Tag: pubmed

J Orthop Res. 2021 Jul 18. doi: 10.1002/jor.25125. Online ahead of print.

ABSTRACT

As cost-effective measures become increasingly implemented in the US healthcare system, changes in patient-reported outcome measure (PROM) scores can be utilized to indicate patient satisfaction following procedures including total knee arthroplasty (TKA). The primary aim of this study was to develop and evaluate machine learning algorithms to predict achievement of the minimal clinically important difference (MCID) for the Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS) at 1-year following TKA. A retrospective review of primary TKA patients between 2016 and 2018 was performed. Variables considered for prediction included demographics and preoperative PROMs. The KOOS-PS MCID was calculated via a distribution-based method. Five machine learning algorithms were developed and tested by discrimination, calibration, Brier score, and decision curve analysis. Among the 744 patients who met the inclusion criteria, 385 (72.8%) patients achieved the MCID. The elastic-net penalized logistic regression model was selected as the best performing model (c-statistic 0.77, calibration intercept -0.02, calibration slope 1.15, and Brier score 0.14). The most important variables for MCID achievement were preoperative KOOS-PS score, preoperative VAS Pain, preoperative opioid use, preoperative PROMIS global mental health score, age, and sex. Algorithms were incorporated into an open-access digital application available at https://sorg-apps.shinyapps.io/tka_koos_mcid/. This study is the first to predict the probability of achieving the KOOS-PS MCID following TKA using a machine learning-based approach. The results were used to develop a clinical decision aid based on commonly collected predictive variables to preoperatively predict an individual patient’s likelihood of attaining an acceptable outcome following TKA.

PMID:34275163 | DOI:10.1002/jor.25125

Adv Ther. 2021 Jul 18. doi: 10.1007/s12325-021-01842-3. Online ahead of print.

ABSTRACT

INTRODUCTION: Dolutegravir (DTG), a novel HIV-integrase strand transfer inhibitor (INSTI), is usually used with multiple antiretrovirals (ARVs) for treatment of HIV. DTG is now approved as Tivicay tablets in over 120 countries and Triumeq combination tablets (DTG/abacavir [ABC]/lamivudine [3TC]) in over 90 countries. In Japan, these formulations have been marketed since 2014 and 2015. The post-marketing prospective surveillance has been conducted as part of the HIV-Related Drug (HRD) cooperative survey aimed to collect actual drug use information in all of these DTG-treated patients in accordance with conditions for initial approvals.

METHODS: The survey has been conducted to evaluate long-term safety and effectiveness of DTG since 2014, for approximately 6 years. The safety was evaluated by incidence of adverse drug reactions (ADRs) and change in body weight. The effectiveness was evaluated by plasma HIV RNA copies/mL and peripheral CD4⁺ cell counts.

RESULTS: Of 2292 patients in 30 Japanese sites, 565 (24.65%) reported ADRs. The most common ADR was blood creatinine increased (4.28%). Incidence of ADRs was statistically significantly higher in patients with severe symptoms (Centers for Disease Control and Prevention [CDC] categories B and C) than those with category A, and in patients with comorbidities than those without comorbidities. Whereas incidence of ADRs was statistically significantly lower in antiretroviral therapy (ART)-experienced patients than that in ART-naïve patients. Incidence of ADRs related to suicide or self-injurious behavior was statistically significantly higher in patients with comorbidities of psychiatric disorders than those without comorbidities. The body weight tended to increase over time and those changes and percentage changes from baseline were greater in ART-naïve patients compared with ART-experienced patients. HIV RNA copies/mL and CD4⁺ cell counts showed favorable shifts from baseline in both ART-naïve and ART-experienced patients.

CONCLUSION: The results of the survey identified no new safety and effectiveness risks in Japanese patients with HIV/AIDS treated with DTG.

PMID:34275116 | DOI:10.1007/s12325-021-01842-3

Int J Health Policy Manag. 2021 Jul 4. doi: 10.34172/ijhpm.2021.62. Online ahead of print.

ABSTRACT

BACKGROUND: To decrease the burden of breast cancer (BC), the Chinese government recently introduced biennial mammography screening for women aged 45-70 years. In this study, we assess the effectiveness and cost-effectiveness of implementing this programme in urban China using a micro-simulation model.

