Category: Statistics

Arch Gynecol Obstet. 2023 Dec 15. doi: 10.1007/s00404-023-07309-w. Online ahead of print.

ABSTRACT

PURPOSE: We have previously published a retrospective matched-case control study comparing the effect of recombinant LH (r-hLH) versus highly purified human menopausal gonadotropin (hMG) supplementation on the follicle-stimulating hormone (FSH) during controlled ovarian hyperstimulation (COH) in the GnRH-antagonist protocol. The result from that study showed that the cumulative live birth rate (CLBR) was significantly higher in the r-hLH group (53% vs. 64%, p = 0.02). In this study, we aim to do a cost analysis between these two groups based on our previous study.

METHODS: The analysis consisted of 425 IVF and ICSI cycles in our previous study. There were 259 cycles in the r-hFSH + hMG group and 166 cycles in the r-hFSH + r-hLH group. The total cost related to the treatment of each patient was recorded. Probabilistic sensitivity analysis (PSA) and a cost-effectiveness acceptability curve (CEAC) were performed and created.

RESULTS: The total treatment cost per patient was significantly higher in the r-hFSH + r-hLH group than in the r-hFSH + hMG group ($4550 ± 798.86 vs. $4290 ± 734.6, p = 0.003). However, the mean cost per live birth in the r-hFSH + hMG group was higher at $8052, vs. $7059 in the r-hFSH + r-hLH group. The CEAC showed that treatment with hFSH + r-hLH proved to be more cost-effective than treatment with r-hFSH + hMG. Willingness-to-pay was evident when considering a hypothetical threshold of $18,513, with the r-hFSH + r-hLH group exhibiting a 99% probability of being considered cost-effective.

CONCLUSION: The cost analysis showed that recombinant LH is more cost-effective than hMG supplementation on r-hFSH during COH in the GnRH-antagonist protocol.

PMID:38099955 | DOI:10.1007/s00404-023-07309-w

J Math Biol. 2023 Dec 15;88(1):10. doi: 10.1007/s00285-023-02027-y.

ABSTRACT

Glioblastoma (GBM) is an aggressive primary brain cancer that currently has minimally effective treatments. Like other cancers, immunosuppression by the PD-L1-PD-1 immune checkpoint complex is a prominent axis by which glioma cells evade the immune system. Myeloid-derived suppressor cells (MDSCs), which are recruited to the glioma microenviroment, also contribute to the immunosuppressed GBM microenvironment by suppressing T cell functions. In this paper, we propose a GBM-specific tumor-immune ordinary differential equations model of glioma cells, T cells, and MDSCs to provide theoretical insights into the interactions between these cells. Equilibrium and stability analysis indicates that there are unique tumorous and tumor-free equilibria which are locally stable under certain conditions. Further, the tumor-free equilibrium is globally stable when T cell activation and the tumor kill rate by T cells overcome tumor growth, T cell inhibition by PD-L1-PD-1 and MDSCs, and the T cell death rate. Bifurcation analysis suggests that a treatment plan that includes surgical resection and therapeutics targeting immune suppression caused by the PD-L1-PD1 complex and MDSCs results in the system tending to the tumor-free equilibrium. Using a set of preclinical experimental data, we implement the approximate Bayesian computation (ABC) rejection method to construct probability density distributions that estimate model parameters. These distributions inform an appropriate search curve for global sensitivity analysis using the extended fourier amplitude sensitivity test. Sensitivity results combined with the ABC method suggest that parameter interaction is occurring between the drivers of tumor burden, which are the tumor growth rate and carrying capacity as well as the tumor kill rate by T cells, and the two modeled forms of immunosuppression, PD-L1-PD-1 immune checkpoint and MDSC suppression of T cells. Thus, treatment with an immune checkpoint inhibitor in combination with a therapeutic targeting the inhibitory mechanisms of MDSCs should be explored.

PMID:38099947 | DOI:10.1007/s00285-023-02027-y

Eur J Clin Pharmacol. 2023 Dec 15. doi: 10.1007/s00228-023-03604-2. Online ahead of print.

ABSTRACT

OBJECTIVES: To explore the characteristics of the occurrence of antineoplastic drug adverse reactions (ADRs) in breast cancer and to utilize a computerized tool to identify early warning indicators of potentially serious ADRs.

