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Nevin Manimala Statistics

Angioplasty with a stent retriever to treat vasospasm secondary to subarachnoid hemorrhage due to an aneurysm: a multicenter study of safety and efficacy

Radiologia (Engl Ed). 2022 Mar-Apr;64(2):103-109. doi: 10.1016/j.rxeng.2020.04.009.

ABSTRACT

OBJECTIVE: To determine the safety and efficacy of angioplasty with a retrievable stent in treating vasospasm secondary to subarachnoid hemorrhage (SAH) due to an aneurysm.

METHODS: We retrospectively analyzed prospectively collected data from consecutive patients undergoing endovascular angioplasty with a retrievable stent to treat vasospasm related to SAH due to an aneurysm in four neurointerventional radiology departments between January 2018 and July 2019. We included patients aged >18 years with vasospasm >50% of the internal carotid artery (ICA), anterior cerebral artery (ACA), and / or middle cerebral artery (MCA) secondary to SAH due to an aneurysm treated with endovascular angioplasty with a retrievable stent. The variables used to measure safety were complications of the procedure and clinical complications. The variables used to measure radiological efficacy were improvement in the degree of stenosis after endovascular treatment and improvement or normalization of cerebral circulation time CTT).

RESULTS: We included 16 angioplasty procedures with retrievable stents in 13 patients, in which 33 arterial segments were treated (10 ICA, 15 MCA, and 8 ACA). We observed no complications of the procedure in any patients and no clinical complications in patients who were not intubated. All but one of the patients who had delayed CTT at the beginning of the procedure showed improvements in CTT. The mean improvement in the degree of stenosis was 18% ± 11.65% in the ICA, 30.67% ± 18.45% in the MCA, and 28.38% ± 15.49% in the ACA. No statistically significant associations were observed between endovascular treatment variables and the degree of improvement in stenosis.

CONCLUSION: Angioplasty with a retrievable stent is a safe and efficacious treatment for vasospasm secondary to SAH due to an aneurysm, improving CTT and stenosis.

PMID:35504675 | DOI:10.1016/j.rxeng.2020.04.009

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Nevin Manimala Statistics

Exploratory analyses in aetiologic research and considerations for assessment of credibility: mini-review of literature

BMJ. 2022 May 3;377:e070113. doi: 10.1136/bmj-2021-070113.

ABSTRACT

OBJECTIVE: To provide considerations for reporting and interpretation that can improve assessment of the credibility of exploratory analyses in aetiologic research.

DESIGN: Mini-review of the literature and account of exploratory research principles.

SETTING: This study focuses on a particular type of causal research, namely aetiologic studies, which investigate the causal effect of one or multiple risk factors on a particular health outcome or disease. The mini review included aetiologic research articles published in four epidemiology journals in the first issue of 2021: American Journal of Epidemiology, Epidemiology, European Journal of Epidemiology, and International Journal of Epidemiology, specifically focusing on observational studies of causal risk factors of diseases.

MAIN OUTCOME MEASURES: Number of exposure-outcome associations reported, grouped by type of analysis (main, sensitivity, and additional).

RESULTS: The journal articles reported many exposure-outcome associations: a mean number of 33 (range 1-120) exposure-outcome associations for the primary analysis, 30 (0-336) for sensitivity analyses, and 163 (0-1467) for additional analyses. Six considerations were discussed that are important in assessing the credibility of exploratory analyses: research problem, protocol, statistical criteria, interpretation of findings, completeness of reporting, and effect of exploratory findings on future causal research.

CONCLUSIONS: Based on this mini-review, exploratory analyses in aetiologic research were not always reported properly. Six considerations for reporting of exploratory analyses in aetiologic research were provided to stimulate a discussion about their preferred handling and reporting. Researchers should take responsibility for the results of exploratory analyses by clearly reporting their exploratory nature and specifying which findings should be investigated in future research and how.

