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Nevin Manimala Statistics

Childhood obesity prevention trials: A systematic review and meta-analysis on trial design and the impact of type 1 error

Obes Rev. 2024 Mar 26:e13736. doi: 10.1111/obr.13736. Online ahead of print.

ABSTRACT

Effect sizes from previously reported trials are often used to determine the meaningful change in weight in childhood obesity prevention interventions because information on clinically meaningful differences is lacking. Estimates from previous trials may be influenced by statistical significance; therefore, it is important that they have a low risk of type 1 error. A systematic review and meta-analysis were conducted to report on the design of child obesity prevention randomized controlled trials and effectiveness according to risk of type 1 error. Eighty-four randomized controlled trials were identified. A large range of assumptions were applied in the sample size calculations. The most common primary outcome was BMI, with detectable effect size differences used in sample size calculations ranging from 0.25 kg/m2 (followed up at 2 years) to 1.1 kg/m2 (at 9 months) and BMI z-score ranging from 0.1 (at 4 years) to 0.67 (at 3 years). There was no consistent relationship between low risk of type 1 error and reports of higher or lower effectiveness. Further clarity of the size of a meaningful difference in weight in childhood obesity prevention trials is required to support evaluation design and decision-making for intervention and policy. Type 1 error risk does not appear to impact effect sizes in a consistent direction.

PMID:38529530 | DOI:10.1111/obr.13736

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Development and validation of a practical clinical risk prediction model for post-endoscopic retrograde cholangiopancreatography pancreatitis

DEN open. 2024 Mar 25;4(1):e355. doi: 10.1002/deo2.355. eCollection 2024 Apr.

ABSTRACT

BACKGROUND: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) can lead to significant morbidity and mortality. We aimed to develop an accurate post-ERCP pancreatitis risk prediction model using easily obtainable variables.

METHODS: Using prospective multi-center ERCP data, we performed logistic regression using stepwise selection on several patient-, procedure-, and endoscopist-related factors that were determined a priori. The final model was based on a combination of the Bayesian information criterion and Akaike’s information criterion performance, balancing the inclusion of clinically relevant variables and model parsimony. All available data were used for model development, with subsequent internal validation performed on bootstrapped data using 10-fold cross-validation.

RESULTS: Data from 3021 ERCPs were used to inform models. There were 151 cases of post-ERCP pancreatitis (5.0% incidence). Variables included in the final model included female sex, pancreatic duct cannulation, native papilla status, pre-cut sphincterotomy, increasing cannulation time, presence of biliary stricture, patient age, and placement of a pancreatic duct stent. The final model was discriminating, with a receiver operating characteristic curve statistic of 0.79, and well-calibrated, with a predicted risk-to-observed risk ratio of 1.003.

CONCLUSIONS: We successfully developed and internally validated a promising post-ERCP pancreatitis clinical prediction model using easily obtainable variables that are known at baseline or observed during the ERCP procedure. The model achieved an area under the curve of 0.79. External validation is planned as additional data becomes available.

PMID:38529515 | PMC:PMC10962486 | DOI:10.1002/deo2.355

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Rectus muscle diastasis in Italian women: determinants of disease severity, and associated disorders

Front Surg. 2024 Mar 11;11:1360207. doi: 10.3389/fsurg.2024.1360207. eCollection 2024.

ABSTRACT

PURPOSE: Diastasis of rectus abdominis (DRA) refers to a separation of the rectus abdominis from the linea alba, which is common in the female population during pregnancy and in the postpartum period. The present study aimed at investigating DRA severity, risk factors and associated disorders.

METHODS: In the present cross-sectional study, a web-based questionnaire was addressed to the 23,000 members of the Women’s Diastasis Association. The questionnaire comprised three parts, dedicated respectively to diastasis characteristics, possible risk factors, and related disorders. Faecal and urinary incontinences were assessed using the Wexner and ICIQ-SF score, respectively. Risk factors for diastasis severity (<3, 3-5, >5 cm) were evaluated by a multinomial regression model.

RESULTS: Four thousand six hundred twenty-nine women with a mean age (SD) of 39.8 (6.5) years and a median BMI of 23.7 kg/m2 (range 16.0-40.0) responded to the questionnaire. Proportion of DRA >5 cm increased from 22.8% in norm weight women to 44.0% in severely obese women, and from 10.0% in nulliparous women to 39.3% in women with >3 pregnancies. These associations were confirmed in multivariable analysis. DRA severity was associated with the risk of abdominal hernia and pelvic prolapse, whose prevalence more than doubled from women with DRA <3 cm (31.6% and 9.7%, respectively) to women with DRA >5 cm (68.2% and 20.2%). In addition, most patients reported postural pain and urinary incontinence, whose frequency increased with DRA severity.

