Tag: statistics

Eur J Cancer. 2022 Mar 18;166:219-228. doi: 10.1016/j.ejca.2022.01.031. Online ahead of print.

ABSTRACT

AIM: The APHINITY trial showed that adding adjuvant pertuzumab (P) to trastuzumab and chemotherapy, compared with adding placebo (Pla), significantly improved invasive disease-free survival (IDFS) for patients with HER2+ early breast cancer both overall and for the node-positive (N+) cohort. We explored whether adding P could benefit some N- subpopulations and whether to consider de-escalation for some N+ subpopulations.

METHODS: Subpopulation Treatment Effect Pattern Plot (STEPP) is an exploratory, graphical method that plots estimates of treatment effect for overlapping patient subpopulations defined by a covariate of interest. We used STEPP to estimate Kaplan-Meier differences in 6-year IDFS percentages (P minus Pla: Δ ± standard error [SE]), both overall and by nodal status, for overlapping subpopulations defined by (1) a clinical composite risk score, (2) tumour infiltrating lymphocytes (TILs) percentage, and (3) human epidermal growth factor receptor 2 (HER2) FISH copy number. Because of multiplicity, a Δ of at least three SE is required to warrant attention.

RESULTS: The average absolute gains in 6-year IDFS percentages were 2.8 ± 0.9 overall; 4.5 ± 1.2 for N+ and 0.1 ± 1.1 for N-. Largest gains were for patients with intermediate clinical composite risk (5.3 ± 1.9 overall; 6.9 ± 2.3 N+; 4.0 ± 3.0 N-), highest TILs percentage (6.3 ± 1.7 overall; 7.4 ± 2.4 N+; 3.2 ± 1.7 N-), and intermediate HER2 copy number (2.8 ± 1.9 overall; 7.4 ± 2.5 N+; -1.3 ± 1.9 N-), but clear evidence indicating a pattern of differential subpopulation treatment effects was lacking.

CONCLUSIONS: STEPP plots for N- did not identify subpopulations clearly benefiting from adding P, and those for N+ did not identify subpopulations warranting de-escalation. TILs percentage appeared to be more predictive of P treatment effect than clinical composite risk score.

TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT01358877.

PMID:35313167 | DOI:10.1016/j.ejca.2022.01.031

Stud Hist Philos Sci. 2022 Mar 18;93:39-46. doi: 10.1016/j.shpsa.2021.12.012. Online ahead of print.

ABSTRACT

Two things about Gregor Mendel are common knowledge: first, that he was the “monk in the garden” whose experiments with peas in mid-nineteenth-century Moravia became the starting point for genetics; second, that, despite that exalted status, there is something fishy, maybe even fraudulent, about the data that Mendel reported. Although the notion that Mendel’s numbers were, in statistical terms, too good to be true was well understood almost immediately after the famous “rediscovery” of his work in 1900, the problem became widely discussed and agonized over only from the 1960s, for reasons having as much to do with Cold War geopolitics as with traditional concerns about the objectivity of science. Appreciating the historical origins of the problem as we have inherited it can be a helpful step in shifting the discussion in more productive directions, scientific as well as historiographic.

PMID:35313209 | DOI:10.1016/j.shpsa.2021.12.012

Value Health Reg Issues. 2022 Mar 18;31:1-9. doi: 10.1016/j.vhri.2022.02.002. Online ahead of print.

ABSTRACT

OBJECTIVES: Estimation of the lost productivity cost of premature deaths because of cancers can provide invaluable information for identifying the priorities and resource needs in the design of cancer control strategies. This study aimed to estimate the premature mortality costs because of cancers using GLOBOCAN estimates in Iran.

METHODS: In this study, we estimated the lost productivity cost of premature deaths because of cancers in Iran from 2012 and 2018, using the human capital approach with respect to the cancer site, sex, and age. Data on cancer mortality were extracted from the GLOBOCAN reports. In addition, economic information, such as annual income, employment rate, housekeeping rate, and gross domestic product, was extracted from the World Bank Data and the Statistical Center of Iran. A discount rate of 3% was applied and costs were reported in constant 2017 international dollars.

