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Nevin Manimala Statistics

Conversion of non-inferiority margin from hazard ratio to restricted mean survival time difference using data from multiple historical trials

Stat Methods Med Res. 2022 May 31:9622802221102621. doi: 10.1177/09622802221102621. Online ahead of print.

ABSTRACT

The restricted mean survival time measure has gained a lot of interests for designing and analyzing oncology trials with time-to-event endpoints due to its intuitive clinical interpretation and potentially high statistical power. In the non-inferiority trial literature, restricted mean survival time has been used as an alternative measure for reanalyzing a completed trial, which was originally designed and analyzed based on traditional proportional hazard model. However, the reanalysis procedure requires a conversion from the non-inferiority margin measured in hazard ratio to a non-inferiority margin measured by restricted mean survival time difference. An existing conversion method assumes a Weibull distribution for the population survival time of the historical active control group under the proportional hazard assumption using data from a single trial. In this article, we develop a methodology for non-inferiority margin conversion when data from multiple historical active control studies are available, and introduce a Kaplan-Meier estimator-based method for the non-inferiority margin conversion to relax the parametric assumption. We report extensive simulation studies to examine the performances of proposed methods under the Weibull data generative models and a piecewise-exponential data generative model that mimic the tumor recurrence and survival characteristics of advanced colon cancer. This work is motivated to achieve non-inferiority margin conversion, using historical patient-level data from a large colon cancer clinical database, to reanalyze an internationally collaborated non-inferiority study that evaluates 6-month versus 3-month duration of adjuvant chemotherapy in stage III colon cancer patients.

PMID:35642291 | DOI:10.1177/09622802221102621

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Nevin Manimala Statistics

Reader reaction to “Outcome-adaptive lasso: Variable selection for causal inference” by Shortreed and Ertefaie (2017)

Biometrics. 2022 May 31. doi: 10.1111/biom.13683. Online ahead of print.

ABSTRACT

Shortreed and Ertefaie introduced a clever propensity score variable selection approach for estimating average causal effects, namely, the outcome adaptive lasso (OAL). OAL aims to select desirable covariates, confounders, and predictors of outcome, to build an unbiased and statistically efficient propensity score estimator. Due to its design, a potential limitation of OAL is how it handles the collinearity problem, which is often encountered in high-dimensional data. As seen in Shortreed and Ertefaie, OAL’s performance degraded with increased correlation between covariates. In this note, we propose the generalized OAL (GOAL) that combines the strengths of the adaptively weighted L1 penalty and the elastic net to better handle the selection of correlated covariates. Two different versions of GOAL, which differ in their procedure (algorithm), are proposed. We compared OAL and GOAL in simulation scenarios that mimic those examined by Shortreed and Ertefaie. Although all approaches performed equivalently with independent covariates, we found that both GOAL versions were more performant than OAL in low and high dimensions with correlated covariates.

PMID:35642320 | DOI:10.1111/biom.13683

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Nevin Manimala Statistics

Differences in Practice in Alveolar Bone Grafting Among American Cleft Palate-Craniofacial Association Members

Cleft Palate Craniofac J. 2022 May 31:10556656221104036. doi: 10.1177/10556656221104036. Online ahead of print.

ABSTRACT

The purpose of this study is to determine areas of agreement and disagreement among American Cleft Palate-Craniofacial Association (ACPA)members in the clinical practice of alveolar bone grafting (ABG), to guide further research to optimize ABG practices.

A cross-sectional survey was conducted.

The respondents were in an academic, combination, or private practice.

The respondents were either plastic or oral and maxillofacial surgeons (OMFS) from various countries.

A de-identified 24-question online survey was distributed to ACPA surgeon members utilizing the Research Electronic Data Capture (REDCap) tool.

Data collected included surgeon specialty, use of various alveolar bone graft surgical techniques, as well as protocols.

There was more variability than consensus between specialties with regards to the preoperative workup, timing of surgery, materials used for bone graft, surgical techniques, perioperative management, and postoperative evaluation. There was consensus on grafting during mixed dentition, not staging soft and hard tissue closure, and using iliac crest for primary and secondary grafting. Disagreements involved factors used to time the procedure and type of imaging used to assess viability. Technical differences involved incision type, part of bone grafted, use of minimally invasive technique, and material used for revisions.

Aside from areas of consensus among surgeons on ABG, several areas, including use of bone substitutes in revision grafting, incision and type of iliac crest graft used during initial grafting, and postoperative protocols, had no consensus. These areas should be targets of further research to determine if there truly is an optimal method to perform ABG.

