bluuebunny/crossref_metadata_2025_split huggingface dataset:
Trends in glycemic control in patients with insulin therapy compared with non-insulin or no drugs in type 2 diabetes in Japan: a long-term view of real-world treatment between 2002 and 2018 (JDDM 66)
Authors: Yokoyama Hiroki , Araki Shin-ichi , Yamazaki Katsuya , Kawai Koichi , Shirabe Shin-Ichiro , Oishi Mariko , Kanatsuka Azuma , Yagi Noriharu , Kabata Daijiro , Shintani Ayumi , Maegawa Hiroshi 
Published: May 2022

IntroductionWe investigated trends in the proportion of diabetes treatment and glycemic control, which may be altered by recent advances in insulin and non-insulin drugs, in Japanese patients with type 2 diabetes.Research design and methodsA serial cross-sectional study was performed using a multicenter large-population database from the Japan Diabetes Clinical Data Management study group. Patients with type 2 diabetes who attended clinics belonging to the study group between 2002 and 2018 were included to examine trends in glycated hemoglobin A1c (HbA1c) by treatment group using multivariable non-linear regression model.ResultsThe proportion of patients with insulin only decreased from 15.0% to 3.6%, patients with insulin+non-insulin drugs increased from 8.1% to 15.1%, patients with non-insulin drugs increased from 50.8% to 67.0%, and those with no drugs decreased from 26.1% to 14.4% from 2002 to 2018, respectively. The HbA1c levels of each group, except for no drugs, continued to decrease until 2014 (unadjusted mean HbA1c (%) from 2002 to 2014: from 7.89 to 7.45 for insulin only, from 8.09 to 7.63 for insulin+non-insulin, and from 7.51 to 6.98 for non-insulin) and remained unchanged thereafter. Among insulin-treated patients, use of human insulin decreased, use of long-acting analog insulin increased, and concomitant use of non-insulin drugs increased (from 35.1% in 2002 to 80.9% in 2018), which included increased use of dipeptidyl peptidase 4 inhibitors, sodium-glucose cotransporter 2 inhibitors, and glucagon-like peptide 1 receptor agonists, and the persistently high use of metformin.ConclusionsDuring the past two decades, combined use of insulin and non-insulin drugs increased and glycemic control improved and leveled off after 2014 in Japanese patients with type 2 diabetes. Further studies of the trend in association with age and factors related to metabolic syndrome are necessary to investigate strategies aiming at personalized medicine in diabetes care.
Effectiveness of Ehteraz digital contact tracing app versus conventional contact tracing in managing the outbreak of COVID-19 in the State of Qatar
Authors: Al-Kuwari Mohamed Ghaith , Ali Al Nuaimi Asma , Semaan Sandy , Gibb John Michael , AbdulMajeed Jazeel , Al Romaihi Hamad Eid 
Published: May 2022

IntroductionContact tracing is an integral component of the overall public health strategy for controlling the outbreak of infectious diseases such as COVID-19. In addition to the conventional contact tracing, Qatar has implemented Ehteraz, a proximity-tracing mobile phone App using global positioning system and Bluetooth technologies. In this paper, we aim to evaluate the accuracy of Ehteraz as a contact tracing App based on the WHO contact tracing criteria and compare its effectiveness to the traditional human led case investigation.MethodsA cross-sectional study was conducted using two databases, including Ehteraz proximity data and swab collection and case investigations reports for the same period.Results46.9% of contacts identified by the Ehteraz app did not meet WHO duration and distance criteria. Among the 5650 contacts flagged by Ehteraz during the period, 4973 (88.0%) of contacts did not share any known relation with the index case they are linked to.ConclusionThe study highlighted the inaccuracy of the Ehteraz tool as its technology enables signals passing through walls, so people in different rooms could be unnecessarily flagged as having had contact. Big segments of the population (eg, Children) do not necessarily use smartphones and are not, therefore, flagged by Ehteraz digital contact tracing App. Similarly, Ehteraz rarely flags close contacts identified by human investigation as Bluetooth is usually turned off in a household or at a workplace. These findings highlight that digital contact tracing would be an efficient public health strategy when integrated to and complementing human investigation.
Maternal over-the-counter analgesics use during pregnancy and adverse perinatal outcomes: cohort study of 151 141 singleton pregnancies
Authors: Zafeiri Aikaterini , Raja Edwin Amalraj , Mitchell Rod Thomas , Hay David C , Bhattacharya Sohinee , Fowler Paul A 
Published: May 2022

