Registry Data Research Articles

Evaluating short-term survivors of glioblastoma: A proposal based on SEER registry data

Abstract Background Glioblastomas (GBMs) are central nervous system tumors with a poor prognosis and limited treatment options. Although small subsets of GBM patients survive longer than 3 years, there is little evidence regarding the prognostic factors of GBM. Therefore, we conducted a thorough characterization of GBM in the United States. Methods We queried the Surveillance, Epidemiology and End Results database between 2000 and 2021 to extract age-adjusted incidence rates (AAIR), age-adjusted mortality rates (AAMR), and survival data for GBM. We compared trends in AAIR, AAMR, and survival time across age groups 0–14, 15–39, 40–69, and 70+ years. Also, we employed the Fine-Gray competing risk model among short-term survivors (STSs), defined as those with a survival time of 6 months or less, and long-term survivors (LTSs), defined as those with a survival time of 3 years or more. Results This study included 60,615 incident GBM cases, 54,998 GBM-specific deaths, and 47,207 GBM patients with available survival time between 2000 and 2021. The mortality-to-incidence ratio was constant among STSs, whereas it increased with age among LTSs. Higher age and male sex were significantly associated with GBM-specific death among LTSs, whereas non-Hispanic White and less intensive treatments were associated with GBM-specific deaths among STSs. Interestingly, higher age was significantly associated with other causes of death among STSs. Conclusions STSs partially consist of populations who died from causes other than GBM. It is important to include only GBM-specific deaths in STS groups to conduct reproducible research comparing STSs and LTSs.

Evaluation of the Implementation of the Smoking Cessation Clinic at Padang Karambia Health Center, Payakumbuh City

The smoking cessation clinic was inaugurated in 2012 at the Puskesmas Padang. Based on clinical register data, the number of patients from 2016 to 2018 continues to decline. This study aims to determine the implementation of the smoking cessation clinic at the Padang Karambia Health Center, Payakumbuh City in 2021. This type of research uses qualitative research which was conducted from February to March 2021 in the Padang Karambia Health Center Work Area. The samples taken were 11 people as informants with purposive sampling technique. Data collection was carried out by in-depth interviews, FGDs, review of documents and observations. The data is processed through data reduction, data presentation, and drawing conclusions, after which triangulation is carried out. The results showed that from the point of view of smoking cessation clinics have staff as officers but have other duties, there is no financial support for the program and no special rooms, the Standard Operating Procedure (SOP) already exists but has not been evaluated and revised. In terms of the process, the socialization was not optimal, there was identification of kilien, counseling and therapy 3 times a week, the follow-up was not going well. There is no measurable activity achievement target and patient visits are still very low. In 2020 there were no patient visits due to the Covid-19 Pandemic, while in 2019 the number has decreased from the previous year. This is due to the lack of socialization / promotion activities due to the absence of a supporting budget, as well as a lack of motivation for smokers to visit. For this reason, the Puskesmas Padang Karambia should allocate funds to support smoking cessation clinical activities so as to increase socialization / promotion. Keywords : Evaluation, Implementation, Smoking Cessation Clinic

A cross-sectional survey on health care professionals' approaches, challenges, and support needs when addressing life threat with recipients of an allogeneic hematopoietic stem cell transplantation and with their relatives.

Patients treated with an allogeneic hematopoietic stem cell transplantation (allo-SCT) face a significant mortality risk, which might trigger existential distress. We aimed to investigate how hematology health care professionals (HCPs) address life-threatening conditions with allo-SCT recipients and their relatives, and what are challenging and supportive aspects. We conducted a multicenter cross-sectional survey, assessing: (1) HCPs' approaches to address life threat, using a self-developed questionnaire with 19 items categorized in four dimensions (proactive, cautious, reactive, avoiding), (2) challenges/support needs, using self-developed multiple-choice questions, and (3) personal attitudes towards death (Death Acceptance subscale of the Life Attitude Profile-Revised; Death Attitude Profile-Revised). Statistics included association, regression and exploratory factor analysis. We included 104 participants (52 physicians, 45 nurses, 7 psycho-oncologists) from the settings of SCT, general hematology and intensive care. Physicians predominantly addressed life threat proactively, while nurses tended to raise the topic when prompted by patients or a clinical worsening. Overall, 10% of HCPs stated to avoid the topic, even in case of a high risk of death. HCPs' approaches correlated weakly with their attitudes towards death. A main challenge was to talk with patients/relatives repressing the risk of death (72%). More time resources for these conversations (71%), and mentoring by palliative-care specialists (67%) or psycho-oncologists (65%) were the most frequent support needs. This comprehensive survey reveals strong differences between professions in addressing life threat, and possible influence from personal death attitudes. Further confirmatory research in larger samples is needed to tailor communication trainings on life threat in multi-professional teams. Registration:German Clinical Trials Register, DRKS00027290, date of registration: 2022-01-10.

