Nevin Manimala

Arch Pediatr. 2021 May 28:S0929-693X(21)00085-3. doi: 10.1016/j.arcped.2021.04.005. Online ahead of print.

ABSTRACT

INTRODUCTION: After discussion with the parents, periviable infants can receive either active treatment or palliative care. The rate of active treatment in France is lower than in other developed countries, as is the survival rate of infants in this gestational age range. This study’s main objective was to assess the effect of a standardized perinatal management protocol (EXPRIM) on the neonatal outcome of children born before 27 weeks of gestation.

METHODS: A before-and-after study was conducted in the two level-3 hospitals of the Risks and Pregnancy DHU to compare two 16-month periods. The EXPRIM protocol was based on routine administration of prenatal corticosteroid therapy and a scheduled combined obstetric-pediatric group prenatal prognostic evaluation, not based solely on gestational age. The study included all births between 22 weeks and 26 weeks+6 days of gestation, except in utero deaths diagnosed at admission and medical terminations of pregnancy for fetal malformation, both excluded. The principal endpoint was survival without severe neonatal morbidity.

RESULTS: The study included 267 women: 116 (128 newborns) in period 1 and 151 (172 newborns) in period 2. The median gestational age at admission to the maternity unit was 2.5 days younger in period 2, and the number of women admitted at 22-23 weeks doubled in period 2 (59 vs 29, respectively). Overall, the rates of live births, NICU transfer, and survival without severe morbidity were similar during the two periods. More infants were liveborn between 22 and 24 weeks in period 2 (66 vs 43). Of all newborns transferred to the NICU, 26 (29%) survived without severe morbidity in period 1 and 46 (39%) in period 2. After multivariate analysis, survival without severe morbidity did not differ significantly.

CONCLUSION: Implementation of the EXPRIM protocol led to active treatment of more mothers and their children at the border of viability, and increased the number of children who survived without severe morbidity even if, overall, there was no statistically significant difference in percentage.

PMID:34059380 | DOI:10.1016/j.arcped.2021.04.005

Patient Educ Couns. 2021 May 21:S0738-3991(21)00386-4. doi: 10.1016/j.pec.2021.05.031. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to synthesize the best available evidence regarding the effectiveness of non-pharmacological interventions on body mass index (BMI), body dissatisfaction, depression and anxiety among individuals with anorexia nervosa (AN).

METHODS: Published studies in English were searched using seven databases (such as PubMed). Grey literature was searched using ProQuest and Scopus. Studies were screened, appraised and extracted by two independent reviewers. Meta-analysis was performed and standardized mean difference was used as an effect measure. Heterogeneity was determined by I² statistics and Cochran χ² test. Publication bias was appraised using funnel plots. Sensitivity and subgroup analyses were also conducted.

RESULTS: Nineteen RCTs from eight different countries were included in this review. Behavioral family system therapy (BFST) was found to enhance BMI while conjoint family therapy (CFT) was more effective in ameliorating depression. Studies implementing combined family and individual therapy and those with longer therapeutic durations produced larger effect sizes.

CONCLUSION: This review provided evidence to support BSFT, CFT and combined family and individual therapy for adolescents with AN.

PRACTICAL IMPLICATIONS: Healthcare professionals may offer the two interventions to adolescents with AN in clinical settings. Future research may further investigate the effectiveness of BSFT and CFT on BMI and depression.

PMID:34059364 | DOI:10.1016/j.pec.2021.05.031

Gynecol Oncol. 2021 May 28:S0090-8258(21)00430-3. doi: 10.1016/j.ygyno.2021.05.024. Online ahead of print.

ABSTRACT

BACKGROUND: Fear of disease progression (FOP) is a rational concern for women with Ovarian Cancer (OC) and depression is also common. To date there have been no randomized trials assessing the impact of psychological intervention on depression and FOP in this patient group.

PATIENTS AND METHODS: Patients with primary or recurrent OC who had recently completed chemotherapy were eligible if they scored between 5 and 19 on the PHQ-9 depression and were randomized 1:1 to Intervention (3 standardized CBT-based sessions in the 6-12 weeks post-chemotherapy) or Control (standard of care). PHQ-9, FOP-Q-SF, EORTC QLQ C30 and OV28 questionnaires were then completed every 3 months for up to 2 years. The primary endpoint was change in PHQ-9 at 3 months. Secondary endpoints were change in other scores at 3 months and all scores at later timepoints.

