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Nevin Manimala Statistics

Dupilumab: Direct Cost and Clinical Evaluation in Patients with Atopic Dermatitis

Dermatol Res Pract. 2023 Feb 15;2023:4592087. doi: 10.1155/2023/4592087. eCollection 2023.

ABSTRACT

Health care spending in Italy is high and continues to increase; assessing the long-term health and economic outcomes of new therapies is essential. Atopic dermatitis (AD) is a chronic, pruritic, immune-mediated inflammatory dermatosis, a clinical condition that significantly affects patients’ quality of life at a high cost and requires continuous care. This retrospective study aimed to assess the direct cost and adverse drug reactions (ADRs) of Dupilumab and patients’ clinical outcomes. All AD patients treated with Dupilumab at the Sassari University Hospital, Italy, between January 2019 and December 2021 were included. Eczema Area Severity Index, Dermatology Life Quality Index, and Itch Numeric Rating Scale scores were measured. ADRs and drug expenses were analyzed. A statistically significant posttreatment improvement was observed for all the indices measured: EASI (P < 0.0001), DLQI (P < 0.0001), NRS (P < 0.0001). The total expenditure for Dupilumab, in the observed period, amounted to € 589.748,66 for 1358 doses, and a positive correlation was shown between annual expenditure and delta percentage of variation pre- and posttreatment for the clinical parameters evaluated.

PMID:36846564 | PMC:PMC9946764 | DOI:10.1155/2023/4592087

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Nevin Manimala Statistics

Early termination in single-parameter model phase II clinical trial designs using decreasingly informative priors

Int J Clin Trials. 2022 Apr-Jun;9(2):107-117. doi: 10.18203/2349-3259.ijct20221110. Epub 2022 Apr 25.

ABSTRACT

BACKGROUND: To exchange the type of subjective Bayesian prior selection for assumptions more directly related to statistical decision making in clinician studies and trials, the decreasingly informative prior (DIP) is considered. We expand standard Bayesian early termination methods in one-parameter statistical models for Phase II clinical trials to include decreasingly informative priors (DIP). These priors are designed to reduce the chance of erroneously adapting trials too early by parameterize skepticism in an amount always equal to the unobserved sample size.

METHOD: We show how to parameterize these priors based on effective prior sample size and provide examples for common single-parameter models, include Bernoulli, Poisson, and Gaussian distributions. We use a simulation study to search through possible values of total sample sizes and termination thresholds to find the smallest total sample size (N) under admissible designs, which we define as having at least 80% power and no greater than 5% type I error rate.

RESULTS: For Bernoulli, Poisson, and Gaussian distributions, the DIP approach requires fewer patients when admissible designs are achieved. In situations where type I error or power are not admissible, the DIP approach yields similar power and better-controlled type I error with comparable or fewer patients than other Bayesian priors by Thall and Simon.

CONCLUSIONS: The DIP helps control type I error rates with comparable or fewer patients, especially for those instances when increased type I error rates arise from erroneous termination early in a trial.

PMID:36846554 | PMC:PMC9957559 | DOI:10.18203/2349-3259.ijct20221110

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Outcomes of surgical management and implant consideration for depressed skull fractures: A systematic review

Adv Neurol (Singap). 2023 Mar 31;2(1):247. doi: 10.36922/an.247. Epub 2023 Feb 3.

ABSTRACT

BACKGROUND: Traumatic brain injuries (TBIs) are associated with high mortality and morbidity. Depressed skull fractures (DSFs) are a subset of fractures characterized by either direct or indirect brain damage, compressing brain tissue. Recent advances in implant use during primary reconstruction surgeries have shown to be effective. In this systematic review, we assess differences in titanium mesh, polyetheretherketone (PEEK) implants, autologous pericranial grafts, and methyl methacrylate (PMMA) implants for DSF treatment.

METHODS: A literature search was conducted in PubMed, Scopus, and Web of Science from their inception to September 2022 to retrieve articles regarding the use of various implant materials for depressed skull fractures. Inclusion criteria included studies specifically describing implant type/material within treatment of depressed skull fractures, particularly during duraplasty. Exclusion criteria were studies reporting only non-primary data, those insufficiently disaggregated to extract implant type, those describing treatment of pathologies other than depressed skull fractures, and non-English or cadaveric studies. The Newcastle-Ottawa Scale was utilized to assess for presence of bias in included studies.

