bluuebunny/crossref_metadata_2025_split huggingface dataset:
Study design and rationale for the PAASIM project: a matched cohort study on urban water supply improvements and infant enteric pathogen infection, gut microbiome development and health in Mozambique
Authors: Levy Karen , Garn Joshua V , Cumbe Zaida Adriano , Muneme Bacelar , Fagnant-Sperati Christine S , Hubbard Sydney , Júnior Antonio , Manuel João Luís , Mangamela Magalhães , McGunegill Sandy , Miller-Petrie Molly K , Snyder Jedidiah S , Victor Courtney , Waller Lance A , Konstantinidis Konstantinos T , Clasen Thomas F , Brown Joe , Nalá Rassul , Freeman Matthew C 
Published: March 2023

IntroductionDespite clear linkages between provision of clean water and improvements in child health, limited information exists about the health impacts of large water infrastructure improvements in low-income settings. Billions of dollars are spent annually to improve urban water supply, and rigorous evaluation of these improvements, especially targeting informal settlements, is critical to guide policy and investment strategies. Objective measures of infection and exposure to pathogens, and measures of gut function, are needed to understand the effectiveness and impact of water supply improvements.Methods and analysisIn the PAASIM study, we examine the impact of water system improvements on acute and chronic health outcomes in children in a low-income urban area of Beira, Mozambique, comprising 62 sub-neighbourhoods and ~26 300 households. This prospective matched cohort study follows 548 mother–child dyads from late pregnancy through 12 months of age. Primary outcomes include measures of enteric pathogen infections, gut microbiome composition and source drinking water microbiological quality, measured at the child’s 12-month visit. Additional outcomes include diarrhoea prevalence, child growth, previous enteric pathogen exposure, child mortality and various measures of water access and quality. Our analyses will compare (1) subjects living in sub-neighbourhoods with the improved water to those living in sub-neighbourhoods without these improvements; and (2) subjects with household water connections on their premises to those without such a connection. This study will provide critical information to understand how to optimise investments for improving child health, filling the information gap about the impact of piped water provision to low-income urban households, using novel gastrointestinal disease outcomes.Ethics and disseminationThis study was approved by the Emory University Institutional Review Board and the National Bio-Ethics Committee for Health in Mozambique. The pre-analysis plan is published on the Open Science Framework platform (https://osf.io/4rkn6/). Results will be shared with relevant stakeholders locally, and through publications.
Local anaesthetic infiltration in rubber band ligation of rectal haemorrhoids: study protocol for a three-arm, double-blind randomised controlled trial (PLATIPUS trial)
Authors: Watson Eleanor G R , Qin Kirby R , Smart Philip J , Burgess Adele N , Mohan Helen M , Proud David M 
Published: March 2023

IntroductionRubber band ligation (‘banding’) is a common approach for the management of symptomatic haemorrhoids. However, up to 90% of patients experience postprocedural pain, and there is no consensus regarding the optimal analgesic strategy. In practice, patients may receive submucosal local anaesthetic, pudendal nerve block or routine periprocedural analgesia. The aim of this study is to compare the efficacy of submucosal local anaesthetic, pudendal nerve block and routine analgesia for postprocedural pain in patients undergoing haemorrhoid banding.Methods and analysisThis is a multicentre, prospective, three-arm, double-blind randomised controlled trial of adults booked for haemorrhoid banding. Participants will be randomised to one of three groups in a 1:1:1 ratio: (1)submucosal bupivacaine injection; (2) pudendal nerve ropivacaine injection and (3) no local anaesthetic. The primary outcome is patient reported postprocedural pain (scored 0–10) from 30 min to 2 weeks. Secondary outcomes include postprocedural analgesia use, time to discharge, patient satisfaction, time to return to work and complications. A sample size of 120 patients is required to achieve statistical significance.Ethics and disseminationThis study received Human Research Ethics Approval from the Austin Health Human Research Ethics Committee (March 2022). Trial results will be submitted to a peer-reviewed journal, and presented at academic meetings. A summary of the trial results will be made available to study participants on request.Trial registration numberACTRN12622000006741p.
Women’s experiences of over-the-counter and prescription medication during pregnancy in the UK: findings from survey free-text responses and narrative interviews
Authors: Sanders Julia , Blaylock Rebecca , Dean Caitlin , Petersen Irene , Trickey Heather , Murphy Clare 
Published: March 2023

