Categories
Nevin Manimala Statistics

Influence of Rheological Properties and Needle Size on Extrusion Forces of Hyaluronic Acid Based Soft Tissue Fillers

J Drugs Dermatol. 2021 May 1;20(5):498-502. doi: 10.36849/JDD.5237.

ABSTRACT

BACKGROUND: To date no precise data are available for extrusion forces related to the G-prime and G-double-prime of fillers in combination with different 27G and 30G needles. Therefore, the objective of this study was to analyze extrusion forces of various product-needle-combinations containing two different 27G and two different 30G needles in combination with fillers of a wide range of elastic moduli starting from 2.0 – 166.0 Pa.

MATERIAL AND METHODS: Four different fillers with the following elastic moduli 1.87, 11.65, 61.80, 165.50 Pa were combined with four different needles: 27G ½”, internal diameter: 0.300 μm; 27G ½”, internal diameter: 0.241 μm; 30G ½”, internal diameter: 0.241 μm and 30G ½“, internal diameter: 0.240 μm. Product-needle-combination were subjected to uni-axial mechanical testing and the respective extrusion force was measured.

RESULTS: The results of this study revealed that the G-prime and the G-double-prime of a product are statistically significantly related to their extrusion force, with higher G-prime/G-double-prime products requiring higher extrusion forces. The results additionally revealed that whether the size of the needle was described as 27G or 30G by the respective manufacturer statistically significant differences between the measured extrusion forces were detected.

CONCLUSION: Injectors need to be aware that not every 27G/30G needle has the same extrusion force even though the external diameter is similar (27G or 30G); this might additionally influence the ability to withdraw blood during a pre-injection aspiration manoeuvre. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5237.

PMID:33938685 | DOI:10.36849/JDD.5237

Categories
Nevin Manimala Statistics

Randomized, Double-Blind, Placebo-Controlled Study of Poly-L-Lactic acid for Treatment of Cellulite in the Lower Extremities

J Drugs Dermatol. 2021 May 1;20(5):529-533. doi: 10.36849/JDD.5380.

ABSTRACT

BACKGROUND: Poly-l-lactic acid (PLLA) is an injectable volumizer with biostimulatory properties used for volumetric structural rejuvenation in patients with facial fat volume loss but has increasingly been utilized for off-face applications.

OBJECTIVE: The objectives of this randomized, double-blind, placebo-controlled single center study was to assess the safety and effectiveness of PLLA for the treatment of lower extremity cellulite in adult women.

METHODS: 31 healthy women were enrolled in the study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections combined with subcision, into each of the glutes or thighs. Follow-up visits were at 1, 3, and 6 months after treatment. Assessments included live ratings, rating of standardized pictures by a blinded evaluator, patient questionnaires, safety, and tolerability ratings.

RESULTS: At the 3 and 6-month follow-up, there was a statistically significant change in the global aesthetic improvement scale (GAIS) compared to baseline as assessed by blinded investigators. Significant improvements were shown in the cellulite severity scale (CSS) as well as in the subject satisfaction questionnaires. Treatments were found to be tolerable, and no severe treatment-related adverse events occurred.

CONCLUSION: Repeated PLLA treatments combined with subcision are effective and safe in improving the appearance of cellulite. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5380.

PMID:33938690 | DOI:10.36849/JDD.5380

Categories
Nevin Manimala Statistics

White blood cells and platelet profiles of diabetic patients at University of Gondar specialized referral hospital: A comparative cross-sectional study

J Clin Lab Anal. 2021 May 3:e23808. doi: 10.1002/jcla.23808. Online ahead of print.

ABSTRACT

BACKGROUND: Altered level of many hematological parameters such as white blood cells (WBC) and platelet function has been observed in diabetes mellitus (DM) patients. Therefore, this study aimed to determine the WBC and platelet profiles and their association with anthropometric measurement and blood pressure in DM patients and healthy controls.