CONCLUSION: The present study confirmed that DRA severity increases with increasing BMI and number of pregnancies. Larger separation between rectal muscles was associated with increased risk of pain/discomfort, urinary incontinence, abdominal hernia and pelvic prolapse. Prospective studies are needed to better evaluate risk factors.

PMID:38529469 | PMC:PMC10961386 | DOI:10.3389/fsurg.2024.1360207

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Nevin Manimala Statistics

Analysis of Sedation Accident Records Available in the Japan Council for Quality Health Care Public Database

Cureus. 2024 Feb 23;16(2):e54793. doi: 10.7759/cureus.54793. eCollection 2024 Feb.

ABSTRACT

OBJECTIVE: Medical accidents occur frequently. However, only a few studies have been conducted on sedation-related medical accidents. This study aimed to classify sedation accidents and analyze their causes using the (Patient-management Software Hardware Environment Livewear (P-mSHELL) model.

METHODS: The Japan Council for Quality Health Care database on medical accidents was used. Sedation accidents that occurred during procedures between January 2010 and June 2022 were included. After examining the accident details for several variables, the accident factors were classified by factors in the P-mSHELL model, and statistical analyses, including multivariate analysis of each factor and outcome (presence or absence of residual disability), were conducted.

RESULTS: Regarding the influence of the P-mSHELL factors on outcome, P factor (odds ratio = 6.347, 95% confidence interval = 2.000, 20.144) was a factor for having disability. There was a significant association between outcome and accident timing (that is, preoperative, intraoperative, or postoperative; p =0.01). No significant association was found between the outcomes and types of drugs used (p =1, 0.722, 0.594); however, there was a significant association between the incidence of respiratory depression and multiple drug use (p <0.001).

CONCLUSIONS: To prevent sedation accidents, it is important to monitor patients throughout the perioperative period. However, it is especially important to know the patient’s condition in advance, and strict postoperative management is essential, especially for high-risk patients, to prevent serious accidents.

PMID:38529461 | PMC:PMC10961928 | DOI:10.7759/cureus.54793

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Congenital Heart Defects in Pregnancies Conceived by Assisted Reproductive Technology: Comparing Functional and Structural Defects

Cureus. 2024 Feb 24;16(2):e54810. doi: 10.7759/cureus.54810. eCollection 2024 Feb.

ABSTRACT

Introduction Congenital heart defects (CHD) are one of the most common congenital anomalies, and their association with assisted reproductive technology (ART) is controversial in different populations. The purpose of this study was to evaluate this association and to provide information about the necessity of specialized echocardiography during pregnancy with ART. Methods This retrospective study was performed on all pregnancies conceived by ART and referred for fetal echocardiography to the Rasoul Akram and Akbar Abadi hospitals in Tehran, Iran. A total of 109 patients were enrolled in the study (56 in the ART group and 53 in the non-ART). Two-dimensional and color Doppler echocardiography were performed on all patients to identify heart problems and anomalies and medical records of the patients were reviewed. The outcome was considered the presence of functional and structural heart defects on echocardiography. Results The study groups were similar in terms of maternal age and GA. The ART group consisted of 31 singletons (55%) and 25 multiples (45%). All pregnancies in the non-ART group were singletons. Following in vitro fertilization (33%), ovulation induction (25%) was the next most used method. The findings of echocardiography were one atrial septal defect (ASD) in ART and one in non-ART, six ventricular septal defects (VSD) in ART and three in non-ART, and one ASD and VSD in the ART group. These structural abnormalities showed no difference in the two groups (P value = 0.58). There was no significant difference in rhythm between the two groups (P = 0.51). Echocardiographic indices of both groups did not differ statistically except in the TR-PG index (P value = 0.02). Conclusions The structural defects of the two groups were not different, and no heart dysfunction was observed in ART fetuses. There was no association between ART and CHD in our study. We concluded that echocardiography by pediatric cardiologists is not necessary for these fetuses.

PMID:38529454 | PMC:PMC10961672 | DOI:10.7759/cureus.54810

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Development and Validation of a Nomogram for Prognosis Prediction in Patients with Synchronous Primary Thyroid and Breast Cancer Based on SEER Database

Cancer Invest. 2024 Mar 25:1-14. doi: 10.1080/07357907.2024.2329963. Online ahead of print.

