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Nevin Manimala Statistics

Monoclonal Gammopathy and Its Association with Progression to Kidney Failure and Mortality in Patients with CKD

Clin J Am Soc Nephrol. 2023 Nov 10. doi: 10.2215/CJN.0000000000000358. Online ahead of print.

ABSTRACT

BACKGROUND: Little is known about the prognostic significance of monoclonal gammopathy of undetermined and renal significance (MGUS and MGRS) in patients with chronic kidney disease (CKD). The objective of this study was to determine the clinical and kidney outcomes of patients with CKD with either MGUS or MGRS compared to those with CKD without MGUS or MGRS.

METHODS: We conducted a retrospective cohort study from 2013 to 2018. Patients who had both CKD diagnosis and monoclonal testing were identified. Patients were divided into MGRS, MGUS and no monoclonal gammopathy groups. Cumulative incidence functions and Cox proportional hazards regression were used to model time to event data and to evaluate the association between monoclonal gammopathy status and risk of kidney failure, with death treated as a competing risk.

RESULTS: Among 1,535 patients, 59 (4%) had MGRS, 648 (42%) had MGUS, and 828 (54%) had no monoclonal gammopathy. Univariable analysis showed that compared to patients with no monoclonal gammopathy, MGRS patients were at higher risk of kidney failure [HR (95% CI): 2.5 (1.5-4.2); P<0.001] but not MGUS patients [HR (95% CI): 1.3 (0.97-1.6); P=0.88], after taking death into account as a competing risk. However, in the multivariable analysis, after adjusting for age, sex, eGFR, proteinuria, and Charlson Comorbidity Index, the risk of progression to kidney failure (with death as competing risk) in the MGRS group was no longer statistically significant [HR: 0.9 (0.5-1.8); P=0.78]. The same was also true for the MGUS group compared to the group with no monoclonal gammopathy [HR: 1.3 (0.95, 1.6), p=0.11]. When evaluating the association between MGUS/MGRS status and overall survival, MGRS was a significantly associated with mortality in fully adjusted models compared to the group with no monoclonal gammopathy while MGUS was not.

CONCLUSIONS: After adjusting for traditional risk factors, MGUS/MGRS status was not associated with a greater risk of kidney failure, but MGRS was associated with a higher risk of mortality compared to patients with no monoclonal gammopathy.

PMID:37948069 | DOI:10.2215/CJN.0000000000000358

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Evaluating video-based consultations in routine clinical practice at a comprehensive cancer center

Acta Oncol. 2023 Nov 10:1-8. doi: 10.1080/0284186X.2023.2278758. Online ahead of print.

ABSTRACT

INTRODUCTION: Integrating telemedicine into cancer care remains a major challenge. There are little clinical evidence for teleconsultation efficacy and safety in daily oncology practice. This study as a pioneering experience, aimed to analyze patient and physician opinions regarding the implementation of telemedicine consultations, and to identify major limitations of telehealth spread in an oncology institute.

MATERIAL AND METHODS: During COVID-19 lockdown, patients and physicians who took part to at least one video-based teleconsultation between March and May 2020, were enrolled in this observational study. All eligible patients received an anonymous online questionnaire. On the other hand, all physicians eligible to participate were asked through email to complete a questionnaire.

RESULTS: In this study, 31 physicians and 304 patients consented to participate in this study by answering the questionnaire and were included. Regarding telemedicine satisfaction, 65.8% of patients were satisfied. The lack of clinical examination was the major limitation reported by 77% of patients. Patients belonging to a high socio-professional category were statistically more dissatisfied with the relationship with their doctor (OR = 2.31 and 95% CI [1.12; 4.74]).

CONCLUSION: This study showed promising results of incorporating video-based teleconsultations into cancer patient management. Randomized clinical trials are needed in order to accelerate the digital implementation in clinical practice.

PMID:37948066 | DOI:10.1080/0284186X.2023.2278758

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Role of Patient Sorting in Avoidable Hospital Stays in Medicare Advantage vs Traditional Medicare

JAMA Health Forum. 2023 Nov 3;4(11):e233931. doi: 10.1001/jamahealthforum.2023.3931.

ABSTRACT

IMPORTANCE: Unlike traditional Medicare (TM), Medicare Advantage (MA) plans limit in-network care to a specific network of Medicare clinicians. MA plans thus play a role in sorting patients to a subset of clinicians. It is unknown whether the performance of physicians who treat MA and TM beneficiaries is different.