Comparison of the effects of lidocaine and articaine used for buccal infiltration and supplemental palatinal infiltration anesthesia in maxillary molars with irreversible pulpitis: a prospective randomized study

ObjectivesThe aim of the study was to compare the efficiency of buccal infiltration versus combination of buccal and palatal infiltration to anesthetize maxillary molars with symptomaticirreversible pulpitis, wither lidocaine or articaine are used.Material-methodsThis randomized clinical study was conducted on 80 patients with symptomatic irreversible pulpitis of the maxillary first and second molars. Eighty patients were divided into 4 groups (n = 20). (1) group buccal infiltration with 1.2 ml 4% articaine containing 1:100,000 epinephrine, (2) group buccal infiltration with 1.2 ml 2% lidocaine containing 80,000 epinephrine, (3) group buccal infiltration with 1.2 ml 4% articaine containing 1:100,000 epinephrine and palatinal infiltration with 0.5 ml 4% articaine containing 1:100,000 epinephrine, 4.group buccal infiltration with 1.2 ml 2% lidocaine containing 80.000 epinephrine and palatinal infiltration with 0.5 ml lidocaine containing 80.000 epinephrine. The pain intensity was measured by the Heft-Parker visual analog scale (VAS) before injection, during access cavity preparation and access palatal canal. The data were analyzed by the chi-square and The Kruskal–Wallis tests.ResultsWithin the results of the study, no statistically significant difference was found between 4% articaine containing 1:100,000 epinephrine and 2% lidocaine containing 1:80,000 epinephrine in terms of anesthesia effectiveness (p > 0.05). When palatal infiltration anesthesia was applied in addition to buccal infiltration, the pain during entry into the palatal canals was significantly reduced compared to buccal infiltration anesthesia alone (p < 0.05).ConclusionsAccording to the results of this study, it may be recommended to use palatal infiltration anesthesia in addition to buccal infiltration anesthesia, independent of the anesthetic solution, for an effective pulpal anesthesia in maxillary molars with irreversible pulpitis.Clinical trial registrationRegistration number is “NCT06342869” and date of registration is 2024-04-02.Retrospectively registered.

Exploring expressed concerns and uncanny feeling in patients with shortness of breath calling out-of-hours primary care

BackgroundPatients contacting out-of-hours primary care (OHS-PC) with shortness of breath (SOB) are often concerned. Sometimes, they also have an uncanny feeling; existential anxiety that something is wrong in their body. How concerns and uncanny feeling are related to critical medical conditions that cause SOB is unknown.We therefore explored the relation between expressed concerns and researcher’s judged uncanny feeling among patients who contact OHS-PC for SOB with potential life-threatening events (LTEs) as the outcome.MethodsThis is an explorative cross-sectional study. We analysed telephone triage conversations from patients with SOB who contacted Dutch OHS-PC between September 2020 and August 2021. We recorded whether patients expressed concerns and we judged whether patients had an uncanny feeling. We calculated odds ratios (ORs) for the association between (i) expressed concerns and (ii) uncanny feeling with the outcome potential LTEs.ResultsOf the 1,843 patients with SOB, 43.6% patients expressed concerns and 33.0% had an uncanny feeling. Potential LTEs were similarly present among those who did and did not express concerns (OR: 1.07; 95% CI 0.84–1.37, mOR: 1.07; 95% CI 0.83–1.36), whereas potential LTEs were more often present among those with an uncanny feeling compared to those without such feeling (OR: 1.36; 95% CI 1.06–1.75, mOR: 1.35; 95% CI 1.05–1.74).ConclusionsAmong patients who contacted OHS-PC with SOB, a perceived uncanny feeling of the patient was associated with a higher odd of potential LTEs, while patient’s expressed concerns were not. Critical reflective interpretation is needed as uncanny feelings are difficult to judge. Nevertheless, our results implicate that further research into uncanny feelings in telephone triage could further improve the understanding of the relation with potential LTEs. Furthermore, this could be used to investigate how triage nurses may become more sensitive to what the patient is feeling but not explicitly saying such as by paying special attention to paralanguage.Trial registrationThe Netherlands Trial Register, number: NL9682, registration date: 20–08-2021.

