Category: Nevin Manimala

Eur J Epidemiol. 2023 Jan 3. doi: 10.1007/s10654-022-00947-5. Online ahead of print.

ABSTRACT

Pregnancy-related factors are important for short- and long-term health in mothers and offspring. The nationwide population-based Swedish Medical Birth Register (MBR) was established in 1973. The present study describes the content and quality of the MBR, using original MBR data, Swedish-language and international publications based on the MBR.The MBR includes around 98% of all births in Sweden. From 1982 onwards, the MBR is based on prospectively recorded information in standardized antenatal, obstetric, and neonatal records. When the mother and infant are discharged from hospital, this information is forwarded to the MBR, which is updated annually. Maternal data include information from first antenatal visit on self-reported obstetric history, infertility, diseases, medication use, cohabitation status, smoking and snuff use, self-reported height and measured weight, allowing calculation of body mass index. Birth and neonatal data include date and time of birth, mode of delivery, singleton or multiple birth, gestational age, stillbirth, birth weight, birth length, head circumference, infant sex, Apgar scores, and maternal and infant diagnoses/procedures, including neonatal care. The overall quality of the MBR is very high, owing to the semi-automated data extraction from the standardized regional electronic health records, Sweden’s universal access to antenatal care, and the possibility to compare mothers and offspring to the Total Population Register in order to identify missing records. Through the unique personal identity numbers of mothers and live-born offspring, the MBR can be linked to other health registers. The Swedish MBR contains high-quality pregnancy-related information on more than 5 million births during five decades.

PMID:36595114 | DOI:10.1007/s10654-022-00947-5

J Assist Reprod Genet. 2023 Jan 3. doi: 10.1007/s10815-022-02705-8. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to compare the feasibility, effectiveness, and safety of transabdominal ultrasound-guided oocyte retrieval (TUGOR) using a vaginal probe and traditional vaginal approach in virgin patients undergoing oocyte cryopreservation.

METHODS: A total of 116 virgin patients who underwent transabdominal ultrasound-guided oocyte retrieval using a vaginal ultrasound probe and 33 patients matched for BMI, antral follicle count, age, day 3 FSH, estradiol, and AMH who underwent vaginal approach were enrolled. Mean number of total oocytes collected, mean number of cryopreserved MII oocytes, duration of the procedure, duration of stimulation, mean gonadotropin consumption, mature oocyte ratio, and a modified follicle-oocyte index were compared between the groups.

RESULTS: No statistical difference was found between the groups in mean number of follicles > 12 mm (4.62 ± 4.54 vs. 5.44 ± 4.52), mean number of oocytes collected (4.44 ± 4.14 vs. 5.33 ± 4.52), mean number of cryopreserved MII oocytes (4.01 ± 3.67 vs. 4.53 ± 4.13), mean duration of the procedure (12.4 ± 1.2 vs. 13.4 ± 1.6 min), mean days of stimulation (8.05 ± 1.91 vs. 8.35 ± 1.72 days), mean gonadotropin consumption (1507.9 ± 475.3 vs. 1571.74 ± 404.6 units), mature oocyte ratio (0.78 ± 0.24 vs. 0.82 ± 0.26), and modified follicle oocyte index (0.86 ± 0.63 vs. 0.84 ± 0.19). In the TUGOR group, superficial epigastric artery injury occurred in two patients and resolved spontaneously.

CONCLUSION: Transabdominal oocyte retrieval using a vaginal ultrasound is a safe, effective, and feasible method of oocyte retrieval in some selected patient groups.

PMID:36595090 | DOI:10.1007/s10815-022-02705-8

Lasers Med Sci. 2023 Jan 3;38(1):31. doi: 10.1007/s10103-022-03698-7.

ABSTRACT

This study aimed to evaluate the influence of laser photobiomodulation on the expression and degranulation of mast cells in chemo-induced oral mucositis (OM) lesions in hamsters. Twelve adult male Syrian hamsters (Mesocricetus auratus), golden lineage, were submitted to OM induction. They were divided into three groups: control-OM without treatment (C), OM treated with red laser (RL), OM treated with infrared laser (IL) and analyzed in the experimental time of 7 days. Three and 4 days after the intraperitoneal injection of the chemotherapy drug fluorouracil, the OM lesions were induced by making grooves in the right cheek pouch. Immediately after chemoinduction, the hamsters were submitted to photobiomodulation every 48 h for 7 days. The specimens were processed and stained using the hematoxylin-eosin and toluidine blue techniques. There was a predominance of mild chronic inflammation in the experimental groups and a greater persistence of neutrophils in the control group (C), although not statistically significant. The group irradiated with red laser (RL) had the highest mean mast cell expression (38.28 ± 19.05) (p < 0.001). As for the degranulation activity in mast cells, the control group (C) showed a greater number of fields with more than 50% of degranulated cells, presenting statistical significance when comparing it with the RL (p < 0.009) and IL (p = 0.036) group. It can be concluded that photobiomodulation, at both wavelengths, decreased mast cell degranulation, accelerating the inflammatory process. The use of infrared laser provided, in addition to less degranulation, the quantitative reduction of mast cells.

