bluuebunny/crossref_metadata_2025_split huggingface dataset:
Study protocol for a pilot randomised controlled trial evaluating the effectiveness of oral trehalose on inflammatory factors, oxidative stress, nutritional and clinical status in traumatic head injury patients receiving enteral nutrition
Authors: Ghorbani Dehbalaei Moazzameh , Sahebkar Amirhossein , Safarian Mohammad , Khadem-Rezaiyan Majid , Rezaee Hamid , Naeini Fatemeh , Norouzy Abdolreza 
Published: September 2022

IntroductionIn traumatic brain injury (TBI) patients, inflammatory processes and oxidative stress have been linked to the development of neurodegenerative diseases, disability, increased rate of muscle catabolism, malnutrition, hospital stay and mortality. Previous in vitro and in vivo studies have shown that trehalose can decrease inflammatory and oxidative factors. Therefore, the present study was designed to evaluate the effect of oral trehalose consumption on this marker in critically ill TBI patients at intensive care unit (ICU).Methods and analysisThis study is a pilot randomised, prospective and double-blind clinical trial. The study sample size is of 20 (10 patients in each group) TBI patients aged 18–65 years at ICU. Randomisation is performed by permuted block randomisation method. The allocation ratio is 1:1. An intervention group will receive 30 g of trehalose instead, as a part of the carbohydrate of daily bolus enteral feeding and the control group will receive standard isocaloric hospital bolus enteral feeding for 12 days. The inflammatory factors (C reactive protein, interleukin 6) and oxidative stress markers (glutathione, malondialdehyde, superoxide dismutase, pro-oxidant–antioxidant balance, total antioxidant capacity) will be measured at the baseline, at the 6th day, and at the end of the study (12th day). Sequential Organ Failure Assessment, Acute Physiology and Chronic Health Evaluation II, Nutrition Risk in the Critically ill scores, 28-day mortality, anthropometric assessments and the clinical and nutritional status will be measured. Each patient’s nutritional needs will be calculated individually. The statistical analysis would be based on the intention to treat.Ethics and disseminationThe vice-chancellor of the research centre of Mashhad University of Medical Sciences is sponsoring this study. IR.MUMS.MEDICAL.REC.1400.113.Trial registration numberIranian Registry of Clinical Trials (IRCT) Id: IRCT20210508051223N1, Registration date: 26 July 2021.
Study protocol for double-blind, randomised placebo-controlled trial evaluating semitendinosus function and morbidity following tendon harvesting for anterior cruciate ligament reconstruction augmented by platelet-rich plasma
Authors: du Moulin William , Kositsky Adam , Bourne Matthew N , Diamond Laura E , Tudor Francois , Vertullo Christopher , Saxby David J 
Published: September 2022

IntroductionAnterior cruciate ligament (ACL) rupture is debilitating, often requiring surgical reconstruction. An ACL reconstruction (ACLR) using a tendon autograft harvested from the semitendinosus results in substantial injury to the donor muscle. Following ACLR, patients rarely return to their preinjury level of physical activity, are at elevated risk of secondary lower limb injuries and early onset knee osteoarthritis. To date, no randomised controlled trial has evaluated the efficacy of platelet-rich plasma (PRP) in aiding knee function and semitendinosus morphology of following ALCR.Methods and analysisThis is a multicentre double-blind randomised placebo-controlled trial. Fifty-four ACLR patients aged 18–50 years will be randomised to receive either a single application of PRP (ACLR+) or placebo saline (ACLR) into the semitendinosus harvest zone at the time of surgery. All patients will undergo normal postoperative rehabilitation recommended by the attending orthopaedic surgeon or physiotherapist. The primary outcome measure is between-limb difference (ACLR compared with intact contralateral) in isometric knee flexor strength at 60o knee flexion, collected 10–12 months postsurgery. This primary outcome measure will be statistically compared between groups (ACLR+ and standard ACLR). Secondary outcome measures include bilateral assessments of hamstring muscle morphology via MRI, biomechanical and electromyographic parameters during an anticipated 45° running side-step cut and multidirectional hopping task and patient-reported outcomes questionaries. Additionally, patient-reported outcomes questionaries will be collected before (baseline) as well as immediately after surgery, and at 2–6 weeks, 3–4 months, 10–12 months and 22–24 months postsurgery 10–12 months following surgery.Ethics and disseminationEthics approval has been granted by Griffith University Human Research Ethics Committee, Greenslopes Research and Ethics Committee, and Royal Brisbane & Women’s Hospital Human Research Ethics Committee. Results will be submitted for publication in a peer-reviewed medical journal.Trial registration numberACTRN12618000762257p.
Evaluating the effectiveness of email-based nudges to reduce postoperative opioid prescribing: study protocol of a randomised controlled trial
Authors: Kirkegaard Allison , Wagner Zachary , Mariano Louis T , Martinez Meghan C , Yan Xiaowei Sherry , Romanelli Robert J , Watkins Katherine E 
Published: September 2022

