bluuebunny/crossref_metadata_2025_split huggingface dataset:
Interventions based on environmental determinants for nutritional and physical activity behaviours in Colombia: a scoping review
Authors: Hernandez Edgar D , Guzman Cristian Arvey , Seron Pamela 
Published: September 2022

ObjectiveTo identify, systematically, the interventions based on environmental determinants to improve the nutritional and physical activity (PA) habits available in Colombia.DesignA scoping review was performed according to the guidelines of the Joanna Briggs Institute.Study selectionAll studies about intervention programmes for PA and nutritional behaviours in Colombia were included.MethodsSearches in Medline/PubMed, Embase, Cochrane, Scielo and Lilacs, using MeSH, Decs and Emtree terms, were performed up to August 2020. Additionally, a manual search was made in specialised national journals. An internet documentary search of the official websites on policies and programmes by departmental, district and municipal secretariats was also performed.Two reviewers independently screened titles and abstracts. Then, the full texts were reviewed to select documents to be included.Data management relevant information from selected documents and articles was extracted. A descriptive analysis was considered.ResultsSixty-seven documents and 70 published articles were found. The programmes were identified in 13 initiatives, 7 in the area of PA and 6 with a nutrition focus. They were on physical and social environmental modifications such as the ‘muévete’ (‘get moving’) programmes in Bogota, Quindio and Cartagena; a modification of ‘ciclovía’; or bicycle path programmes as well as nutrition programmes in schools, universities and companies.ConclusionThis scoping review identified national programmes and policies in Colombia in the area of nutrition and PA from the environmental perspective in different scenarios: from schools to workplaces and communities. The need to implement such programmes from public and private institutions is also noted, promoting the practice of PA and healthy eating in every scenario in the national territory. New research to determine the impact of these programmes is essential to get a glimpse of the effects of these programmes and the implications for public health.
Defining and identifying critical elements of, and lessons learned from addressing, ‘operational readiness’ for public health emergency events, including COVID-19: a scoping review protocol
Authors: English Rene , Yauka Nyasulu Juliet Charity , Berner Karina , Geduld Heike , McCaul Michael , Joseph Conran , Pappin Michele , Gobat Nina , Boulanger Linda Lucy , Louw Quinette 
Published: September 2022

IntroductionMuch is known around public health preparedness and response phases. However, between the two phases is operational readiness that comprises the immediate actions needed to respond to a developing risk or hazard. Currently, emergency readiness is embedded in multiple frameworks and policy documents related to the health emergency cycle. However, knowledge about operational readiness’ critical readiness components and actions required by countries to respond to public health eminent threat is not well known. Therefore, we aim to define and identify the critical elements of ‘operational readiness’ for public health emergencies, including COVID-19, and identify lessons learnt from addressing it, to inform the WHO Operational Readiness Framework.Methods and analysisThis is a scoping review following the Joanna Briggs Institute guidance. Reporting will be according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. MEDLINE, Embase and Web of Science databases and grey literature will be searched and exported into an online systematic review software (eg, Rayyan in this case) for review. The review team, which apart from scoping review methodological experts include content experts in health systems and public health and emergency medicine, prepared an a priori study protocol in consultation with WHO representatives. ATLAS.ti V.9 will be used to conduct thematic data analysis as well as store, organise and retrieve data. Data analysis and presentation will be carried out by five reviewers.Ethics and disseminationThis review will reveal new insights, knowledge and lessons learnt that will translate into an operational framework for readiness actions. In consultation with WHO, findings will be disseminated as appropriate (eg, through professional bodies, conferences and research papers). No ethics approvals are required as no humans will be involved in data collection.Protocol registrationThis rapid scoping review has been registered on Open Science Framework (doi:10.17605/OSF.IO/6SYAH).
Study protocol for a randomised, double-blind, placebo-controlled crossover trial assessing the impact of the SGLT2 inhibitor empagliflozin on postprandial hypoglycaemia after gastric bypass
Authors: Ferreira Antonio , Emara Ahmed Fahiem Abdelsalam , Herzig David , Melmer Andreas , Vogt Andreas P , Nakas Christos T , Facchinetti Andrea , Dalla Man Chiara , Bally Lia 
Published: September 2022