ObjectivesTo explore women’s experiences of over-the-counter and prescription medication advice and use during pregnancy.DesignA study design consisting of an online survey and nested in-depth interviews with a subsample of participants. We analysed data from survey free-text responses and in-depth interviews using thematic analysis. Quantitative survey data is published elsewhere.SettingThe UK.ParticipantsWomen were eligible if living in the UK, aged 16–45 years, were pregnant or had been pregnant in the last 5 years regardless of pregnancy outcome. A total of 7090 women completed the survey, and 34 women who collectively had experienced 68 pregnancies were subsequently interviewed.ResultsMedication prescribing and use during pregnancy was common. The prescribing, dispensing and taking of some advised medications were restricted through women’s or prescribers’ fear of fetal harm. Lack of adherence to national prescribing guidance, conflicting professional opinion and poor communication resulted in maternal anxiety, avoidable morbidity and women negotiating complex and distressing pathways to obtain recommended medications. In contrast, some women felt overmedicated and that pharmacological treatments were used without exploring other options first.ConclusionIncreased translation of national guidance into practice and greater personalisation of antenatal care are needed to improve the safety, efficacy and personalisation of prescribing in pregnancy.
Designing a library of lived experience for mental health (LoLEM): protocol for integrating a realist synthesis and experience based codesign approach
Authors: Lobban Fiona , Marshall Paul , Barbrook John , Collins Grace , Foster Sheena , Glossop Zoe , Inkster Clare , Jebb Paul , Johnston Rose , Khan Hameed , Lodge Christopher , Machin Karen , Michalak Erin , Powell Sarah , Rycroft-Malone Jo , Slade Mike , Whittaker Lesley , Jones Steven H 
Published: March 2023

IntroductionPeople with lived expertise in managing mental health challenges can be an important source of knowledge and support for other people facing similar challenges, and for carers to learn how best to help. However, opportunities for sharing lived expertise are limited. Living libraries support people with lived expertise to be ‘living books’, sharing their experiences in dialogue with ‘readers’ who can ask questions. Living libraries have been piloted worldwide in health-related contexts but without a clear model of how they work or rigorous evaluation of their impacts. We aim to develop a programme theory about how a living library could be used to improve mental health outcomes, using this theory to codesign an implementation guide that can be evaluated across different contexts.Methods and analysisWe will use a novel integration of realist synthesis and experience-based codesign (EBCD) to produce a programme theory about how living libraries work and a theory and experience informed guide to establishing a library of lived experience for mental health (LoLEM). Two workstreams will run concurrently: (1) a realist synthesis of literature on living libraries, combined with stakeholder interviews, will produce several programme theories; theories will be developed collaboratively with an expert advisory group of stakeholders who have hosted or taken part in a living library and will form our initial analysis framework; a systematic search will identify literature about living libraries; data will be coded into our analysis framework, and we will use retroductive reasoning to explain living libraries’ impacts across multiple contexts. Individual stakeholder interviews will help refine and test theories; (2) data from workstream 1 will inform 10 EBCD workshops with people with experience of managing mental health difficulties and health professionals to produce a LoLEM implementation guide; data from this process will also inform the theory in workstream 1.Ethics and disseminationEthical approval was granted by Coventry and Warwick National Health Service Research Ethics Committee on 29 December 2021 (reference number 305975). The programme theory and implementation guide will be published as open access and shared widely through a knowledge exchange event, a study website, mental health provider and peer support networks, peer reviewed journals and a funders report.PROSPERO registration detailsCRD42022312789.
Understanding the healthcare providers’ perspective for bringing the assessment of burden of chronic conditions tool to practice: a protocol for an implementation study
Authors: Claessens Danny , Vervloet Marcia , Boudewijns Esther Adriana , Keijsers Lotte C E M , Gidding-Slok Annerika H M , van Schayck Onno C P , van Dijk Liset 
Published: March 2023

