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Nevin Manimala Statistics

The effect of various types of COVID-19 vaccines on the retinal microvasculature

Photodiagnosis Photodyn Ther. 2023 Jan 8:103275. doi: 10.1016/j.pdpdt.2023.103275. Online ahead of print.

ABSTRACT

PURPOSE: to detect the effect of various types of COVID-19 vaccine on macular and optic disc microvasculature.

METHOD: one hundred subjects receiving various types of COVID-19 vaccine (AstraZeneca, Sinopharm, Sinovac, Pfizer, and Moderna) were included in this study. A complete ophthalmic examination was done which included best-corrected visual acuity measurement, slit-lamp biomicroscopy, intraocular pressure measurement with Goldmann applanation tonometry, and fundus examination. Optical coherence tomography angiography (OCT-A) was done before and 1 week after receiving the vaccine. Superficial and deep macular capillary densities were measured in the form of the whole image, fovea, parafoveal, and perifoveal capillary density. Optic disc vessel density in the form of the whole disc, inside disc, and peripapillary were also measured.

RESULTS: The superficial macular vessel densities, (whole image, fovea, parafoveal, and perifoveal) showed statistically non-significant changes with P-values (0.269, 0.167, 0.346, and 0.476) respectively. Also, the deep macular vessel densities showed statistically non-significant changes with P-values (0.491, 0.096, 0.724, and 0.386) for the whole image, fovea, parafoveal, and perifoveal respectively. Moreover, RPC (radial peripapillary capillary) density showed no significant changes either (the whole disc, inside disc, or peripapillary) with P-values (0.807, 0.141, 0.883) respectively.

CONCLUSION: various types of COVID-19 vaccines had no statistically significant effects on macular or optic disc microvasculature.

PMID:36632871 | DOI:10.1016/j.pdpdt.2023.103275

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Nevin Manimala Statistics

On the mathematization of epidemiology as a socially-engaged quantitative science

Am J Epidemiol. 2023 Jan 11:kwad010. doi: 10.1093/aje/kwad010. Online ahead of print.

ABSTRACT

Ensuring that patients with opioid use disorder (OUD) have access to optimal medication therapies is a critical challenge in substance use epidemiology. The paper by Rudolph et al. (Am J Epidemiol. 2022; XXX(X):XXXX-XXXX) demonstrated that sophisticated data-adaptive statistical techniques can be used to learn optimal, individualized treatment rules which can aid providers in choosing a medication for opioid use disorder (MOUD) treatment modality for a particular patient. This important work also highlights the effects of the mathematization of epidemiologic research. Here, we define mathematization and demonstrate how it operates in the context of MOUD effectiveness research using the paper by Rudolph et al. as a springboard. In particular, we address the normative dimension of mathematization, and how it tends to resolve a fundamental tension in epidemiologic practice between technical sophistication and public health considerations in favor of more technical solutions. The process of mathematization is a fundamental part of epidemiology; we argue not for eliminating it but for balancing mathematization and technical demands equally with practical and community-centric public health needs.

PMID:36632844 | DOI:10.1093/aje/kwad010

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Pan-immune-inflammation value is associated with poor prognosis in patients undergoing peritoneal dialysis

Ren Fail. 2023 Dec;45(1):2158103. doi: 10.1080/0886022X.2022.2158103.

ABSTRACT

BACKGROUND: Immune-inflammatory biomarkers (IIBs) have been shown to be correlated with prognosis in patients undergoing peritoneal dialysis (PD). In this study, we aimed to evaluate the relationship between a novel comprehensive biomarker, the pan-immune-inflammation value (PIV), and the prognosis of patients undergoing PD.

METHODS: We retrospectively analyzed data from a multicenter, large-sample PD database. PIV was calculated as (neutrophil count × platelet count × monocyte count)/lymphocyte count. The prognostic endpoints in this study were all-cause death all-cause, cardiovascular disease (CVD) and infection-related death. The Kaplan-Meier method, a Cox proportional hazards regression, Fine-Gray competing risk model, smooth curve, and subgroup analysis were used to analyze the independent relationship between PIV and the prognosis of patients undergoing PD.