METHOD: A comparative cross-sectional study was conducted on a total of 246 participants at the University of Gondar Specialized Referral Hospital. Venous blood with K2 EDTA anticoagulant was drawn and analyzed by using Sysmex KX21N hematology analyzers for WBC and platelet parameters. Data were analyzed using Statistical Package for Social Sciences (SPSS) version 20. Results were presented as frequency and mean ± standard deviation (SD). The independent sample t test was used to compare quantitative variables between DM and control groups. The bivariate (spearman’s rank) correlation was used to analyze continuous variables. A p-value ˂ 0.05 was considered as statistically significant.

RESULTS: The mean platelet count was significantly higher among diabetics (252.77 ± 77.7) compared to non-diabetic controls (208.22 ± 68), p < 0.001. Similarly, the total WBC count was higher among DM patients (6.95 ± 2.23) than in the controls (6.15 ± 1.95), p = 0.04. A significant negative correlation was also found between neutrophil and duration of illness in DM patients. Besides, there is a significant positive correlation between WBC and lymphocyte number with systolic blood pressure (SBP) in DM patients.

CONCLUSION: Platelet and WBC count were significantly higher in DM patients than in the controls. Therefore, routine screening and profile checking of those abnormal indices is recommended to minimize DM-related complications.

PMID:33938591 | DOI:10.1002/jcla.23808

Categories
Nevin Manimala Statistics

Priorities and preferences for care of people with multiple chronic conditions

Health Expect. 2021 May 3. doi: 10.1111/hex.13262. Online ahead of print.

ABSTRACT

BACKGROUND: To guide the development of high-quality care for people with multiple chronic conditions, partners of the European Joint Action CHRODIS developed the Integrated Multimorbidity Care Model. To assess its suitability for improving care for people with multimorbidity in the Netherlands, the model was piloted in a primary care setting with both patients and care providers.

AIM: This paper reports on the patient perspective, and aims to explore the priorities, underlying values and preferences for care of people with multimorbidity.

PARTICIPANTS AND METHODS: Twenty persons with multimorbidity (selected from general practice registries) participated in a focus group or telephone interview. Subsequently, a questionnaire was completed by 863 persons with multimorbidity registered with 14 general practices. Qualitative data were thematically analysed and quantitative data by means of descriptive statistics.

RESULTS: Frequently prioritized elements of care were the use of shared electronic health records, regular comprehensive assessments, self-management support and shared decision making, and care coordination. Preferences for how these elements should be specifically addressed differed according to individual values (eg weighing safety against privacy) and needs (eg ways of coping with multimorbidity).

CONCLUSION: The JA-CHRODIS Integrated Multimorbidity Care Model reflects the priorities and preferences for care of people with multimorbidity in the Netherlands, which supports its relevance to guide the development of person-centred integrated care for people with multiple chronic conditions in the Netherlands.

PATIENT CONTRIBUTION: European patient experts contributed to the development and applicability assessment of the JA-CHRODIS Integrated Multimorbidity Care Model; Dutch patients participated in focus groups, interviews and a survey.

PMID:33938597 | DOI:10.1111/hex.13262

Categories
Nevin Manimala Statistics

A New Method for Aortic Valve Planimetry with High-Resolution 3-Dimensional MRI and Its Comparison with Conventional Cine MRI and Echocardiography for Assessing the Severity of Aortic Valvular Stenosis

Korean J Radiol. 2021 Apr 23. doi: 10.3348/kjr.2020.1218. Online ahead of print.

ABSTRACT

OBJECTIVE: We aimed to compare the aortic valve area (AVA) calculated using fast high-resolution three-dimensional (3D) magnetic resonance (MR) image acquisition with that of the conventional two-dimensional (2D) cine MR technique.

