bluuebunny/crossref_metadata_2025_split huggingface dataset:
Induction of labour at 39 weeks versus expectant management in low-risk obese women: study protocol for a randomised controlled study
Authors: Krogh Lise Qvirin , Boie Sidsel , Henriksen Tine Brink , Thornton Jim , Fuglsang Jens , Glavind Julie 
Published: May 2022

IntroductionObesity is associated with many pregnancy complications, including both fetal macrosomia and prolonged labour. As a result, there is often also an increased risk of caesarean section. In other settings, labour induction near to term reduces adverse outcomes such as stillbirth and birth injury, without causing more caesarean deliveries. It has been suggested that induction will reduce adverse events in this setting too, but there have been no trials and the effect on caesarean section is unknown. The objective of this study is to compare induction of labour in gestational week 39 with expectant management on the risk of caesarean section in women with body mass index ≥30 kg/m2.Methods and analysisAn open label randomised controlled multicentre trial are conducted at Danish delivery departments with an in-house neonatal intensive care unit. Recruitment started October 2020. A total of 1900 women with a prepregnancy body mass index ≥30 kg/m2 are randomised in a 1:1 ratio to either labour induction at 39 weeks and 0 to 3 days of gestation or to expectant management; that is, waiting for spontaneous labour onset or induction if medically indicated. The primary outcome is caesarean section. Data will be analysed according to intention-to-treat.Ethics and disseminationThe Central Denmark Region Committee on Biomedical Research Ethics approved the study. The study is conducted in accordance with the ethical principles outlined in the latest version of the ‘Declaration of Helsinki’ and the ‘Guideline for Good Clinical Practice’ related to experiments on humans. The trial findings will be disseminated to participants, clinicians, commissioning groups and via peer-reviewed publications.Trial registration numberNCT04603859.
Needs of patients with parkinsonism and their caregivers: a protocol for the PRIME-UK cross-sectional study
Authors: Tenison Emma , Lithander Fiona E , Smith Matthew D , Pendry-Brazier Danielle , Ben-Shlomo Yoav , Henderson Emily J 
Published: May 2022

IntroductionPeople with parkinsonism are a highly heterogeneous group and the disease encompasses a spectrum of motor and non-motor symptoms which variably emerge and manifest across the disease course, fluctuate over time and negatively impact quality of life. While parkinsonism is not directly the result of ageing, it is a condition that mostly affects older people, who may also be living with frailty and multimorbidity. This study aims to describe the broad range of health needs for people with parkinsonism and their carers in relation to their symptomatology, disability, disease stage, comorbidities and sociodemographic characteristics.Methods and analysisIn this single site cross-sectional study, people with parkinsonism will be sent a study information pack for themselves and their primary informal caregiver, if relevant. Data are collected via questionnaire, with additional support, if required, to maximise participation. A specific strategy has been developed to target and proactively recruit patients lacking capacity to consent, including those in residential care settings, with input from a personal consultee prior to completion of a bespoke questionnaire by a representative. Caregivers are also recruited to look at various health outcomes. Results will be displayed as descriptive statistics and regression models will be used to test simple associations and interactions.Ethics and disseminationThis protocol was approved by the London—Brighton & Sussex Research Ethics Committee (REC reference 20/LO/0890). The results of this protocol will be disseminated through publication in an international peer-reviewed journal; presentation at academic meetings and conferences; and a lay summary uploaded to the PRIME-Parkinson website.Trial registration numberISRCTN11452969; Pre-results.
Projected impact of change in the percentage of energy from each NOVA group intake on cardiovascular disease mortality in Brazil: a modelling study
Authors: Vasconcelos Leitão Moreira Patricia , da Costa Pereira de Arruda Neta Adélia , Leite de Lima Ferreira Flávia Emília , de Araújo Jevuks Matheus , da Costa Louzada Maria Laura , Lira Formiga Cavalcanti de Lima Rafaela , Pinheiro de Toledo Vianna Rodrigo , Moreira da Silva Neto José , Colombet Zoe , O’Flaherty Martin 
Published: May 2022

