Tag: nevin manimala

Int Orthod. 2021 Jul 22:S1761-7227(21)00083-8. doi: 10.1016/j.ortho.2021.06.004. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the outcome quality of subjects treated with a completely customized lingual appliance (CCLA) in a postgraduate university program, using the ABO Objective Grading System (OGS), by testing the null-hypothesis of a significant proportion of post-treatment cases exceeding an adjusted â€̃exam failure’ threshold value of OGS=24.

MATERIALS AND METHODS: This retrospective single-arm study included 66 consecutively debonded CCLA cases (m/f 19/47; mean age: 25.1±9 years) treated at Hannover Medical School (MHH, Hannover, Germany). The discrepancy index (DI) was assessed on initial plaster casts. The OGS of the cast-radiograph evaluation was scored for both set-up and post-treatment casts, including the seven components of alignment/rotation, marginal ridges, buccolingual inclination, overjet, occlusal contacts, occlusal relationships and interproximal contacts, to parameterize differences between those.

RESULTS: DI score distribution (≥20, <20) was 25 (37.9%)/41 (62.1%) subjects. Mean initial DI was 17.3±8.5. Mean set-up OGS was 10.4±4.4 (min-max: 3—21), mean final OGS was 17.7±5.9 (min-max: 7—33), and the difference 7.3 (post-treatment – set-up) was statistically significant (p<0.0001; 95% CI [5.8, 8.7]). The null-hypothesis was rejected: A statistically significant proportion of the final casts (n=58; 87.8%) scored below OGS=24 by exact binomial test (P<0.0001; 95% CI [77.5%, 94.6%]). The rate of a final OGS score<24 was not significantly different (P=0.98) between both DI (≥20, <20) groups.

CONCLUSIONS: The outcome quality of the CCLA treatment in this postgraduate university setting was high and therefore sufficient for a vast majority of treated cases to pass the ABO-OGS clinical examination.

PMID:34305012 | DOI:10.1016/j.ortho.2021.06.004

J Sex Med. 2021 Jul 22:S1743-6095(21)00572-5. doi: 10.1016/j.jsxm.2021.06.015. Online ahead of print.

ABSTRACT

BACKGROUND: Penile cancer surgery affects physical, psychological, and sexual well-being, but the patient- and treatment-related factors predisposing to worse health-related quality of life (HRQoL) have not been well characterized.

AIM: We report treatment-related HRQoL changes among penile cancer survivors compared to the general population and the specific deficits that have the most profound effect, and we identify patient-related factors that predispose to a worse perceived HRQoL.

METHODS: Patients (n = 107) who underwent operations for invasive penile cancer in two Finnish university hospitals from 2009 to 2019 were sent the Patient Reported Outcomes (PROs) questionnaire designed to measure HRQoL, self-esteem, overall sexual functioning, erections, and change in sexual function. We collected clinical information and socio-demographic characteristics, including age, partner status, children, vocational education, and employment status. Associations between patient- and treatment-related factors and HRQoL were analyzed using descriptive statistics and non-parametric tests. Linear regression models were used to compare the HRQoL differences between patients with penile cancer and the age-standardized average for the Finnish population.

OUTCOMES: A generic measure of HRQoL (15D), the Rosenberg Self-Esteem Scale, Overall Sexual Functioning Questionnaire, the Erection Hardness Score, and self-reported change in sexual functioning.

RESULTS: Low scores in overall sexual functioning, erectile function, and changes in sexual functioning were associated with a lower HRQoL. An association was found between HRQoL and age, educational level, employment status, and place of residence. The HRQoL had a negative correlation with age. Patients with a high educational level, who were employed, or who lived in urban areas reported higher HRQoL. The mean HRQoL of penile cancer survivors was significantly lower than the age-standardized average HRQoL of the Finnish population.

CLINICAL IMPLICATIONS: Enhanced support and counseling is needed among penile cancer patients to improve the HRQoL during survivorship.

STRENGTHS & LIMITATIONS: A nationwide sample with detailed information allowed comparisons of HRQoL between penile cancer patients and the general population. Due to cross-sectional nature of the study, the time between the surgery and the study intervention was heterogeneous, and this may have affected the results.