Life expectancy losses in the Gaza Strip during the period October, 2023, to September, 2024.

In the context of the ongoing war in the Gaza Strip, the Gaza Health Ministry (GHM) has reported 45 936 fatalities and more than 10 000 individuals missing or under the rubble for the period Oct 7, 2023, to Jan 8, 2025. The scope of this death count is difficult to fully interpret because it does not account for the size and age distribution of the Gaza Strip population. Moreover, the quality of this death count has been questioned. In this study, we evaluated the quality of the GHM death count by comparing GHM data against register data, and we estimated life expectancy losses in the Gaza Strip for the period October, 2023, to September, 2024, ie, the first 12 months of the war. We matched individuals included in the GHM nominative list of killed individuals for the period Oct 7, 2023, to Aug 30, 2024, with individuals included in the refugee register maintained by the UN Relief and Works Agency for Palestine Refugees in the Near East (UNRWA), which covers about 66% of the Gaza Strip population. We compared proportions of matched fatalities with proportions of registered refugees in the 2017 census. We then used census data, vital registration data, and GHM fatality information since Oct 7, 2023, to produce estimates of life expectancy losses in the Gaza Strip for the first 12 months of the war. We used three scenarios for these life expectancy estimates, based on the different types of counts provided by GHM. These scenarios did not account for the indirect effect of the war. 21 953 (63·9%) of 34 344 individuals in the GHM list of killed individuals (and 19 744 [64·4%] of 30 673 excluding those who were not yet born at the time of the 2017 census) were matched with individuals included in the UNRWA refugee register. This proportion is similar to the proportion of registered refugees in the 2017 census (65·7%), providing additional evidence regarding the reliability of the GHM data. In the central variant, life expectancy in the Gaza Strip decreased by 34·9 years during the first 12 months of the war, about half (-46·3%) the prewar level of 75·5 years. Life expectancy losses were larger for males (-38·0 years [-51·6%]) than for females, but nonetheless, females also suffered large losses (-29·9 years [-38·6%]). Losses between the low and high variants ranged between -31·1 years (-41·1%) and -39·4 years (-52·2%) for both sexes combined. Our approach to estimating life expectancy losses in this study is conservative as it ignores the indirect effect of the war on mortality. Even ignoring this indirect effect, results show that the ongoing war in the Gaza Strip generated a life expectancy loss of more than 30 years during the first 12 months of the war, nearly halving prewar levels. Actual losses are likely to be higher. None.

Dural arteriovenous fistula research and management in China (DREAM-INI): initial characterization and patient cohort outcomes

BackgroundIntracranial dural arteriovenous fistulas (DAVFs) are rare lesions, making it challenging to fully understand and improve their management. Globally, only two major large-scale studies have focused on DAVFs. This report...

Success and safety of neonatal endotracheal tube exchanges: a NEAR4NEOS multicentre retrospective cohort study

ObjectivesTo compare success and safety of endotracheal tube (ETT) exchanges with primary intubations and identify factors associated with ETT exchange outcomes.DesignRetrospective observational study of prospectively collected National Emergency Airway Registry...

Antibiotics in decompensated liver disease - who, when and for how long?

