Nevin Manimala

Daru. 2022 Jan 24. doi: 10.1007/s40199-021-00431-7. Online ahead of print.

ABSTRACT

PURPOSE: To examine the impact of the COVID-19 pandemic on calcineurin inhibitors and related prescriptions for community patients in England.

METHODS: Data from all primary-care patients who had calcineurin inhibitors prescriptions, dispensed in the community in England were included. Descriptive statistics and interrupted time series analysis over 27 months (15 months before and 12 months after 1^st lockdown) was evaluated.

RESULTS: Descriptive statistics show that mean values have declined since the pandemic’s onset. Over the 27 months: mean Tacrolimus 865,045 doses, standard deviation (SD) 76,147 doses, with 95% CI 834,923, 895,168, (min 567,508, max 1,010,900), ciclosporin 315,496 doses, SD 40,094, 95% CI 299,635, 331,356 (min 191,281, max 382,253) and sirolimus 21,384 doses, SD 2,610, 95% CI 20,352, 22,417 (min 13,022, max 26,156). Analysis of variance between the pre- and post- periods show significant variations in quantities of tacrolimus F 7.432, p = 0.012, ciclosporin F 33.147, p < 0.001 and sirolimus F 18.596, p < 0.001 (1df), mirrored in price analysis. The Interrupted Time Series (ARIMA Modelling) shows declining trends. After the pandemic’s onset, a statistically significant downward trend in quantity for tacrolimus p = 0.008 is observed, with an estimated monthly decline of 14,524 doses, ciclosporin p = 0.185, with an estimated decline of 2,161 doses and sirolimus p = 0.002 with an estimated decline of 485 doses, along with declining prices.

CONCLUSION: A decrease in prescription medicines use raises concerns for the care of (renal) transplant patients. Patients are encouraged to discuss their planned care with their doctor, secure supplies and remain adherent to their medication.

PMID:35075618 | DOI:10.1007/s40199-021-00431-7

Clin Chem Lab Med. 2022 Jan 21. doi: 10.1515/cclm-2021-0899. Online ahead of print.

ABSTRACT

OBJECTIVES: The use of BD Vacutainer^® Barricor™ tubes (BAR) can reduce turnaround time (TAT) and improve separation of plasma from cellular components using a specific mechanical separator. Concentrations of amino acids (AAs) and cytokines, known to be labile during pre-analytical time delays, were compared in heparin (BAR, BD Heparin standard tube [PST]), EDTA and serum gel tubes (SER) to validate previously identified quality indicators (QIs) in BAR.

METHODS: Samples of healthy individuals (n=10) were collected in heparin, EDTA and SER tubes and exposed to varying pre- and post-centrifugation delays at room temperature (RT). Cytokines (interleukin [IL]-8, IL-16 and sCD40L) were analyzed by enzyme-linked immunosorbent assay (ELISA) and AAs were characterized by liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).

RESULTS: All QIs, AAs/AA ratio and cytokines increased during prolonged blood storage in heparin plasma (PST, BAR) and SER tubes. Comparison of 53 h/1 h pre-centrifugation delay resulted in an increase in taurine (Tau) and glutamic acid (Glu) concentrations by more than three times, soluble CD40L increased by 13.6, 9.2 and 4.3 fold in PST, BAR-CTRL and BAR-FAST, and IL-8 increased even more by 112.8 (PST), 266.1 (BAR-CTRL), 268.1 (BAR-FAST) and 70.0 (SER) fold, respectively. Overall, compared to prolonged blood storage, effects of post-centrifugation delays were less pronounced in all tested materials.

CONCLUSIONS: BAR tubes are compatible with the use of several established QIs and can therefore be used in clinical biobanking to reduce pre-analytical TAT without compromising QIs and thus pre-analytical sample quality analysis.

PMID:35073617 | DOI:10.1515/cclm-2021-0899

Gesundheitswesen. 2022 Jan 24. doi: 10.1055/a-1696-1616. Online ahead of print.

ABSTRACT

INTRODUCTION: Following upon our publication “Maturity Levels of Quality and Risk Management at the University Hospital Schleswig-Holstein” in 2018, we present the further development of the maturity model. Quality and risk management in hospitals is not only required by law but also plays a significant role in an optimized patient- and process-oriented health care.

