Tag: statistics

Health Econ. 2021 Sep 25. doi: 10.1002/hec.4408. Online ahead of print.

ABSTRACT

Cost-effectiveness analyses (CEA) are recommended to include sensitivity analyses which make a range of contextually plausible assumptions about missing data. However, with longitudinal data on, for example, patients’ health-related quality of life (HRQoL), the missingness patterns can be complicated because data are often missing both at specific timepoints (interim missingness) and following loss to follow-up. Methods to handle these complex missing data patterns have not been developed for CEA, and must recognize that data may be missing not at random, while accommodating both the correlation between costs and health outcomes and the non-normal distribution of these endpoints. We develop flexible Bayesian longitudinal models that allow the impact of interim missingness and loss to follow-up to be disentangled. This modeling framework enables studies to undertake sensitivity analyses according to various contextually plausible missing data mechanisms, jointly model costs and outcomes using appropriate distributions, and recognize the correlation among these endpoints over time. We exemplify these models in the REFLUX study in which 52% of participants had HRQoL data missing for at least one timepoint over the 5-year follow-up period. We provide guidance for sensitivity analyses and accompanying code to help future studies handle these complex forms of missing data.

PMID:34562295 | DOI:10.1002/hec.4408

Nurs Inq. 2021 Sep 25:e12465. doi: 10.1111/nin.12465. Online ahead of print.

ABSTRACT

One challenge for those reading methodological debates in low consensus fields is determining the outcome when participants do not share standards. When parties to a debate do not agree on the standards to be used in assessing their arguments (i.e., quality), it may be useful to ask first if parties’ contributions meet their own expectations (i.e., integrity). Most protocols for review of qualitative research specify some form of quality assessment. These protocols normally require some test of internal coherence. Coherence is also relevant when describing the match between a rebuttal and the argument it answers. In 2019, Nursing Inquiry published a critique and rebuttal of the methods used by the Joanna Briggs Institute. In this essay, we attempted to use the Joanna Briggs Institute’s own quality assessment standards to assess their rebuttal of this fundamental critique. We found it possible to use the Joanna Briggs Institute’s own quality assessment standards to assess this rebuttal, and we found that JBI’s rebuttal did not meet their own standards.

PMID:34562297 | DOI:10.1111/nin.12465

Diabetes Ther. 2021 Sep 25. doi: 10.1007/s13300-021-01141-8. Online ahead of print.

ABSTRACT

INTRODUCTION: Once-weekly (OW) semaglutide was associated with clinically relevant improvements in glycaemic control and body weight versus comparators in the SUSTAIN randomised controlled trials (RCTs). SURE UK, which is one of a series of individual studies that comprise the SURE programme, evaluated the use of OW semaglutide in a real-world patient population with type 2 diabetes (T2D) in the UK.

METHODS: In this prospective, observational study, adults (≥ 18 years) with ≥ 1 documented glycated haemoglobin (HbA_1c) value ≤ 12 weeks before semaglutide initiation were enrolled. The primary endpoint was change in HbA_1c from baseline to end of study (EOS; ~ 30 weeks, although due to the COVID-19 pandemic, visits up to week 52 were permitted). Secondary endpoints included change in body weight, waist circumference and patient-reported outcomes (PROs). Physicians were to report all episodes of documented or severe hypoglycaemia, fatal events, serious adverse drug reactions, pregnancies and adverse events (AEs) in foetuses/newborn infants; other AEs during the study period could be reported on a voluntary basis.

RESULT: The estimated mean change in HbA_1c from baseline to EOS was – 16.3 mmol/mol [95% confidence interval (CI): – 18.22, – 14.37] (- 1.5%-points [95% CI – 1.67, – 1.31]; p < 0.0001) among the 171 enrolled patients who completed the study on treatment. Mean body weight change was – 5.8 kg (95% CI – 6.75, – 4.94; p < 0.0001). Sensitivity analyses showed similar results. Improvements were also observed in other secondary endpoints, including PROs. No new safety concerns were identified with semaglutide treatment.

