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Nevin Manimala Statistics

Medicare Utilization and Cost Trends for CAR T Cell Therapies Across Settings of Care in the Treatment of Diffuse Large B-Cell Lymphoma

Adv Ther. 2024 Jun 25. doi: 10.1007/s12325-024-02917-7. Online ahead of print.

ABSTRACT

INTRODUCTION: Chimeric antigen receptor T-cell (CAR T) therapies have transformed diffuse large B-cell lymphoma (DLBCL) treatment. It is important to better understand their use in Medicare Fee-for-Service (FFS) patients, who often differ from commercially insured populations in important ways.

METHODS: We analyzed Medicare FFS claims data, focusing on the utilization patterns across three CAR T products-lisocabtagene maraleucel (liso-cel), tisagenlecleucel (tisa-cel), and axicabtagene autoleucel (axi-cel)-which are indicated for the treatment of DLBCL. Our investigation covered the period from 2021 through 2022. This analysis spanned a 180-day period prior to CAR T procedure and extended to a 90-day post-CAR T. Utilization of healthcare services, healthcare spending, and comorbidities were assessed in the pre- and post-periods. Clinical trial and PPS-exempt center claims were removed from the analysis. Statistical comparisons between inpatient and outpatient cohorts were made using Wilcoxon’s rank-sum tests for continuous variables and Chi-square tests or Fisher’s exact tests for categorical variables.

RESULTS: Among the total 391 CAR T claims assessed, most of the CAR T therapies were administered in the inpatient setting (79%) compared to outpatient (21%). CAR T therapy in the inpatient setting received an average Medicare cost of US$498,723 ($276,138-$1,066,524), while the average Medicare cost for outpatient CAR T claims was $414,393 ($276,980-$849,878). There was a higher 3-month average post-period cost for those hospitals utilizing CAR T in the outpatient setting than the inpatient setting ($15,794 vs. $10,244). Despite the higher post-period cost, when looking at the CAR T procedure and pre- and post-periods as a single episode, beneficiaries receiving outpatient CAR T had less cost for the total episode of care ($587,908 vs. $529,188). Follow-up inpatient claims were also assessed post-CAR T procedure for 30 days. The rate of post-CAR T inpatient re-admission was significantly lower for beneficiaries receiving the index CAR T in the inpatient setting (21%) compared to outpatient CAR T (59%). Days between index CAR T discharge and IP admission were also significantly shorter for OP CAR T compared to IP CAR T (8.0 vs. 14.1 days, p < 0.0001). Additionally, IP CAR T had a longer ALOS on the admission claim (6.9 vs. 6.2 days).

CONCLUSION: CAR T therapy for the treatment of LBCL has become more common within the Medicare population, primarily in the inpatient setting. This study helps understand providers’ cost and associated patient care around CAR T administration. The data show that the average cost received by hospitals encompasses the expenses related to both the CAR T drug and the medical services delivered to patients.

PMID:38916811 | DOI:10.1007/s12325-024-02917-7

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Nevin Manimala Statistics

Particulate and gaseous air pollutants exceed WHO guideline values and have the potential to damage human health in Faisalabad, Metropolitan, Pakistan

Environ Monit Assess. 2024 Jun 25;196(7):659. doi: 10.1007/s10661-024-12763-3.