ObjectivesTo identify any associations between in utero exposure to five over-the-counter (non-prescription) analgesics (paracetamol, ibuprofen, aspirin, diclofenac, naproxen) and adverse neonatal outcomes.DesignRetrospective cohort study using the Aberdeen Maternity and Neonatal Databank.Participants151 141 singleton pregnancies between 1985 and 2015.Main outcome measuresPremature delivery (<37 weeks), stillbirth, neonatal death, birth weight, standardised birthweight score, neonatal unit admission, APGAR score at 1 and 5 min, neural tube and amniotic band defects, gastroschisis and, in males, cryptorchidism and hypospadias.Results83.7% of women taking over-the-counter analgesics reported first trimester use when specifically asked about use at their first antenatal clinic visit. Pregnancies exposed to at least one of the five analgesics were significantly independently associated with increased risks for premature delivery <37 weeks (adjusted OR (aOR)=1.50, 95% CI 1.43 to 1.58), stillbirth (aOR=1.33, 95% CI 1.15 to 1.54), neonatal death (aOR=1.56, 95% CI 1.27 to 1.93), birth weight <2500 g (aOR=1.28, 95% CI 1.20 to 1.37), birth weight >4000 g (aOR=1.09, 95% CI 1.05 to 1.13), admission to neonatal unit (aOR=1.57, 95% CI 1.51 to 1.64), APGAR score <7 at 1 min (aOR=1.18, 95% CI 1.13 to 1.23) and 5 min (aOR=1.48, 95% CI 1.35 to 1.62), neural tube defects (aOR=1.64, 95% CI 1.08 to 2.47) and hypospadias (aOR=1.27, 95% CI 1.05 to 1.54 males only). The overall prevalence of over-the-counter analgesics use during pregnancy was 29.1%, however it rapidly increased over the 30-year study period, to include over 60% of women in the last 7 years of the study. This makes our findings highly relevant to the wider pregnant population.ConclusionsOver-the-counter (non-prescription) analgesics consumption during pregnancy was associated with a substantially higher risk for adverse perinatal health outcomes in the offspring. The use of paracetamol in combination with other non-steroidal anti-inflammatory drugs conferred the highest risk. The increased risks of adverse neonatal outcomes associated with non-prescribed, over-the-counter, analgesics use during pregnancy indicate that healthcare guidance for pregnant women regarding analgesic use need urgent updating.
ASSERT (Acute Sacral inSufficiEncy fractuRe augmenTation): randomised controlled, feasibility trial in older people
Authors: Ong Terence , Suazo Di Paola Ana , Brookes Cassandra , Drummond Avril , Hendrick Paul , Leighton Paul , Jones Matthew , Salem Khalid , Quraishi Nasir , Sahota Opinder 
Published: May 2022

ObjectiveTo determine the feasibility of designing and conducting a definitive trial to evaluate the effectiveness of sacral fracture fixation compared with non-surgical management among older people admitted with a lateral compression pelvic fragility fracture (PFF).DesignSingle-site, parallel, two-arm randomised controlled feasibility trial.SettingA UK tertiary centre hospital.ParticipantsPatients aged ≥70 years who were ambulating pre-injury requiring hospital admission (within 28 days of injury) with a type 1 lateral compression PFF.InterventionsThe intervention group received sacral fracture fixation (cement augmentation±screw fixation) within 7 days of randomisation. Routine preoperative and postoperative care followed each surgical intervention. The control group received usual care consisting of analgesia, and regular input from the medical and therapy team.Primary and secondary outcome measuresThe feasibility outcomes were the number of eligible patients, willingness to be randomised, adherence to allocated treatment, retention, data on the completeness and variability of the proposed definitive trial outcome measures, and reported adverse events.Results241 patients were screened. 13 (5.4%) were deemed eligible to participate. Among the eligible participants, nine (69.2%) were willing to participate. Five participants were randomised to the intervention group and four to the control group. The clinicians involved were willing to allow their patients to be randomised and adhere to the allocated treatment. One participant in the intervention group and two participants in the control group received their allocated treatment. All participants were followed up until 12 weeks post-randomisation, and had an additional safety follow-up assessment at 12 months. Overall, the proportion of completeness of outcome measures was at least 75%. No adverse events were directly related to the trial.ConclusionsThere were significant challenges in recruiting sufficient participants which will need to be addressed prior to a definitive trial.Trial registration numberISRCTN16719542.
Very early invasive angiography versus standard of care in higher-risk non-ST elevation myocardial infarction: study protocol for the prospective multicentre randomised controlled RAPID N-STEMI trial
Authors: Kite Thomas A , Banning Amerjeet S , Ladwiniec Andrew , Gale Chris P , Greenwood John P , Dalby Miles , Hobson Rachel , Barber Shaun , Parker Emma , Berry Colin , Flather Marcus D , Curzen Nick , Banning Adrian P , McCann Gerry P , Gershlick Anthony H 
Published: May 2022

