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Nevin Manimala Statistics

Analysis of the Potential of Blood Transvascular Sublingual with Light-Emitting Diode Irradiation in COVID-19 Patients: A Pilot Clinical Study

Photobiomodul Photomed Laser Surg. 2022 Sep 7. doi: 10.1089/photob.2021.0177. Online ahead of print.

ABSTRACT

Background: Due to the high morbidity and mortality rates of this century, the COVID-19 pandemic has had a devastating impact on the health of the global population. Objective: The aim was to evaluate the disturbing impact of in-hospital stay length and the appeal of severe problems for supplemental oxygen for our patients with COVID-19 in moderate stage who were undergoing transvascular blood irradiation onto sublingual vessels. The demand for supplemental oxygen and the serum oxygen levels were measured, and the impact on the length of hospital stay was assessed. Methods: This randomized, prospective, clinical pilot study evaluated the diagnosis of COVID-19 patients admitted to the ventilatory care unit and undergoing treatment protocol usage of light-emitting diode (LED) irradiation by transvascular application onto the sublingual vessels daily. Patients were selected and enrolled into two groups: the Placebo group (n = 7) that received conventional treatment by the device off (LED-off), and the photobiomodulation therapy (PBMT) group (n = 7) that also received the same therapy plus LED irradiation. Results: There was a statistically significant clinical improvement, such as a reduction in serum creatinine, and oxygen usage per few days less in the PBMT group compared with the Placebo group. All patients in the PBMT group had normalized SatO2, while a quarter of patients in the Placebo group required longer O2 supplementation until hospital discharge. Conclusions: The surveillance of clinical improvement in moderate stage indicated that the daily PBMT was able to diminish oxygen supplementation within a short time, besides reducing the hospital stay length in the PBMT group, particularly, when compared with the Placebo group. Clinical Trial Registration number: The study was reviewed by the Ethics Committee in UNINOVE research under number 42325020.6.0000.5511 and approved through number 5,090,119.

PMID:36070590 | DOI:10.1089/photob.2021.0177

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Factors Influencing the Results of COVID-19 Case Outreach-Results From a California Case Investigation/Contact Tracing Program

J Public Health Manag Pract. 2022 Sep 5. doi: 10.1097/PHH.0000000000001622. Online ahead of print.

ABSTRACT

CONTEXT: Considerable research has examined impacts of case investigation and contact tracing (CI/CT) programs on the spread of infectious diseases such as COVID-19, but there are few reports on factors affecting the ability of these programs to obtain interviews and acquire key information.

OBJECTIVE: To investigate programmatic and case-specific factors associated with CI outcomes using data from the Public Health Institute’s Tracing Health CI/CT program. Analyses were designed to detect variability in predictors of whether interviews and key information were obtained rather than quantify specific relationships.

DESIGN: Logistic regression models examined variability in the predictive value of interview timeliness and respondent characteristics on outreach outcomes and interview results.

SETTING AND PARTICIPANTS: Participants were members of a large California health care network with a positive laboratory test for COVID-19 and outreach from January 1 to July 31, 2021.

MAIN OUTCOME MEASURES: The primary outcome was the result of outreach attempts: completed interview, refused interview, or failure to reach the infected person. Secondary outcomes considered whether respondents provided information on symptom onset, employment, and contact information or a reason for declining to provide information, and whether resource support was requested or accepted.

RESULTS: Of 9391 eligible records, 65.6% were for completed interviews, 6.0% were refusals, and 28.3% were failed outreach. One-third of respondents (36.7%) provided information on contacts (mean = 0.97 contacts per respondent, 2.6 for those naming at least 1). Privacy concerns were the most common reasons for not providing contact information. Among respondent characteristics and interview timeliness, only race and number of symptoms showed statistically significant effects in all adjusted analyses.