METHODS: A questionnaire-based self-assessment was carried out by 46 clinical units of the UKSH (location Kiel and Lübeck) for the analysis of nine quality criteria overall. Four of these criteria (quality assurance (QS), critical incident reporting system (CIRS), complaint management (BM) and process management (PM)) were already analysed in 2016 and were extended to the five new aspects, namely audits and on-site inspections, responsibilities, morbidity and mortality conferences, hygiene training and surgical safety checklist. Every quality item was graded into four categories from “A” (fully implemented) to “D” (not implemented at all).

RESULTS: The comparison of the results for quality criteria QS, CIRS, BM, PM and the overall maturity level between 2016 and 2020 demonstrated statistically significant improvements in 2020 concerning the criteria QS (p=0.013), CIRS (p=0.026), PM (p=0.000) and the overall maturity levels (p=0.019). The criteria BM did not show any statistically significant improvement. The five newly added quality criteria demonstrated maturity levels “A” (fully implemented) and “B” (largely implemented) the following: audits and on-site inspections (100%), responsibilities (95.6%), morbidity and mortality conferences (65.2%), hygiene training (95.6%), and surgical safety checklist (100%).

CONCLUSION: An integrated quality and risk management has already been a firm element of UKSH for years. Nevertheless, review of effectiveness of the initiated targeted measures is still a challenge. This is the reason why it is necessary to develop effective and resource-saving approaches for the evaluation of measures and the identification of potential for improvement. The recognised potential for improvement should be risk-prioritized and completely exploited using sustainable measures. Following this principle, we designed a qualitative model of maturity levels for the evaluation of our quality and risk management system at the UKSH in 2016, whose further development we demonstrate here.

PMID:35073592 | DOI:10.1055/a-1696-1616

Diabetes. 2022 Jan 24:db210704. doi: 10.2337/db21-0704. Online ahead of print.

ABSTRACT

MiRNAs are small non-coding RNAs that may contribute to common diseases via epigenetic regulation of gene expression; little is known regarding their role in type 2 diabetes (T2D). We performed miRNA-sequencing and transcriptomic profiling of peripheral monocytes from the longitudinal Multi-Ethnic Study of Atherosclerosis (MESA; N=1,154). We examined associations between miRNAs and prevalent impaired fasting glucose and T2D and evaluated the T2D-associated miRNAs effect on incident T2D. Of 774 detected miRNAs, six (miR-22-3p, miR-33a-5p, miR-181c-5p, miR-92b-3p, miR-222-3p, and miR-944) were associated with prevalent T2D. For five of the six miRNAs (all but miR-222-3p) our findings suggested a doseresponse relationship with impaired fasting glucose and type 2 diabetes. Two of the six miRNAs were associated with incident T2D (miR-92b-3p: HR 1.64, p=1.30E-03; miR-222-3p: HR 1.97, p=9.10E-03 in the highest versus lowest tertile of expression). Most of the T2D associated miRNAs were also associated with HDL cholesterol concentrations. The genes targeted by these miRNAs belong to key nodes of a cholesterol metabolism transcriptomic network. Higher levels of miRNA expression expected to increase intracellular cholesterol accumulation in monocytes are linked to an increase in T2D risk.

PMID:35073575 | DOI:10.2337/db21-0704

Pharmacology. 2022 Jan 24:1-11. doi: 10.1159/000521531. Online ahead of print.

ABSTRACT

INTRODUCTION: The interindividual variability of the antiplatelet effect of clopidogrel is determined by multiple clinical and genetic factors. A lot of genotype-oriented studies have concentrated on the impact of CYP2C19 gene polymorphisms on platelet aggregation in patients receiving clopidogrel. However, the influence of this polymorphism may be only 12-20%, so other genetic markers should also be investigated. The aim of this work was to study the impact of carriage of CES1, PON1, ABCG2, CYP4F2, CYP3A4, IGTB3, P2Y12, PEAR1, and B4GALT2 polymorphisms on antiplatelet effect of clopidogrel and clinical outcomes in patients with acute coronary syndrome (ACS) and atrial fibrillation (AF).