IntroductionPostprandial hypoglycaemia after gastric bypass surgery (also known as postbariatric hypoglycaemia or PBH) is an increasingly encountered clinical problem. PBH is characterised by meal-induced rapid spikes and consequent falls in glycaemia, resulting in both hypoglycaemia burden and high glycaemic variability. Despite its frequency, there is currently no approved pharmacotherapy. The purpose of this investigation is to evaluate efficacy and safety of empagliflozin 25 mg, a sodium-glucose cotransporter 2-inhibitor, to reduce glucose excursions and hypoglycaemia burden in patients with PBH after gastric bypass surgery.Methods and analysisIn a prospective, single-centre, randomised, double-blind, placebo-controlled, crossover trial, we plan to enrol 22 adults (≥18 years) with PBH after Roux-en-Y gastric bypass surgery (plasma or sensor glucose <3.0 mmol/L). Eligible patients will be randomised to receive empagliflozin 25 mg and placebo once daily, each for 20 days, in random order. Study periods will be separated by a 2–6 weeks wash-out period. The primary efficacy outcome will be the amplitude of plasma glucose excursion (peak to nadir) during a mixed meal tolerance test. Results will be presented as paired-differences±SD plus 95% CIs with p values and hypothesis testing for primary and secondary outcomes according to intention-to-treat. Secondary outcomes include continuous glucose monitoring-based outcomes, further metabolic measures and safety.Ethics and disseminationThe DEEP-EMPA trial (original protocol title: Randomized, double-blind, placebo-controlled crossover trialassessing the impact of the SGLT2 inhibitor empagliflozin onpostprandial hypoglycaemia after gastric bypass) was approved by the Bern Ethics Committee (ID 2021-01187) and Swissmedic (Ref. Number: 102663190) in October and November 2021, respectively. First results are expected in the first quarter of 2023 and will be disseminated via peer-reviewed publications and presented at national and international conferences. The acronym DEEP was derived from an overarching project title (DEciphering the Enigma of Postprandial Hyperinsulinaemic Hypoglycaemia after Bariatric Surgery), the term EMPA stands for the drug empagliflozin.Trial registration numberNCT05057819.
Narrative medicine to investigate the quality of life and emotional impact of inherited retinal disorders through the perspectives of patients, caregivers and clinicians: an Italian multicentre project
Authors: Simonelli Francesca , Sodi Andrea , Falsini Benedetto , Bacci Giacomo , Iarossi Giancarlo , Di Iorio Valentina , Giorgio Dario , Placidi Giorgio , Andrao Assia , Reale Luigi , Fiorencis Alessandra , Aoun Manar 
Published: September 2022

ObjectivesAlthough inherited retinal disorders (IRDs) related to the gene encoding the retinal pigment epithelium 65kD protein (RPE65) significantly impact the vision-related quality of life (VRQoL), their emotional and social aspects remain poorly investigated in Italy. Narrative Medicine (NM) reveals the more intimate aspects of the illness experience, providing insights into clinical practice.Design and settingThis NM project was conducted in Italy between July and December 2020 and involved five eye clinics specialised in IRDs. Illness plots and parallel charts, together with a sociodemographic survey, were collected through the project’s website; remote in-depth interviews were also conducted. Narratives and interviews were analysed through NVivo software and interpretive coding.Participants3 paediatric and 5 adult patients and eight caregivers participated in the project; 11 retinologists globally wrote 27 parallel charts; 5 professionals from hospital-based multidisciplinary teams and one patient association member were interviewed.ResultsFindings confirmed that RPE65-related IRDs impact VRQoL in terms of activities and mobility limitations. The emotional aspects emerged as crucial in the clinical encounter and as informative on IRD management challenges and real-life experiences, while psychological support was addressed as critical from clinical diagnosis throughout the care pathway for both patients and caregivers; the need for an IRDs ‘culture’ emerged to acknowledge these conditions, and therefore, promoting diversity within society.ConclusionsThe project was the first effort to investigate the impact of RPE65-related IRDs on the illness experience through NM, concomitantly addressing the perspectives of paediatric and adult patients, caregivers and healthcare professionals and provided preliminary insights for the knowledge of RPE65-related IRDs and the clinical practice.
‘Like building a plane and flying it all in one go’: an interview study of infection prevention and control in Australian general practice during the first 2 years of the SARS-CoV-2 pandemic
Authors: Hor Su-Yin , Burns Penelope , Yong Faith R , Barratt Ruth , Degeling Chris , Williams Veazey Leah , Wyer Mary , Gilbert Gwendolyn L 
Published: September 2022

