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Nevin Manimala Statistics

Interaction between valproic acid and meropenem or ertapenem in patients with epilepsy: clinical relevance and results from pharmaceutical intervention

Farm Hosp. 2021 Sep 28;45(6):335-339.

ABSTRACT

OBJECTIVE: The literature has described the interaction between valproic acid and carbapenems. This interaction leads to decreases in plasma concentrations of valproic acid. The main objectives of this study were to assess its relevance in clinical practice, to identify variables associated with increased seizure episode rates, and to analyse the impact of pharmaceutical intervention on avoiding the effects of this interaction.

METHOD: An observational retrospective study of inpatients with epilepsy admitted between 2016 and 2020. Their pharmacological treatment throughout admission was recorded, and the presence of other interactions leading to decreased plasma concentrations of valproic acid was reviewed. The seizure rate during the year prior to admission was compared to that during the interaction period. For every episode in which the interaction was detected, an intervention was conducted by providing the prescriber with information on the interaction and suggesting a change of antibiotherapy as well as the pharmacokinetic monitoring of valproic acid.

RESULTS: 37 episodes were included. 58.1% of the patients were male and median age was 70 years. In total, 56.8% of the patients received meropenem and 43.2% received ertapenem. The median duration of concomitant treatment with valproic acid and carbapenem was 4 days. The incidence rate ratio was 2.60 (95% confidence interval: 1.61-4.21). Thus, this interaction was associated with a higher seizure rate. A statistically significant association was found between higher seizure rates and patients treated with more than one anti-epileptic drug. Hospital pharmacists detected 24 episodes (64.9%). In total, 17 interventions (70.8%) were accepted and 13 combinations were discontinued. Pharmacokinetic monitoring was conducted in 13 episodes (35.1%) and infratherapeutic levels were found in all of them.

CONCLUSIONS: The interaction between valproic acid and meropenem or ertapenem is clinically relevant. It is recommended that this combination should be avoided provided that a viable alternative is available. Pharmaceutical intervention may contribute to preventing seizures associated with this combination.

PMID:34806574

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The role of the pharmacist within an immune-mediated inflammatory disease unit: Results of a survey of healthcare providers and patients

Farm Hosp. 2021 Nov 2;45(6):305-316.

ABSTRACT

OBJECTIVE: To evaluate the importance and need for pharmacists to expand their role to new activities and to promote and maintain others they already carried out prior to the implementation of a new Immunemediated Inflammatory Diseases Unit to be created in our hospital; to prioritize the new activities incorporated based on the results obtained.

METHOD: This was a single center cross-sectional based on a survey administered during January 2020 to all clinical healthcare providers due to be part of the new unit, as well as to a sample of patients. It was structured into two categories: actions related to patients’ pharmaceutical care, and actions related to practitioners of the Immune-mediated Inflammatory Diseases Unit. Each item was assigned a score from 0 to 10, where 10 indicated maximum interest or need. A prioritization template was applied to quantify and evaluate each activity and implement the new ones in order of priority.

RESULTS: A total of 90 responses were obtained (30 from patients and 60 from healthcare workers). An analysis was performed of the median scores of each of the 20 activities proposed, which ranged between 8 and 10 points. When comparing the scores obtained, it was observed that more statistically significant differences were obtained in the pharmacists vs doctors group than in the pharmacists vs nurses group, or the pharmacists vs patients one. After prioritization, the first action taken was to implement electronic prescriptions for outpatients with immune-mediated inflammatory diseases.

CONCLUSIONS: The survey revealed the expectations of healthcare providers and patients regarding the role pharmacists should play in the newly created unit and provided an insight into the most valued activities. This information will be useful in prioritizing the implementation of the new activities to be carried out by the unit.

PMID:34806570

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Bariatric surgery alleviates depression in obese patients: A systematic review and meta-analysis

Obes Res Clin Pract. 2021 Nov 18:S1871-403X(21)00145-9. doi: 10.1016/j.orcp.2021.11.002. Online ahead of print.

ABSTRACT

BACKGROUND: With the rapid increase in the incidence of depression, there have been studies investigating whether bariatric surgery can alleviate this condition. In this study, we aimed to explore the effect of bariatric surgery on depression in obese patients.

METHODS: We searched the PubMed, Embase, Web of Science and the Cochrane Library databases for studies on bariatric surgery and depression. Then, the clinical significance of bariatric surgery on depression was evaluated based on Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale (HADS) or Patient Health Questionnaire (PHQ-9). Subgroup analysis was carried out in terms of surgery types, assessment tool, follow-up time and nationalism. Dichotomous data were analyzed using odds ratio (OR), and continuous data were evaluated using the weighted mean difference (WMD) or standardized mean difference (SMD).

