bluuebunny/crossref_metadata_2025_split huggingface dataset:
Lessons learned from the COVID-19 pandemic about sample access for research in the UK
Authors: Sims Jessica M , Lawrence Emma , Glazer Katy , Gander Amir , Fuller Barry , Davidson Brian R , Garibaldi Jonathan , Quinlan Philip R 
Published: April 2022

ObjectiveAnnotated clinical samples taken from patients are a foundation of translational medical research and give mechanistic insight into drug trials. Prior research by the Tissue Directory and Coordination Centre (TDCC) indicated that researchers, particularly those in industry, face many barriers in accessing patient samples. The arrival of the COVID-19 pandemic to the UK produced an immediate and extreme shockwave, which impacted on the ability to undertake all crucial translational research. As a national coordination centre, the TDCC is tasked with improving efficiency in the biobanking sector. Thus, we took responsibility to identify and coordinate UK tissue sample collection organisations (biobanks) able to collect COVID-19-related samples for researchers between March and September 2020.FindingsAlmost a third of UK biobanks were closed during the first wave of the UK COVID-19 pandemic. Of the remainder, 43% had limited capabilities while 26% maintained normal activity. Of the nationally prioritised COVID-19 interventional studies, just three of the five that responded to questioning were collecting human samples. Of the 41 requests for COVID-19 samples received by the TDCC, only four could be fulfilled due to a lack of UK coordinated strategy. Meanwhile, in the background there are numerous reports that sample collections in the UK remain largely underutilised.ConclusionThe response to a pandemic demands high level co-ordinated research responses to reduce mortality. Our study highlights the lack of efficiency and coordination between human sample collections and clinical trials across the UK. UK sample access is not working for researchers, clinicians or patients. A radical change is required in the strategy for sample collection and distribution to maximise this valuable resource of human-donated samples.
Evaluation of medication risk at the transition of care: a cross-sectional study of patients from the ICU to the non-ICU setting
Authors: Wang Yao , Zhang Xueting , Hu Xu , Sun Xuqun , Wang Yuanyuan , Huang Kaiyu , Sun Sijia , Lv Xiongwen , Xie Xuefeng 
Published: April 2022

ObjectivesTo describe the incidence and types of medication errors occurring during the transfer of patients from the intensive care unit (ICU) to the non-ICU setting and explore the key factors affecting medication safety in transfer care.DesignMulticentre, retrospective, epidemiological study.ParticipantsPatients transferred from the ICU to a non-ICU setting between 1 July 2019 and 30 June 2020.Main outcome measuresIncidence and types of medication errors.ResultsOf the 1546 patients transferred during the study period, 899 (58.15%) had at least one medication error. Most errors (83.00%) were National Coordinating Council (NCC) for Medication Error Reporting and Prevention (MERP) category C. A small number of errors (17.00%) were category D. Among patients with medication errors, there was an average of 1.68 (SD, 0.90; range, 1–5) errors per patient. The most common types of errors were route of administration 570 (37.85%), dosage 271 (17.99%) and frequency 139 (9.23%). Eighty-three per cent of medication errors reached patients but did not cause harm. Daytime ICU transfer (07:00–14:59) and an admission diagnosis of severe kidney disease were found to be factors associated with the occurrence of medication errors as compared with the reference category (OR, 1.40; 95% CI 1.01 to 1.95; OR, 6.78; 95% CI 1.46 to 31.60, respectively).Orders for bronchorespiratory (OR, 5.92; 95% CI 4.2 to 8.32), cardiovascular (OR, 1.91; 95% CI 1.34 to 2.73), hepatic (OR, 1.95; 95% CI 1.30 to 2.91), endocrine (OR, 1.99; 95% CI 1.37 to 2.91), haematologic (OR, 2.58; 95% CI 1.84 to 3.64), anti-inflammatory/pain (OR, 2.80; 95% CI 1.90 to 4.12) and vitamin (OR, 1.73; 95% CI 1.26 to 2.37) medications at transition of care were associated with an increased odds of medication error.ConclusionsMore than half of ICU patients experienced medication errors during the transition of care. The vast majority of medication errors reached the patient but did not cause harm.
Adverse childhood experiences and implications of perceived stress, anxiety and cortisol among women in Pakistan: a cross-sectional study
Authors: Ikram Naira , Frost Allison , LeMasters Katherine , Hagaman Ashley , Baranov Victoria , Gallis John , Sikander Siham , Scherer Elissa , Maselko Joanna 
Published: April 2022