RESULTS: A total of 2796 cases of PD were included, and the study population was divided into Tertiles 1, 2, and 3, according to the tertiles of baseline PIVs. After adjusting for multiple model factors, patients in the Tertile 3 group had a significantly higher risk of all-cause death, CVD death and infection-related death compared with patients with PIV in the Tertile 1 group. Interaction tests showed no positive correlations for subgroup parameters. Regarding all-cause death, compared with the lowest tertile, the multivariable-adjusted hazard ratios (95% confidence intervals) of the highest and middle tertiles were 1.55 (1.25-1.94) and 1.77 (1.43-2.19), respectively; PIV (log2 processing) was associated with 17% excess of mortality in the continuous model.

CONCLUSIONS: A high PIV at baseline was significantly associated with an increased risk of deaths due to all-causes, CVD and infection in patients undergoing PD.

PMID:36632816 | DOI:10.1080/0886022X.2022.2158103

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Nuclear medicine procedure volume and estimation of collective effective dose in Tamil Nadu towards the establishment of diagnostic reference level

Radiat Prot Dosimetry. 2023 Jan 11:ncac297. doi: 10.1093/rpd/ncac297. Online ahead of print.

ABSTRACT

With an objective to establish adult diagnostic reference levels in the practice of nuclear medicine (NM) in the state of Tamil Nadu (TN), data on the predominant NM procedures carried out in the state are analyzed. In this study, data on total NM diagnostic procedures during the years 2015-19 along with patient-specific diagnostic NM procedure data for the period April-June 2021 from all centers in Tamil Nadu are collected and analyzed using SPSS statistical software. Nine predominant types of NM scans are analyzed. Collective effective dose from NM scans and per capita dose for the TN population are estimated. The 75th percentile of the distribution and average administered activity (AAA) has been derived and local reference levels are reported. Based on the statistical analysis, it is observed that the whole-body positron emission tomography (PET), renal diethylenetriamine pentaacetate (DTPA) scan, bone methylene diphosphonate (MDP) scan, iodine-131 whole body scan, thyroid studies using Technetium per technetate, renal dimercaptosuccinic acid (DMSA), myocardial perfusion methoxyisobutyl isonitrile sestamibi (MIBI), mebrofenin, Galium-68 prostate-specific membrane antigen (PSMA) are the most common procedure covering >90% of the practices carried out. The collective effective dose is 410 man-Sv in the year 2019, leading to a mean effective dose of 0.006 mSv per capita of the TN state population. The 75th percentile of the distribution of AA is slightly higher than diagnostic reference level (DRL) as compared with Australian DRL (310 MBq). It is also observed that F-18 PET procedures are primarily responsible for most of the collective effective dose, local DRL is 316 MBq and it is important to establish national DRLs for NM diagnostic scans to optimize the NM examinations.

PMID:36632802 | DOI:10.1093/rpd/ncac297

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Associations of abdominal discomfort and length of clinical signs with surgical procedure in 181 cases of canine small intestinal foreign body obstruction

Vet Med Sci. 2023 Jan 12. doi: 10.1002/vms3.1045. Online ahead of print.

ABSTRACT

BACKGROUND: Gastrointestinal foreign bodies are a common indication for abdominal exploratory surgery.

OBJECTIVES: The objective of this study was to evaluate the relationship of pre-operative abdominal discomfort and duration of clinical signs with surgical resolution of canine small intestinal foreign body obstructions (SIFBO).

METHODS: We performed a retrospective study of 181 canine abdominal exploratory surgeries for confirmed SIFBO at two referral hospitals. Animals were categorized into five surgical groups (gastrotomy after manipulation into the stomach, enterotomy, resection-and-anastomosis [R&A], manipulated into colon, already in colon) and further grouped by whether entry into the gastrointestinal tract (GIT) was required.

