bluuebunny/crossref_metadata_2025_split huggingface dataset:
Half-dose fulvestrant plus anastrozole as a first-line treatment for hormone receptor-positive metastatic breast cancer: a cost-effectiveness analysis
Authors: Huang Xiaoting , Weng Xiuhua , Lin Shen , Liu Yiwei , Luo Shaohong , Wang Hang , Ming Wai-kit , Huang Pinfang 
Published: August 2020

ObjectiveThe S0226 trial demonstrated that the combination of half-dose fulvestrant (FUL) and anastrozole (ANA) (F&A) caused a significant improvement in overall survival (OS) versus ANA monotherapy for first-line treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer (PMW-MBC (HR+)). The objective of this study was to evaluate the cost-effectiveness of F&A in the first-line treatment for PMW-MBC (HR+) in China.DesignWe constructed a Markov model over a life-time horizon. The clinical outcomes and utility data were obtained from published literature. Cost data were obtained from official Chinese websites. Sensitivity analyses were performed to test result uncertainty.SettingChinese healthcare system perspective.PopulationA hypothetical cohort of adult patients presenting with PMW-MBC (HR+).InterventionsF&A compared with full-dose FUL and ANAmonotherapy.Main outcome measuresThe main outcome of this study was the incremental cost-effectiveness ratio (ICER) and quality-adjusted life-years (QALY).ResultsANA was estimated to have the lowest cost and minimum life-years. The ICER of F&A versus ANA was US$15 665.891/QALY with incremental cost and QALY of US$12 401.120 and 0.792, respectively, which was less than the willingness-to-pay of US$29 383/QALY. Compared with F&A, FUL yielded a higher cost and a shorter lifetime; hence, it was identified as a dominated strategy. The univariate sensitivity analysis indicated the price of FUL was the most influential factor in our study. The probability that F&A was cost-effective at a threshold of US$29 383/QALY in China was 86.5%.ConclusionF&A is a cost-effective alternative to FUL and ANA monotherapy for the first-line treatment of PMW-MBC (HR+) in China. F&A is a promising first-line treatment for PMW-MBC (HR+), and more research is needed to evaluate the economy of using F&A in other countries.
Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect
Authors: Reif Lindsey K , Belizaire Marie Elmase , Seo Grace , Rouzier Vanessa , Severe Patrice , Joseph Joseph Marie , Joseph Bernadette , Apollon Sandra , Abrams Elaine J , Arpadi Stephen M , Elul Batya , Pape Jean W , McNairy Margaret L , Fitzgerald Daniel W , Kuhn Louise 
Published: August 2020

IntroductionAdolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression.Methods and analysisThis non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10–24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence.Ethics and disseminationThis study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.Trial registration numberNCT03288246.
Trends in cancer incidence and survival in the Augsburg study region—results from the Augsburg cancer registry
Authors: Grundmann Nina , Meisinger Christa , Trepel Martin , Müller-Nordhorn Jacqueline , Schenkirsch Gerhard , Linseisen Jakob 
Published: August 2020

