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Nevin Manimala Statistics

Bleeding patterns of women with heavy menstrual bleeding or dysmenorrhoea using the levonorgestrel-releasing intrauterine system: results from a real-world observational study in Japan (J-MIRAI)

Eur J Contracept Reprod Health Care. 2022 May 25:1-8. doi: 10.1080/13625187.2022.2067329. Online ahead of print.

ABSTRACT

PURPOSE: To collect real-world safety and clinical outcome data on the levonorgestrel-releasing intrauterine system (LNG-IUS) for functional/organic heavy menstrual bleeding (HMB) and dysmenorrhoea in Japanese women (J-MIRAI).

MATERIALS AND METHODS: In this prospective, multicentre, single-cohort, open-label, post-authorisation study, we assessed menstrual blood loss after LNG-IUS insertion by changes from baseline in pictorial blood loss assessment chart (PBAC) scores. Scores for the menorrhagia multi-attribute scale (MMAS) were collected for 12 months to assess quality of life.

RESULTS: We included 47 patients with complete PBAC score and patient diary data. The median PBAC score before LNG-IUS insertion was 159.0, which decreased significantly to 6.0 at 12 months post-insertion; for patients with adenomyosis (n = 20), PBAC score decreased from 174.5 pre-insertion to 19.5 at 12 months. The number of patient-reported bleeding days was correlated with PBAC score ≥5. The proportion of women with prolonged bleeding decreased from 85.7% to 34.6% by the study’s end. Some women reported no bleeding after the first 90-day reference period. The mean MMAS overall score significantly increased from 50.50 before insertion to 88.67 at 12 months.

CONCLUSIONS: Japanese women with functional/organic HMB experienced substantial reductions in bleeding symptoms and improvements in quality of life after 12-month use of the LNG-IUS.

PMID:35611632 | DOI:10.1080/13625187.2022.2067329

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Identifying cell-to-cell variability in internalization using flow cytometry

J R Soc Interface. 2022 May;19(190):20220019. doi: 10.1098/rsif.2022.0019. Epub 2022 May 25.

ABSTRACT

Biological heterogeneity is a primary contributor to the variation observed in experiments that probe dynamical processes, such as the internalization of material by cells. Given that internalization is a critical process by which many therapeutics and viruses reach their intracellular site of action, quantifying cell-to-cell variability in internalization is of high biological interest. Yet, it is common for studies of internalization to neglect cell-to-cell variability. We develop a simple mathematical model of internalization that captures the dynamical behaviour, cell-to-cell variation, and extrinsic noise introduced by flow cytometry. We calibrate our model through a novel distribution-matching approximate Bayesian computation algorithm to flow cytometry data of internalization of anti-transferrin receptor antibody in a human B-cell lymphoblastoid cell line. This approach provides information relating to the region of the parameter space, and consequentially the nature of cell-to-cell variability, that produces model realizations consistent with the experimental data. Given that our approach is agnostic to sample size and signal-to-noise ratio, our modelling framework is broadly applicable to identify biological variability in single-cell data from internalization assays and similar experiments that probe cellular dynamical processes.

PMID:35611619 | DOI:10.1098/rsif.2022.0019

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Effects of pre-surgical aerobic dance-based exercise on lower extremity in people with morbid obesity awaiting bariatric surgery: Randomized controlled study

Clin Obes. 2022 May 25:e12529. doi: 10.1111/cob.12529. Online ahead of print.

ABSTRACT

To investigate what are the effects of pre-surgical aerobic dance-based exercise programme (PSADBE) and physical activity counselling (PAC) programme on lower extremity functions after surgery in people with morbid obesity awaiting bariatric surgery (PMOABS). This study was a single-blind, randomized controlled study. Groups were divided into Group I (PSADBE and PAC) and Group II (PAC). Both groups received PAC, Group I completed the PSADBE programme accompanied by music for 60 min/2 days/8 weeks. Thirty-four PMOABS were included in the study. The 6-Minute Walking Test, as primary outcomes, and The Stair Climbing Up-Down Test for evaluating functional capacity, Biodex Isokinetic Test and Exercise System® for evaluating muscle strength were used. Besides, muscle endurance, physical activity (PA) level, fatigue and quality of life (QoL) were also assessed. All measurements were repeated three times; pre-treatment, post-treatment and the fifth-month post-surgery. After 8 weeks, significant changes were found in functional capacity, muscle strength and endurance, PA level, fatigue and QoL in both groups (p < .05). Comparing the groups, the changes in functional capacity, muscle strength and endurance, PA and fatigue scores after treatment and the fifth-month post-surgery were statistically superior in Group I (p < .05). Adding an 8-week PSADBE programme to PAC is an effective treatment option for improving postoperative functional capacity, muscle strength and endurance, PA level and fatigue in PMOABS.