RESULTS: Abdominal discomfort was noted in 107/181 cases (59.1%), but no significant differences in abdominal discomfort rates were present among the surgical groups or between GIT entry and no entry groups. Clinical sign duration was associated with surgical procedure; median durations were R&A = 3 days (range, 1-9), enterotomy = 2 days (range, 1-14), gastrotomy = 2 days (range, 1-6), already in colon = 1.5 days (range, 1-2), and manipulated into colon = 1 day (range, 1-7). In a pairwise comparison, differences in the duration of clinical signs were found for obstructions manipulated into the colon versus R&A, gastrotomy versus R&A, and in colon versus R&A. When patients were grouped according to GIT entry, cases with entry had a longer duration of clinical signs (median = 2 days [range, 1-14] versus 1 day [range, 1-7], respectively).

CONCLUSIONS: Abdominal discomfort was not associated with surgical complexity; however, the duration of clinical signs was associated with surgical complexity, with longer duration being associated with entry into the GIT and R&A. Despite statistical significance, the maximum difference of 2 days between surgical groups is unlikely to be clinically relevant.

PMID:36632768 | DOI:10.1002/vms3.1045

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Observing expert opinion of medical affairs pharmaceutical physicians on the value of their clinical experience to the pharmaceutical industry using the Jandhyala method

Curr Med Res Opin. 2023 Jan 12:1-25. doi: 10.1080/03007995.2023.2165814. Online ahead of print.

ABSTRACT

BACKGROUND: The pharmaceutical industry requires a highly qualified workforce with diverse skillsets. Medical affairs pharmaceutical physicians (MAPPs) have unique qualifications among pharmaceutical company employees, but the exact contribution of their education and training is unknown. This study aimed to identify the medical education and training competencies MAPPs use in the pharmaceutical industry in relation to the four external stakeholders, regulators, payors, prescribers, and patients.

METHOD: Ten MAPPs were recruited using convenience sampling via professional networks. A systematic literature review and the Jandhyala method, a two-stage qualitative online consensus method, identified which of MAPPs’ medical education and training competencies they used in their work with each external stakeholder. Statistical analyses determined heterogeneity in the relevance of competencies and competency categories to each stakeholder.

RESULTS: Nine MAPPs completed the study. Of the 59 competencies identified, 54 were relevant to all external stakeholders. Relevance of competencies varied significantly between external stakeholders (p = 0.0434). Binary competency scores varied significantly for three pairs of stakeholders, ‘patient vs payor’ (p = 0.025), ‘prescriber vs regulator’ (p = 0.013) and ‘prescriber vs payor’ (p = 0.008). Between-stakeholder overall frequency count varied significantly for two of the nine competency categories.

CONCLUSION: MAPPs develop a highly specialized set of competencies during medical education and training from which they use distinct subsets to meet the needs of external stakeholders in the pharmaceutical industry. Undergraduate and postgraduate competency-based medical education appears to prepare MAPPs for cognitive and technical work. Further exploration may aid understanding of how they develop soft skills.

PMID:36632732 | DOI:10.1080/03007995.2023.2165814

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Sustaining Long-term Asthma Outcomes at a Community and Tertiary Care Pediatric Hospital

Hosp Pediatr. 2023 Jan 12:e2021006224. doi: 10.1542/hpeds.2021-006224. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Implementing asthma Clinical Practice Guidelines (CPG) have been shown to improve length of stay (LOS) and readmission rates on a short-term basis at both tertiary care and community hospital settings. Whether these outcomes are sustained long term is not known. The goal of this study was to measure the long-term impact of CPG implementation at both tertiary and community sites in 1 hospital system.

METHODS: A retrospective study was conducted using the Pediatric Health Information System database. LOS and 7- and 14-day emergency department (ED) revisit and readmission rates from 2009 to 2020 were compared pre and post implementation of asthma CPG in 2012 at both sites. Implementation involved electronic order sets, early metered dose inhaler introduction, and empowering respiratory therapists to wean per the bronchodilator weaning protocol. Interrupted time series and statistical process control charts were used to assess CPG impact.