RESULTS: From 2012 and 2018, the lost productivity cost of premature deaths because of cancers increased by 18% in Iran ($2453 million in 2012 and $2887 million in 2018). In contrast, the number of deaths and the years of life lost because of cancers increased by approximately 8%. The mortality cost was approximately 35% and 56% higher in men than in women in 2012 and 2018, respectively. Stomach, colorectal, esophageal, and breast cancers accounted for > 40% of total cancer mortality costs in 2012. Stomach cancer, brain cancer, nervous system cancer, lung cancer, and leukemia were responsible for 57% of cancer mortality costs in 2018.

CONCLUSIONS: Based on the findings, the lost productivity costs of premature mortality because of cancers have increased significantly in Iran. Overall, evidence-based policy making for managing the costs of cancers and resource allocation depends on analyzing epidemiological and economic data in the health sector. This study presented helpful findings on cancer mortality costs to support evidence for decision making in healthcare systems.

PMID:35313156 | DOI:10.1016/j.vhri.2022.02.002

Eur J Obstet Gynecol Reprod Biol. 2022 Mar 11;272:144-149. doi: 10.1016/j.ejogrb.2022.03.021. Online ahead of print.

ABSTRACT

OBJECTIVE: Dyspareunia is a main symptom of urethral diverticulum in the female population, reported up to 60% of patients. Pain may cease after diverticulectomy as published in previous retrospective studies. To date scarce or no data exists on the postoperative outcome in terms of sexual function. The present study wants to quantify sexual function and evaluate lower urinary tract symptoms in sexually active patients after resection of urethral diverticulum.

STUDY DESIGN: In this prospective cohort trial at a tertiary referral center, we evaluated 40 female patients who presented with symptomatic urethral diverticulum and were sexually active. All of them underwent a standardized surgical procedure with inverted U-shape colpotomy between 2008 and 2018. The patients completed the Female Sexual Function Index (FSFI), which is determined by the mean score of the different domains, and underwent urodynamic assessment both at baseline examination before surgery and 12 months postoperatively. For statistical analysis, we conducted a paired Wilcoxon rank sum test analyzing the non-normally distributed non-parametric variables of the female sexual function index.

RESULTS: In two patients a malignancy was found in postoperative histology and received a different therapeutical approach. They have been excluded from statistical analysis. Sexual function improved in all domains (n = 38): total score (Z = -5.4, P < 0.000), satisfaction (Z = -5.3, P < 0.000), pain (Z = -5.4, P < 0.000), arousal (Z = -2.6, P = 0.010), lubrication (Z = -2.4, P = 0.020), desire (Z = -2.6, P = 0.009) and orgasm (Z = -2.2, P = 0.029). Maximum urethral closure pressure deteriorated from 39 to 36 cmH2O (P = 0.0008) and residual urine increased from 10 ml to 20 ml after surgery (P = 0.0019). No statistical significance is found for bladder capacity and free urinary flow.

CONCLUSIONS: All domains of the female sexual function index improved. Patients’ bothersome symptoms, mainly pain may cease and sexual satisfaction increases, which is reassuring concerning patients’ preoperative consent. We should be aware that occasionally an unexpected malignancy may be detected and it is mandatory to examine all excised tissue histologically. Lower urinary tract function remains clinically unchanged, although maximum urethral closure pressure deteriorated and postvoid residual increased though not being clinically significant.

PMID:35313135 | DOI:10.1016/j.ejogrb.2022.03.021

Soc Sci Med. 2022 Feb 16;299:114828. doi: 10.1016/j.socscimed.2022.114828. Online ahead of print.