PMID:35504648 | DOI:10.1136/bmj-2021-070113

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Nevin Manimala Statistics

Determinants of neonatal sepsis among neonates admitted to the neonatal intensive care unit of public hospitals in Hawassa City Administration, Sidama Region, Ethiopia, 2020: an unmatched, case-control study

BMJ Open. 2022 May 3;12(5):e056669. doi: 10.1136/bmjopen-2021-056669.

ABSTRACT

OBJECTIVE: This study was conducted to assess the determinants of neonatal sepsis in the neonatal intensive care units of public hospitals in Hawassa City Administration, Sidama Region, Ethiopia, in 2020.

DESIGN: Institutional-based, unmatched, case-control study.

SETTING: The study was conducted in three public hospitals (Hawassa University Teaching Hospital, Adare General Hospital and Hawela Tula Primary Hospital) of Hawassa City, Ethiopia.

PARTICIPANTS: A total of 331 (110 cases and 221 controls) neonates with their index mothers were included in the study from 1 August to 30 September 2020.

OUTCOME MEASURES: A pretested, interviewer-administered questionnaire and data extraction checklist were used to collect data. Data were coded and entered into EpiData V.3.1 before being exported to SPSS V.20 for analysis. The factors associated with neonatal sepsis were assessed using bivariable and multivariable logistic regression analyses. P value of less than 0.05 was used to establish statistically significant association of variables.

RESULTS: Caesarean section delivery (adjusted OR (AOR)=2.56, 95 % CI 1.3 to 5.00), maternal anaemia (AOR=2.58, 95 % CI 1.45 to 4.6) and lack of vaccination with tetanus toxoid (AOR=3.5, 95% CI 2.07 to 6.19) were all identified as factors significantly associated with neonatal sepsis.

CONCLUSIONS: Caesarean section delivery, maternal history of anaemia and lack of vaccination with tetanus toxoid were found to be risk factors for neonatal sepsis. Establishing preconception care practice, strengthening the quality of antenatal care and standardising infection prevention practice are needed to improve neonatal health.

PMID:35504644 | DOI:10.1136/bmjopen-2021-056669

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Nevin Manimala Statistics

Maternal over-the-counter analgesics use during pregnancy and adverse perinatal outcomes: cohort study of 151 141 singleton pregnancies

BMJ Open. 2022 May 3;12(5):e048092. doi: 10.1136/bmjopen-2020-048092.

ABSTRACT

OBJECTIVES: To identify any associations between in utero exposure to five over-the-counter (non-prescription) analgesics (paracetamol, ibuprofen, aspirin, diclofenac, naproxen) and adverse neonatal outcomes.

DESIGN: Retrospective cohort study using the Aberdeen Maternity and Neonatal Databank.

PARTICIPANTS: 151 141 singleton pregnancies between 1985 and 2015.

MAIN OUTCOME MEASURES: Premature delivery (<37 weeks), stillbirth, neonatal death, birth weight, standardised birthweight score, neonatal unit admission, APGAR score at 1 and 5 min, neural tube and amniotic band defects, gastroschisis and, in males, cryptorchidism and hypospadias.

RESULTS: 83.7% of women taking over-the-counter analgesics reported first trimester use when specifically asked about use at their first antenatal clinic visit. Pregnancies exposed to at least one of the five analgesics were significantly independently associated with increased risks for premature delivery <37 weeks (adjusted OR (aOR)=1.50, 95% CI 1.43 to 1.58), stillbirth (aOR=1.33, 95% CI 1.15 to 1.54), neonatal death (aOR=1.56, 95% CI 1.27 to 1.93), birth weight <2500 g (aOR=1.28, 95% CI 1.20 to 1.37), birth weight >4000 g (aOR=1.09, 95% CI 1.05 to 1.13), admission to neonatal unit (aOR=1.57, 95% CI 1.51 to 1.64), APGAR score <7 at 1 min (aOR=1.18, 95% CI 1.13 to 1.23) and 5 min (aOR=1.48, 95% CI 1.35 to 1.62), neural tube defects (aOR=1.64, 95% CI 1.08 to 2.47) and hypospadias (aOR=1.27, 95% CI 1.05 to 1.54 males only). The overall prevalence of over-the-counter analgesics use during pregnancy was 29.1%, however it rapidly increased over the 30-year study period, to include over 60% of women in the last 7 years of the study. This makes our findings highly relevant to the wider pregnant population.