RESULTS: 182 patients registered; 107 were randomized; 54 to Intervention and 53 to Control; mean age 59 years; 75 (70%) had completed chemotherapy for primary and 32 (30%) for relapsed OC and 67 patients completed both baseline and 3-month questionnaires. Improvement in PHQ-9 was observed for patients in both study arms at three months compared to baseline but there was no significant difference in change between Intervention and Control. A significant improvement on FOP-Q-SF scores was seen in the Intervention arm, whereas for those in the Control arm FOP-Q-SF scores deteriorated at 3 months (intervention effect = -4.4 (-7.57, -1.22), p-value = 0.008).

CONCLUSIONS: CBT-based psychological support provided after chemotherapy did not significantly alter the spontaneously improving trajectory of depression scores at three months but caused a significant improvement in FOP. Our findings call for the routine implementation of FOP support for ovarian cancer patients.

PMID:34059348 | DOI:10.1016/j.ygyno.2021.05.024

Clin Ther. 2021 May 28:S0149-2918(21)00127-2. doi: 10.1016/j.clinthera.2021.03.015. Online ahead of print.

ABSTRACT

PURPOSE: Mirogabalin besylate has been approved in several countries to treat peripheral neuropathic pain. This pooled analysis, using data from the two pivotal Phase III studies in Asian patients with diabetic peripheral neuropathic pain and post-herpetic neuralgia, aimed to provide clinicians with more detailed and precise information relating to mirogabalin’s safety and efficacy.

METHODS: Data were pooled from 2 multicenter, double-blind, placebo-controlled, parallel-group, 14-week treatment studies of mirogabalin conducted at ∼350 study sites (Japan, South Korea, Taiwan, Singapore, Malaysia, and Thailand). Eligible patients in both studies were randomized in a 2:1:1:1 ratio, stratified according to a baseline average daily pain score (ADPS) of <6 or ≥6, to placebo, mirogabalin 15-mg once daily (QD), mirogabalin 10-mg twice daily (BID), or mirogabalin 15-mg BID treatment groups. Safety was assessed based on treatment-emergent adverse events identified from the adverse events collected throughout both studies. The primary efficacy end point of both studies was the change from baseline in ADPS at week 14.

FINDINGS: In total, 1587 patients (824 with diabetic peripheral neuropathic pain; 763 with post-herpetic neuralgia) who received at least 1 dose of study drug were analyzed (633 received placebo, 954 treated with mirogabalin). Treatment-emergent adverse events included somnolence (3.8%, 10.8%, 14.5%, and 19.1%) and dizziness (2.7%, 5.7%, 9.1%, and 13.1%) in patients receiving placebo, mirogabalin 15 mg QD, mirogabalin 10 mg BID, and mirogabalin 15 mg BID, respectively. In patients treated with mirogabalin 15 mg QD, 2 (0.6%) of 316 patients discontinued due to somnolence. In the mirogabalin 10-mg BID group, somnolence, edema, and peripheral edema each resulted in 3 (0.9%) of 318 patient discontinuations. In the mirogabalin 15-mg BID group, 6 (1.9%) of 320 patients discontinued due to dizziness and 3 (0.9%) due to somnolence. At week 14, mirogabalin 10 mg BID and 15 mg BID statistically significantly improved ADPS versus placebo, with least squares mean changes (95% CI) of -0.31 (-0.55, -0.08) and -0.63 (-0.86, -0.40). Post hoc analysis showed a statistically significant difference 2 days after administration in the mirogabalin 10-mg and 15-mg BID groups compared with placebo. Female sex, age ≥65 years, and baseline weight <60 kg may influence the safety of mirogabalin, particularly regarding the incidence of somnolence and dizziness, but had no notable impact on efficacy. ClinicalTrials.gov identifiers: NCT02318706 and NCT02318719. (Clin Ther. 2021;43:XXX-XXX) © 2021 Elsevier HS Journals, Inc.

IMPLICATIONS: This pooled analysis showed that mirogabalin was efficacious and well-tolerated by Asian patients with peripheral neuropathic pain.

PMID:34059327 | DOI:10.1016/j.clinthera.2021.03.015

Clin Ther. 2021 May 28:S0149-2918(21)00213-7. doi: 10.1016/j.clinthera.2021.04.018. Online ahead of print.

ABSTRACT

PURPOSE: The SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma.

METHODS: This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs).

FINDINGS: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926-24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses.

IMPLICATIONS: This economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.

PMID:34059326 | DOI:10.1016/j.clinthera.2021.04.018

Injury. 2021 May 17:S0020-1383(21)00438-1. doi: 10.1016/j.injury.2021.05.013. Online ahead of print.

ABSTRACT

INTRODUCTION: The calcaneus is the most commonly fractured hindfoot bone, accounting for over 60% of all tarsal fractures. The aim of this study was to compare the mechanism of injury and psychological health status in patients presenting with calcaneal fractures to an age- and sex-matched control group with ankle fractures.