CONCLUSION: Patients receiving OW semaglutide experienced statistically significant and clinically relevant reductions from baseline in HbA_1c and body weight. These results are in line with those of the SUSTAIN RCTs and support the use of OW semaglutide in routine clinical practice in adults with T2D in the UK.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03876015.

PMID:34562237 | DOI:10.1007/s13300-021-01141-8

Int J Cancer. 2021 Sep 25. doi: 10.1002/ijc.33823. Online ahead of print.

ABSTRACT

Treatment options for metastatic osteosarcomas are scarce. Following failure of standard first line therapy, patients who relapse present a challenging treatment dilemma, and have a poor prognosis. Surgical removal of all metastases is essential. A retrospective analysis of patients with metastatic osteosarcomas was conducted in 15 French Sarcoma Group centers. From January 2009 to December 2018, we identified 120 adult patients; 36 with synchronous and 84 with metachronous metastases with 74 males and 46 females. Mean age was 30 years (18-53). Metastatic sites were lung, bone and other in 91, 11 and 24 patients respectively. Mean time to first metachronous metastases was 22 months (4-97). All patients except 13 (10.8%) with metachronous metastases received a first line systemic treatment for relapse, and 39 patients (32.5%) were included in a clinical trial. Eighty-one patients (67.5%) had local treatment of distant metastases. Median progression free survival (PFS) and overall survival (OS) were 5.5 (95%CI 4.6-6.4) and 20.5 months (95%CI 13.2-27.7) respectively for the overall group. In multivariate analysis; > 5 metastases, time to 1^st metastases < 24 months, were statistically significant negative prognostic factors for OS and PFS (p= 0.002, ≤0.001 and p=0.006, ≤0.001 respectively). Surgery of metastases was associated with better prognosis on OS and PFS (p=0.001 and 0.037 respectively). The presence of bone metastases was a negative prognostic factor on OS but not on PFS (p=0.021). In reference sarcoma centers, relapsed osteosarcoma patients with > 1 metastasis commonly receive more than one line of systemic therapy, and are included in clinical trial if available. This article is protected by copyright. All rights reserved.

PMID:34562271 | DOI:10.1002/ijc.33823

Environ Sci Pollut Res Int. 2021 Sep 25. doi: 10.1007/s11356-021-16512-8. Online ahead of print.

ABSTRACT

Although West African nations are flourishing economically of late, they still have environmental issues due to the high rate of emissions in the bloc. Despite the worsening environmental condition, there have been limited studies on the causal agents of this situation in the region. Therefore, drawing strength from the United Nations’ Sustainable Development Goals (SDGs) and their targeted impacts of 2030, this study explored the nexus between financial development and environmental sustainability in West Africa (WA) for the period 1990 to 2016. The cross-sectional autoregressive distributed lag (CS-ARDL) estimator alongside the cross-sectionally augmented distributed lag (CS-DL) and the cross-sectional augmented error correction (CAEC) estimators were engaged to examine the elastic effects of the explanatory variables on the explained variable and from the results, financial development was harmful to environmental sustainability in WA through high carbon emissions. Also, control variables foreign direct investments, energy consumption, industrialization, and population growth were detrimental to the sustainability of the environment. On the causal connections amid the series, a unidirectional causality from financial development and population growth to carbon emissions was uncovered. Also, feedback causalities between foreign direct investments and carbon emissions, between energy consumption and the effluents of carbon, and between industrialization and environmental pollution were unraveled. Based on the findings, the study recommended among others that the countries should integrate environmental welfare objectives into their financial development policies. Also, the nations should ensure that their citizens have access to energy that is affordable, reliable, sustainable, and modern (SDG 7). Finally, improvement in energy efficiency, sustainable infrastructure, and good use of resources (SDG 12) should be promoted by the nations. The above recommendations if seriously taken into consideration will help the region to combat climate change and its impacts, which is the focus of SDG 13. The main flaw of this exploration was the lack of data for some specific time periods. Therefore, in future when such data become available, similar investigations could be carried out to confirm the robustness of the study’s results.