ObjectiveEstimate reductions in cardiovascular mortality achievable through improvement in nutrient intakes according to processing level (NOVA classification), that is, reducing consumption of culinary ingredients (G2), processed (G3) and ultra-processed foods (G4) while encouraging consumption of unprocessed and minimally processed foods (G1).DesignModelling study.SettingGeneral adult population of Brazil.ParticipantsMen and women aged 25 or more years (34 003) investigated in the Household Budget Survey 2017–2018, in the consumption data module.Main outcome measuresWe used the IMPACT Food Policy Model to estimate the reduction in deaths from cardiovascular diseases (CVD) up to 2048 in five scenarios with reductions in saturated fat, trans fat, salt and added sugar intakes resulting from changes in NOVA groups. (1) The optimistic scenario modelised an increase in the energy intake provided by G1 and a reduction in the energy intake from G2, G3 and G4, return to previous levels. (2) The minimal scenario modelised a 3.7% increase in the energy intake from G1, and a reduction in the energy intake from G4 to the 2008–2009 level. (3) The modest scenario only modelised a 25.0% reduction of the energy intake from G2 and G3. (4) The intermediary scenario modelised the minimal scenario plus a 25.0% reduction in the energy intake from G2. (5) Finally, the advanced scenario modelised the minimal scenario plus a 25.0% reduction in the energy intake from G2 and G3.ResultsProposed changes in the optimistic scenario could prevent or delay 52.8% CVD-related deaths by 2048. Changes modelled in the minimal, modest, intermediary and advanced scenarios may result in a 10.1%, 28.4%, 31.4% and 38.6% reduction in 2048 CVD mortality, respectively.ConclusionsSubstantial health gains can be achieved by improving the diet, through plausible modifications aimed at the level of processing as a tool for Brazilian food policies.
Impact of cardiovascular evaluations and interventions on fall risk in older adults: a protocol for a scoping review and evidence map
Authors: Wang Liping , van Poelgeest Eveline P , Pronk Anouschka C , Daams Joost G , Leeflang Mariska M G , Hoekstra Alfons G , van der Velde Nathalie 
Published: May 2022

IntroductionCardiovascular disorders are increasingly recognised as important fall risk factors in older adults. Falls are a major public health problem in older adults, and therefore, effective interventions for reducing falls are essential for this population. Cardiovascular disease is a clinically relevant (but often overlooked) and potentially modifiable risk factor for falls. Literature describing the effects of cardiovascular assessments and treatments on fall prevention has generally focused on only one specific test or treatment. A comprehensive, comparative overview surrounding the effectiveness of available assessments and treatments on cardiovascular related fall risk is currently lacking.Methods and analysisA scoping review and evidence map will be conducted to summarise the available evidence regarding the (comparative) effectiveness of cardiovascular assessments and therapeutic interventions on reducing fall risk in older individuals. A systematic and comprehensive literature search will be performed in MEDLINE and Embase using the key components ‘older adults’, ‘cardiovascular evaluation’, ‘cardiovascular intervention’ and ‘falls’. Furthermore, we will create an evidence map to summarise the quantity and quality of currently available evidence identified in the scoping review. The evidence map will consider, but will not be limited to, observational studies, randomised controlled trials and reviews evaluating cardiovascular tests and treatments (vs controls) on fall risk in older adults.Ethics and disseminationThe scoping review and evidence map will only include data that are publicly available and, therefore, ethical approval is not required. The results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.
Association between gut MIcrobiota, GROWth and Diet in peripubertal children from the TARGet Kids! cohort (The MiGrowD) study: protocol for studying gut microbiota at a community-based primary healthcare setting
Authors: Massara Paraskevi , Spiegel-Feld Carolyn , Hamilton Jill , Maguire Jonathon L , Birken Catherine , Bandsma Robert , Comelli Elena M 
Published: May 2022