METHODS: The ‘Simulation Model on radiation Risk and breast cancer Screening’ (SiMRiSc) was applied, with parameters updated based on available data for the Chinese population. The base scenario was biennial mammography screening for women aged 45-70 years, and this was compared to a reference population with no screening. Seven alternative scenarios were then simulated by varying the screening intervals and participant ages. This analysis was conducted from a societal perspective. The discounted incremental cost-effectiveness ratio (ICER) was compared to a threshold of triple the gross domestic product (GDP) per life years gained (LYG), which was 30 785 USD/LYG. Univariate sensitivity analyses were conducted to evaluate model robustness. In addition, a budget impact analysis was performed by comparing biennial screening with no screening at a time horizon of 10 years.

RESULTS: Compared with no screening, the base scenario was cost-effective in urban China, giving a discounted average cost-effectiveness ratio (ACER) of 17 309 USD/LYG. The model was most sensitive to the cost of mammography per screen, followed by mean size of self-detected tumours, mammographic breast density and the cumulative lifetime risk of BC. The efficient frontier showed that at a threshold of 30 785 USD/LYG, the base scenario was the optimal scenario with a discounted ICER of 25 261 USD/LYG. Over 10 years, screening would incur a net cost of almost 38.1 million USD for a city with 1 million citizens.

CONCLUSION: Compared to no screening, biennial mammography screening for women aged from 45-70 is cost-effective in urban China.

PMID:34273933 | DOI:10.34172/ijhpm.2021.62

Oral Dis. 2021 Jul 17. doi: 10.1111/odi.13968. Online ahead of print.

ABSTRACT

OBJECTIVE: Osteoradionecrosis of the jaw (ORNJ) is one of the most common and serious complications after radiotherapy of head and neck malignancies due to the high incidence of nasopharyngeal cancer in Southern China. Clinicians lack understanding and consensus on anti-infective treatment in ORNJ lesions. This research aims to provide evidence for rational use of antibiotics by reviewing the bacterial spectrums and antimicrobial susceptibility test of ORNJ patients.

METHODS: We collected patient who was diagnosed with ORNJ from November 2012 to June 2019 in our hospital. Exudate or bone unexposed wound surface sampling, agar plates culturing and susceptibility testing were analyzed. Descriptive statistics were used for data presentation.

RESULTS: A total of 219 samples were collected in our retrospective study. The most common cultured bacteria were Klebsiella Pneumoniae (15.10%), Pseudomonas aeruginosa (13.54%) and Staphylococcus aureus (10.94%). Methicillin-resistant Staphylococcus aureus (MRSA) accounted for 5.21% in the whole positive samples. Ticarcillin, Ofloxacin, Vancomycin, Tigecycline, Meropenem were more susceptible than other antibiotics to treat uncontrollable infection.

CONCLUSIONS: Our research provided objective evidence for understanding the types of local bacterial flora and drug susceptibility in ORNJ lesions, and gave a guiding reference for empirical antibiotics medication.

PMID:34273905 | DOI:10.1111/odi.13968

Environ Int. 2021 Jul 14;156:106765. doi: 10.1016/j.envint.2021.106765. Online ahead of print.

ABSTRACT

BACKGROUND: Telomere length has been associated with the occurrence and progression of common chronic and age-related diseases, and in younger populations, may represent a biomarker of disease susceptibility. Early childhood is a critical period for telomere biology as this period is characterized by a rapid decline in telomere length due to a large turnover of highly proliferative cells and may represent a period of unique sensitivity to environmental insults. Arsenic (As) exposure has been associated with both telomere lengthening and shortening in adults and children and some evidence suggests the effects may differ by level and timing of exposure.

OBJECTIVES: Given the lack of clarity across studies, we investigated the association between urinary As and leukocyte telomere length among 476 five- to seven-year-old children enrolled in the Bangladesh Environmental Research in Children’s Health (BiRCH) cohort.

METHODS: In a series of multivariable models, adjusted for key covariates, we examined associations between urinary As and relative telomere length (RTL) of whole blood DNA.

RESULTS: We observed small but consistent, negative associations between urinary As and RTL, such that a doubling of urinary As was associated with a -0.017 (95% CI: -0.030, -0.005; p = 0.0056) decrease in RTL, in fully adjusted models. We also observed a somewhat stronger inverse relationship between urinary As concentration and RTL among children born to fathers ≥ 30 years of age at the time of birth, than those < 30 years; however, we did not observe a statistically significant interaction.

DISCUSSION: Our study suggests that As influences RTL, with detectable associations in early to mid-childhood. Further studies are needed to confirm our findings and investigate the potential long-term impacts of telomere shortening in childhood on later life health outcomes. Additional studies exploring how dose and timing of exposure may relate to RTL are critical to understanding As’s relationship to telomere length.

