Categories
Nevin Manimala Statistics

Jagged-1 Expression Level Is Correlated With Recurrence of Stage III Colorectal Cancer in Patients Receiving Adjuvant Chemotherapy

Anticancer Res. 2021 Sep;41(9):4645-4650. doi: 10.21873/anticanres.15278.

ABSTRACT

BACKGROUND/AIM: Previous reports have indicated that increased expression of Jagged-1 (JAG1) may predict chemotherapy response and poor prognosis for patients with recurrent or metastatic colorectal cancer (CRC). This study aimed to investigate the clinical impact of JAG1 expression level in patients with CRC, including recurrence, especially in those diagnosed with lymph node-positive stage III CRC who underwent complete resection and appropriate adjuvant chemotherapy.

PATIENTS AND METHODS: All patients were enrolled through a retrospective chart review, and only those for whom the clinical course and all clinical information were adequately determined according to the inclusion criteria were selected for retrospective review through medical records. Immunohistochemical staining of JAG1 was performed using paraffin-embedded tissue. JAG1 expression was determined by scoring for staining intensity and percentage of positively stained cells; the final JAG1 score was determined as the sum of both scores.

RESULTS: Sixteen patients who experienced relapse and 15 without (for over 3 years) were selected. The protein expression level of JAG1 showed a tendency for being lower in the group without recurrence, although not statistically significantly (p=0.083); however, the mean JAG1 expression score was significantly lower in the group without recurrence (1.53 vs. 3.19; p=0.004). The patients were divided into two groups with low and high JAG1 expression. The results showed that high JAG1 expression was significantly associated with recurrence of stage III CRC (p=0.029).

CONCLUSION: The expression of JAG1 may be a potential novel biomarker for predicting CRC recurrence.

PMID:34475093 | DOI:10.21873/anticanres.15278

Categories
Nevin Manimala Statistics

A Novel Prediction Model for Colon Cancer Recurrence Using Auto-artificial Intelligence

Anticancer Res. 2021 Sep;41(9):4629-4636. doi: 10.21873/anticanres.15276.

ABSTRACT

BACKGROUND/AIM: We aimed to develop a novel recurrence prediction model for stage II-III colon cancer using simple auto-artificial intelligence (AI) with improved accuracy compared to conventional statistical models.

PATIENTS AND METHODS: A total of 787 patients who had undergone curative surgery for stage II-III colon cancer between 2000 and 2018 were included. Binomial logistic regression analysis was used to calculate the effect of variables on recurrence. The auto-AI software ‘Prediction One’ (Sony Network Communications Inc.) was used to predict recurrence with the same dataset used for the conventional statical model. Predictive accuracy was assessed by the area under the receiver operating characteristic curve (AUC).

RESULTS: The AUC of the multivariate model was 0.719 (95%CI=0.655-0.784), whereas that of the AI model was 0.815, showing a significant improvement.

CONCLUSION: This auto-AI prediction model demonstrates improved accuracy compared to the conventional model. It could be constructed by clinical surgeons who are not familiar with AI.

PMID:34475091 | DOI:10.21873/anticanres.15276

Categories
Nevin Manimala Statistics

Early Menopause and Cardiovascular Disease Risk in Women With or Without Type 2 Diabetes: A Pooled Analysis of 9,374 Postmenopausal Women

Diabetes Care. 2021 Sep 2:dc211107. doi: 10.2337/dc21-1107. Online ahead of print.

ABSTRACT

OBJECTIVE: Early menopause may be associated with higher cardiovascular disease (CVD) risk. Type 2 diabetes mellitus (T2DM), coupled with early menopause, may result in even greater CVD risk in women. We examined CVD risk in women with early compared with normal-age menopause, with and without T2DM overall, and by race/ethnicity.

RESEARCH DESIGN AND METHODS: We pooled data from the Atherosclerosis Risk in Communities study, the Multi-Ethnic Study of Atherosclerosis, and the Jackson Heart Study. We included women with data on menopausal status, menopausal age, and T2DM, excluding pre- or perimenopausal women and those with prevalent CVD. Outcomes included incident coronary heart disease (CHD), stroke, heart failure (HF), and atherosclerotic cardiovascular disease (ASCVD) (CHD or stroke). We estimated the risk associated with early (<45 years) compared with normal-age menopause using Cox proportional hazards models. Covariates included age, race/ethnicity, education, BMI, blood pressure, cholesterol, smoking, alcohol consumption, antihypertensive medication, lipid-lowering medication, hormone therapy use, and pregnancy history.