RESULTS: Overall, 33 studies with a combined total of 12,556 participants met the inclusion criteria. Statistical results were significantly different whether continuous or dichotomous, and depression was improved in obese patients after surgery (SMD = -0.87, p < 0.001; and OR = 0.29, p < 0.001, respectively). In addition, subgroup analysis showed that bariatric surgery improved depression in obese patients regardless of surgery types, assessment tool, follow-up and country.

CONCLUSION: Bariatric surgery alleviates depression in obese patients. However, further studies are needed to elucidate on the complex effect of between bariatric surgery on depression.

PMID:34802982 | DOI:10.1016/j.orcp.2021.11.002

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A Comparison of the Clinical Outcomes of Haploidentical Transplantation and Other Graft Sources in Acute Lymphoblastic Leukemia: A Systematic Review and Meta-Analysis

Clin Lymphoma Myeloma Leuk. 2021 Oct 20:S2152-2650(21)02412-5. doi: 10.1016/j.clml.2021.09.024. Online ahead of print.

ABSTRACT

BACKGROUND: Most likely due to the availability of potential stem cell sources, there appears to be a growing usage of haploidentical (haplo) donors for cases of acute lymphoblastic leukemia involving high-risk features or relapse.

PATIENTS AND METHODS: This study compared the outcomes of stem cell transplantations (SCTs) using haplo and other stem cell sources, namely, matched sibling donors (MSDs), matched unrelated donors (MUDs), and cord blood transplantations (CBTs). Literature searches were conducted of the MEDLINE and Embase databases from inception to December 2020.

RESULTS: Twenty-eight studies were examined (17 retrospective and 11 prospective). There were no significant differences in the overall survival of haplo and those of the other stem-cell sources. For haplo versus matched donor (MSD or MUD), the pooled odds ratio (OR) was 0.94 (95% CI, 0.79-1.12; I2, 22%); while for haplo versus CBT, the OR was 1.24 (95% CI, 0.78-1.96; I2, 28%). The cumulative relapse incidence was significantly higher for MSD than haplo (OR, 0.69; 95% CI, 0.48-0.99; I2, 48%). Both grade II-IV acute and long-term graft-versus-host disease (GVHD) were significantly higher for haplo than MSD (OR, 1.78; 95% CI, 1.15-2.74; I2, 28%; and OR, 1.33; 95% CI, 1.00-1.77; I2, 14%, respectively). The other clinical outcomes did not demonstrate any statistical differences.

CONCLUSION: The outcomes of patients treated with haplo-SCT appear comparable with those of the SCTs using other sources. The higher probability of developing GVHD supports the need for a novel method to harness T-cell alloreactivity.

PMID:34802994 | DOI:10.1016/j.clml.2021.09.024

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Percutaneous mitral valve repair in severe secondary mitral regurgitation: Analysis of index hospitalization and economic evaluation based on the MITRA-FR trial

Arch Cardiovasc Dis. 2021 Nov 18:S1875-2136(21)00174-1. doi: 10.1016/j.acvd.2021.10.005. Online ahead of print.

ABSTRACT

BACKGROUND: Percutaneous mitral valve repair (pMVR) is reimbursed in France for severe secondary mitral regurgitation (SMR), but French data regarding the hospitalization index stay are lacking.

AIMS: Our objectives were to describe the index hospitalization stay and to evaluate the cost of hospital stay for pMVR used in SMR.

METHODS: A secondary evaluation based on patients who were randomized to the intervention group of the MITRA-FR study was undertaken. The economic evaluation was conducted according to the French hospital perspective. Medical resource use was estimated using specific data collected from patients enrolled in the MITRA-FR study and non-specific data from national statistics.

RESULTS: The population was represented by 144 patients who underwent pMVR at 33 French centres. There was a mean±standard deviation of 7.9±1.5 hospital staff during procedures. The mean procedure duration was 154±68 minutes and increased with the number of implanted clips. Median total length of stay was 8 days. The occurrence of a serious adverse event was not associated with an increased risk of admission to the critical care unit, but was associated with an increased length of stay. The mean total cost was 28,025±3424€, which includes 21,547€ for the cost of medical devices used during pMVR and 6478±3424€ for other costs.

CONCLUSION: The cost of pMVR is substantial for patients with SMR, which advocates for further efforts to identify the patients with SMR who are likely to derive a clear clinical benefit from the procedure.