IntroductionSurgical patients are commonly prescribed more opioids at discharge than needed to manage their postoperative pain. These excess opioids increase the risks of new persistent opioid use, opioid-induced ventilatory impairment and opioid diversion. This study tests the effectiveness of two behavioural nudges, one based on peer behaviour and one based on best practice guidelines, in reducing excessive postoperative opioid prescriptions.Methods and analysisThe study will be conducted at 19 hospitals within a large healthcare delivery system in northern California, USA. Three surgical specialties (general surgery, orthopaedic surgery and obstetric/gynaecological surgery) at each hospital will be randomised either to a control group or to one of two active intervention arms. One intervention is grounded in the theory of injunctive norms, and provides feedback to surgeons on their postoperative opioid prescribing relative to prescribing guidelines endorsed by their institution. The other intervention draws from the theory of descriptive norms, and provides feedback similar to the first intervention but using peers’ behaviour rather than guidelines as the benchmark for the surgeon’s prescribing behaviour. The interventions will be delivered by a monthly email. Both interventions will be active for twelve months. The effects of each intervention relative to the control group and to each other will be tested using a four-level hierarchical model adjusted for multiple hypothesis testing.Ethics and disseminationUsing behavioural nudges rather than rigid policy changes allows us to target excessive prescribing without preventing clinicians from using their clinical judgement to address patient pain. All study activities have been approved by the RAND Human Subjects Protection Committee (ID 2018-0988). Findings will be disseminated through conference presentations, peer-reviewed publications and social media accounts.Trial registration numberNCT05070338.
Profiling the real-world management status of high-risk human papillomavirus infection: a protocol to establish a prospective cohort of high-risk human papillomavirus-infected women in Lueyang County, China
Authors: Yang Siyuan , Bai Li , Xu Wei , Zhang Ruoyi , Hu Dehua , Nie Yuxian , Xiang Rumei , Shi Qiuling 
Published: September 2022

IntroductionPersistent infection with high-risk human papillomavirus (hrHPV) is the main cause of cervical cancer. Thus, the effective treatment against HPV represents an opportunity to reduce the incidence of cervical cancer. Although various treatments are effective in treating HPV infection, they still provide limited benefit in reducing the rate of cervical cancer due to the lack of implementation of a standardised protocol in many low/middle-income areas. This proposed cohort study aims to describe the status quo of treatment, attributions of the treatment decision-making process and potential factors influencing treatment decisions.Methods and analysisThis is a mixed-method, 5-year prospective longitudinal study in Lueyang County, China, one of the areas with the highest cervical cancer incidence rates and lowest mean income in China. We will enrol women with hrHPV infection (at least one HPV type in the 13 high‐risk subtypes) diagnosed via a county-wide HPV infection and cervical cancer screening programme. The study procedures describe the treatment patterns and explore the potential influencing factors in treatment decision-making through questionnaires, laboratory examinations and in-depth interviews. All participants will be evaluated at baseline and at 6, 12, 24, 36, 48 and 60 months. The primary outcome is the treatment pattern, the type and duration of which will be described later. The secondary outcomes include guideline compliance and changes in the HPV infection status. The HPV impact profile, intimate relationship satisfaction, and costs within different management groups are also described and compared.Ethics and disseminationThis study was reviewed, and all of the relevant approvals were obtained from the Ethics Committee of the Maternity Service Centre of Lueyang Maternal and Child Health Care Hospital (2021-001). The findings from this study will be disseminated through peer-reviewed publications, conference presentations and academic workshops.Trial registration numberChiCTR2100053757.
How do cohabitation and marital status affect mortality risk? Results from a cohort study in Thailand
Authors: Zhao Jiaying , Law Chi Kin , Kelly Matthew , Yiengprugsawan Vasoontara , Seubsman Sam-Ang , Sleigh Adrian 
Published: September 2022

