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Nevin Manimala Statistics

Trajectory of Cognitive Function After Incident Heart Failure

Circ Heart Fail. 2025 Feb 18:e011837. doi: 10.1161/CIRCHEARTFAILURE.124.011837. Online ahead of print.

ABSTRACT

BACKGROUND: The magnitude of cognitive changes after incident heart failure (HF) is unclear. We assessed whether incident HF is associated with changes in cognition after accounting for pre-HF cognitive trajectories and known determinants of cognition.

METHODS: This pooled cohort study included adults without HF, stroke, or dementia from 6 US population-based studies from 1971 to 2019. Linear mixed-effects models estimated cognitive change with incident HF diagnosis and the rate of cognitive change over the years after HF, controlling for pre-HF cognitive trajectories and participant factors. Outcomes included change in global cognition (primary outcome), executive function, and memory (secondary outcomes). Cognitive outcomes were standardized to a t score metric (mean [SD], 50 [10]); a 1-point difference represented a 0.1-SD difference in cognition.

RESULTS: We included 29 614 adults (mean [SD] age was 61 [10] years, 55% female, 70% White). During a median follow-up of 6.6 (Q1-Q3, 5.0-19.8) years, 1407 (5%) adults received an incident diagnosis of HF. Incident HF diagnosis was associated with initial decreases in global cognition (-1.1 points [95% CI, -1.4 to -0.8]) and executive function (-0.6 points [95% CI, -1.0 to -0.3]). Larger decreases in global cognition after HF were seen with older age, female sex, and White race. Participants with incident HF diagnosis demonstrated faster and long-term declines in global cognition (-0.1 points per year [95% CI, -0.2 to -0.1]) and executive function (-0.2 points per year [95% CI, -0.2 to -0.1]). The change in memory with incident HF diagnosis was not statistically significant but showed a similar trend with an initial decline of -0.5 points (95% CI, -1.4 to +0.3) and a slope of -0.1 points per year (95% CI, -0.3 to 0.0).

CONCLUSIONS: In this pooled cohort study, incident HF diagnosis was associated with initial decreases in global cognition and executive function and faster, persistent declines in these domains at follow-up.

PMID:39963777 | DOI:10.1161/CIRCHEARTFAILURE.124.011837

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Nevin Manimala Statistics

Oral propranolol and its impact on vital signs in hospitalized pediatric patients for the Management of Infantile Hemangiomas

Pediatr Dermatol. 2025 Feb 18. doi: 10.1111/pde.15740. Online ahead of print.

ABSTRACT

BACKGROUND: Infantile hemangiomas (IH) affect 2%-10% of the pediatric population. The current standard treatment for complicated IH is oral propranolol. Propranolol initiation protocols vary depending on institution and may occur in an inpatient setting for patients <5-week-corrected-age, with a history of premature birth, and or with low weight to allow for heart rate (HR), blood pressure (BP), and glucose monitoring.

OBJECTIVE: Our study aimed to determine the clinical outcomes of monitoring inpatient propranolol initiation and to evaluate if complications occurred during admission.

METHODS: Retrospective chart review of patients seen at the University of Minnesota Department of Dermatology between January 01, 2012 and July 31, 2022 was completed. Inclusion criteria include less than 1 year of age at time of admission, a diagnosis of IH and or PHACE syndrome, and admission for propranolol initiation and monitoring.

RESULTS: Admissions for 78 pediatric patients were reviewed. After initiation of propranolol, significant decreases in BP (systolic p = .005; diastolic p = .002) and HR (p = .004) were noted; however, average BPs and HRs remained above the lower limit of normal. No patients experienced symptomatic hypoglycemia. No statistically significant or clinically meaningful differences in vital sign alterations were observed between patients <5 versus >5 kg; preterm vs term gestation; or <5-week-corrected-age versus >5-week-corrected-age.