PMID:34802961 | DOI:10.1016/j.acvd.2021.10.005

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Effects of meditation compared to music listening on biomarkers in breast cancer survivors with cognitive complaints: secondary outcomes of a pilot randomized control trial

Explore (NY). 2021 Nov 10:S1550-8307(21)00230-5. doi: 10.1016/j.explore.2021.10.011. Online ahead of print.

ABSTRACT

CONTEXT: We previously reported positive behavioral effects of both daily mantra meditation and classical music listening interventions in breast cancer survivors with cancer related cognitive complaints.

OBJECTIVE: The objective of this pilot study was to compare the effects of the meditation intervention to a music listening intervention on biomarkers of inflammation and cellular aging (secondary outcomes) in breast cancer survivors.

DESIGN: Randomized control trial, baseline data collection (time 1), post intervention data collection (time 2) SETTING: Community-based, Central Texas PARTICIPANTS: 25 breast cancer survivors (BCS) who were 3 months to 6 years post chemotherapy completion and reported cognitive changes.

INTERVENTION(S): Kirtan Kriya meditation (KK) or classical music listening (ML), 8 weeks, 12 min a day MAIN OUTCOME: Telomerase activity [TA], c-reactive protein [CRP], soluble IL-2 receptor alpha [sIL-2Rα], soluble IL-4 receptor [sIL-4R], soluble IL-6 receptor [sIL-6R], soluble tumor necrosis factor receptor II [sTNF-RII], VEGF receptor 2 [sVEGF-R2], and VEGF receptor 3 [sVEGF-R3] RESULTS: Repeated measures analysis of variance models were analyzed from time 1 to time 2 by group for each biomarker. A pattern of greater telomerase activity across time in both groups (F (1,15) = 3.98, p = .06, ω2 = 0.04); significant decreases in sIL-4R across time for both groups (F (1,22) = 6.28, p = .02, ω2 = .003); group*time effect was nominally different but not statistically different for sIL-4R (F(1,22) = 3.82, p = .06, ω2 = .001); and a pattern for a group*time effect with ML group showing higher levels of sVEGF-R3 at time 2 (F (1,20) = 2.59, p = .12, ω2 = .009). No significant effects were found for CRP, sIL-2Rα, sIL-6R, sTNF-RII, or sVEGF-R2.

PMID:34802955 | DOI:10.1016/j.explore.2021.10.011

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Effects of allyl isothiocyanate on the expression, function, and its mechanism of ABCA1 and ABCG1 in pulmonary of COPD rats

Int Immunopharmacol. 2021 Nov 18:108373. doi: 10.1016/j.intimp.2021.108373. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Allyl isothiocyanate(AITC) has been shown to play an important role in the improved symptoms of chronic obstructive pulmonary disease(COPD) and the inhibition of inflammation, but the role in COPD lipid metabolism disorder and the molecular mechanism remains unclear. We aimed to explore whether and how AITC affects COPD by regulating lipid metabolism and inflammatory response.

METHODS: The COPD rat model was established by cigarette smoke exposure. Cigarette smoke extract stimulated 16HBE cells to induce a cell model. The effect of AITC treatment was detected by lung function test, H&E staining, Oil red O staining, immunohistochemistry, ELISA, CCK-8, HPLC, fluorescence efflux test, siRNA, RT-PCR, and Western blotting. Biological analysis was performed to analyze the results. Graphpad Prism 8.0 software was used for statistical analysis.

RESULTS: AITC can improve lung function and pathological injury in COPD rats. The levels of IL-1 β and TNF- α in the AITC treatment group were significantly lower than those in the model group(P < 0.05), and the lipid metabolism was also improved (P < 0.05). AITC reverses CSE-induced down-regulation of LXR α, ABCA1, and ABCG1 expression and function in a time-and concentration-dependent manner (P < 0.05). AITC regulates the cholesterol metabolism disorder induced by CSE in NR8383 cells and attenuates macrophage inflammation (P < 0.05). In addition, after silencing LXR α with siRNA, the effect of AITC was also inhibited.

CONCLUSION: These results suggest that AITC improves COPD by promoting RCT process and reducing inflammatory response via activating LXR pathways.

PMID:34802946 | DOI:10.1016/j.intimp.2021.108373

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Statistical analysis plan for the coaching for healthy AGEing trial – a cluster-randomised controlled trial to enhance physical activity and prevent falls in community-dwelling older people

Braz J Phys Ther. 2021 Nov 12:S1413-3555(21)00098-8. doi: 10.1016/j.bjpt.2021.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: This statistical analysis plan details the Coaching for Healthy AGEing (CHAnGE) trial analysis methodology.

