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Nevin Manimala Statistics

What is the impact of corpus uterine invasion on oncologic outcomes in surgically treated cervical cancer?

J Obstet Gynaecol Res. 2021 Aug 1. doi: 10.1111/jog.14953. Online ahead of print.

ABSTRACT

AIM: To investigate the clinical significance of uterine corpus involvement in patients with surgically treated cervical cancer.

METHODS: Patients (n = 354) with clinical early-stage (stage IB1-IIA2) cervical cancer who underwent radical hysterectomy and pelvic ± paraaortic lymphadenectomy were evaluated.

RESULTS: Uterine invasion was detected in 60 (16.9%) patients. Patients with uterine invasion had a higher rate of pelvic lymph node metastasis than those without uterine invasion (35% vs 22.8%, p = 0.046). In multivariate analysis, no statistically significant difference was identified between patients with and without uterine invasion for pelvic lymph node metastasis (p = 0.953). Uterine invasion was identified as an independent risk factor for paraaortic lymph node metastasis in multivariate analysis (p = 0.012). The presence of pelvic lymph node metastasis was found to be another significant predictor of paraaortic lymph node involvement (p = 0.022). In addition, uterine invasion and lymph node metastasis were identified as an independent risk factors regarding poor prognosis in cancer-specific survival (hazard ratio [HR]: 4.537; 95% confidence interval [CI], 1.304-15.782; p = 0.017 and HR: 5.598; 95% CI, 1.581-19.823; p = 0.008, respectively).

CONCLUSIONS: Uterine invasion is an independent predictor of decreased survival and the presence of paraaortic lymph node metastasis in cervical cancer. The presence of the uterine invasion in cervical cancer should be considered as a poor prognostic factor in the decision of treatment.

PMID:34333801 | DOI:10.1111/jog.14953

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Needs for information about lifestyle and rehabilitation in long-term young adult cancer survivors

Support Care Cancer. 2021 Aug 1. doi: 10.1007/s00520-021-06418-z. Online ahead of print.

ABSTRACT

BACKGROUND: Healthy lifestyle and rehabilitation may mitigate late effects after cancer treatment, but knowledge about lifestyle and rehabilitation information needs among long-term young adult cancer survivors (YACSs) (≥ 5 years from diagnosis) is limited. The present study aimed to examine such information needs among long-term YACSs, and identify characteristics of those with needs.

MATERIAL AND METHODS: The Cancer Registry of Norway identified long-term YACSs diagnosed with breast cancer, colorectal cancer, non-Hodgkin lymphoma, leukemia, or malignant melanoma at the age of 19-39 years, between 1985 and 2009. Survivors were mailed a questionnaire, in which respondents reported their information needs on physical activity, diet, and rehabilitation services 5-30 years post-diagnosis. Descriptive statistics and logistic regression analyses were used to examine the prevalence of information needs and associated factors.

RESULTS: Of 1488 respondents (a response rate of 42%), 947 were included. Median age at diagnosis was 35 years (range 19-39) and median observation time since diagnosis was 14 years (range 5-30). In total, 41% reported information needs for information about physical activity, 45% about diet, and 47% about rehabilitation services. Information needs were associated with higher treatment intensity, increasing number of late effects, and an unhealthy lifestyle.

CONCLUSION: A large proportion of long-term YACSs report information needs regarding lifestyle and/or rehabilitation more than a decade beyond treatment. Assessments of such information needs should become a part of long-term care of these cancer survivors.

PMID:34333716 | DOI:10.1007/s00520-021-06418-z

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Global fractional anisotropy predicts transition to psychosis after 12 months in individuals at ultra-high risk for psychosis

Acta Psychiatr Scand. 2021 Aug 1. doi: 10.1111/acps.13355. Online ahead of print.

ABSTRACT

OBJECTIVE: Psychosis spectrum disorders are associated with cerebral changes, but the prognostic value and clinical utility of these findings is unclear. Here we applied a multivariate statistical model to examine the predictive accuracy of global white matter fractional anisotropy (FA) for transition to psychosis in individuals at ultra-high risk for psychosis (UHR).

