Tag: statistics

Subst Abuse Treat Prev Policy. 2022 Jul 15;17(1):52. doi: 10.1186/s13011-022-00481-3.

ABSTRACT

BACKGROUND: In recent years, female drinking has been on the rise worldwide, and this trend can be observed in Korea as well. Accordingly, this study aimed to examine the heterogeneous longitudinal changes in drinking patterns among Korean women, while also exploring the determinants of these changes. In particular, the study identified the gender perspective-related determinants of the classified patterns of problem drinking.

METHODS: Data on 4615 adult women who participated in the Korea Welfare Panel Study (KOWEPS) for 3 years (2018-2020) were analyzed longitudinally using SPSS Statistics 22.0 and M-plus 7.0. The changes in female drinking patterns were analyzed using latent class growth analysis. Subsequently, multinomial logistic regression analysis was performed to identify the predictive factors affecting the changes in drinking patterns.

RESULTS: Latent class analysis yielded three classes: “low problem drinking/decreased,” “moderate problem drinking/maintained,” and “high problem drinking/increased.” Of the participants, 80.4% were in the first class, 14.5% in the second, and 5.1% in the third. After controlling for sociodemographic and psychosocial factors, we found: i) domestic violence, work-family balance stress, and gender role perception were not statistically significant for the “moderate problem drinking/maintained” class; lower levels of depression (odds ratio; OR = .750, p < .05) and higher levels of satisfaction with social relationships (OR = 1.257, p < .05) increased the probability of belonging to the “moderate problem drinking/maintained” group compared to the low problem drinking/decreased class; ii) in the “high problem drinking/increased” class, relative to the low problem drinking/decreased class, experience of domestic violence (OR = 1.857, p < .05), work-family balance stress (OR = 1.309, p < .05), and gender role perception (OR = .705, p < .05) were significant predictors of drinking behavior.

CONCLUSIONS: Problem drinking in Korean women demonstrated heterogeneous patterns of change, with gender-specific factors being the main predictors of this change. Therefore, this study developed a strategy for reducing the harmful effects of female drinking, which considers the characteristics of the changes in women’s drinking patterns as well as factors from the gender perspective.

PMID:35841103 | DOI:10.1186/s13011-022-00481-3

Anesth Analg. 2022 Aug 1;135(2):406-413. doi: 10.1213/ANE.0000000000006102. Epub 2022 Jun 3.

ABSTRACT

BACKGROUND: An important variable in the operating room is the nonoperative time (NOT), the time between skin closure on a previous case and skin incision on the following case. Mismanagement of NOT can result in significant financial losses and delays in the operating room (OR) schedule, which can negatively impact efficiency and patient, surgeon, and staff satisfaction. NOT includes general anesthesia induction time (IT), emergence time (ET), and turnover time (TOT), and can be calculated by adding the 3 components. OR efficiency can be increased by applying parallel processing for general anesthesia induction and OR cleaning and reversal of neuromuscular blockade with sugammadex to reduce the 3 components of NOT without compromising patient safety.

METHODS: This is a prospective, randomized study of 111 patients 18 to 75 years of age, American Society of Anesthesiologists (ASA) I-III, undergoing surgery requiring general anesthesia and muscle relaxation. Patients were randomly assigned to the control group (traditional linear processing for induction of anesthesia and OR cleaning and neuromuscular blockade reversal with neostigmine/glycopyrrolate) and the active group (parallel processing for induction of anesthesia and OR cleaning and neuromuscular blockade reversal with sugammadex). The primary outcome measured is the difference in the NOT. The secondary outcomes are surgeon and patient satisfaction.

RESULTS: NOT was significantly shorter in patients who underwent the parallel processing strategy and received sugammadex compared to the patients in the control group (25.0 [18.0-44.0] vs 48.0 [40.0-64.5] minutes; Cliff’ delta = 0.57; P < .001). After excluding the cases in the experimental group that were put into sleep in the OR (ie, the first case of the room), IT, ET, TOT, and NOT were further reduced and remained statistically significantly lower than the control group. Satisfaction scores from surgeons were significantly higher in the active group than in the control group (P < .001). There was no significant difference in the satisfaction scores of patients between the 2 groups.