RESULTS: Following final study selection, 18 articles were included for quantitative and qualitative analysis. Of the 177 patients (152 males), mean age was 30.8 years with 82% implanted with autologous graft material, and 18% with non-autologous material. Data were pooled and analyzed with respect to the total patient set, and additionally stratified into those treated through autologous and non-autologous implant material.There were no differences between the two cohorts regarding mean time to encounter, pre-operative Glasgow coma scale (GCS), fracture location, length to cranioplasty, and complication rate. There were statistically significant differences in post-operative GCS (p < 0.0001), LOS (p = 0.0274), and minimum follow-up time (p = 0.000796).

CONCLUSION: Differences in measurable post-operative outcomes between implant groups were largely minimal or none. Future research should aim to probe these basic results deeper with a larger, non-biased sample.

PMID:36846546 | PMC:PMC9948107 | DOI:10.36922/an.247

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Nevin Manimala Statistics

Discovering spatiotemporal usage patterns of a bike-sharing system by type of pass: a case study from Seoul

Transportation (Amst). 2023 Feb 21:1-35. doi: 10.1007/s11116-023-10371-7. Online ahead of print.

ABSTRACT

Determining bike-sharing usage patterns and their explanatory factors on demand is essential for the effective and efficient operation of bike-sharing systems (BSSs). Most BSSs provide different passes that vary with the period of use. However, studies investigating the differences in usage patterns are rare compared to studies conducted at the system level, even though explanatory factors depending on the type of pass may cause different characteristics in terms of usage patterns. This study explores the differences in the usage patterns of BSSs and the impact of explanatory factors on the demand depending on the type of pass. Various machine learning techniques, including clustering, regression, and classification, are used, in addition to basic statistical analysis. As observed, long-term season passes of over six months are mainly used for transportation (especially commuting), whereas one-day or short-term season passes seem to be used more for leisure than for other purposes. Furthermore, differences in the purpose of bike rentals seem to cause differences in usage patterns and variations in demand over time and space. This study improves ther understanding of the usage patterns that appear differently for each pass type, and provides insights into the efficient operation of BSSs in urban areas.

SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11116-023-10371-7.

PMID:36846545 | PMC:PMC9942648 | DOI:10.1007/s11116-023-10371-7

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Nevin Manimala Statistics

Epidural Analgesia for Labour: Comparing the Effects of Continuous Epidural Infusion (CEI) and Programmed Intermittent Epidural Bolus (PIEB) on Obstetric Outcomes

Rom J Anaesth Intensive Care. 2022 Sep 25;28(1):29-35. doi: 10.2478/rjaic-2021-0005. eCollection 2021 Jul.

ABSTRACT

OBJECTIVE: In the last few years there is a trend of transiting from the continuous epidural infusion (CEI) method for epidural analgesia to a new method – programmed intermittent epidural analgesia (PIEB). This change improves the quality of epidural analgesia, thanks to an increased spread of the anaesthetic in the epidural space and higher maternal satisfaction. Nevertheless, we must make sure that such change of method does not lead to worse obstetric and neonatal outcomes.

MATERIALS AND METHODS: This is a retrospective observational case control study. We compared several obstetrical outcomes between the CEI and PIEB groups, such as the rates of instrumental delivery, rates of caesarean section, duration of first and second stages of labour well as APGAR scores. We further segmented the subjects and examined them in groups of nulliparous and multiparous parturients.

RESULTS: 2696 parturients were included in this study: 1387 (51.4%) parturients in the CEI group and 1309 (48.6%) parturients in the PIEB group. No significant difference was found in instrumental or caesarean section delivery rates between groups. This result held even when the groups were differentiated between nulliparous and multiparous. No differences were revealed regarding first and second stage duration or APGAR scores.

CONCLUSION: Our study demonstrates transition from the CEI to the PIEB method does not lead to any statistically significant effects on either obstetric or neonatal outcomes.