RESULTS: We included 9,374 postmenopausal women for a median follow-up of 15 years. We observed 1,068 CHD, 659 stroke, 1,412 HF, and 1,567 ASCVD events. T2DM significantly modified the effect of early menopause on CVD risk. Adjusted hazard ratios for early menopause and the outcomes were greater in women with T2DM versus those without (CHD 1.15 [95% CI 1.00, 1.33] vs. 1.09 [1.03, 1.15]; stroke 1.21 [1.04, 1.40] vs. 1.10 [1.04, 1.16]; ASCVD 1.29 [1.09, 1.51] vs. 1.10 [1.04, 1.17]; HF 1.18 [1.00, 1.39] vs. 1.09 [1.03, 1.16]). The modifying effect of T2DM on the association between early menopause and ASCVD was only statistically significant in Black compared with White women.

CONCLUSIONS: Early menopause was associated with an increased risk for CVD in postmenopausal women. T2DM may further augment the risk, particularly in Black women.

PMID:34475032 | DOI:10.2337/dc21-1107

Categories
Nevin Manimala Statistics

Kernel density estimation in mixture models with known mixture proportions

Stat Med. 2021 Sep 2. doi: 10.1002/sim.9187. Online ahead of print.

ABSTRACT

In this article, we consider the density estimation for data with a mixture structure, where the component densities are assumed unknown, but for each observation, the probabilities of its membership to the subpopulations are known or estimable from other resources. Data of this kind arise from practice and have wide applications. Motivated from the classical kernel density estimation method for a single population, we propose a weighted kernel density estimation method to estimate the component density functions nonparametrically. Within the framework of the EM algorithm, we derive an algorithm that computes our proposed estimates effectively. Via extensive simulation studies, we demonstrate that our methods outperform the existing methods in most occasions. We further compare our methods with existing methods by real data examples.

PMID:34474504 | DOI:10.1002/sim.9187

Categories
Nevin Manimala Statistics

Application of Bloom’s taxonomy to formative assessment in real-time online classes in Korea

Korean J Med Educ. 2021 Sep;33(3):191-201. doi: 10.3946/kjme.2021.199. Epub 2021 Aug 27.

ABSTRACT

PURPOSE: This study aims to design that using formative assessment as an instructional strategy in real-time online classes, and to explore the application of Bloom’s taxonomy in the development of formative assessment items.

METHODS: We designed the instruction using formative assessment in real-time online classes, developed the items of formative assessment, analyzed the items statistically, and investigated students’ perceptions of formative assessment through a survey.

RESULTS: It is designed to consist of 2-3 learning outcomes per hour of class and to conduct the formative assessment with 1-2 items after the lecture for each learning outcome. Formative assessment was 31 times in the physiology classes (total 48 hours) of three basic medicine integrated. There were nine “knowledge” items, 40 “comprehension” items, and 55 “application” items. There were 33 items (31.7%) with a correct rate of 80% or higher, which the instructor thought was appropriate. As a result of the survey on students’ perceptions of formative assessment, they answered that it was able to concentrate on the class and that it was helpful in achieving learning outcomes.

CONCLUSION: The students focused during class because they had to take formative assessment immediately after the learning outcome lecture. “Integration of lesson and assessments” was maximized by solving the assessment items as well as through the instructor’s immediate explanation of answers. Through formative assessment, the students were able to utilize metacognition by learning what content they understood or did not understand. Items that consider Bloom’s taxonomy allow students to remember, understand, and apply to clinical contexts.

PMID:34474526 | DOI:10.3946/kjme.2021.199

Categories
Nevin Manimala Statistics

A simulation-extrapolation approach for regression analysis of misclassified current status data with the additive hazards model

Stat Med. 2021 Sep 2. doi: 10.1002/sim.9184. Online ahead of print.