METHODS: 110 UHR-individuals underwent 3 Tesla diffusion weighted imaging and clinical assessments at baseline, and after 6 and 12 months. Using logistic regression, we examined the reliability of global FA at baseline as a predictor for psychosis transition after 12 months. We tested the predictive accuracy, sensitivity and specificity of global FA in a multivariate prediction-model accounting for potential confounders to FA (head motion in scanner, age, gender, antipsychotic medication, parental socioeconomic status, and activity level). In secondary analyses, we tested FA as a predictor of clinical symptoms and functional level using multivariate linear regression.

RESULTS: Ten UHR-individuals had transitioned to psychosis after 12 months (9%). The model reliably predicted transition at 12 months (χ2 =17.595, p=0.040), accounted for 15-33% of the variance in transition outcome with a sensitivity of 0.70, a specificity of 0.88, and AUC of 0.87. Global FA predicted level of UHR-symptoms (R2 =0.055, F=6.084, p=0.016) and functional level (R2 = 0.040, F=4.57, p=0.036) at 6 months, but not at 12 months.

CONCLUSION: Global FA provided prognostic information on clinical outcome and symptom course of UHR-individuals. Our findings suggest that the application of prediction models including neuroimaging data can inform clinical management on risk for psychosis transition.

PMID:34333760 | DOI:10.1111/acps.13355

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Impact of Choosing Wisely Recommendations on Sentinel Lymph Node Biopsy and Postoperative Radiation Rates in Women Over Age 70 Years with Hormone-Positive Breast Cancer

Ann Surg Oncol. 2021 Jul 31. doi: 10.1245/s10434-021-10460-w. Online ahead of print.

ABSTRACT

BACKGROUND: In 2016, the Society of Surgical Oncology released a Choosing Wisely guideline recommending sentinel lymph node biopsy (SLNB) omission in females ≥70 years of age with early-stage, hormone-positive, clinically node-negative invasive breast cancer. This study investigated the impact of this guideline on SLNB and radiotherapy rates, in addition to assessing temporal trends of nodal biopsy and factors associated with recurrence.

METHODS: The study involved a retrospective review of women who met the guideline criteria and underwent partial mastectomy at a single institution between 2009 and 2018. Using the same inclusion criteria, the National Cancer Database was queried to obtain a separate dataset. Statistical analyses included univariate comparisons, and multivariate logistic regression modeling to predict radiotherapy delivery.

RESULTS: In our institutional series, 487 patients were included, 274 (56.3%) of whom received radiotherapy. There were 414 patients (85.0%) who underwent SLNB, with a nodal positivity rate of 11%. SLNB correlated with higher rates of radiotherapy (63.5% vs. 15.1%, p < 0.001). Age <80 years was an independent predictor of radiotherapy receipt (odds ratio 3.0, 95% confidence interval 0.22-0.52). SLNB performance decreased after 2016 (88.4% vs. 78.4%, p = 0.003). Median follow-up was 4.8 years, with 19 (3.9%) documented recurrences. SLNB performance was not associated with recurrence (2.9% vs. 5.5%, p = 0.279), whereas radiotherapy resulted in reduced recurrence (1.1% vs. 6.1%, p = 0.002). One (0.2%) disease-related mortality was observed.

CONCLUSION: Recurrence rates and disease-related mortality remain low in this demographic regardless of treatment rendered. Omission of SLNB and radiotherapy should remain a consideration, and efforts in both patient and physician education should continue.

PMID:34333704 | DOI:10.1245/s10434-021-10460-w

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American Society of Breast Surgeons’ Practice Patterns for Patients at Risk and Affected by Breast Cancer-Related Lymphedema

Ann Surg Oncol. 2021 Jul 31. doi: 10.1245/s10434-021-10494-0. Online ahead of print.