PMID:36595054 | DOI:10.1007/s10103-022-03698-7

Knee Surg Sports Traumatol Arthrosc. 2023 Jan 3. doi: 10.1007/s00167-022-07302-x. Online ahead of print.

ABSTRACT

BACKGROUND: Many radiographic lower limb alignment measurements are dependent on patients’ position, which makes a standardised image acquisition of long-leg radiographs (LLRs) essential for valid measurements. The purpose of this study was to investigate the influence of rotation and flexion of the lower limb on common radiological alignment parameters using three-dimensional (3D) simulation.

METHODS: Joint angles and alignment parameters of 3D lower limb bone models (n = 60), generated from computed tomography (CT) scans, were assessed and projected into the coronal plane to mimic radiographic imaging. Bone models were subsequently rotated around the longitudinal mechanical axis up to 15° inward/outward and additionally flexed along the femoral intercondylar axis up to 30°. This resulted in 28 combinations of rotation and flexion for each leg. The results were statistically analysed on a descriptive level and using a linear mixed effects model.

RESULTS: A total of 1680 simulations were performed. Mechanical axis deviation (MAD) revealed a medial deviation with increasing internal rotation and a lateral deviation with increasing external rotation. This effect increased significantly (p < 0.05) with combined flexion up to 30° flexion (- 25.4 mm to 25.2 mm). With the knee extended, the mean deviation of hip-knee-ankle angle (HKA) was small over all rotational steps but increased toward more varus/valgus when combined with flexion (8.4° to – 8.5°). Rotation alone changed the medial proximal tibial angle (MPTA) and the mechanical lateral distal femoral angle (mLDFA) in opposite directions, and the effects increased significantly (p < 0.05) when flexion was present.

CONCLUSIONS: Axial rotation and flexion of the 3D lower limb has a huge impact on the projected two-dimensional alignment measurements in the coronal plane. The observed effects were small for isolated rotation or flexion, but became pronounced and clinically relevant when there was a combination of both. This must be considered when evaluating X-ray images. Extension deficits of the knee make LLR prone to error and this calls into question direct postoperative alignment controls.

LEVEL OF EVIDENCE: III (retrospective cohort study).

PMID:36595052 | DOI:10.1007/s00167-022-07302-x

Eur Arch Otorhinolaryngol. 2023 Jan 3. doi: 10.1007/s00405-022-07803-y. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the completeness of harms reporting in systematic reviews (SRs) pertaining to functional endoscopic sinus surgery (FESS).

METHODS: Using a cross-sectional study design, we performed a comprehensive search using MEDLINE (PubMed and Ovid), EMBASE, Epistemonikos, and the Cochrane Database of Systematic Reviews databases for SRs regarding FESS on May 15th, 2022. Returns were screened and data were extracted in a masked, duplicate manner. Following established methodology, we extracted general study characteristics, harms items, and overall methodological quality for each SR in our sample. Corrected covered area (CCA) was calculated for SR dyads. For data analysis, using Stata 16.1 we performed a bivariate analysis between variables.

RESULTS: Fifty-five SR’s were included in our sample after excluding 375 studies that did not meet our inclusion criteria. Of the included SRs, 19 (19/55, 34.5%) did not report harms and 39 (39/55, 70.9%) reported half of the harms items or fewer. Our study found that 23 (23/55, 41.8%) of SRs demonstrated a method of harms data collection, 26 (26/55, 47.3%) of SRs had patients available for harms analysis in their results, and 25 (25/55, 45.5%) of SRs had a balanced discussion of harms and benefits of FESS. Fifty-two SRs were appraised as “critically low” quality using AMSTAR-2. A significant association was found between completeness of harms reporting (Mahady) and whether harms were listed as a primary outcome. No other associations were statistically significant. Two SR dyads had CCAs between 20% and 50% overlap and were compared for unique and shared harms.

CONCLUSIONS: Our study demonstrates gaps in harms reporting regarding FESS in SRs. We recommend future studies implement guidelines such as the STROCCS guidelines or the harms extension of the PRISMA guidelines to improve harms reporting. Accurate harms reporting may advance patient safety and promote a more objective risk-benefit analysis for physicians and patients.

PMID:36595047 | DOI:10.1007/s00405-022-07803-y

J Cancer Res Clin Oncol. 2023 Jan 3. doi: 10.1007/s00432-022-04563-4. Online ahead of print.

