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Nevin Manimala Statistics

Plasma exchange-A useful adjunct therapy to red cell exchange in patients with sickle cell disease and multiorgan dysfunction

Transfusion. 2023 Jun 15. doi: 10.1111/trf.17448. Online ahead of print.

ABSTRACT

BACKGROUND: Urgent red cell exchange (RBCx) is indicated for many complications of sickle cell disease (SCD), including acute chest syndrome, stroke, and hepatic/splenic sequestration. Many who receive RBCx remain hospitalized and develop further complications, including multiple organ dysfunction syndrome (MODS), a leading cause of death in intensive care units. Therapeutic plasma exchange (TPE) has been advocated as an effective treatment of MODS, but its role in SCD compared with RBCx alone is not well studied.

METHODS: We identified all ICU encounters from 2013 to 2019 involving RBCx procedures for MODS or SCD crisis that progressed to MODS, a total of 12 encounters. Data regarding hospital length of stay (LOS), survival, number of TPE procedures following RBCx, and procedure characteristics were collected. Surrogate laboratory markers of end-organ damage and disease severity scores were recorded at the time of admission, post-RBCx, post-TPE, and at discharge.

RESULTS: Eight encounters involved RBCx followed by TPE (TPE group) while four involved RBCx alone (RBCx group). The TPE group had a higher SOFA score at ICU admission (9.5 vs. 7.0), greater predicted mortality, and a statistical trend toward higher disease severity scores following RBCx relative to the RBCx group (p = 0.10). The TPE group showed a significantly greater decrease in SOFA score between RBCx and discharge (p = 0.04). No significant difference in mortality or hospital LOS was observed between the groups.

CONCLUSION: The findings suggest TPE may be considered as an adjunct treatment for patients with acute complications of SCD that progress to MODS, especially in cases where there is no significant improvement following RBCx.

PMID:37317564 | DOI:10.1111/trf.17448

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Risk Factors for Surgical Site Infection in Spinal Surgery and Interventions: A Retrospective Study

Kurume Med J. 2023 Jun 14. doi: 10.2739/kurumemedj.MS6834004. Online ahead of print.

ABSTRACT

BACKGROUND: Surgical site infection following spinal surgery causes prolonged delay in recovery after surgery, increases cost, and sometimes leads to additional surgical procedures. We investigated risk factors for the occurrence of surgical site infection events in terms of patient-related, surgery-related, and postoperative factors.

METHODS: This retrospective study included 1000 patients who underwent spinal surgery in our hospital between April 2016 and March 2019.

RESULTS: Patient-related factors were dementia, length of preoperative hospital stay (≥ 14 days), and diagnosis at the time of surgery (traumatic injury or deformity). The one surgery-related factor was multilevel surgery (≥ 9 intervertebral levels), and the one postoperative factor was time to ambulation (≥ 7 days) were statistically significant risk factors for spinal surgical site infection.

CONCLUSION: One risk factor identified in this study that is amenable to intervention is time to ambulation. As delayed ambulation is a risk factor for postoperative surgical site infection, how medical staff can intervene in postoperative ambulation to further reduce the incidence of surgical site infection is a topic for future research.

PMID:37316293 | DOI:10.2739/kurumemedj.MS6834004

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Risk Factors Related to Severity in COVID-19 Patients: A Real-world Retrospective Cohort Study

Intern Med. 2023 Jun 14. doi: 10.2169/internalmedicine.1934-23. Online ahead of print.

ABSTRACT

Background Understanding the clinical factors associated with the severity of COVID-19 is very important for the effective use of limited medical resources, including the appropriate evaluation of the need for hospitalization and discharge. Methods Patients hospitalized with a diagnosis of COVID-19 from March 2021 to October 2022 were included in the study. Patients admitted to our facility were classified into four waves: 4th (April to June 2021), 5th (July to October 2021), 6th (January to June 2022), and 7th waves (July to October 2022). We analyzed the severity, patients’ background characteristics, presence of pneumonia on chest computed tomography (CT), and blood test results in each wave. Patients were further classified into respiratory failure and nonrespiratory failure groups and statistically compared. Results Of the 565 patients diagnosed with COVID-19, 546 were included in this study. The percentage of patients classified as mild was approximately 10% in the 4th and 5th waves, but the rate increased after the 6th wave, with rates of 55.7% and 54.8% in each wave. Although more than 80% of patients in the 4th and 5th waves showed pneumonia on chest CT, the percentage decreased to approximately 40% after the 6th wave. Further comparisons between the respiratory failure group (n=75) and the nonrespiratory failure group (n=471) revealed significant differences in the age, sex, vaccination history, and biomarker values between the two groups. Conclusions In this study, elderly men were found to be more likely to develop severe disease than others, and biomarkers of COVID-19, such as C-reactive protein and lactate dehydrogenase, were useful for predicting severity. This study also suggested that vaccination may have contributed to a reduced disease severity.