The study was approved by the University of Illinois at Chicago Institutional Review Board. A de-identified 24-question online survey was distributed to surgeon members of the ACPA utilizing the REDCap tool on August 7, 2020. The survey questions consisted of multiple choice and multiple selection questions including an option to select “other” and specify the information in a blank space. Data collected included surgeon specialty, use of various alveolar bone graft surgical techniques, as well as pre and postoperative protocols. The full survey is included in online Supplemental material. Data analysis was performed in SPSS Statistics 27 (IBM Corp.). Descriptive statistics were performed, and chi-square was used to test for significant differences in survey responses between groups.

PMID:35642289 | DOI:10.1177/10556656221104036

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Nevin Manimala Statistics

Effects of 24-week basketball programme on body composition and functional fitness on adults with Down syndrome

J Intellect Disabil Res. 2022 May 31. doi: 10.1111/jir.12951. Online ahead of print.

ABSTRACT

BACKGROUND: The body index [body mass, body mass index (BMI), waist circumference and waist-height ratio] and functional fitness (aerobic capacity, muscular strength, balance, flexibility and functional ability) of people with Down syndrome (DS) are substantially lower than those in the general population, as DS has an overall negative impact on health.

AIMS: This study explored the effect of a 24-week basketball training programme on the body composition and functional fitness of adults with DS.

METHODS AND PROCEDURE OUTCOMES: Twenty-two adults with DS (24 ± 6 years; 25 ± 4 kg/m2 ) were randomly allocated to the experimental (n = 11, 67.04 kg) and control groups (n = 11, 69.36 kg). The experimental group performed 24 weeks of basketball programme training (3 times per week, 60 min per session), while the control group maintained their daily activities without any special physical training. Body composition and functional fitness parameters were measured before and after the intervention. To evaluate the differences between groups, an analysis of covariance (ANCOVA) was used while controlling for differences at baseline.

RESULTS: Hip circumference and waist-height ratio were statistically different at baseline between the intervention and control groups. After the 24-week basketball training programme, the results showed significant differences between the exercise and control groups for hip circumference, body mass, BMI, waist circumference, hip circumference, waist-height ratio, flexibility, aerobic capacity, static and dynamic balance, balance and basketball functional ability (P < 0.05). The exercise group showed significant improvements in all variables of body composition and functional fitness (P < 0.05) except for the waist-hip ratio. There was no statistical significance between all physical composition and functional health variables in the control group except for the standing long jump (P > 0.05), with effect sizes ranging from small to large.

CONCLUSIONS AND IMPLICATIONS: The basketball training programme improved body composition and functional fitness of adults with DS.

PMID:35642288 | DOI:10.1111/jir.12951

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Nevin Manimala Statistics

An interdisciplinary program for emerging leaders in patient safety

Clin Teach. 2022 May 31. doi: 10.1111/tct.13507. Online ahead of print.

ABSTRACT

BACKGROUND: Having previously shown that an interprofessional immersive course, AELPS (Academy for Emerging Leaders in Patient Safety) can change the way young clinicians think about patient safety, we surveyed them between 1 and 5 years later to determine its longer-term influence on careers, relationships with colleagues and with patients.

METHODS: All alumni from 2016 to 2019 (n = 116) were invited to complete a survey on the usefulness of their AELPS experience in: obtaining their current position; doing patient safety projects; understanding and working with patients; improving communication skills; breaking down hierarchies; networking; mentoring and using new skills in the workplace. Data were analysed using descriptive statistics and thematic analysis.

RESULTS: Response rate was 56%. Over 85% reported ongoing improvement in medication safety knowledge, communication with patients, use of graded assertiveness, communicating more effectively with colleagues, seeking views of their patients about treatment options and seeing things from the patient perspective. Sixty seven per cent agreed that AELPS helped them in their career choice and 57% agreed it had helped them obtain their current position. Skills transferred to the workplace included ability to make improvements, establish education initiatives and model patient-centred care. Stumbling blocks included a hierarchal culture and lack of accountability for patient safety practices in some hospitals.

DISCUSSION: An intensive, interdisciplinary program on patient safety can provide future health leaders with ongoing tools to improve communication, understand the patient view and speak up on behalf of the patient, all factors that contribute to improving safety of patients.

PMID:35642287 | DOI:10.1111/tct.13507

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Nevin Manimala Statistics

Comparison of modelling approaches for the prediction of kinetic growth parameters of Pseudomonas spp. in oyster mushroom (Pleurotus ostreatus)

Food Sci Technol Int. 2022 May 31:10820132221105476. doi: 10.1177/10820132221105476. Online ahead of print.