ObjectivesAdverse childhood experiences (ACEs) are linked to poor maternal mental health. The goal of this study is to examine the associations between ACEs and multiple manifestations of stress (including perceived stress, anxiety and cortisol) among mothers in rural Pakistan.DesignThis study used a cross-sectional design. Mothers were originally recruited during their third trimester of pregnancy and followed until 36 months post partum. Cortisol was collected at 12 months post partum, and self-report data were collected at 36 months post partum.SettingAll participants reside in rural villages in Rawalpindi, Pakistan. The measures were administered at home visits by field interviewers.ParticipantsData were collected from 889 mothers. All mothers in the sample provided data on ACEs and perceived stress, 623 provided data on anxiety and 90 provided hair cortisol.Primary and secondary outcomes measuresACEs were captured retrospectively using an adapted version of the ACE International Questionnaire, and represented as a continuous variable and subdomains (neglect, home violence, family psychological distress, community violence). Primary outcomes included perceived stress measured with the Cohen Perceived Stress Scale (PSS) and anxiety measured with the Generalised Anxiety Disorder-7 scale (GAD-7). Hair-derived cortisol was included as a secondary outcome. Generalised linear models with cluster-robust SEs were used to estimate associations between ACEs and the outcome variables.ResultsAll models featured positive associations between ACE items and PSS. The continuous total ACE score (B=0.4; 95% CI 0.0 to 0.8) was associated with higher anxiety symptoms on the GAD-7. Home violence (B=6.7; 95% CI 2.7 to 10.8) and community violence (B=7.5; 95% CI 1.4 to 13.6) were associated with increased hair cortisol production.ConclusionsAll four ACE domains were associated with elevated levels of perceived stress, anxiety and cortisol, with varying precision and strength of estimates, indicating that the type of ACE has a differential impact. This study informed our understanding of the differential impact of specific ACEs on perceived stress, anxiety and hypothalamic pituitary adrenal-axis functioning, providing implications for future clinical intervention and research development.
Individualised non-contrast MRI-based risk estimation and shared decision-making in men with a suspicion of prostate cancer: protocol for multicentre randomised controlled trial (multi-IMPROD V.2.0)
Authors: Ettala Otto , Jambor Ivan , Montoya Perez Ileana , Seppänen Marjo , Kaipia Antti , Seikkula Heikki , Syvänen Kari T , Taimen Pekka , Verho Janne , Steiner Aida , Saunavaara Jani , Saukko Ekaterina , Löyttyniemi Eliisa , Sjoberg Daniel D , Vickers Andrew , Aronen Hannu , Boström Peter 
Published: April 2022

IntroductionEuropean Association of Urology and UK National Institute for Health and Care Excellence guidelines recommend that all men with suspicions of prostate cancer should undergo prebiopsy contrast enhanced, that is, multiparametric prostate MRI. Subsequent prostate biopsies should also be performed if MRI is positive, that is, Prostate Imaging–Reporting and Data System (PI-RADS) scores 3–5. However, several retrospective post hoc analyses have shown that this approach still leads to many unnecessary biopsy procedures. For example, 88%–96% of men with PI-RADS, three findings are still diagnosed with clinically non-significant prostate cancer or no cancer at all.Methods and analysisThis is a prospective, randomised, controlled, multicentre trial, being conducted in Finland, to demonstrate non-inferiority in clinically significant cancer detection rates among men undergoing prostate biopsies post-MRI and men undergoing prostate biopsies post-MRI only after a shared decision based on individualised risk estimation. Men without previous diagnosis of prostate cancer and with abnormal digital rectal examination findings and/or prostate-specific antigen between 2.5 ug/L and 20.0 ug/L are included. We aim to recruit 830 men who are randomised at a 1:1 ratio into control (all undergo biopsies after MRI) and intervention arms (the decision to perform biopsies is based on risk estimation and shared decision-making). The primary outcome of the study is the proportion of men with clinically significant prostate cancer (Gleason 4+3 prostate cancer or higher). We will also compare the overall biopsy rate, benign biopsy rate and the detection of non-significant prostate cancer between the two study groups.Ethics and disseminationThe study (protocol V.2.0, 4 January 2021) was approved by the Ethics Committee of the Hospital District of Southwest Finland (IORG number: 0001744, IBR number: 00002216; trial number: 99/1801/2019). Participants are required to provide written informed consent. Full reports of this study will be submitted to peer-reviewed journals, mainly urology and radiology.Trial registration numberNCT04287088; the study is registered at ClinicalTrials.gov.
Barriers and facilitators of lung cancer screening uptake: protocol of a mixed methods systematic review
Authors: Lin Yu-an , Hong Yu ting , Chen Bo ni , Xiao Hui min , Huang Fei fei 
Published: April 2022