METHODS: We conducted descriptive statistical analyses of the demographic features, medication use characteristics, and clinical manifestations of suspected ADRs in ADR-exposed patients using data from the Shaanxi Provincial Adverse Drug Reaction Monitoring Center, China, from 2017 to 2021. Using disproportionality methods (reporting odds ratio, proportional reporting ratio, and comprehensive standard method), the relationship between drugs and ADRs was measured. Finally, a web-based clinical prediction model for serious ADRs based on binary logistic regression was developed to estimate individual event probabilities numerically.

RESULTS: We developed a new computer-mineable breast cancer-ADR system. In total, 1119 ADR reports were received between 2017 and 2021, with an increasing trend in the number. Antineoplastic medications of natural sources made up the greatest portion of the drug category (530, 38.10%) while targeted drugs’ part increased with time. The medicine with the greatest number of ADR cases was docetaxel. Bone marrow failure was the most reported ADR. The disproportionality methods produced 19 signals of disproportionate reporting, two signals of disproportionate reporting were unknown ADRs. The occurrence of serious ADRs was shown to be substantially correlated with gender, platinum drugs, and blood and lymphatic system disorders. The clinical prediction model for serious ADRs had above-moderate discriminatory power (C-index was 0.775).

CONCLUSIONS: The number of ADRs to breast cancer antineoplastic drugs was constantly increasing, with docetaxel ranking first, with the majority of ADRs presenting as bone marrow suppression, nausea, and vomiting. Data mining identified 19 signals of disproportionate reporting.

PMID:38099939 | DOI:10.1007/s00228-023-03604-2

JBI Evid Synth. 2023 Dec 18. doi: 10.11124/JBIES-23-00136. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this scoping review is to investigate the reporting and comparison of process-of-care time measures in hyperacute stroke trials and systematic reviews of trials (subsequently referred to as “studies”).

INTRODUCTION: Stroke is a leading cause of death and disability worldwide. A crucial factor in determining the effectiveness of stroke care in improving patient outcomes is time, and, therefore, time measures are frequently reported in studies of hyperacute stroke interventions. However, there is inconsistency in how these measures are reported and compared. Furthermore, there is a lack of clarity in how compatible the reporting methods are with the statistical analysis methods.

INCLUSION CRITERIA: This scoping review will include studies that report and/or compare time measures between key events of interest in the delivery of hyperacute stroke care. Studies of thrombolytic therapy and/or thrombectomy, as well as controlled trials of mobile stroke unit interventions, will be included.

METHODS: The scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the JBI methodology for scoping reviews. The search will be executed in MEDLINE (PubMed), Embase (Ovid), and clinical trials registries ANZCTR, ISRCTN, and ClinicalTrials.gov. Title and abstract screening will be followed by full-text screening and subsequent data extraction from eligible studies. The results from this scoping review will be presented in tables and narratively summarized.

REVIEW REGISTRATION: Open Science Framework osf.io/y98wz.

PMID:38099923 | DOI:10.11124/JBIES-23-00136

J Adolesc Health. 2023 Dec 13:S1054-139X(23)00582-7. doi: 10.1016/j.jadohealth.2023.10.031. Online ahead of print.

ABSTRACT

PURPOSE: To estimate the effect of the Making Proud Choices! (MPC) curriculum, one of the most popular evidence-based teen pregnancy prevention curricula being implemented nationwide.

METHODS: A cluster randomized trial was used to assign high schools to receive the MPC program or to serve as a standard care comparison group. The study took place in 15 schools in four cities in the United States. A total of 31 clusters and over 2,800 youth (predominantly in grades 9 and 10) were assigned to condition between 2016 and 2019. Student surveys administered at baseline and approximately 9 months after baseline were used to estimate the effects of MPC on risk and protective factors (knowledge, attitudes, self-efficacy) as well as sexual behavior outcomes.

RESULTS: The evaluation showed several large, statistically significant, and favorable impacts on nearly all of the risk and protective factors for risky sexual behavior. In addition, the study found a favorable effect of MPC on reducing the number of episodes of sex in the past 3 months.

DISCUSSION: The evaluation showed that MPC, as it is commonly implemented today, has evidence of effectiveness on improving both risk and protective factors, and sexual behavior outcomes. Based on these findings, MPC will continue to be seen as an evidence-based teen pregnancy prevention program for implementation through federal grant programs.