ABSTRACT

RATIONALE: Determining who is particularly vulnerable to mental health deterioration during the COVID-19 pandemic is essential when designing and targeting interventions to mitigate the adverse psychological impacts of the outbreak. Older people have appeared to be less exposed to mental health deterioration compared with younger individuals, but most exposed to the risk of severe illness and death from the virus, as well as less equipped to use technologies for coping with lockdown measures.

OBJECTIVE: Amongst the old population, we aim at determining how depressive symptoms have changed during the first wave of the COVID-19 pandemic and identifying individual risk factors associated with changes in reporting depression. We are particularly interested in exploring the role of pre-existing mental health problems and evaluating gender differences.

METHOD: Data come from the Survey of Health, Ageing and Retirement in Europe, in particular from the first COVID-19 survey administered in summer 2020. Logistic models are estimated and Average Marginal Effects computed to take the degree of individual unobserved heterogeneity into account comparing point estimates across samples. Multiple Imputation (implemented through Multivariate Imputation by Chained Equations) is used to replace missing data. Statistical power of the effect sizes is estimated by a simulation approach.

RESULTS: Pre-existing mental health problems, a diagnosis of affective/emotional disorders, a recent diagnosis of a major illness, and (only for men) job loss during the first wave of the outbreak are the most important risk factors. Statistical differences between genders emerge, with women experiencing higher levels of depression and greater worsening of mental health than men.

CONCLUSIONS: To identify people at greater risk of depression deterioration during an outbreak it is very important to consider their pre-existing mental and general health, distinguishing severity level. On population level, it is also crucial to evaluate depression disorders separately by gender.

PMID:35313142 | DOI:10.1016/j.socscimed.2022.114828

Ann Intern Med. 2022 Mar 22. doi: 10.7326/M21-3931. Online ahead of print.

ABSTRACT

BACKGROUND: Approximately 20.4 million Americans met criteria for a substance use disorder (SUD) in 2019; however, only about 12.2% of persons with an SUD receive specialty care. Telehealth offers alternatives to traditional forms of substance use treatment.

PURPOSE: To synthesize recent findings on the efficacy of telehealth for SUDs.

DATA SOURCES: MEDLINE, Embase, PubMed, and the Cochrane Library from January 2015 through August 2021 (English language only).

STUDY SELECTION: Randomized controlled trials (RCTs) of adults with a diagnosis of SUD based on the Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases.

DATA EXTRACTION: One investigator abstracted data and assessed study quality, and a second checked for accuracy.

DATA SYNTHESIS: This rapid review synthesized evidence from 17 RCTs. Evidence is very uncertain that telehealth provided as videoconference therapy (1 RCT) or web-based cognitive behavioral therapy (CBT) (3 RCTs) has similar effects to in-person therapy for improving abstinence from alcohol or cannabis. Low-strength evidence suggests that web-based CBT has similar effects for improving abstinence in multiple SUDs (2 RCTs). Low-strength evidence suggests that adding supportive text messaging to follow-up care improves abstinence and amount of alcohol per day (2 RCTs) but does not improve emergency department visits or frequency of consumption (2 RCTs). Enhanced telephone monitoring likely reduces readmissions for SUD detoxification compared with usual follow-up alone (1 RCT) but does not reduce days of substance use (low-strength evidence).

LIMITATION: Narrative synthesis, heterogeneity of telehealth interventions, no assessment of publication bias, and study methodology.

CONCLUSION: Evidence is very uncertain that telehealth is similar to in-person care for SUD outcomes. Limited evidence suggests some benefit of adding telehealth to usual SUD care.

PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs Veterans Health Administration.

PMID:35313116 | DOI:10.7326/M21-3931

J Perinat Med. 2022 Mar 22. doi: 10.1515/jpm-2021-0247. Online ahead of print.

ABSTRACT

OBJECTIVES: To identify antenatal risk factors that may predict the need for insulin treatment upon diagnosis of gestational diabetes (GDM), that is, to identify the specific characteristics of women diagnosed with GDM who did not achieve good glycemic control through lifestyle modifications.

