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Randomized trial of transversus abdominis plane block with liposomal bupivacaine after cesarean delivery with or without intrathecal morphine

J Clin Anesth. 2021 Oct 6;75:110527. doi: 10.1016/j.jclinane.2021.110527. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: To investigate efficacy and safety of liposomal bupivacaine (LB) transversus abdominis plane (TAP) block with or without intrathecal morphine (ITM) compared with ITM alone for postsurgical analgesia after cesarean delivery (CD).

DESIGN: Multicenter, open-label, randomized trial (NCT03853694).

SETTING: Operating room.

PATIENTS: Women with term pregnancy of 37 to 42 weeks scheduled for elective CD under spinal anesthesia.

INTERVENTION: Patients were randomized 1:1:1 to LB 266 mg TAP block alone (LB group), ITM 50 μg followed by LB 266 mg TAP block (LB + ITM group), or ITM 150 μg alone (ITM group). All groups received the same postsurgical multimodal analgesic regimen.

MEASUREMENTS: The LB and LB + ITM groups were compared with the ITM group for all efficacy outcomes. Postsurgical opioid consumption in morphine milligram equivalents (MMEs) through 72 h was compared by assessing noninferiority before testing superiority. Postsurgical pruritus severity was assessed on an 11-point numerical rating scale.

MAIN RESULTS: Between March 4, 2019, and January 10, 2020, 153 patients (LB, n = 52; LB + ITM, n = 48; ITM, n = 53) were enrolled. Baseline characteristics were comparable across groups. The LB group had statistically noninferior postsurgical opioid consumption through 72 h compared with the ITM group (least squares mean [LSM], 19.2 vs 16.4 MMEs; LSM treatment ratio, 1.17 [95% confidence interval (CI), 0.74-1.86]; noninferiority P < 0.0034) as did the LB + ITM group (LSM, 14.6 vs 16.4 MMEs; LSM treatment ratio, 0.89 [95% CI, 0.55-1.44]; noninferiority P < 0.0001). The LB and LB + ITM groups had significantly reduced pruritus severity scores through 12, 24, 48, and 72 h compared with the ITM group (P ≤ 0.0121). Adverse events occurred in 58%, 85%, and 81% of the LB, LB + ITM, and ITM groups, respectively.

CONCLUSIONS: LB TAP block with or without ITM resulted in statistically noninferior postsurgical opioid consumption through 72 h, reduced pruritus, and favorable safety compared with ITM in women undergoing CD.

PMID:34626927 | DOI:10.1016/j.jclinane.2021.110527

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Effects of an elemental diet to reduce adverse events in patients with esophageal cancer receiving docetaxel/cisplatin/5-fluorouracil: a phase III randomized controlled trial-EPOC 2 (JFMC49-1601-C5)

ESMO Open. 2021 Oct 6;6(5):100277. doi: 10.1016/j.esmoop.2021.100277. Online ahead of print.

ABSTRACT

BACKGROUND: Oral mucositis (OM) is an unpleasant adverse event in patients receiving chemotherapy. A prospective feasibility study showed that elemental diet (ED), an oral supplement that does not require digestion, may prevent OM. Based on this, we established a central review system for oral cavity assessment by dental oncology specialists blinded to background data. We used this system to elucidate the preventive effect of an ED against OM in patients with esophageal cancer receiving docetaxel, cisplatin, and 5-fluorouracil (DCF) therapy.

PATIENTS AND METHODS: In this phase III, multicenter, parallel-group, controlled trial, patients consuming a normal diet orally were randomly assigned (1 : 1) to receive two cycles of DCF with (group A) or without (group B) an ED (Elental® 160 g/day). We assessed the incidence of grade ≥2 OM evaluated by two reviewers, changes in body weight, prealbumin, C-reactive protein, and DCF completion rate based on ED compliance.