PMID:35611581 | DOI:10.1111/cob.12529

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Effectiveness of instrument-assisted soft tissue mobilization for the management of upper body, lower body, and spinal conditions. An updated systematic review with meta-analyses

Disabil Rehabil. 2022 May 25:1-11. doi: 10.1080/09638288.2022.2070288. Online ahead of print.

ABSTRACT

PURPOSE: To critically appraise randomized controlled trials (RCTs) on Instrument-Assisted Soft Tissue Mobilisation (IASTM) and quantify the effects of IASTM compared with other treatment individuals with or without pathologies on function, pain, and range of motion.

MATERIALS AND METHODS: We search four electronic databases from January 1999 to January 2022 and included RCTs of healthy participants/athletes and people with upper, lower, or spinal conditions, who received IASTM versus other active treatment for clinical outcomes (function, pain, and range of motion).

RESULTS: Forty-six RCTs were considered eligible for data analysis. Effects of IASTM plus other treatment versus other treatment on function and pain intensity were not statistically significant or clinically meaningful (very low quality, SMD -0.28, 95% CI -0.66 to 0.09) and (very low quality, SMD -0.05, 95% CI -0.53 to 0.43) at up to one-year follow-up respectively. No clinically meaningful improvements were found on range of motion outcomes. Out of the 46 included RCTs, only 10 assessed and reported IASTM-related adverse events.

CONCLUSION: Evidence of very low-quality certainty does not support the efficacy of IASTM in individuals with or without various pathologies on function, pain, and range of motion in the management of upper body, lower body, or spinal conditions. IMPLICATIONS FOR REHABILITATIONThe included RCTs had a high risk of bias and were assessed as very-low quality evidence for all the included outcomes.IASTM does not lead to clinically meaningful improvements in function, pain, or range of motion in individuals with upper body, lower body, and spinal conditions.The publication of IASTM trials in suspected predatory journals is increasing.The available evidence on IASTM does not support its use to improve function, pain, or range of motion in individuals with upper body, lower body, and spinal conditions.Health care practitioners should consider other evidence-based management strategies (physical activity and exercise) to improve function, pain, or range of motion in individuals with musculoskeletal injuries and disorders.Given the rise of publications on IASTM in suspected predatory journals, health care practitioners should be judicious to examine the legitimacy of a journal when searching for evidence on IASTM treatment technique.

PMID:35611579 | DOI:10.1080/09638288.2022.2070288

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Outcome of eviscerations and enucleations at a Swedish tertiary referral centre between 2008 and 2019: improved surgical management leading to reduced complication rate

Orbit. 2022 May 25:1-7. doi: 10.1080/01676830.2022.2078844. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to investigate the results of all eviscerations and enucleations performed at the Department of Ophthalmology, Sahlgrenska University Hospital, during 2008-2019 and to compare them with previously collected data from 1999 to 2007.

METHODS: This was a retrospective investigation using the medical records for all patients having had an evisceration or an enucleation at the Department of Ophthalmology, Sahlgrenska University Hospital, during the two defined periods of time. Main outcome measure was postoperative complications.

RESULTS: During 1999-2007, 181 surgeries were performed, 100 with implants, and 28/100 exposed implants and 9/100 removed implants were recorded during follow-up. During 2008-2019, 250 operations were performed with 158 implants, and there were 3/158 exposed implants and 2/158 extruded implants. Two ruptures of the surgical wound without implant exposure were noted, and one implant was exchanged. The reduction of exposed implants between the two periods was statistically significant (p < .001, Chi-square test). In enucleations, the use of one kind of porous polyethylene implant in the recent study period replaced a multitude of implants in the earlier study period. In eviscerations, the major change between the two study periods was the introduction of the split sclera technique and smaller implant size.

CONCLUSION: The change in surgical technique between the two periods led to a significant reduction in implant-related complications.

PMID:35611572 | DOI:10.1080/01676830.2022.2078844

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Radiotherapy respiratory motion management in hepatobiliary and pancreatic malignancies: a systematic review of patient factors influencing effectiveness of motion reduction with abdominal compression

Acta Oncol. 2022 May 25:1-9. doi: 10.1080/0284186X.2022.2073186. Online ahead of print.

ABSTRACT

BACKGROUND: The effectiveness of abdominal compression for motion management in hepatobiliary-pancreatic (HPB) radiotherapy has not been systematically evaluated.