PATIENTS AND METHODS: This retrospective study was undertaken within an orthopaedic unit at a tertiary hospital. An electronic medical record chart review was performed to identify eligible patients. Descriptive statistics were used to summarise the demographic and clinical characteristics of the patients. Between-group differences were analysed with the Mann-Whitney U test and Fisher’s exact test for continuous and categorical variables, respectively. Multivariable binary logistic regression was used to determine the relationship between fracture type and underlying psychopathology, adjusting for mechanism of injury.

RESULTS: Two-hundred and fifteen patients met the eligibility criteria for calcaneal fractures and these patients were subsequently matched to 215 ankle fracture patients. Men accounted for 154 (71.6%) of the patients in each group. Over half (51.2%) of all calcaneal fractures were due to an uncontrolled fall above one-metre, as opposed to 26.0% of ankle fractures, p < 0.001. Falling from a standing height was more common in the ankle fracture group, 37 (17.2%) versus 10 (4.7%), p < 0.001. Patients with calcaneal fractures were more likely to have a diagnosed psychological health complaint, 63 (29.3%) versus 32 (14.9%), p < 0.001. Suicidal ideation was significantly more common in the calcaneal fracture group 14 (6.5%) versus 3 (1.4%), p = 0.011. The presence of premorbid psychopathology was associated with calcaneal fracture, after adjusting for mechanism of injury (odds ratio 2.20, 95% confidence interval 1.32 to 3.65, p = 0.003).

CONCLUSION: Calcaneal and ankle fractures display differences in both the mechanism of injury and the history of psychological health conditions. However, after adjusting for the mechanism of injury, diagnosed premorbid psychopathology remains twice as likely in someone with a calcaneal fracture as opposed to an ankle fracture. It may be prudent for orthopaedic surgeons to consider further investigations of psychological health when managing patients with a calcaneal fracture.

PMID:34059323 | DOI:10.1016/j.injury.2021.05.013

Int J Food Microbiol. 2021 May 24:109248. doi: 10.1016/j.ijfoodmicro.2021.109248. Online ahead of print.

ABSTRACT

This work was carried out to elaborate selenium (Se) bio-enriched fermented Mediterranean fruit juices. To this purpose, pomegranate and table red grape juices were added with sodium selenite (Na₂SeO₃) and fermented by Levilactobacillus brevis CRL 2051 and Fructobacillus tropaeoli CRL 2034 individually or combined. To better evaluate the effect of selenite addition and starter strain inoculums on the total bacterial community of the fruit juices, fermentation trials were performed with raw and pasteurized fruit juices. No statistical significant differences were observed for total mesophilic microorganisms (TMM) and rod-shaped lactic acid bacteria (LAB) levels among raw and pasteurized juices inoculated with the starter strains, while significant differences between those juices with and without selenite were registered. LAB cocci, Pseudomonadaceae and yeasts were detected only for the raw juice preparations. The dominance of L. brevis CRL 2051 and F. tropaeoli CRL 2034 was confirmed by randomly amplified polymorphic DNA (RAPD)-PCR analysis. After fermentation, pH dropped for all inoculated trials and control raw juices. The soluble solid content (SSC) levels of the raw juices were higher than the corresponding pasteurized trials. The thermal treatment affected consistently yellowness of grape juice trials and redness of pomegranate juices. No microbial Se accumulation was registered for pomegranate juices, while F. tropaeoli CRL 2034 accumulated the highest amount of Se (65.5 μg/L) in the grape juice. For this reason, only trials carried out with raw grape juices were investigated by metagenomics analysis by Illumina MiSeq technology. Non-inoculated grape juices were massively fermented by acetic acid bacteria while Fructobacillus and Lactobacillus (previous genus name of Levilactobacillus) represented the highest operational taxonomy units (OTUs) relative abundance % of the trials inoculated with the starter strains as confirmed by this technique.

PMID:34059319 | DOI:10.1016/j.ijfoodmicro.2021.109248

J Prosthet Dent. 2021 May 28:S0022-3913(21)00198-0. doi: 10.1016/j.prosdent.2021.03.023. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: The wear of monolithic zirconia against enamel has been widely studied, but how zirconia affects different opposing restorative materials is not clear.

PURPOSE: The purpose of this in vitro study was to investigate the depth of wear and volumetric loss of different restorative materials opposed by monolithic zirconia.