CONCLUSION: Penile cancer patients exhibit significant physical and psychological dysfunction, and the lack of sexual activity in general is what most compromises the QoL of penile cancer survivors. Harju E, Pakarainen T, Vasarainen H, et al. Health-Related Quality of Life, Self-esteem and Sexual Functioning Among Patients Operated for Penile Cancer – A Cross-sectional Study. J Sex Med 2021;XX:XXX-XXX.

PMID:34305021 | DOI:10.1016/j.jsxm.2021.06.015

Intensive Crit Care Nurs. 2021 Jul 22:103084. doi: 10.1016/j.iccn.2021.103084. Online ahead of print.

ABSTRACT

OBJECTIVES: Independent of the underlying disease, intensive care unit survivors often suffer from cognitive, physical and mental impairments, also known as post-intensive care syndrome (PICS). Specific follow-up services are recommended for these patients. This study aims to capture the perspectives of health care providers on the development of the first intensive care unit follow-up-clinic in Germany.

RESEARCH METHODOLOGY: A qualitative study with six focus groups (n = 41) and six expert interviews, followed by a quantitative survey was conducted, involving nine different professions. Qualitative and quantitative data were analysed using thematic analysis and descriptive statistics, respectively.

FINDINGS: Participants described aftercare of former intensive care unit patients as complex and appreciated the idea of an intensive care unit follow-up clinic to improve continuity of care and multidisciplinary collaboration. The favoured model combined diagnostics and targeted referral of patients to specialists and therapists with the provision of information. In the survey, participants disagreed on how to implement this referral system but agreed that assessments should be multidimensional.

CONCLUSION: The necessity of and important criteria for the design of an intensive care unit follow-up clinic were identified. We will integrate these data with further evidence to develop a concept for a complex intervention.

PMID:34304978 | DOI:10.1016/j.iccn.2021.103084

Urol Oncol. 2021 Jul 22:S1078-1439(21)00253-2. doi: 10.1016/j.urolonc.2021.05.032. Online ahead of print.

ABSTRACT

BACKGROUND: Androgen deprivation therapy (ADT) is associated with numerous toxicities that are potentially modifiable. We sought to evaluate the impact of participation in a multidisciplinary clinic, STAND (Supportive Therapy in Androgen Deprivation) Clinic, designed to provide individualized lifestyle modification and management of ADT-related side effects.

METHODS: This phase II study recruited men with prostate cancer who had started ADT <6 months prior to enrollment, and in whom ADT was planned for at least 12 months following enrollment. Patients were randomized in a 1:1 ratio to either the STAND Clinic or usual care. Patients randomized to the STAND Clinic were provided monthly multidisciplinary assessment and counseling on exercise, nutrition, and symptom management for 12 months on a rotating schedule. Primary outcome was change from baseline to 12 months in percent body fat. Feasibility outcomes were also assessed by measuring percentage of completed visits. Secondary outcomes included change from baseline to 12 months in 3 domains: (1) metabolic impact and bone health, (2) quality of life (QOL), and (3) physical activity.

RESULTS: A total of 25 men were randomized to STAND clinic, and 23 were randomized to usual care. The study did not meet its accrual target of 32 men in each arm and was closed early due to lack of financial support. Overall, 91% (295 of 325) of STAND clinic visits were completed. Eighteen out of the 25 patients in STAND clinic arm (72%) completed all 12 months of STAND clinic visits, and 80% (20 of 25) completed the first 6 months. For all primary and secondary outcomes, there were no statistically significant differences between treatment arms.

CONCLUSION: Individualized and comprehensive management of ADT toxicities in a multidisciplinary clinic was well attended by patients. However, we did not find any differences in the outcomes assessed between the intervention arm and control.

PMID:34304981 | DOI:10.1016/j.urolonc.2021.05.032

Auris Nasus Larynx. 2021 Jul 23:S0385-8146(21)00194-2. doi: 10.1016/j.anl.2021.07.002. Online ahead of print.

ABSTRACT

OBJECTIVE: Limited low frequency (LF) pitch and temporal fine structure (TFS) sensitivity have been thought to contribute significantly to poor music perception in cochlear implant (CI) listeners. Thus, this study aimed to evaluate music perception in relation to LF pitch perception and temporal coding, specifically in people with bimodal stimulation as a promising approach to improve spectro-temporal sensitivity in CI listeners.