PMID:38099897 | DOI:10.1016/j.jadohealth.2023.10.031

J Health Serv Res Policy. 2023 Dec 15:13558196231213298. doi: 10.1177/13558196231213298. Online ahead of print.

ABSTRACT

BACKGROUND: The characterization and influence of preoperative health care use on quality-of-care indicators (e.g., readmissions) has received limited attention in populations with musculoskeletal disorders. The purpose of this study was to characterize preoperative health care use and examine its effect on quality-of-care indicators among patients undergoing elective surgery for osteoarthritis.

METHODS: Data on health care use for 124,750 patients with elective surgery for osteoarthritis in Ontario, Canada, from April 1, 2015 to March 31, 2018 were linked across health administrative databases. Using total health care use one-year previous to surgery, patients were grouped from low to very high users. We used Poisson regression models to estimate rate ratios, while examining the relationship between preoperative health care use and quality-of-care indicators (e.g., extended length of stay, complications, and 90-day hospital readmissions). We controlled for covariates (age, sex, neighborhood income, rural/urban residence, comorbidities, and surgical anatomical site).

RESULTS: We found a statistically significant trend of increasing worse outcomes by health care use gradients that persisted after controlling for patient demographics and comorbidities. Findings were consistent across surgical anatomical sites. Moreover, very high users have relatively large numbers of visits to non-musculoskeletal specialists.

CONCLUSIONS: Our findings highlight that information on patients’ preoperative health care use, together with other risk factors (such as comorbidities), could help decision-making when benchmarking or reimbursing hospitals caring for complex patients undergoing surgery for osteoarthritis.

PMID:38099445 | DOI:10.1177/13558196231213298

Stroke. 2023 Dec 15. doi: 10.1161/STROKEAHA.123.043033. Online ahead of print.

ABSTRACT

Intracerebral hemorrhage is the most serious type of stroke, leading to high rates of severe disability and mortality. Hematoma expansion is an independent predictor of poor functional outcome and is a compelling target for intervention. For decades, randomized trials aimed at decreasing hematoma expansion through single interventions have failed to meet their primary outcomes of statistically significant improvement in neurological outcomes. A wide range of evidence suggests that ultra-early bundled care, with multiple simultaneous interventions in the acute phase, offers the best hope of limiting hematoma expansion and improving functional recovery. Patients with intracerebral hemorrhage who fail to receive early aggressive care have worse outcomes, suggesting that an important treatment opportunity exists. This consensus statement puts forth a call to action to establish a protocol for Code ICH, similar to current strategies used for the management of acute ischemic stroke, through which early intervention, bundled care, and time-based metrics have substantially improved neurological outcomes. Based on current evidence, we advocate for the widespread adoption of an early bundle of care for patients with intracerebral hemorrhage focused on time-based metrics for blood pressure control and emergency reversal of anticoagulation, with the goal of optimizing the benefit of these already widely used interventions. We hope Code ICH will endure as a structural platform for continued innovation, standardization of best practices, and ongoing quality improvement for years to come.

PMID:38099439 | DOI:10.1161/STROKEAHA.123.043033

West Afr J Med. 2023 Nov 30;40(11):1223-1231.

ABSTRACT

BACKGROUND: Secondary peritonitis is a common emergency surgical condition with varying aetiologies managed by surgeons all over the world. One important morbidity associated with it is postoperative surgical site infection (SSI). A better prevention strategy can be instituted if this complication in patients can be correctly predicted. The study aimed to identify factors in patients with peritonitis that have a significant bearing on the development of postoperative SSI.

METHOD: A total of fifty patients operated on for peritonitis in a period of one year were studied. Factors including age, gender, comorbidities, presenting symptoms, time of presentation, time of intervention, intraoperative findings, duration of surgery, and postoperative SSI were noted. Chi-square, Fisher’s exact test and Student’s t-test were used to test for association where appropriate and a p-value of < 0.05 was considered statistically significant.

RESULTS: Peritonitis was most commonly due to a ruptured appendix (46%) followed by perforated peptic ulcer disease (42%). The incidence of SSI was 44%. For the patients that developed SSI, the lowest rate was observed in cases of ruptured appendix (39.1%) and the highest in perforated gastric ulcer (64.3%) which was closely followed by perforated duodenal ulcer (57.1%). The association between the time of presentation and the occurrence of SSI was statistically significant (p = 0.028).