Bacterial infections are a leading cause of hospitalization and mortality in patients with decompensated cirrhosis. Antibiotic prophylaxis in cirrhotic patients has demonstrated significant short-term reductions in bacterial infections in randomized controlled trials, but at the cost of drug resistance and with uncertain survival benefits. This review examines antibiotic use in cirrhosis, focusing on patient most likely to benefit from antibiotic prophylaxis, management strategies for infections through risk-based antibiotic selection and timely treatment initiation, challenges posed by the emergence of multidrug-resistant organisms, and principles of antimicrobial stewardship. The efficacy of prophylaxis has decreased over time, and current registry data have questioned its use, emphasizing the need for better risk-based individualized strategies. When bacterial infections occur, the efficacy of antimicrobial therapies depends heavily on local epidemiological patterns and individual patient risk factors, necessitating tailored antibiotic selection based on regional resistance data and specific clinical scenarios. Nosocomial infections, colonization with multidrug-resistant organisms, and prior exposure to systemic antibiotics are key risk factors that should guide empirical therapy selection. Until evidence-based algorithms are available, clinicians should continue to adopt individualized approaches, guided by available evidence, local specificities, and antimicrobial stewardship principles to optimize patient outcomes.

Gender gaps in contributions to tax-incentivised pension investment. Early experiences from post-transition Estonia

ABSTRACT This paper studies the gender gaps in voluntary pension investment during the build-up phase of the tax-subsidised scheme. The analysis uses register data for 2014 for the full population aged 20 to 55 in Estonia The analysis considers both the extensive and intensive margins of the annual contribution to voluntary pension investment. Around 2.51% of all men, but only 2.35% of all women contributed a positive amount, which implies a raw gender gap in the probability of contributing of 6.5%. Among those contributing, the gender gap in the amount contributed is 25.6% in the mean, and 11.1% in the median. Regression analysis and Oaxaca-Blinder decomposition reveal that the gender gaps in voluntary pension investment cannot be attributed to differences in the various observable characteristics, but likely reflect different choices or preferences of men and women.

Prediction of imminent osteoporotic fracture risk in Danish postmenopausal women—can the addition of self-reported clinical risk factors improve the prediction of the register-based FREM algorithm?

SummaryObtaining accurate self-reports on clinical risk factors, such as parental hip fracture or alcohol and tobacco use, limits the utility of conventional risk scores for fracture risk. We demonstrate that fracture-risk prediction based on administrative health data alone performs equally to prediction based on self-reported clinical risk factors.BackgroundAccurate assessment of fracture risk is crucial. Unlike established risk prediction tools that rely on patient recall, the Fracture Risk Evaluation Model (FREM) utilises register data to estimate the risk of major osteoporotic fracture (MOF). We investigated whether adding self-reported clinical risk factors for osteoporosis to the FREM algorithm improved the prediction of 1-year fracture risk by comparing three approaches: the FREM algorithm (FREMorig), clinical risk factors (CRFonly), and FREM combined with clinical risk factors (FREM-CRF).MethodClinical risk factor information was obtained through questionnaires sent to women aged 65–80 years living in the Region of Southern Denmark in 2010, who participated in the Risk-stratified Osteoporosis Strategy Evaluation study. Register data was obtained through national health registers and linked to the survey data. Positive and negative predictive values and concordance statistics were calculated for the performance of each approach using logistic regression and Cox proportional hazards models.ResultsOf the 18,605 women included, 280 sustained a MOF within 1 year. All three approaches performed similarly in 1-year fracture risk prediction for low- and high-risk individuals. However, the FREMorig and FREM-CRF approach slightly overestimated fracture risk for medium-risk individuals.ConclusionAdding self-reported clinical data to FREM did not increase precision in predicting 1-year MOF risk. The discrimination of FREMorig was similar to that of CRFonly, suggesting it may be possible to estimate fracture risk with the same precision by using register data instead of self-reported risk information. Register-based prediction models may be applicable in individualised risk monitoring or large-scale osteoporosis screening programmes.

Path model explaining the association between fear of falling and health-related quality of life in (pre-)frail older adults

