bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pre-diabetes, diabetes and fluctuations of glucose tolerance after gestational diabetes mellitus: 5-year follow-up of a contemporary, prospective study in Germany
Authors: Haschka Stefanie J , Gar Christina , Sacco Vanessa , Banning Friederike , Ferrari Uta , Freibothe Ines , Kern-Matschilles Stefanie , Potzel Anne L , Rauch Barbara , Fueessl Louise U , Meisel Mandy , Benz Irina , Then Cornelia , Seissler Jochen , Lechner Andreas 
Published: March 2022

IntroductionTen years ago, Germany started offering screening for gestational diabetes mellitus (GDM) to all pregnant women. This approach revealed more but also, on average, less severe cases of GDM than the risk-based screening practiced previously. We now examined the incidence of pre-diabetes and diabetes following a GDM diagnosis in the era of universal screening in Germany and compared our results with studies in the previous period. Additionally, we examined the year-to-year fluctuations of glucose tolerance after a pregnancy complicated by GDM.Research design and methodsWe report 5-year follow-up data from 202 women in the prospective, monocenter, postpartum study PPSDiab. Consecutive recruitment took place in Munich, Germany between 2011 and 2016. In the study, we conducted yearly examinations that included anthropometrics, laboratory chemistry and oral glucose tolerance testing.ResultsDuring the first 5 years post partum, 111 (55%) and 12 (6%) of the women developed pre-diabetes and type 2 diabetes, respectively, while 2 (1%) developed type 1 diabetes. Impaired fasting glucose (IFG) was the most common first manifestation of disturbed glucose tolerance, followed by impaired glucose tolerance (IGT), the combination of IFG and IGT, and diabetes. Glucose tolerance did not deteriorate steadily in most women but fluctuated from year to year.ConclusionsIn our analysis, the incidence of diabetes, both type 1 and type 2, after GDM diagnosed in universal screening was substantially lower than in studies from the previous period of risk-based screening. Nevertheless, the high incidence of pre-diabetes we observed after GDM still confirms the importance of this diagnosis as a risk marker. Additionally, we documented frequent fluctuations of glucose tolerance from 1 year to the next. Therefore, a single postpartum glucose tolerance test, as currently practiced in routine care, may be insufficient for reliable risk stratification after GDM.
Towards the elimination of cervical cancer in low-income and lower-middle-income countries: modelled evaluation of the effectiveness and cost-effectiveness of point-of-care HPV self-collected screening and treatment in Papua New Guinea
Authors: Nguyen Diep Thi Ngoc , Simms Kate T , Keane Adam , Mola Glen , Bolnga John Walpe , Kuk Joseph , Toliman Pamela J , Badman Steven G , Saville Marion , Kaldor John , Vallely Andrew , Canfell Karen 
Published: March 2022

IntroductionWHO has launched updated cervical screening guidelines, including provisions for primary HPV screen-and-treat. Papua New Guinea (PNG) has a high burden of cervical cancer, but no national cervical screening programme. We recently completed the first field trials of a screen-and-treat algorithm using point-of-care self-collected HPV and same-day treatment (hereafter self-collected HPV S&T) and showed this had superior clinical performance and acceptability to visual inspection of the cervix with acetic acid (VIA). We, therefore, evaluated the effectiveness, cost-effectiveness and resource implications of a national cervical screening programme using self-collected HPV S&T compared with VIA in PNG.MethodsAn extensively validated platform (‘Policy1-Cervix’) was calibrated to PNG. A total of 38 strategies were selected for investigation, and these incorporated variations in age ranges and screening frequencies and allowed for the identification of the optimal strategy across a wide range of possibilities. A selection of strategies that were identified as being the most effective and cost-effective were then selected for further investigation for longer-term outcomes and budget impact estimation. In the base case, we assumed primary HPV testing has a sensitivity to cervical intraepithelial neoplasia 2 (CIN2+) + of 91.8% and primary VIA of 51.5% based on our earlier field evaluation combined with evidence from the literature. We conservatively assumed HPV sampling and testing would cost US$18. Costs were estimated from a service provider perspective based on data from local field trials and local consultation.ResultsSelf-collected HPV S&T was more effective and more cost-effective than VIA. Either twice or thrice lifetime self-collected HPV S&T would be cost-effective at 0.5× gross domestic product (GDP) per capita (incremental cost-effectiveness ratio: US$460–US$656/life-years saved; 1GDPper-capita: US$2829 or PGK9446 (year 2019)) and could prevent 33 000–42 000 cases and 23 000–29 000 deaths in PNG over the next 50 years, if scale-up reached 70% coverage from 2023.ConclusionSelf-collected HPV S&T was effective and cost-effective in the high-burden, low-resource setting of PNG, and, if scaled-up rapidly, could prevent over 20 000 deaths over the next 50 years. VIA screening was not effective or cost-effective. These findings support, at a country level, WHO updated cervical screening guidelines and indicate that similar approaches could be appropriate for other low-resource settings.
Utility of KI-67 as a prognostic biomarker in pulmonary neuroendocrine neoplasms: a systematic review and meta-analysis
Authors: Naheed Salma , Holden Chloe , Tanno Lulu , Pattini Linda , Pearce Neil W , Green Bryan , Jaynes Eleanor , Cave Judith , Ottensmeier Christian H. , Pelosi Giuseppe 
Published: March 2022