ABSTRACT

In predictive microbiology, primary and secondary models can be used to predict microbial growth, usually in a two-step modelling approach. The inverse dynamic modelling approach is an alternative method to direct modelling methods, in which the primary and secondary models are fitted simultaneously from non-isothermal data, minimising experimental effort and costs. Thus, the main aim of the present study was to compare the prediction capabilities of the mathematical modelling approaches used for calculating growth kinetics of microorganisms in predictive food microbiology field. For this purpose, the bacterial growth data of Pseudomonas spp. in oyster mushroom (Pleurotus ostreatus) subjected to isothermal and non-isothermal storage temperatures were collected from previously published growth curves. Temperature-dependent kinetic growth parameters (maximum specific growth rate ‘µmax‘ and lag phase duration ‘λ‘) were described as a function of storage temperature using the direct two-step, direct one-step and inverse dynamic modelling approach based on Baranyi and Huang models. The fitting capability of the modelling approaches was separately compared, and the one-step modelling approach for the direct methods provided better goodness of fit results regardless of used primary models, which leads the Huang model with being RMSE = 0.226 and R2adj = 0.949 became best for direct methods. Like seen in direct methods, the Huang model gave better goodness of fit results than Baranyi model for inverse method. Results revealed there was no significant difference (p > 0.05) between the growth kinetic parameters obtained from direct one-step modelling approach and inverse modelling approaches based on the Huang model. Satisfactorily statistical indexes show that the inverse dynamic modelling approach can be reliably used as an alternative way of describing the growth behaviour of Pseudomonas spp. in oyster mushroom in a fast and minimum labour effort.

PMID:35642261 | DOI:10.1177/10820132221105476

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Nevin Manimala Statistics

Pharmacy practitioners’ adherence to safe-handling practices of chemotherapeutic drugs: A cross-sectional study in Saudi Arabia

J Oncol Pharm Pract. 2022 May 31:10781552221105584. doi: 10.1177/10781552221105584. Online ahead of print.

ABSTRACT

BACKGROUND: Chemotherapy drug handling and occupational exposure are topics of concern for a variety of oncology health care professionals. Inappropriate handling can pose health risks to practitioners particularly, those who handle them on a daily basis. Therefore, this study aimed to assess chemotherapy handling practices among oncology pharmacists and pharmacy technicians in Saudi Arabia.

METHODS: A cross-sectional study was conducted using an online survey with a structured pre-validated questionnaire. Data was collected from pharmacists and pharmacy technicians who handle chemotherapeutic agents in Saudi Arabia, and analyzed using descriptive and inferential statistics.

RESULTS: A total of 79 oncology pharmacy practitioners responded to the survey. The majority (92.4%) had written chemotherapy guidelines at their workplaces. Almost all participants (98.7%) reported the availability of protective gloves and gowns, however, the availability of eye protection was only 57%. Most used chemotherapy-designated gloves (83.6%), and gowns (86.1%). However, 54.4% have reused disposable gowns. The extent of utilization of most protective equipment ranged from 70% (always using closed system transfer device) to 98% (always using shoe cover); while the practice of always using eye protection and face shield was only 30.4% and 38%, respectively. With regard to cleaning practice, the work area was cleaned at least once a day by 35%; monthly decontamination (77%); certification by the biomedical department every 6 months (67%) and at least yearly (95%). Accidental exposure was reported by 28%, and the most common adverse effect was skin irritation (82%). There was no workplace medical surveillance available for 50%. The majority (88.6%) received relevant training, but not periodic updates on their training (38%). The main barriers against the use of personal protective equipment were: that some personal protective equipments were not always available (38%), and personal protective equipments were too uncomfortable to use (30.4%). The demographic variables did not have a statistically significant effect (p > 0.05) on the responses except for type of institution (workplace) on some of the cleaning practices that showed significant differences namely, the monthly decontamination and certification by the biomedical department.

CONCLUSIONS: Most protective equipment and chemotherapy guidelines were available, and the majority of pharmacy practitioners adhered to many aspects of chemotherapy safe-handling practices. Nevertheless, some areas such as medical surveillance programs, use of eye protection and face shields, the practice of re-using disposable gowns, some of the barriers against personal protective equipment use, and the provision of periodic training need improvement for better protection of the health care professionals.

PMID:35642271 | DOI:10.1177/10781552221105584

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Nevin Manimala Statistics

Prevalence of psychological distress among people living with HIV/AIDS: a systematic review and meta-analysis

AIDS Care. 2022 May 31:1-12. doi: 10.1080/09540121.2022.2080802. Online ahead of print.