OBJECTIVE: To investigate the effect of a combined physical activity and fall prevention program on physical activity and falls compared to a healthy eating among people aged 60 years and over.

METHODS: The CHAnGE trial is a pragmatic parallel-group cluster-randomised controlled trial with allocation concealment and blinded assessors. Clusters are allocated to either (1) a physical activity and fall prevention intervention or (2) to a healthy eating intervention. The primary outcomes are: objectively measured physical activity at 12 months post-randomisation, and self-reported falls throughout the 12-month trial period. Secondary outcomes include the proportion of participants reporting a fall, the proportion of participants meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and use of health and community services.

ANALYSIS: We will follow the intention-to-treat principle. All analysis will allow for cluster randomisation using a generalised estimating equation approach. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression models adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will take into account cluster randomisation and will be adjusted for baseline scores. A subgroup analysis will assess differential effects of the intervention by baseline physical activity levels and history of falls.

PMID:34802917 | DOI:10.1016/j.bjpt.2021.10.003

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Improving Obstuctive Sleep Apnea Care in the Postanesthesia Care Unit

J Perianesth Nurs. 2021 Nov 18:S1089-9472(21)00286-0. doi: 10.1016/j.jopan.2021.07.007. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this quality improvement project was to improve care of obstructive sleep apnea (OSA) patients through increased staff recognition of OSA in the postanesthesia care unit (PACU).

DESIGN: Retrospective chart review with implementation of best practice guideline form to front of patient’s chart.

METHODS: Baseline data were collected during June 2020. Staff education was provided on current hospital policy of OSA patients. Implementation of a care guideline sheet was added to the front of patient charts for patients meeting inclusion criteria; it consisted of continuous pulse oximetry, 30-degree head of bed elevation, continuous positive airway pressure (CPAP) therapy, 1 hour minimum postoperative observation, nonopioid analgesics, and referral to polysomnography. A retrospective chart review was performed following the OSA guideline intervention.

FINDINGS: Both pre- (N = 413) and postintervention (N = 420) groups had statistically similar demographics. CPAP use increased from 16 to 22 (t = 0.890; P = .336). The number of patients experiencing dyspnea decreased from 10 to 8 (t = 0.263; P = .608). The number of patients experiencing acute respiratory events (AREs) decreased from 24 to 18 (t = 1.012; P = .314).

CONCLUSION: There were no significant statistical findings. However, increased recognition of OSA patients by PACU staff can lead to improved care alterations.

PMID:34802923 | DOI:10.1016/j.jopan.2021.07.007

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Nevin Manimala Statistics

Diagnostic Efficiency of Diffusion Sequences and a Clinical Nomogram for Detecting Lymph Node Metastases from Rectal Cancer

Acad Radiol. 2021 Nov 19:S1076-6332(21)00469-4. doi: 10.1016/j.acra.2021.10.009. Online ahead of print.

ABSTRACT

RATIONALE AND OBJECTIVES: First, to evaluate and compare three different diffusion sequences (i.e., standard DWI, IVIM, and DKI) for nodal staging. Second, to combine the DWI, and anatomic information to assess metastatic lymph node (LN).

MATERIALS AND METHODS: We retrospectively identified 136 patients of rectal adenocarcinoma who met the inclusion criteria. Three diffusion sequences (i.e., standard DWI, IVIM, and DKI) were performed, and quantitative parameters were evaluated. Univariate and multivariate analyses were used to assess the associations between the anatomic and DWI information and LN pathology. Multivariate logistic regression was used to identify independent risk factors. A nomogram model was established, and the model performance was evaluated by the concordance index (c-index) and calibration curve.

RESULTS: There was a statistical difference in variables (LN long diameter, LN short diameter, LN boundary, LN signal, peri-LN signal intensity, ADC-1000, ADC-1400, ADC-2000, Kapp and D) between metastatic and non-metastatic LN for training and validation cohorts (p < 0.05). The ADC value derived from b = 1000 mm/s (ADC-1000) showed the relative higher AUC (AUC = 0.780) than the ADC value derived from b = 1400 mm/s (ADC-1400) (AUC = 0.703). The predictive accuracy of the nomogram measured by the c-index was 0.854 and 0.812 in the training and validation cohort, respectively.

CONCLUSION: The IVIM and DKI model’s diagnostic efficiency was not significantly improved compared to conventional DWI. The diagnostic accuracy of metastatic LN can be enhanced using the nomogram model, leading to a rational therapeutic choice.

PMID:34802905 | DOI:10.1016/j.acra.2021.10.009