ObjectivesKi-67, a marker of cellular proliferation, is associated with prognosis across a wide range of tumours, including gastroenteropancreatic neuroendocrine neoplasms (NENs), lymphoma, urothelial tumours and breast carcinomas. Its omission from the classification system of pulmonary NENs is controversial. This systematic review sought to assess whether Ki-67 is a prognostic biomarker in lung NENs and, if feasible, proceed to a meta-analysis.Research design and methodsMedline (Ovid), Embase, Scopus and the Cochrane library were searched for studies published prior to 28 February 2019 and investigating the role of Ki-67 in lung NENs. Eligible studies were those that included more than 20 patients and provided details of survival outcomes, namely, HRs with CIs according to Ki-67 percentage. Studies not available as a full text or without an English manuscript were excluded. This study was prospectively registered with PROSPERO.ResultsOf 11 814 records identified, seven studies met the inclusion criteria. These retrospective studies provided data for 1268 patients (693 TC, 281 AC, 94 large cell neuroendocrine carcinomas and 190 small cell lung carcinomas) and a meta-analysis was carried out to estimate a pooled effect. Random effects analyses demonstrated an association between a high Ki-67 index and poorer overall survival (HR of 2.02, 95% CI 1.16 to 3.52) and recurrence-free survival (HR 1.42; 95% CI 1.01 to 2.00).ConclusionThis meta-analysis provides evidence that high Ki-67 labelling indices are associated with poor clinical outcomes for patients diagnosed with pulmonary NENs. This study is subject to inherent limitations, but it does provide valuable insights regarding the use of the biomarker Ki-67, in a rare tumour.Prospero registration numberCRD42018093389.
Medical expenditure and its influencing factors of patients with hypertension in Shanxi Province, China: a study based on ‘System of Health Accounts 2011’ and multiple-layer perceptron neural network
Authors: Liu Guojie , Fang Quan , Ji Xinyu , OuYang Jing , Zhu Yalan , Wang Leying , Wang Xin 
Published: March 2022

ObjectivesTo study the medical expenditure and influencing factors of patients with hypertension in Shanxi Province, China.DesignA cross-sectional study.Setting1088 medical institutions, including general hospitals, traditional Chinese medicine hospitals, special hospitals, basic medical institutions and public health institutions.Participants180 441 hypertensive outpatients and 14 763 inpatients from 1 January to 31 December 2017.Primary and secondary outcome measuresCurative care expenditure for hypertension (CCEht) was measured based on System of Health Accounts 2011. Influenced factors were analysed by univariate analysis and multiple layer perceptron neural network.ResultsIn 2017, CCEhtwas US$307.71 million, accounting for 3.63% of total CCE and 0.14% of gross domestic product (GDP) in Shanxi Province of China. CCE of hypertensive outpatients (CCEht-out) and inpatients (CCEht-in) accounted for 44.49% and 55.51% of CCEht. Drug fee accounted for 81.55% of CCEht-outand 22.50% of CCEht-in, respectively. The top three influencing factors were drug fee, surgical fee and hospitalisation days for inpatients, and drug fee, examination fee and test fee for outpatients.ConclusionsThe medical expenditure of hypertension is still heavy for individuals and society. The diagnosis and treatment capacities of primary healthcare system has been enhanced. New rural cooperation medical insurance and urban employee basic medical insurance have a trend of overusing, and the burden of family healthcare expenditure is still heavy. To ease the economic burden of patients with hypertension and improve the efficiency of social resources utilisation, policymakers should pay more attention to key groups, further increase support for primary healthcare system, standardise the treatment and reimbursement of hypertension and incline the reimbursement policy to outpatient service.
Urban scaling of opioid overdose deaths in the USA: a cross-sectional study in three periods between 2005 and 2017
Authors: Mullachery Pricila H , Lankenau Stephen , Diez Roux Ana V , Li Ran , Henson Rosie Mae , Bilal Usama 
Published: March 2022