RESULTS: Implementation of asthma CPG was associated with significant reductions in the variability of LOS without impacting ED revisit or readmission rates at both the tertiary and community sites. Secular trends in the interrupted time series did not demonstrate significant impact of CPG on LOS. However, the overall trend toward decreased LOS that started before CPG implementation was sustained for 7 years after CPG implementation.

CONCLUSIONS: Early metered dose inhaler introduction, respiratory therapist-driven bronchodilator weaning, and electronic order sets at both the community and tertiary care site led to a significant reduction in the variation of LOS, without impacting ED revisit or readmission rate.

PMID:36632719 | DOI:10.1542/hpeds.2021-006224

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Characteristics, ICU Interventions, and Clinical Outcomes of Patients With Palliative Care Triggers in a Mixed Community-Based Intensive Care Unit

J Palliat Care. 2023 Jan 11:8258597221145326. doi: 10.1177/08258597221145326. Online ahead of print.

ABSTRACT

Objective: Integration of palliative care initiatives in the intensive care unit (ICU) benefit patients and improve outcomes. Palliative care triggers (PCTs) is a screening tool that aides in stratifying patients who would benefit most from an early palliative care approach. There is no consensus on PCT selection or best timing for implementation. We evaluated the clinical characteristics, ICU and palliative care interventions, and clinical outcomes of critically ill patients with PCT in a community-based mixed ICU. Methods: This retrospective study was conducted in a 44-bed adult, mixed ICU in a 407-bed community-based teaching hospital in Florida. Eleven PCTs were used as a screening tool during multidisciplinary rounds (MDRs). Patients were analyzed based on presence or absence of PCT as well as having met high (>2) versus low (<2) PCT. Data collected included patient demographics, ICU resource utilization and clinical outcomes. We considered a two-sided P value of less than .05 to indicate statistical significance with a 95% confidence interval. Results: Of 388 ICU patients, 189 (48.7%) met at least 1 PCT and 199 (51.3%) did not. The trigger group had higher Acute Physiology and Chronic Evaluation (APACHE) and Sequential Organ Failure Assessment (SOFA) scores within 24 h of ICU admission. The most common PCTs identified were ICU length of stay greater than 7 days or readmission to ICU, terminal prognosis and assisting family in transitioning goals of care. There were statistically significant differences in ICU resource utilization, palliative care interventions, and overall worse clinical outcomes in the trigger-detected group. Similar findings were seen in the cohort with high PCT (>2). Conclusions: Our study supports the implementation of a tailored 11-item palliative care screening tool to effectively identify ICU patients with high ICU and palliative care interventions and worse clinical outcomes.

PMID:36632687 | DOI:10.1177/08258597221145326

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Explosive eye injuries: characteristics, traumatic mechanisms, and prognostic factors for poor visual outcomes

Mil Med Res. 2023 Jan 12;10(1):3. doi: 10.1186/s40779-022-00438-4.

ABSTRACT

BACKGROUND: Explosions can produce blast waves, high-speed medium, thermal radiation, and chemical spatter, leading to complex and compound eye injuries. However, few studies have comprehensively investigated the clinical features of different eye injury types or possible risk factors for poor prognosis.

METHODS: We retrospectively reviewed all consecutive records of explosive eye injuries (1449 eyes in 1115 inpatients) in 14 tertiary referral hospitals in China over 12 years (between January 2008 and December 2019). Data on demographics, eye injury types, ocular findings, treatments, and factors affecting visual prognosis were extracted from a standardized database of eye injuries and statistically analyzed.