BackgroundFear of falling (FoF) is estimated to be prevalent in over 50% of older adults and several studies suggest that it negatively affects health-related quality of life (HrQoL). Unlike previous studies that examined only few mediating variables, this study aimed to develop a more comprehensive path model explaining the association between FoF and HrQoL.MethodsA theoretical path model was developed based on existing evidence and expert feedback and fitted to cross-sectional baseline data on 385 community-dwelling (pre-)frail older adults from the PromeTheus randomized controlled trial using robust weighted least squares estimation. FoF and HrQoL were operationalized by the Short Falls Efficacy Scale International and EQ-5D Index, respectively. The model included potential explanatory pathways through physical activity (German Physical Activity Questionnaire for middle-aged and older adults), physical capacity (Short Physical Performance Battery), physical performance (Late-Life Function and Disability Instrument [LLFDI] function component), disability (LLFDI disability component – short form), and affect (visual analogue scales on ‘happiness’, ‘sadness’, ‘calmness’ and ‘tension’). Age, sex, education, and previous falls were considered as covariates.ResultsThe model demonstrated good fit to the data and the remaining direct effect of FoF on HrQoL was small (β=-0.05). Physical capacity and physical performance were the most important mediators (combined indirect effect of β=-0.17, accounting for > 50% of the total effect). Pathways of minor individual relevance (e.g. through disability or affect) contributed considerably to the total indirect effect when combined. Controlling for sociodemographic data and previous falls only had minor effects on model fit and path coefficients.ConclusionPhysical capacity and physical performance are particularly important levers for reducing the impact of FoF on HrQoL through interventions. However, the other pathways also had a considerable influence when taken together. Hence, research on the association of FoF and HrQol should acknowledge the complexity of causal pathways that may explain this association and not neglect minor pathways. The proposed model should be tested on an alternative sample, using longitudinal data, and extended to include additional explanatory factors (e.g. activity avoidance).Trial registrationGerman Clinical Trials Register, ID: DRKS00024638, https://drks.de/search/en/trial/DRKS00024638, date of registration: March 11th 2021.

HMGB-1 as a predictor of major bleeding requiring activation of a massive transfusion protocol in severe trauma

Massive bleeding causes approximately 50% of deaths in patients with major trauma. Most patients die within 6 h of injury, which is preventable in at least 10% of cases. For these patients, early activation of the massive transfusion protocol (MTP) is a critical survival factor. With severe trauma, high-mobility group box 1 (HMGB-1, i.e., amphoterin) is released into the blood, and its levels correlate with the development of a systemic inflammatory response, traumatic coagulopathy, and fibrinolysis. Previous work has shown that higher levels of HMGB-1 are associated with a higher use of red blood cell transfusions. We conducted a retrospective analysis of previous prospective single-center study to assess the value of admission HMGB-1 levels in predicting activation of MTP in the emergency department. From July 11, 2019, to April 23, 2022, a total of 104 consecutive adult patients with severe trauma (injury severity score > 16) were enrolled. A blood sample was taken at admission, and HMGB-1 was measured. MTP activation in the emergency department was recorded in the study documentation. The total amount of blood products and fibrinogen administered to patients within 6 h of admission was monitored. Among those patients with massive bleeding requiring MTP activation, we found significantly higher levels of HMGB-1 compared to patients without MTP activation (median [interquartile range]: 84.3 µg/L [34.2–145.9] vs. 21.1 µg/L [15.7–30.4]; p < 0.001). HMGB-1 level showed good performance in predicting MTP activation, with an area under the receiver operating characteristic curve of 0.84 (95% CI 0.75–0.93) and a cut-off value of 30.55 µg/L. HMGB-1 levels correlated significantly with the number of red blood cell units (rs [95% CI] 0.46 [0.28–0.61]; p < 0.001), units of fresh frozen plasma (rs 0.46 [0.27–0.61]; p < 0.001), platelets (rs 0.48 [0.30–0.62]; p < 0.001), and fibrinogen (rs 0.48 [0.32–0.62]; p < 0.001) administered in the first 6 h after hospital admission. Admission HMGB-1 levels reliably predict severe bleeding requiring MTP activation in the emergency department and correlate with the amount of blood products and fibrinogen administered during the first 6 h of hemorrhagic shock resuscitation.Trial registration: NCT03986736. Registration date: June 4, 2019.

An analysis of controlled human infection studies registered on ClinicalTrials.gov

ObjectivesControlled human infection studies (CHIS) involve intentional exposure of human volunteers to infectious agents. A previous systematic review found that adverse event (AE) reporting across CHIS is inconsistent, which makes...

The association between coding for chronic kidney disease and kidney replacement therapy incidence at CCG-level in England: an ecological study.