DISCUSSION: Our findings complement current literature confirming that propranolol initiation is safe in pediatric patients. Propranolol initiation likely requires less laboratory and vital sign monitoring than currently performed for these patient populations.

PMID:39963769 | DOI:10.1111/pde.15740

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Nevin Manimala Statistics

Preparing for death: a survey on rituals in the dying phase in the Christian context in Germany

Ann Palliat Med. 2025 Jan;14(1):79-89. doi: 10.21037/apm-24-119.

ABSTRACT

BACKGROUND: In the majority of cultures, death is accompanied by a series of rituals that assist the bereaved in coping with this significant transition. However, there is a paucity of empirical literature on the organisation of such rituals. The objective of this multidisciplinary study was to collate an inventory of rituals and ritual elements. This data will be employed to develop a repertoire of rituals. The research was conducted in Germany. The participants in the second phase were primarily hospital chaplains. Consequently, the data collected primarily related to rituals anchored in a Christian context.

METHODS: We initiated a multidisciplinary research project (palliative medicine, cultural anthropology, theology) on rituals in end-of-life care. The study employed a mixed-methods approach, comprising three phases, and was conducted in Germany. In this paper, we present the results of a survey on professionals conducted using an online questionnaire. The aim was to explore the general understanding, demands, practices and further suggestions from clinical practice (phase 2). The questionnaire consisted of both open and closed questions. It should be noted that the survey did not enquire about the respondents’ religious affiliation. The responses to the closed questions were analysed statistically, while the open-ended responses were analysed qualitatively.

RESULTS: A total of 299 questionnaires were completed, primarily by chaplains, nurses, and doctors. The respondents described a wide range of rituals, and across all professions, there was a high to medium perceived need for the use of rituals for patients nearing the end of their lives and their relatives. Rituals at the end of life were found to be highly relevant in terms of providing support and structure, expressing emotions, and experiencing community. The spectrum of rituals extends from established and extensive religious rituals to smaller everyday actions that are elevated to the status of rituals.

CONCLUSIONS: As religious traditions are no longer practised by an increasing number of people; it may be reasonable to develop new rituals for the dying phase that can be adapted and used by palliative care staff to suit the respective context. These rituals could make a valuable contribution to the care of the dying, their relatives and the professional team.

PMID:39963760 | DOI:10.21037/apm-24-119

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Nevin Manimala Statistics

The role of community health workers in a collaborative care management intervention for cancer pain management: a feasibility study for a randomized controlled trial

Ann Palliat Med. 2025 Jan;14(1):13-28. doi: 10.21037/apm-24-125.

ABSTRACT

BACKGROUND: Despite the plausible role for community health workers (CHWs) in supporting historically disenfranchised patients experiencing cancer-related pain, few survivorship care models currently include CHWs. The purpose of our study was to learn from existing CHWs regarding the feasibility of working with rural dwelling and/or Hispanic/Latino patients and their cancer care teams; as well as assessing their anticipated barriers and facilitators of delivering a proposed collaborative care pain intervention [Achieving Equity through SocioCulturally-informed, Digitally-Enabled Cancer Pain managemeNT (ASCENT)].

METHODS: Guided by the National Institute on Minority Health and Health Disparities (NIMHD) Research Framework, we recruited experienced CHWs to a mixed-methods feasibility study, including survey, interview and/or focus group. The survey assessed CHWs’ comfort level with proposed intervention-related tasks (e.g., working with patients diagnosed with cancer). Interviews and focus groups explored potential training needs, as well as perceived intervention implementation barriers and facilitators. We summarized results using descriptive statistics and a rapid qualitative analytic approach.

RESULTS: In total, 12 CHWs participated. Data included surveys (n=12), interviews (n=8), and a focus group with 4 participants. Overall, participant-CHWs felt confident they could participate in healthcare teams and remotely engage rural-dwelling and/or Hispanic/Latino patients diagnosed with cancer. Implementation barriers and facilitators included: working remotely in an unfamiliar geographic area, resource availability, technology, implementation-specific challenges, and patient level factors (e.g., loss of motivation).