ABSTRACT

This study aimed to develop prognostic prediction models for patients diagnosed with synchronous thyroid and breast cancer (TBC). Utilizing the SEER database, key predictive factors were identified, including T stage of thyroid cancer, T stage of breast cancer, M stage of breast cancer, patient age, thyroid cancer surgery type, and isotope therapy. A nomogram predicting 5-year and 10-year survival rates was constructed and validated, exhibiting strong performance (C-statistic: 0.79 in the development cohort (95% CI: 0.74-0.84), and 0.82 in the validation cohort (95% CI: 0.77-0.89)). The area under the Receiver Operator Characteristic (ROC) curve ranged from 0.798 to 0.883 for both cohorts. Calibration and decision curve analyses further affirmed the model’s clinical utility. Stratifying patients into high-risk and low-risk groups using the nomogram revealed significant differences in survival rates (P < 0.0001). The successful development and validation of this nomogram for predicting 5-year and 10-year survival rates in patients with synchronous TBC hold promise for similar patient populations, contributing significantly to cancer research.

PMID:38527848 | DOI:10.1080/07357907.2024.2329963

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Single non-blood-related umbilical cord blood transplantation using a reduced-intensity conditioning regimen for the treatment of severe aplastic anemia

Zhonghua Xue Ye Xue Za Zhi. 2024 Jan 14;45(1):68-73. doi: 10.3760/cma.j.issn.0253-2727.121090-20230928-00146.

ABSTRACT

Objective: To evaluated the clinical efficacy of a reduced-intensity preconditioning regimen for single non-blood-related umbilical cord blood transplantation (sUCBT) in the treatment of severe aplastic anemia (SAA) . Methods: The clinical data of 63 patients with SAA who underwent sUCBT from January 2021 to July 2023 at the Department of Hematology of the First Affiliated Hospital of USTC were retrospectively analyzed. Fifty-two patients received total body irradiation/total bone marrow irradiation (TMI) combined with fludarabine or a cyclophosphamide- conditioning regimen (non-rATG group) , while 11 patients received rabbit anti-human thymocyte immunoglobulin (rATG) combined with TMI, fludarabine, or the cyclophosphamide-conditioning regimen (rATG group) . All patients received cyclosporine A and mycophenolate mofetil for graft-versus-host disease (GVHD) prophylaxis. Complications post-transplantation and long-term survival were compared between the two groups. Results: The baseline parameters were balanced between the two groups (P>0.05) . In the rATG group, all patients achieved stem cell engraftment, and in the non-rATG group, five patients had primary graft failure. There was no significant difference in the cumulative incidence of neutrophil engraftment at 42 days after transplantation or platelet engraftment at 60 days between the two groups. The incidence of grade Ⅱ-Ⅳ acute GVHD in the rATG group was significantly lower than in the non-rATG group (10.0% vs. 46.2% , P=0.032) , and the differences in the cumulative incidences of grade Ⅲ/Ⅳ acute GVHD and 1-year chronic GVHD were not statistically significant (P=0.367 and P=0.053, respectively) . There were no significant differences in the incidences of pre-engraftment syndrome, bacterial bloodstream infections, cytomegalovirus viremia, or hemorrhagic cystitis between the two groups (P>0.05 for all) . The median follow-up time for surviving patients was 536 (61-993) days, and the 1-year transplantation related mortality (TRM) of all patients after transplantation was 13.0% (95% CI 6.7% -24.3% ) . Among the patients in the non-rATG and rATG groups, 15.5% (95% CI 8.1% -28.6% ) and 0% (P=0.189) , respectively, had mutations. The 1-year overall survival (OS) rate of all patients after transplantation was 87.0% (95% CI 75.7% -93.3% ) . The 1-year OS rates in the rATG group and non-rATG group after transplantation were 100% and 84.5% , respectively (95% CI 71.4% -91.9% ) (P=0.198) . Conclusion: The preliminary results of sUCBT with a low-dose irradiation-based reduced-intensity conditioning regimen with fludarabine/cyclophosphamide for the treatment of patients with SAA showed good efficacy. Early application of low-dose rATG can reduce the incidence of acute GVHD after transplantation without increasing the risk of implantation failure or infection.

PMID:38527841 | DOI:10.3760/cma.j.issn.0253-2727.121090-20230928-00146

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Effects of calcium channel blockers on perioperative ischemic events in hypertensive patients with intracranial aneurysms undergoing neurointervention

J Neurointerv Surg. 2024 Mar 25:jnis-2024-021543. doi: 10.1136/jnis-2024-021543. Online ahead of print.

ABSTRACT

BACKGROUND: Although calcium channel blockers (CCBs) are useful in stroke prevention, their specific role in preventing stroke in hypertensive patients with intracranial aneurysms undergoing endovascular stent placement remains unclear.