IntroductionThe gut microbiota interacts with diet to affect body health throughout the life cycle. Critical periods of growth, such as infancy and puberty, are characterised by microbiota remodelling and changes in dietary habits. While the relationship between gut microbiota and growth in early life has been studied, our understanding of this relationship during puberty remains limited. Here, we describe the MIcrobiota, GROWth and Diet in peripubertal children (The MiGrowD) study, which aims to assess the tripartite growth-gut microbiota-diet relationship at puberty.Methods and analysisThe MiGrowD study will be a cross-sectional, community-based study involving children 8–12 years participating in the TARGet Kids! cohort. TARGet Kids! is a primary healthcare practice-based research network in Canada. Children will be asked to provide a stool sample, complete two non-consecutive 24-hour dietary recalls and a pubertal self-assessment based on Tanner Stages. Anthropometry will also be conducted. The primary outcome is the association between gut microbiota composition and longitudinal growth from birth until entry into the study. Anthropometrics data from birth will be from the data collected prospectively through TARGet Kids!. Body mass index z-scores will be calculated according to WHO. The secondary outcome is the association between gut microbiota, diet and pubertal stage.Ethics and disseminationEthics approval has been obtained by the Hospital for Sick Children and St. Michael’s Hospital—Unity Health, and the University of Toronto. Results will be disseminated in the public and academic sector, including participants, TARGet Kids! primary healthcare physicians teams, scientists via participation in the TARGet Kids! science and physician meetings, conferences and publications in peer-reviewed journals. The MiGrowD study results will help researchers understand the relationships underlying growth, gut microbiota and pubertal maturation in children.
Development of an intervention to improve informational continuity of care in older patients with polypharmacy at the interface between general practice and hospital care: protocol for a participatory qualitative study in Germany
Authors: Brueckle Maria-Sophie , Dinh Truc Sophia , Klein Astrid-Alexandra , Rietschel Lisa , Petermann Jenny , Brosse Franziska , Schulz-Rothe Sylvia , Gonzalez-Gonzalez Ana Isabel , Kramer Martin , Engler Jennifer , Mergenthal Karola , Muth Christiane , Voigt Karen , van den Akker Marjan 
Published: May 2022

IntroductionOlder patients with multimorbidity, polypharmacy and related complex care needs represent a growing proportion of the population and a challenge for healthcare systems. Particularly in transitional care (hospital admission and hospital discharge), medical errors, inappropriate treatment, patient concerns and lack of confidence in healthcare are major problems that may arise from a lack of information continuity. The aim of this study is to develop an intervention to improve informational continuity of care at the interface between general practice and hospital care.Methods and analysisA qualitative approach will be used to develop our participatory intervention. Overall, 32 semistructured interviews with relevant stakeholders will be conducted and analysed. The stakeholders will include healthcare professionals from the outpatient setting (general practitioners, healthcare assistants, ambulatory care nurses) and the inpatient setting (clinical doctors, nurses, pharmacists, clinical information scientists) as well as patients and informal caregivers. At a series of workshops based on the results of the stakeholder analyses, we aim to develop a participatory intervention that will then be implemented in a subsequent pilot study. The same stakeholder groups will be invited for participation in the workshops.Ethics and disseminationEthical approval for this study was waived by the Ethics Committee of Goethe University Frankfurt because of the nature of the proposed study. Written informed consent will be obtained from all study participants prior to participation. Results will be tested in a pilot study and disseminated at (inter)national conferences and via publication in peer-reviewed journals.Trial registation numberClinical Trials Register: registration number DRKS00027649.
Progression of chronic pain and associated health-related quality of life and healthcare resource use over 5 years after total knee replacement: evidence from a cohort study
Authors: Cole Sophie , Kolovos Spyros , Soni Anushka , Delmestri Antonella , Sanchez-Santos Maria T , Judge Andrew , Arden Nigel K , Beswick Andrew David , Wylde Vikki , Gooberman-Hill Rachael , Pinedo-Villanueva Rafael 
Published: May 2022