ObjectivesTo describe the association between population size, population growth and opioid overdose deaths—overall and by type of opioid—in US commuting zones (CZs) in three periods between 2005 and 2017.Settings741 CZs covering the entirety of the US CZs are aggregations of counties based on commuting patterns that reflect local economies.ParticipantsWe used mortality data at the county level from 2005 to 2017 from the National Center for Health Statistics.OutcomeOpioid overdose deaths were defined using underlying and contributory causes of death codes from the International Classification of Diseases, 10th revision (ICD-10). We used the underlying cause of death to identify all drug poisoning deaths. Contributory cause of death was used to classify opioid overdose deaths according to the three major types of opioid, that is, prescription opioids, heroin and synthetic opioids other than methadone.ResultsOpioid overdose deaths were disproportionally higher in largely populated CZs. A CZ with 1.0% larger population had 1.10%, 1.10%, and 1.16% higher opioid death count in 2005–2009, 2010–2014, and 2015–2017, respectively. This pattern was largely driven by a high number of deaths involving heroin and synthetic opioids, particularly in 2015–2017. Population growth over time was associated with lower age-adjusted opioid overdose mortality rate: a 1.0% increase in population over time was associated with 1.4% (95% CI: −2.8% to 0.1%), 4.5% (95% CI: −5.8% to −3.2%), and 1.2% (95% CI: −4.2% to 1.8%) lower opioid overdose mortality in 2005–2009, 2010–2014, and 2015–2017, respectively. The association between positive population growth and lower opioid mortality rates was stronger in larger CZs.ConclusionsOpioid overdose mortality in the USA was disproportionately higher in mid-sized and large CZs, particularly those affected by declines in population over time, regardless of the region where they are located.
Severe acute kidney injury predicting model based on transcontinental databases: a single-centre prospective study
Authors: Liang Qiqiang , Xu Yongfeng , Zhou Yu , Chen Xinyi , Chen Juan , Huang Man 
Published: March 2022

ObjectivesThere are many studies of acute kidney injury (AKI) diagnosis models lack of external validation and prospective validation. We constructed the models using three databases to predict severe AKI within 48 hours in intensive care unit (ICU) patients.DesignA retrospective and prospective cohort study.SettingWe studied critically ill patients in our database (SHZJU-ICU) and two other public databases, the Medical Information Mart for Intensive Care (MIMIC) and AmsterdamUMC databases, including basic demographics, vital signs and laboratory results. We predicted the diagnosis of severe AKI in patients in the next 48 hours using machine-learning algorithms with the three databases. Then, we carried out real-time severe AKI prediction in the prospective validation study at our centre for 1 year.ParticipantsAll patients included in three databases with uniform exclusion criteria.Primary and secondary outcome measuresEffect evaluation index of prediction models.ResultsWe included 58 492 patients, and a total of 5257 (9.0%) patients met the definition of severe AKI. In the internal validation of the SHZJU-ICU and MIMIC databases, the best area under the receiver operating characteristic curve (AUROC) of the model was 0.86. The external validation results by AmsterdamUMC database were also satisfactory, with the best AUROC of 0.86. A total of 2532 patients were admitted to the centre for prospective validation; 358 positive results were predicted and 344 patients were diagnosed with severe AKI, with the best sensitivity of 0.72, the specificity of 0.80 and the AUROC of 0.84.ConclusionThe prediction model of severe AKI exhibits promises as a clinical application based on dynamic vital signs and laboratory results of multicentre databases with prospective and external validation.
Protocol for the implementation of a stepped-care model to address fear of cancer recurrence in patients previously diagnosed with early-stage (0–II) melanoma
Authors: Thompson Jake R , Smith Andrea L , Lo Serigne N , Kasparian Nadine A , Saw Robyn PM , Dieng Mbathio , Seaman Linda , Martin Linda K , Guitera Pascale , Milne Donna , Schmid Helen , Cust Anne E , Bartula Iris 
Published: March 2022