CONCLUSIONS: Our study showed that interventions, such as parallel processing during induction of anesthesia and room cleaning instead of linear processing and the use of the faster-acting sugammadex instead of the combination of neostigmine and glycopyrrolate for the reversal of rocuronium-induced neuromuscular blockade, resulted in shorter IT, ET, TOT, and therefore NOT, in addition to higher surgeon’s satisfaction.

PMID:35839499 | DOI:10.1213/ANE.0000000000006102

Biom J. 2022 Jul 15. doi: 10.1002/bimj.202100309. Online ahead of print.

ABSTRACT

False discovery rates are routinely controlled by application of the Benjamini-Hochberg step-up procedure to a set of p-values. A method is demonstrated for representing the values so obtained (the BH-FDRs) on a quantile-quantile (Q-Q) plot of the p-values transformed to the negative-logarithmic scale. Recognition of this connection between the BH-FDR and the Q-Q plot facilitates both understanding of the meaning of the BH-FDR and interpretation of the BH-FDR in a particular data set.

PMID:35839474 | DOI:10.1002/bimj.202100309

Cancer Epidemiol Biomarkers Prev. 2022 Jul 15:EPI-21-1451. doi: 10.1158/1055-9965.EPI-21-1451. Online ahead of print.

ABSTRACT

BACKGROUND: Evaluations of cancer etiology and safety and effectiveness of cancer treatments are predicated on large numbers of patients with sufficient baseline and follow-up data. To assess feasibility of FDA’s Sentinel System’s electronic healthcare data for surveillance of malignancy onset and examination of product safety, this study examined patterns of enrollment surrounding new-onset cancers.

METHODS: Using a retrospective cohort of patients based on administrative claims, we identified incident events of 19 cancers among 292.5 million health plan members from January 2000 through February 2020 using International Classification of Diseases (ICD) diagnosis codes. Annual incident cases were stratified by sex, age, medical and drug coverage, and insurer type. Descriptive statistics were calculated for observable time prior to and following diagnosis.

RESULTS: We identified 10,697,573 incident cancer events among members with medical coverage. When drug coverage was additionally required, number of incident cancers was reduced by 41%. Medicare data contributed 61% of cases, with similar duration trends as other insurers. Mean duration of follow-up prior to diagnosis ranged from 4.0-4.6 years, while follow-up post diagnosis ranged from 1.1-3.3 years. Approximately a third (36.1%) had at least 2 years both prior to and following diagnosis.

CONCLUSIONS: The FDA Sentinel System’s electronic healthcare data may be useful for characterizing relatively short latency cancer risk, examining cancer drug utilization and safety post diagnosis, and conducting surveillance for acute adverse events among patients with cancers.

IMPACT: A national distributed system with electronic health data, the Sentinel system provides opportunity for rapid pharmacoepidemiologic assessments relevant in oncology.

PMID:35839466 | DOI:10.1158/1055-9965.EPI-21-1451

Blood. 2022 Jul 15:blood.2022015478. doi: 10.1182/blood.2022015478. Online ahead of print.