CONCLUSIONS: Over-the-counter (non-prescription) analgesics consumption during pregnancy was associated with a substantially higher risk for adverse perinatal health outcomes in the offspring. The use of paracetamol in combination with other non-steroidal anti-inflammatory drugs conferred the highest risk. The increased risks of adverse neonatal outcomes associated with non-prescribed, over-the-counter, analgesics use during pregnancy indicate that healthcare guidance for pregnant women regarding analgesic use need urgent updating.

PMID:35504638 | DOI:10.1136/bmjopen-2020-048092

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Nevin Manimala Statistics

Rivaroxaban population pharmacokinetic and pharmacodynamic modeling in Iranian patients

J Clin Pharm Ther. 2022 May 3. doi: 10.1111/jcpt.13673. Online ahead of print.

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Although predictable pharmacokinetic and pharmacodynamic of rivaroxaban allow fixed dosing regimens without routine coagulation monitoring, there is still the necessity to monitor and predict the effects of rivaroxaban in specific conditions and different populations. The current study was designed and conducted to analyze the rivaroxaban population pharmacokinetics in Iranian patients and establish a pharmacokinetic/pharmacodynamic model to predict the relationship between rivaroxaban concentration and its anticoagulant activity.

METHODS: A sequential nonlinear mixed effect pharmacokinetic/pharmacodynamic modeling method was used to establish the relation between rivaroxaban concentration and anti-factor Xa activity, prothrombin time, and activated partial thromboplastin time (aPTT) as pharmacodynamic biomarkers in a population of sixty-nine Iranian patients under treatment with oral rivaroxaban. Rivaroxaban plasma concentration was quantified by a validated high-performance liquid chromatography-tandem mass spectrometry.

RESULTS AND DISCUSSION: The typical population values (inter-individual variability%) of the oral volume of distribution and clearance for a one-compartment model were 61.2 L (21%) and 3.68 L·h-1 (61%), respectively. Creatinine clearance and Child-Turcotte-Pugh score were found to affect the clearance. A direct link linear structural model best fitted the data for both prothrombin time and aPTT. The baseline estimates of aPTT and prothrombin time in the population were 35.0 (15%) and 12.6 (2%) seconds, respectively. The slope of the relationship between apTT, prothrombin time, and rivaroxaban concentration was 0.033 (28%) and 0.018 (54%) s·ml·ng-1 , respectively. The selected model for anti-factor Xa activity consisted of a direct link inhibitory Emax model with Hill coefficient. The maximum level of inhibition (Emax ) was 4 IU·ml-1 . The concentration of rivaroxaban producing 50% of the maximum inhibitory effect (EC50 ) was 180 (24%) ng·ml-1 , and Hill coefficient (γ) was 1.44 (108%). No covariates showed a statistically significant effect on PT and activated partial thromboplastin time prolonging properties and anti-factor Xa activity.

WHAT IS NEW AND CONCLUSION: Our results confirmed that pharmacokinetic/pharmacodynamic models similar to those of the other studies describe the relationship between the rivaroxaban concentration and its anticoagulant effect in Iranian patients. However, considerable differences were observed in the parameters of the pharmacodynamics-pharmacokinetic models with the results of other reports that can explain the unpredictable effects of rivaroxaban in some patients.

PMID:35504629 | DOI:10.1111/jcpt.13673

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Nevin Manimala Statistics

The Doctors in the House: Examining Physician Legislators in the US Congress from 2011 to 2020

South Med J. 2022 May;115(5):322-327. doi: 10.14423/SMJ.0000000000001389.