PMID:34273872 | DOI:10.1016/j.envint.2021.106765

Spectrochim Acta A Mol Biomol Spectrosc. 2021 Jul 2;263:120137. doi: 10.1016/j.saa.2021.120137. Online ahead of print.

ABSTRACT

Five simple, selective and accurate spectrophotometric methods have been applied and developed for first time for simultaneous determination of amlodipine besylate (AML) and celecoxib (CEL) in presence of one harmful impurity, 4-methylacetophenone (MAP), in their ternary mixture without prior separation. Those spectrophotometric methods were developed and called: dual wave length in ratio spectra (DWRS), successive ratio-derivative spectra (SDR), modified absorption factor method (MAFM), modified amplitude center method (MACM) and first derivative -zero crossing coupled with amplitude factor method (FDAF). These methods include various steps using zero /or ratio /or derivative spectra and some mathematical techniques. Linear calibration curves were constructed over the concentration range of 2-100, 10-200 and 0.5-20 µg/mL for AML, CEL and MAP, respectively. High sensitivity with low LOD values 0.583, 3.118 and 0.147 for AML, CEL and MAP, respectively were obtained. Moreover, validation of the proposed methods was achieved according to ICH guidelines and satisfactory results were obtained indicating that the developed methods can be used for quality control analysis of AML and CEL concerning its impurity. No significant difference was observed when the obtained results of the developed methods were statistically compared with the reported HPLC method.

PMID:34273891 | DOI:10.1016/j.saa.2021.120137

J Eur Acad Dermatol Venereol. 2021 Jul 17. doi: 10.1111/jdv.17525. Online ahead of print.

ABSTRACT

BACKGROUND: Cross-cultural differences in healthcare policies and patient-physician communication may influence the quality of care and patients’ perceived benefits and satisfaction with psoriasis treatment.

OBJECTIVES: To compare the disease burden and patient needs at baseline, and patient benefits and satisfaction with secukinumab treatment across Europe.

METHODS: PROSE was an open-label, prospective, non-randomised, stratified multicentre study of 52 weeks of secukinumab treatment, in 16 European countries. Secondary analysis of the PROSE study data by European regions was performed to identify cross-cultural differences in disease burden and patient needs at baseline, and in clinical improvement, patient-reported treatment benefits and satisfaction at 52 weeks post-treatment.

RESULTS: At baseline, Dermatology Life Quality Index impairment was reported to be greater in patients from Eastern Europe (EE:15.4±7.1) versus Northern Europe (NE:13.3±6.7) and Western Europe (WE:13.6±6.9), but while differences were statistically significant (F-test=5.5, p<0.001), their clinical significance is uncertain. There were no significant differences between regions in Psoriasis Area and Severity Index at baseline (F-test=1.6). There were considerable differences in patients’ needs (Patient Need Questionnaire) between geographical regions, with WE focused more on reducing physical impairment versus Southern Europe [SE]/EE), EE on reducing social impairment (versus NE/WE), and SE on reducing impairment due to therapy (versus NE/WE). At Week 52, patients from EE reported more benefits (Patient Benefit Index) with secukinumab treatment (versus WE/SE), while patients from NE reported higher global treatment satisfaction (versus SE).

CONCLUSIONS: Differences in patients’ needs and treatment satisfaction across Europe are likely a result of diverse medical systems, socio-economic status and infrastructural access. A patient-centred approach to treating psoriasis may fulfil patient needs and maximise treatment satisfaction. (NCT02752776).

PMID:34273904 | DOI:10.1111/jdv.17525

Appl Ergon. 2021 Jul 14;97:103532. doi: 10.1016/j.apergo.2021.103532. Online ahead of print.

ABSTRACT

Smartphone hard key locations need to be ergonomically determined to improve grip stability and operational efficiency for users’ convenience. The present study proposed an ergonomic design process that determines smartphone hard key locations by statistically analyzing the preferred hard key control areas of users with various hand sizes based on users’ preferred grip postures and hard key control areas. The proposed design process analyzes the characteristics of product design, user, task, and use context, the types of preferred grip posture, the preference distribution of grip posture, and the preference distribution of hard-key area, and then recommends the locations of hard keys by considering the preference distribution of hard-key area and design constraints. The proposed design process was applied to a smartphone with a 5-inch screen, resulting in 77-96 mm from the bottom of the device for a volume key to 20 mm on the left side and 88-97 mm for a power key to 10 mm on the right side. The proposed design process for the determination of smartphone hard-key locations would be of use to determine the locations of various portable product interfaces.