IntroductionThe global uptake rates of lung cancer screening (LCS) with low-dose CT remain low. Since numerous factors contribute to the underuse of LCS, a theory-informed approach to identify and address the uptake of LCS barriers and facilitators is required. This study aims to document the methods which were used to identify, appraise, and synthesise the available qualitative, quantitative, and mixed methods evidence, addressing the barriers and facilitators at the individual and healthcare provider level, according to the social–ecological model, before identifying gaps to aid future practices and policies.Methods and analysisThe following databases will be searched: PubMed, Ovid (Journals @ Ovid Full Text and Ovid MEDLINE), EMBASE, CINAHL, PsycINFO, Cochrane Library, Chinese Biomedical Database, Chinese National Knowledge Infrastructure, and Wanfang database, from their creation up to 31 December 2020. Two reviewers will be involved in independently screening, reviewing, and synthesising the data; and calibration exercises will be conducted at each stage. Disagreements between the two reviewers will be resolved by arbitration by a third reviewer. The Critical Appraisal Checklist for Studies Reporting Prevalence Data from the Joanna Briggs Institute, the Critical Appraisal Skills Programme criteria adapted for qualitative studies, and the 16-item Quality Assessment Tool (QATSDD) will be used in the quality assessment of primary studies. We will perform data synthesis using the Review Manager software, V.5.3.Ethics and disseminationThis study is a review of published data and therefore needs no ethical approval. The findings of this systematic review will be published in a peer-reviewed journal.Trial registration numberCRD42020162802.
Health workers’ Perceptions and REsponses in implementing COVID-19 Immunisation StratEgy in South Western Sydney (PRECISE): an observational study
Authors: Chow Josephine Sau Fan , D'Souza Annamarie , Lane Brian , Descallar Joseph , Ford Megan , Marshall Sonia , Pennings Susan 
Published: April 2022

ObjectivesTo understand the views and motivations of healthcare workers at a vaccination hub who received a COVID-19 vaccination in March–May 2021.Study designThis is an observational study via an anonymous electronic survey of seven questions focus on where survey recipients received information about the vaccine roll-out, their motivations for receiving the vaccine and their level of comfort in receiving the vaccine.SettingThe Liverpool Vaccination Hub is located in South Western Sydney.ParticipantsParticipants were healthcare workers who received the first dose of a COVID-19 vaccine in the Australian Government’s Phase 1a and 1b priority categories. The majority of survey respondents (70%) were female (median aged between 35 and 44 years). The majority of survey respondents were clinical workers, such as nurse, paramedics and doctors.Outcome measuresχ2analysis was used for analysis of survey responses in univariate analysis. Logistic regression was used to analyse survey responses, adjusting for week, type of health worker and age.Results4746 healthcare workers responded to the survey after receiving their first vaccine dose, a response rate of 23%. Over 90% of respondents said that COVID-19 vaccination information from their organisation was easily available. Most of them reported that they were comfortable receiving a COVID-19 vaccine. The majority of respondents were motivated to receive the vaccine due to concern about contracting COVID-19 themselves (75%), or concerns about transmitting it to other people such as patients (52%), family members (65%) or other community members (54%). Younger respondents were more likely to have preferred more information on vaccine safety (p<0.0001) and the effectiveness of the vaccine (p<0.0001).ConclusionThe majority of healthcare workers who received a COVID-19 vaccine reported that it was easy to find useful information about the vaccination roll-out and they had a positive experience being vaccinated.
Effectiveness of the eVISualisation of physical activity and pain intervention (eVIS) in Swedish Interdisciplinary Pain Rehabilitation Programmes: study protocol for a registry-based randomised controlled clinical trial
Authors: Sjöberg Veronica , Tseli Elena , Monnier Andreas , Westergren Jens , LoMartire Riccardo , Äng Björn O , Hagströmer Maria , Björk Mathilda , Vixner Linda 
Published: April 2022