RESULTS: Mechanical ocular trauma accounted for 94.00% of explosion-related eye injuries, among which intraocular foreign bodies (IOFBs) resulted in 55.17% of open globe injuries (OGIs) and contusion caused 60.22% of close globe injuries (CGIs). Proliferative vitreous retinopathy (PVR) was more common in perforating (47.06%) and IOFB (26.84%) than in penetrating (8.79%) injuries, and more common with laceration (24.25%) than rupture (9.22%, P < 0.01). However, no difference was observed between rupture and contusion. Ultimately, 9.59% of eyes were removed and the final vision was ≤ 4/200 in 45.82% of patients. Poor presenting vision [odds ratio (OR) = 5.789], full-thickness laceration of the eyeball ≥ 5 mm (OR = 3.665), vitreous hemorrhage (OR = 3.474), IOFB (OR = 3.510), non-mechanical eye injury (NMEI, OR = 2.622, P < 0.001), rupture (OR = 2.362), traumatic optic neuropathy (OR = 2.102), retinal detachment (RD, OR = 2.033), endophthalmitis (OR = 3.281, P < 0.01), contusion (OR = 1.679), ciliary body detachment (OR = 6.592), zone III OGI (OR = 1.940), and PVR (OR = 1.615, P < 0.05) were significant negative predictors for poor visual outcomes.

CONCLUSIONS: Explosion ocular trauma has complex mechanisms, with multiple eyes involved and poor prognosis. In lethal level I explosion injuries, eyeball rupture is a serious condition, whereas contusion is more likely to improve. In level II injuries, IOFBs are more harmful than penetrating injuries, and level IV represents burn-related eye injuries. PVR is more associated with penetrating mechanisms than with OGI. Identifying the risk predictors for visual prognosis can guide clinicians in the evaluation and treatment of ocular blast injuries.

PMID:36631894 | DOI:10.1186/s40779-022-00438-4

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Comparison of telemonitoring combined with intensive patient support with standard care in patients with chronic cardiovascular disease – a randomized clinical trial

Eur J Med Res. 2023 Jan 11;28(1):22. doi: 10.1186/s40001-023-00991-1.

ABSTRACT

IMPORTANCE: Healthcare concepts for chronic diseases based on tele-monitoring have become increasingly important during COVID-19 pandemic.

OBJECTIVE: To study the effectiveness of a novel integrated care concept (NICC) that combines tele-monitoring with the support of a call centre in addition to guideline therapy for patients with atrial fibrillation, heart failure, or treatment-resistant hypertension.

DESIGN: A prospective, parallel-group, open-label, randomized, controlled trial.

SETTING: Between December 2017 and August 2019 at the Rostock University Medical Center (Germany).

PARTICIPANTS: Including 960 patients with either atrial fibrillation, heart failure, or treatment-resistant hypertension.

INTERVENTIONS: Patients were randomized to either NICC (n = 478) or standard-of-care (SoC) (n = 482) in a 1:1 ratio. Patients in the NICC group received a combination of tele-monitoring and intensive follow-up and care through a call centre.

MAIN OUTCOMES AND MEASURES: Three primary endpoints were formulated: (1) composite of all-cause mortality, stroke, and myocardial infarction; (2) number of inpatient days; (3) the first plus cardiac decompensation, all measured at 12-months follow-up. Superiority was evaluated using a hierarchical multiple testing strategy for the 3 primary endpoints, where the first step is to test the second primary endpoint (hospitalization) at two-sided 5%-significance level. In case of a non-significant difference between the groups for the rate of hospitalization, the superiority of NICC over SoC is not shown.

RESULTS: The first primary endpoint occurred in 1.5% of NICC and 5.2% of SoC patients (OR: 3.3 [95%CI 1.4-8.3], p = 0.009). The number of inpatient treatment days did not differ significantly between both groups (p = 0.122). The third primary endpoint occurred in 3.6% of NICC and 8.1% of SoC patients (OR: 2.2 [95%CI 1.2-4.2], p = 0.016). Four patients died of all-cause death in the NICC and 23 in the SoC groups (OR: 4.4 [95%CI 1.6-12.6], p = 0.006). Based on the prespecified hierarchical statistical analysis protocol for multiple testing, the trial did not meet its primary outcome measure.

CONCLUSIONS AND RELEVANCE: Among patients with atrial fibrillation, heart failure, or treatment-resistant hypertension, the NICC approach was not superior over SoC, despite a significant reduction in all-cause mortality, stroke, myocardial infarction and cardiac decompensation. Trial registration ClinicalTrials.gov Identifier: NCT03317951.

PMID:36631889 | DOI:10.1186/s40001-023-00991-1