IntroductionThe Assessment of Burden of Chronic Conditions (ABCC) tool is developed and validated to support and facilitate a personalised approach to care for people with chronic conditions. The benefit of using the ABCC-tool greatly depends on how it is implemented. To enable a deeper understanding of when, how and by whom the ABCC-tool is used, this study protocol describes the design of an implementation study in which the context, experiences and implementation process of the ABCC-tool by primary care healthcare providers (HCPs) in the Netherlands will be investigated.Methods and analysisThis protocol describes an implementation study alongside an effectiveness trial, in which the ABCC-tool is evaluated in general practices. The implementation strategy of the tool in the trial confines to providing written information and an instruction video explaining the technical use of the ABCC-tool. The outcomes include a description of: (1) the barriers and facilitators of HCPs for implementation of the ABCC-tool, guided by the Consolidated Framework for Implementation Research (CFIR) and (2) the implementation outcomes guided by the Reach-Effect-Adoption-Implementation-Maintenance (RE-AIM) framework Carroll’s fidelity framework. All outcomes will be gathered through individual semistructured interviews throughout 12 months of use. Interviews will be audiorecorded and transcribed. Transcripts will be analysed using content analysis for identifying barriers and facilitators (based on CFIR) and thematic analyses of HCPs’ experiences (based on the RE-AIM and the fidelity frameworks).Ethics and disseminationThe presented study was approved by the Medical Ethics Committee of Zuyderland Hospital, Heerlen (METCZ20180131). Written informed consent is mandatory prior to participation in the study. The results from the study in this protocol will be disseminated through publication in peer-reviewed scientific journals and conference presentations.
Effects of non-invasive brain stimulation (NIBS) for executive function on subjects with ADHD: a protocol for a systematic review and meta-analysis
Authors: Peng Lihong , Tian Liyan , Wang Tiantian , Wang Qiu , Li Na , Zhou Hui 
Published: March 2023

IntroductionAttention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder with a high risk of multiple mental health and social difficulties. Executive function domains are associated with distinct ADHD symptom burdens. Non-invasive brain stimulation (NIBS) mainly includes repetitive transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), which is a promising technique, but its impact on the executive function of ADHD is uncertain. Therefore, the aim of this systematic review and meta-analysis is to derive solid and updated estimates on the effect of NIBS on executive function in children/adults with ADHD.Methods and analysisA systematic search will be performed through EMBASE, MEDLINE, PsycINFO and Web of Science databases from inception until 22 August 2022. Handsearching of grey literature and the reference lists of selected articles will also be conducted. Empirical studies assessing the effect of NIBS (TMS or tDCS) on executive function in children or adults with ADHD will be included. Two investigators will independently perform literature identification, data extraction and risk of bias assessment. Relevant data will be pooled by a fixed-effects or random-effects model according to I2statistic. Sensitivity analysis will be performed to test the robustness of the pooled estimates. Subgroup analyses will be conducted to investigate the potential heterogeneity. This protocol will generate a systematic review and meta-analysis that comprehensively synthesises the evidence on the NIBS treatment of executive function deficit of ADHD.Ethics approval is not required as this is a protocol for a systematic review of published literature. The results will be submitted to a peer-reviewed journal or a conference.PROSPERO registration numberCRD42022356476.
Lipid management in ischaemic stroke or transient ischaemic attack in China: result from China National Stroke Registry III
Authors: Xu Yu-Yuan , Chen Wei-Qi , Wang Meng-Xing , Pan Yue-Song , Li Zi-Xiao , Liu Li-Ping , Zhao Xing-Quan , Wang Yi-Long , Li Hao , Wang Yong-Jun , Meng Xia 
Published: March 2023