MATERIALS AND METHODS: We included 139 consecutive patients (mean age ± standard deviation [SD], 68.5 ± 9.4 years) with aortic valvular stenosis (AS) and 21 asymptomatic controls (52.3 ± 14.2 years). High-resolution T2-prepared 3D steady-state free precession (SSFP) images (2.0 mm slice thickness, 10 contiguous slices) for 3D planimetry (3DP) were acquired with a single breath hold during mid-systole. 2D SSFP cine MR images (6.0 mm slice thickness) for 2D planimetry (2DP) were also obtained at three aortic valve levels. The calculations for the effective AVA based on the MR images were compared with the transthoracic echocardiographic (TTE) measurements using the continuity equation.

RESULTS: The mean AVA ± SD derived by 3DP, 2DP, and TTE in the AS group were 0.81 ± 0.26 cm², 0.82 ± 0.34 cm², and 0.80 ± 0.26 cm², respectively (p = 0.366). The intra-observer agreement was higher for 3DP than 2DP in one observer: intraclass correlation coefficient (ICC) of 0.95 (95% confidence interval [CI], 0.94-0.97) and 0.87 (95% CI, 0.82-0.91), respectively, for observer 1 and 0.97 (95% CI, 0.96-0.98) and 0.98 (95% CI, 0.97-0.99), respectively, for observer 2. Inter-observer agreement was similar between 3DP and 2DP, with the ICC of 0.92 (95% CI, 0.89-0.94) and 0.91 (95% CI, 0.88-0.93), respectively. 3DP-derived AVA showed a slightly higher agreement with AVA measured by TTE than the 2DP-derived AVA, with the ICC of 0.87 (95% CI, 0.82-0.91) vs. 0.85 (95% CI, 0.79-0.89).

CONCLUSION: High-resolution 3D MR image acquisition, with single-breath-hold SSFP sequences, gave AVA measurement with low observer variability that correlated highly with those obtained by TTE.

PMID:33938648 | DOI:10.3348/kjr.2020.1218

Categories
Nevin Manimala Statistics

History of Weight Cycling Is Prospectively Associated With Shorter and Poorer-Quality Sleep and Higher Sleep Apnea Risk in Diverse US Women

J Cardiovasc Nurs. 2021 Apr 30. doi: 10.1097/JCN.0000000000000818. Online ahead of print.

ABSTRACT

BACKGROUND: Poor sleep and history of weight cycling (HWC) are associated with worse cardiovascular health, yet limited research has evaluated the association between HWC and poor sleep patterns.

METHODS: The American Heart Association Go Red for Women Strategically Focused Research Network cohort at Columbia University (n = 506; mean age, 37 ± 15.7 years; 61% racial/ethnic minority) was used to evaluate the cross-sectional associations of HWC and sleep at baseline and the prospective associations of HWC from baseline with sleep at the 1-year visit. History of weight cycling, defined as losing and gaining 10 lb or more at least once (excluding pregnancy), was self-reported. Sleep duration, sleep quality, insomnia severity, and obstructive sleep apnea risk were assessed using the validated Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Berlin questionnaires. Linear and logistic regression models, adjusted for age, race/ethnicity, education, health insurance status, pregnancy history, and menopausal status, were used to evaluate the relation of HWC with sleep.

RESULTS: Most women reported 1 or more episodes of weight cycling (72%). In linear models of cross-sectional and prospective data, each additional weight cycling episode was related to shorter sleep duration, poorer sleep quality, longer sleep onset latency, greater insomnia severity, more sleep disturbances, lower sleep efficiency, and higher sleep medication use frequency. In the logistic models, HWC (≥1 vs 0 episodes) was associated with greater odds for short sleep, poor sleep quality, long sleep onset latency (≥26 minutes), high obstructive sleep apnea risk, and sleep efficiency lower than 85%.

CONCLUSION: History of weight cycling predicted poor sleep among women, suggesting that weight maintenance may represent an important strategy to promote sleep health. The potential bidirectional relationship between HWC and sleep requires further investigation.