BackgroundThere are a paucity of randomised data on the optimal timing of invasive coronary angiography (ICA) in higher-risk patients with non-ST elevation myocardial infarction (N-STEMI). International guideline recommendations for early ICA are primarily based on retrospective subgroup analyses of neutral trials.AimsThe RAPID N-STEMI trial aims to determine whether very early percutaneous revascularisation improves clinical outcomes as compared with a standard of care strategy in higher-risk N-STEMI patients.Methods and analysisRAPID N-STEMI is a prospective, multicentre, open-label, randomised-controlled, pragmatic strategy trial. Higher-risk N-STEMI patients, as defined by Global Registry of Acute Coronary Events 2.0 score ≥118, or >90 with at least one additional high-risk feature, were randomised to either: very early ICA±revascularisation or standard of care timing of ICA±revascularisation. The primary outcome is the proportion of participants with at least one of the following events (all-cause mortality, non-fatal myocardial infarction and hospital admission for heart failure) at 12 months. Key secondary outcomes include major bleeding and stroke. A hypothesis generating cardiac magnetic resonance (CMR) substudy will provide mechanistic data on infarct size, myocardial salvage and residual ischaemia post percutaneous coronary intervention. On 7 April 2021, the sponsor discontinued enrolment due to the impact of the COVID-19 pandemic and lower than expected event rates. 425 patients were enrolled, and 61 patients underwent CMR.Ethics and disseminationThe trial has been reviewed and approved by the East of England Cambridge East Research Ethics Committee (18/EE/0222). The study results will be submitted for publication within 6 months of completion.Trial registration numberNCT03707314; Pre-results.
Survey to identify research priorities for primary care in Scotland during and following the COVID-19 pandemic
Authors: Hubbard Gill , Grist Fiona , Pope Lindsey Margaret , Cunningham Scott , Maxwell Margaret , Bennie Marion , Guthrie Bruce , Mercer Stewart W 
Published: May 2022

ObjectivesTo identify research priorities for primary care in Scotland following the COVID-19 pandemic.DesignModified James Lind Alliance methodology; respondents completed an online survey to make research suggestions and rank research themes in order of priority.SettingScotland primary care.ParticipantsHealthcare professionals in primary care in Scotland and members of primary care patient and public involvement groups. 512 respondents provided research suggestions; 8% (n=40) did not work in health or social care; of those who did work, 68.8% worked in primary care, 16.3% community care, 11.7% secondary care, 4.5% third sector, 4.2% university (respondents could select multiple options). Of those respondents who identified as healthcare professionals, 33% were in nursing and midwifery professions, 25% were in allied health professions (of whom 45% were occupational therapists and 35% were physiotherapists), 20% were in the medical profession and 10% were in the pharmacy profession.Main outcomesSuggestions for research for primary care made by respondents were categorised into themes and subthemes by researchers and ranked in order of priority by respondents.ResultsThere were 1274 research suggestions which were categorised under 12 themes and 30 subthemes. The following five themes received the most suggestions for research: disease and illness (n=461 suggestions), access (n=202), workforce (n=164), multidisciplinary team (MDT; n=143) and integration (n=108). One hundred and three (20%) respondents to the survey participated in ranking the list of 12 themes in order of research priority. The five most highly ranked research priorities were disease and illness, health inequalities, access, workforce and MDTs. The disease and illness theme had the greatest number of suggestions for research and was scored the most highly in the ranking exercise. The subtheme ranked as the most important research priority in the disease and illness theme was ‘mental health’.ConclusionsThe themes and subthemes identified in this study should inform research funders so that the direction of primary healthcare is informed by evidence.
Sex-disaggregated analysis of the injury patterns, outcome data and trapped status of major trauma patients injured in motor vehicle collisions: a prespecified analysis of the UK trauma registry (TARN)
Authors: Nutbeam Tim , Weekes Lauren , Heidari Shirin , Fenwick Rob , Bouamra Omar , Smith Jason , Stassen Willem 
Published: May 2022