ObjectiveAs part of the STAR Programme, a comprehensive study exploring long-term pain after surgery, we investigated how pain and function, health-related quality of life (HRQL), and healthcare resource use evolved over 5 years after total knee replacement (TKR) for those with and without chronic pain 1 year after their primary surgery.MethodsWe used data from the Clinical Outcomes in Arthroplasty Study prospective cohort study, which followed patients undergoing TKR from two English hospitals for 5 years. Chronic pain was defined using the Oxford Knee Score Pain Subscale (OKS-PS) where participants reporting a score of 14 or lower were classified as having chronic pain 1-year postsurgery. Pain and function were measured with the OKS, HRQL using the EuroQoL-5 Dimension, resource use from yearly questionnaires, and costs estimated from a healthcare system perspective. We analysed the changes in OKS-PS, HRQL and resource use over a 5-year follow-up period. Multiple imputation accounted for missing data.ResultsChronic pain was reported in 70/552 operated knees (12.7%) 1 year after surgery. The chronic pain group had worse pain, function and HRQL presurgery and postsurgery than the non-chronic pain group. Those without chronic pain markedly improved right after surgery, then plateaued. Those with chronic pain improved slowly but steadily. Participants with chronic pain reported greater healthcare resource use and costs than those without, especially 1 year after surgery, and mostly from hospital readmissions. 64.7% of those in chronic pain recovered during the following 4 years, while 30.9% fluctuated in and out of chronic pain.ConclusionAlthough TKR is often highly beneficial, some patients experienced chronic pain postsurgery. Although many fluctuated in their pain levels and most recovered over time, identifying people most likely to have chronic pain and supporting their recovery would benefit patients and healthcare systems.
Randomised, double-blind, placebo-controlled, phase 2, superiority trial to demonstrate the effectiveness of faecal microbiota transplantation for selective intestinal decolonisation of patients colonised by carbapenemase-producing Klebsiella pneumoniae (KAPEDIS)
Authors: Pérez-Nadales Elena , Cano Ángela , Recio Manuel , Artacho María José , Guzmán-Puche Julia , Doblas Antonio , Vidal Elisa , Natera Clara , Martínez-Martínez Luis , Torre-Cisneros Julian , Castón Juan José 
Published: May 2022

IntroductionInfections caused by carbapenemase-producing Enterobacterales are frequent and associated with high rates of mortality. Intestinal carriers are at increased risk of infection by these microorganisms. Decolonisation strategies with antibiotics have not obtained conclusive results. Faecal microbiota transplantation (FMT) could be an effective and safe strategy to decolonise intestinal carriers of KPC-producing Klebsiella pneumoniae (KPC-Kp) but this hypothesis needs evaluation in appropriate clinical trials.Methods and analysisThe KAPEDIS trial is a single-centre, randomised, double-blind, placebo-controlled, phase 2, superiority clinical trial of FMT for eradication of intestinal colonisation by KPC-Kp. One hundred and twenty patients with rectal colonisation by KPC-Kp will be randomised 1:1 to receive encapsulated lyophilised FMT or placebo. The primary outcome is KPC-Kp eradication at 30 days. Secondary outcomes are: (1) frequency of adverse events; (2) changes in KPC-Kp relative load within the intestinal microbiota at 7, 30 and 90 days, estimated by real-time quantitative PCR analysis of rectal swab samples and (3) rates of persistent eradication, KPC-Kp infection and crude mortality at 90 days. Participants will be monitored for adverse effects throughout the intervention.Ethics and disseminationEthical approval was obtained from Reina Sofía University Hospital Institutional Review Board (approval reference number: 2019-003808-13). Trial results will be published in peer-reviewed journals and disseminated at national and international conferences.Trial registration numberNCT04760665.
Qualitative assessment of caregiver experiences when navigating childhood immunisation in urban communities in Sierra Leone
Authors: Jalloh Mohamed F , Patel Palak , Sutton Roberta , Kulkarni Shibani , Toure Mame , Wiley Kerrie , Sessay Tom , Lahuerta Maria 
Published: May 2022