ObjectivesKnowledge about time trends of cancer incidence and cancer survival in a defined region is an essential prerequisite for the planning of regional healthcare infrastructure. The aim of the study was to provide population-based analyses of all common tumour sites to assess the cancer burden in the Augsburg study region.SettingTotal population of the study region of Augsburg (668 522 residents), Southern Germany.ParticipantsThe data obtained from the Cancer Registry Augsburg comprised 37 487 incident cases of malignant tumours (19 313 men and 18 174 women) diagnosed between 2005 and 2016 in the Augsburg region’s resident population.Primary and secondary outcome measuresWe calculated sex-specific, age-standardised incidence rates and annual percent change to assess time trends. In men and in women, 3-year and 5-year relative survival was calculated and results were compared with the latest German estimates. Survival trends were presented for the most common cancers only.ResultsDecreasing age-standardised incidence rates were observed for prostate cancer and for colorectal cancer in men. For oropharyngeal cancer, rates declined in men, but significantly increased in women. Incidence for female breast cancer remained stable. Five-year relative survival ranged between 6.4% (95% CI: 4.1% to 10.1%) for pancreatic cancer and 97.7% (95% CI: 96.0% to 99.4%) for prostate cancer in men and between 10.2% (95% CI: 7.1% to 14.6%) for pancreatic cancer and 96.6% (95% CI: 93.6% to 99.6%) for malignant melanoma in women. Trends in 3-year survival of the five most common tumour sites in men showed a significant increase for lung and oropharyngeal cancer. In women, continuously rising survival trends were observed for breast cancer.ConclusionsSurvival of cancer patients in the Augsburg study region was largely concordant with the situation in Germany as a whole, while incidence showed slight deviations in some cancer sites. Regional evaluations on cancer survival are a valuable instrument for identifying deficits and determining advances in oncological health management.
Determining the long-term health burden and risk of sequelae for 14 foodborne infections in British Columbia, Canada: protocol for a retrospective population-based cohort study
Authors: Majowicz Shannon E , Panagiotoglou Dimitra , Taylor Marsha , Gohari Mahmood R , Kaplan Gilaad G , Chaurasia Ashok , Leatherdale Scott T , Cook Richard J , Patrick David M , Ethelberg Steen , Galanis Eleni 
Published: August 2020

IntroductionOver one in eight Canadians is affected by a foodborne infection annually; however, the long-term consequences, including the risks and costs of sequelae, are unclear. We aim to estimate the health burden and direct costs of 14 infections commonly transmitted by food, considering the acute illness and subsequent sequelae and mortality, for the population of British Columbia, Canada (~4.7 million).Methods and analysisWe will conduct a population-based retrospective cohort study of the British Columbia provincial population, over a 10-year study period (1 January 2005 to 31 December 2014). Exposure is defined as a provincially reported illness caused byClostridium botulinum,Campylobacter,Cryptosporidium, Cyclospora, Giardia, hepatitis A virus,Listeria, non-typhoidalSalmonellaspp,SalmonellaTyphi,SalmonellaParatyphi, Shiga toxin-producingEscherichia coli,Shigella,Vibrio parahaemolyticusorYersinia(excludingpestis). We will link individual-level longitudinal data from eight province-wide administrative health and reportable disease databases that include physician visits, hospitalisations and day surgeries, deaths, stillbirths, prescription medications (except those to treat HIV) and reportable foodborne diseases. Using these linked databases, we will investigate the likelihood of various sequelae and death. Hazard models will be used to estimate the risk of outcomes and their association with the type of foodborne infection. Epidemiological analyses will be conducted to determine the progression of illness and the fraction of sequelae attributable to specific foodborne infections. Economic analyses will assess the consequent direct healthcare costs.Ethics and disseminationThis study has been approved by a University of Waterloo Research Ethics Committee (no 30645), the University of British Columbia Behavioral Research Ethics Board (no H16-00021) and McGill University’s Institutional Review Board (no A03-M12-19A). Results will be disseminated via presentations to academics, public health practitioners and knowledge users, and publication in peer-reviewed journals. Where such publications are not open access, manuscripts will also be available via the University of Waterloo’s Institutional Repository (https://uwspace.uwaterloo.ca).
Eye health and quality of life: an umbrella review protocol
Authors: Assi Lama , Rosman Lori , Chamseddine Fatimah , Ibrahim Perla , Sabbagh Hadi , Congdon Nathan , Evans Jennifer , Ramke Jacqueline , Kuper Hannah , Burton Matthew J , Ehrlich Joshua R , Swenor Bonnielin K 
Published: August 2020