ObjectivesGeneral practitioners (GPs) and their staff have been at the frontline of the SARS-CoV-2 pandemic in Australia. However, their experiences of responding to and managing the risks of viral transmission within their facilities are poorly described. The aim of this study was to describe the experiences, and infection prevention and control (IPC) strategies adopted by general practices, including enablers of and challenges to implementation, to contribute to our understanding of the pandemic response in this critical sector.DesignSemistructured interviews were conducted in person, by telephone or online video conferencing software, between November 2020 and August 2021.ParticipantsTwenty general practice personnel working in New South Wales, Australia, including nine GPs, one general practice registrar, four registered nurses, one nurse practitioner, two practice managers and two receptionists.ResultsParticipants described implementing wide-ranging repertoires of IPC strategies—including telehealth, screening of patients and staff, altered clinic layouts and portable outdoor shelters, in addition to appropriate use of personal protective equipment (PPE)—to manage the demands of the SARS-CoV-2 pandemic. Strategies were proactive, influenced by the varied contexts of different practices and the needs and preferences of individual GPs as well as responsive to local, state and national requirements, which changed frequently as the pandemic evolved.ConclusionsUsing the ‘hierarchy of controls’ as a framework for analysis, we found that the different strategies adopted in general practice often functioned in concert with one another. Most strategies, particularly administrative and PPE controls, were subjected to human variability and so were less reliable from a human factors perspective. However, our findings highlight the creativity, resilience and resourcefulness of general practice staff in developing, implementing and adapting their IPC strategies amidst constantly changing pandemic conditions.
Study protocol of REpeat versus SIngle ShoT Antibiotic prophylaxis in major Abdominal Surgery (RESISTAAS I): a prospective observational study of antibiotic prophylaxis practice for patients undergoing major abdominal surgery
Authors: Murtha-Lemekhova Anastasia , Fuchs Juri , Teroerde Miriam , Rau Heike , Frey Otto R , Hornuss Daniel , Billeter Adrian , Klotz Rosa , Chiriac Ute , Larmann Jan , Weigand Markus A , Probst Pascal , Hoffmann Katrin 
Published: September 2022

IntroductionSurgical site infections (SSIs) are among the most common complications after abdominal surgery and develop in approximately 20% of patients. These patients suffer a 12% increase in mortality, underlying the need for strategies reducing SSI. Perioperative antibiotic prophylaxis is paramount for SSI prevention in major abdominal surgery. Yet, intraoperative redosing criteria are subjective and whether patients benefit from it remains unclear.Methods and analysisThe REpeat versus SIngle ShoT Antibiotic prophylaxis in major Abdominal Surgery (RESISTAAS I) study is a single-centre, prospective, observational study investigating redosing of antibiotic prophylaxis in 300 patients undergoing major abdominal surgery. Adult patients scheduled for major abdominal surgery will be included. Current practice of redosing regarding number and time period will be recorded. Postoperative SSIs, nosocomial infections, clinically relevant infection-associated bacteria, postoperative antibiotic treatment, in addition to other clinical, pharmacological and economical outcomes will be evaluated. Differences between groups will be analysed with analysis of covariance.Ethics and disseminationRESISTAAS I will be conducted in accordance with the Declaration of Helsinki and internal, national and international standards of GCP. The Medical Ethics Review Board of Heidelberg University has approved the study prior to initiation (S-404/2021). The study has been registered on 7 February 2022 at German Clinical Trials Register, with identifier DRKS00027892. We plan to disseminate the results of the study in a peer-reviewed journal.Trial registrationGerman Clinical Trials Register (DRKS): DRKS00027892.
Inforatio technique to promote wound healing of diabetic foot ulcers: study protocol for a parallel-group, evaluator-blinded, randomised clinical trial
Authors: Moeini Sahar , Gottlieb Hans , Jørgensen Tue Smith , Aagaard Thomas Vedste , Kornø Maj Raundrup , Larsen Malene Ringholm Bæk , Brorson Stig 
Published: September 2022