PMID:37316272 | DOI:10.2169/internalmedicine.1934-23

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Rebleeding following aneurysmal subarachnoid hemorrhage before ‘endovascular first’ treatment: a retrospective case-control study of published scoring systems

J Neurointerv Surg. 2023 Jun 14:jnis-2023-020390. doi: 10.1136/jnis-2023-020390. Online ahead of print.

ABSTRACT

BACKGROUND: Pre-treatment re-bleeding following aneurysmal subarachnoid hemorrhage (aSAH) affects up to 7.2% of patients even with ultra-early treatment within 24 hours. We retrospectively compared the utility of three published re-bleed prediction models and individual predictors between cases who re-bled matched to controls using size and parent vessel location from a cohort of patients treated in an ultra-early, ‘endovascular first’ manner.

METHODS: On retrospective analysis of our 9-year cohort of 707 patients suffering 710 episodes of aSAH, there were 53 episodes of pre-treatment re-bleeding (7.5%). Forty-seven cases who had a single culprit aneurysm were matched to 141 controls. Demographic, clinical and radiological data were extracted and predictive scores calculated. Univariate, multivariate, area under the receiver operator characteristic curve (AUROCC) and Kaplan-Meier (KM) survival curve analyses were performed.

RESULTS: The majority of patients (84%) were treated using endovascular techniques at a median 14.5 hours post-diagnosis. On AUROCC analysis the score of Liu et al. had minimal utility (C-statistic 0.553, 95% confidence interval (CI) 0.463 to 0.643) while the risk score of Oppong et al. (C-statistic 0.645 95% CI 0.558 to 0.732) and the ARISE-extended score of van Lieshout et al. (C-statistic 0.53 95% CI 0.562 to 0.744) had moderate utility. On multivariate modeling, the World Federation of Neurosurgical Societies (WFNS) grade was the most parsimonious predictor of re-bleeding (C-statistic 0.740, 95% CI 0.664 to 0.816).

CONCLUSIONS: For aSAH patients treated in an ultra-early timeframe matched on size and parent vessel location, WFNS grade was superior to three published models for re-bleed prediction. Future re-bleed prediction models should incorporate the WFNS grade.

PMID:37316197 | DOI:10.1136/jnis-2023-020390

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Variation in radial head fracture treatment recommendations in terrible triad injuries is not influenced by viewing two-dimensional computed tomography

Clin Shoulder Elb. 2023 Jun;26(2):156-161. doi: 10.5397/cise.2022.01368. Epub 2023 May 17.

ABSTRACT

BACKGROUND: We analyzed association between viewing two-dimensional computed tomography (2D CT) images in addition to radiographs with radial head treatment recommendations after accounting for patient and surgeon factors in a survey-based experiment.

METHODS: One hundred and fifty-four surgeons reviewed 15 patient scenarios with terrible triad fracture dislocations of the elbow. Surgeons were randomized to view either radiographs only or radiographs and 2D CT images. The scenarios randomized patient age, hand dominance, and occupation. For each scenario, surgeons were asked if they would recommend fixation or arthroplasty of the radial head. Multi-level logistic regression analysis identified variables associated with radial head treatment recommendations.

RESULTS: Reviewing 2D CT images in addition to radiographs had no statistical association with treatment recommendations. A higher likelihood of recommending prosthetic arthroplasty was associated with older patient age, patient occupation not requiring manual labor, surgeon practice location in the United States, practicing for five years or less, and the subspecialties “trauma” and “shoulder and elbow.”

CONCLUSIONS: The results of this study suggest that in terrible triad injuries, the imaging appearance of radial head fractures has no measurable influence on treatment recommendations. Personal surgeon factors and patient demographic characteristics may have a larger role in surgical decision making. Level of evidence: Level III, therapeutic case-control study.