ABSTRACT

First-ever measurements of particulate matter (PM2.5, PM10, and TSP) along with gaseous pollutants (CO, NO2, and SO2) were performed from June 2019 to April 2020 in Faisalabad, Metropolitan, Pakistan, to assess their seasonal variations; Summer 2019, Autumn 2019, Winter 2019-2020, and Spring 2020. Pollutant measurements were carried out at 30 locations with a 3-km grid distance from the Sitara Chemical Industry in District Faisalabad to Bhianwala, Sargodha Road, Tehsil Lalian, District Chiniot. ArcGIS 10.8 was used to interpolate pollutant concentrations using the inverse distance weightage method. PM2.5, PM10, and TSP concentrations were highest in summer, and lowest in autumn or winter. CO, NO2, and SO2 concentrations were highest in summer or spring and lowest in winter. Seasonal average NO2 and SO2 concentrations exceeded WHO annual air quality guide values. For all 4 seasons, some sites had better air quality than others. Even in these cleaner sites air quality index (AQI) was unhealthy for sensitive groups and the less good sites showed Very critical AQI (> 500). Dust-bound carbon and sulfur contents were higher in spring (64 mg g-1) and summer (1.17 mg g-1) and lower in autumn (55 mg g-1) and winter (1.08 mg g-1). Venous blood analysis of 20 individuals showed cadmium and lead concentrations higher than WHO permissible limits. Those individuals exposed to direct roadside pollution for longer periods because of their occupation tended to show higher Pb and Cd blood concentrations. It is concluded that air quality along the roadside is extremely poor and potentially damaging to the health of exposed workers.

PMID:38916809 | DOI:10.1007/s10661-024-12763-3

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Expression and Relations of Unique miRNAs Investigated in Metabolic Bariatric Surgery: A Systematic Review

Obes Surg. 2024 Jun 25. doi: 10.1007/s11695-024-07302-5. Online ahead of print.

ABSTRACT

Several studies have indicated that miRNAs play crucial roles in adipogenesis, insulin resistance, and inflammatory pathways associated with obesity and change after metabolic bariatric surgery (MBS). This systematic review explores and maps the existing literature on how miRNAs are expressed and investigates the unique miRNAs with the effects after MBS. The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and EMBASE were searched from 2019 until February 2024. This SR found 825 miRNAs from 25 studies, identifying 507 unique ones not used twice in the same study. A total of 21 studies (84%) measured RNA before and after surgery. The miRNA used per study ranged from 1 to 146 miRNA types, with a median study sample size of just 27 patients per study, raising concerns about some conclusions’ robustness. From the 507 unique miRNAs, only 16 were consistently analyzed in 4 to 7 studies, which gave 77 different outcomes in relation to miRNA after MBS. MiRNA 122 and 122-5p were analyzed the most. Others were 106b-5p, 140-5p, 183-5p, 199b-5p, 20b-5p, 424-5p, 486-5p, 7-5p, 92a, 93-5p, 194-5p, 21-5p, 221, 320a, and 223-3p. A gap was observed in many studies, whereby the results were not the same, or there was no explanation for the effects after MBS was given within the same miRNA. Fifteen miRNAs were reported to have the same upward and downward trend, although not within the same study, and only 26.1% employed some form of statistical modeling to account for bias or confounding factors. Directions and effects in miRNA are visible, but still, inconsistent outcomes linked to the same miRNA after MBS, underscoring the need for clarity in miRNA-outcome relationships. Collaborative efforts, consensus-driven miRNA dictionaries, and larger, more rigorous studies are necessary to improve methodology designs and improve outcomes.

PMID:38916799 | DOI:10.1007/s11695-024-07302-5

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Insulin Resistance and White Matter Microstructural Abnormalities in Nondiabetic Adult: A Population-Based Study

Int J Stroke. 2024 Jun 25:17474930241266796. doi: 10.1177/17474930241266796. Online ahead of print.

ABSTRACT

BACKGROUND: Insulin resistance (IR) is of growing concern yet its association with white matter integrity remains controversial. We aimed to investigate the association between IR and white matter integrity in nondiabetic adults.

METHODS: This cross-sectional analysis was conducted based on the PolyvasculaR Evaluation for Cognitive Impairment and vaScular Events (PRECISE) study. A total of 1709 Nondiabetic community-dwelling adults with available diffusion weighted imaging based on brain magnetic resonance imaging and completed oral glucose tolerance test were included. IR was measured non-invasively by insulin sensitivity indices (ISI), including ISIcomposite and ISI0,120, as well as homeostasis model assessment of insulin resistance (HOMA-IR). White matter microstructure abnormalities were identified by diffusion weighted imaging along with tract-based spatial statistics analysis to compare diffusion metrics between groups. The multivariable linear regression models were applied to measure the association between white matter microstructure abnormalities and IR.

