bluuebunny/crossref_metadata_2025_split huggingface dataset:
New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-label, randomised, prospective, phase-2 clinical trial in the Plurinational State of Bolivia
Authors: Alonso-Vega Cristina , Urbina Julio A , Sanz Sergi , Pinazo María-Jesús , Pinto Jimy José , Gonzalez Virginia R , Rojas Gimena , Ortiz Lourdes , Garcia Wilson , Lozano Daniel , Soy Dolors , Maldonado Rosa A , Nagarkatti Rana , Debrabant Alain , Schijman Alejandro , Thomas M Carmen , López Manuel Carlos , Michael Katja , Ribeiro Isabela , Gascon Joaquim , Torrico Faustino , Almeida Igor C 
Published: December 2021

IntroductionChagas disease (CD) affects ~7 million people worldwide. Benznidazole (BZN) and nifurtimox (NFX) are the only approved drugs for CD chemotherapy. Although both drugs are highly effective in acute and paediatric infections, their efficacy in adults with chronic CD (CCD) is lower and variable. Moreover, the high incidence of adverse events (AEs) with both drugs has hampered their widespread use. Trials in CCD adults showed that quantitative PCR (qPCR) assays remain negative for 12 months after standard-of-care (SoC) BZN treatment in ~80% patients. BZN pharmacokinetic data and the nonsynchronous nature of the proliferative mammal-dwelling parasite stage suggested that a lower BZN/NFX dosing frequency, combined with standard or extended treatment duration, might have the same or better efficacy than either drug SoC, with fewer AEs.Methods and analysisNew ThErapies and Biomarkers for ChagaS infEctiOn (TESEO) is an open-label, randomised, prospective, phase-2 clinical trial, with six treatment arms (75 patients/arm, 450 patients). Primary objectives are to compare the safety and efficacy of two new proposed chemotherapy regimens of BZN and NFX in adults with CCD with the current SoC for BZN and NFX, evaluated by qPCR and biomarkers for 36 months posttreatment and correlated with CD conventional serology. Recruitment of patients was initiated on 18 December 2019 and on 20 May 2021, 450 patients (study goal) were randomised among the six treatment arms. The treatment phase was finalised on 18 August 2021. Secondary objectives include evaluation of population pharmacokinetics of both drugs in all treatment arms, the incidence of AEs, and parasite genotyping.Ethics and disseminationThe TESEO study was approved by the National Institutes of Health (NIH), U.S. Food and Drug Administration (FDA), federal regulatory agency of the Plurinational State of Bolivia and the Ethics Committees of the participating institutions. The results will be disseminated via publications in peer-reviewed journals, conferences and reports to the NIH, FDA and participating institutions.Trial registration numberNCT03981523.
Comorbidity patterns and associated characteristics in children with obstructive sleep apnoea–hypopnoea syndrome in Shanghai, China: a cross-sectional study
Authors: Li Ziyun , Gao Xiang , Chen Ning , Zhou Liang , Wang Hui , Chen Chen , Yang Yan , Yu Dehua , Jin Hua , Zhou Huining , Hou Tianchun , Huang Jiaoling , Wang Zhaoxin , Shi Jianwei 
Published: December 2021