IntroductionFear of cancer recurrence (FCR) is commonly reported by patients diagnosed with early-stage (0–II) melanoma and can have a significant impact on daily functioning. This study will pilot the implementation of the Melanoma Care Program, an evidence-based, psychological intervention to reduce FCR, into routine practice, using a stepped-care model.Methods and analysisIntervention effectiveness and level of implementation will be investigated using a hybrid type I design. Between 4 weeks before and 1 week after their next dermatological appointment, patients with melanoma will be invited to complete the Fear of Cancer Recurrence Inventory Short-Form, measuring self-reported FCR severity. Using a stepped-care model, clinical cut-off points will guide the level of support offered to patients. This includes: (1) usual care, (2) Melanoma: Questions and Answers psychoeducational booklet, and (3) three or five psychotherapeutic telehealth sessions. This longitudinal, mixed-methods pilot implementation study aims to recruit 108 patients previously diagnosed with stage 0–II melanoma. The primary effectiveness outcome is change in FCR severity over time. Secondary effectiveness outcomes include change in anxiety, depression, stress, health-related quality of life and melanoma-related knowledge over time. All outcomes are measured at baseline, within 1 week of the final telehealth session, and 6 and 12 months post-intervention. Implementation stakeholders at each study site and interested patients will provide feedback on intervention acceptability and appropriateness. Implementation stakeholders will also provide feedback on intervention cost, feasibility, fidelity and sustainability. These outcomes will be measured throughout implementation, using questionnaires and semistructured interviews/expert group discussions. Descriptive statistics, linear mixed-effects regression and thematic analysis will be used to analyse study data.Ethics and disseminationEthics approval was granted by the Sydney Local Health District–Royal Prince Alfred Zone (2020/ETH02518), protocol number: X20-0495. Results will be disseminated through peer-reviewed journals, conference presentations, social media and result summaries distributed to interested participants.Trial registration details(ACTRN12621000145808).
Variations of urinary N-acetyl-β-D-glucosaminidase levels and its performance in detecting acute kidney injury under different thyroid hormones levels: a prospectively recruited, observational study
Authors: Liang Silin , Luo Dandong , Hu Linhui , Fang Miaoxian , Li Jiaxin , Deng Jia , Fang Heng , Zhang Huidan , He Linling , Xu Jing , Liang Yufan , Chen Chunbo 
Published: March 2022

ObjectiveChanges in thyroid function will be accompanied by changes in urinary N-acetyl-β-D-glucosaminidase (uNAG) levels. Therefore, whether thyroid hormones interfere the ability of uNAG in detecting acute kidney injury (AKI) has raised concern in patients with critical illness.DesignA prospectively recruited, observational study was performed.SettingAdults admitted to the intensive care unit of a grade A tertiary hospital in China.ParticipantsA total of 1919 critically ill patients were enrolled in the study.Main outcome measuresTo investigate the variations of the ability of uNAG to detect AKI in patients with critical illness under different thyroid hormones levels (differences in area under the curve (AUC) for uNAG diagnosis and prediction of AKI with different thyroid hormones levels).ResultsThe bivariate correlation analysis revealed that FT3 and TT3 levels were independently associated with uNAG levels (p<0.001). FT3 and uNAG also showed correlation in multivariable linear regression analysis (p<0.001). After stratification according to the levels of FT3 or TT3, significant variation was observed in the uNAG levels with different quartiles (p<0.05). However, in patients with varying FT3 and TT3 levels, no significant difference was found in the AUCs of uNAG to detect AKI (p>0.05).ConclusionsEven if uNAG levels varied with FT3 and TT3 levels, these hormones did not interfere with uNAG’s ability to detect AKI in patients with critical illness.
Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1
Authors: Berger Frédérique , Marce Margaux , Delaloge Suzette , Hardy-Bessard Anne-Claire , Bachelot Thomas , Bièche Ivan , Pradines Anne , De La Motte Rouge Thibault , Canon Jean-Luc , André Fabrice , Arnould Laurent , Clatot Florian , Lemonnier Jérôme , Marques Sandrine , Bidard François-Clement 
Published: March 2022