With ageing of the population both prevalence of chronic kidney disease (CKD) and incidence of kidney replacement therapy (KRT) are rising. Existing research suggests that Read-coding for CKD in those affected is associated with better implementation of recommended care and fewer hospitalisations for heart failure. To investigate whether coding for CKD is associated with regional KRT incidence in England. This is an ecological study using the clinical commissioning groups (CCG) in England as geographical units. KRT incidence rates were calculated using UK Renal Registry (UKRR) data from 01/2019 to 12/2021. Data on the percentage of uncoded CKD patients (PUCP) who had laboratory evidence of CKD but lacked a diagnostic code were obtained from the CVDPREVENT Audit, a national audit that extracts routinely held general practitioner data. Data on confounders and acute kidney injury (AKI) mortality as a marker for population frailty were obtained from CVDPREVENT and the UKRR, respectively. Poisson models assessed the association between PUCP and KRT incidence. After adjusting, the PUCP was non-linearly associated with KRT incidence, with the CCGs in the lowest PUCP quintile having a lower KRT incidence than the others. There was evidence that this association was more pronounced in CCGs with high AKI mortality compared to CCGs with low AKI mortality. At the geographical level in England, the data suggests that the prevalence of not having formally diagnosed CKD is non-linearly associated with a higher KRT incidence rate, especially in areas with a high AKI mortality.

Identifying proximal humerus fractures: an algorithmic approach using registers and radiological visit data.

The aim of this study was to investigate how reliably proximal humerus fractures can be identified from different administrative datasets without manual review. Using the national medical registers, namely the Care Register for Health Careand the Register for Primary Health Care Visits, as well as the regionalradiological image archive PACS, we developed algorithms for automated identification of proximal humerus fractures. In addition to these sources, we used data from patient records as well as from the self-reports gathered by the Kuopio Osteoporosis Risk Factor and Prevention Study (OSTPRE) to establish a gold standard of fractures for validating the algorithms. This gold standard included proximal humerus fractures for a cohort of 11,863 post-menopausal women living in the Kuopio region between 2004 and 2022. We report the national registers' yearly accuracy in identifying proximal humerus fractures. During the studied 19-year period, the registers' coverage initially improved but then settled at 75%. We show that the image archive provides almost complete coverage of radiographs for the fracture cases, but excluding false positives poses a challenge. In addition, we propose a simple approach that combines register and radiography visit data to improve the accuracy of automated fracture identification. Our algorithm improves the coverage from 74 to 81% and reduces the false discovery rate from 8 to 7% compared to the traditional register analysis. The proposed approach enables a more reliable way of identifying proximal humerus fractures from administrative data. This study contributes to the objective of automatically tracking all types of fragility fractures in large datasets.

Effects of 12-month physical and cognitive training on sarcopenia determinants in older adults: a subgroup analysis of a randomised clinical trial

BackgroundLow physical activity is a major risk for sarcopenia. Whether training according to physical activity guidelines accompanied with cognitive training is effective on sarcopenia, remains unclear.AimsWe investigated whether the effects of 12-month physical and cognitive training (PTCT) and physical training (PT) on grip and knee extension strength, muscle mass, and walking speed differed between older adults with and without sarcopenia.MethodsCommunity-dwelling older adults (N = 314, mean age 74.5 ± 3.8 years, 60% women) who did not meet physical activity guidelines were randomized to PTCT and PT groups. PT for both groups included supervised and home-based multicomponent physical training. Cognitive training (CT) included computer-based exercises for executive functioning. Sarcopenia was determined according to the European Working Group on Sarcopenia in Older People 2019 criteria. Generalized estimation equation analysis were conducted.ResultsCompared to PT, PTCT had no additive effect on strength, muscle mass, or walking speed in participants with or without sarcopenia. In pooled data (PT + PTCT) change in the grip strength was greater in sarcopenia (n = 49) group compared to non-sarcopenia (n = 264) group (interaction, p =.014). Both groups improved knee extension strength, and walking speed, but no statistically significant difference between the groups were observed. Muscle mass did not change in either group.ConclusionPhysical training according to physical activity recommendations improves muscle strength, walking speed, and maintains muscle mass in sarcopenia. Additional cognitive training had no benefits on these outcomes.Trial registration numberISRCTN52388040 and date of registration 20/1/2017.