ABSTRACT

BACKGROUND: Bevacizumab (Avastin^®) is a monoclonal antibody targeting the vascular endothelial growth factor (VEGF). Used alone or in combination with chemotherapy and/or immunotherapy, Avastin^® has shown promising efficacy in many cancers. This study compared the efficacy and safety of TAB008 with Avastin^® sourced from the EU (bevacizumab-EU), in patients with non-squamous non-small cell lung cancer (nsNSCLC).

METHOD: In this randomized, double-blind, multicenter, phase III similarity study, treatment naïve for metastatic lung cancer., EGFR wild-type, locally advanced, metastatic, or recurrent non-squamous, non-small cell, lung cancer (nsNSCLC) patients were enrolled and randomized (1:1) into TAB008 or Avastin^® groups. Patients received TAB008 or Avastin^® 15 mg/kg intravenously plus paclitaxel/carboplatin for 4-6 cycles followed by TAB008 or Avastin^® 7.5 mg/kg until disease progression, unacceptable toxicity or death. The primary endpoint compared the objective response rate (ORR) within 6 cycles as read by an independent radiological review committee (IRRC). Secondary endpoints compared disease control rate (DCR) Within 6 cycles, duration of response (DoR), progression-free survival (PFS), a year overall survival rate (OSR), overall survival (OS), safety, immunogenicity, and steady-state pharmacokinetics.

RESULTS: A total of 549 nsNSCLC patients were enrolled (277 in TAB008 group and 272 in Avastin^® group). In the full analysis set, ORRs were 55.957% for TAB008 and 55.720% for Avastin^®, and the ORR ratio was 1 (90% CI 0.89-1.14), well within the predefined equivalence margin of 0.75-1.33. No significant differences were found in DCR within 6 cycles (95.703% vs 95.367%, p = 0.8536), DoR (8.17 vs 7.3 months, p = 0.3526), PFS (9.10 vs. 7.97 months, p = 0.9457), 1 year overall survival rate (66.2% vs 68%, p = 0.6793), or OS (20.4 vs 17.6 months, p = 0.6549). Serious adverse events (SAEs) occurred in 37.55% (104/277) of patients in the TAB008 group and 34.32% (93/271) in the Avastin^® group. Anti-drug antibodies were reported in 3 of 277 (1.08%) TAB008 patients, and 5 of 271 (1.85%) Avastin^® patients, neutralizing antibody (Nab) was positive in 1 patient on Avastin^®, which became negative upon follow-up. The steady-state trough concentrations (C_ssmin) were 106.13 μg/mL in TAB008 group and 96.03 μg/mL in Avastin^® groups, with the treatment group ratio of LS geometric means fully contained within the bioequivalence limits of 80.00-125.00% (90% CI was 101.74-120.05%).

CONCLUSIONS: TAB008 is similar to Avastin^® in terms of efficacy, safety, and pharmacokinetic parameters, with comparable immunogenicity.

TRIAL REGISTRATION: ClinicalTrials.gov number; NCT05427305.

PMID:36595042 | DOI:10.1007/s00432-022-04563-4

Med Microbiol Immunol. 2023 Jan 3. doi: 10.1007/s00430-022-00759-0. Online ahead of print.

ABSTRACT

Measurement of anti-pneumococcal capsular polysaccharides (anti-PnPs) IgG titers is an important tool in the immunologic assessment of patients with suspected immunodeficiency disorders (ID) to reduce the morbi-mortality and minimize severe infections. Retrospectively, we studied the relationship among anti-PnPs IgG response to 3 doses of Prevenar®13, levels of immune system components, leukocyte populations, and clinical data in children with ID. Serum samples were collected at least 4 weeks post vaccination. Subsequently, multi-serotype enzyme-linked immunosorbent assay (ELISA) was performed. Eighty-seven children (under 12 years) were enrolled. Primary immunodeficiency disorder (PID) was the most common disorder (45) followed by possible immunodeficiency disorder (POID) (19), secondary immunodeficiency disorder (SID) (15), and mixed immunodeficiency disorder (MID) (8). The median age was 3 (1.50-5.33) years, 65% of patients were male. Deficient production of anti-PnPs IgG (titer ≤ 50 mg/L) was detected in 47 patients (54%), especially in the MID group, all of them under immunosuppressive therapy. In PCV13 responders, the mean of leukocyte population levels was higher with statistically significance differences in CD4 + /CD8 + T lymphocytes (p = 0.372, p = 0.014) and CD56 + /CD16 + NK (p = 0.016). Patients with previous bone marrow transplantation were the worst PCV13 responders. Pneumococcal IgG antibody titers (post-vaccination) along with clinical and analytical markers represented.

PMID:36595027 | DOI:10.1007/s00430-022-00759-0

Eur J Cardiovasc Nurs. 2023 Jan 3:zvad005. doi: 10.1093/eurjcn/zvad005. Online ahead of print.