ABSTRACT

Current status data arise when each subject is observed only once and the failure time of interest is only known to be either smaller or larger than the observation time rather than observed exactly. For the situation, due to the use of imperfect diagnostic tests, the failure status could often suffer misclassification or one observes misclassified data, which may result in severely biased estimation if not taken into account. In this article, we discuss regression analysis of such misclassified current status data arising from the additive hazards model, and a simulation-extrapolation (SIMEX) approach is developed for the estimation. Furthermore, the asymptotic properties of the proposed estimators are established, and a simulation study is conducted to assess the empirical performance of the method, which indicates that the proposed procedure performs well. In particular, it can correct the estimation bias given by the naive method that ignores the existence of misclassification. An application to a medical study on gonorrhea is also provided.

PMID:34474502 | DOI:10.1002/sim.9184

Categories
Nevin Manimala Statistics

Red Blood Cell Transfusion and its Relationship with Pedicle Thrombosis in Microvascular Free Flaps

J Reconstr Microsurg. 2021 Sep 2. doi: 10.1055/s-0041-1733994. Online ahead of print.

ABSTRACT

BACKGROUND: Free flaps have become a highly valuable tool for complex reconstructive surgeries. The requirement of red blood cell transfusion (RBCT) during the perioperative period is common and its effect on the free flap survival is debatable. The aim of this study was to determine the relationship between perioperative RBCT and vascular pedicle thrombosis (VPT).

METHODS: For this study 302 free flaps performed between January 2006 and December 2019 were retrospectively analyzed. It included their characteristics from before, during, and after the surgical procedure. The incidence of VPT and flap survival were calculated based on Kaplan Meier’s method and the relationship between VPT and perioperative variables were analyzed by Cox regression models.

RESULTS: The transfusion group was represented by 62 flaps (20.5%) and no transfusion by 240 flaps. The overall transfusion requirement was 20.5% and the cumulative incidence of VPT was 9.11%. A statistically significant relationship was not demonstrated between flap survival and transfusion status (HR = 1.73 IC 95%: 0.5 to 3.96; p = 0.192) (p = 0.192) independently from the number of units transfused, the preoperative diagnosis of anemia, and the type of flap used and did not establish an increased risk of VPT.

CONCLUSIONS: This study did not demonstrate an association between RBCT during preoperative period and the risk for VPT or microvascular free flap survival rate on postoperative follow up.

PMID:34474496 | DOI:10.1055/s-0041-1733994

Categories
Nevin Manimala Statistics

Quantifying the feasibility of shortening clinical trial duration using surrogate markers

Stat Med. 2021 Sep 2. doi: 10.1002/sim.9185. Online ahead of print.

ABSTRACT

The potential benefit of using a surrogate marker in place of a long-term primary outcome is very attractive in terms of the impact on study length and cost. Many available methods for quantifying the effectiveness of a surrogate endpoint either rely on strict parametric modeling assumptions or require that the primary outcome and surrogate marker are fully observed that is, not subject to censoring. Moreover, available methods for quantifying surrogacy typically provide a proportion of treatment effect explained (PTE) measure and do not directly address the important questions of whether and how the trial can be ended earlier using the surrogate marker. In this article, we specifically address these important questions by proposing a PTE measure to quantify the feasibility of ending trials early based on endpoint information collected at an earlier landmark point t0 in a time-to-event outcome setting. We provide a framework for deriving an optimally predicted outcome for individual patients at t0 based on a combination of surrogate marker and event time information in the presence of censoring. We propose a non-parametric estimator for the PTE measure and derive the asymptotic properties of our estimators. Finite sample performance of our estimators are illustrated via extensive simulation studies and a real data application examining the potential of hemoglobin A1c and fasting plasma glucose to predict treatment effects on long term diabetes risk based on the Diabetes Prevention Program study.

PMID:34474500 | DOI:10.1002/sim.9185

Categories
Nevin Manimala Statistics

Clinical and Patient-Reported Outcomes after Posterior (PLIF) versus Transforaminal Lumbar Interbody Fusion (TLIF) – A Propensity-Score Matched Cohort Study on 422 Patients with two-Year Follow-up

Spine (Phila Pa 1976). 2021 Aug 31. doi: 10.1097/BRS.0000000000004215. Online ahead of print.