ObjectiveTo gain in-depth understanding of the caregiver experience when navigating urban immunisation services for their children.DesignAn exploratory qualitative assessment comprising 16 in-depth interviews using an interpretative phenomenology approach.SettingCaregivers were purposively recruited from slums (n=8) and other urban communities (n=8) in the capital city of Sierra Leone.ParticipantsCaregivers of children ages 6–36 months old who were fully vaccinated (n=8) or undervaccinated (n=8).ResultsEmotional enablers of vaccination were evident in caregivers’ sense of parental obligation to their children while also anticipating reciprocal benefits in children’s ability to take care of their parents later in life. Practical enablers were found in the diversity of immunisation reminders, information access, information trust, getting fathers more involved, positive experiences with health workers and postvaccination information sharing in the community. Underlying barriers to childhood vaccination were due to practical constraints such as overcrowding and long waiting times at the clinic, feeling disrespected by health workers, expecting to give money to health workers for free services and fear of serious vaccine side effects. To improve vaccination outcomes, caregivers desired more convenient and positive clinic experiences and deeper community engagement.ConclusionsHealth system interventions, community engagement and vaccination outreach need to be tailored for urban settings. Vaccine communication efforts may resonate more strongly with caregivers when vaccination is framed both around parental responsibilities to do the right thing for the child and the future benefits to the parent.
Do P2Y12 receptor inhibitors prescribed poststroke modify the risk of cognitive disorder or dementia? Protocol for a target trial using multiple national Swedish registries
Authors: Hinwood Madeleine , Nyberg Jenny , Leigh Lucy , Gustavsson Sara , Attia John , Oldmeadow Christopher , Ilicic Marina , Linden Thomas , Åberg N David , Levi Chris , Spratt Neil , Carey Leeanne M , Pollack Michael , Johnson Sarah J , Kuhn Georg Hans , Walker Frederick R , Nilsson Michael 
Published: May 2022

IntroductionThe target of a class of antiplatelet medicines, P2Y12R inhibitors, exists both on platelets and on brain immune cells (microglia). This protocol aims to describe a causal (based on a counterfactual model) approach for analysing whether P2Y12R inhibitors prescribed for secondary prevention poststroke may increase the risk of cognitive disorder or dementia via their actions on microglia, using real-world evidence.Methods and analysisThis will be a cohort study nested within the Swedish National Health and Medical Registers, including all people with incident stroke from 2006 to 2016. We developed directed acyclic graphs to operationalise the causal research question considering potential time-independent and time-dependent confounding, using input from several experts. We developed a study protocol following the components of the target trial approach described by Hernan et al and describe the data structure that would be required in order to make a causal inference. We also describe the statistical approach required to derive the causal estimand associated with this important clinical question; that is, a time-to-event analysis for the development of cognitive disorder or dementia at 1, 2 and 5-year follow-up, based on approaches for competing events to account for the risk of all-cause mortality. Causal effect estimates and the precision in these estimates will be quantified.Ethics and disseminationThis study has been approved by the Ethics Committee of the University of Gothenburg and Confidentiality Clearance at Statistics Sweden with Dnr 937-18, and an approved addendum with Dnr 2019-0157. The analysis and interpretation of the results will be heavily reliant on the structure, quality and potential for bias of the databases used. When we implement the protocol, we will consider and document any biases specific to the dataset and conduct appropriate sensitivity analyses. Findings will be disseminated to local stakeholders via conferences, and published in appropriate scientific journals.
Spatial scenery of congenital syphilis in Brazil between 2007 and 2018: an ecological study
Authors: Seabra Iaron , Ferreira Glenda Roberta Oliveira Naiff , Sorensen William , Oliveira Carmem , Parente Andressa Tavares , Gir Elucir , Reis Renata Karina , Ferrari Rosângela Aparecida Pimenta , Botelho Eliã 
Published: May 2022

ObjectiveTo analysis the epidemiological scenery of the congenital syphilis (CS) in Brazil employing spatial analysis techniques.DesignEcological study.SettingsThis study was conducted in BrazilSampleA total of 151 601 CS cases notified to the Diseases and Notification Information System from 2007 to 2018 from children aged 0–23 months and born from mothers living in Brazil were included in this study.Primary outcome measuresThe CS incidence rates were calculated by triad (2007–2010, 2011–2014 and 2015–2018) for all Brazilian municipalities following the Boxcox transformation to remove the discrepant values. The transformed rates were analysed through the spatial autocorrelation of Moran, Kernel density estimative and spatial scan.ResultsFrom 2007 to 2018, the CS incidence rates increased in all Brazilian regions. The CS spread towards the interior of Brazil, and a higher expansion was noticed between 2015 and 2018. The municipalities that were greatly affected by the CS were those having a high migration of people, such as the ones bordering other countries and the touristic cities. Recife, Campo Grande, Rio de Janeiro, Porto Alegre and Manaus were the capitals with the greatest spatial and spatiotemporal risk.ConclusionThis study provides assistance to health authorities to fight CS in Brazil. More investment is necessary in prenatal care quality focusing on pregnant women and their partners to guarantee their full access to preventive resources against sexually transmitted infections.