METHODS: Eleven postlingually deafened bimodal listeners participated in the study (mean age=55.5 years, range 36-75 years, SD=11.7). LF pitch/TFS sensitivity was evaluated by using two recently developed tests: Harmonic Intonation (HI) and Disharmonic Intonation (DI). The music perception protocol was based on three audio files in the genres of Classical, Jazz and Soul music and a music quality questionnaire regarding four subjective aspects: Clarity, Pleasantness, Naturalness and General Quality of Sounds.

RESULTS: CI alone and bimodal findings showed statistically significant differences for both temporal coding and music perception. DI findings showed statistically significant correlations with music quality ratings (p<0.05).

CONCLUSION: Bimodal music quality ratings were significantly better, indicating a significant improvement in the quality of music towards being significantly more clear, more natural, more pleasant, and better quality. Similarly, bimodal HI/DI findings improved significantly, although the amount of benefit was greater for the DI task with spectral information only below 300 Hz. Significant DI correlations with music quality ratings supported the test to be more indicative of better temporal coding of LF residual hearing and its effects on music perception.

PMID:34304943 | DOI:10.1016/j.anl.2021.07.002

Eur J Surg Oncol. 2021 Jul 20:S0748-7983(21)00635-1. doi: 10.1016/j.ejso.2021.07.014. Online ahead of print.

ABSTRACT

BACKGROUND: To investigate the prognostic value of dual-energy CT (DECT) based radiomics to predict disease-free survival (DFS) and overall survival (OS) for patients with advanced gastric cancer (AGC) after neoadjuvant chemotherapy (NAC).

METHODS: From January 2014 to December 2018, a total of 156 AGC patients were enrolled and randomly allocated into a training cohort and a testing cohort at a ratio of 2:1. Volume of interest of primary tumor was delineated on eight image series. Four feature sets derived from pre-NAC and delta radiomics were generated for each survival arm. Random survival forest was used for generating the optimal radiomics signature (RS). Statistical metrics for model evaluation included Harrell’s concordance index (C-index) and the average cumulative/dynamic AUC throughout follow-up. A clinical model and a combined Rad-clinical model were built for comparison.

RESULTS: The pre-IU (derived from iodine uptake images before NAC) RS performed best for DFS and OS in the testing cohort (C-indices, 0.784 and 0.698; the average cumulative/dynamic AUCs, 0.80 and 0.77). When compared with the clinical model, the radiomics model had significantly higher C-index to predict DFS in the testing cohort (0.784 vs. 0.635, p < 0.001), but no statistical difference was found for OS (0.698 vs. 0.680, p = 0.473). The combined Rad-clinical models showed improved performance in the testing cohort, with C-indices of 0.810 and 0.710 for DFS and OS, respectively.

CONCLUSION: DECT-derived radiomics serves as a promising non-invasive biomarker to predict survival for AGC patients after NAC, providing an opportunity for transforming proper treatment.

PMID:34304951 | DOI:10.1016/j.ejso.2021.07.014

Ann Emerg Med. 2021 Jul 23:S0196-0644(21)00300-0. doi: 10.1016/j.annemergmed.2021.04.017. Online ahead of print.

ABSTRACT

STUDY OBJECTIVE: Patient experience metrics have become increasingly important in evaluations of health care organizations and physician performance. Although such measures have been touted as a way to make objective comparisons of performance, they are subject to many of the same biases as other survey instruments, including gender bias.

METHODS: A total of 320 surveys were conducted between February and October 2020. Surveys included vignettes describing different scenarios, and respondents were asked to rate the vignette physician in each scenario on 1 of 3 themes: listening, time, or courtesy. Three vignettes per theme were used. Half of the surveys used a male physician and half used a female physician. Using tests of difference, we compared the ratings of male and female vignette physicians. We also used a statistical technique known as anchoring vignettes to show how respondents’ ratings of vignette physicians related to their ratings of their own physicians.