ObjectivesPaediatric obstructive sleep apnoea–hypopnoea syndrome (OSAHS), which usually cooccurs with various diseases, significantly impacts health and social resources. Domestic paediatric OSAHS studies have not included comorbidity patterns or distribution characteristics. Thus, we investigated the comorbid characteristics of paediatric OSAHS in Shanghai, China.DesignLarge hospital-based cross-sectional study.SettingPaediatric ward medical data from the Pudong New Area, Shanghai, China from 2013 to 2016.Participants4045 Chinese children aged 0–18 years.Primary and secondary outcome measuresPaediatric OSAHS was diagnosed using the Paediatric Sleep Questionnaire with a cut-off score of 8 points. The outcomes were comorbidity patterns and their characteristics. χ2tests were performed to compare differences among the top comorbidity patterns.ResultsMajor comorbidities were otolaryngological morbidities. Among one-comorbidity patterns, OSAHS+chronic rhinitis (37.53%) and OSAHS+allergic rhinitis (28.13%) were most common. Among two-comorbidity patterns, OSAHS+chronic rhinitis +chronic exudative otitis media (10.88%), OSAHS+allergic rhinitis +chronic exudative otitis media (7.94%), OSAHS+allergic rhinitis +chronic tonsillitis (4.43%) and OSAHS+chronic rhinitis +chronic tonsillitis (4.23%) were most common. Males predominated in all comorbidity groups. Age differences for the top five patterns in both the one-comorbidity (p=0.035) and two comorbidities (p<0.001) groups were statistically significant. In the one-comorbidity group, patients were more likely to have one operation (p<0.001), and in the two comorbidities group, patterns of ‘OSAHS+chronic rhinitis +chronic exudative otitis media’ and ‘OSAHS+allergic rhinitis +chronic exudative otitis media’ were more common in the ≥2 operations group (p<0.001). Notably, the top five patterns of the 2-comorbidities group were significantly associated with the length of stay (LOS) (p<0.001), while those in the one-comorbidity group were not.ConclusionOSAHS+rhinitis (chronic rhinitis or allergic rhinitis) was the most common diagnosis. Age, number of operations, and LOS are significantly associated with the patterns. This emphasises the importance of better understanding complex otolaryngological comorbidity diagnoses and treatments in paediatric OSAHS to reverse clinical outcomes and save health resources.
Glasgow Prognostic Score and modified Glasgow Prognostic Score and survival in patients with hepatocellular carcinoma: a meta-analysis
Authors: Lu Lingling , Lin Kunzhe , Zheng Jiaolong , Wu Haicong , Li Dongliang 
Published: December 2021

ObjectiveTo evaluate the association between inflammation-related markers, modified Glasgow Prognostic Score (mGPS) and Glasgow Prognostic Score (GPS), and survival outcome and recurrence risk in patients with hepatocellular carcinoma (HCC) after treatment.DesignSystematic reviews and meta-analysis of cohort studies.Date sourcesEmbase, Scopus, Web of Science and PubMed were searched through 10 March 2021.Eligibility criteriaWe included cohort studies that assessed the effect of pretreatment mGPS/GPS levels on survival outcomes in patients with HCC.Data extraction and synthesisTwo researchers independently selected the data and reached a consensus. In case of disagreement, a third researcher was required to assist. The HRs and 95% CIs were used as the effect size indexes. Newcastle-Ottawa Scale was used to assess risk of bias and quality assessment of the included studies.ResultsThe meta-analysis included 23 studies, most of which were retrospective. Participants were grouped according to the score of mGPS/GPS. When analysed into two groups (1/2 vs 0), the results showed that patients with a mGPS/GPS of 1 or 2 had poorer overall survival (OS) than those with a score of 0 (both p<0.001). When analysed into three groups (1 vs 0 and 2 vs 0), the results revealed that an mGPS/GPS of 2 is related to poorer OS in patients with HCC (HR=2.46, 95% CI 2.06 to 2.95, and HR=3.45, 95% CI 1.68 to 7.10, respectively). However, a GPS of 1 (p=0.005) but not an mGPS of 1 (p=0.177) had a significant association with OS. No association was found between mGPS/GPS and disease-free survival or recurrence-free survival.ConclusionGPS was more closely associated the survival in patients with HCC than mGPS. A higher GPS has an association with poorer survival. It can be combined with tumour staging to assess the OS of HCC more accurately.PROSPERO registration numberCRD42021242049.
Diseases with oral manifestations among adult asthmatics in Finland: a population-based matched cohort study
Authors: Lemmetyinen Riikka , Karjalainen Jussi , But Anna , Renkonen Risto , Pekkanen Juha , Haukka Jari , Toppila-Salmi Sanna 
Published: December 2021

