Categories
Nevin Manimala Statistics

A Prospective Multicenter Observational Study of Venous Thromboembolism after Gastric Cancer Surgery (SHISA-1601)

Eur Surg Res. 2021 Mar 3:1-10. doi: 10.1159/000514309. Online ahead of print.

ABSTRACT

INTRODUCTION: This study aimed to clarify the frequency and risk factors of intercurrent venous thromboembolism (VTE) in patients undergoing major curative gastric cancer surgery.

METHODS: This prospective, multicenter, observational study included patients with gastric cancer who underwent radical gastrectomy at 5 hospitals between June 2016 and May 2018. Patients who were preoperatively administered anticoagulants were excluded.

RESULTS: A total of 126 patients were eligible to participate. VTE occurred within 9 days postoperatively in 5 cases (4.0%; 2 symptomatic and 3 asymptomatic). Postoperative day (POD) 1 plasma D-dimer and soluble fibrin (SF) levels were significantly higher in the VTE group than in the non-VTE group. Receiver-operating characteristic curve (ROC) analysis indicated a statistically significant ability of POD 1 D-dimer and SF levels to predict postoperative VTE development after gastrectomy; this finding was reflected by an area under the curve (AUC) of 0.97 (95% CI 0.92-1.0) and 0.87 (95% CI 0.74-1.0), respectively. Cutoff values of D-dimer (24.6 µg/mL) and SF (64.1 µg/mL) were determined. Intraoperative blood transfusion (odds ratio [OR] 7.86), POD 1 D-dimer ≥24.6 µg/mL (OR 17.35), and POD 1 SF ≥64.1 µg/mL (OR 19.5) were independent predictive factors for postoperative VTE (p < 0.05).

CONCLUSION: VTE occurred in 4.0% patients (1.6% symptomatic and 2.4% asymptomatic) after gastric cancer surgery; however, with an early diagnosis and anticoagulant therapy, no patients experienced progression. Careful observation of patients with a high risk for VTE, including intraoperative blood transfusion and high POD 1 D-dimer or SF levels, would contribute to the early detection of VTE.

PMID:33657552 | DOI:10.1159/000514309

Categories
Nevin Manimala Statistics

An analysis of scatter characteristics in x-ray CT spectral correction

Phys Med Biol. 2021 Mar 3. doi: 10.1088/1361-6560/abebab. Online ahead of print.

ABSTRACT

X-ray scatter remains a major physics challenge in volumetric computed tomography (CT), whose physical and statistical behaviors have been commonly leveraged in order to eliminate its impact on CT image quality. In this work, we conduct an in-depth derivation of how the scatter distribution and scatter to primary ratio (SPR) will change during the spectral correction, leading to an interesting finding on the property of scatter. Such a characterization of scatter’s behavior provides an analytic approach of compensating for the SPR as well as approximating the change of scatter distribution after spectral correction, even though both of them might be significantly distorted as the linearization mapping function in spectral correction could vary a lot from one detector pixel to another. We conduct an evaluation of SPR compensations on a Catphan phantom and an anthropomorphic chest phantom to validate the characteristics of scatter. In addition, this scatter property is also directly adopted into CT imaging using a spectral modulator with flying focal spot technology (SMFFS) as an example to demonstrate its potential in practical applications. For cone-beam CT scans at both 80 and 120 kVp, CT images with accurate CT numbers can be achieved after spectral correction followed by the appropriate SPR compensation based on our presented scatter property. In the case of the SMFFS based cone-beam CT scan of the Catphan phantom at 120 kVp, after a scatter correction using an analytic algorithm derived from the scatter property, CT image quality was significantly improved, with the averaged root mean square error reduced from 297.9 to 6.5 Hounsfield units (HU).