OBJECTIVE: To examine whether avoidable hospital stay differences between MA and TM can be explained by the primary care clinicians who treat MA and TM beneficiaries.

DESIGN, SETTING, AND PARTICIPANTS: This was a cross-sectional study of a nationally representative sample of MA and TM beneficiaries in 2019 with any of 5 chronic ambulatory care-sensitive conditions (ACSCs). The relative risk (RR) of avoidable hospital stays in MA compared with TM was estimated with inverse probability of treatment-weighted Poisson regression, both without and with clinician fixed effects. The degree to which the estimated MA vs TM difference could be explained by patient sorting was calculated by comparing the 2 RR estimates. Data were analyzed between February 2022 and April 2023.

EXPOSURE: Enrollment in MA.

MAIN OUTCOME AND MEASURES: Whether a beneficiary had avoidable hospital stays in 2019 due to any of the ACSCs. Avoidable hospital stays included both hospitalizations and observation stays.

RESULTS: The study sample comprised 1 323 481 MA beneficiaries (mean [SD] age, 75.4 [7.0] years; 56.9% women; 69.3% White) and 1 965 863 TM beneficiaries (mean [SD] age, 75.9 [7.4] years; 57.1% women; 82.5% White). When controlling for the primary care clinician, the RR of avoidable hospital stays in MA vs TM changed by 2.6 percentage points (95% CI, 1.72-3.50; P < .001), suggesting that compared with TM beneficiaries, MA beneficiaries saw clinicians with lower rates of avoidable hospital stays. This effect size was statistically significant to explain the 2% lower rate of avoidable hospital stays in MA than in TM.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of MA and TM beneficiaries, the lower rate of avoidable hospital stays among MA beneficiaries than TM beneficiaries was attributable to MA beneficiaries visiting clinicians with lower rates of avoidable hospital stays. The patient sorting that occurs in MA plays a critical role in the lower rates of avoidable hospital stays compared with TM.

PMID:37948062 | DOI:10.1001/jamahealthforum.2023.3931

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Gendered Patterns in Manifest and Latent Mental Health Indicators Among Suicide Decedents: 2003-2020 US National Violent Death Reporting System (NVDRS)

Am J Public Health. 2023 Nov 10:e1-e10. doi: 10.2105/AJPH.2023.307427. Online ahead of print.

ABSTRACT

Objectives. To investigate differences in the documentation of mental health symptomology between male and female suicide decedents in the 2003-2020 US National Violent Death Reporting System (NVDRS). Methods. Using information on 271 998 suicides in the 2003-2020 NVDRS, we evaluated precoded mental health-related variables and topic model-derived latent mental health themes in the law enforcement and coroner or medical examiner death narratives compiled by trained public health workers. Results. Public health records of male compared with female suicides were less likely to include notations of mental health conditions or treatment interventions. However, topic modeling of death summaries revealed that male suicide decedents were more likely to evidence several subclinical cognitive and emotional indicators of distress. Conclusions. Suicide death records vary by gender, both in recorded evidence for mental health conditions at time of death and in accompanying narratives describing proximal circumstances surrounding these deaths. Our findings hint that patterns of subclinical mental health changes among men might be less well captured in commonly used mental health indicators, suggesting that prevention efforts may benefit from measures that also target assessment of subclinical distress. (Am J Public Health. Published online ahead of print November 10, 2023:e1-e10. https://doi.org/10.2105/AJPH.2023.307427).

PMID:37948056 | DOI:10.2105/AJPH.2023.307427

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Nevin Manimala Statistics

Promoting Competence in Nursing and Pharmacy Interprofessional Collaboration Through Telehealth Simulation

Nurs Educ Perspect. 2023 Nov 10. doi: 10.1097/01.NEP.0000000000001208. Online ahead of print.

ABSTRACT

Competence in interprofessional collaboration is essential for safe patient outcomes. This study examined the impact of an interprofessional telehealth pharmacology simulation on prelicensure nursing and pharmacy students’ perceptions of interprofessional roles. A pretest-posttest design was used to compare participants’ perceptions of interprofessional roles prior to and following the simulation. Data were collected using the Interdisciplinary Education Perception Scale (IEPS). Paired-samples t-tests showed statistically significant increases in scores for both the full IEPS (n = 99) and two subscales, Competency and Autonomy (n = 99) and Perception of Actual Cooperation (n = 99). Nurse educators should provide regular interprofessional experiences to foster learners’ competence in interprofessional collaboration and communication.