CONCLUSIONS: Significant variation existed in outreach outcomes by subject characteristics and interview timeliness. CI/CT programs carefully focused to characteristics and needs of specific communities will likely have the greatest impact on the spread of COVID-19 and other communicable diseases.

PMID:36070585 | DOI:10.1097/PHH.0000000000001622

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Clinical Evaluation of Diode Laser-Assisted Surgical Periodontal Therapy: A Randomized Split-Mouth Clinical Trial and Bacteriological Study

Photobiomodul Photomed Laser Surg. 2022 Sep 7. doi: 10.1089/photob.2022.0035. Online ahead of print.

ABSTRACT

Background: Stage 3 grade C periodontitis (S3GCP) has always been a challenge for clinicians. However, it is proposed that the use of lasers in addition to periodontal therapy can result in a more efficient therapy outcome. Objective: The aim of this clinical study was to determine the effects of additional application of diode laser (DL, 810 nm ±5) on clinical and microbiological values during Modified Widman Flap (MWF) periodontal surgery in the S3GCP patients. Methods: A total of 18 patients were randomly assigned to the test site (MWF + activeDL) and the control site (MFW alone). Clinical parameters and microbial samples were taken preoperatively, and postoperatively at 6 weeks, 3 months, and 6 months. Visual analog scale (VAS), tissue edema (TE), tissue color (TC), and pain medication (PM) consumption, were evaluated postoperatively at 10th day. Results: All bacteria were significantly decreased at follow-up times compared with preoperative amounts in both therapy sites (p < 0.05). Bacterial amounts of Treponema denticola, Prevotella intermedia, Tannerella forsythia, and Aggregatibacter actinomycetemcomitans at 6 weeks, Porphyromonas gingivalis and T. denticola at 3 months, T. denticola and A. actinomycetemcomitans at 6 months were statistically lower in the test site than the control site. All clinical parameters significantly improved after MWF surgery at follow-up times compared with preoperative values in intragroup comparisons, but a significant difference was not detected in the intergroup comparison. No differences were found in terms of VAS, PM, TE, and only TC was statistically more pink in the test site than the control site. Conclusions: The present study findings suggest that the use of DL together with MWF may have positive effects in the therapy of S3GCP patients by reducing the microbial load. Clinical Trial.org: NCT05108727.

PMID:36070584 | DOI:10.1089/photob.2022.0035

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Nevin Manimala Statistics

Analysis of Cross-sectional and Longitudinal HLA and Anti-viral Responses After COVID Infection in Renal Allograft Recipients: Differences and Correlates

Transplantation. 2022 Sep 2. doi: 10.1097/TP.0000000000004277. Online ahead of print.

ABSTRACT

BACKGROUND: Characterization of anti-HLA versus anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) immune globulin isotypes in organ transplant recipients after coronavirus disease 2019 (COVID-19) infection has not been reported. We aimed to determine changes in anti-HLA antibodies in renal transplant patients with COVID-19 and compare the immunoglobulin and epitope-binding pattern versus anti-SARS-CoV-2 antibodies.

METHODS: This is a cross-sectional study of 46 kidney transplant recipients including 21 with longitudinal sampling. Using a semi-quantitative multiplex assay, we determined immunoglobulin (Ig) M, IgA, IgG, and IgG1-2-3-4 antibodies against Class I and Class II HLA, and 5 SARS-CoV-2 epitopes including the nucleocapsid protein and multiple regions of the spike protein.

RESULTS: Fourteen of 46 (30%) patients had donor-specific anti-HLA antibodies (donor-specific antibody [DSA]), 12 (26%) had non-DSA anti-HLA antibodies and 45 (98%) had anti-SARS-CoV-2 antibodies. Most DSAs targeted HLA-DQ (71%), with a dominant IgG isotype and IgG1 subtype prevalence (93%), and/or IgG3 (64%), followed by IgG2 (36%). Comparatively, there was a higher prevalence of IgA (85% versus 14%, P = 0.0001) and IgM (87%, versus 36%, P = 0.001) in the anti-SARS-CoV-2 antibody profile, when compared to DSAs, respectively. Anti-SARS-CoV-2 antibody profile was characterized by increased prevalence of IgM and IgA, when compared to DSAs. The median calculated panel reactive antibody before COVID-19 diagnosis (24%) tended to decrease after COVID-19 diagnosis (10%) but it was not statistically significant (P = 0.1).