ObjectivesThe aims of the study were to assess the management of low-density lipoprotein cholesterol (LDL-C) and the goal achievement, as well as to investigate the association between baseline LDL-C level, lipid-lowering treatment (LLT), and stroke recurrence in patients with ischaemic stroke or transient ischaemic attack (TIA).DesignOur study was a post hoc analysis of the Third China National Stroke Registry (CNSR-III).SettingWe derived data from the CNSR-III - a nationwide clinical registry of ischaemic stroke and TIA based on 201 participating hospitals in mainland China.Participants15,166 patients were included in this study with demographic characteristics, etiology, imaging, and biological markers from August 2015 to March 2018.Primary and secondary outcome measuresThe primary outcome was a new stroke, LDL-C goal (LDL-C<1.8mmol/L and LDL-C<1.4mmol/L, respectively) achievement rates, and LLT compliance within 3, 6, and 12 months. The secondary outcomes included major adverse cardiovascular events (MACE) and all caused death at 3 and 12 months.ResultsAmong the 15,166 patients, over 90% of patients received LLT during hospitalization and 2 weeks after discharge; the LLT compliance was 84.5% at 3 months, 75.6% at 6 months, and 64.8% at 12 months. At 12 months, LDL-C goal achievement rate for 1.8mmol/L and 1.4mmol/L was 35.4% and 17.6%, respectively. LLT at discharge was associated with reduced risk of ischemic stroke recurrence (HR=0.69, 95% CI: 0.48-0.99, p=0.04) at 3 months. The rate of LDL-C reduction from baseline to 3-month follow-up was not associated with a reduced risk of stroke recurrence or major adverse cardiovascular events (MACE) at 12 months. Patients with baseline LDL-C ≤1.4mmol/L had a numerically lower risk of stroke, ischemic stroke and MACE at both 3 months and 12 months.ConclusionsThe LDL-C goal achievement rate has increased mildly in the stroke and TIA population in mainland China. Lowered baseline LDL-C level was significantly associated with a decreased short- and long-term risk of ischemic stroke among stroke and TIA patients. LDL-C<1.4mmol/L might be a safe standard for this population.
What is the NCD service capacity and disruptions due to COVID-19? Results from the WHO non-communicable disease country capacity survey in the Americas region
Authors: Luciani Silvana , Caixeta Roberta , Chavez Carolina , Ondarsuhu Dolores , Hennis Anselm 
Published: March 2023

ObjectiveThis article presents the Americas regional results of the WHO non-communicable diseases (NCDs) Country Capacity Survey from 2019 to 2021, on NCD service capacity and disruptions from the COVID-19 pandemic.SettingInformation on public sector primary care services for NCDs, and related technical inputs from 35 countries in the Americas region are provided.ParticipantsAll Ministry of Health officials managing a national NCD programme, from a WHO Member State in the Americas region, were included throughout this study. Government health officials from countries that are not WHO Member States were excluded.Outcome measuresThe availability of evidence-based NCD guidelines, essential NCD medicines and basic technologies in primary care, cardiovascular disease risk stratification, cancer screening and palliative care services were measured in 2019, 2020 and 2021. NCD service interruptions, reassignments of NCD staff during the COVID-19 pandemic and mitigation strategies to reduce disruptions for NCD services were measured in 2020 and 2021.ResultsMore than 50% of countries reported a lack of comprehensive package of NCD guidelines, essential medicines and related service inputs. Extensive disruptions in NCD services resulted from the pandemic, with only 12/35 countries (34%), reporting that outpatient NCD services were functioning normally. Ministry of Health staff were largely redirected to work on the COVID-19 response, either full time or partially, reducing the human resources available for NCD services. Six of 24 countries (25%) reported stock out of essential NCD medicines and/or diagnostics at health facilities which affected service continuity. Mitigation strategies to ensure continuity of care for people with NCDs were deployed in many countries and included triaging patients, telemedicine and teleconsultations, and electronic prescriptions and other novel prescribing practices.ConclusionsThe findings from this regional survey suggest significant and sustained disruptions, affecting all countries regardless of the country’s level of investments in healthcare or NCD burden.
Prospective observational study on the accuracy of predictors of high-grade atrioventricular conduction block after transcatheter aortic valve implantation (CONDUCT-TAVI): study protocol, background and significance
Authors: Rao Karan , Bhatia Kunwardeep , Chan Bernard , Cowan Mitchell , Saad Natasha , Baer Alexandra , Sritharan Hari , Bromhead Ingrid , Whalley David , Allahwala Usaid K , Hansen Peter , Bhindi Ravinay 
Published: March 2023