ABSTRACT

BACKGROUND: In 2017, the American Society of Breast Surgeons (ASBrS) published expert panel recommendations for patients at risk for breast cancer-related lymphedema (BCRL) and those affected by BCRL. This study sought to determine BCRL practice patterns.

METHODS: A survey was sent to 2975 ASBrS members. Questions evaluated members’ clinical practice type, practice duration, and familiarity with BCRL recommendations. Descriptive statistics, the chi-square test, and Fisher’s exact test were used.

RESULTS: Of the ASBrS members surveyed, 390 (13.1%) responded. Most of the breast surgeons (58.5%, 228/390) indicated unfamiliarity with recommendations. Nearly all respondents (98.7%, 385/390) educate at-risk patients. Most (60.2%, 234/389) instruct patients to avoid venipuncture, injection or blood pressure measurements in the at-risk arm, and 35.6% (138/388) recommend prophylactic compression sleeve use during air travel. Nearly all (97.7%, 380/389) encourage those at-risk to exercise, including resistance exercise (86.2%, 331/384). Most do not perform axillary reverse mapping (ARM) (67.9%, 264/389) or a lymphatic preventive healing approach (LYMPHA) (84.9%, 331/390). Most (76.1%, 296/389) screen at-risk patients for BCRL. The most frequently used screening tools include self-reported symptoms (81%, 255/315), circumferential tape measure (54%, 170/315) and bioimpedance spectroscopy (27.3%, 86/315). After a BCRL diagnosis, most (90%, 351/390) refer management to a lymphedema-certified physical therapist. For affected patients, nearly all encourage exercise (98.7%, 384/389). Many (49%, 191/390) refer affected patients for consideration of lymphovenous bypass or lymph node transfer.

CONCLUSION: Most respondents were unfamiliar with the ASBrS expert panel recommendations for patients at risk for BCRL and those affected by BCRL. Opportunities exist to increase awareness of best practices and to acquire ARM and LYMPHA technical expertise.

PMID:34333706 | DOI:10.1245/s10434-021-10494-0

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Quality and cost outcomes of an integrated supportive care program

Support Care Cancer. 2021 Aug 1. doi: 10.1007/s00520-021-06450-z. Online ahead of print.

ABSTRACT

PURPOSE: This article reports findings from a demonstration project funded by the Center for Medicare and Medicaid Innovation (CMMI). The purpose of the project was to test a supportive care program on the outcomes of quality of care and quality of life, and costs in patients with advanced cancer.

METHODS: The project was conducted between February 2015 and February 2018, enrolling adult, Medicare or Medicaid beneficiaries with advanced or progressed solid tumor malignancy. A comparative longitudinal comparison of the program with both a concurrent control and an historic control was used to evaluate outcomes. The intervention included routine electronic biopsychosocial screening, early access to specialty palliative care, and nurse care coordination. Quality of life, aggressiveness of care, and healthcare utilization were measured.

RESULTS: A total of 1340 people were enrolled, with 71% of the total sample being Caucasian; 41.4% had stage IV cancer, and 20% utilized Medicaid only. Significant differences in the enrolled patients and the comparison group were controlled for through statistical analysis. There were significantly fewer ED visits, unplanned admissions, and fewer total hospitalization days in the intervention group. In the last 30 days of life, hospital and ICU admissions were less and a greater proportion of patients were enrolled in hospice in the intervention group. Quality of life had a marked improvement for enrolled patients. Average cost per member per month was not less in the enrolled group.

CONCLUSION: This pragmatic demonstration project confirmed the clinical benefits of an integration of supportive care for patients with advanced cancer, although no reduction in costs was found.

PMID:34333699 | DOI:10.1007/s00520-021-06450-z

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Relationship between vitamin D status in the first trimester of the pregnancy and gestational weight gain: a mediation analysis

Arch Gynecol Obstet. 2021 Jul 31. doi: 10.1007/s00404-021-06163-y. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the total, and direct effects of vitamin D, measured by circulating 25-hydroxyvitamin D [25(OH)D] levels, on GWG after adjustment for confounding variables, and then assess the indirect effects by demonstrating the role of gestational age at birth as a mediator in this association.