RESULTS: Of the 117 patients randomly assigned to treatment, four failed to start treatment and were excluded from the primary analysis; thus, groups A and B comprised 55 and 58 patients, respectively. There were no significant differences in background characteristics. Grade ≥2 OM was observed in eight (15%) and 20 (34%) patients in groups A and B, respectively (P = 0.0141). Changes in body weight and prealbumin during the two DCF cycles were significantly higher in group A than B (P = 0.0022 and 0.0203, respectively). During the first cycle, changes in C-reactive protein were significantly lower in group A than B (P = 0.0338). In group A (receiving ED), the DCF completion rate was 100% in patients with 100% ED compliance and 70% in patients failing ED completion (P = 0.0046).

CONCLUSIONS: The study findings demonstrate that an ED can prevent OM in patients with esophageal cancer receiving chemotherapy.

PMID:34626918 | DOI:10.1016/j.esmoop.2021.100277

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Opium use as an independent risk factor for pancreatic cancer: A case-control study

Cancer Epidemiol. 2021 Oct 6;75:102017. doi: 10.1016/j.canep.2021.102017. Online ahead of print.

ABSTRACT

BACKGROUND: Pancreatic cancer (PC) is ranked as the seventh leading cause of cancer deaths worldwide. The current study was conducted to explore the correlation between the use of opium and its derivatives (opium) and PC in Iran.

METHODS: In this case-control study which was conducted in Kerman province, south east part of Iran; 176 patients with PC, and 352 healthy individuals as the control group were matched in terms of age, sex, and place of residence. A structured questionnaire including questions of opium usage, alcohol usage, cigarette smoking, and diet was used to collect the data. The relation between the use of opium and PC was adjusted for tobacco smoking, education, daily intake of fruit, vegetables, red meat, and hydrogenated fats and analyzed using the conditional logistic regression.

RESULTS: There was a positive relationship between the opium use and the increased risk of PC (Adjusted Odds Ratio (AOR) = 4.33, 95 % CI: 2.09-8.95), which was even stronger than its association with cigarette smoking (AOR = 1.67, 95 % CI: 0.86-3.24), although their difference was not statistically significant. A significant dose-response relation was detected between the use of opium; as the relation was stronger in heavy users (AOR low users = 4.93, 95 % CI: 1.79-13.54 and AOR heavy users = 5.10, 95 % CI: 2.10-12.35). Moreover, PC was higher among participants starting the use of opium at a younger age than those who started opium at an older age (AOR = 8.03, 95 % CI: 3.19-20.23).

CONCLUSION: This study demonstrated that opium use is associated with a high and strong risk of PC as an independent risk factor. Further studies should be done to reduce the use of opium in Iran and other world countries.

PMID:34626910 | DOI:10.1016/j.canep.2021.102017

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Implementation of In vivo exposure therapy to decrease injury-related fear in females with a history of ACL-Reconstruction: A pilot study

Phys Ther Sport. 2021 Sep 27;52:217-223. doi: 10.1016/j.ptsp.2021.09.009. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this pilot study was to examine the preliminary feasibility and efficacy of in vivo exposure therapy (IVET) to decrease injury-related fear in females with history of ACLR.

DESIGN: Pilot Study.

SETTING: Sports Medicine Research Laboratory.

PARTICIPANTS: 12 female participants with history of ACLR (≥ 1 year post-operative) were randomized into a 5-week IVET group (n = 6) or 5-week sham physical activity (PA) monitoring group (n = 6).

MAIN OUTCOME MEASURES: The independent variables were Group and Time. The dependent variables were the Photographic Series of Sports Activities for ACLR (PHOSA-ACLR) and the Tampa Scale of Kinesiophobia-11 (TSK-11) scores. A Group x Time repeated measures two-way analysis of variance was completed for the PHOSA-ACLR and the TSK-11. Partial η2 effect sizes were used to examine clinically meaningful differences.

RESULTS: High retention and adherence rates were observed in the intervention group. The PHOSA-ACLR exhibited a significant main effect for Time (F1,10 = 9.92, p = 0.01, partial η2 = 0.50), but not for Group. No statistically significant or clinically meaningful differences were observed for the TSK-11.