METHODS: 103 patients who underwent ACS with or without percutaneous coronary intervention and concomitant nonvalvular AF were included in an open multicenter prospective study to assess efficacy and safety of combined antithrombotic therapy. The study assessed the frequency of different primary clinical outcomes (incidence of major bleeding, hospital mortality, cardiovascular mortality, stroke and transient ischemic attacks (TIAs), renal mortality) and secondary outcomes (resistance to therapy – high residual platelet reactivity, excessive platelet suppression). Residual platelet reactivity was examined using the VerifyNow system (Accumetrics, Latham, NY, USA).

RESULTS: None of the studied genetic markers had no statistically significant effect on the antiaggregant response to clopidogrel in patients with ACS and AF. However, CYP4F2 C(Val433Met) T, PEAR1 rs41273215 C>T were statistically significantly associated with an increased frequency of bleeding on antithrombotic therapy. B4GALT2 rs1061781 was statistically significantly associated with increased frequency of strokes and TIA.

CONCLUSION: In our study, we determined that carriers of CYP4F2 gene polymorphisms C(Val433Met)T, PEAR1 rs41273215 C>T (CT+TT) were associated with lower safety of antithrombotic therapy in patients with ACS and AF. And, the B4GALT2 rs1061781 gene polymorphism was associated with a greater risk of insufficient efficacy of the therapy. The data obtained in our study may improve the understanding of the effect of less studied genetic markers on the efficacy and safety of antithrombotic therapy in patients with ACS and AF.

PMID:35073541 | DOI:10.1159/000521531

Biomed Mater. 2022 Jan 24. doi: 10.1088/1748-605X/ac4e65. Online ahead of print.

ABSTRACT

Lithium disilicate (Li₂Si₂O₅) glass-ceramic is a commonly used dental ceramic material. In this study, Li₂Si₂O₅whiskers were prepared by the hydrothermal method, mixed with Li₂Si₂O₅glass powders, and Li₂Si₂O₅whisker-reinforced glass-ceramics were prepared by reaction sintering. The biosafety of the new Li₂Si₂O₅glass-ceramics were evaluated by in vitro cytotoxicity, hemolysis, oral mucosal irritation, acute systemic toxicity, and subacute systemic toxicity (oral route) tests according to ISO 7405/ISO 10993 standards. The cytotoxicity test results showed that the cell growth of the experimental group was good, and the cell number and morphology were not significantly different from those of the blank group (P > 0.05). The toxicity grading for both experimental and blank control groups were 0. The hemolysis rate of the material was 1.25%, which indicated that it did not cause hemolytic reaction. The material was non-irritating to the oral mucosa. In acute systemic toxicity test, animals in the experimental group showed increased body weight, moved freely, with no signs of poisoning. The food utilization rate and relative growth rate (change of the weight) of rats in the subacute systemic toxicity test were not statistically different from those of the control group (P > 0.05). Preliminary evaluation of the biosafety of the Li₂Si₂O₅whisker-reinforced glass-ceramics showed that it met the existing regulatory standards, and further biosafety experiments can be conducted, following which the material may be expected to be applied in clinical practice.

PMID:35073528 | DOI:10.1088/1748-605X/ac4e65

Am J Health Promot. 2022 Jan 24:8901171211053450. doi: 10.1177/08901171211053450. Online ahead of print.

ABSTRACT

PURPOSE: To examine the feasibility and acceptability of a social network weight loss intervention delivered by lay health promoters (HPs) to immigrant populations.

DESIGN: Single-arm, non-randomized, pilot study of a social network weight loss intervention developed by a community-based participatory research partnership and delivered by HPs.

SETTING: Community-based setting in Southeastern Minnesota, United States.

SAMPLE: Somali and Hispanic immigrants to the United States: 4 social networks of adults (2 Hispanic and 2 Somali) with 39 network participants.

INTERVENTION: Twelve-week behavioral weight loss intervention delivered by HPs (4 weeks in-person and then 8 weeks virtual).