PMID:33657536 | DOI:10.1088/1361-6560/abebab

Categories
Nevin Manimala Statistics

Evaluation of the efficacy of vaginal progesterone in preventing preterm birth after abdominal trachelectomy

Eur J Obstet Gynecol Reprod Biol. 2021 Feb 13;259:119-124. doi: 10.1016/j.ejogrb.2021.02.009. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine whether vaginal progesterone (VP) reduces the rate of preterm birth in pregnant women after abdominal trachelectomy (AT) for early-stage cervical cancer STUDY DESIGN: This is an interventional study with a historical cohort. For the interventional study participants who had singleton pregnancies after AT between October 2016 and September 2020, the administration of vaginal progesterone was started between 16+ and 19+6 weeks of gestation and discontinued at 34 weeks of gestation or at the time of delivery, rupture of membranes, or massive uterine bleeding. We investigated obstetric and neonatal outcomes among the study participants and compared them with outcomes of the historical control group participants, included women with singleton pregnancies after AT who were managed without VP at our institution between January 2007 and September 2016, using Fisher’s exact test and the Mann-Whitney U test The main outcomes were the gestational age at delivery and incidence of preterm birth before 37 weeks and 34 weeks of gestation.

RESULT: Twelve pregnancies in ten women were included in the VP group. In contrast, 19 pregnancies in 17 women were included in the historical control group. The incidence of preterm birth at <37 weeks was 10/12 (83 %) in the VP group and 11/19 (58 %) in the control group. The incidence of preterm birth at <34 weeks was 6/12 (50 %) in the VP group and 9/19 (48 %) in the control group. The incidence of preterm birth in the two groups was similar, and the difference between the two groups was not statistically significant.

CONCLUSION: The administration of vaginal progesterone did not reduce the rate of preterm birth among pregnant women after AT.

PMID:33657512 | DOI:10.1016/j.ejogrb.2021.02.009

Categories
Nevin Manimala Statistics

The electrocardiographic manifestations and derangements of 2019 novel coronavirus disease (COVID-19)

Indian Pacing Electrophysiol J. 2021 Feb 28:S0972-6292(21)00024-3. doi: 10.1016/j.ipej.2021.02.005. Online ahead of print.

ABSTRACT

Electrocardiographic (ECG) findings in patients admitted with COVID-19 and a decision tree to predict their survival were assessed. 145 consecutive patients with severe COVID-19 infection were selected. Patient demographics, ECG variables, peak troponins, use of standard medications, and clinical outcomes were analyzed using descriptive and inferential statistics, and a predictive model of survival was developed using classification tree analysis. Of the 145 admitted patients, 38 (26%) died. Deceased patients were more likely to have a significantly higher incidence of poor R-Wave progression [6 of 37 (16.2%) Vs. 0 of 104 (0%), p < 0.001] as well as prolonged QTc values [24 of 37 (64.9%) Vs. 38 of 99 (38.4%), p 0.006]. Significant ST segment depressions were found in 5 of 37 (13.5%) of the deceased category compared to 0% in the non-deceased (p < 0.01). Right and/or left atrial enlargement was more prevalent in the deceased cohort [7 of 37 (18.9%) Vs. 4 of 104 (3.8%), p = 0.03]. Bundle branch blocks were more prevalent in the deceased group [9 of 35 (25.8%) Vs. 7 of 104 (6.7%), p 0.002]. Peak troponins were significantly higher in the deceased group (1.0 Vs 0.07 ng/ml, p < 0.001) A prediction tree built utilizing age, PACs, troponins and QTc had an accuracy of 85.5%. 65 of 74 patients (87.8%) were correctly predicted to survive, while 23 of 29 (79.3%) were correctly predicted to become deceased. Among patients hospitalized with Covid-19, the parameters of age, QT interval, troponin and PACs are useful for prognostication and help predict survival with reasonable accuracy.

PMID:33657456 | DOI:10.1016/j.ipej.2021.02.005

Categories
Nevin Manimala Statistics

Counseling, Contraception, and Conception Rates in Patients Undergoing Bariatric Surgery: A Retrospective Review

Contraception. 2021 Feb 28:S0010-7824(21)00053-6. doi: 10.1016/j.contraception.2021.02.012. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine conception rates, contraceptive use patterns, and frequency of counseling regarding pregnancy recommendations in patients undergoing bariatric surgery.