ObjectiveTo examine the relationship between baseline union status (ie, including marriage and cohabitation) and mortality, paying attention to gender differentials, through an 11-year follow-up of a large cohort in Thailand.DesignCohort data from Thai Cohort Study (TCS) were linked official death records over an 11-year follow-up period.SettingCommunity-based adults in Thailand.Participants87 151 Thai adults participated in TCS cohort.MethodCox regression models measured longitudinal associations between union status and 11-year mortality.ResultsFrom 2005 (baseline) to 2016, persons who cohabited and lived with a partner, married persons but not living with a partner and separated/divorced/widowed people were more likely to die compared with those married and living together with a partner. Those who did not have good family support had a higher death risk than those having good family support.Single or cohabiting women had higher risks of mortality than women who were married and living together with a partner throughout follow-up, while separated/divorced/widowed men had higher risks of mortality than counterpart males.ConclusionsOur study reveals the protective effect of marriage and living together on mortality in Thailand, an understudied setting where institutionalisation of cohabitation is low leading to a limited mortality protection. Public policies for moderating mortality should thus be gender nuanced, culturally and institutionally specific. Also, we demonstrate that in settings such as Thailand, where marital status is not always defined in the same way as in western cultures, the need to measure cohabitation in locally relevant terms is important.
Street images classification according to COVID-19 risk in Lima, Peru: a convolutional neural networks feasibility analysis
Authors: Carrillo-Larco Rodrigo M , Castillo-Cara Manuel , Hernández Santa Cruz Jose Francisco 
Published: September 2022

ObjectivesDuring the COVID-19 pandemic, convolutional neural networks (CNNs) have been used in clinical medicine (eg, X-rays classification). Whether CNNs could inform the epidemiology of COVID-19 classifying street images according to COVID-19 risk is unknown, yet it could pinpoint high-risk places and relevant features of the built environment. In a feasibility study, we trained CNNs to classify the area surrounding bus stops (Lima, Peru) into moderate or extreme COVID-19 risk.DesignCNN analysis based on images from bus stops and the surrounding area. We used transfer learning and updated the output layer of five CNNs: NASNetLarge, InceptionResNetV2, Xception, ResNet152V2 and ResNet101V2. We chose the best performing CNN, which was further tuned. We used GradCam to understand the classification process.SettingBus stops from Lima, Peru. We used five images per bus stop.Primary and secondary outcome measuresBus stop images were classified according to COVID-19 risk into two labels: moderate or extreme.ResultsNASNetLarge outperformed the other CNNs except in the recall metric for the moderate label and in the precision metric for the extreme label; the ResNet152V2 performed better in these two metrics (85% vs 76% and 63% vs 60%, respectively). The NASNetLarge was further tuned. The best recall (75%) and F1 score (65%) for the extreme label were reached with data augmentation techniques. Areas close to buildings or with people were often classified as extreme risk.ConclusionsThis feasibility study showed that CNNs have the potential to classify street images according to levels of COVID-19 risk. In addition to applications in clinical medicine, CNNs and street images could advance the epidemiology of COVID-19 at the population level.
Research priority setting related to older adults: a scoping review to inform the Cochrane-Campbell Global Ageing Partnership work programme
Authors: Barbeau Victoria I , Madani Leen , Al Ameer Abdulah , Tanjong Ghogomu Elizabeth , Beecher Deirdre , Conde Monserrat , Howe Tracey E , Marcus Sue , Morley Richard , Nasser Mona , Smith Maureen , Thompson Coon Jo , Welch Vivian A 
Published: September 2022