METHODS: We retrospectively examined 458 hypertensive patients with intracranial aneurysms who underwent stent treatment, drawn from a larger multicenter cohort comprising 1326 patients across eight centers. Patients were dichotomized into two groups according to use of a CCB. Propensity score matching (PSM) was performed to balance group differences in patient and aneurysm characteristics. We conducted a comparison of patient and aneurysm characteristics, ischemic complications, and clinical outcomes between the two groups.

RESULTS: The CCB and non-CCB groups comprised 279 and 179 patients, respectively. PSM resulted in 165 matched pairs. After PSM, the incidence of ischemic events within 1 month of the procedure (4.2% vs 10.9%; P=0.022) and proportion of patients with modified Rankin Scale score >2 at last follow-up (1.5% vs 7.8%; P=0.013) were significantly lower in the CCB group. Among patients treated with combination therapy, inclusion of a CCB was associated with a lower incidence of ischemic events (1.5% vs 13.3%; P=0.345), but the difference was not statistically significant after correction.

CONCLUSIONS: CCB use in hypertensive patients undergoing endovascular stenting for treatment of intracranial aneurysms is associated with a lower incidence of ischemic events and a lower incidence of unfavorable neurological outcomes, especially when used in combination therapy.

PMID:38527796 | DOI:10.1136/jnis-2024-021543

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Adolescents flexibly adapt action selection based on controllability inferences

Learn Mem. 2024 Mar 25;31(3):a053901. doi: 10.1101/lm.053901.123. Print 2024 Mar.

ABSTRACT

From early in life, we encounter both controllable environments, in which our actions can causally influence the reward outcomes we experience, and uncontrollable environments, in which they cannot. Environmental controllability is theoretically proposed to organize our behavior. In controllable contexts, we can learn to proactively select instrumental actions that bring about desired outcomes. In uncontrollable environments, Pavlovian learning enables hard-wired, reflexive reactions to anticipated, motivationally salient events, providing “default” behavioral responses. Previous studies characterizing the balance between Pavlovian and instrumental learning systems across development have yielded divergent findings, with some studies observing heightened expression of Pavlovian learning during adolescence and others observing a reduced influence of Pavlovian learning during this developmental stage. In this study, we aimed to investigate whether a theoretical model of controllability-dependent arbitration between learning systems might explain these seemingly divergent findings in the developmental literature, with the specific hypothesis that adolescents’ action selection might be particularly sensitive to environmental controllability. To test this hypothesis, 90 participants, aged 8-27, performed a probabilistic-learning task that enables estimation of Pavlovian influence on instrumental learning, across both controllable and uncontrollable conditions. We fit participants’ data with a reinforcement-learning model in which controllability inferences adaptively modulate the dominance of Pavlovian versus instrumental control. Relative to children and adults, adolescents exhibited greater flexibility in calibrating the expression of Pavlovian bias to the degree of environmental controllability. These findings suggest that sensitivity to environmental reward statistics that organize motivated behavior may be heightened during adolescence.

PMID:38527752 | DOI:10.1101/lm.053901.123

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Long-term trends in the work hours of physicians in Canada

CMAJ. 2024 Mar 24;196(11):E369-E376. doi: 10.1503/cmaj.231166.

ABSTRACT

BACKGROUND: Physician work hours directly influence patient access to health care services and play a vital role in physician human resource planning. We sought to evaluate long-term trends in hours worked by physicians in Canada, overall and by subgroup.

METHODS: We used Statistics Canada’s Labour Force Survey to identify physicians via occupation and industry coding information. We estimated descriptive statistics and performed graphical analysis of the average weekly hours worked by physicians over the 1987-2021 period.

RESULTS: Overall, weekly physician work hours remained stable from 1987 until 1997, after which they declined. Average weekly hours decreased by 6.9 hours (p < 0.001), from 52.8 in 1987-1991 to 45.9 in 2017-2021. Among male physicians, work hours declined notably after 1997, while those of female physicians remained relatively stable at around 45 per week. Hours worked by married physicians declined significantly, amounting to 7.4 fewer hours per week (p = 0.001). In contrast, unmarried physicians displayed a statistically insignificant decline of 2.2 hours (p = 0.3). The COVID-19 pandemic was associated with a sharp but brief disruption in weekly hours; by the end of 2020, physicians’ work hours had returned to prepandemic levels.

INTERPRETATION: These findings may indicate a long-term shift in work preferences among Canadian physicians; male physicians may be seeking a better work-life balance, which, in turn, has narrowed the gap in hours worked by sex, with potential implications for pay equity. Policymakers and planners should carefully consider changes in hours worked, rather than just the total number of physicians, to ensure an accurate evaluation of the physician workforce.

PMID:38527745 | DOI:10.1503/cmaj.231166