STUDY DESIGN: Using a database of bariatric surgery patients at our institution, we identified female patients aged 18 to 45 who underwent surgery from 2013 to 2018. Patient charts were reviewed for demographic information, documentation of counseling regarding pregnancy recommendations, conception during the postoperative period, and pre and postoperative contraception use. We examined rates of contraception use and used standard statistical tests to compare conception rates between groups.

RESULTS: Of the 460 patients that met inclusion criteria and did not have a history of permanent contraception, 54% (95% CI 49-58) had documented postoperative contraception use, most commonly the levonorgestrel-releasing intrauterine device followed by combination oral contraceptive pills. In the 18 months following bariatric surgery, 6% of patients (95% CI 4-8) had a documented pregnancy. Over 50% (95% CI 35-71) of pregnancies occurred in patients without documented postoperative contraception.

CONCLUSION: For bariatric surgery patients at risk of pregnancy, postoperative contraception use patterns and conception rates are not consistent with the recommendation to refrain from pregnancy for 18 months.

IMPLICATIONS: Individualized contraceptive counseling that includes a discussion of fertility and weight loss goals, planned bariatric procedure type, and patient preference should be implemented as part of standard preoperative care for patients at risk of pregnancy undergoing bariatric surgery.

PMID:33657426 | DOI:10.1016/j.contraception.2021.02.012

Categories
Nevin Manimala Statistics

Rivaroxaban Monotherapy versus Combination Therapy According to Patient Risk of Stroke and Bleeding in Atrial Fibrillation and Stable Coronary Disease: AFIRE trial sub-analysis

Am Heart J. 2021 Feb 28:S0002-8703(21)00063-6. doi: 10.1016/j.ahj.2021.02.021. Online ahead of print.

ABSTRACT

BACKGROUND: In the AFIRE trial, rivaroxaban monotherapy was non-inferior to combination therapy with rivaroxaban and an antiplatelet agent for thromboembolic events or death, and superior for major bleeding in patients with atrial fibrillation (AF) and stable coronary artery disease (CAD). Little is known about impacts of stroke and bleeding risks on the efficacy and safety of rivaroxaban monotherapy.

METHODS: In this sub-analysis of the AFIRE trial, we assessed the risk of stroke and bleeding by the CHADS2, CHA2DS2-VASc, and HAS-BLED scores. The primary efficacy endpoint was the composite of stroke, systemic embolism, myocardial infarction (MI), unstable angina requiring revascularization, or death from any cause. The primary safety endpoint was major bleeding defined by the International Society on Thrombosis and Haemostasis.

RESULTS: Rivaroxaban monotherapy significantly reduced the primary efficacy and safety endpoints with no evidence of differential effects by stroke risk (CHADS2, p for interaction=0.727 for efficacy, 0.395 for safety; CHA2DS2-VASc, p for interaction=0.740 for efficacy, 0.265 for safety) or bleeding risk (HAS-BLED, p for interaction=0.581 for efficacy, 0.225 for safety). There was also no evidence of statistical heterogeneity across patient risk categories for other endpoints; stroke or systemic embolism, ischemic stroke, hemorrhagic stroke, MI, MI or unstable angina, death from any cause, any bleeding, or net adverse clinical events.

CONCLUSIONS: The advantages of rivaroxaban monotherapy compared with those of combination therapy with respect to all pre-specified endpoints, including thromboembolism, bleeding, and mortality were similar across patients with AF and stable CAD, irrespective of their risk for stroke and bleeding.

CLINICAL TRIAL REGISTRATION: UMIN Clinical Trials Registry number, UMIN000016612, and ClinicalTrials.gov number, NCT02642419.