ObjectiveTo explore and map the findings of prior research priority-setting initiatives related to improving the health and well-being of older adults.DesignScoping review.Data sourcesSearched MEDLINE, EMBASE, AgeLine, CINAHL and PsycINFO databases from January 2014 to 26 April 2021, and the James Lind Alliance top 10 priorities.Eligibility criteriaWe included primary studies reporting research priorities gathered from stakeholders that focused on ageing or the health of older adults (≥60 years). There were no restrictions by setting, but language was limited to English and French.Data extraction and synthesisWe used a modified Reporting Guideline for Priority Setting of Health Research (REPRISE) guideline to assess the transparency of the reported methods. Population–intervention–control–outcome (PICO) priorities were categorised according to their associated International Classification of Health Interventions (ICHI) and International Classification of Functioning (ICF) outcomes. Broad research topics were categorised thematically.ResultsSixty-four studies met our inclusion criteria. The studies gathered opinions from various stakeholder groups, including clinicians (n=56 studies) and older adults (n=35), and caregivers (n=24), with 75% of the initiatives involving multiple groups. None of the included priority-setting initiatives reported gathering opinions from stakeholders located in low-income or middle-income countries. Of the priorities extracted, 272 were identified as broad research topics, while 217 were identified as PICO priorities. PICO priorities that involved clinical outcomes (n=165 priorities) and interventions concerning health-related behaviours (n=59) were identified most often. Broad research topics on health services and systems were identified most often (n=60). Across all these included studies, the reporting of six REPRISE elements was deemed to be critically low.ConclusionFuture priority setting initiatives should focus on documenting a more detailed methodology with all initiatives eliciting opinions from caregivers and older adults to ensure priorities reflect the opinions of all key stakeholder groups.
Evidence for stratified conflicts of interest policies in research contexts: a methodological review
Authors: Graham S Scott , Karnes Martha S , Jensen Jared T , Sharma Nandini , Barbour Joshua B , Majdik Zoltan P , Rousseau Justin F 
Published: September 2022

ObjectivesThe purpose of this study was to conduct a methodological review of research on the effects of conflicts of interest (COIs) in research contexts.DesignMethodological review.Data sourcesOvid.Eligibility criteriaStudies published between 1986 and 2021 conducting quantitative assessments of relationships between industry funding or COI and four target outcomes: positive study results, methodological biases, reporting quality and results–conclusions concordance.Data extraction and synthesisWe assessed key facets of study design: our primary analysis identified whether studies stratified industry funding or COI variables by magnitude (ie, number of COI or disbursement amount), type (employment, travel fees, speaking fees) or if they assessed dichotomous variables (ie, conflict present or absent). Secondary analyses focused on target outcomes and available effects measures.ResultsOf the 167 articles included in this study, a substantial majority (98.2%) evaluated the effects of industry sponsorship. None evaluated associations between funding magnitude and outcomes of interest. Seven studies (4.3%) stratified industry funding based on the mechanism of disbursement or funder relationship to product (manufacturer or competitor). A fifth of the articles (19.8%) assessed the effects of author COI on target outcomes. None evaluated COI magnitude, and three studies (9.1%) stratified COI by disbursement type and/or reporting practices. Participation of an industry-employed author showed the most consistent effect on favourability of results across studies.ConclusionsSubstantial evidence demonstrates that industry funding and COI can bias biomedical research. Evidence-based policies are essential for mitigating the risks associated with COI. Although most policies stratify guidelines for managing COI, differentiating COIs based on the type of relationship or monetary value, this review shows that the available research has generally not been designed to assess the differential risks of COI types or magnitudes. Targeted research is necessary to establish an evidence base that can effectively inform policy to manage COI.
Epidemiology, diagnostics and factors associated with mortality during a cholera epidemic in Nigeria, October 2020–October 2021: a retrospective analysis of national surveillance data
Authors: Elimian Kelly , Yennan Sebastian , Musah Anwar , Cheshi Iliya Danladi , King Carina , Dunkwu Lauryn , Mohammed Ahmed Ladan , Ekeng Eme , Akande Oluwatosin Wuraola , Ayres Stephanie , Gandi Benjamin , Pembi Emmanuel , Saleh Fatima , Omar Ahmed Nasir , Crawford Emily , Olopha Olubunmi Omowumi , Nnaji Robinson , Muhammad Basheer , Luka-Lawal Rejoice , Ihueze Adachioma Chinonso , Olatunji David , Ojukwu Chidimma , Akinpelu Afolabi Muftau , Adaga Ene , Abubakar Yusuf , Nwadiuto Ifeoma , Ngishe Samuel , Alowooye Agnes Bosede , Nwogwugwu Peace Chinma , Kamaldeen Khadeejah , Abah Henry Nweke , Chukwuebuka Egbuna Hyacinth , Yusuff Hakeem Abiola , Mamadu Ibrahim , Mohammed Abbas Aliyu , Peter Sarah , Abbah Okpachi Christopher , Oladotun Popoola Michael , Oifoh Santino , Olugbile Micheal , Agogo Emmanuel , Ndodo Nnaemeka , Babatunde Olajumoke , Mba Nwando , Oladejo John , Ilori Elsie , Alfvén Tobias , Myles Puja , Ochu Chinwe Lucia , Ihekweazu Chikwe , Adetifa Ifedayo 
Published: September 2022