IntroductionDiabetic foot ulcers (DFUs) are associated with extensive consequences for the affected patients and treatment of these hard-to-heal ulcers is known for being challenging. New treatment methods to supplement the current standard care may improve the prognosis for these patients.A preceding feasibility trial with promising results, facilitated this trial that aims to study the effect of a novel simple treatment, called inforatio technique, which may promote healing of DFUs. The inforatio technique is a minimally invasive procedure where small cuts are made on wound beds with punch biopsy tools.Methods and analysisThis multicentre randomised clinical trial will be conducted at outpatient clinics at Zealand University Hospital, Herlev University Hospital, Slagelse Hospital and Nykoebing Falster Hospital. 100 participants will be included and randomised in a 1:1 ratio to either a control group that receives usual care or an intervention group that receives both usual care and the inforatio technique.The primary outcome is complete healing evaluated on digital images by blinded observers. It is not possible to blind participants or the outpatient clinic staff because the inforatio technique is visible in wound beds after application. Change in EQ-5D-5L (EuroQoL-5 Dimension- 5 Level) Visual Analogue Scale Score and Wound-QoL Global Score from baseline to end of follow-up are secondary outcomes.Ethics and disseminationEthics approval has been granted by the Danish National Committee on Health Research Ethics on 15 December 2021 (approval ID: SJ-904). Trial results are planned to be published in a high-impact peer-reviewed journal.Trial registration numberNCT05189470.
Psychologically informed oral health interventions in pregnancy and type 2 diabetes: a scoping review protocol
Authors: Böhme Kristensen Camilla , Ide Mark , Forbes Angus , Asimakopoulou Koula 
Published: September 2022

IntroductionPeriodontal health is becoming a recognised component in managing gestational diabetes. Gestational diabetes is characterised as raised blood glucose levels first discovered in pregnancy and managed similarly to type 2 diabetes. Currently, the standard intervention for gestational diabetes in the UK entails dietary modifications and physical activity interventions. However, considering the literature discussed in this review, it is argued that oral health advice and support should also become an integrated part of gestational diabetes management.ObjectiveThe objective of this scoping review is to map out psychologically informed oral health interventions in pregnancy and type 2 diabetes. This will inform the development of a new behavioural intervention to promote oral health-related behaviours in women with gestational diabetes. As no literature exists on oral health interventions in gestational diabetes, it was deemed appropriate to synthesise the evidence on oral health interventions designed for pregnant women and individuals with type 2 diabetes.MethodologyThe scoping review will be conducted using the Joanna Briggs Institute’s methodology for scoping reviews. Studies including pregnant women and individuals with type 2 diabetes over 18 years of age will be included. Only studies including a psychologically informed oral health intervention will be considered. The authors will consider experimental and quasi-experimental research designs. The Ovid Interface including EMBASE, Medline, Global Health, APA PsychInfo, Health Management Information, Maternity, Infant Care Database and the Cochrane Library will be used as information sources. The planned searches will commence on the week of the 25 July 2022. Only articles in Danish and English will be considered. The study selection will follow the Preferred Reporting Items for Scoping Reviews process. The data will be presented using narrative synthesis.Ethics and disseminationNo ethical approval is needed for this review. The results will be published in a relevant scientific journal.
Study protocol for a phase II, double-blind, randomised controlled trial of cannabidiol (CBD) compared with placebo for reduction of brain neuroinflammation in adults with chronic low back pain
Authors: Pike Chelsea K , Kim Minhae , Schnitzer Kristina , Mercaldo Nathaniel , Edwards Robert , Napadow Vitaly , Zhang Yi , Morrissey Erin Janas , Alshelh Zeynab , Evins A Eden , Loggia Marco L , Gilman Jodi M 
Published: September 2022