PMID:33657403 | DOI:10.1016/j.ahj.2021.02.021

Categories
Nevin Manimala Statistics

Caregiver Perspectives on School Participation Among Students With Craniofacial Microsomia

Am J Occup Ther. 2021 Mar-Apr;75(2):7502205100p1-7502205100p10. doi: 10.5014/ajot.2021.041277.

ABSTRACT

IMPORTANCE: Knowledge of unmet school participation needs for students with craniofacial microsomia (CFM) can inform decisions regarding intervention support.

OBJECTIVE: To compare students with and without CFM on school participation (i.e., frequency, involvement, desire for participation to change) and caregivers’ perceptions of environmental support for participation in occupations.

DESIGN: Cross-sectional design using secondary analyses of a subset of data.

SETTING: Multisite cohort study.

PARTICIPANTS: Caregivers of students with CFM (n = 120) and of students without CFM (n = 315), stratified by history of education- and health-related service use.

OUTCOMES AND MEASURES: School participation and environmental support, obtained with the Participation and Environment Measure-Children and Youth.

RESULTS: Significant group differences were found in frequency of school participation (effect size [ES] = -0.38, 95% confidence interval [-0.64, -0.12], p = .005), level of involvement (ES = -0.14, p = .029), and desired change (p = .001), with students with CFM exhibiting greater participation restriction than students without CFM and no history of service use. No statistically significant group differences were found in environmental support for participation in the school setting. Item-level findings showed statistically significant higher desire for participation to change in three of five school occupations (odds ratio = 1.77-2.39, p = .003-.045) for students with CFM compared with students without CFM and no history of service use.

CONCLUSIONS AND RELEVANCE: The results suggest that students with CFM experience restriction in participation at school.

WHAT THIS ARTICLE ADDS: Students with CFM may benefit from targeted school-based interventions to optimize their inclusion.

PMID:33657352 | DOI:10.5014/ajot.2021.041277

Categories
Nevin Manimala Statistics

Reliability and Validity of the Spanish Version of the Executive Function Performance Test (EFPT) in Assessing People in Treatment for Substance Addiction

Am J Occup Ther. 2021 Mar-Apr;75(2):7502205080p1-7502205080p11. doi: 10.5014/ajot.2020.041897.

ABSTRACT

IMPORTANCE: Assessing people’s executive function (EF) during addiction treatment makes it possible to design individualized occupational goals.

OBJECTIVE: To determine the reliability and validity of the Spanish version of the Executive Function Performance Test (EFPT) in the occupational assessment of people being treated for substance addiction.

DESIGN: Cross-sectional, observational study to determine the EFPT’s internal consistency as well as its convergent and discriminant validity with complementary tests.

SETTING: A public, free addiction treatment center operated by Madrid Salud (Madrid City Council, Spain).

PARTICIPANTS: Fifty-two people referred to an occupational therapy department for evaluation and intervention. Inclusion was based on Diagnostic and Statistical Manual of Mental Disorders (4th ed., text revision) criteria for substance abuse or dependence; the exclusion criterion consisted of any circumstances that made it difficult for a person to understand or perform the test.

OUTCOMES AND MEASURES: The EFPT, other occupational tests (Allen Cognitive Level Screen-5, Lowenstein Occupational Therapy Cognitive Assessment), and a battery of neuropsychological EF tests.

RESULTS: The EFPT had an unequivocal unifactorial structure and showed strong correlations between its components and adequate consistency with the scales and the complete test. As expected, the EFPT correlated with the neuropsychological tests with a considerable effect size (-.40 < r < -.60).

CONCLUSIONS AND RELEVANCE: The EFPT’s psychometric properties are adequate to assess the EF of people being treated for substance addiction from an occupational perspective using real activities of daily living (ADLs).

WHAT THIS ARTICLE ADDS: The results show that the EFPT can be used to assess performance of ADLs without needing to use tests from disciplines other than occupational therapy. Further studies in different sociocultural settings are needed to generalize the results.