ObjectivesMany comorbidities are associated with adult asthma and may exacerbate the asthma burden of disease. This study aims to investigate the risk for major oral diseases or oral-manifesting diseases in asthmatic compared with non-asthmatic adults.DesignWe conducted a population-based matched cohort study with a 13.8-year follow-up.SettingA baseline questionnaire was completed by participants in 1997 and follow-up data were extracted from the national hospital discharge registry of the National Institute for Health and Welfare in Finland from 1997 to 2014.ParticipantsA total of 1394 adults with asthma were matched with 2398 adults without asthma based on sex, age and area of residence. Asthmatic adults were identified from the Drug Reimbursement Register of the Finnish Social Insurance Institution based on a special drug reimbursement right resulting from asthma. Participants without asthma were identified from the Population Register.Main outcomes and measuresOral health-related primary diagnoses were retrieved using codes from the International Classification of Diseases, 10th edition and divided into groups of diseases. Cox’s proportional hazards models stratified by matching unit and models matched and adjusted for pack-years, education level and body mass index (when possible) were used to evaluate the matched and further adjusted HRs for diseases comparing asthmatic and non-asthmatic cohorts.ResultsAdult asthma was associated with a higher risk for any oral-manifesting disease (adjusted HR 1.41, 95% CI 1.11 to 1.80), herpes zoster (adjusted HR 6.18, 95% CI 1.21 to 31.6), benign tumours of the oral cavity and pharynx (matched HR 1.94, 95% CI 1.05 to 3.56) and dermatological diseases (pemphigus, pemphigoid, dermatitis herpetiformis, psoriasis and lichen planus, HR 1.67, 95% CI 1.01 to 2.78).ConclusionsIn this study, adult asthmatics experienced a higher risk for a major oral disease or oral-manifesting disease.
Assessment of the effects of methodological choice in continuity of care research: a real-world example with dyslipidaemia cohort
Authors: Choo Eunjung , Choi Eunyoung , Lee Juhee , Siachalinga Linda , Jang Eun Jin , Lee Iyn-Hyang 
Published: December 2021

ObjectiveTo determine if the choice of methodological elements affects the results in continuity of care studies.DesignThis is a retrospective cohort study. The association between continuity of care and clinical outcome was investigated using the Continuity of Care Index. The association was explored in 12 scenarios based on four definitions of the relative timing of continuity and outcome measurements in three populations (threePs × fourTs).SettingNational Health Insurance claims from all primary and secondary care facilities in South Korea between 2007 and 2015.ParticipantsParticipants were patients diagnosed with dyslipidaemia, made ≥2 ambulatory visits and were newly prescribed with ≥1 antihyperlipidaemic agent at an ambulatory setting in 2008. Three study populations were defined based on the number of ambulatory visits: 10 084 patients in population 1 (P1), 8454 in population 2 (P2) and 4754 in population 3 (P3).Main outcome measureHospitalisation related to one of the four atherosclerotic cardiovascular diseases, including myocardial infarction, stable or unstable angina, ischaemic stroke and transient ischaemic attack.ResultsConcurrent measure of continuity and outcome (T1) showed a significantly higher risk of hospitalisation (adjusted HRs: 2.73–3.07, p<0.0001) in the low continuity of care group, whereas T2, which measured continuity until the outcome occurred, showed no risk difference between the continuity of care groups. T3, which measured continuity as a time-varying variable, had adjusted HRs of 1.31–1.55 (p<0.05), and T4, measuring continuity for a predefined period and measuring outcomes in the remaining period, had adjusted HRs of 1.34–1.46 (p<0.05) in the low continuity of care. Within each temporal relationship, the effect estimates became more substantial as the inclusion criteria became stricter.ConclusionsThe study design in continuity of care studies should be planned carefully because the results are sensitive to the temporal relationship between continuity and outcome and the population selection criteria.
What are the financial implications of an open right hemicolectomy to hospital trusts within NHS England? A cost analysis
Authors: Daniels Ian , Tuson Richard , Hargreaves Judith 
Published: December 2021