ABSTRACT

OBJECTIVES: Legislation dictating federal healthcare policy is drafted largely by members of the US Senate and House of Representatives. As such, their personal and professional backgrounds play important roles in setting the national healthcare agenda. We examine the professional and legislative records of the 28 federal physician legislators with voting privileges between 2011 and 2020.

METHODS: Two researchers compiled the names of every federal legislator in both the US Senate and the US House of Representatives who served at any time between 2011 and 2020. The researchers used publicly available records to abstract information regarding their professional and legislative records. Data were then analyzed using descriptive statistics.

RESULTS: The majority of the 28 federal physician legislators are Doctor of Medicine graduates (96%), Republican (86%), represent southern states (71%), were in private practice before serving as legislators (78.5%), and have not previously held elected positions as legislators (57%). Approximately 15% of the bills that they sponsor are related to health policy. Obstetrics/Gynecology, Surgery, and Family Medicine are the most common specialties. On average, it takes 25 years from medical school graduation to election to their federal legislative position. Approximately half represent states, or districts within states, in which they attended medical school or completed residency.

CONCLUSIONS: To engage in meaningful healthcare policy advocacy, professional organizations must support and encourage leadership training for physicians, increase the geographic and professional diversity of physician legislators, prioritize the election of physicians from both political parties, and inculcate deep and lasting professional relationships to physicians in Congress.

PMID:35504614 | DOI:10.14423/SMJ.0000000000001389

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Sex Education and Sexual Risk Behavior among Adolescents and Youth in the Deep South: Implications for Youth HIV Prevention

South Med J. 2022 May;115(5):310-314. doi: 10.14423/SMJ.0000000000001391.

ABSTRACT

OBJECTIVES: Adolescents and young adults represent the largest group of new human immunodeficiency virus (HIV) infections in the United States, especially in the South. We wanted to determine whether abstinence only until marriage (AOUM) sex education programs were effective in reducing HIV vulnerability among youth in Mississippi.

METHODS: Using the 2015 Mississippi Youth Risk Behavior Surveillance System, we examined the effect of AOUM sex education among a sample of youth ages 12 to 18 years on 4 HIV-related sexual risk behaviors.

RESULTS: Compared with youth not enrolled in AOUM sex education, we found no statistically significant differences on sexual risk behaviors. Race, age, and gender were significant risk factors in predicting sexual risk behavior.

CONCLUSIONS: AOUM sex education programs are ineffective in reducing HIV vulnerability among youth in Mississippi. There is an urgent need to implement comprehensive sex education if we are to reduce the numbers of new HIV infections among youth and achieve our goals of ending the HIV epidemic by 2030.

PMID:35504611 | DOI:10.14423/SMJ.0000000000001391

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Nevin Manimala Statistics

Developing Awareness and Allies: Simulating Difficult Conversations about Microaggressions for Faculty and Students

South Med J. 2022 May;115(5):283-289. doi: 10.14423/SMJ.0000000000001396.

ABSTRACT

OBJECTIVES: Discrimination and bias in clinical training often take the form of microaggressions, which, albeit unintentional, are detrimental to the learning environment and well-being of students. Although there are a few reports of medical schools training students to respond to microaggressions, none have included a complementery student-led faculty training module. The aim of this study was to develop and evaluate a case-based approach to improving student resilience and increasing faculty awareness of microaggressions in the clinical setting.

METHODS: We created four realistic cases of microaggressions and uncomfortable conversations, based on students’ experiences on the wards, to implement training for incoming third-year students and their core faculty. Standardized patients were trained to effectively portray discriminatory faculty, residents, and patients. Institutional review board-approved surveys were administered and statistically analyzed to evaluate for efficacy.

RESULTS: Students had greater mean confidence scores for responding to microaggressions immediately and at 6 months after the sessions (P < 0.05). Faculty showed improved mean confidence and understanding of the definition of a microaggression (P < 0.05).