PMID:33657350 | DOI:10.5014/ajot.2020.041897

Categories
Nevin Manimala Statistics

Post-Transplant Cyclophosphamide (PTCy) is Associated with Increased Cytomegalovirus Infection: A CIBMTR Analysis

Blood. 2021 Mar 3:blood.2020009362. doi: 10.1182/blood.2020009362. Online ahead of print.

ABSTRACT

Prior studies suggest increased CMV infection following haploidentical donor transplantation with post-transplant cyclophosphamide (HaploCy). The role of allograft source and PTCy in CMV infection and disease is unclear. We analyzed the effect of graft source and PTCy on incidence of CMV infection as well as transplant outcomes as it relates to CMV serostatus and occurrence of CMV infection by d180. We examined patients reported to CIBMTR between 2012-2017 who had received HaploCy (n = 757), Sib with PTCy (SibCy, n=403), or Sib with calcineurin inhibitor-based prophylaxis (SibCNI, n=1605) for AML/ALL/MDS. Cumulative incidences of CMV infection by d180 were 42% (99% CI, 37-46), 37% (31 – 43), and 23% (20 – 26), respectively [p<0.001]. CMV end-organ disease was statistically comparable. CMV infection risk was highest for CMV-Seropositive recipients (R+), but significantly higher in PTCy recipients regardless of donor [HaploCy (n=545): HR 50.3 (14.4 – 175.2); SibCy (n=279): HR 47.7 (13.3 – 171.4); SibCNI (n=1065): HR 24.4 (7.2 – 83.1); p<0.001]. D+/R- patients also had increased risk for CMV infection. Among seropositive recipients or those developing CMV infection, HaploCy had worse OS and NRM. Relapse was unaffected by CMV infection or serostatus. PTCy was associated with lower chronic GVHD overall, but CMV infection in PTCy recipients was associated with higher cGVHD (p=0.006). PTCy, regardless of donor, is associated with higher incidence of CMV infection, augmenting the risk of seropositivity. Additionally CMV infection may negate the cGVHD protection of PTCy. This study supports aggressive prevention strategies in all patients receiving PTCy.

PMID:33657221 | DOI:10.1182/blood.2020009362

Categories
Nevin Manimala Statistics

Adaptive learning algorithms to optimize mobile applications for behavioral health: guidelines for design decisions

J Am Med Inform Assoc. 2021 Feb 28:ocab001. doi: 10.1093/jamia/ocab001. Online ahead of print.

ABSTRACT

OBJECTIVE: Providing behavioral health interventions via smartphones allows these interventions to be adapted to the changing behavior, preferences, and needs of individuals. This can be achieved through reinforcement learning (RL), a sub-area of machine learning. However, many challenges could affect the effectiveness of these algorithms in the real world. We provide guidelines for decision-making.

MATERIALS AND METHODS: Using thematic analysis, we describe challenges, considerations, and solutions for algorithm design decisions in a collaboration between health services researchers, clinicians, and data scientists. We use the design process of an RL algorithm for a mobile health study “DIAMANTE” for increasing physical activity in underserved patients with diabetes and depression. Over the 1.5-year project, we kept track of the research process using collaborative cloud Google Documents, Whatsapp messenger, and video teleconferencing. We discussed, categorized, and coded critical challenges. We grouped challenges to create thematic topic process domains.

RESULTS: Nine challenges emerged, which we divided into 3 major themes: 1. Choosing the model for decision-making, including appropriate contextual and reward variables; 2. Data handling/collection, such as how to deal with missing or incorrect data in real-time; 3. Weighing the algorithm performance vs effectiveness/implementation in real-world settings.

CONCLUSION: The creation of effective behavioral health interventions does not depend only on final algorithm performance. Many decisions in the real world are necessary to formulate the design of problem parameters to which an algorithm is applied. Researchers must document and evaulate these considerations and decisions before and during the intervention period, to increase transparency, accountability, and reproducibility.

TRIAL REGISTRATION: clinicaltrials.gov, NCT03490253.

PMID:33657217 | DOI:10.1093/jamia/ocab001