PMID:33938536 | DOI:10.1097/JCN.0000000000000818

Categories
Nevin Manimala Statistics

Long-term trajectory of acquired demyelinating syndrome and multiple sclerosis in children

Dev Med Child Neurol. 2021 May 3. doi: 10.1111/dmcn.14912. Online ahead of print.

ABSTRACT

AIM: We assessed the frequency, characteristics, and future trajectory of monophasic acquired demyelinating syndromes (ADS) associated with conversion to paediatric multiple sclerosis.

METHOD: This was a retrospective observational study of Sardinian children (<18y of age) with onset of ADS between 2001 and 2018.

RESULTS: We identified 44 children with ADS (21 males, 23 females; median age at onset 16y, range 4mo-18y), 21 of whom were already presenting with criteria for paediatric multiple sclerosis. The mean crude prevalence of ADS in Sardinian children was 59.2 per 100 000, while incidence was 3.1 per 100 000 per year (1.3 in children aged ≤10y and 11.9 in those aged 10-17y). After a mean (SD) follow-up of 8 years 5 months (5y 4mo), the most common (n=32) trajectory was conversion to paediatric multiple sclerosis. At onset, the total prevalence and mean annual incidence of paediatric multiple sclerosis were 35.6 per 100 000 and 2.3 per 100 000 respectively (0.5 in individuals aged ≤10y, 10.0 in the older group).

INTERPRETATION: Sardinia is a very high risk area for ADS in children. Nearly half of this population can already be diagnosed with paediatric multiple sclerosis at onset. Overall, 72% of those with ADS will have paediatric multiple sclerosis after a mean of 8 years.

PMID:33938575 | DOI:10.1111/dmcn.14912

Categories
Nevin Manimala Statistics

The mitigating effect of low firearm background check requirements on firearm homicides in border states

J Inj Violence Res. 2021 May 3;13(2). doi: 10.5249/jivr.v13i2.1555. Online ahead of print.

ABSTRACT

BACKGROUND: Firearm-related violence is a significant public health issue in the US. Research has found an increase in guns used in crimes sourced from low gun law states into high gun law states. The purpose of this study is to evaluate the effect of distance from states without universal background checks (UBC), background checks at shows (BCS), or permit to purchase (PTP) laws on firearm homicide rates in states with them.

METHODS: States were identified based on their enactment of laws that are designed to prevent the private sale of firearms to criminals. Demographic data for each county were obtained for the years 2014 through 2017. The border distance from a county in a state with the evaluated gun laws to the nearest border state without the gun laws was obtained using Google Maps. Multiple regression analyses were performed to test the relationship between border distance and firearm homicide rates.

RESULTS: The regression model evaluating all formats found the border distance was negatively associated with firearm homicides (p=.009). The parameter estimate indicated as border distance increased, the firearm homicide rate decreased. When counties with UBC or PTP on all guns were evaluated separately from all formats model, the statistical significance was lost (p=.62). In counties where all handgun sales either require a background check or a PTP is required, the distance was also not statistically significant (p=.11).

CONCLUSIONS: This study provides evidence that there may be a mitigating effect on the reduction of firearm homicides in states that require background checks or PTP on private sales when there is a state in close proximity that did not have these laws. Limited counties at certain distances may have contributed to the insignificant findings in other models.

PMID:33938458 | DOI:10.5249/jivr.v13i2.1555

Categories
Nevin Manimala Statistics

MAJOR DEPRESSION AND SURVIVAL IN PEOPLE WITH CANCER

Psychosom Med. 2021 Apr 28. doi: 10.1097/PSY.0000000000000942. Online ahead of print.

ABSTRACT

OBJECTIVE: The question of whether depression is associated with worse survival in people with cancer remains unanswered because of methodological criticism of the published research on the topic. We aimed to study the association in a large methodologically robust study.