ObjectiveThis study aimed to quantify the actual costs to National Health Service (NHS) England of open right/extended right hemicolectomy (ORH) patient episodes compared with national tariffs to determine whether the total cost of care for these patients is adequately reimbursed to NHS Trusts.Design2017–2018 NHS Improvement reference cost data for elective and non-elective ORH Healthcare Resource Group 4+ (HRG4+)-coded procedures were used to calculate the actual mean initial admission costs of ORH and compare with corresponding 2017–2018 national tariffs. Costs of postoperative complications were estimated based on 2017–2018 Hospital Episode Statistics (intensive care unit (ICU)/high-dependency unit (HDU) stay and surgical site infection (SSI)) or further associated HRG4+-coded procedures (anastomotic leakage, SSI or hernia).Setting and patient cohortData were analysed for all ORH inpatients reported as treated at 140 secondary care Hospital Trusts in England during the 2017–2018 financial year.Results9812 ORH HRG4+-coded procedures were reported across 140 Hospital Trusts (74.0% elective; 26.0% non-elective). A total 1-year deficit of £993 335 was estimated between actual initial admission costs incurred and tariffs reimbursed for all patient episodes, 93.7% of which was associated with elective admissions. The cost of the average length of stay (LoS) in ICU/HDU after an ORH was £6818. The additional cost of an extended LoS in ICU/HDU due to an SSI was £45 316.ConclusionThe total cost of delivering care for these patients declared by NHS England was far higher than the tariff provided, which may be significantly underestimating the true cost of an ORH, leading to inadequate national tariff-setting by NHS Improvement.
’We weren't checked in on, nobody spoke to us’: an exploratory qualitative analysis of two focus groups on the concerns of ethnic minority NHS staff during COVID-19
Authors: Jesuthasan Jehanita , Powell Richard A , Burmester Victoria , Nicholls Dasha 
Published: December 2021

ObjectiveTo gain exploratory insights into the multifaceted, lived experience impact of COVID-19 on a small sample of ethnic minority healthcare staff to cocreate a module of questions for follow-up online surveys on the well-being of healthcare staff during the pandemic.DesignA cross-sectional design using two online focus groups among ethnic minority healthcare workers who worked in care or supportive roles in a hospital, community health or primary care setting for at least 12 months.ParticipantsThirteen healthcare workers (11 female) aged 26–62 years from diverse ethnic minority backgrounds, 11 working in clinical roles.ResultsFive primary thematic domains emerged: (1)viral vulnerability, centring around perceived individual risk and vulnerability perceptions; (2)risk assessment, comprising pressures to comply, perception of a tick-box exercise and issues with risk and resource stratification; (3)interpersonal relations in the workplace, highlighting deficient consultation of ethnic minority staff, cultural insensitivity, need for support and collegiate judgement; (4)lived experience of racial inequality, consisting of job insecurity and the exacerbation of systemic racism and its emotional burden; (5)community attitudes, including public prejudice and judgement, and patient appreciation.ConclusionsOur novel study has shown ethnic minority National Health Service (NHS) staff have experienced COVID-19 in a complex, multidimensional manner. Future research with a larger sample should further examine the complexity of these experiences and should enumerate the extent to which these varied thematic experiences are shared among ethnic minority NHS workers so that more empathetic and supportive management and related occupational practices can be instituted.
Heart Watch Study: protocol for a pragmatic randomised controlled trial
Authors: Dhruva Sanket S , Shah Nilay D , Vemulapalli Sreekanth , Deshmukh Abhishek , Beatty Alexis L , Gamble Ginger M , Freeman James V , Hummel James P , Piccini Jonathan P , Akar Joseph G , Ervin Keondae , Arges Kristine L , Emanuel Lindsay , Noseworthy Peter A , Hu Tiffany , Bartlett Victoria , Ross Joseph S 
Published: December 2021

IntroductionPersonal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed to consumers. Despite their widespread and increasing use, data about the impact of personal digital device use on patient-reported outcomes and healthcare utilisation are sparse. Among a population of patients with atrial fibrillation and/or atrial flutter undergoing cardioversion, our primary aim is to determine the impact of the heart rate measurement, irregular rhythm notification, and ECG features of the Apple Watch on quality of life and healthcare utilisation.Methods and analysisWe are conducting a prospective, open-label multicentre pragmatic randomised clinical trial, leveraging a unique patient-centred health data sharing platform for enrolment and follow-up. A total of 150 patients undergoing cardioversion for atrial fibrillation or atrial flutter will be randomised 1:1 to receive the Apple Watch Series 6 or Withings Move at the time of cardioversion. The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months postcardioversion. Secondary outcomes include inpatient and outpatient healthcare utilisation. Additional secondary outcomes include a comparison of the Apple Watch ECG and pulse oximeter features with gold-standard data obtained in routine clinical care settings.Ethics and disseminationThe Institutional Review Boards at Yale University, Mayo Clinic, and Duke University Health System have approved the trial protocol. This trial will provide important data to policymakers, clinicians and patients about the impact of the heart rate, irregular rhythm notification, and ECG features of widely used personal digital devices on patient quality of life and healthcare utilisation. Findings will be disseminated to study participants, at professional society meetings and in peer-reviewed journals.Trial registration numberNCT04468321
INtrinsic Capacity and its RElAtionship With Life-SpacE Mobility (INCREASE): a cross-sectional study of community-dwelling older adults in Singapore
Authors: Lee Jia Qi , Ding Yew Yoong , Latib Aisyah , Tay Laura , Ng Yee Sien 
Published: December 2021