Association of alcohol abstinence with risk of hyperuricemia in rural Chinese adults: the Henan Rural Cohort Study

BackgroundAlcohol drinking can cause hyperuricemia (HUA), but few studies have explored alcohol abstinence’s health effects, particularly the abstinence duration on HUA. This study aimed to evaluate the associations of abstinence with HUA in rural Chinese adults.MethodsThis was a cross-sectional study of 38,855 participants (15,371 males and 23,484 females) using the baseline data (2015–2017) from the Henan Rural Cohort Study. A questionnaire survey collected information on alcohol consumption patterns. Multivariate logistic regression analyses were used to evaluate the associations of type of alcoholic beverages, abstinence status and abstinence duration with HUA, respectively. Restricted cubic spline models were applied to visualize the dose-response trend of HUA risk with increasing abstinence duration.Results3,978 cases of 38,855 participants were identified with HUA. Total alcohol intake, including beer, liquor and rice wine intake was significantly associated with the increased risk of HUA, especially for male participants. Compared with current drinkers, former drinkers and non-drinkers presented lower ORs (95%CIs) of 0.686 (0.676, 0.844) and 0.718 (0.649, 0.793) for HUA. Furthermore, the aORs (95%CIs) for those former drinkers with < 5, 6–10 and ≥ 11 years abstinence duration were 0.868 (0.693, 1.086), 0.753 (0.519, 1.092) and 0.717 (0.517, 0.990), respectively. In addition, the risk of HUA decreased with the increasing years of abstinence duration (P for trend < 0.050) and negative linear dose-response associations were observed.ConclusionFormer drinkers were associated with a reduced risk of HUA compared with current drinkers. Moreover, sustained alcohol abstinence could be beneficial for preventing HUA.Clinical Trial RegistrationThe Henan Rural Cohort Study was registered on the Chinese Clinical Trial Register (Registration number: ChiCTR-OOC-15006699). Date of registration: 2015-07-06 http://www.chictr.org.cn/showproj.aspx?proj=11375.

Comparative Effectiveness of First-Line Pembrolizumab vs. Chemotherapy in aNSCLC: A Norwegian Population-Based Cohort Study.

The KEYNOTE-0421,2 trial showed the benefit of treating patients with non-oncogene addicted advanced NSCLC with PD-L1 tumor proportion score over 50% with pembrolizumab as monotherapy over platinum-doublet chemotherapy. To contextualize these results, we undertake a detailed emulation of the inclusion criteria in KEYNOTE-042 using Norwegian health registry data and discuss both the clinical contexts, as well as the general utility of such registry data for pharmacoepidemiologic research in oncology. Within the population of patients with PD-L1 tumor proportion score over 50%, an observational analog of an intention-to-treat analysis showed similar results to those of the KEYNOTE-042 study.

RNA editing-based biomarker blood test for the diagnosis of bipolar disorder: protocol of the EDIT-B study

IntroductionMisdiagnosis of bipolar disorder (BD) can lead to ineffective treatment, increased risk of manic episodes, and increased severity. Objective diagnostic tests or precise tools to diagnose BD and distinguish it from major depressive disorder (MDD) in depressed patients are lacking.AimTo assess the external diagnostic validity of a blood-based test using an RNA epigenetic signature for the differential diagnosis of BD versus MDD in patients with depression.Methods and analysisMulticentre cross-sectional study including an adult sample of inpatients or outpatients diagnosed with BD or MDD, currently treated for a major depressive episode. A structured diagnostic interview based on validated scales will be conducted. Sociodemographic variables, clinical history, toxic consumption, current treatment and quality of life will be assessed. Blood samples will be obtained and stored at −80 °C until RNA sequencing analysis. The EDIT-B is a blood-based test that combines RNA editing biomarkers and individual data (e.g., age, sex, and tobacco consumption). The clinical validation performance of the EDIT-B will be evaluated using the area under the curve, sensitivity, specificity, positive and negative predictive values, and likelihood ratios.Ethics and disseminationThe principles of the Declaration of Helsinki 2013, precision psychiatry research and good clinical practice will be followed. The Research Ethics Committees of the participating centres approved the study. Participants will receive an information sheet and must sign the informed consent before the interview. Participants’ data will be pseudonymized at the research sites. Any publication will use fully anonymized data. Publications with the final study results will be disseminated in international peer-reviewed journals and presented at international conferences.Study registration: This study has been registered on clinicaltrials.gov (NCT05603819). Registration date: 28-10-2022.