METHODS & MATERIALS: A systematic review was carried out using PubMed/Medline, Cochrane Library, Web of Science, and CINAHL databases up to 1 July 2021. No date restrictions were applied. Additional searches were carried out using the University of Manchester digital library, Google Scholar and of retrieved papers’ reference lists. Studies conducted evaluating respiratory motion utilising imaging with and without abdominal compression in the same patients available in English were included. Studies conducted in healthy volunteers or majority non-HPB sites, not providing descriptive motion statistics or patient characteristics before and after compression in the same patients or published without peer-review were excluded. A narrative synthesis was employed by tabulating retrieved studies and organising chronologically by abdominal compression device type to help identify patterns in the evidence.

RESULTS: The inclusion criteria were met by 6 studies with a total of 152 patients. Designs were a mix of retrospective and prospective quantitative designs with chronological, non-randomised recruitment. Abdominal compression reduced craniocaudal respiratory motion in the majority of patients, although in four studies there were increases seen in at least one direction. The influence of patient comorbidities on effectiveness of compression, and/or comfort with compression was not evaluated in any study.

CONCLUSION: Abdominal compression may not be appropriate for all patients, and benefit should be weighed with potential increase in motion or discomfort in patients with small initial motion (<5 mm). Patient factors including male sex, and high body mass index (BMI) were found to impact the effectiveness of compression, however with limited evidence. High-quality studies are warranted to fully assess the clinical impact of abdominal compression on treatment outcomes and toxicity prospective in comparison to other motion management strategies.

PMID:35611555 | DOI:10.1080/0284186X.2022.2073186

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Nevin Manimala Statistics

Medium Optimization for Submerged Fermentative Production of β-Cyclodextrin Glucosyltransferase by Isolated Novel Alkalihalophilic Bacillus sp. NCIM 5799 Using Statistical Approach

Lett Appl Microbiol. 2022 May 25. doi: 10.1111/lam.13746. Online ahead of print.

ABSTRACT

β-cyclodextrin glucosyltransferase (β-CGTase) is an essential enzyme to catalyze the biotransformation of starch into β-cyclodextrins (β-CD). β-CD has widespread applications in the biomedical, pharmaceutical, and food industries. The present study focused on β-CGTase production using an efficient natural microbial strain and statistical production optimization for enhanced production. The isolated organism Bacillus sp. NCIM 5799 was found to be 5μm short bacilli under FE-SEM and alkalihalophilic in nature. The β-CGTase production was optimized using a combination of Plackett-Burman design (PBD) and Central Composite Design – Response Surface Methodology (CCD-RSM). On PBD screening Na2 CO3 , peptone, and MgSO4 .7H2 O were found to be significant for optimal β-CGTase production, whereas the soluble starch and K2 HPO4 concentrations were found to be non-significant for β-CGTase production. The significant factors obtained after PBD were further optimized using CCD-RSM design. Peptone was found to have a significant interaction effect with Na2 CO3 , and MgSO4 .7H2 O and Na2 CO3 exhibited significant effect on production of CGTase. The production of β-CGTase was enhanced in the presence of peptone (3%) and Na2 CO3 (0.8%). CGTase production obtained was 156.76 U/ml when optimized using CCD-RSM. The final optimized medium (RSM) shows 7.7 and 5.4 fold high production as compared to un-optimized and one factor at a time production media.

PMID:35611566 | DOI:10.1111/lam.13746

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Delayed hospitalisation for heart failure after transcatheter repair or medical treatment for secondary mitral regurgitation: a landmark analysis of the MITRA-FR trial

EuroIntervention. 2022 May 25:EIJ-D-21-00846. doi: 10.4244/EIJ-D-21-00846. Online ahead of print.

ABSTRACT

BACKGROUND: In the MITRA-FR trial, transcatheter mitral valve repair (TMVR) was not associated with a 2-year clinical benefit in patients with secondary mitral regurgitation (SMR).

AIMS: This landmark analysis aimed at investigating a potential reduction of the hospitalisation rate for heart failure (HF) between 12 and 24 months after inclusion in the MITRA-FR trial in patients randomised to the intervention group (TMVR with the MitraClip device), as compared with patients randomised to the control group (guideline-directed medical therapy [GDMT]).

METHODS: The MITRA-FR trial randomised 307 patients with SMR for TMVR on top of GDMT (TMVR group; n=152) or for GDMT alone (control group; n=155). We conducted a 12-month landmark analysis in surviving patients who were not hospitalised for HF within the first 12 months of follow-up. The primary endpoint was the 1-year cumulative number of HF hospitalisations.