ABSTRACT

STUDY DESIGN: This was a dual-center study over an eight-year period on patients undergoing single level fusion surgery with either posterior- (PLIF) or transforaminal lumbar interbody fusion (TLIF). We analyzed prospectively collected pre- and postoperative data from the national Danish surgical spine database (DaneSpine).

OBJECTIVE: To compare clinical and patient-reported outcome (PRO) two years after TLIF or PLIF in patients with symptomatic lumbar mechanical disc degeneration.

SUMMARY OF BACKGROUND DATA: PLIF and TLIF are well-described techniques for treating lumbar mechanical disc degeneration but whether the theoretical differences between the two techniques translate to different clinical outcomes is unknown.

METHODS: The primary outcome was Oswestry Disability Index (ODI) score at two-year follow-up. Secondary outcome measures were scores on the European Quality of Life-5 Dimensions (EQ-5D) and visual analog scale (VAS) and the rate of intraoperative complications. To minimize baseline differences between the groups, propensity-score matching was employed in a 1:1 fashion, balancing the groups on preoperative factors including age, sex, back and leg pain, ODI, EQ-5D and previous spine surgery.

RESULTS: The matched cohort included 211 patients in each cohort. There was no significant difference between the groups in the mean score on the ODI at two years (PLIF: 33 ± 20 vs. TLIF: 35 ± 20, p = 0.328). We found no statistically significant differences in EQ-5D score (0.54 ± 0.35 vs. 0.51 ± 0.34, p = 0.327), VAS score for back pain (47 ± 32 vs. 48 ± 29, p = 0.570) or leg pain (42 ± 33 vs.41 ± 32, p = 0.936) between the PLIF and TLIF groups, respectively at two-year follow-up. Dural tears occurred in 9.5% in the PLIF group and 1.9% in the TLIF group (p = 0.002) corresponding to a relative risk of 5.0 (95%CI 1.7-14.4).

CONCLUSIONS: We found no significant difference in PRO at two-year follow-up between PLIF and TLIF for the treatment of lumbar disc degeneration. PLIF is associated with a five-times higher risk of dural tears.Level of evidence: 3.

PMID:34474454 | DOI:10.1097/BRS.0000000000004215

Categories
Nevin Manimala Statistics

“Prevalence of Anxiety and Depression in Patients with Primary Glaucoma in Western India”

J Glaucoma. 2021 Sep 2. doi: 10.1097/IJG.0000000000001935. Online ahead of print.

ABSTRACT

PRECIS: Glaucoma can cause disturbance in psychological and emotional functioning of patients, leading to anxiety and depression, even early in the disease. Identification and management of these problems should be included as a part of the holistic approach for patient care.

PURPOSE: To assess the prevalence of anxiety and depression in patients with primary glaucoma using a standard validated questionnaire.

METHODS: A cross-sectional prevalence study was carried out on 200 patients attending the glaucoma outpatient clinic at a tertiary care eye hospital in Pune, India. After obtaining written consent, all patients underwent a thorough ophthalmic examination. Those with primary glaucoma were included in the study and classified on the basis of the Hodapp-Parrish-Anderson criteria. Participants were asked to respond to the Hospital Anxiety and Depression Scale (HADS) questionnaire and responses were analyzed statistically.

RESULTS: Mean HADS- Anxiety (HADS-A) score was 4.5 (SD 3.4) while HADS-Depression (HADS-D) was 4.1 (SD 3.8). Severity of disease was associated with significantly higher HADS scores. Mean HADS-A scores were 3.1 (SD 2.9) mild glaucoma, 4.4 (SD 2.6) for moderate and 7.7 (SD 3.0) for advanced disease (P<0.001). Similarly mean HADS-D scores were 2.0 (SD 2.6), 4.2 (SD 3.0) and 8.3 (SD 3.3) respectively for mild, moderate and severe glaucoma (P<0.001). Based on HADS scores, a quarter of patients (25.5%) were symptomatic for anxiety or depression, out of which 25 (12.5%) could be classified as definite cases. Duration of treatment had no association with HADS scores.

CONCLUSION: An association exists between the amount of visual loss among patients with glaucoma, and symptoms of anxiety and depression, irrespective of disease duration. This information may help to choose treatment approaches most likely to be beneficial to the patients.

PMID:34474423 | DOI:10.1097/IJG.0000000000001935