ObjectivesTo examine the association of intrinsic capacity (IC) with life-space mobility (LSM) among community-dwelling older adults and to determine whether age and gender modify this relationship.DesignCross-sectional study.SettingPublic housing blocks, senior activity centres and community centres in the Northeastern region of Singapore.Participants751 community-dwelling older adults aged ≥55 years old and able to ambulate independently with or without walking aid.Primary and secondary outcome measuresIC and LSM. Standardised IC factor scores were calculated through confirmatory factor analysis using variables representing the five IC domains cognition, locomotion, sensory, vitality and psychological. LSM was measured using the University of Alabama at Birmingham Study of Aging Life-Space Assessment instrument. Association of IC with LSM and its effect modification by age and gender were examined with regression analyses.ResultsThe participants had a mean age of 67.6 and mean LSM score of 88.6. IC showed a positive and significant association with LSM (β=6.33; 95% CI=4.94 to 7.72) and the effect remained significant even after controlling for potential confounders (β=4.76; 95% CI=3.22 to 6.29), with p<0.001 for both. Age and gender did not demonstrate significant modification on this relationship.ConclusionsOur findings support the empirical rigour of the International Classification of Functioning, Disability and Health framework, which suggests that IC influences the extent to which a person participates in the community. Our findings also provide guidance for healthcare providers who aim to enhance LSM and promote healthy ageing in older adults.
Associations between diabetes duration and self-stigma development in Japanese people with type 2 diabetes: a secondary analysis of cross-sectional data
Authors: Kato Asuka , Fujimaki Yuko , Fujimori Shin , Isogawa Akihiro , Onishi Yukiko , Suzuki Ryo , Ueki Kohjiro , Yamauchi Toshimasa , Kadowaki Takashi , Hashimoto Hideki 
Published: December 2021

ObjectivesTo examine the associations between self-stigma and diabetes duration in a sample of Japanese people with type 2 diabetes.DesignA secondary analysis of a cross-sectional study.SettingTwo university hospitals, one general hospital and one clinic in Tokyo, Japan.ParticipantsOutpatients with type 2 diabetes aged 20–74 years and receiving treatment from diabetes specialist physicians (n=209) completed a self-administered questionnaire.Primary and secondary outcome measuresSelf-stigma was measured as the primary outcome. Patient Activation Measure, body mass index and haemoglobin A1c were measured as secondary outcomes.ResultsOne-way analysis of covariance showed significant differences in self-stigma levels between the five groups of diabetes duration (≤5 years, 6–10 years, 11–15 years, 16–21 years and 22 years or more) after controlling for age, gender, education, marital status, diabetes treatment (insulin use) and diabetes-related complications, F(4,198)=2.83, p=0.026. Multiple comparisons using Bonferroni correction showed statistically significant differences in self-stigma levels between the groups with ≤5 years (95% CI 59.63 to 69.73) and 11–15 years with diabetes (95% CI 71.12 to 80.82; p=0.020). The highest mean level of self-stigma was observed in the group having diabetes for 11–15 years.ConclusionsSelf-stigma was associated with diabetes duration and was lowest after diagnosis and gradually increased, with its highest levels being observed in those having diabetes for 11–15 years. Self-stigma takes time to develop and gradually increases in individuals as it is learnt through direct experiences of diabetes-related stigma after self-administering treatment in everyday social situations.