ABSTRACT

Here we report the first comparative analysis of patient-reported outcomes (PROs) with chimeric antigen receptor T-cell therapy versus standard-of-care (SOC) therapy in second-line relapsed/refractory large B-cell lymphoma (R/R LBCL) from the pivotal randomized phase 3 ZUMA-7 (NCT03391466) study of axicabtagene ciloleucel (axi-cel) versus SOC. PRO instruments were administered at baseline, day 50, day 100, day 150, month 9, and every 3 months from randomization until 24 months or an event-free survival event. The quality of life (QoL) analysis set comprised patients with a baseline and ≥1 follow-up PRO completion. Prespecified hypotheses for QLQ-C30 Physical Functioning, Global Health Status/QoL, and EQ-5D-5L visual analogue scale (VAS) were tested using mixed-effect models with repeated measures. Clinically meaningful changes were defined as 10 points for QLQ-C30 and 7 for EQ-5D-5L VAS. Among 359 patients, 296 (165 axi-cel, 131 SOC) met inclusion criteria for QoL analysis. At day 100, statistically significant and clinically meaningful differences in mean change of scores from baseline were observed favoring axi-cel over SOC for QLQ-C30 Global Health Status/QoL (estimated difference 18.1 [95% CI, 12.3-23.9]), Physical Functioning (13.1 [95% CI, 8.0-18.2]), and EQ-5D-5L VAS (13.7 [95% CI, 8.5-18.8]; P<.0001 for all). At day 150, scores significantly favored axi-cel versus SOC for Global Health Status/QoL (9.8 [95% CI, 2.6-17.0]; P=.0124) and EQ-5D-5L VAS (11.3 [95% CI, 5.4-17.1]; P=.0004). Axi-cel showed clinically meaningful improvements in QoL over SOC. Superior clinical outcomes and favorable patient experience with axi-cel should help inform treatment choices in second-line R/R LBCL.

PMID:35839452 | DOI:10.1182/blood.2022015478

J Clin Oncol. 2022 Jul 15:JCO2102707. doi: 10.1200/JCO.21.02707. Online ahead of print.

ABSTRACT

PURPOSE: Peripheral T-cell lymphoma (PTCL) includes heterogeneous clinicopathologic entities with numerous diagnostic and treatment challenges. We previously defined robust transcriptomic signatures that distinguish common PTCL entities and identified two novel biologic and prognostic PTCL-not otherwise specified subtypes (PTCL-TBX21 and PTCL-GATA3). We aimed to consolidate a gene expression-based subclassification using formalin-fixed, paraffin-embedded (FFPE) tissues to improve the accuracy and precision in PTCL diagnosis.

MATERIALS AND METHODS: We assembled a well-characterized PTCL training cohort (n = 105) with gene expression profiling data to derive a diagnostic signature using fresh-frozen tissue on the HG-U133plus2.0 platform (Affymetrix, Inc, Santa Clara, CA) subsequently validated using matched FFPE tissues in a digital gene expression profiling platform (nCounter, NanoString Technologies, Inc, Seattle, WA). Statistical filtering approaches were applied to refine the transcriptomic signatures and then validated in another PTCL cohort (n = 140) with rigorous pathology review and ancillary assays.

RESULTS: In the training cohort, the refined transcriptomic classifier in FFPE tissues showed high sensitivity (> 80%), specificity (> 95%), and accuracy (> 94%) for PTCL subclassification compared with the fresh-frozen-derived diagnostic model and showed high reproducibility between three independent laboratories. In the validation cohort, the transcriptional classifier matched the pathology diagnosis rendered by three expert hematopathologists in 85% (n = 119) of the cases, showed borderline association with the molecular signatures in 6% (n = 8), and disagreed in 8% (n = 11). The classifier improved the pathology diagnosis in two cases, validated by clinical findings. Of the 11 cases with disagreements, four had a molecular classification that may provide an improvement over pathology diagnosis on the basis of overall transcriptomic and morphological features. The molecular subclassification provided a comprehensive molecular characterization of PTCL subtypes, including viral etiologic factors and translocation partners.

CONCLUSION: We developed a novel transcriptomic approach for PTCL subclassification that facilitates translation into clinical practice with higher precision and uniformity than conventional pathology diagnosis.

PMID:35839444 | DOI:10.1200/JCO.21.02707

JCO Glob Oncol. 2022 Jul;8:e2200131. doi: 10.1200/GO.22.00131.