MEASURES: Feasibility was assessed by recruitment and retention rates. Acceptability was assessed by surveys and focus groups with HPs and participants. Behavioral measures included servings of fruits and vegetables, drinking soda, and physical activity. Physiologic measures included weight, blood pressure, glucose, cholesterol, and triglycerides.

ANALYSIS: Paired t-tests of pre- to post-intervention changes at the end of 12 weeks of treatment.

RESULTS: Recruitment was feasible and post-intervention was 100%. Participants highly rated the intervention on satisfaction, motivation, and confidence to eat a healthy diet, be physically active, and lose weight. Participants were motivated by group social support and cohesion of their social networks. On average, participants lost weight (91.6 ± 15.9 to 89.7 ± 16.6 kg, P < .0001), lowered their systolic blood pressure (133.9±16.9 to 127.2 ± 15.8 mm Hg; P < .001), lowered their diastolic blood pressure (81 ± 9.5 to 75.8 ± 9.6 mm Hg; P < .0001), had more servings of vegetables per day (1.9 ± 1.2 to 2.6 ± 1.4; P < .001), and increased their physical activity (2690 ± 3231 to 6595 ± 7322 MET-minutes per week; P = .02).

CONCLUSION: This pilot study of 2 immigrant communities who participated in a peer-led weight loss social network intervention delivered during the COVID-19 pandemic demonstrated high feasibility and acceptability. Participants lost weight, improved their health status, and improved their health behaviors.

PMID:35073499 | DOI:10.1177/08901171211053450

Clin Exp Optom. 2022 Jan 24:1-7. doi: 10.1080/08164622.2022.2029684. Online ahead of print.

ABSTRACT

CLINICAL RELEVANCE: Dual-focus soft contact lenses are effective in slowing myopia progression; however, their influence on near work-induced transient myopia (NITM) remains unknown. When performing a 5-min near task at 20 cm, we observed that dual-focus soft contact lens wear induced greater lags of accommodation and a lower initial NITM than single-vision soft contact lenses, which provides relevant information for better understanding the impact of using this optical design on the accommodative function.

BACKGROUND: NITM has been proposed as a myogenic factor, although it is a matter of debate by the scientific community. The main objective of this study was to assess the short-term effect of wearing dual-focus soft contact lenses for myopia control on the steady-state accommodative response and NITM.

METHODS: Twenty-four young myope adults wore, on two different days, dual-focus and single-vision soft contact lenses, while the accommodative response was dynamically measured with an open-field autorefractor during the execution of the NITM task. The shift and the time required to recover baseline levels in the refractive state after performing the 5-min near task (20 cm) were the main dependent variables.

RESULTS: We found a lower magnitude of accommodation during the execution of the near task with the dual-focus in comparison to the single-vision soft contact lenses (p < 0.001). There was a lower initial NITM with the dual-focus when compared to the single-vision lenses (corrected p-value = 0.003, Cohen’s d = 0.68), but no statistically significant differences were observed for decay duration (p = 0.984).

CONCLUSIONS: Dual-focus soft contact lens wear causes a reduced accommodative response during a near task, and an initial small myopic shift at distance after a 5-min period of near viewing. The current findings may help to understand the mechanisms involved in myopia control with this optical strategy.

PMID:35073496 | DOI:10.1080/08164622.2022.2029684

J Speech Lang Hear Res. 2022 Jan 24:1-13. doi: 10.1044/2021_JSLHR-21-00210. Online ahead of print.

ABSTRACT

PURPOSE: Tinnitus retraining therapy (TRT) has been widely used for 30 years, but its efficacy and the component contributions from counseling and sound therapy remain controversial. The purpose of this secondary analysis from the Tinnitus Retraining Therapy Trial (TRTT) was to compare treatment response dynamics for TRT (counseling and conventional sound generators) with partial TRT (pTRT; counseling and placebo sound generators) and standard of care (SOC; a patient-centered counseling control).

