examinations, surgical information, medication information and rehabilitation evaluation will be recorded. This will facilitate the development of a prediction model for complications and prognosis of patients with acute SCI and an evaluation of the current management of acute SCI. Among these variables, detailed information on surgical treatment will also be used to assess procedures for acute SCI treatment. Outcome measurements, including the International Standard for Neurological Classification of Spinal Cord Injury examinations, the occurrence of complications and death, will be performed repeatedly during follow-up. We will analyse imaging data and blood samples to develop SCI imaging markers and biomarkers.Ethics and disseminationThis study protocol has been approved by the Medical Ethics Committee of the Qilu Hospital of Shandong University and all other participating centres. The findings will be disseminated in peer-reviewed journals and academic conferences.