MATERIAL AND METHODS: Sixty-six Ø10×3-mm specimens (n=11) were fabricated from monolithic zirconia, zirconia reinforced ceramic, lithium disilicate ceramic, feldspathic ceramic, ORMOCER, and ceramic optimized polymer. A 2-body pin-on-disk wear test was performed by using monolithic zirconia pins. The specimens were scanned with a noncontact profilometer after the tests. The scan parameters were a frame size area of 1.5×1.5 mm, frequency of 400 Hz, and scan sensitivity of 2 μm. After the evaluation of depth and volume loss, the specimens were analyzed with a scanning electron microscope. The Kruskal-Wallis test was used to analyze the differences in wear values across the specimen groups, and pairwise comparison tests were performed with a post hoc test (α=.05).

RESULTS: Maximum depth of wear was 257.55 ±18.88 μm for lithium disilicate ceramic, 295.36 ±14.46 μm for zirconia reinforced ceramic, 421.82 ±214.49 μm for ORMOCER, 333.73 ±79.09 μm for ceramic optimized polymer, 146.27 ±22.86 μm for feldspathic ceramic, and 41.55 ±5.04 μm for monolithic zirconia. The depth of wear was not significantly different among lithium disilicate, zirconia-reinforced ceramic, ORMOCER, and ceramic optimized polymer (P<.05). However, the depth of wear of monolithic zirconia and feldspathic ceramic was less than that of other materials (P<.001). Volume loss of lithium disilicate was 1.68 ±0.25 mm³, 1.08 ±0.35 mm³ for zirconia reinforced ceramic, 4.29 ±2.91 mm³ for ORMOCER, 2.46 ±0.63 mm³ for resin ceramic, 1.07 ±0.09 mm³ for feldspathic ceramic, and 0.19 ±0.02 mm³ for monolithic zirconia. Feldspathic ceramic and monolithic zirconia had significantly less volume loss than the other groups (P<.001), and the difference between them for volume loss was statistically insignificant (P>.05).

CONCLUSIONS: The tested ceramic-based materials had favorable wear resistance compared with the tested composite resin-based ones. However, the ceramics tended to crack formation than the composite resins.

PMID:34059295 | DOI:10.1016/j.prosdent.2021.03.023

Methods Enzymol. 2021;652:321-340. doi: 10.1016/bs.mie.2021.02.018. Epub 2021 Mar 27.

ABSTRACT

During reconstitution, membrane proteins are randomly inserted into liposomes according to Poisson distribution statistics. When the protein to lipid ratios in the reconstitution mixture are varied systematically, the characteristics of this statistical capture permit inferences about the proteins themselves, such as the number of subunits that assemble into a single functional unit. This chapter describes the Poisson distribution as applied to the reconstitution of membrane proteins into proteoliposomes and focuses on an application whereby this statistical behavior is used to determine the number of ion channel subunits that assemble into a functional pore. Practical considerations for performing these experiments are emphasized. Harnessing Poisson dilution statistics provides a function-based method to determine ion channel oligomerization, complementing other biophysical, biochemical, or structural approaches.

PMID:34059289 | DOI:10.1016/bs.mie.2021.02.018

Facial Plast Surg. 2021 May 31. doi: 10.1055/s-0041-1730385. Online ahead of print.

ABSTRACT

The short nose represents one of the greatest challenges in rhinoplasty. It is characterized by a reduced distance from the nasal radix to the tip-defining points, often associated with inadequate tip projection. Several techniques have been described for correction of short nose with the common objective of replacing and rebuilding the osteocartilaginous framework. One of the most effective method to correct the short nose is the septal extension graft. The authors describe the caudal septum pivot (CSP) technique, a simple method to elongate short noses by using a graft inserted in the dorsal septum after its division using as pivot the caudal portion, without detaching it from its natural anchorage to the anterior nasal spine. A retrospective analysis was performed reviewing the clinical charts and the operative records of 315 patients who underwent revision rhinoplasty from January 2015 to June 2019; among this group, 34 were considered eligible for the study. The patients (8 men, 26 women; mean age: 25.4 years; age range: 22-53 years) were divided into two groups: in 12 patients (Group 1) the CSP technique was performed, while Group 2 was composed of 22 patients who received a more classic treatment with a septal extension graft. To evaluate the outcomes, nasal length, tip projection, and tip rotation were measured pre- and 1 year postoperatively on digital photographs of each patient. Nasal anthropometric measurements revealed, at 12-month visit follow-up, an improvement in nasal length, tip projection, and nasolabial angle was achieved in all the patients. The comparison of the pre- and postoperative values showed a statistically significant reduction in the nasolabial angle (p < 0.05) and an increase in the tip projection (p < 0.05) and in the nasal lengthening (p < 0.05) in both groups. In authors’ experience, the CSP technique could be considered a safe, reliable, and effective alternative technique in selected patients.

PMID:34058786 | DOI:10.1055/s-0041-1730385