RESULTS: A total of 1709 nondiabetic individuals with a mean age of 60.8±6.4 years and 53.5% female were included. We found that IR was associated with a significant increase in mean diffusivity, axial diffusivity, and radial diffusivity extensively in cerebral white matter in regions such as the anterior corona radiata, superior corona radiata, anterior limb of internal capsule, external capsule, and body of corpus callosum. The pattern of associations was more marked for ISIcomposite and ISI0,120. However, the effect of insulin resistance on white matter integrity was attenuated after additionally adjustment for history of hypertension and cardiovascular disease and antihypertensive medication use.

CONCLUSION: Our findings indicate a significant association between IR and white matter microstructural abnormalities in nondiabetic middle-aged community residents, while these associations were greatly influenced by the history of hypertension and cardiovascular disease, and antihypertensive medication use. Further investigation is needed to clarify the role of IR in white matter integrity, whereas prophylactic strategies of maintaining a low IR status may ameliorate disturbances in white matter integrity.

PMID:38916129 | DOI:10.1177/17474930241266796

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A Dwindling Matter: An Analysis of Medicare Reimbursement for Endocrine Surgery Procedures from 2000-23

Ann Surg. 2024 Jun 25. doi: 10.1097/SLA.0000000000006423. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate Medicare reimbursement trends for endocrine surgeries from 2000-23.

BACKGROUND: As the population ages, demand for endocrine surgeries is expected to increase. Understanding reimbursement trends is essential to ensure the financial sustainability of endocrine surgery.

METHODS: Data were extracted from Medicare Inpatient and Outpatient Hospital datasets, National Summary, and Physician Fee Look-up Files for nine common thyroid, parathyroid and adrenal surgeries. Data were adjusted for inflation. Descriptive statistics, compound annual growth rate (CAGR), and linear regression models were built to evaluate practice and reimbursement trends.

RESULTS: From 2000-23, there was a 63.8% increase in endocrine surgery volume. However, inflation-adjusted average procedure reimbursements decreased by 43.2% from $1709 to $972 (CAGR -2.4%), which is the largest decrease for any surgical subspecialty reported in the published literature. At the current CAGR, the average estimated reimbursement is projected to decrease to $868 by 2030 (P<0.001). Average facility reimbursements for inpatient and outpatient hospitalizations increased. However, substantial practice pattern shifts in the study period led to decreased overall facility reimbursements, with a $17.9 million decrease in total inpatient reimbursements between 2016-21 that was only partially offset by a $3.2 million increase in outpatient hospital reimbursements.

CONCLUSION: Medicare procedure reimbursements for endocrine surgeries have been outpaced by inflation, with large decreases since 2000. Concurrent changes in practice patterns have also resulted in markedly fewer inpatient stays leading to lower total facility reimbursements. Our data raise concern over the financial sustainability of the endocrine surgery field as the demand for endocrine surgery procedures increases.

PMID:38916100 | DOI:10.1097/SLA.0000000000006423

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Nevin Manimala Statistics

Examination time-distance characteristics of gait and pelvic kinematics in individuals with Diabetic polyneuropathy: a case-control study

Neurol Res. 2024 Jun 25:1-6. doi: 10.1080/01616412.2024.2367938. Online ahead of print.

ABSTRACT

BACKGROUND: Diabetic Peripheral Neuropathy (DPN) disrupts body and movement biomechanics, increases mechanical stress during walking, and predisposes individuals to injuries owing to the repetitive effects of these stresses.

AIMS: This study aimed to assess and compare the impact of neuropathy on gait and pelvic kinematics in individuals with DPN.

METHODS: This case-control study included two groups: 23 individuals diagnosed with DPN aged between 35-70 and 23 healthy individuals aged-35-70. The BTS-G, a wireless motion sensor, was used to assess the time-distance characteristics of walking in all participants. The system analyzed data pertaining to walking speed, cadence, percentages of stance and swing phases, durations of walking cycles, double-step lengths, pelvic tilt, obliquity, and rotation symmetries.