RESULTS: A total of 140 patients (TMVR group: 67; GDMT group: 73) were selected for this landmark analysis with similar characteristics at inclusion in the trial. The primary endpoint was 28 events per 100 patient-years in the TMVR group, as compared with 60 events per 100 patient-years in the GDMT group (hazard ratio [HR] 0.46, 95% confidence interval [CI]: 0.20-1.02; p=0.057).

CONCLUSIONS: In this landmark analysis of the MITRA-FR trial, the cumulative rate of HF hospitalisation between 12 and 24 months among patients treated with TMVR on top of GDMT was approximately half as many as those of patients treated with GDMT alone, a difference which did not reach statistical significance in the setting of a low number of events.

PMID:35611516 | DOI:10.4244/EIJ-D-21-00846

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The Effects of Acupressure in the Prevention of Nausea and Vomiting Related to Chemotherapy in Children: A Randomized Double-Blinded Placebo-Controlled Study

J Pediatr Hematol Oncol Nurs. 2022 May 25:27527530221092324. doi: 10.1177/27527530221092324. Online ahead of print.

ABSTRACT

Background: Acupressure is known to be a nursing intervention used to prevent chemotherapy-induced nausea and vomiting in children. Methods: This study was conducted to evaluate and compare the effectiveness of manual and wristband acupressure in the prevention of chemotherapy-induced nausea and vomiting in children. This double-blinded and placebo-controlled study was conducted with 44 children aged between 5 and 18 years receiving chemotherapy in a university hospital’s pediatric oncology clinic. Children were randomized into groups using a 2 × 2 factorial design: (a) The child who was given manual acupressure before the first chemotherapy was given placebo manual acupressure before the next chemotherapy; (b) the same child who was administered wristband acupressure before the first chemotherapy was administered placebo wristband acupressure before the next chemotherapy. After all interventions, the severity and number of episodes of nausea and vomiting and additional antiemetic needs in the children were monitored for 24 h. Results: In both groups, the severity and number of nausea and vomiting were lower according to their own placebo groups. Manual and wristband acupressure were effective in reducing the severity and number of nausea and vomiting, but manual acupressure was more effective in reducing the severity and number of nausea and vomiting in comparison to wristband acupressure (p < .05). No statistically significant difference was found between the groups regarding additional antiemetic drug use. Discussion: In this study, manual and wristband acupressure were determined to be effective in reducing the severity and number of nausea and vomiting related to chemotherapy.

PMID:35611515 | DOI:10.1177/27527530221092324

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Association Between Glycemic Gap and Mortality in Critically Ill Patients with Diabetes

J Intensive Care Med. 2022 May 25:8850666221101856. doi: 10.1177/08850666221101856. Online ahead of print.

ABSTRACT

OBJECTIVES: Dysglycemia is associated with poor outcomes in critically ill patients,which is uncertain in patients with diabetes regarding to the situation of glucose control before hospitalization. This study was aimed to investigate the effect of the difference between the level of blood glucose during ICU stay and before admission to ICU upon the outcomes of critically ill patients with diabetes.

METHOD: Patients with diabetes expected to stay for more than 24hs were enrolled, HbA1c was converted to A1C-derived average glucose (ADAG) by the equation: ADAG = [ (HbA1c * 28.7) – 46.7 ] * 18-1, blood glucose were measured four times a day during the first 7 days after admission, the mean glucose level(MGL) and SOFA (within 3, 5, and 7days) were calculated for each person, GAPadm and GAPmean was calculated as admission blood glucose and MGL minus ADAG, the incidence of moderate hypoglycemia(MH), severe hypoglycemia (SH), total dosage of glucocorticoids and average daily dosage of insulin, duration of renal replacement therapy(RRT), ventilator-free hours, and non-ICU days were also collected. Patients were divided into survival group and nonsurvival group according to survival or not at 28-day, the relationship between GAP and mortality were analyzed.

RESULTS: 431 patients were divided into survival group and nonsurvival group. The two groups had a comparable level of HbA1c, the nonsurvivors had greater APACHE II, SOFA, GAPadm, GAPmean-3, GAPmean-5, GAPmean-7 and higher MH and SH incidences. Less duration of ventilator-free, non-ICU stay and longer duration of RRT were recorded in the nonsurvival group. GAPmean-5 had the greatest predictive power with an AUC of 0.807(95%CI: 0.762-0.851), the cut-off value was 3.6 mmol/L (sensitivity 77.7% and specificity 76.6%). The AUC was increased to 0.852(95%CI: 0.814-0.889) incorporated with SOFA5 (NRI = 11.34%).

CONCLUSION: Glycemic GAP between the MGL within 5 days and ADAG was independently associated with 28-day mortality of critically ill patients with diabetes. The predictive power was optimized with addition of SOFA5.

PMID:35611506 | DOI:10.1177/08850666221101856