PMID:34562217 | DOI:10.1007/s11356-021-16512-8

Eat Weight Disord. 2021 Sep 25. doi: 10.1007/s40519-021-01302-5. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the association between migraine and signs and symptoms of eating disorders among teenagers. And as secondary objectives: to investigate the prevalence of eating disorders signs and symptoms and to identify the prevalence of migraine among teenagers.

METHODS: Cross-sectional study was carried out in public schools which included adolescents aged 11-18 years, of both sexes. For eating disorders evaluation two self-reported questionnaires were used: Eating Attitudes Test-26 (EAT-26) and The Bulimic Investigatory Test of Edinburg (BITE). The presence and characterization of headache were verified following the International Classification of Headache Disorders (ICHD-II).

RESULTS: 607 adolescents (388 females) with mean age of 13.9 years (95% CI: 13.7; 14) were included. The eating disorders symptoms based on EAT-26 (p = 0.041) and the bulimia nervosa symptoms (p = 0.014) evaluation were more prevalent among teenagers with migraine compared with non-migraine. Also, in multivariate analysis, the adjusted odds ratio (OR) to present bulimia nervosa symptoms is 1.85 times higher among females than males. And, the adjusted OR to present bulimia nervosa symptoms among teenagers with migraine is 1.51 times (OR) higher than among non-migraine.

CONCLUSIONS: The presence of migraine symptoms were associated with a higher likelihood to present eating disorders symptoms among teenagers, especially in females, that was associated with a 1.85-fold increase in the risk to present bulimia nervosa symptoms.

LEVEL OF EVIDENCE: III, Evidence obtained from cross-sectional study.

PMID:34562226 | DOI:10.1007/s40519-021-01302-5

Ir J Med Sci. 2021 Sep 25. doi: 10.1007/s11845-021-02790-1. Online ahead of print.

ABSTRACT

INTRODUCTION: Epistaxis represents a massive burden upon NHS resources. Despite being an extremely common reason for emergency ENT admissions, there remains significant variation in its management. Although the evidence base is continually growing, there appears to be a lack of guidance towards managing anti-coagulants and anti-platelet medications and identifying patient-specific outcomes in this setting. Epistaxis has long been associated with a multitude of risk factors but none have shown consistent, direct correlation.

MATERIALS AND METHODS: We aimed to identify if the use of anti-thrombotic medication was associated with a longer length of hospital admission or conferred a higher requirement for nasal packing, re-packing, surgery or re-admission. We conducted a retrospective analysis of 100 consecutive adult patients admitted over a 6-month period. Statistical analysis was conducted using SPSS software.

RESULTS: Sixty-five percent of patients were taking anti-thrombotic medication. The variability of admission INR values in those taking warfarin did not relate with any outcome measure. There was no statistical difference between patients taking anti-thrombotic medication and those who do not, with regards to our primary outcome measures. Re-admission rates within 28 days were found to be 13%, with anti-thrombotic medication use and pre-existing cardiovascular disease recognised as commonly encountered risk factors. Three percent of patients required surgical intervention. Eight percent of patients required re-packing, with a Rapid Rhino chosen in all instances.

CONCLUSION: The use of anti-thrombotic medication is not associated with increased morbidity or increased rate of complications. Anti-thrombotic usage and more than one medical co-morbidity increase the risk of re-admission within 28 days.

PMID:34562192 | DOI:10.1007/s11845-021-02790-1

Biol Trace Elem Res. 2021 Sep 25. doi: 10.1007/s12011-021-02928-3. Online ahead of print.