PMID:36846539 | PMC:PMC9949009 | DOI:10.2478/rjaic-2021-0005

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Evaluation of the Effect of Intubation Box use on Tracheal Intubation Difficulty with King Vision® and Truview Videolaryngoscope in Manikin in a Tertiary Care Hospital

Rom J Anaesth Intensive Care. 2022 Sep 25;28(1):25-28. doi: 10.2478/rjaic-2021-0004. eCollection 2021 Jul.

ABSTRACT

BACKGROUND: The procedures of introducing an airway by intubation are associated with increased risk of aerosolisation of SARS-CoV-2 virus, posing a high risk to the personnel involved. Newer and novel methods such as the intubation box have been developed to increase the safety of healthcare workers during intubation.

METHODS DESIGN: In this study, 33 anaesthesiologist and critical care specialists intubated the trachea of the airway manikin (US Laerdal Medical AS™) 4 times using a King Vision® videolaryngoscope and TRUVIEW PCD™ videolaryngoscope (with and without an intubation box as described by Lai). Intubation time was primary outcome. Secondary outcomes were first-pass intubation success rate, percentage of glottic opening (POGO) score and peak force to maxillary incisors.

RESULTS: Intubation time and the number of times a click was heard during tracheal intubation were considerably higher in both groups when an intubation box was used (Table 1). When comparing the two laryngoscopes, the King Vision® videolaryngoscope enabled much less time to intubate than did the TRUVIEW laryngoscope, both with and without the intubation box. (P<0.001) In both laryngoscope groups, first-pass successful intubation was higher without the intubation box, although the difference was statistically insignificant. POGO score was not affected by intubation box but a higher score was observed with King Vision® laryngoscope (Tables 1,2).

CONCLUSION: This study indicates that use of an intubation box makes intubation difficult and increases the time needed to perform it. King Vision® videolaryngoscope results in lesser intubation time and better glottic view as compared to TRUVIEW laryngoscope.

PMID:36846538 | PMC:PMC9949008 | DOI:10.2478/rjaic-2021-0004

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The association of patient-reported social determinants of health and hospitalization rate: A scoping review

Health Sci Rep. 2023 Feb 22;6(2):e1124. doi: 10.1002/hsr2.1124. eCollection 2023 Feb.

ABSTRACT

INTRODUCTION: The interplay between social determinants of health (SDOH) and hospitalization is significant as targeted interventions can improve the social status of the individuals. This interrelation has been historically overlooked in health care. In the present study, we reviewed studies in which the association between patient-reported social risks and hospitalization rate was assessed.

METHOD: We performed a scoping literature review of articles published until September 1, 2022 without time limit. We searched PubMed, Embase, Web of Science, Scopus, and Google Scholar to find relevant studies using terms representing “social determinants of health” and “hospitalization.” Forward and backward reference checking was done for the included studies. All studies that used patient-reported data as a proxy of social risks to determine the association between social risks and hospitalization rates were included. The screening and data extraction processes were done independently by two authors. In case of disagreement, senior authors were consulted.

RESULTS: Our search process retrieved a total of 14,852 records. After the duplicate removal and screening process, eight studies met the eligibility criteria, all of which were published from 2020 to 2022. The sample size of the studies ranged from 226 to 56,155 participants. All eight studies investigated the impact of food security on hospitalization, and six investigated economic status. In three studies, latent class analysis was applied to divide participants based on their social risks. Seven studies found a statistically significant association between social risks and hospitalization rates.

CONCLUSION: Individuals with social risk factors are more susceptible to hospitalization. There is a need for a paradigm shift to meet these needs and reduce the number of preventable hospitalizations.

PMID:36846535 | PMC:PMC9944244 | DOI:10.1002/hsr2.1124

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Preterm birth characteristics and outcomes in Portugal, between 2010 and 2018-A cross-sectional sequential study

Health Sci Rep. 2023 Feb 22;6(2):e1054. doi: 10.1002/hsr2.1054. eCollection 2023 Feb.

ABSTRACT

INTRODUCTION: According to the World Health Organization, 11% of all children are born prematurely, representing 15 million births annually. An extensive analysis on preterm birth, from extreme to late prematurity and associated deaths, has not been published. The authors characterize premature births in Portugal, between 2010 and 2018, according to gestational age, geographic distribution, month, multiple gestations, comorbidities, and outcomes.