METHODS: We performed a comprehensive literature search in PubMed, Science Direct, Ebsco, and Scielo for studies evaluating the associations between antenatal factors and the need for insulin treatment published until January 28th, 2021. Random-effects models were used to estimate risk ratios and their 95% confidence interval. The quality of studies was assessed using the Newcastle-Ottawa Scale. Random-effects models were used to estimate outcomes, and effects reported as risk ratio and their 95% confidence interval. The systematic review and meta-analysis were registered in the International Prospective Register of Systematic Reviews.

RESULTS: Eighteen observational studies were selected, reporting 14,951 women with GDM of whom 5,371 received insulin treatment. There were statistically significant associations between the need for insulin treatment and BMI ≥ 30 (RR:2.2; 95%CI: 1.44-3.41), family history of type 2 diabetes mellitus (RR:1.74; 95%CI: 1.56-1.93), prior personal history of GDM (RR:2.10; 95%CI: 1.56-2.82), glycated hemoglobin value at GDM diagnosis (RR:2.12; 95%CI: 1.77-2.54), and basal glycemia obtained in the diagnostic curve (RR: 1.2; 95%CI: 1.12-1.28). Nulliparity and maternal age were not determinants factor. There was moderate-to-high heterogeneity among the included studies.

CONCLUSIONS: the strong causal association between BMI ≥ 30, family history of type 2 diabetes mellitus, prior history of GDM and glycosylated hemoglobin with the need for insulin treatment was revealed.

PMID:35313096 | DOI:10.1515/jpm-2021-0247

Clin Chem Lab Med. 2022 Mar 18. doi: 10.1515/cclm-2021-1176. Online ahead of print.

ABSTRACT

OBJECTIVES: Cholestasis and elevated serum bile¹ acid levels are common in critically ill patients. This study aims to define the specific pattern of bile acids associated with acute respiratory distress syndrome (ARDS) and the changes in pattern over time.

METHODS: Prospective observational study. Serum samples of 70 ARDS patients were analyzed for primary bile acids (cholic acid, chenodeoxycholic acid) and secondary bile acids (deoxycholic acid, litocholic acid, and ursodeoxycholic acid) as well as their glycine and taurine glycation products.

RESULTS: Primary bile acid levels increased from day zero to day five by almost 50% (p<0.05). This change bases on a statistically significant increase in all primary bile acids between day 0 and day 5 (cholic acid [CA] p=0.001, taurocholic acid [TCA] p=0.004, glycocholic acid [GCA] p<0.001, chenodeoxycholic acid [CDCA] p=0.036, taurochenodeoxycholic acid [TCDCA] p<0.001, glycochenodeoxycholic acid [GCDCA] p<0.001). Secondary bile acids showed predominantly decreased levels on day 0 compared to the control group and remained stable throughout the study period; the differences between day zero and day five were not statistically significant. Non-survivors exhibited significantly higher levels of TCDCA on day 5 (p<0.05) than survivors. This value was also independently associated with survival in a logistic regression model with an odds ratio of 2.24 (95% CI 0.53-9.46).

CONCLUSIONS: The individual bile acid profile of this ARDS patient cohort is unique compared to other disease states. The combination of changes in individual bile acids reflects a shift toward the acidic pathway of bile acid synthesis. Our results support the concept of ARDS-specific plasma levels of bile acids in a specific pattern as an adaptive response mechanism.

PMID:35313097 | DOI:10.1515/cclm-2021-1176

Clin Exp Dent Res. 2022 Mar 21. doi: 10.1002/cre2.558. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this study was to compare porcelain veneer strength on screw-retained implant-supported fixed full-arch prostheses with a framework of either milled titanium (Ti), cobalt-chromium (CoCr), and yttria-stabilized zirconia (Y-TZP) in an in vitro loading model.