CONCLUSIONS: This approach had results similar to other studies, with the additional benefit of training faculty with the same scenarios. We believe that this method helped bridge the gap between students’ notions of discrimination and faculty understanding of microaggressions.

PMID:35504606 | DOI:10.14423/SMJ.0000000000001396

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Nevin Manimala Statistics

Association of High-Density Lipoprotein Cholesterol Phenotypes with the Risk of Cardiovascular Diseases and Mortality: A Cohort Study in Korea

Endocrinol Metab (Seoul). 2022 Apr;37(2):261-271. doi: 10.3803/EnM.2021.1259. Epub 2022 Apr 25.

ABSTRACT

BACKGROUND: We investigated whether low high-density lipoprotein cholesterol (HDL-C) and isolated and non-isolated low HDL-C levels are associated with the risk of cardiovascular diseases and all-cause mortality among Korean adults.

METHODS: We included 8,665,841 individuals aged ≥20 years who had undergone a health examination provided by the Korean National Health Insurance Service (NHIS) in 2009 and were followed up until the end of 2018. The hazard ratios (HRs) and 95% confidence intervals (CIs) for study outcomes were calculated using multivariable Cox proportional hazard regression analysis.

RESULTS: During the 8.2 years of mean follow-up, myocardial infarction (MI), stroke, and all-cause mortality occurred in 81,431, 110,996, and 244,309 individuals, respectively. After adjusting for confounding variables (model 3), individuals with low HDL-C and lower HDL quartiles were associated with significantly increased risks of all three outcomes, compared to those with normal HDL-C and highest HDL-C quartile (all P<0.001), respectively. HRs for incident MI (1.28; 95% CI, 1.26 to 1.30), stroke (1.13; 95% CI, 1.11 to 1.15), and all-cause mortality (1.07; 95% CI, 1.05 to 1.08) increased in the non-isolated low HDL-C group compared to the normal HDL-C group. Isolated low HDL-C also showed an increase in the HRs of incident stroke (1.06; 95% CI, 1.04 to 1.08) and all-cause mortality (1.30; 95% CI, 1.28 to 1.32).

CONCLUSION: Low HDL-C and non-isolated low HDL-C were associated with increased risk of MI, stroke, and all-cause mortality, and isolated low HDL-C was associated with incident stroke and all-cause mortality risk.

PMID:35504601 | DOI:10.3803/EnM.2021.1259

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Nevin Manimala Statistics

Decreasing pre-procedural fasting times in hospitalized children

J Hosp Med. 2022 Feb;17(2):96-103. doi: 10.1002/jhm.12782. Epub 2022 Feb 14.

ABSTRACT

OBJECTIVE: Prolonged pre-procedural fasting in children is associated with decreased patient and family satisfaction and increased patient hemodynamic instability. Practice guidelines recommend clear liquid fasting times of 2 h. We aimed to decrease pre-procedural clear liquid fasting time from 10 h 13 min to 5 h for pediatric hospital medicine (PHM) patients.

METHODS: All children admitted to the PHM service at a quaternary care children’s hospital with an NPO (nil per os) order associated with a procedure requiring general anesthesia or sedation from November 2, 2017 to September 19, 2021 were included. The primary outcome measure was the average time from clear liquid fasting end time to anesthesia start time. The process measure was the percent of NPO orders including a documented clear liquid fasting end time. Balancing measures were aspiration events and case delays/cancellations. Statistical process control charts were used to analyze outcomes.

RESULTS: Shortly after implementation of a SmartPhrase in the NPO order, there was special cause variation resulting in a centerline shift from a mean of 10 h 13 min to 6 h 37 min and an increase in the process measure from a baseline of 2%-52%. Following implementation of a hospital-wide change to the NPO order format, another centerline shift to 6 h 7 min occurred which has been sustained for 6 months. No aspiration events and four NPO violations occurred during the intervention period.

CONCLUSION: Quality improvement methodology and higher reliability interventions safely decreased the average pre-procedural fasting time in hospitalized children.

PMID:35504576 | DOI:10.1002/jhm.12782