METHODS: A sequential, cross-sectional, observational epidemiologic study was conducted, and data were collected from the Hospital Morbidity Database, an anonymous administrative database containing information on all hospitalizations in National Health Service hospitals in Portugal, and coded according to the ICD-9-CM (International Classification of Diseases), until 2016, and ICD-10 subsequently. Data from the National Institute of Statistics was utilized to compare the Portuguese population. Data were analyzed using R software.

RESULTS: In this 9-year study, 51.316 births were preterm, representing an overall prematurity rate of 7.7%. Under 29 weeks, birth rates varied between 5.5% and 7.6%, while births between 33 and 36 weeks varied between 76.9% and 81.0%. Urban districts presented the highest preterm rates. Multiple births were 8× more likely preterm and accounted for 37%-42% of all preterm births. Preterm birth rates slightly increased in February, July, August, and October. Overall, respiratory distress syndrome (RDS), sepsis, and intraventricular hemorrhage were the most common morbidities. Preterm mortality rates varied significantly with gestational age.

CONCLUSION: In Portugal, 1 in 13 babies was born prematurely. Prematurity was more common in predominantly urban districts, a surprise finding that warrants further studies. Seasonal preterm variation rates also require further analysis and modelling to factor in heat waves and low temperatures. A decrease in the case rate of RDS and sepsis was observed. Compared with previously published results, preterm mortality per gestational age decreased; however, further improvements are attainable in comparison with other countries.

PMID:36846533 | PMC:PMC9945543 | DOI:10.1002/hsr2.1054

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Nevin Manimala Statistics

Local administration of vancomycin powder in orthopaedic fracture surgery: current practice and trends

OTA Int. 2023 Feb 21;6(1):e223. doi: 10.1097/OI9.0000000000000223. eCollection 2023 Mar.

ABSTRACT

OBJECTIVES: Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system-level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers.

METHODS: Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed.

RESULTS: A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases.

CONCLUSIONS: Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions.

LEVEL OF EVIDENCE: Prognostic-III.

PMID:36846524 | PMC:PMC9953039 | DOI:10.1097/OI9.0000000000000223

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Using Artificial Intelligence to Develop a Multivariate Model with a Machine Learning Model to Predict Complications in Mexican Diabetic Patients without Arterial Hypertension (National Nested Case-Control Study): Metformin and Elevated Normal Blood Pressure Are Risk Factors, and Obesity Is Protective

J Diabetes Res. 2023 Feb 16;2023:8898958. doi: 10.1155/2023/8898958. eCollection 2023.

ABSTRACT

Diabetes mellitus is a disease with no cure that can cause complications and even death. Moreover, over time, it will lead to chronic complications. Predictive models have been used to identify people with a tendency to develop diabetes mellitus. At the same time, there is limited information regarding the chronic complications of patients with diabetes. Our study is aimed at creating a machine-learning model that will be able to identify the risk factors of a diabetic patient developing chronic complications such as amputations, myocardial infarction, stroke, nephropathy, and retinopathy. The design is a national nested case-control study with 63,776 patients and 215 predictors with four years of data. Using an XGBoost model, the prediction of chronic complications has an AUC of 84%, and the model has identified the risk factors for chronic complications in patients with diabetes. According to the analysis, the most crucial risk factors based on SHAP values (Shapley additive explanations) are continued management, metformin treatment, age between 68 and 104 years, nutrition consultation, and treatment adherence. But we highlight two exciting findings. The first is a reaffirmation that high blood pressure figures across patients with diabetes without hypertension become a significant risk factor at diastolic > 70 mmHg (OR: 1.095, 95% CI: 1.078-1.113) or systolic > 120 mmHg (OR: 1.147, 95% CI: 1.124-1.171). Furthermore, people with diabetes with a BMI > 32 (overall obesity) (OR: 0.816, 95% CI: 0.8-0.833) have a statistically significant protective factor, which the paradox of obesity may explain. In conclusion, the results we have obtained show that artificial intelligence is a powerful and feasible tool to use for this type of study. However, we suggest that more studies be conducted to verify and elaborate upon our findings.

PMID:36846513 | PMC:PMC9949947 | DOI:10.1155/2023/8898958