CONCLUSION: Both groups exhibited decreased injury-related fear for specific functional tasks. Future research should further examine the efficacy of IVET and PA monitoring to decrease injury-related fear in patients after ACLR.

PMID:34626890 | DOI:10.1016/j.ptsp.2021.09.009

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A comparison of automated atrophy measures across the frontotemporal dementia spectrum: Implications for trials

Neuroimage Clin. 2021 Oct 5;32:102842. doi: 10.1016/j.nicl.2021.102842. Online ahead of print.

ABSTRACT

BACKGROUND: Frontotemporal dementia (FTD) is a common cause of young onset dementia, and whilst there are currently no treatments, there are several promising candidates in development and early phase trials. Comprehensive investigations of neuroimaging markers of disease progression across the full spectrum of FTD disorders are lacking and urgently needed to facilitate these trials.

OBJECTIVE: To investigate the comparative performance of multiple automated segmentation and registration pipelines used to quantify longitudinal whole-brain atrophy across the clinical, genetic and pathological subgroups of FTD, in order to inform upcoming trials about suitable neuroimaging-based endpoints.

METHODS: Seventeen fully automated techniques for extracting whole-brain atrophy measures were applied and directly compared in a cohort of 226 participants who had undergone longitudinal structural 3D T1-weighted imaging. Clinical diagnoses were behavioural variant FTD (n = 56) and primary progressive aphasia (PPA, n = 104), comprising semantic variant PPA (n = 38), non-fluent variant PPA (n = 42), logopenic variant PPA (n = 18), and PPA-not otherwise specified (n = 6). 49 of these patients had either a known pathogenic mutation or postmortem confirmation of their underlying pathology. 66 healthy controls were included for comparison. Sample size estimates to detect a 30% reduction in atrophy (80% power; 0.05 significance) were computed to explore the relative feasibility of these brain measures as surrogate markers of disease progression and their ability to detect putative disease-modifying treatment effects.

RESULTS: Multiple automated techniques showed great promise, detecting significantly increased rates of whole-brain atrophy (p<0.001) and requiring sample sizes of substantially less than 100 patients per treatment arm. Across the different FTD subgroups, direct measures of volume change consistently outperformed their indirect counterparts, irrespective of the initial segmentation quality. Significant differences in performance were found between both techniques and patient subgroups, highlighting the importance of informed biomarker choice based on the patient population of interest.

CONCLUSION: This work expands current knowledge and builds on the limited longitudinal investigations currently available in FTD, as well as providing valuable information about the potential of fully automated neuroimaging biomarkers for sporadic and genetic FTD trials.

PMID:34626889 | DOI:10.1016/j.nicl.2021.102842

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Biomechanical comparison of two medial patellofemoral ligament reconstruction techniques: Quadriceps tendon fixation versus single-tunnel patella fixation with gracilis autograft did not differ in load to failure and stiffness

Knee. 2021 Oct 6;33:169-175. doi: 10.1016/j.knee.2021.09.007. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of this study was to evaluate the ultimate failure load and stiffness of two patellar fixation techniques for medial patellofemoral ligament (MPFL) reconstruction: (1) quadriceps tendon fixation (QT), (2) single tunnel (STG) patella fixation with gracilis autograft.

METHODS: A total of 16 fresh-frozen cadaveric knees (eight matched pairs) were randomized into two groups (QT vs. STG). The MPFL reconstructions were subjected to cyclic loading for 10 cycles to 30 N and then tested to failure at a constant displacement rate of 15 mm/min using a materials-testing machine (MTS 810 Universal Testing System). Failure mode, ultimate failure load and stiffness were recorded for each cadaveric specimen.

RESULTS: There was no significant difference in mean ultimate failure load among groups (P = 0.35). The STG group failed at a mean ultimate load of 190.04 N [standard deviation (SD) 23.18] and the QT group failed at 206.24 N (SD 37.99). The STG group had a mean stiffness of 21.38 N/mm (SD 1.44). This was not significantly higher than the mean stiffness value achieved for the QT group at 20.36 N/mm (SD 1.3) (P = 0.19). In the QT group all reconstructions failed due to tendon rupture at the patella attachment. The reason for failure in the STG group was the graft-suture connection.