RESULTS: There were no statistically significant differences between the groups in cadence, left and right stance phase percentages, or left and right swing phase percentages (p > 0.05). However, significant differences were observed between the groups in terms of speed, left and right walking cycle durations, and left and right double-step lengths (p < 0.05). Additionally, no statistically significant difference was found between the groups in pelvic tilt symmetry and left and right pelvic tilt range of motion values (p > 0.05). Nevertheless, significant differences were identified between the groups in pelvic obliquity symmetry, pelvic rotation symmetry, left and right pelvic obliquity range of motion, and left and right pelvic rotation range of motion values (p < 0.05).

CONCLUSIONS: The findings of this study suggest that individuals with DPN exhibit decreased walking speed, prolonged gait cycle duration, increased double step length, and reduced pelvic obliquity and rotation range of motion.

PMID:38916096 | DOI:10.1080/01616412.2024.2367938

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Habitual physical activity and COVID-19

J Sports Med Phys Fitness. 2024 Jul;64(7):685-693. doi: 10.23736/S0022-4707.24.15516-8.

ABSTRACT

BACKGROUND: Physical activity (PA) is known to decrease COVID-19 risk factors and can attenuate symptoms of viral infections. However, difficulty exercising and fatigue are common complaints after COVID-19. It is unknown whether prior habitual PA will improve outcomes and what the time course is until full recovery of PA after COVID-19.

METHODS: Invitations were emailed to 21,933 adults who were SARS-CoV-2 positive between March 2020 and February 2021. Participants completed intake surveys and the Physical Activity History (PAH) questionnaire regarding PA during the 3-month prior to infection. Monthly thereafter, for up to 23 months, participants were emailed surveys. Scores were computed for moderate and heavy PA. Long COVID (LC) was defined as having recurring/persistent symptoms 9 months after diagnosis.

RESULTS: Overall, 993 patients completed the intake survey (age 50.7±15.8 years, BMI 27.3±9.2, 58% women); 28% had been hospitalized. One-third had recovered to their pre-infection level of PA at 9 months post-infection; this increased to 65% at one year, and 90% at two years. Higher pre-diagnosis PA reduced odds of hospitalization (P<0.05) but not of LC. Factors predictive of poor PA recovery were higher pre-diagnosis PA, shortness of breath and fatigue during acute illness, and fatigue chronically. Participants who reported ongoing symptoms had consistently poorer recovery of habitual PA compared to those not reporting chronic symptoms.

CONCLUSIONS: Habitual PA reduced odds of hospitalization but not of LC. Thirty-five percent had not returned to pre-COVID-19 levels of PA one year after infection, representing a major public health threat.

PMID:38916092 | DOI:10.23736/S0022-4707.24.15516-8

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Using a combination of three clinical tests for detecting meniscal tears increases the accuracy of the clinical examination

J Sports Med Phys Fitness. 2024 Jul;64(7):661-667. doi: 10.23736/S0022-4707.24.15584-3.

ABSTRACT

BACKGROUND: Recent studies indicate that using combination of two or more clinical tests for detecting meniscal tear gets a higher sensitivity and specificity than any clinical test performed individually.

METHODS: The study involved 84 participants who were divided into two groups: the “OP group” consisting of participants diagnosed with a meniscal tear and who consequently underwent arthroscopic meniscectomy, and the “CN group” comprising of healthy participants with no history of knee injury. Two independent observers (orthopedic surgeons) recorded the results of six clinical tests: Thessaly Test, joint line tenderness, McMurray Test, Ege Test, Steinmann I Test, and atrophy of the thigh muscles. The tests were grouped into two combinations of three tests each. The first combination included Thessaly Test, joint line tenderness and McMurray Test, while the second combination comprised of remaining three tests. Cochran’s Q Test was used to calculate interobserver variability for both combinations of clinical tests and for each test performed individually.