PMID:37948042 | DOI:10.1097/01.NEP.0000000000001208

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Estimating Costs Associated with Disease Model States Using Generalized Linear Models: A Tutorial

Pharmacoeconomics. 2023 Nov 10. doi: 10.1007/s40273-023-01319-x. Online ahead of print.

ABSTRACT

Estimates of costs associated with disease states are required to inform decision analytic disease models to evaluate interventions that modify disease trajectory. Increasingly, decision analytic models are developed using patient-level data with a focus on heterogeneity between patients, and there is a demand for costs informing such models to reflect individual patient costs. Statistical models of health care costs need to recognize the specific features of costs data which typically include a large number of zero observations for non-users, and a skewed and heavy right-hand tailed distribution due to a small number of heavy healthcare users. Different methods are available for modelling costs, such as generalized linear models (GLMs), extended estimating equations and latent class approaches. While there are tutorials addressing approaches to decision modelling, there is no practical guidance on the cost estimation to inform such models. Therefore, this tutorial aims to provide a general guidance on estimating healthcare costs associated with disease states in decision analytic models. Specifically, we present a step-by-step guide to how individual participant data can be used to estimate costs over discrete periods for participants with particular characteristics, based on the GLM framework. We focus on the practical aspects of cost modelling from the conceptualization of the research question to the derivation of costs for an individual in particular disease states. We provide a practical example with step-by-step R code illustrating the process of modelling the hospital costs associated with disease states for a cardiovascular disease model.

PMID:37948040 | DOI:10.1007/s40273-023-01319-x

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Is there a connection between neurocognitive profile in treatment naïve non-cirrhotic HCV patients and level of systemic inflammation?

J Neurovirol. 2023 Nov 10. doi: 10.1007/s13365-023-01184-6. Online ahead of print.

ABSTRACT

Hepatitis C virus (HCV) infection is a progressive, systemic disease which leads to the development of end-stage liver disease. In 70% of patients, HCV infection is followed by the development of extrahepatic manifestations (EHM). A common EHM is HCV associated neurocognitive disorder (HCV-AND), characterized by neuropsychological changes in attention, working memory, psychomotor speed, executive function, verbal learning, and recall. The aim of this study is to examine the correlation between the neurocognitive profile and routine, available laboratory parameters of inflammation, liver function tests, grade of liver fibrosis, and clinical and laboratory parameters of mixed cryoglobulinemia in treatment naïve non-cirrhotic HCV patients. This is a single-center exploratory study in which we examined 38 HCV + treatment naïve patients. The complete blood count and hematological parameters of systemic inflammation, liver function tests, biopsy confirmed grade of liver fibrosis, and clinical and laboratory parameters of mixed cryoglobulinemia caused by chronic HCV infection were observed. In the study, we used a battery of neuropsychological tests assessing multiple cognitive domains: executive functions, verbal fluency, delayed memory, working memory and learning, and one measure for visuo-constructive performance. Before the Bonferroni correction for multiple comparisons, the results show significant correlations between the scores in the neurocognitive variables and the single measures of inflammation, liver function parameters, and mixed cryoglobulinemia. It has not found a statistically significant correlation between systemic inflammation and neurocognitive variables. After the Bonferroni adjustment, no correlations remained significant. Certainly, the obtained results can be a recommendation for additional validation through future research.

PMID:37948037 | DOI:10.1007/s13365-023-01184-6

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Frailty index trajectories in Chinese older adults with diverse levels of social participation: findings from a national population-based longitudinal study

Aging Clin Exp Res. 2023 Nov 10. doi: 10.1007/s40520-023-02617-2. Online ahead of print.

ABSTRACT

BACKGROUND: Aging and frailty pose significant challenges globally, placing a substantial burden on healthcare and social services due to their adverse consequences.

AIM: The primary objective of this study was to investigate the relationship between social participation and development of frailty transition and trajectory.

METHODS: This study utilized data from the CLHLS Cohort, a 10-year follow-up study involving 6713 participants, to investigate the association between social participation and development of frailty. Frailty reflects a comprehensive decline in various body functions. The study employed a group-based trajectory model to analyze the development trajectory of the frailty index and used logistic regression to assess the odds ratio (OR) of frailty risk.