CONCLUSIONS: This cadaver study showed no statistically significant difference in biomechanical performance of the evaluated patella fixation techniques, in terms of maximum load to failure and stiffness. Both techniques are reliable in terms of biomechanical properties and could offer additional surgical solutions.

PMID:34626887 | DOI:10.1016/j.knee.2021.09.007

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Effect of IL-6, IL-8/CXCL8, IP-10/CXCL 10 Levels on the Severity in COVID 19 Infection

Int J Clin Pract. 2021 Oct 9:e14970. doi: 10.1111/ijcp.14970. Online ahead of print.

ABSTRACT

BACKGROUND: COVID 19 was first observed in December 2019 and has affected the world entire. Effective laboratory markers and prognostic indicators are needed to predict the clinical progression of the disease.

AIMS: The purpose of this study was to investigate IL6, IL8/CXCL8, and IP10/CXCL10, and biochemical parameters associated with SARS, MERS, and SARS-CoV-2 infections and their significance on prognosis in healthy volunteers and mild-moderate and severe COVID 19 patients.

METHODS: Healthy volunteers (n=30), and patients with mild-moderate (n=30) and severe (n=30) COVID-19 patients were included in the study. IL-6, IL-8 and IP-10 levels and biochemical parameters were assessed among the groups and their correlations with each other were subjected to statistical analysis.

RESULTS: Blood serum IL-6, IL-8 and IP-10 levels were the highest in the severe patient group (p=0.001), and also higher in the mild-moderate group as compared to the healthy volunteers (p=0.001). Statistically significant positive correlations were identified between serum IL-8 and IL-6 levels (p=0.001 r=0.660), between serum IP-10 and IL-6 (p=0.001 r =0.599) and between serum IP-10 and IL-8 (p=0.001 r=0.729).

CONCLUSIONS: A statistically significant difference was found in WBC, NE%, NE, LY%, LY, HB, BUN, total protein, albumin, D-dimer, sedimentation differed significantly between the groups. Biomarkers of potential significance in terms of the severity of COVID 19 disease were examined, and high IL-6, IL-8, IP-10, CRP, PCT, and LY parameters values emerged as associated with the severity of the disease.

PMID:34626520 | DOI:10.1111/ijcp.14970

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Conceptual and methodological advances in habitat-selection modeling: guidelines for ecology and evolution

Ecol Appl. 2021 Oct 9:e02470. doi: 10.1002/eap.2470. Online ahead of print.

ABSTRACT

Habitat selection is a fundamental animal behavior that shapes a wide range of ecological processes, including animal movement, nutrient transfer, trophic dynamics and population distribution. Although habitat selection has been a focus of ecological studies for decades, technological, conceptual and methodological advances over the last 20 years have led to a surge in studies addressing this process. Despite the substantial literature focused on quantifying the habitat-selection patterns of animals, there is a marked lack of guidance on best analytical practices. The conceptual foundations of the most commonly applied modeling frameworks can be confusing even to those well versed in their application. Further, there has yet to be a synthesis of the advances made over the last 20 years. Thus, there is a need for both synthesis of the current state of knowledge on habitat selection, and guidance for those seeking to study this process. Here, we provide an approachable overview and synthesis of the literature on habitat-selection analyses (HSAs) conducted using selection functions, which are by far the most applied modeling framework for understanding the habitat-selection process. This review is purposefully non-technical and focused on understanding without heavy mathematical and statistical notation, which can confuse many practitioners. We offer an overview and history of HSAs, describing the tortuous conceptual path to our current understanding. Through this overview, we also aim to address the areas of greatest confusion in the literature. We synthesize the literature outlining the most exciting conceptual advances in the field of habitat-selection modeling, discussing the substantial ecological and evolutionary inference that can be made using contemporary techniques. We aim for this paper to provide clarity for those navigating the complex literature on HSAs while acting as a reference and best practices guide for practitioners.