IntroductionVision impairment and eye disease are major global health concerns and have been associated with increased morbidity and mortality, and lower quality of life. Quality of life, whether generic, vision-specific or disease-specific, is an important measure of the impact of eye health on people’s daily activities, well-being and visual function, and is increasingly used to evaluate the impact of ophthalmic interventions and new devices. While many studies and reviews have examined the relationship between vision or eye health and quality of life across different contexts, there has yet to be a synthesis of the impact of vision impairment, eye disease and ophthalmic interventions on quality of life globally and across the lifespan.Methods and analysisAn umbrella review of systematic reviews will be conducted to address these two questions: (1) What is the association of vision impairment and eye disease with quality of life? (2) What is the impact of ophthalmic interventions on quality of life? A search of related literature will be performed on the 11 February 2020 in Medline Ovid, Embase.com, Cochrane Database of Systematic Reviews, Proquest Dissertations and Theses Global, and the grey literature, and repeated at the synthesis stage. Title/abstract and full-text screening, methodological quality assessment and data extraction will be conducted by reviewers working independently and in duplicate. Assessment of methodological quality and data extraction will be performed using Joanna Briggs Institute standard forms. Findings from the systematic reviews and their methodological quality will be summarised qualitatively in the text and using tables.Ethics and disseminationNo ethical approval is required. Results of this umbrella review will be published in a peer-reviewed journal and summarised in theLancet Global HealthCommission on Global Eye Health.Trial registration numberThis protocol was registered in the Open Science Framework Registries (https://osf.io/qhv9g/).
Mortality and hospitalisation in the Danish Helicopter Emergency Medical Service (HEMS) population from 2014 to 2018: a national population-based study of HEMS triage
Authors: Alstrup Karen , Petersen Jens Aage Kølsen , Sollid Stephen , Johnsen Søren Paaske , Rognås Leif 
Published: August 2020

ObjectiveTo describe characteristics and outcomes for patients where the Danish Helicopter Emergency Medical Service (HEMS) either transported the patient to hospital, treated the patient on scene but did not transport the patient or was dispatched but cancelled en route to the patient (aborted mission), and to assess the field triage by comparing these outcomes.DesignNational population-based study.Setting and participantsHEMS dispatches are undertaken from the five Danish emergency dispatch medical centres according to national guidelines. The study analysed all primary missions with helicopter take off where the patient was admitted to hospital between 1st October 2014 and 30th April 2018.Main outcome measuresMortality rates, admittance to an intensive care unit (ICU), need of mechanical ventilation and length of hospital stay (LOS).Results6931 patients were admitted to hospital; 3311 patients were air lifted, 164 patients were ground escorted by a HEMS physician, 1421 were assisted on scene by HEMS, but escorted by the ground units and 2035 missions were aborted. The mortality was highest among the airlifted and ground escorted patients, and lowest among the patients in the aborted mission group. Mortality for the airlifted patients increased from 8.2% (95% CI; 7.3 to 9.2) at day 1 to 19.5% (95% CI; 18.2 to 20.9) after 1 year. The airlifted and ground escorted patients were frequently admitted to ICU and subsequently mechanically ventilated and they also had an increased LOS compared with the patients only assisted on scene by HEMS and the patients in the aborted mission group.ConclusionPatients to whom HEMS are dispatched are often critically ill or injured and have a relatively high mortality. The patients airlifted or ground escorted to hospital by HEMS appear more critically ill or injured compared with the assisted patients and the patients in the aborted mission group. The on-scene triage seems appropriate.
New types of diaphragms and cervical caps versus older types of diaphragms and different gels for contraception: a systematic review
Authors: Lindh Ingela , Othman Jwan , Hansson Mariann , Ekelund Ann-Catrin , Svanberg Therese , Strandell Annika 
Published: August 2020

IntroductionOur primary objective was to evaluate whether new types of single-size diaphragms or cervical caps differ in prevention of pregnancy compared with older types of diaphragms, and whether different types of gels differ in their ability to prevent pregnancy. A secondary aim was to evaluate method discontinuation and complications.MethodsA comprehensive search was conducted in PubMed, Embase and the Cochrane Library. The certainty of evidence was assessed according to the GRADE system.ResultsFour randomised controlled studies were included in the assessment. When comparing the new and old types of female barrier contraceptives the 6-month pregnancy rate varied between 11%–15% and 8%–12%, respectively. More women reported inability to insert or remove the FemCap device (1.1%) compared with the Ortho All-Flex diaphragm (0%) (p<0.0306). Urinary tract infections were lower when using the single-size Caya, a difference of −6.4% (95% CI −8.9 to −4.09) compared with the Ortho All-Flex diaphragm. The 6-month pregnancy rate for acid-buffering gel and spermicidal nonoxynol-9 gel varied between 10% and 12%. The discontinuation rate was lower in women who used acid-buffering gel compared with nonoxynol-9 gel (risk ratio (RR) 0.77, 95% CI 0.68 to 0.97).ConclusionsPregnancy rates were generally high in women using female barrier contraceptives. There was no difference in the efficacy for pregnancy prevention between the new types of diaphragms and cervical caps and the older diaphragms. The new types of diaphragms and cervical caps resulted in fewer urinary tract infections. Acid-buffering gels did not differ from spermicidal nonoxynol-9 gels regarding pregnancies but seemed to be better tolerated.
Anakinra for constrictive pericarditis associated with incessant or recurrent pericarditis
Authors: Andreis Alessandro , Imazio Massimo , Giustetto Carla , Brucato Antonio , Adler Yehuda , De Ferrari Gaetano Maria 
Published: August 2020