RESULTS: In all 9 vignette scenarios, the male vignette physician was rated more highly than the female vignette physician. These differences were statistically significant in 2 of 9 scenarios. Male vignette physicians were given more top-box ratings than female vignette physicians. Anchoring vignettes showed a statistically nonsignificant association between vignette ratings and ratings of respondents’ own physicians.

CONCLUSION: Our findings revealed a pattern of higher ratings of male vignette physicians when compared to female vignette physicians, which may translate to ratings of patients’ own physicians. These findings suggest that current methods to evaluate patients’ experiences with their own physicians may disadvantage female physicians.

PMID:34304916 | DOI:10.1016/j.annemergmed.2021.04.017

Burns. 2021 Jul 7:S0305-4179(21)00162-5. doi: 10.1016/j.burns.2021.06.007. Online ahead of print.

ABSTRACT

OBJECTIVES: To describe incidence and characteristics of hospital presentations and deaths due to burn injury in the Australian state of Victoria from 2008 to 2017 and identify trends in incidence and patterns.

METHODS: Three population-based datasets were used to ascertain burn-related hospital admissions, emergency department presentations, and deaths. These were the Victorian Admitted Episodes Dataset (VAED), Victorian Emergency Minimum Dataset (VEMD), and the Cause of Death-Unit Record File (COD-URF), respectively. Descriptive statistics on demographics (age and gender), burn injury characteristics (intent, cause, burn size and body region) and hospital burden (length of stay (LOS) and costs) were used to present the profile of patients. Incidence rates by age, gender and intent were calculated. Trend analysis on incidence was carried out using forced Poisson Regression models with the natural logarithm of the annual populations as an offset. Incident rate ratios were used to interpret the models. Risk ratios were used to compare the risk differences between population sub-groups. A negative binomial model was used to test the association between LOS and age and the total body surface area (TBSA) of the burn.

RESULTS: Overall males had higher rates of death, admission and ED presentation. For adults, the elderly had the highest rates of deaths and admissions while for children, the very young had highest rates for admissions and presentations. Exposure to smoke, fire and flames was the most common cause of deaths, and contact with heat and hot substances was most common among ED presentations. The elderly and those with Total Body Surface Area (TBSA) burn ≥20% had a higher risk of longer hospital stay. Rates of severe burns and deaths from burns remained stable during the study period in the setting of an annual 2% increase in population. Paediatric hospital admission rates decreased over time.

CONCLUSION: The risk of sustaining burn injury, the types of burn and outcomes, varied by age and gender. We found evidence of a limited decrease in burn injury rates in some sub-groups: appropriate and effective targeted prevention strategies for burns are needed to avoid the significant short and long-term suffering experienced.

PMID:34304930 | DOI:10.1016/j.burns.2021.06.007

Clin Ther. 2021 Jul 22:S0149-2918(21)00231-9. doi: 10.1016/j.clinthera.2021.06.001. Online ahead of print.

ABSTRACT

PURPOSE: Evogliptin is one of the latest dipeptidyl peptidase-4 (DPP-4) inhibitor, and a number of clinical trials have been performed following its development, including several randomized controlled trials (RCTs) performed to evaluate its efficacy and tolerability. In our study, we performed a systematic review and meta-analysis of its efficacy and tolerability by collecting RCTs and confirmed the results with Bayesian inference. Moreover, an updated quality-management system was integrated into the study process of systematic review.

METHODS: PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched for literature published between May 1990 and November 2020. We selected 6 homogeneous RCTs in 1017 subjects for efficacy and 1070 subjects for tolerability analysis. Regarding the efficacy profile, the mean differences from baseline (95% CIs) in hemoglobin (Hb) A_1c and fasting plasma glucose (FPG) were generated as end points and derived from each study. Regarding the tolerability profile, risk ratios of adverse events (AEs), serious AEs, adverse drug reactions, and hypoglycemia were generated from baseline to outcome measurements as derived from each study. A subsequent meta-analysis was performed with Bayesian inference.