IntroductionAortic stenosis is the most common cardiac valve pathology worldwide and has a mortality rate of over 50% at 5 years if left untreated. Transcatheter aortic valve implantation (TAVI) is a minimally invasive and highly effective alternative treatment option to open-heart surgery. High-grade atrioventricular conduction block (HGAVB) is one of the most common complications after TAVI and requires a permanent pacemaker. Due to this, patients are typically monitored for 48 hours post TAVI, however up to 40% of HGAVB may delayed, and occur after discharge. Delayed HGAVB can cause syncope or sudden unexplained cardiac death in a vulnerable population, and no accurate methods currently exist to identify patients at risk.Methods and analysisThe prospective observational study on the accuracy of predictors of high-grade atrioventricular conduction block after transcatheter aortic valve implantation (CONDUCT-TAVI) trial is an Australian-led, multicentre, prospective observational study, aiming to improve the prediction of HGAVB, after TAVI. The primary objective of the trial is to assess whether published and novel invasive electrophysiology predictors performed immediately before and after TAVI can help predict HGAVB after TAVI. The secondary objective aims to further evaluate the accuracy of previously published predictors of HGAVB after TAVI, including CT measurements, 12-lead ECG, valve characteristics, percentage oversizing and implantation depth. Follow-up will be for 2 years, and detailed continuous heart rhythm monitoring will be obtained by inserting an implantable loop recorder in all participants.Ethics and disseminationEthics approval has been obtained for the two participating centres. Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration numberACTRN12621001700820.
Examining the acceptability of actigraphic devices in children using qualitative and quantitative approaches: protocol for a systematic review and meta-analysis
Authors: Morris Anna Charlotte , Telesia Laurence , Wickersham Alice , Epstein Sophie , Matcham Faith , Sonuga-Barke Edmund , Downs Johnny 
Published: March 2023

IntroductionActigraphy is commonly used to record free living physical activity in both typically and atypically developing children. While the accuracy and reliability of actigraphy have been explored extensively, research regarding young people’s opinion towards these devices is scarce. This review aims to identify and synthesise evidence relating to the acceptability of actigraphic devices in 5–11 year olds.Methods and analysisDatabase searches will be applied to Embase, MEDLINE, PsychInfo and Social Policy and Practice through the OVID interface; and Education Resources Information Center (ERIC), British Education Index and CINAHL through the EBSCO interface from January 2018 until February 2023. Supplementary forward and backward citation and grey literature database searches, including Healthcare Management Information Consortium (HMIC) and PsycEXTRA will be conducted. Qualitative and quantitative studies, excluding review articles and meta-analyses, will be eligible, without date restrictions. Article screening and data extraction will be undertaken by two review authors and disagreements will be deferred to a third reviewer. The primary outcome, actigraphic acceptability, will derive from the narrative synthesis of the main themes identified from included qualitative literature and pooled descriptive statistics relating to acceptability identified from quantitative literature. Subgroup analyses will determine if acceptability changes as a function of the key participant and actigraphic device factors.Ethics and disseminationEthical approval is not required for this systematic review as it uses data from previously published literature. The results will be presented in a manuscript and published in a peer review journal and will be considered alongside a separate stream of codesign research to inform the development of a novel child-worn actigraphic device.PROSPERO registration numberCRD42021232466.