RESULTS: First combination of three clinical tests when considering the combination positive if two tests are positive had high sensitivity of 95%, specificity of 90.9%, and an overall accuracy of 92.9%. Furthermore, when compared to clinical tests performed individually, the combination demonstrated superior results.

CONCLUSIONS: This study shows that using a combination of three clinical tests for detection of meniscal tear (Thessaly Test, joint line tenderness, McMurray Test), when considering the combination positive if two tests are positive, has greater accuracy than six clinical tests performed individually. There were no statistically significant differences between observers.

PMID:38916089 | DOI:10.23736/S0022-4707.24.15584-3

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Nevin Manimala Statistics

Patterns of contraception utilization among reproductive-aged women with thyroid cancer undergoing radioiodine ablation: A study at Hasan Sadikin Hospital

Afr J Reprod Health. 2024 May 31;28(5):39-46. doi: 10.29063/ajrh2024/v28i5.5.

ABSTRACT

The incidence of new cases of thyroid cancer worldwide is around 10.1/100.000 in woman dan 3.1/100.000 in men. Women with thyroid cancer are advised to avoid pregnancy while undergoing radioablation due to teratogenicity. Therefore, it is crucial to utilize contraception to avoid pregnancy during treatment. The purpose of this study was to determine the characteristics of contraceptive use patterns in women with thyroid cancer of reproductive age who underwent radioablation at Hasan Sadikin Hospital Bandung.Cross-sectional study conducted at Hasan Sadikin Hospital Bandung in May 2023. The research sample was all female thyroid cancer of reproductive age who underwent radioablation at the Nuclear Medicine polyclinic of Dr. Hasan Sadikin Bandung in January-December 2022 by purposive sampling. Data obtained from patient medical records and primary data from patients. A total of 450 patients fulfilled inclusion criteria, but only 329 analyzed with complete data. Majority of the patient was in age group 35-49 years (58.1%), parity >1 (55.9%), last education high school (39.2%), married (81.8%), type of papillary thyroid carcinoma (79.9%), sources of information about contraception from doctors (71.7%), and 75.4% use contraception. The most widely used type of contraception was intrauterine device (IUD), accounting for 28.6% patients. Approximately 75.4% patient use contraception. The most widely used type of contraception is the IUD. Contraception counselling is important for increasing contraceptive use rates among women with thyroid cancer. Further research in the form of analytical research is needed to assess the factors that influence contraceptive use in women with thyroid cancer of reproductive age.

PMID:38916057 | DOI:10.29063/ajrh2024/v28i5.5

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Quality Improvement Project Reducing Sputum Cultures for Pediatric Patients With a Tracheostomy

Hosp Pediatr. 2024 Jun 25:e2023007125. doi: 10.1542/hpeds.2023-007125. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Current research implies overuse of diagnostic testing and overtreatment in children with tracheostomies. There are no guidelines for obtaining sputum cultures for these patients, yet they are commonly obtained without significantly affecting management or outcomes. The aim of our quality improvement project was to decrease rate of sputum cultures in this population by 50%, from 64% to 32%.

METHODS: This was a single-center quality improvement project conducted in a pediatric emergency department (ED). Key drivers included: Standardized decision-making, appropriate culture collection, knowledge regarding colonization versus clinically relevant growth, and viral versus bacterial infections in this population. The study team developed an algorithm, used modification to electronic medical records orders, and provided education to drive change. Six months of preintervention and 12 months postintervention data were collected. Run charts/statistical process charts were created for the rate of cultures, length of stay, and return to the ED.

RESULTS: There were 159 patient encounters and the rate of sputum cultures decreased from 64% at baseline to 25% without change in length of stay or increased rate at which patients returned to the ED, including during local coronavirus disease 2019 and respiratory syncytial virus surges. We observed nonrandom data patterns after introduction of algorithm resulting in centerline shifts.

CONCLUSIONS: The study team was able to introduce an algorithm coinciding with a reduction in number of sputum cultures obtained. Next steps would be determining safety and efficacy of such an algorithm over a larger population.

PMID:38916049 | DOI:10.1542/hpeds.2023-007125