METHOD: The TRTT randomized 151 participants with primary tinnitus (no significant hearing or sound tolerance problems) to TRT, pTRT, or SOC, each of which encouraged use of enriched environmental sound. The primary outcome, mean change in Tinnitus Questionnaire score assessed at baseline and follow-up across 18 months, was normalized for a common baseline and fitted with an exponential model. Time constants were estimated to quantify and compare the treatment response dynamics, which were evaluated for statistical significance using bootstrap analyses.

RESULTS: The change in response to TRT took less time to achieve than that for either pTRT or SOC, as demonstrated by time for normalized Tinnitus Questionnaire scores to decline to 63% and 99% of baseline TRT values: 1.2 months (95% CI [0.2, 1.9]) and 5.7 months (95% CI [0.9, 9.0]), respectively. Corresponding SOC values were 2.7 months (95% CI [1.5, 4.1]) and 12.4 months (95% CI [6.9, 19.0]), while those for pTRT were 2.2 months (95% CI [1.2, 3.4]) and 10.1 months (95% CI [5.7, 15.9]). The differences were significant for TRT versus SOC (p = .020), borderline significant for TRT versus pTRT (p = .057), but nonsignificant for pTRT versus SOC (p = .285). The magnitude of the asymptotic treatment response did not differ significantly among groups.

CONCLUSION: Sound generator use in TRT increases treatment efficiency (beyond any advantage from enriched environmental sound) without affecting treatment efficacy (determined by counseling).

PMID:35073492 | DOI:10.1044/2021_JSLHR-21-00210

J Osteopath Med. 2022 Jan 21. doi: 10.1515/jom-2021-0157. Online ahead of print.

ABSTRACT

CONTEXT: Transurethral resection (TUR) is the mainstay for diagnosis, staging, and treatment of both high-grade and low-grade nonmuscle invasive bladder cancer (NMIBC). It is reported that 51% of initial transurethral resection of bladder tumors (iTURBT) does not contain muscle, which results in higher rates of clinical upstaging on repeat transurethral resection (reTUR) and worse oncologic outcomes. Presence of muscle on iTURBT specimen and performing reTUR within 6 weeks in high-risk NMIBC aids in accurate staging and, therefore, guides proper treatment.

OBJECTIVES: This study aimed to assess and improve TURBT quality by making surgeons aware of their practice patterns and setting improvement goals.

METHODS: Patients who received TURBT for a newly diagnosed bladder mass were analyzed by retrospective chart review for 9 months prior to quality improvement (QI) intervention. Data were collected pertaining to muscle presence/absence on biopsy, pathology of the tumor, risk stratification, whether reTUR was indicated, and time to reTUR. The primary endpoints were the presence of muscle on initial TURBT, whether a reTUR was performed when clinically indicated, and time to reTUR. Tumors requiring reTUR were defined as being HGT1 or HGTa >3 cm. The QI intervention, physician education, was then implemented by presenting initial performance results to the physicians, and a second dataset was then collected by prospective analysis for another 9 months to assess for changes in practice patterns. A total of 101 patients receiving TURBT were reviewed, including 52 patients prior to and 49 patients following QI intervention. Patients with a history of, or treatment for, bladder cancer were excluded, along with those without assessment of muscle on pathological analysis. Fisher’s exact test was utilized to determine differences in categorical data by comparing each of the following groups prior to and following QI intervention: percent of muscle presence on iTURBT, percent reTUR performed when indicated, and mean time to reTUR in days. A p<0.05 was considered statistically significant.

RESULTS: After comparing the TURBT results before and after our QI intervention, we found a significant improvement in the number of patients receiving a reTUR when indicated, with 5/13 (38.5%) before compared to 15/19 (78.9%) after, p=0.03. The number of specimens on iTURBT with muscle present were not significantly different, with 38/52 (73.1%) before and 33/49 (67.3%) after, p=0.66. The average time to reTUR before (32.4 days; n=5; range, 21-50 days) and after (42.4 days; n=15; range, 11-77 days) QI intervention was also not significantly different, p=0.28.

CONCLUSIONS: Our data suggest that critical analysis of physician practice patterns followed by education and setting improvement goals can significantly impact clinical practices and improve quality of care. Future studies will be performed to determine the impact that these changes have on oncologic outcomes.

PMID:35073474 | DOI:10.1515/jom-2021-0157