ObjectiveFrequent flares of pericardial inflammation in recurrent or incessant pericarditis with corticosteroid dependence and colchicine resistance may represent a risk factor for constrictive pericarditis (CP). This study was aimed at the identification of CP in these patients, evaluating the efficacy and safety of anakinra, a third-line treatment based on interleukin-1 inhibition, to treat CP and prevent the need for pericardiectomy.MethodsConsecutive patients with recurrent or incessant pericarditis with corticosteroid dependence and colchicine resistance were included in a prospective cohort study from 2015 to 2018. Enrolled patients received anakinra 100 mg once daily subcutaneously. The primary end point was the occurrence of CP. A clinical and echocardiographic follow-up was performed at 1, 3, 6 months and then every 6 months.ResultsThirty-nine patients (mean age 42 years, 67% females) were assessed, with a baseline recurrence rate of 2.76 flares/patient-year and a median disease duration of 12 months (IQR 9–20). During follow-up, CP was diagnosed in 8/39 (20%) patients. After anakinra dose of 100 mg/day, 5 patients (63%) had a complete resolution of pericardial constriction within a median of 1.2 months (IQR 1–4). In other three patients (37%), CP became chronic, requiring pericardiectomy within a median of 2.8 months (IQR 2–5). CP occurred in 11 patients (28%) with incessant course, which was associated with an increased risk of CP over time (HR for CP 30.6, 95% CI 3.69 to 253.09).ConclusionsIn patients with recurrent or incessant pericarditis, anakinra may have a role in CP reversal. The risk of CP is associated with incessant rather than recurrent course.
Impact of COVID-19 on percutaneous coronary intervention for ST-elevation myocardial infarction
Authors: Kwok Chun Shing , Gale Chris P , Kinnaird Tim , Curzen Nick , Ludman Peter , Kontopantelis Evan , Wu Jianhua , Denwood Tom , Fazal Nadeem , Deanfield John , de Belder Mark A , Mamas Mamas 
Published: August 2020

BackgroundThe objective of the study was to identify any changes in primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) in England by analysing procedural numbers, clinical characteristics and patient outcomes during the COVID-19 pandemic.MethodsWe conducted a retrospective cohort study of patients who underwent PCI in England between January 2017 and April 2020 in the British Cardiovascular Intervention Society-National Institute of Cardiovascular Outcomes Research database. Analysis was restricted to 44 hospitals that reported contemporaneous activity on PCI. Only patients with primary PCI for STEMI were included in the analysis.ResultsA total of 34 127 patients with STEMI (primary PCI 33 938, facilitated PCI 108, rescue PCI 81) were included in the study. There was a decline in the number of procedures by 43% (n=497) in April 2020 compared with the average monthly procedures between 2017 and 2019 (n=865). For all patients, the median time from symptom to hospital showed increased after the lockdown (150 (99–270) vs 135 (89–250) min, p=0.004) and a longer door-to-balloon time after the lockdown (48 (21–112) vs 37 (16–94) min, p<0.001). The in-hospital mortality rate was 4.8% before the lockdown and 3.5% after the lockdown (p=0.12). Following adjustment for baseline characteristics, no differences were observed for in-hospital death (OR 0.87, 95% CI 0.45 to 1.68, p=0.67) and major adverse cardiovascular events (OR 0.71, 95% CI 0.39 to 1.32, p=0.28).ConclusionsFollowing the lockdown in England, we observed a decline in primary PCI procedures for STEMI and increases in overall symptom-to-hospital and door-to-balloon time for patients with STEMI. Restructuring health services during COVID-19 has not adversely influenced in-hospital outcomes.
Chronic inflammatory demyelinating polyneuropathy associated with diabetes: a European multicentre comparative reappraisal
Authors: Rajabally Yusuf A , Peric Stojan , Cobeljic Mina , Afzal Saadia , Bozovic Ivo , Palibrk Aleksa , Basta Ivana 
Published: August 2020