ABSTRACT

Although people living with HIV/AIDS (PLWHA) are known to be vulnerable to psychological distress (PD), little is known about the prevalence of PD among PLWHA. A systematic literature search of several databases was conducted from inception to August 2021 focusing on studies reporting on PD symptoms among PLWHA. The overall prevalence estimates were pooled using a random-effects meta-analysis. Differences according to study-level characteristics were examined using stratified meta-analysis. We pooled and analyzed data from 15 studies comprising 5593 PLWHA. The prevalence rate of PD among PLWHA was 43.7% (95% Confidence Interval: 29.9-57.5%). Subgroup analyses by gender, country, CD4 count, employment status and ever attended school found no statistically significant differences in the prevalence of PD. Heterogeneity in the prevalence of PD among PLWHA was partially explained by the assessment tool. Further large-scale studies of high quality are warranted to identify risk factors of PD in PLWHA in their respective socio-cultural contexts.

PMID:35642250 | DOI:10.1080/09540121.2022.2080802

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Nevin Manimala Statistics

Gastrointestinal Features of 22Q11.2 Deletion Syndrome Include Chronic Motility Problems from Childhood to Adulthood

J Pediatr Gastroenterol Nutr. 2022 Jun 1. doi: 10.1097/MPG.0000000000003491. Online ahead of print.

ABSTRACT

OBJECTIVES: 22q11.2 deletion syndrome (22q11.2DS) is the most common chromosomal microdeletion syndrome and has a multi-systemic presentation including gastrointestinal features that have not yet been fully described. Our aim was to examine lifetime gastrointestinal problems in a large cohort of patients with 22q11.2DS.

METHODS: All patients followed in the 22q and You Center at the Children’s Hospital of Philadelphia (n = 1,421) were retrospectively screened for 1) age ≥ 17 years, 2) documented chromosomal microdeletion within the 22q11.2 LCR22A-LCR22D region, and 3) sufficient clinical data to characterize the adult gastrointestinal phenotype. Gastrointestinal problems in childhood, adolescence, and adulthood were summarized. Statistical association testing of symptoms against other patient characteristics was performed.

RESULTS: Included patients (n = 206; 46% female; mean age 27 years; median follow up 21 years) had similar clinical characteristics to the overall cohort. Genetic distribution was also similar, with 96% having deletions including the critical LCR22A-LCR22B segment (95% in the overall cohort). Most patients experienced chronic gastrointestinal symptoms in their lifetime (91%), but congenital gastrointestinal malformations (3.5%) and gastrointestinal autoimmune diseases (1.5%) were uncommon. Chronic symptoms without anatomic or pathologic abnormalities represented the vast burden of illness. Chronic symptoms in adulthood associated with other chronic gastrointestinal symptoms and psychiatric comorbidities (p < 0.01) but not with deletion size or physiologic comorbidities (p > 0.05). One exception was increased nausea/vomiting in hypothyroidism (p = 0.002).

CONCLUSIONS: Functional gastrointestinal disorders (FGIDs) are a common cause of ill health in children and adults with 22q11.2DS. Providers should consider screening for the deletion in patients presenting with FGIDs and associated comorbidities such as neuropsychiatric illness, congenital heart disease, and palatal abnormalities.

PMID:35641891 | DOI:10.1097/MPG.0000000000003491

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Nevin Manimala Statistics

Local and distant brain control in melanoma and NSCLC brain metastases with concurrent radiosurgery and immune checkpoint inhibition

J Neurooncol. 2022 May 31. doi: 10.1007/s11060-022-04038-z. Online ahead of print.

ABSTRACT

INTRODUCTION: The treatment of brain metastases with stereotactic radiosurgery (SRS) in combination with immune checkpoint inhibitors (ICI) has become more common in recent years, but there is a lack of prospective data on cancer control outcomes when these therapies are administered concurrently.

METHODS: Data were retrospectively reviewed for patients with non-small cell lung cancer (NSCLC) and melanoma brain metastases treated with SRS at a single institution from May 2008 to January 2017. A parametric proportional hazard model is used to detect the effect of concurrent ICI within 30, 60, or 90 days of ICI administration on local control and distant in-brain control. Other patient and lesion characteristics are treated as covariates and adjusted in the regression. A frailty term is added in the baseline hazard to capture the within-patient correlation.

RESULTS: We identified 144 patients with 477 total lesions, including 95 NSCLC patients (66.0%), and 49 (34.0%) melanoma patients. On multivariate analysis, concurrent SRS and ICI (SRS within 30 days of ICI administration) was not associated with local control but was associated with distant brain control. When controlling for prior treatment to lesion, number of lesions, and presence of extracranial metastases, patients receiving this combination had a statistically significant decrease in distant brain failure compared to patients that received non-concurrent ICI or no ICI (HR 0.15; 95% CI 0.05-0.47, p = 0.0011).

CONCLUSION: Concurrent ICI can enhance the efficacy of SRS. Prospective studies would allow for stronger evidence to support the impact of concurrent SRS and ICI on disease outcomes.

PMID:35641840 | DOI:10.1007/s11060-022-04038-z