METHODS: Data collected in “Khuzestan Vitamin D Deficiency Screening Program in Pregnancy” were used for the present study; it included the data of 900 pregnant women referred to the health centers of Shushtar (Khuzestan Province, Iran), whose vitamin D status during the third trimester of pregnancy was available. A mediation analysis was applied to detect the causal relationship between serum level of 25(OH)D, covariates (maternal age, parity, education level, and baseline maternal weight), mediator (gestational age), and outcome (GWG).

RESULTS: Of 900 pregnant women referred to the health centers, a total of 726 eligible participants were analyzed for the study. The adjusted total effect of vitamin D on GWG was estimated 0.07 (95% CI 0.06, 0.09; P = 0.000). This study also revealed adjusted direct effect of vitamin D on GWG was statistically significant 0.02 (95% CI: 0.003, 0.04; P = 0.021). In addition, the adjusted indirect effect of this micronutrient on GWG by considering gestational age as a mediator was found to be significant [0.05 (95% CI 0.04, 0.06; P = 0.000)]. This study revealed an increase in the trend of weight gain during pregnancy trimesters for women with different levels of 25(OH)D; however, women with severe vitamin D deficiency had the lowest speed as compared to moderate and normal levels.

CONCLUSION: This study shows that maternal vitamin D status directly affects the gestational weight gain independent of gestational age. Therefore, the detection and treatment of women with vitamin D inadequacy can directly improve the trend of their weight gain in addition to its indirect effect on reducing the risk of preterm delivery.

PMID:34333703 | DOI:10.1007/s00404-021-06163-y

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Association of the apoptotic marker APO1/Fas with children’s predisposing factors for metabolic syndrome and with mean platelet volume

J Pediatr Endocrinol Metab. 2021 Aug 2. doi: 10.1515/jpem-2021-0352. Online ahead of print.

ABSTRACT

BACKGROUND: Apoptosis antigen 1/FAS receptor (APO1/Fas) signaling in endothelial cells plays a significant role in angiogenesis while increased mean platelet volume (MPV) is an important marker for platelet activation. We investigated the possible correlation between APO1/Fas and both metabolic parameters and platelet activity (indicated by the MPV) in a healthy pediatric population.

METHODS: One hundred and eighty-five children, aged 5-17 years old, were enrolled in the study. The participants were divided into subgroups according to their age and body mass index percentile (BMI%). APO1/Fas was measured by enzyme-linked immunosorbent assay (ELISA) and MPV by the MEK-6410K.

RESULTS: Eighty-one children (43.8%) had excess weight, which was more prevalent in children ≤9 years of age. Sixty-five children (35.1%) exhibited a predisposition for metabolic syndrome. A negative correlation was found between APO1/Fas and predisposing factors for metabolic syndrome: Glucose, cholesterol, uric acid, low-density lipoprotein (LDL), and triglycerides. In contrast, a positive correlation was found between APO1/Fas and C-reactive protein (CRP). Receiver operating characteristic (ROC) analysis showed a predisposition to metabolic syndrome when APO1/Fas was <78.46 pg/mL. A negative correlation was also observed between APO1/Fas and MPV. MPV was also positively correlated with predisposing factors for metabolic syndrome: BMI%, glucose, cholesterol, uric acid, LDL, and negatively with high-density lipoprotein.

CONCLUSIONS: APO1/Fas expression is associated with a lower predisposition to metabolic syndrome may be through endothelial homeostasis, the induction of apoptosis of cells involved in atherosclerosis, and platelet activity. It may also enhance CRP-mediated noninflammatory clearance of apoptotic cells. Early monitoring of all the components of metabolic syndrome in overweight children is important in order to prevent metabolic and cardiovascular complications.