FINDINGS: For HbA_1c and FPG, the results suggested a statistically significant improvement with evogliptin versus placebo (HbA_1c, -0.44 [95% CI, -0.54 to -0.34; P < 0.00001] and posterior median, -0.38 [95% CI, -0.51 to -0.24]; FPG, -0.61 [95% CI, -0.90 to -0.31; P < 0.0001] and posterior median, -0.48 [95% CI, -0.90 to -0.16]), but no statistically significant difference with evogliptin versus other DPP-4 inhibitors (HbA_1c, -0.01 [95% CI, -0.14 to 0.12] and posterior median, -0.06 [95% CI, -0.25 to 0.12]; FPG, 0.17 [95% CI, -0.10 to 0.44] and posterior median, 0.27 [95% CI, -0.12 to 0.65]). In terms of tolerability, the overall prevalence of adverse events, including hypoglycemia, was similar between evogliptin and other DPP-4 inhibitors and placebo.

IMPLICATIONS: Evogliptin appears more efficacious in terms of changes in HbA_1c and FPG compared with placebo, with an efficacy comparable to those of other DPP-4 inhibitors, although with the limited data studied and the minuscule sample sizes, the predictions of posterior medians, mean differences, and risk ratios of HbA_1c, FPG, and AEs by Bayesian inference were consistent with our findings through our quality-management system.

PMID:34304912 | DOI:10.1016/j.clinthera.2021.06.001

Clin Ther. 2021 Jul 22:S0149-2918(21)00219-8. doi: 10.1016/j.clinthera.2021.05.004. Online ahead of print.

ABSTRACT

PURPOSE: This study evaluated antipyretic efficacy and onset of a novel fixed-dose combination (FDC) of ibuprofen (IBU; 250 mg) and acetaminophen (APAP; 500 mg) compared with placebo and IBU or APAP monocomponents. MET: This single-center, randomized, double-blind, placebo-controlled, full-factorial study was conducted in healthy males aged 18 to 55 years with pyrexia induced by intravenous administration of reference standard endotoxin (RSE). After attainment of an oral temperature ≥38.1°C, subjects were randomized 3:3:3:1 to a double-blind single oral dose of FDC IBU/APAP 250 mg/500 mg, APAP 500 mg, IBU 250 mg, or placebo. Oral temperature was measured every 10 minutes for 2 hours, then every 30 minutes until 8 hours postdose. Time-weighted sum of temperature differences from baseline to 8 hours (WSTD_0-8) after study medication administration was the primary efficacy end point. Secondary end points included WSTD scores from 0 to 2 hours, 0 to 4 hours, 0 to 6 hours, and 6 to 8 hours; time to return to “normal” temperature; time to rescue medication use; and global drug evaluation. Safety was assessed via adverse events (AEs).

FINDINGS: Two hundred ninety subjects were randomized; 273 were included in the primary efficacy analysis. WSTD_0-8 was significantly better for FDC IBU/APAP 250 mg/500 mg (P = 0.002), IBU 250 mg (P = 0.030), and APAP 500 mg (P = 0.023) versus placebo; there were no significant differences between active treatments. For WSTD_0-2, only the FDC was statistically significant versus placebo (P = 0.004). All active treatments were significantly better (P < 0.05) for WSTD_0-4 and WSTD_0-6 versus placebo; there were no differences in WSTD_6-8 between cohorts. Temperature returned to normal during the 8-hour treatment period in ∼50% of subjects in each cohort. Only 1 subject (IBU cohort) took rescue medication. Post hoc analyses at early time points revealed significant treatment differences favoring FDC versus placebo and IBU for the WSTD from baseline during the 50- to 110-minute posttreatment window; for WSTD from baseline during the 80- to 110-minute posttreatment window, FDC provided significant treatment differences versus placebo and both monocomponents. Overall, 223 (76.9%) of 290 subjects experienced AEs related to RSE; only 2 subjects experienced treatment-related AEs (FDC, rash; placebo, ear pain).

IMPLICATIONS: Although the primary end point was not met, these results suggest that FDC IBU/APAP 250 mg/500 mg provides effective antipyresis with a faster onset versus equal doses of IBU and APAP alone. ClinicalTrials.gov identifier: NCT02761980. (Clin Ther. 2021;43:XXX-XXX) © 2021 Elsevier HS Journals, Inc.

PMID:34304913 | DOI:10.1016/j.clinthera.2021.05.004