ObjectivesNigeria reported an upsurge in cholera cases in October 2020, which then transitioned into a large, disseminated epidemic for most of 2021. This study aimed to describe the epidemiology, diagnostic performance of rapid diagnostic test (RDT) kits and the factors associated with mortality during the epidemic.DesignA retrospective analysis of national surveillance data.Setting33 of 37 states (including the Federal Capital Territory) in Nigeria.ParticipantsPersons who met cholera case definition (a person of any age with acute watery diarrhoea, with or without vomiting) between October 2020 and October 2021 within the Nigeria Centre for Disease Control surveillance data.Outcome measuresAttack rate (AR; per 100 000 persons), case fatality rate (CFR; %) and accuracy of RDT performance compared with culture using area under the receiver operating characteristic curve (AUROC). Additionally, individual factors associated with cholera deaths and hospitalisation were presented as adjusted OR with 95% CIs.ResultsOverall, 93 598 cholera cases and 3298 deaths (CFR: 3.5%) were reported across 33 of 37 states in Nigeria within the study period. The proportions of cholera cases were higher in men aged 5–14 years and women aged 25–44 years. The overall AR was 46.5 per 100 000 persons. The North-West region recorded the highest AR with 102 per 100 000. Older age, male gender, residency in the North-Central region and severe dehydration significantly increased the odds of cholera deaths. The cholera RDT had excellent diagnostic accuracy (AUROC=0.91; 95% CI 0.87 to 0.96).ConclusionsCholera remains a serious public health threat in Nigeria with a high mortality rate. Thus, we recommend making RDT kits more widely accessible for improved surveillance and prompt case management across the country.
Process of youth engagement in school health promotion: a scoping review protocol
Authors: Kontak Julia C , Kirk Sara F 
Published: September 2022

IntroductionSchool environments are an essential setting to shape and influence the health and well-being of students. Health promoting school (HPS) is a whole-school approach that strengthens and builds a safe and healthy school environment for students to learn and develop. A core component of HPS is the meaningful participation of youth. Despite promising outcomes arising from youth engagement in school health promotion, there is less known on the process of how students are involved in school health promotion and in what form. This scoping review will explore and map the different components of the student engagement process in school health promotion with specific focus on whole-school approaches like HPS.Methods and analysisWe will follow scoping review guidelines employed by the Joanna Briggs Institute and Arksey and O’Malley’s framework. We will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews to guide reporting. We will follow the PCC mnemonic (participant, concept and context) to develop eligibility criteria. Both published and unpublished literature will be included. Databases to be searched include: CINAHL, ERIC, MEDLINE, Scopus, ProQuest Dissertations & Theses Global databases and Google Scholar. Relevant organisational websites and sources identified by experts will also be reviewed. Two reviewers will screen the title, abstract and full text of the sourced articles. Data from included articles will be charted using a data charting tool. The socioecological model and Hart’s Ladder of Participation will be used to guide charting. Descriptive analysis will be conducted for quantitative data, and thematic analysis will be employed for qualitative data. Data will be displayed through tables and narrative descriptions.Ethics and disseminationNo ethical approval is required for this study. To disseminate our work, we plan to develop an open-access publication, accompanied by a conference presentation and other knowledge translation products.