ABSTRACT

PURPOSE: In describing our ten-year experience with treating chronic myeloid leukemia (CML) as part of the Glivec Patient Assistance Program (GIPAP) in rural Rwanda, we evaluate (1) patient characteristics and treatment outcomes, (2) resource-adapted management strategies, and (3) the impact of diagnostic capacity development.

METHODS: We retrospectively reviewed all patients with BCR-ABL-positive CML enrolled in this GIPAP program between 2009 and 2018. Clinical data were analyzed using descriptive statistics, Kaplan-Meier methods, proportional hazards regression, and the Kruskal-Wallis test.

RESULTS: One hundred twenty-four patients were included. The median age at diagnosis was 34 (range 8-81) years. On imatinib, 91% achieved complete hematologic response (CHR) after a median of 49 days. Seven (6%) and 12 (11%) patients had primary and secondary imatinib resistance, respectively. The 3-year overall survival was 80% (95% CI, 72 to 87) for the cohort, with superior survival in imatinib responders compared with those with primary and secondary resistance. The median time from imatinib initiation to CHR was 59 versus 38 days (P = .040) before and after in-country diagnostic testing, whereas the median time to diagnosis (P = .056) and imatinib initiation (P = .170) was not significantly different.

CONCLUSION: Coupling molecular diagnostics with affordable access to imatinib within a comprehensive cancer care delivery program is a successful long-term strategy to treat CML in resource-constrained settings. Our patients are younger and have higher rates of imatinib resistance compared with historic cohorts in high-income countries. High imatinib resistance rates highlight the need for access to molecular monitoring, resistance testing, and second-generation tyrosine kinase inhibitors, as well as systems to support drug adherence. Hematologic response is an accurate resource-adapted predictor of survival in this setting. Local diagnostic capacity development has allowed for continuous, timely CML care delivery in Rwanda.

PMID:35839427 | DOI:10.1200/GO.22.00131

J Clin Oncol. 2022 Jul 15:JCO2102478. doi: 10.1200/JCO.21.02478. Online ahead of print.

ABSTRACT

PURPOSE: Postconsolidation immunotherapy including dinutuximab, granulocyte-macrophage colony-stimulating factor, and interleukin-2 improved outcomes for patients with high-risk neuroblastoma enrolled on the randomized portion of Children’s Oncology Group study ANBL0032. After random assignment ended, all patients were assigned to immunotherapy. Survival and toxicities were assessed.

PATIENTS AND METHODS: Patients with a pre-autologous stem cell transplant (ASCT) response (excluding bone marrow) of partial response or better were eligible. Demographics, stage, tumor biology, pre-ASCT response, and adverse events were summarized using descriptive statistics. Event-free survival (EFS) and overall survival (OS) from time of enrollment (up to day +200 from last ASCT) were evaluated.

RESULTS: From 2009 to 2015, 1,183 patients were treated. Five-year EFS and OS for the entire cohort were 61.1 ± 1.9% and 71.9 ± 1.7%, respectively. For patients ≥ 18 months old at diagnosis with International Neuroblastoma Staging System stage 4 disease (n = 662) 5-year EFS and OS were 57.0 ± 2.4% and 70.9 ± 2.2%, respectively. EFS was superior for patients with complete response/very good partial response pre-ASCT compared with those with PR (5-year EFS: 64.2 ± 2.2% v 55.4 ± 3.2%, P = .0133); however, OS was not significantly different. Allergic reactions, capillary leak, fever, and hypotension were more frequent during interleukin-2-containing cycles than granulocyte-macrophage colony-stimulating factor-containing cycles (P < .0001). EFS was superior in patients with higher peak dinutuximab levels during cycle 1 (P = .034) and those with a high affinity FCGR3A genotype (P = .0418). Human antichimeric antibody status did not correlate with survival.

CONCLUSION: Analysis of a cohort assigned to immunotherapy after cessation of random assignment on ANBL0032 confirmed previously described survival and toxicity outcomes. EFS was highest among patients with end-induction complete response/very good partial response. Among patients with available data, higher dinutuximab levels and FCGR3A genotype were associated with superior EFS. These may be predictive biomarkers for dinutuximab therapy.