RESULTS: We identified two distinct groups of frailty progression trajectories: the “stable development group” and the “rapid growth group.” Individuals who engaged in social activities at least once a month, but not daily, exhibited a significant association with an increased risk of transitioning into the “rapid growth group” (OR 1.305, 95% CI 1.032-1.649). Those with social participation less than once a month had an even greater risk (OR 1.872, 95% CI 1.423-2.463). Moreover, low social participation frequency (occasionally/never) has a more pronounced impact on frailty progression in males.

CONCLUSION: A higher frequency of social participation is associated with a lower risk of being classified into the “rapid growth group” and a slower rate of frailty index progression. Preventing the progression of frailty can contribute to enhanced support for healthy aging among older adults.

PMID:37948011 | DOI:10.1007/s40520-023-02617-2

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Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial

Neurol Ther. 2023 Nov 10. doi: 10.1007/s40120-023-00562-w. Online ahead of print.

ABSTRACT

INTRODUCTION: There have been no prior trials directly comparing the efficacy of different calcitonin gene-related peptide (CGRP) antagonists for migraine prevention. Reported are the results from the first head-to-head study of two CGRP antagonists, galcanezumab (monoclonal antibody) versus rimegepant (gepant), for the prevention of episodic migraine.

METHODS: In this 3-month, double-blind, double-dummy study, participants were randomized (1:1) to subcutaneous (SC) galcanezumab 120 mg per month (after a 240 mg loading dose) and a placebo oral disintegrating tablet (ODT) every other day (q.o.d.) or to rimegepant 75 mg ODT q.o.d. and a monthly SC placebo. The primary endpoint was the proportion of participants with a ≥ 50% reduction in migraine headache days per month from baseline across the 3-month double-blind treatment period. Key secondary endpoints were overall mean change from baseline in: migraine headache days per month across 3 months and at month 3, 2, and 1; migraine headache days per month with acute migraine medication use; Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive domain score at month 3; and a ≥ 75% and 100% reduction from baseline in migraine headache days per month across 3 months.

RESULTS: Of 580 randomized participants (galcanezumab: 287, rimegepant: 293; mean age: 42 years), 83% were female and 81% Caucasian. Galcanezumab was not superior to rimegepant in achieving a ≥ 50% reduction from baseline in migraine headache days per month (62% versus 61% respectively; P = 0.70). Given the pre-specified multiple testing procedure, key secondary endpoints cannot be considered statistically significant. Overall, treatment-emergent adverse events were reported by 21% of participants, with no significant differences between study intervention groups.

CONCLUSIONS: Galcanezumab was not superior to rimegepant for the primary endpoint; however, both interventions demonstrated efficacy as preventive treatments in participants with episodic migraine. The efficacy and safety profiles observed in galcanezumab-treated participants were consistent with previous studies.

TRIAL REGISTRATION: ClinTrials.gov-NCT05127486 (I5Q-MC-CGBD).

PMID:37948006 | DOI:10.1007/s40120-023-00562-w

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Hemodynamic predictors of negative false lumen remodeling after frozen elephant trunk for acute aortic dissection

Gen Thorac Cardiovasc Surg. 2023 Nov 10. doi: 10.1007/s11748-023-01984-x. Online ahead of print.

ABSTRACT

OBJECTIVE: We evaluated the blood flow within the downstream aortic false lumen after frozen elephant trunk repair for acute aortic dissection and identified hemodynamic predictors of false lumen expansion and negative false lumen remodeling using four-dimensional flow magnetic resonance imaging.

METHODS: Thirty-one patients (Stanford type A, n = 28; Stanford type B, n = 3) with patent false lumen who underwent frozen elephant trunk procedures for acute aortic dissection were included in this observational study. Each patient underwent computed tomography during the follow-up period and four-dimensional flow magnetic resonance imaging within 3 postoperative months. The false lumen volumetric expansion rate was calculated using computed tomography data. The direction and the rate of flow in the lower descending aortic false lumen were analyzed. Negative false lumen remodeling was defined as a volumetric increase of > 10% from the baseline volume.

RESULTS: Negative false lumen remodeling had developed in 6 of the 31 patients during the observation period. Most of the false lumen flows were biphasic during systole. The range between peak and nadir flow rates was associated with the false lumen volumetric expansion rate (β coefficient = 6.77; p < 0.01, R2 = 0.43).

CONCLUSIONS: The range between peak and nadir flow rates may serve as a hemodynamic predictor of negative false lumen remodeling, enabling further treatment for patients at risk of expansion in the downstream aorta.

PMID:37948001 | DOI:10.1007/s11748-023-01984-x