CONCLUSIONS: Participant-CHWs viewed serving on a multidisciplinary healthcare team to support Hispanic/Latino and rural-dwelling cancer patients experiencing pain as feasible but identified training and resourcing needs.

PMID:39963755 | DOI:10.21037/apm-24-125

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Nevin Manimala Statistics

Slightly increased level of DNA migration in the comet assay: does statistical significance equal biological significance?

Mutagenesis. 2025 Feb 18:geaf004. doi: 10.1093/mutage/geaf004. Online ahead of print.

ABSTRACT

In the comet assay, DNA damage is assessed by differences in DNA migration from gel-embedded nucleoids. Even a small difference in DNA migration between exposure groups can be statistically significant, but may invite speculation about the biological significance of such slight increases in DNA migration. A small difference can be defined as a net difference of 1-2% Tail DNA, but background levels of DNA migration typically vary already more than 1-2% Tail DNA between studies. Here we have used studies on ionizing radiation to assess lowest detectable differences in DNA migration; variation in exposure-effect relationships; variation in central tendencies of DNA migration; unsystematic (residual) variation; and the actual number of lesions detectable with the comet assay. A total of 51 studies on ionizing radiation exposure in mammalian cells have been systematically reviewed, including results from ring-trial studies where the same batch of irradiated cells has been analyzed in different laboratories. Ring-trial studies have shown that unsystematic variation is approximately 4% Tail DNA in studies on ionizing radiation. Studies on ionizing radiation in cell cultures have shown statistically significant effects when the net increase of DNA migration is 0.3-3.1% Tail DNA. Among those experiments, the ones with optimal assay conditions to detect low levels of DNA damage show statistically significant effects with doses of around 0.30 Gy, which corresponds to approximately 350 lesions per diploid cell. However, it has also been shown that the same dose of ionizing radiation can give rise to different levels of DNA migration (i.e. 0.7-7.8% Tail DNA per Gy) in different studies.. In summary, the results show that even a small statistically significant difference in DNA migration has biological significance within the same experiment, but comparisons of DNA migration values between studies have limited biological implications.

PMID:39963750 | DOI:10.1093/mutage/geaf004

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Nevin Manimala Statistics

Expected Value of Sample Information Calculations for Risk Prediction Model Validation

Med Decis Making. 2025 Feb 18:272989X251314010. doi: 10.1177/0272989X251314010. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of external validation of a risk prediction model is to evaluate its performance before recommending it for use in a new population. Sample size calculations for such validation studies are currently based on classical inferential statistics around metrics of discrimination, calibration, and net benefit (NB). For NB as a measure of clinical utility, the relevance of inferential statistics is doubtful. Value-of-information methodology enables quantifying the value of collecting validation data in terms of expected gain in clinical utility.

METHODS: We define the validation expected value of sample information (EVSI) as the expected gain in NB by procuring a validation sample of a given size. We propose 3 algorithms for EVSI computation and compare their face validity and computation time in simulation studies. In a case study, we use the non-US subset of a clinical trial to create a risk prediction model for short-term mortality after myocardial infarction and calculate validation EVSI at a range of sample sizes for the US population.

RESULTS: Computation methods generated similar EVSI values in simulation studies, although they differed in numerical accuracy and computation times. At 2% risk threshold, procuring 1,000 observations for external validation, had an EVSI of 0.00101 in true-positive units or 0.04938 in false-positive units. Scaled by heart attack incidence in the United States, the population EVSI was 806 in true positives gained, or 39,500 in false positives averted, annually. Validation studies with >4,000 observations had diminishing returns, as the EVSIs were approaching their maximum possible value.

CONCLUSION: Value-of-information methodology quantifies the return on investment from conducting an external validation study and can provide a value-based perspective when designing such studies.