PMID:35839426 | DOI:10.1200/JCO.21.02478

J Am Coll Surg. 2022 Aug 1;235(2):278-284. doi: 10.1097/XCS.0000000000000220. Epub 2022 Apr 8.

ABSTRACT

BACKGROUND: Older trauma patients present with poor preinjury functional status and more comorbidities. Advances in care have increased the chance of survival from previously fatal injuries with many left debilitated with chronic critical illness and severe disability. Palliative care (PC) is ideally suited to address the goals of care and symptom management in this critically ill population. A retrospective chart review was done to identify the impact of PC consults on hospital length of stay (LOS), ICU LOS, and surgical decisions.

STUDY DESIGN: A Level 1 Trauma Center Registry was used to identify adult patients who were provided PC consultation in a selected 3-year time period. These PC patients were matched with non-PC trauma patients on the basis of age, sex, race, Glasgow Coma Scale, and Injury Severity Score. Chi-square tests and Student’s t-tests were used to analyze categorical and continuous variables, respectively. Any p value >0.05 was considered statistically significant.

RESULTS: PC patients were less likely to receive a percutaneous endoscopic gastric tube or tracheostomy. PC patients spent less time on ventilator support, spent less time in the ICU, and had a shorter hospital stay. PC consultation was requested 16.48 days into the patient’s hospital stay. Approximately 82% of consults were to assist with goals of care.

CONCLUSION: Specialist PC team involvement in the care of the trauma ICU patients may have a beneficial impact on hospital LOS, ICU LOS, and surgical care rendered. Earlier consultation during hospitalization may lead to higher rates of goal-directed care and improved patient satisfaction.

PMID:35839403 | DOI:10.1097/XCS.0000000000000220

J Am Coll Surg. 2022 Aug 1;235(2):227-239. doi: 10.1097/XCS.0000000000000236. Epub 2022 Apr 18.

ABSTRACT

BACKGROUND: Although satisfactory volume reduction in secondary unilateral lower limb lymphedema after lymphaticovenous anastomosis (LVA) in the affected limb has been well reported, alleviation of muscle edema and the impact of LVA on the contralateral limb have not been investigated.

STUDY DESIGN: This retrospective cohort study enrolled patients who underwent supermicrosurgical LVA between November 2015 and January 2017. Pre- and post-LVA muscle edema were assessed using fractional anisotropy (FA) and apparent diffusion coefficient (ADC). The primary endpoint was changes in limb/subfascial volume assessed with magnetic resonance volumetry at least 6 months after LVA.

RESULTS: Twenty-one patients were enrolled in this study. Significant percentage reductions in post-LVA muscle edema were found in the affected thigh (83.6% [interquartile range = range of Q1 to Q3; 29.8-137.1] [FA], 53.3% [27.0-78.4] [ADC]) as well as limb (21.7% [4.4-26.5]) and subfascial (18.7% [10.7-39.1]) volumes. Similar findings were noted in the affected lower leg: 71.8% [44.0-100.1] (FA), 59.1% [45.8-91.2] (ADC), 21.2% [6.8-38.2], and 28.2% [8.5-44.8], respectively (all p < 0.001). Significant alleviation of muscle edema was also evident in the contralateral limbs (thigh: 25.1% [20.4-57.5] [FA]; 10.7% [6.6-17.7] [ADC]; lower leg: 47.1% [35.0-62.8] [FA]; 14.6% [6.5-22.1] [ADC]; both p < 0.001), despite no statistically significant difference in limb and subfascial volumes.

CONCLUSIONS: Our study found significant reductions in muscle edema and limb/subfascial volumes in the affected limb after LVA. Our findings regarding edema in the contralateral limb were consistent with possible lymphedema-associated systemic influence on the unaffected limb, which could be surgically relieved.

PMID:35839398 | DOI:10.1097/XCS.0000000000000236