PMID:37316176 | DOI:10.5397/cise.2022.01368

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A retrospective hospital benefit and cost analysis of the management of human tissues for orthopaedic allografts

Eur J Hosp Pharm. 2023 Jun 14:ejhpharm-2023-003744. doi: 10.1136/ejhpharm-2023-003744. Online ahead of print.

ABSTRACT

OBJECTIVES: The transplantation of human tissues is a greatly expanding field of medicine with unquestionable benefits that raise questions about safety, quality and ethics. Since 1 October 2019, the Fondazione Banca dei Tessuti del Veneto (FBTV) stopped sending thawed and ready to be transplanted cadaveric human tissues to hospitals. A retrospective analysis of the period 2016-2019 found a significant number of unused tissues. For this reason, the hospital pharmacy has developed a new centralised service characterised by thawing and washing human tissues for orthopaedic allografts. This study aims to analyse the hospital cost and benefit derived from this new service.

METHODS: Aggregate data relating to tissue flows were obtained retrospectively for the period 2016-2022 through the hospital data warehouse. All tissues arriving from FBTV for each year were analysed, dividing them according to the outcome (if used or wasted). The percentage of wasted tissues as well as the economic loss due to wasted allografts were analysed per year and trimester.

RESULTS: We identified 2484 allografts requested for the period 2016-2022. In the last 3 years of the analysis, characterised by the new tissue management of the pharmacy department, we found a statistically significant reduction in wasted tissues (p<0.0001) from 16.33% (216/1323) with a cost to the hospital of 176 866€ during the period 2016-2019 to 6.72% (78/1161) with a cost to the hospital of 79 423€ during the period 2020-2022.

CONCLUSION: This study shows how the centralised processing of human tissues in the hospital pharmacy makes the procedure safer and more efficient, demonstrating how the synergy between different hospital departments, high professional skills and ethics can lead to a clinical advantage for patients and a better economic impact for the hospital.

PMID:37316166 | DOI:10.1136/ejhpharm-2023-003744

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Cost-effectiveness of a telemonitoring programme in patients with cardiovascular diseases compared with standard of care

Heart. 2023 Jun 14:heartjnl-2023-322518. doi: 10.1136/heartjnl-2023-322518. Online ahead of print.

ABSTRACT

OBJECTIVES: The main aim of this work was to analyse the cost-effectiveness of an integrated care concept (NICC) that combines telemonitoring with the support of a care centre in addition to guideline therapy for patients. Secondary aims were to compare health utility and health-related quality of life (QoL) between NICC and standard of care (SoC).

METHODS: The randomised controlled CardioCare MV Trial compared NICC and SoC in patients from Mecklenburg-West Pomerania (Germany) with atrial fibrillation, heart failure or treatment-resistant hypertension. QoL was measured using the EQ-5D-5L at baseline, 6 months and 1 year follow-up. Quality-adjusted life years (QALYs), EQ5D utility scores, Visual Analogue Scale (VAS) Scores and VAS adjusted life years (VAS-AL) were calculated. Cost data were obtained from health insurance companies, and the payer perspective was taken in health economic analyses. Quantile regression was used with adjustments for stratification variables.

RESULTS: The net benefit of NICC (QALY) was 0.031 (95% CI 0.012 to 0.050; p=0.001) in this trial involving 957 patients. EQ5D Index values, VAS-ALs and VAS were larger for NICC compared with SoC at 1 year follow-up (all p≤0.004). Direct cost per patient and year were €323 (CI €157 to €489) lower in the NICC group. When 2000 patients are served by the care centre, NICC is cost-effective if one is willing to pay €10 652 per QALY per year.

CONCLUSION: NICC was associated with higher QoL and health utility. The programme is cost-effective if one is willing to pay approximately €11 000 per QALY per year.

PMID:37316165 | DOI:10.1136/heartjnl-2023-322518

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Green TLC-Densitometric Method for Simultaneous Determination of Antazoline and Tetryzoline: Application to Pharmaceutical Formulation and Rabbit Aqueous Humor

J Chromatogr Sci. 2023 Jun 14:bmad042. doi: 10.1093/chromsci/bmad042. Online ahead of print.