ABSTRACT

AIM: Reduction of blood pressure and improvement of stress and sleep disorders in patients with essential hypertension were important factors. Auricular acupressure was an appropriate complementary therapy for the elderly with essential hypertension for whom pharmacological therapy was not available.

METHODS AND RESULTS: This study was a single-blind, randomized, placebo-controlled study. The experimental group (n = 23) received 8 weeks of auricular acupressure intervention on specific acupoints (superior triangular fossa, Shenmen, kidney, heart, occiput) related to blood pressure, pulse rate, stress, and sleep, whereas the control group (n = 23) received auricular acupressure on nonspecific acupoints. The primary outcomes were the systolic and diastolic blood pressure measured weekly. The secondary outcomes were the pulse rate, heart rate variability, actigraphy measured through Fitbit, and the PSQI were measured before and after the experiment. There were statistically significant differences in systolic blood pressure (F = 5.67, p = .022), diastolic blood pressure (17.53, p < .001), and pulse rate (F = 6.78, p = .013) over time. Stress index (χ2 = 2.12, p = .040) and sleep efficiency (χ2 = 3.57, p = .001) were also significantly different before and after the experiment. However, there was no significant difference in the Pittsburgh Sleep Quality Index.

CONCLUSION: The findings showed that auricular acupressure leads to improvements in blood pressure, stress, and sleep in elderly people with essential hypertension. Therefore, auricular acupressure can be used as an alternative nursing intervention for hypertension prevention, stress, and sleep management.

REGISTRATION: WHO ICTRP KCT0007364.

PMID:36594992 | DOI:10.1093/eurjcn/zvad005

Am J Primatol. 2023 Jan 3:e23463. doi: 10.1002/ajp.23463. Online ahead of print.

ABSTRACT

The self-initiated split of a social group, known as fission, is a challenge faced by many group-living animals. The study of group fission and the social restructuring process in real time provides insights into the mechanism of this biologically important process. Previous studies on fission in Japanese macaques (Macaca fuscata) assigned individuals to newly reorganized groups mainly using behavioral observations and group attendance records based on periods before or after fission itself. Here, we present a novel framework for group classification during the process of fission that uses quantifiable behavioral variables and statistical analyses. The framework was tested on a group fission process at Affenberg Landskron (Austria), a park that housed around 160 semi-free-ranging Japanese macaques. The behavioral data were collected for 26 days during fission. We analyzed three behavioral developments recurrent in fissions in Japanese macaques, that is, independence of behavior, participation in group movements, and separation of nomadic ranges. These analyses were combined to assign individuals to different groups. Our study resulted in one main group (N = 33), one subgroup (N = 36) and 56 individuals whose group membership was still undefined. The demographic characteristics of these newly formed groups were comparable with those of fissioned groups in wild populations. Furthermore, we found that these newly forming groups showed early social dynamics of fission five months before group level movements, that is: grouping based on spatial proximity and spatial withdrawal of the subgroup to the periphery. These results underline the validity of our novel framework to study social dynamics in Japanese macaques during the process of fission. It represents an important addition to existing methods, and we recommend testing its scope in other primate societies.

PMID:36594448 | DOI:10.1002/ajp.23463

Magn Reson Med. 2023 Jan 3. doi: 10.1002/mrm.29576. Online ahead of print.

ABSTRACT

PURPOSE: To increase the effectiveness of respiratory gating in radial stack-of-stars MRI, particularly when imaging at high spatial resolutions or with multiple echoes.

METHODS: Free induction decay (FID) navigators were integrated into a three-dimensional gradient echo radial stack-of-stars pulse sequence. These navigators provided a motion signal with a high temporal resolution, which allowed single-spoke binning (SSB): each spoke at each phase encode step was sorted individually to the corresponding motion state of the respiratory signal. SSB was compared with spoke-angle binning (SAB), in which all phase encode steps of one projection angle were sorted without the use of additional navigator data. To illustrate the benefit of SSB over SAB, images of a motion phantom and of six free-breathing volunteers were reconstructed after motion-gating using either method. Image sharpness was quantitatively compared using image gradient entropies.

RESULTS: The proposed method resulted in sharper images of the motion phantom and free-breathing volunteers. Differences in gradient entropy were statistically significant (p = 0.03) in favor of SSB. The increased accuracy of motion-gating led to a decrease of streaking artifacts in motion-gated four-dimensional reconstructions. To consistently estimate respiratory signals from the FID-navigator data, specific types of gradient spoiler waveforms were required.

CONCLUSION: SSB allowed high-resolution motion-corrected MR imaging, even when acquiring multiple gradient echo signals or large acquisition matrices, without sacrificing accuracy of motion-gating. SSB thus relieves restrictions on the choice of pulse sequence parameters, enabling the use of motion-gated radial stack-of-stars MRI in a broader domain of clinical applications.

PMID:36594436 | DOI:10.1002/mrm.29576