ABSTRACT

Few researches have been conducted on elements in whole blood of young people. Our study was to investigate the influence of age, gender and season on the contents of magnesium (Mg), calcium (Ca), iron (Fe), copper (Cu), zinc (Zn), manganese (Mn), selenium (Se), and strontium (Sr) as well as to establish reference intervals (RIs). We conducted a retrospective study of 589 apparently healthy children and adolescents. Quantitative analysis had been carried out using inductively coupled plasma-mass spectrometry (ICP-MS). Test results were analyzed using and MannWhitney U test, Spearman and Pearson statistical analyses. RIs were defined by using 95% confidence interval. Differences between contents of Mg, Fe, Cu, and Zn in girls’ and boys’ whole blood were found. Positive correlations for Fe, Zn, Se, and Sr, while negative for Ca and Cu were found with age. Increasing trends were found for Fe, Zn, and Se, while for Ca and Cu, changes were even decreasing for children and teenagers. The most frequently correlating element pairs were FeZn, MgSe, and FeSe in five successive age groups. Lower contents of Mg, Ca, Fe, Zn, and Se were found in summer. Finally, the reference interval of each element was initially established according to age and gender grouping. The contents of elements in whole blood vary depending mainly on the gender and age of children and adolescents. The reference intervals of elements in whole blood grouped by age and gender provide a reference basis for clinical diagnosis and treatment of element-related diseases.

PMID:34562194 | DOI:10.1007/s12011-021-02928-3

Virchows Arch. 2021 Sep 25. doi: 10.1007/s00428-021-03210-6. Online ahead of print.

ABSTRACT

Glutaminase 1 (GLS) is a therapeutic target for breast cancer; although GLS inhibitors have been developed, only a few subjects responded well to the therapy. Considering that the expression of histone H3 lysine 27 trimethylation (H3K27me3) and menopausal status was closely linked to GLS, we examined the effects of H3K27me3 and menopausal status on GLS to breast cancer prognosis. Data for 962 women diagnosed with primary invasive breast cancer were analyzed. H3K27me3 and GLS expression in tumors were evaluated with tissue microarrays by immunohistochemistry. Hazard ratios (HRs) and their 95% confidence intervals (CIs) for overall survival and progression-free survival were estimated using Cox regression models. Statistical interaction was assessed on multiplicative scale. There was a beneficial prognostic effect of GLS expression on overall survival for those with low H3K27me3 level (HR = 0.50, 95% CI: 0.20-1.28) but an adverse prognostic effect for those with high H3K27me3 level (HR = 3.90, 95% CI: 1.29-11.78) among premenopausal women, and the statistical interaction was significant (P_interaction = 0.003). Similar pattern was further observed for progression-free survival (HR = 0.44, 95% CI: 0.20-0.95 for low H3K27me3 level, HR = 1.35, 95% CI: 0.74-2.48 for high H3K27me3 level, P_interaction = 0.024). The statistical interaction did not occur among postmenopausal women. Our study showed that the prognostic effects of GLS on breast cancer correlated to the expression level of H3K27me3 and menopausal status, which would help optimize the medication strategies of GLS inhibitors.

PMID:34562173 | DOI:10.1007/s00428-021-03210-6

J Gastroenterol. 2021 Sep 25. doi: 10.1007/s00535-021-01831-x. Online ahead of print.

ABSTRACT

BACKGROUND: Standard risk assessment algorithms for gastrointestinal stromal tumor (GIST) are based on anatomic and histopathological variables with arbitrarily defined subcategories. Our goal was to improve risk assessment for GIST through retrospective analysis of patient data.

METHODS: The National Cancer Database (NCDB) was queried for patients with GIST; the final cohort consisted of 19,030 cases. Main outcomes were metastasis at presentation and overall survival. A test dataset was used to reevaluate risk stratification parameters in multivariate regression models. A novel risk assessment system was applied to the validation dataset and compared to other currently used risk assessment schemes.

RESULTS: Analysis of observed prevalence of metastases at presentation suggested 7 cm and mitotic rates > 10 per 5 mm² as optimal threshold values. A proposed risk stratification score showed statistical superiority compared to the National Comprehensive Cancer Network, American Joint Committee on Cancer, and modified National Institute of Health classifications in predicting probability of presentation with metastasis at diagnosis and 4-year overall survival after accounting for important covariables including patient age and comorbidities, year of diagnosis, and surgical/systemic therapeutic regimen.

CONCLUSIONS: Reexamination of prognostic factors for GIST demonstrated that current threshold values for tumor size and mitotic rate are suboptimal. A risk stratification score based on revised categorization of these factors outperformed currently used risk assessment algorithms.

PMID:34562180 | DOI:10.1007/s00535-021-01831-x