ObjectivesTo identify the differences between women and men in the probability of entrapment, frequency of injury and outcomes following a motor vehicle collision. Publishing sex-disaggregated data, understanding differential patterns and exploring the reasons for these will assist with ensuring equity of outcomes especially in respect to triage, rescue and treatment of all patients.DesignWe examined data from the Trauma Audit and Research Network (TARN) registry to explore sex differences in entrapment, injuries and outcomes. We explored the relationship between age, sex and trapped status using multivariate logistical regression.SettingTARN is a UK-based trauma registry covering England and Wales.ParticipantsWe examined data for 450 357 patients submitted to TARN during the study period (2012–2019), of which 70 027 met the inclusion criteria. There were 18 175 (26%) female and 51 852 (74%) male patients.Primary and secondary outcome measuresWe report difference in entrapment status, injury and outcome between female and male patients. For trapped patients, we examined the effect of sex and age on death from any cause.ResultsFemale patients were more frequently trapped than male patients (female patients (F) 15.8%, male patients (M) 9.4%; p<0.0001). Trapped male patients more frequently suffered head (M 1318 (27.0%), F 578 (20.1%)), face, (M 46 (0.9%), F 6 (0.2%)), thoracic (M 2721 (55.8%), F 1438 (49.9%)) and limb injuries (M 1744 (35.8%), F 778 (27.0%); all p<0.0001). Female patients had more injuries to the pelvis (F 420 (14.6%), M 475 (9.7%); p<0.0001) and spine (F 359 (12.5%), M 485 (9.9%); p=0.001). Following adjustment for the interaction between age and sex, injury severity score, Glasgow Coma Scale and the Charlson Comorbidity Index, no difference in mortality was found between female and male patients.ConclusionsThere are significant differences between female and male patients in the frequency at which patients are trapped and the injuries these patients sustain. This sex-disaggregated data may help vehicle manufacturers, road safety organisations and emergency services to tailor responses with the aim of equitable outcomes by targeting equal performance of safety measures and reducing excessive risk to one sex or gender.
Effects of temporarily suspending low-dose methotrexate treatment for 2 weeks after SARS-CoV-2 vaccine booster on vaccine response in immunosuppressed adults with inflammatory conditions: protocol for a multicentre randomised controlled trial and nested mechanistic substudy (Vaccine Response On/Off Methotrexate (VROOM) study)
Authors: Abhishek Abhishek , Boyton RJ , McKnight Áine , Coates Laura , Bluett James , Barber Vicki S , Cureton Lucy , Francis Anne , Appelbe Duncan , Eldridge Lucy , Julier Patrick , Peckham Nicholas , Valdes Ana M , Rombach Ines , Altmann Daniel M , Nguyen-Van-Tam Jonathan , Williams Hywel C , Cook Jonathan Alistair 
Published: May 2022

IntroductionIt is unknown if a temporary break in long-term immune-suppressive treatment after vaccination against COVID-19 improves vaccine response. The objective of this study was to evaluate if a 2-week interruption in low-dose weekly methotrexate treatment after SARS-CoV-2 vaccine boosters enhances the immune response compared with continuing treatment in adults with autoimmune inflammatory conditions.Methods and analysisAn open-label, pragmatic, prospective, parallel group, randomised controlled superiority trial with internal feasibility assessment and nested mechanistic substudy will be conducted in rheumatology and dermatology clinics in approximately 25 UK hospitals. The sample size is 560, randomised 1:1 to intervention and usual care arms. The main outcome measure is anti-spike receptor-binding domain (RBD) antibody level, collected at prebooster (baseline), 4 weeks (primary outcome) and 12 weeks (secondary outcome) post booster vaccination. Other secondary outcome measures are patient global assessments of disease activity, disease flares and their treatment, EuroQol 5- dimention 5-level (EQ-5D-5L), self-reported adherence with advice to interrupt or continue methotrexate, neutralising antibody titre against SARS-CoV-2 (mechanistic substudy) and oral methotrexate biochemical adherence (mechanistic substudy). Analysis of B-cell memory and T-cell responses at baseline and weeks 4 and 12 will be investigated subject to obtaining additional funding. The principal analysis will be performed on the groups as randomised (ie, intention to treat). The difference between the study arms in anti-spike RBD antibody level will be estimated using mixed effects model, allowing for repeated measures clustered within participants. The models will be adjusted for randomisation factors and prior SARS-CoV-2 infection status.Ethics and disseminationThis study was approved by the Leeds West Research Ethics Committee and Health Research Authority (REC reference: 21/HRA/3483, IRAS 303827). Participants will be required to give written informed consent before taking part in the trial. Dissemination will be via peer review publications, newsletters and conferences. Results will be communicated to policymakers.Trial registration numberISRCTN11442263.
Returning persons with SARS-CoV-2 to the field of play in professional golf: a risk assessment and risk reduction approach
Authors: Robinson Patrick Gordon , Murray Andrew , Close Graeme , Glover Danny , Du Plessis Wimpie J 
Published: May 2022