CONCLUSIONS: Anti-HLA antibody strength and calculated panel reactive antibody in kidney transplant recipients after COVID-19 do not significantly increase after infection. Although the IgG isotype was the dominant form in both HLA and SARS-CoV-2 antigens, the alloimmune response had a low IgA pattern, whereas anti-SARS-CoV-2 antibodies were high IgA/IgM.

PMID:36070571 | DOI:10.1097/TP.0000000000004277

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Nevin Manimala Statistics

Cost effectiveness of treatment strategies for high risk prostate cancer

Cancer. 2022 Sep 7. doi: 10.1002/cncr.34450. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with high-risk prostate cancer (HRPC) have multiple accepted treatment options. Because there is no overall survival benefit of one option over another, appropriate treatment must consider patient life expectancy, quality of life, and cost.

METHODS: The authors compared quality-adjusted life years (QALYs) and cost effectiveness among treatment options for HRPC using a Markov model with three treatment arms: (1) external-beam radiotherapy (EBRT) delivered with 20 fractions, (2) EBRT with 23 fractions followed by low-dose-rate (LDR) brachytherapy boost, or (3) radical prostatectomy alone. An exploratory analysis considered a simultaneous integrated boost according to the FLAME trial (ClinicalTrials.gov identifier NCT01168479).

RESULTS: Treatment strategies were compared using the incremental cost-effectiveness ratio (ICER). EBRT with LDR brachytherapy boost was a cost-effective strategy (ICER, $20,929 per QALY gained). These results were most sensitive to variations in the biochemical failure rate. However, the results still demonstrated cost effectiveness for the brachytherapy boost paradigm, regardless of any tested parameter ranges. Probabilistic sensitivity analysis demonstrated that EBRT with LDR brachytherapy was favored in 52% of 100,000 Monte Carlo iterations. In an exploratory analysis, EBRT with a simultaneous integrated boost was also a cost-effective strategy, resulting in an ICER of $62,607 per QALY gained; however, it was not cost effective compared with EBRT plus LDR brachytherapy boost.

CONCLUSIONS: EBRT with LDR brachytherapy boost may be a cost-effective treatment strategy compared with EBRT alone and radical prostatectomy for HRPC, demonstrating high-value care. The current analysis suggests that a reduction in biochemical failure alone can result in cost-effective care, despite no change in overall survival.

PMID:36070558 | DOI:10.1002/cncr.34450

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Nevin Manimala Statistics

A Cell-Phone Medication Error eHealth App for Managing Safety in Chronically Ill Young Patients at Home: A Prospective Study

Telemed J E Health. 2022 Sep 7. doi: 10.1089/tmj.2022.0042. Online ahead of print.

ABSTRACT

Introduction: Whereas ample information describes medication errors (MEs) in children or in mixed pediatric and adult populations discharged with acute or chronic diseases from hospital to community settings, little is known about MEs in children and adolescents with chronic diseases discharged home, a major concern. To promote home medication safety, we trained parents of children discharged with chronic diseases to record ME with a tailored cell-phone eHealth app. Methods: In a 1-year prospective study, we used the app to monitor ME in patients with chronic diseases discharged home from a tertiary hospital in Rome, Italy. Univariate and multivariate analyses detected the ME incidence rate ratio (IRR). Results: Of the 310 parents enrolled, 194 used the app. The 41 MEs involved all drug management phases. The ME IRR was 0.46 errors per child. Children <1 year had the highest ME risk (1.69 vs. 0.35, p = 0.002). Children discharged from the cardiology unit had a statistically higher ME IRR than others (3.66, 95% confidence interval: 1.01-13.23%). Conclusions: The highest ME risk at home involves children with chronic diseases <1 year old. A significant ME IRR at home concerns children with heart diseases of any age. Parents find a tailored eHealth app for monitoring and reporting ME at home easy to use. At discharge, clinical teams need to identify age-related and disease-residual risks to target additional actions for monitoring ME, thus increasing medication safety at home.