IntroductionLiving with chronic pain often involves negative consequences. Interdisciplinary Pain Rehabilitation Programmes (IPRP) is considered superior to single-treatment measures in patients with chronic pain. Despite this, effects emerge suboptimal and more than 20% of patients deteriorate in patient-reported physical health outcomes after IPRP. A novel e-Health intervention, eVISualisation (eVIS) of physical activity and pain, was systematically developed to facilitate individualisation of physical activity levels. By adding elements of data collection, visualisation and communication of objectively measured physical activity and patient-reported outcomes (pain intensity, interference of pain, pharmaceutical consumption) to existing treatment modalities in IPRP, the IPRP team acquires prerequisites to adapt advice and physical activity prescriptions and to evaluate set activity goals. The overall aim is twofold. First, the aim is to evaluate the feasibility of the subsequent registry-based randomised controlled clinical trial (R-RCT). Second, the aim is to prospectively evaluate the effectiveness of the eVIS-intervention as a supplement to IPRP on our defined primary (physical health) and secondary outcomes.Methods and analysisIn the R-RCT, recruitment of 400 patients with chronic pain will be performed at 15 IPRP units. A random allocation to either IPRP + eVIS or to control group that will receive IPRP only will be performed. Data from the initial 30 participants completing the study period (6 months) will be included in a pilot study, where key feasibility outcomes (recruitment, randomisation, implementation, treatment integrity, data collection procedure, preliminary outcome measures) will be evaluated. Outcome variables will be extracted from the web application Pain And TRaining ON-line (PATRON) and from six national registries. Multivariate statistics and repeated measure analyses will be performed. Quality-adjusted life years and incremental cost-effectiveness ratio will be calculated for cost-effectiveness evaluation.Ethics/disseminationThe Swedish Ethics Review Board granted approval (Dnr 2021/02109). Results will be disseminated through peer-reviewed journals.Trial registration numberNCT05009459. Protocol V.1.
Research outcomes of linked prescription drug monitoring program data: a scoping review protocol
Authors: Cummins Mollie , Turcotte Catherine , McFarland Mary M , Staes Catherine 
Published: April 2022

IntroductionThe objective of this scoping review is to describe the extent and nature of research studies based on linked prescription drug monitoring program (PDMP) data; defined as PDMP data linked to other clinical, administrative or public health data sets. The population is prescribed and dispensed controlled substances. The concept is analysis of linked PDMP data to other clinical, administrative or public health data sets. The context is the USA.Methods and analysisThe scoping review will be conducted with guidance from the latest version of the JBI Manual for Evidence Synthesis, using the framework as outlined by Arksey and O’Malley. Search strategies will be peer-reviewed according to the Peer Review of Electronic Search Strategies (PRESS) guidelines. For transparency and reproducibility, we will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews reporting guidelines in reporting results. Two reviewers will independently screen titles and abstracts, then independently review full text to select papers or studies for inclusion. When consensus cannot be reached with discussion, a third reviewer will resolve the conflicts. From our included studies, we will extract variables describing aspects of population, concept and context (USA).Ethics and disseminationEthical approval was not required for this review. This scoping review entails analysis of previously published, peer-reviewed research. We intend to publish findings in a peer-reviewed journal.
Sex differences in outcomes after mechanical thrombectomy for acute ischemic stroke in the ‘real world’: protocol for a systematic review and meta-analysis study
Authors: Xu Lixin , Li Binglong , Zhang Xiao , Bai Xuesong , Dmytriw Adam Andrew , Wang Tao , Wang Xue , Yang Kun , Min Xiaoli , Jiao Liqun 
Published: April 2022