PMID:34273813 | DOI:10.1016/j.apergo.2021.103532

Tissue Cell. 2021 Jun 29;71:101587. doi: 10.1016/j.tice.2021.101587. Online ahead of print.

ABSTRACT

This study investigated the abundance of pro-regenerative growth factors in bone marrow-derived platelet-rich plasma (BM-PRP) and their effects on bone marrow-derived mesenchymal stem cells (BM-MSC) and bone marrow-derived endothelial progenitor cells (BM-EPC). Four 4-5 months-old domestic pigs were included, and each underwent bone marrow aspiration from its humerus bones and processed into bone marrow aspiration concentrate (BMAC) samples. The plasma and cellular portions of BMAC were subsequently separated and collected. The concentration of growth factors including BMP-2, PDGF-BB, TGF-β1 and VEGF in the plasma portion was measured and compared between BM-PRP and bone marrow-derived platelet-poor plasma (BM-PPP). It was found that platelet count was significantly higher in BM-PRP than in BM-PPP, but the concentration of above-mentioned growth factors was not significantly different between BM-PRP and BM-PPP. As most existing literature has indicated the regenerative potency of PRP, this study focused on assessing the effect of BM-PRP treatment on BM-MSC and BM-EPC proliferation, osteogenic differentiation and angiogenesis capacity by comparing samples with 2.5% BM-PRP treatment and samples without BM-PRP treatment (control). In response to BM-PRP treatment, the cellular doubling time increased with culturing time and was significantly shorter in the BM-PRP-treated samples than in control samples. For osteogenic differentiation, BM-PRP-treated BM-MSCs demonstrated a time-dependent increase in alkaline phosphatase (ALP) activity and expression levels of osteogenic differentiation markers. For the expression of angiogenic genes, none of the differences reached statistical significance despite a tendency of stronger expression at day 18 in BM-PRP-treated BM-EPCs. In conclusion, this in vitro study suggests that most BMP-2, PDGF-BB, TGF-β1 and VEGF-A contained in BM-PRP are not platelet-released and BM-PRP may have some stimulation (less than 1-fold) for MSC, EPC proliferation and MSC osteogenic differentiation.

PMID:34273802 | DOI:10.1016/j.tice.2021.101587

Int J Nurs Stud. 2021 Jun 18;121:104003. doi: 10.1016/j.ijnurstu.2021.104003. Online ahead of print.

ABSTRACT

BACKGROUND: The negative synergistic effect of cancer and a peripherally inserted central catheter could significantly increase the incidence of thrombosis. Rather than identifying risk factors for peripherally inserted central catheter-related thrombosis, exploring the effect of these risk factors might be a promising method to improve the outcomes of thrombosis.

OBJECTIVES: To analyze the effect of systemic and local risk factors on triggering peripherally inserted central catheter-related thrombosis in the first two weeks post-insertion in cancer patients.

DESIGN: A prospective cohort study.

SETTING: The study was conducted at a 4500-bed university-affiliated medical center in China.

PARTICIPANTS: One hundred seventy-three cancer patients with peripherally inserted central catheters were included.

METHODS: Peripherally inserted central catheter-related thrombosis was assessed using ultrasound at a series of timepoints, once every two days post-insertion. Data on age, body mass index, blood hypercoagulation, insertion attempts, catheter-to-vein ratio, and blood flow velocity were collected as risk factors. Descriptive statistics and structural equation modeling were used to describe the study samples and analyze the effects of systemic and local risk factors.

RESULTS: Among the 173 cancer patients included, 126 (72.8%) patients were diagnosed with peripherally inserted central catheter-related thrombosis. Most thromboses (n = 118, 93.7%) were detected within five days, and 100% were detected within nine days post-insertion. Structural equation modeling analysis showed that local risk factors [catheter-to-vein ratio (standardized path coefficient = 0.32, p < 0.05) and blood flow velocity (standardized path coefficient = -0.35, p < 0.05)] had a greater effect than systemic factors [age (standardized path coefficient = 0.13, p < 0.05) and blood hypercoagulation (standardized path coefficient = 0.17, p < 0.05)] on triggering peripherally inserted central catheter-related thrombosis.

CONCLUSION: Peripherally inserted central catheter-related thrombosis is quite common and can occur very early post-insertion in cancer patients. Among the common risk factors, local risk factors reflecting peripherally inserted central catheter technology itself had a greater effect than systemic risk factors reflecting predisposition to thrombosis. Clinical Registration: Clinical Trials ChiCTR1900024890.

PMID:34273807 | DOI:10.1016/j.ijnurstu.2021.104003