HIGHLIGHTS: In external validation studies of risk prediction models, the finite size of the validation sample leads to uncertain conclusions about the performance of the model. This uncertainty has hitherto been approached from a classical inferential perspective (e.g., confidence interval around the c-statistic).Correspondingly, sample size calculations for validation studies have been based on classical inferential statistics. For measures of clinical utility such as net benefit, the relevance of this approach is doubtful.This article defines the expected value of sample information (EVSI) for model validation and suggests algorithms for its computation. Validation EVSI quantifies the return on investment from conducting a validation study.Value-based approaches rooted in decision theory can complement contemporary study design and sample size calculation methods in predictive analytics.

PMID:39963746 | DOI:10.1177/0272989X251314010

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Nevin Manimala Statistics

Forecasting with Excel

Acta Medica (Hradec Kralove). 2024;67(3):87-90. doi: 10.14712/18059694.2025.3.

ABSTRACT

INTRODUCTION: Time series analysis is used by statisticians to make predictions from time-ordered data. This is crucial for planning for the future. The inclusion of little-known forecasting function in Excel™ has brought this type of analysis within the ability of less mathematically sophisticated individuals, including doctors. There are two main models for time series analysis: ARIMA (Autoregressive Integrated Moving Average) and exponential smoothing. This paper will demonstrate how the ubiquitous Excel facilitates a little-known sophisticated forecasting technique that employs the latter and presents a facilitating spreadsheet.

METHODS: Excel’s FORECAST.ETS function was invoked with supporting macros.

RESULTS: A bespoke spreadsheet was created that would prompt for data to be pasted in columns A and B, formatted as a valid date in A and data in B. After error trapping and a horizon date, the FORECAST.ETS function calculates forecasts with 95% CI and a line graph. The FORECAST.ETS.CONFINT was also invoked using a macro to obtain a 95, 96, 97, 98 and 99% confidence intervals table.

DISCUSSION: Forecasting is vital in all fields, including the medical field, for innumerable reasons. Statisticians are capable of far more sophisticated time series analyses and techniques and may use multiple techniques that are beyond the competence of ordinary clinicians. However, the sophisticated Excel tool described in this paper allows simple forecasting by anyone with some knowledge of this ubiquitous software. It is hoped that the spreadsheet included with this paper helps to encourage colleagues to engage with this simple-to-use Excel function.

PMID:39963736 | DOI:10.14712/18059694.2025.3

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Nevin Manimala Statistics

Sensorineural Hearing Loss in Otosclerosis Surgery

Acta Medica (Hradec Kralove). 2024;67(3):73-78. doi: 10.14712/18059694.2025.1.

ABSTRACT

BACKGROUND: During otosclerosis surgery, operative trauma can lead to decreased bone conduction.

AIMS: The study aims to observe the bone conduction changes after otosclerosis operations and analyse possible factors affecting the postoperative decrease in bone conduction.

MATERIAL AND METHODS: Authors retrospectively processed the data of 109 patients and evaluated pure tone audiometry before surgery and consequently 2 days, 1 month and 1 year after surgery.

RESULTS: We noted a deterioration of bone conduction >5 dB on the second postoperative day in 28% (30/109) of patients, which persisted one year after the surgery in 9% (10/109) cases. Analysis of individual factors affecting bone conduction loss revealed a higher risk of permanent loss of bone conduction in patients with early postoperative loss in higher frequencies, in older patients and patients with a preoperative threshold of bone conduction >20 dB. Revision surgery was not a statistically significant factor.

CONCLUSION AND SIGNIFICANCE: The bone conduction decrease after otosclerosis surgery is usually temporary. The recovery of bone conduction is influenced by the age of patients and the level of bone conduction before the surgery. The early postoperative decrease of bone conduction in higher frequencies is a negative predictive factor for permanent hearing loss.