IntroductionMechanical thrombectomy (MT) had been regarded as the first-line therapy for acute ischaemic stroke patients. The sex differences in post-MT treatment outcomes were analysed by randomised controlled trial (RCT) studies with inconsistent conclusions. We suggest the results from the real-world data may differ from RCT containing studies. Therefore, the sex difference in non-clinical trial populations needs to be clarified.Methods and analysisIn order to obtain relative studies comprehensively, we will search the main document databases, consisting of Web of Science, Medline in Ovid, Embase in Ovid and Cochrane Library, and trials registers, including Clinical Trails register. The clinical outcomes of real-world studies published between January 2015 and March 2022 will be included. The assessment methods of bias risk will be performed according to study type. The inclusion of studies, evaluation of risk and publication bias, data extraction will be implemented by two reviewers, respectively. The primary outcomes include successful recanalisation and 90-day favourable outcome. Secondary outcomes include vascular complication, hospital-related complications, death during hospital stay and follow-up, and intracerebral haemorrhage. The risk bias of observational studies will be evaluated by Newcastle-Ottawa Scale. I2 statistic will be used to perform the assessment of study heterogeneity.Ethics and disseminationWith no need of ethics approval in this review, results in this review ground on public data. The results of the study will be eventually presented at international conferences or in a related journal.PROSPERO registration numberCRD42021242597.
Prevalence and associated factors of external hernia among adult patients visiting the surgical outpatient department at the University of Gondar Comprehensive Specialised Hospital, Northwest Ethiopia: a cross-sectional study
Authors: Kibret Anteneh Ayelign , Tekle Solomon Yirdaw , H/Mariam Miklol Mengistu , Worede Amanuel Girma , Dessie M A 
Published: April 2022

ObjectivesThis study was aimed to assess the prevalence and associated factors of external hernia among adult patients visiting the surgical outpatient department (OPD) at the University of Gondar Comprehensive Specialised Hospital (UOGCSH), Northwest Ethiopia.Study designInstitution-based cross-sectional study was conducted from 5 April 2020 to 22 June 2020.Study settingUOGCSH.ParticipantsAll adult patients above 18 years of age who visited the surgical OPD at the UOGCSH.OutcomePrevalence of external hernia.ResultA total of 403 study participants were involved in this study with a response rate of 100%. The prevalence of external hernia was 11.7% (95% CI 8.8% to 15.1%). The epigastric hernia had the highest prevalence 16 (34%), followed by inguinal hernia 14 (29.8%). Old age (adjusted OR (AOR) =2.47, 95% CI 1.06 to 5.78), constipation (AOR 3.67, 95% CI 1.68 to 8.11), chronic cough (AOR 5.18, 95% CI 2.17 to 12.3) and lifting of heavy objects (AOR 7.39, 95% CI 3.36 to 16.2) had a statistically significant association with external hernia.ConclusionRegardless of hardly any significant gender difference, the overall prevalence of external hernia was high. Old age, constipation, chronic cough and lifting of heavy objects were found to have a significant association with an external hernia. Patients who have constipation and cough should get appropriate treatment early.
Understanding the importance of social determinants and rurality for the long-term outcome after acute myocardial infarction: study protocol for a single-centre cohort study
Authors: Sasko Benjamin , Jaehn Philipp , Müller Rhea , Andresen Henrike , Müters Stephan , Holmberg Christine , Ritter Oliver , Pagonas Nikolaos 
Published: April 2022

IntroductionAcute myocardial infarction (AMI) is a major public health issue in Germany with considerable regional differences in morbidity and mortality. Possible reasons for regional differences include a higher prevalence of cardiovascular risk factors, infrastructural deficits, different levels of healthcare quality or social determinants. We aim to study associations of social determinants and of rural infrastructure with the quality of medical care (eg, time to reperfusion or medication adherence) and on the long-term outcome after myocardial infarction.Methods and analysisWe will employ a prospective cohort study design. Patients who are admitted with AMI will be invited to participate. We aim to recruit a total of 1000 participants over the course of 5 years. Information on outpatient care prior to AMI, acute healthcare of AMI, healthcare-related environmental factors and social determinants will be collected. Baseline data will be assessed in interviews and from the electronic data system of the hospital. Follow-up will be conducted after an observation period of 1 year via patient interviews. The outcomes of interest are cardiac and all-cause mortality, changes in quality of life, changes in health status of heart failure, major adverse cardiovascular events and participation in rehabilitation programmes.Ethics and disseminationEthical approval was obtained from the Ethics Committee of Brandenburg Medical School (reference: E-01-20200923). Research findings will be disseminated and shared in different ways and include presenting at international and national conferences, publishing in peer-reviewed journals and facilitating dissemination workshops within local communities with patients and healthcare professionals.Trials registration numberDRKS00024463.