MATERIALS AND METHODS: Fifteen screw-retained maxillary implant-supported full-arch prostheses (FDP), five each of Ti, CoCr, and Y-TZP frameworks with porcelain veneers were included. All FDPs were subjected to thermocycling before loading until fracture of the veneer. The load was applied at the distal fossa of the occlusal area of the pontic replacing 24. Fracture loads were analyzed, and the fracture quality was assessed. Statistical analysis on the fracture load was performed using Kruskal-Wallis test. The statistical significance was set at p < .05.

RESULTS: There was no statistical significance found between the groups regarding fracture load. The highest and lowest load was seen within the CoCr FDP, varying between 340 and 1484 N. Different types of fracture appearances were seen. The Y-TZP FDPs had a higher number of fractures locally in the loaded area while CoCr and Ti more often showed cracks in the anterior region, at a distance from the loaded area.

CONCLUSIONS: Within the limitations of this study, the conclusion was that framework material may affect the fracture behavior of maxillary full-arch bridges; however, there were no differences in veneer fracture strength when frameworks of Ti, CoCr, or Y-TZP were compared.

PMID:35313086 | DOI:10.1002/cre2.558

Surg Technol Int. 2022 Mar 21;40:sti40/1566. Online ahead of print.

ABSTRACT

BACKGROUND: Gastroparesis, a chronic disorder distinguished by delays in gastric emptying, has been a concern for both health providers and hospitals due to several of its characteristics. Gastroparesis is heterogeneous in nature and is associated with several comorbidities and increasing mortality rates. It can often be caused by underlying conditions, most of which are not well understood. This lack of knowledge regarding its underlying mechanisms creates a need to better understand the risk factors involved in this patient population. This study was undertaken to understand the risk factors involved in the mortality of patients who present with gastroparesis.

METHODS: This retrospective study considered data from the National Inpatient Sample for patients who were admitted with a primary diagnosis of gastroparesis from 2005 to 2014. The data were stratified according to various factors of interest to identify risk factors involved in mortality using statistical tools, including a multivariable logistic regression model with backward elimination.

RESULTS: A total of 27,000 patients were admitted emergently with a primary diagnosis of gastroparesis. The mortality rate in adult patients (0.18%, N=39) was much lower than that in elderly patients (1.27%, N=71). Females accounted for the majority of patients in both the adult (73.7%) and elderly (71%) populations. The mean age of patients in the adult and elderly groups was 43 and 75 years, respectively. The association between mortality and age was significant in both adults (OR=1.04, 95%CI=1.005-1.08, p<0.025) and the elderly (OR=1.08, 95%CI=1.04-1.12, p<0.001). The hospital length of stay (HLOS, days) in adult females (5.08, SD=5.04) was significantly longer than that in adult males (4.41, SD=5.10) (p<0.001). The association between mortality and HLOS was significant in both adults (OR=1.12, 95%CI=1.09-1.15, p<0.001) and elderly patients (OR=1.10, 95%CI=1.06-1.14, p<0.001). A lower percentage of adults (6.6%, N=1,402) underwent an operation compared to the elderly (9.6%, N=538). The mean time to operation was 4.76 days for adult patients who survived and 17.50 days for adult patients who did not survive (SD=5.37 and 9.37, respectively, p=0.006). On the other hand, this value was 5.57 and 9.10 days for elderly patients (SD=6.50 and 7.15, respectively, p=0.037). Among patients who underwent an operation, the association between mortality and time to operation was significant for both adults (OR=1.17, 95%CI=1.094-1.247, p<0.001) and elderly patients (OR=1.05, 95%CI=1.005-1.124, p<0.001).

CONCLUSION: The risk of mortality in elderly patients with emergent gastroparesis was 7-fold greater than that in adult patients. The odds of mortality increased by 8% for every year increase in age in elderly patients and by 4% in adults.

PMID:35313001