PMID:36070555 | DOI:10.1089/tmj.2022.0042

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T2 Turbo Spin Echo With Compressed Sensing and Propeller Acquisition (Sampling k-Space by Utilizing Rotating Blades) for Fast and Motion Robust Prostate MRI: Comparison With Conventional Acquisition

Invest Radiol. 2022 Sep 1. doi: 10.1097/RLI.0000000000000923. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this study was to compare a new compressed sensing (CS) method for T2-weighted propeller acquisitions (T2CS) with conventional T2-weighted propeller sequences (T2conv) in terms of achieving a higher image quality, while reducing the acquisition time.

MATERIALS AND METHODS: Male participants with a clinical suspicion of prostate cancer were prospectively enrolled and underwent prostate magnetic resonance imaging at 3 T. Axial and sagittal images of the T2conv sequence and the T2CS sequence were acquired. Sequences were qualitatively assessed by 2 blinded radiologists concerning artifacts, image-sharpness, lesion conspicuity, capsule delineation, and overall image quality using 5-point Likert items ranging from 1 (nondiagnostic) to 5 (excellent). The apparent signal-to-noise ratio and apparent contrast-to-noise ratio were evaluated. PI-RADS scores were assessed for both sequences. Statistical analysis was performed by using Wilcoxon signed rank test and paired samples t test. Intrarater and interrater reliability of qualitative image evaluation was assessed using intraclass correlation coefficient (ICC) estimates.

RESULTS: A total of 29 male participants were included (mean age, 66 ± 8 years). The acquisition time of the T2CS sequence was respectively 26% (axial plane) and 24% (sagittal plane) shorter compared with the T2conv sequence (eg, axial: 171 vs 232 seconds; P < 0.001). In the axial plane, the T2CS sequence had fewer artifacts (4 [4-4.5] vs 4 [3-4]; P < 0.001), better image-sharpness (4 [4-4.5] vs 3 [3-3.5]; P < 0.001), better capsule delineation (4 [3-4] vs 3 [3-3.5]; P < 0.001), and better overall image quality (4 [4-4] vs 4 [3-4]; P < 0.001) compared with the T2conv sequence. The ratings of lesion conspicuity were similar (4 [4-4] vs 4 [3-4]; P = 0.166). In the sagittal plane, the T2CS sequence outperformed the T2conv sequence in the categories artifacts (4 [4-4] vs 3 [3-4]; P < 0.001), image sharpness (4 [4-5] vs 4 [3-4]; P < 0.001), lesion conspicuity (4 [4-4] vs 4 [3-4]; P = 0.002), and overall image quality (4 [4-4] vs 4 [3-4]; P = 0.002). Capsule delineation was similar between both sequences (3 [3-4] vs 3 [3-3]; P = 0.07). Intraobserver and interobserver reliability for qualitative scoring were good (ICC intra: 0.92; ICC inter: 0.86). Quantitative analysis revealed a higher apparent signal-to-noise ratio (eg, axial: 52.2 ± 9.7 vs 22.8 ± 3.6; P < 0.001) and a higher apparent contrast-to-noise ratio (eg, axial: 44.0 ± 9.6 vs 18.6 ± 3.7; P ≤ 0.001) of the T2CS sequence. PI-RADS scores were the same for both sequences in all participants.

CONCLUSIONS: CS-accelerated T2-weighted propeller acquisition had a superior image quality compared with conventional T2-weighted propeller sequences while significantly reducing the acquisition time.