PMID:34626518 | DOI:10.1002/eap.2470

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Comparison of Emotional Approaches of Medical Doctors Against Covid-19 Pandemic: Eastern and Western Mediterranean Countries

Int J Clin Pract. 2021 Oct 9:e14973. doi: 10.1111/ijcp.14973. Online ahead of print.

ABSTRACT

BACKGROUND: Pandemics are states of disease that occur worldwide and sharply increase in populations. It causes life events which trigger anxiety, depression, anger, sleep deprivation, emotional distress and stress. World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19) a pandemic on March 11, pointing to the over 118,000 cases in over 110 countries. Many healthcare workers became ill during the pandemic and some among them died. In this study we aimed to evaluate and compare level of stress against COVID-19 pandemic among doctors from Turkey and Italy.

METHODS: This research is a cross-sectional study in which Perceived Stress Scale (PSS-10) and Secondary Traumatic Stress Scale (STSS) are administered online via social networks. All data collection tools were delivered to individuals between 1-15 June 2020 and filled in online with Google Forms application. In total 618 individuals were included in this study and all of them were medical doctors.

RESULTS: Higher PS and STS levels were found related to woman gender, being married, working in pandemic hospital and older ages. Stress levels were found statistically higher in Turkish doctors comparing to Italian doctors for both stress scales (Turkish/Italian PSS:20.18±7.90/ 19.35±6.71, STSS: 44.19±13.29/ 38.83±13.74).

CONCLUSION: The number of doctors per 1,000 of population is lower and per capita visits to a physician is higher in Turkey comparing to Italy. Besides pandemic, these heavier working conditions, increased weekly working hours can cause stress for Turkish doctors. Reporting information such this study and international collaborations are essential to plan future prevention strategies. We need to strengthen international ties and build more international collaborations rather than staying within our national silos. Additionally, interventions to promote mental well-being in health care professionals exposed to COVID-19 need to be immediately implemented.

PMID:34626512 | DOI:10.1111/ijcp.14973

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HDL subgroups and their paraoxonase-1 activity in the obese, overweight and normal weight subjects

Int J Clin Pract. 2021 Oct 9:e14969. doi: 10.1111/ijcp.14969. Online ahead of print.

ABSTRACT

BACKGROUND: Obesity and overweight are significant public health problems due to higher risk for coronary artery disease (CAD). It is very important to determine new predictive markers to identify the CAD risk in obese and overweight. To aim this, we analyzed HDL-C subgroups (HDL2-C and HDL3-C) and their paraoxonase-1 (PON-1) activity in obese, overweight and normal weight subjects.

METHOD: 71 obese, 40 overweight and 30 healthy subjects as a control group were enrolled the study. Serum lipids levels were determined with enzymatic colorimetric method. Further, PON-1 activities and HDL-C levels were determined by spectrophotometric methods. Non-HDL3-C concentrations were calculated with the subtraction of HDL3-C from total HDL-C.

RESULTS: The mean serum levels of total HDL-C, HDL3-C, Non-HDL3-C and ApoA1 were higher in control group than obese and overweight groups. There were a statistically significant difference between obese and control group in terms of Lp(a), hsCRP and HOMA index. Higher total PON-1, non-HDL3 PON-1 and HDL3 PON-1 activities were found in the control group compared to obese and overweight groups. Total HDL was weakly negative correlated with the HOMA index, BMI and waist circumference. There was a weak negative correlation between non-HDL3-C and waist circumference.

CONCLUSION: Altered HDL-subgroups pattern and decreased PON-1 activities may cause increased risk for CVD in obese and overweight individuals. Therefore determination of HDL subgroups and their PON-1 activity may improve risk prediction compared with measuring total HDL-C levels and its PON-1 activity alone. Body weight and insulin resistance appear to have a role in the decreased HDL-C levels and PON-1activity in obese. Further studies should be conducted to shed more light on impacts of these markers in CVD.

PMID:34626508 | DOI:10.1111/ijcp.14969