PMID:34332515 | DOI:10.1515/jpem-2021-0352

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MRI study of changes in knee bone marrow edema-like signal in asymptomatic amateur marathon runners before and after half-marathon running

Clin Imaging. 2021 May 18;80:150-157. doi: 10.1016/j.clinimag.2021.05.005. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the incidence of knee bone marrow edema-like signal and its changes before and after running a half marathon running in asymptomatic amateur marathon runners to explore the impact of the half marathon on knee bone marrow edema-like signal.

METHODS: 50 asymptomatic amateur marathon runners (30 males, 20 females) were recruited. T1-weighted imaging (T1WI), fat-suppressed protein density weighted imaging (fs-PDWI) and three-dimensional double-echo steady-state (3D-DESS) sequence on the right knee were performed before and within 3 h after a half-marathon running. 20 healthy volunteers were recruited as control. According to the whole-organ magnetic resonance imaging score (WORMS) system, the involvement of bone marrow edema-like signal in 15 regions of knee was graded from 0 to 3. The results were classified and Mann Whitney U test was used for comparison between groups.

RESULTS: The total incidence of bone marrow edema-like signal in amateur marathon group was 62%. Among them, the incidence of grade 1-3 was 48% (24/50), 12% (6/50), 2% (1/50), respectively, which was statistically significant compared with the controls (P = 0.007). There was no significant difference between gender before running (P = 0.172) and after running (P = 0.162). There was no significant difference before and after running (P > 0.05). However, 3 subjects showed new lesions, 8 subjects showed progression and 4 subjects showed decreased signal.

CONCLUSION: The occurrence of knee bone marrow edema-like signal in amateur marathon runners is more common. The lesions of bone marrow edema-like signal will show aggravation or improvement in a certain extent after the half marathon.

PMID:34332463 | DOI:10.1016/j.clinimag.2021.05.005

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Challenges in replicating secondary analysis of electronic health records data with multiple computable phenotypes: A case study on methicillin-resistant Staphylococcus aureus bacteremia infections

Int J Med Inform. 2021 Jul 16;153:104531. doi: 10.1016/j.ijmedinf.2021.104531. Online ahead of print.

ABSTRACT

BACKGROUND: Replication of prediction modeling using electronic health records (EHR) is challenging because of the necessity to compute phenotypes including study cohort, outcomes, and covariates. However, some phenotypes may not be easily replicated across EHR data sources due to a variety of reasons such as the lack of gold standard definitions and documentation variations across systems, which may lead to measurement error and potential bias. Methicillin-resistant Staphylococcus aureus (MRSA) infections are responsible for high mortality worldwide. With limited treatment options for the infection, the ability to predict MRSA outcome is of interest. However, replicating these MRSA outcome prediction models using EHR data is problematic due to the lack of well-defined computable phenotypes for many of the predictors as well as study inclusion and outcome criteria.

OBJECTIVE: In this study, we aimed to evaluate a prediction model for 30-day mortality after MRSA bacteremia infection diagnosis with reduced vancomycin susceptibility (MRSA-RVS) considering multiple computable phenotypes using EHR data.

METHODS: We used EHR data from a large academic health center in the United States to replicate the original study conducted in Taiwan. We derived multiple computable phenotypes of risk factors and predictors used in the original study, reported stratified descriptive statistics, and assessed the performance of the prediction model.

RESULTS: In our replication study, it was possible to (re)compute most of the original variables. Nevertheless, for certain variables, their computable phenotypes can only be approximated by proxy with structured EHR data items, especially the composite clinical indices such as the Pitt bacteremia score. Even computable phenotype for the outcome variable was subject to variation on the basis of the admission/discharge windows. The replicated prediction model exhibited only a mild discriminatory ability.

CONCLUSION: Despite the rich information in EHR data, replication of prediction models involving complex predictors is still challenging, often due to the limited availability of validated computable phenotypes. On the other hand, it is often possible to derive proxy computable phenotypes that can be further validated and calibrated.

PMID:34332468 | DOI:10.1016/j.ijmedinf.2021.104531