PMID:36070533 | DOI:10.1097/RLI.0000000000000923

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Long-term outcome prediction for chronic thromboembolic pulmonary hypertension after pulmonary endarterectomy

Clin Cardiol. 2022 Sep 7. doi: 10.1002/clc.23900. Online ahead of print.

ABSTRACT

BACKGROUND: The definitive treatment for chronic thromboembolic pulmonary hypertension (CTEPH) is pulmonary endarterectomy (PEA), which has good long-term outcomes. However, after surgery, a quarter of the patients still have residual pulmonary hypertension (RPH). In pulmonary hemodynamics, there are no unified criteria for RPH, even though the level may affect long-term survival.

METHODS: Between March 1997 and December 2021, 253 CTEPH patients were treated at our center with PEA. Patients were evaluated retrospectively and classified into early (1997-2014) and late (2015-2021) groups. The clinical characteristics and perioperative outcomes of the two groups were compared, and risk factor analysis for RPH and long-term survival for all cases was performed.

RESULTS: There was no statistically significant difference in demographics between the two groups. However, the Early Group had a significantly higher rate of perioperative death (9.8% vs. 1.2%, p = .001), RPH (48.8% vs. 14.0%, p < .001), and reperfusion pulmonary edema (18.3% vs. 2.9%, p < .001). The median follow-up time was 66.0 months, and overall survival rates at 5, 10, 15, and 18 years after PEA were 91.2%, 83.9%, 64.5%, and 46.0%, respectively. Age and postoperative systolic pulmonary artery pressure (sPAP) were independently related to long-term outcomes in the multivariate Cox analyses. Patients with postoperative sPAP less than 46 mm Hg had a higher chance of survival.

CONCLUSIONS: PEA improved CTEPH hemodynamics immediately and had a positive effect on long-term survival. Patients with postoperative sPAP ≥ 46 mm Hg indicate clinically significant RPH and have a lower long-term survival rate.

PMID:36070474 | DOI:10.1002/clc.23900

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Individualised risk prediction for improved chronic wound management

Adv Wound Care (New Rochelle). 2022 Sep 7. doi: 10.1089/wound.2022.0017. Online ahead of print.

ABSTRACT

Significance Chronic wounds are associated with significant morbidity, marked loss of quality of life and considerable economic burden. Evidence-based risk prediction to guide improved wound prevention and treatment is limited by the complexity in their aetiology, clinical underreporting and a lack of studies using large high-quality datasets. Recent Advancements The objective of this review is to summarise key components and challenges in the development of personalised risk prediction tools for both prevention and management of chronic wounds, while highlighting several innovations in the development of better risk stratification. Critical issues Regression-based risk prediction approaches remain important for assessment of prognosis and risk stratification in chronic wound management. Advances in statistical computing have boosted the development of several promising machine learning and other semi-automated classification tools. These methods may be better placed to handle large number of wound healing risk factors from large datasets, potentially resulting in better risk prediction when combined with conventional methods and clinical experience and expertise. Future directions Where the number of predictors is large and heterogenous, the correlations between various risk factors complex, and very large data sets are available, then machine learning may prove a powerful adjuvant for risk-stratifying patients predisposed to chronic wounds. Conventional regression-based approaches remain important, particularly where the number of predictors is relatively small. Translating estimated risk derived from machine learning algorithms into practical prediction tools for use in clinical practice remains challenging.

PMID:36070447 | DOI:10.1089/wound.2022.0017

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In Defense of Hypothesis Testing: A Response to the Joint Editorial from the International Society of Physiotherapy Journal Editors on Statistical Inference through Estimation

Phys Ther. 2022 Sep 7:pzac118. doi: 10.1093/ptj/pzac118. Online ahead of print.

NO ABSTRACT

PMID:36070432 | DOI:10.1093/ptj/pzac118