METHODS: We analysed data on 20,582 patients with breast, colorectal, gynaecological, lung and prostate cancers who had attended cancer outpatient clinics in Scotland, UK. Patients had completed two-stage screening for major depression as part of their cancer care. These data on depression status were linked to demographic, cancer and subsequent mortality data from national databases. We estimated the association of major depression with survival for each cancer using Cox regression. We adjusted for potential confounders and interactions between potentially time-varying confounders and the interval between cancer diagnosis and depression screening, and used multiple imputation for missing depression and confounder data. We pooled the cancer-specific results using fixed-effects meta-analysis.

RESULTS: Major depression was associated with worse survival for all cancers, with similar adjusted hazard ratios: breast cancer (HR 1.42, 95% CI 1.15-1.75), colorectal cancer (HR 1.47, 95% CI 1.11-1.94), gynaecological cancer (HR 1.36, 95% CI 1.08-1.71), lung cancer (HR 1.39, 95% CI 1.24-1.56), prostate cancer (HR 1.76, 95% CI 1.08-2.85). The pooled hazard ratio was 1.41 (95% CI 1.29-1.54, p<0.001, I2=0%). These findings were not materially different when we only considered the deaths (90%) that were attributed to cancer.

CONCLUSIONS: Major depression is associated with worse survival in patients with common cancers. The mechanisms of this association and the clinical implications require further study.

PMID:33938501 | DOI:10.1097/PSY.0000000000000942

Categories
Nevin Manimala Statistics

Statistical, Clinical, Methodological Evaluation of Local Recurrence Following Transanal Total Mesorectal Excision for Rectal Cancer: A Systematic Review

Dis Colon Rectum. 2021 Apr 22. doi: 10.1097/DCR.0000000000002110. Online ahead of print.

ABSTRACT

BACKGROUND: A recent Norwegian moratorium challenged the status quo of transanal total mesorectal excision for rectal cancer reporting increased early multifocal local recurrences.

OBJECTIVE: The aim of this systematic review and meta-analysis was to evaluate the local recurrence rates following transanal total mesorectal excision as well as to assess statistical, clinical, and methodological bias in reports published to date.

DATA SOURCES: The Pubmed and MEDLINE (via Ovid) databases were systematically searched.

STUDY SELECTION: Descriptive or comparative studies reporting rates of local recurrence at a median follow-up of 6 months (or more) after transanal total mesorectal excision were included.

INTERVENTIONS: Transanal total mesorectal excision.

MAIN OUTCOME MEASURES: Local recurrence was any recurrence located in the pelvic surgery site. Untransformed proportion method of one-arm meta-analysis was utilized. Untransformed percent proportion with 95% confidence interval was reported. Ad-hoc meta-regression with Omnibus test was utilized to assess risk factors for local recurrence. Among-study heterogeneity was evaluated: statistical by I2 and tau2, clinical by summary tables, and methodological by a 33-item questionnaire.

RESULTS: Twenty-nine studies totaling 2,906 patients were included. The pooled rate of local recurrence was 3.4% (2.7%, 4.0%) at an average of 20.1 months with low statistical heterogeneity (I2=0%). Meta-regression yielded no correlation between complete total mesorectal excision quality (p=0.855), circumferential resection margin (p=0.268), distal margin (p=0.886), and local recurrence rates. Clinical heterogeneity was substantial. Methodological heterogeneity was linked to excitement of novelty, loss aversion, reactivity to criticism, indication for transanal total mesorectal excision, non-probability sampling, circular reasoning, misclassification, inadequate follow-up, reporting bias, conflict-of-interest, and self-licensing.

LIMITATIONS: Included studies had observational design, limited sample and follow-up.

CONCLUSION: This systematic review found a pooled rate of local recurrence of 3.4% at 20 months. However, given the substantial clinical and methodological heterogeneity across the studies, the evidence for or against transanal total mesorectal excision is inconclusive at this time.

PMID:33938532 | DOI:10.1097/DCR.0000000000002110