IntroductionChronic pain is a debilitating medical problem that is difficult to treat. Neuroinflammatory pathways have emerged as a potential therapeutic target, as preclinical studies have demonstrated that glial cells and neuroglial interactions play a role in the establishment and maintenance of pain. Recently, we used positron emission tomography (PET) to demonstrate increased levels of 18 kDa translocator protein (TSPO) binding, a marker of glial activation, in patients with chronic low back pain (cLBP). Cannabidiol (CBD) is a glial inhibitor in animal models, but studies have not assessed whether CBD reduces neuroinflammation in humans. The principal aim of this trial is to evaluate whether CBD, compared with placebo, affects neuroinflammation, as measured by TSPO levels.Methods and analysisThis is a double-blind, randomised, placebo-controlled, phase II clinical trial. Eighty adults (aged 18–75) with cLBP for >6 months will be randomised to either an FDA-approved CBD medication (Epidiolex) or matching placebo for 4 weeks using a dose-escalation design. All participants will undergo integrated PET/MRI at baseline and after 4 weeks of treatment to evaluate neuroinflammation using [11C]PBR28, a second-generation radioligand for TSPO. Our primary hypothesis is that participants randomised to CBD will demonstrate larger reductions in thalamic [11C]PBR28 signal compared with those receiving placebo. We will also assess the effect of CBD on (1) [11C]PBR28 signal from limbic regions, which our prior work has linked to depressive symptoms and (2) striatal activation in response to a reward task. Additionally, we will evaluate self-report measures of cLBP intensity and bothersomeness, depression and quality of life at baseline and 4 weeks.Ethics and disseminationThis protocol is approved by the Massachusetts General Brigham Human Research Committee (protocol number: 2021P002617) and FDA (IND number: 143861) and registered with ClinicalTrials.gov. Results will be published in peer-reviewed journals and presented at conferences.Trial registration numberNCT05066308; ClinicalTrials.gov.
Paediatric death after withdrawal of life-sustaining therapies: a scoping review protocol
Authors: Francoeur Conall , Hornby Laura , Silva Amina , Scales Nathan B , Weiss Matthew , Dhanani Sonny 
Published: September 2022

IntroductionThe physiology of dying after withdrawal of life-sustaining measures (WLSM) is not well described in children. This lack of knowledge makes predicting the duration of the dying process difficult. For families, not knowing this process’s duration interferes with planning of rituals related to dying, travel for distant relatives and emotional strain during the wait for death. Time-to-death also impacts end-of-life care and determines whether a child will be eligible for donation after circulatory determination of death. This scoping review will summarise the current literature about what is known about the dying process in children after WLSM in paediatric intensive care units (PICUs).Methods and analysisThis review will use Joanna Briggs Institute methodology for scoping reviews. Databases searched will include Ovid MEDLINE, Ovid Embase, Cochrane Central Register of Controlled Trials via EBM Reviews Ovid, Ovid PsycINFO, CINAHL and Web of Science. Literature reporting on the physiology of dying process after WLSM, or tools that predict time of death in children after WLSM among children aged 0–18 years in PICUs worldwide will be considered. Literature describing the impact of prediction or timing of death after WLSM on families, healthcare workers and the organ donation process will also be included. Quantitative and qualitative studies will be evaluated. Two independent reviewers will screen references by title and abstract, and then by full text, and complete data extraction and analysis.Ethics and disseminationThe review uses published data and does not require ethics review. Review results will be published in a peer-reviewed scientific journal.