CONCLUSION: The SSI rate (44%) from peritonitis in our centre was quite high and the time of presentation played a crucial role. Prevention strategies focusing on predictors of SSI is necessary to reduce the rate of SSI in our setting.

PMID:38099433

Alcohol Clin Exp Res (Hoboken). 2023 Dec 15. doi: 10.1111/acer.15242. Online ahead of print.

ABSTRACT

BACKGROUND: Understanding how treatments for alcohol use disorder (AUD) facilitate behavior change has long been recognized as an important area of research for advancing clinical care. Even after decades of research, however, the specific mechanisms of change for most AUD treatments remain largely unknown because most prior work in the field has solely focused on statistical mediation. Statistical mediation is a necessary but not sufficient condition for establishing evidence for a mechanism of change. Mediators are intermediate variables that statistically account for the relationship between an independent and dependent variable whereas mechanisms provide more detailed explanations of how an intervention leads to a desired outcome. Thus, mediators and mechanisms are not equivalent.

METHODS: To advance mechanisms of behavior change research, this critical review provides an overview of methodological shortfalls of existing AUD treatment mechanisms research and introduces an etiologically informed precision medicine approach that facilitates testing mechanisms of behavior change rather than treatment mediators.

RESULTS: We propose a framework for studying mechanisms in alcohol treatment research that holds promise for facilitating our understanding of behavior change and precision medicine (i.e., for whom a given mechanisms of behavior change operates under what conditions). The framework forwarded in this review has several overarching goals including providing a methodological roadmap for testing AUD recovery mechanisms. We provide two examples of our framework, one pharmacological and one behavioral, to facilitate future efforts to implement this methodological approach to mechanisms research.

CONCLUSIONS: The framework proposed in this critical review facilitates the alignment of AUD treatment mechanisms research with current theories of etiologic mechanisms, precision medicine efforts, and cross-disciplinary approaches to testing mechanisms. Although no framework can resolve all the challenges related to mechanisms research, our goal is to help facilitate a shift towards more rigorous and falsifiable behavior change research.

PMID:38099412 | DOI:10.1111/acer.15242

Indian J Ophthalmol. 2023 Dec 15. doi: 10.4103/IJO.IJO_495_23. Online ahead of print.

ABSTRACT

PURPOSE: To study the epidemiological profile of various pediatric orbital tumors and determine their clinicopathological correlation over 20 years.

METHODS: A retrospective analysis of all pediatric patients with orbital tumors from the medical records between 1995 and 2015 was done. Tumors were categorized based on their cellular origin. Demographic details, clinical and histopathological diagnoses, frequency, and clinicopathological correlation were studied.

RESULTS: A total of 265 pediatric patients with orbital tumors were analyzed, of which 145 (54.7%) patients were males and 120 (45.3%) were females. The mean age was 7 years (median: 6 years; range: 10 days-16 years).The distribution of lesions in each group was as follows: vasculogenic, 76 (28.7%); lipogenic and myxoid, 66 (25%); myogenic, 31 (11.7%); optic nerve and meningeal, 22 (8.3%); lymphoid and lymphoproliferative, 18 (6.8%); secondary orbital tumors, 14 (5.2%); histiocytic, 9 (3.4%); miscellaneous, 9 (3.4%), lacrimal gland, 8 (3%); mesenchymal with neural differentiation, 6 (2%); osseous, 4 (1.5%), and fibrocystic, 2 (0.8%). The most common benign and malignant pediatric orbital tumors were dermoid cysts (65, 24.5%) and rhabdomyosarcoma (31, 11.7%). A statistically significant (P < 0.0001) clinicopathological correlation was observed in 208 (83.2%) out of 250 biopsy-proven cases.

CONCLUSION: Pediatric orbital neoplasms include a broad spectrum of benign and malignant lesions. Vasculogenic tumors constitute the majority of them, followed by lipogenic and myxoid tumors. A thorough knowledge of the incidence, clinical profile, imaging features, and histopathology of specific orbital tumors aids in accurate diagnosis and their successful management.

PMID:38099389 | DOI:10.4103/IJO.IJO_495_23