PMID:39963734 | DOI:10.14712/18059694.2025.1

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Nevin Manimala Statistics

Nutritional management and outcomes of malnourished children under 2 years with intestinal failure

J Pediatr Gastroenterol Nutr. 2025 Feb 18. doi: 10.1002/jpn3.70018. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to assess the evolution of nutritional status, parenteral nutrition (PN) composition, and PN dependence index (PNDI) in children under 2 years old with intestinal failure (IF) and malnutrition.

METHODS: This retrospective cohort included patients admitted between November 1, 2016, and August 31, 2021, with IF, age ≤24 months, and weight-for-age (Wt/A) <-2 standard deviation with a follow-up of 12 months. Data collected included demographic, anthropometric, biochemical, and nutritional information. The PNDI was compared between enteral autonomy (EA) and nonenteral autonomy (non-EA) groups.

RESULTS: Thirty patients (16 males, 53.33%) were included, and short bowel syndrome (SBS) was the leading cause of IF (n = 27, 90%). The mean age at admission was 7.23 ± 3.90 months, and 36.66% of the patients had a conjugated bilirubin (CB) level >2 mg/dL; 87% had a Wt/A z-score <-3 and 90% had a height-for-age (Ht/A) z-score <-3. At 5 months, the mean Wt/A z-score improved to -1.82. At admission, median protein, lipid, and glucose intake on PN were 3, 1.6, and 17.27 g/kg/day, respectively. In the PNDI analysis, the EA group had a mean index of 141% versus 158% for the non-EA group at admission, with no statistical differences. From the sixth month onward, the EA group showed a significantly lower PNDI (50% vs. 108% for non-EA patients; p = 0.032). Both groups demonstrated adequate nutritional recovery.

CONCLUSION: Adequate multidisciplinary care can reverse severe malnutrition, and the PNDI may be a predictor of EA.

PMID:39963728 | DOI:10.1002/jpn3.70018

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Nevin Manimala Statistics

Clinical Features and Outcomes of Myroides Species Infections

Open Forum Infect Dis. 2025 Jan 28;12(2):ofaf049. doi: 10.1093/ofid/ofaf049. eCollection 2025 Feb.

ABSTRACT

BACKGROUND: Myroides species, Gram-negative bacilli from the Flavobacteriaceae family, are typically considered low-virulence pathogens but have previously been described as extensively drug-resistant. This study investigates the clinical features and outcomes of Myroides infections.

METHODS: We conducted a retrospective cohort study of patients hospitalized at Cleveland Clinic with Myroides infection. Infections were defined as a positive Myroides culture from a sterile site that were treated with an antibiotic to which the isolate was susceptible. Controls were hospitalized patients with a positive culture for Myroides, who did not meet the definition for infection. Survival for infected patients and uninfected controls was compared using Cox proportional hazards regression.

RESULTS: Between January 2015 and September 2023, 52 positive Myroides species cultures were identified, with 21 deemed infections. A higher proportion of Myroides-infected patients than controls had diabetes mellitus. The most common infections were skin/soft-tissue infections (42.8%), osteomyelitis (33.3%), and urinary tract infections (19%); and 28.5% were bacteremic infections. All isolates were resistant to aminoglycosides, but the majority were susceptible to trimethoprim-sulfamethoxazole (81%), ciprofloxacin (57%), and meropenem (68%). The main antimicrobial treatments provided were meropenem, ciprofloxacin, and trimethoprim-sulfamethoxazole. A significant difference in survival was not found between patients with Myroides infection and uninfected controls (hazard ratio, 3.42; 95% confidence interval, .63-18.74; P = .16).

CONCLUSIONS: All patients in this study had reasonable treatment options, belying previous reports of extensive antibiotic resistance in Myroides. Our small study did not detect a statistically significant decrease in survival among Myroides-infected patients compared to controls.

PMID:39963698 | PMC:PMC11832043 | DOI:10.1093/ofid/ofaf049