ABSTRACT

Ophthalmic pharmaceutical preparation containing antazoline (ANT) and tetryzoline (TET) is prescribed widely as an over the counter medication for allergic conjunctivitis treatment. Development of a selective, simple and environmentally friendly thin-layer chromatographic method established to determine both ANT and TET in their pure forms, pharmaceutical formulation and spiked aqueous humor samples. By using silica gel plates and means of a developing system consists of ethyl acetate:ethanol (5:5, by volume), the studied drugs separation was achieved, and scanning was carried out at 220.0 nm for the separated bands with a 0.2-18.0 μg/band concentration range for each of ANT and TET. Standard addition technique application was carried out to determine the proposed method validity. Statistical comparison was made between the proposed method and the official methods ANT and TET showing no significant difference concerning accuracy and precision. Furthermore, greenness profile assessment was accomplished by means of four metric tools, namely, analytical greenness, green analytical procedure index, analytical eco-scale and national environmental method index.

Highlights.

PMID:37316161 | DOI:10.1093/chromsci/bmad042

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Development, Validation, and Reliability of a P1 Objective Structured Clinical Examination Assessing the National EPAs

Am J Pharm Educ. 2023 Jun;87(6):100054. doi: 10.1016/j.ajpe.2023.100054. Epub 2023 Mar 15.

ABSTRACT

OBJECTIVE: To document the performance of first-year pharmacy students on a revised objective structured clinical examination (OSCE) based on national entrustable professional activities, identify risk factors for poor performance, and assess its validity and reliability.

METHODS: A working group developed the OSCE to verify students’ progress toward readiness for advanced pharmacy practice experiences at the L1 level of entrustment (ready for thoughtful observation) on the national entrustable professional activities, with stations cross-mapped to the Accreditation Council for Pharmacy Education educational outcomes. Baseline characteristics and academic performance were used to investigate risk factors for poor performance and validity, respectively, by comparing students who were successful on the first attempt with those who were not. Reliability was evaluated using re-grading by a blinded, independent grader, and analyzed using Cohen’s kappa.

RESULTS: A total of 65 students completed the OSCE. Of these, 33 (50.8%) successfully completed all stations on first attempt, and 32 (49.2%) had to re-attempt at least 1 station. Successful students had higher Health Sciences Reasoning Test scores (mean difference 5, 95% CI 2-9). First professional year grade point average was higher for students who passed all stations on first attempt (mean difference 0.4 on a 4-point scale, 95% CI 0.1-0.7). When evaluated in a multiple logistic regression, no differences were statistically significant between groups. Most kappa values were above 0.4 (range 0.404-0.708), suggesting moderate to substantial reliability.

CONCLUSION: Though predictors of poor performance were not identified when accounting for covariates, the OSCE was found to have good validity and reliability.

PMID:37316140 | DOI:10.1016/j.ajpe.2023.100054

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Opioid Use Disorder Curricular Content in US-Based Doctor of Pharmacy Programs

Am J Pharm Educ. 2023 Jun;87(6):100061. doi: 10.1016/j.ajpe.2023.100061. Epub 2023 Mar 15.

ABSTRACT

OBJECTIVES: To characterize the instructional settings, delivery methods, and assessment methods of opioid use disorder (OUD) content in Doctor of Pharmacy (PharmD) programs; assess faculty perceptions of OUD content; and assess faculty perceptions of a shared OUD curriculum.

METHODS: This national, cross-sectional, descriptive survey study was designed to characterize OUD content, faculty perceptions, and faculty and institutional demographics. A contact list was developed for accredited, US-based PharmD programs with publicly-accessible online faculty directories (n = 137). Recruitment and telephone survey administration occurred between August and December 2021. Descriptive statistics were computed for all items. Open-ended items were reviewed to identify common themes.

RESULTS: A faculty member from 67 (48.9%) of 137 institutions contacted completed the survey. All programs incorporated OUD content into required coursework. Didactic lectures were the most common delivery method (98.5%). Programs delivered a median of 7.0 h (range, 1.5-33.0) of OUD content in required coursework, with 85.1% achieving the 4-hour minimum for substance use disorder-related content recommended by the American Association of Colleges of Pharmacy. Just over half (56.8%) of faculty agreed or strongly agreed that their students were adequately prepared to provide opioid interventions; however, 50.0% or fewer perceived topics such as prescription interventions, screening and assessment interventions, resource referral interventions, and stigma to be covered adequately. Almost all (97.0%) indicated moderate, high, or extremely high interest in a shared OUD curriculum.

CONCLUSION: Enhanced OUD education is needed in PharmD programs. A shared OUD curriculum was of interest to faculty and should be explored as a potentially viable solution for addressing this need.

PMID:37316134 | DOI:10.1016/j.ajpe.2023.100061