ObjectivesThis pilot study aimed to see whether a risk assessment and risk reduction approach was a practical and feasible approach, as compared with standard isolation for fully vaccinated, asymptomatic persons positive for SARS-CoV-2.MethodsThis prospective cohort study included all players and caddies participating in two large professional golf events from 7 to 20 February 2022 in South Africa. Fully vaccinated persons testing positive who were asymptomatic were subject to risk assessment and risk reduction measures to protect the integrity of the event. Asymptomatic individuals who could socially distance in outdoor areas were allowed to participate. Close contacts were subject to daily rapid antigen tests and asked to prioritise outdoor space.ResultsThe protocols put in place for the events were practical, feasible, and well accepted by event participants and staff during the study period. There was a total of 378 player-week episodes and 378 caddie-week episodes during the study period. Three persons tested positive while registered at events during the study period (0.4% of person episodes). The positive tests were returned from two players and one caddie, all of which were asymptomatic at the time of testing. There was one high-risk contact who consistently returned negative antigen tests. There was no evidence of transmission.ConclusionsThe approach was practical and feasible. A risk assessment and risk reduction approach allowed fully vaccinated asymptomatic persons with SARS-CoV-2 to participate in golf, an outdoor sport where social distancing is possible, compared with standard isolation.
A decade of hospital costs for firearm injuries in the United States by region, 2005–2015: government healthcare costs and firearm policies
Authors: Spitzer Sarabeth A , Forrester Joseph D , Tennakoon Lakshika , Spain David A , Weiser Thomas G 
Published: May 2022

BackgroundFirearm injuries are a costly, national public health emergency, and government-sponsored programs frequently pay these hospital costs. Understanding regional differences in firearm injury burden may be useful for crafting appropriate policies, especially with widely varying state gun laws.ObjectiveTo estimate the volume of, and hospital costs for, fatal and non-fatal firearm injuries from 2005 to 2015 for each region of the United States and analyze the proportionate cost by payer status.MethodsWe used the Healthcare Cost and Utilization Project Nationwide Inpatient Sample to identify patients admitted for firearm-related injuries from 2005 to 2015. We converted hospitalization charges to costs, which were inflation-adjusted to 2015 dollars. We used survey weights to create regional estimates. We used the Brady Gun Law to determine significance between firearm restrictiveness and firearm hospitalizations by region.ResultsThere were a total of 317 479 firearm related admissions over the study period: 52 829 (16.66%), 66 671 (21.0%), 134 008 (42.2%), and 63 972 (20.2%) for the Northeast, Midwest, South, and West respectively, demonstrating high regional variability. In the Northeast, hospital costs were $1.98 billion (13.9% of total), of which 56.0% was covered by government payers; for the Midwest, costs were $1.53 billion (19.7% of total), 40.4% of which was covered by government payers; in the South costs were highest at $3.2 billion (41.4% of total), but government payers only covered 34.3%; and costs for the West were $1.94 billion (25.0% of total), with government programs covering 41.6% of the cost burden.ConclusionsHospital admissions and costs for firearm injuries demonstrated wide variation by region, suggesting opportunities for financial savings. As government insurance programs cover 41.5% of costs, tax dollars heavily subsidize the financial burden of firearm injuries and cost recovery options for treating residents injured by firearms should be considered. Injury control strategies have not been well applied to this national public health crisis.Level of evidenceLevel II, Economic and Value Based Evaluation