IntroductionThe association between chronic inflammatory demyelinating polyneuropathy (CIDP) and diabetes is uncertain despite important diagnostic and management implications.MethodsWe retrospectively analysed two European cohorts, totaling 257 patients with ‘definite’ or ‘probable’ CIDP, from Serbia and Birmingham, UK.ResultsDiabetes was present at CIDP diagnosis in 25/139 (18%) subjects in the Serbian cohort and in 23/118 (19.5%) in the UK cohort. In both cohorts, diabetes prevalence was higher than local general population prevalence rates (RR: 2.09; 95% CI 1.39 to 2.95 and RR: 2.22; 95% CI 1.46 to 3.17, respectively). Considering typical CIDP only, diabetes prevalence was greater than expected in both cohorts (RR: 2.58; 95% CI 1.60 to 3.82 and RR: 2.68; 95% CI 1.71 to 3.87, respectively). CIDP with diabetes occurred later in life than CIDP without diabetes (58.96 years, SD: 11.09 vs 51.71 years, SD: 16.02; p=0.003) and presented more frequently in the typical form than in patients without diabetes (79.2% vs 61.2%; p=0.02). Baseline Inflammatory Neuropathy Cause and Treatment disability scores were similar in patients with and without diabetes (p=0.90). Proportions of treatment responders were similar in both groups (70% vs 74.9%; p=0.65), as were response amplitudes (p=0.87).DiscussionOur results, both for all CIDP and typical CIDP presentations, support a twofold increased relative risk of diabetes compared with the general population. CIDP with diabetes appears to present older and more frequently in the typical form, as compared with CIDP without diabetes. CIDP with diabetes appears similar to CIDP without diabetes in disability levels at diagnosis and probability, as well as amplitude of treatment response.
The frequency of uveitis in patients with adult versus childhood spondyloarthritis
Authors: Turk Matthew , Hayworth Jacqueline , Nevskaya Tatiana , Pope Janet 
Published: August 2020

ObjectivesThis meta-analysis investigated the frequency of ocular involvement in childhood and adult spondyloarthritis (SpA).MethodsA systematic review of the literature was conducted. Medline, Web of Science and Cochrane databases were searched upto October 2018 identifying publications related to SpA, including ankylosing spondylitis (AS) with ocular conditions (OC) (uveitis, iritis, retinitis, chorioretinitis and other ocular involvement). The rates of OC were extracted and random effects models estimated their frequency. Heterogeneity was evaluated using I2. Inclusion criteria were studies in SpA of either children or adults who included a frequency of OC.Results3164 studies were identified, and 41 analysed which included frequencies of uveitis/iritis. Other OC were too infrequent to analyse. A pooled random effects model showed that the prevalence of uveitis was 24% in adult AS (23 studies, 11 943 patients), 10% in adult psoriatic arthritis (PsA) (9 studies, 1817) and 17% in undifferentiated adult SpA (9 studies, 6568 patients). In juveniles with AS, the prevalence of uveitis was 27% (8 studies, 927 patients), in juvenile PsA it was 16% (5 studies, N=498) and in juvenile undifferentiated SpA, uveitis occurred in 7% (2 studies, 1531 patients). In all evaluated SpA subgroups, there were no statistical differences in the frequency of uveitis between juveniles and adults.ConclusionsUveitis in adult versus child-onset SpA is similar in AS but more common in adult-onset undifferentiated SpA, and less frequent in adult-onset PsA compared to child-onset PsA, but the differences were not significant.