IntroductionThe combination of a CDK4/6 inhibitor with an aromatase inhibitor (AI) has recently become the gold standard for AI-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2−) advanced breast cancer. However, most patients receiving this combination will ultimately progress and require further therapies.Several studies have demonstrated that the onset of a ESR1 gene mutation lead to AIs resistance in the advanced setting. ESR1 mutations can be detected in circulating tumour DNA (ctDNA) using a digital PCR assay. Our study aims to prove the clinical efficacy of periodic monitoring for emerging or rise of ESR1 mutations in ctDNA to trigger an early change from AI plus palbociclib to fulvestrant plus palbociclib treatment while assessing global safety.MethodsPADA-1 is a randomised, open-label, multicentric, phase III trial conducted in patients receiving AI and palbociclib as first line therapy for metastatic ER +HER2- breast cancer. 1000 patients will be included and treated with palbociclib in combination with an AI. Patients will be screened for circulating blood ESR1 mutation detection at regular intervals. Patients for whom a rising circulating ESR1 mutation is detected without tumour progression (up to N=200) will be randomised (1:1) between (1) Arm A: no modification of therapy; and (2) Arm B: palbociclib in combination with fulvestrant, a selective ER down-regulator. At tumour progression, an optional crossover will be offered to patients randomised in arm A. The coprimary endpoints are (1) Grade ≥3 haematological toxicities and their associations with baseline characteristics and (2) progression-free survival in randomised patients.Ethics and disseminationThe study has been approved by the French medicines agency (ANSM) and by an ethics committee (ref 01/17_1 CPP Ouest-IV Nantes) in January 2017. The trial results will be published in academic conference presentations and international peer-reviewed journals.Trial registration numbersEudraCT: 2016-004360-18; NCT03079011.
Early impact of the COVID-19 pandemic on in-person outpatient care utilisation: a rapid review
Authors: Dupraz Julien , Le Pogam Marie-Annick , Peytremann-Bridevaux Isabelle 
Published: March 2022

ObjectivesTo quantitatively assess the early impact of the COVID-19 pandemic on in-person outpatient care utilisation worldwide, as well as across categories of services, types of care and medical specialties.DesignRapid review.MethodA search of MEDLINE and Embase was conducted to identify studies published from 1 January 2020 to 12 February 2021, which quantitatively reported the impact of the COVID-19 pandemic on the amount of outpatient care services delivered (in-person visits, diagnostic/screening procedures and treatments). There was no restriction on the type of medical care (emergency/primary/specialty care) or target population (adult/paediatric). All articles presenting primary data from studies reporting on outpatient care utilisation were included. Studies describing conditions requiring hospitalisation or limited to telehealth services were excluded.ResultsA total of 517 articles reporting 1011 outpatient care utilisation measures in 49 countries worldwide were eligible for inclusion. Of those, 93% focused on the first semester of 2020 (January to June). The reported results showed an almost universal decline in in-person outpatient care utilisation, with a 56% overall median relative decrease. Heterogeneity across countries was high, with median decreases ranging from 10% to 91%. Diagnostic and screening procedures (−63%), as well as in-person visits (−56%), were more affected than treatments (−36%). Emergency care showed a smaller relative decline (−49%) than primary (−60%) and specialty care (−58%).ConclusionsThe provision of in-person outpatient care services has been strongly impacted by the COVID-19 pandemic, but heterogeneously across countries. The long-term population health consequences of the disruption of outpatient care service delivery remain currently unknown and need to be studied.PROSPERO registration numberCRD42021237366.