Tag: pubmed

J Med Radiat Sci. 2021 Sep 22. doi: 10.1002/jmrs.530. Online ahead of print.

ABSTRACT

INTRODUCTION: Adjuvant radiation therapy (RT) following primary surgery in women affected by early breast cancer (EBC) plays a central role in reducing local recurrences and overall mortality. The FAST-FORWARD trial recently demonstrated that 1-week hypofractionated adjuvant RT is not inferior to the standard schedule in terms of local relapse, cosmetic outcomes and toxicity. The aim of this in silico study was to evaluate the dosimetric aspects of a 1-week RT course, administered through volumetric modulated arc therapy (VMAT), compared with traditional three-dimensional conformal radiation therapy (3D-CRT) with tangential fields.

METHODS: Patients affected by left-side EBC undergoing adjuvant RT were selected. ESTRO guidelines for the clinical target volume (CTV) delineation and FAST-FORWARD protocol for CTV to planning target volume (PTV) margin definition were followed. Total prescribed dose was 26 Gy in five fractions. The homogeneity index (HI) and the global conformity index (GCI) were taken into account for planning and dose distribution optimisation purposes. Both 3D-CRT tangential fields and VMAT plans were generated for each patient.

RESULTS: The analysis included 21 patients. PTV coverage comparison between 3D-CRT and VMAT plans showed significant increases for GCI (P < 0.05) in VMAT technique; no statistically significant differences were observed regarding HI. For organs at risks (OAR), statistically significant increases were observed in terms of skin V103% (P < 0.002) and ipsilateral lung V30% (P < 0.05) with 3D-CRT and of heart V5% (P < 0.05) with VMAT technique.

CONCLUSIONS: This in silico study showed that both 3D-CRT and VMAT are dosimetrically feasible techniques in the framework of 1-week hypofractionated treatments for left EBC.

PMID:34551211 | DOI:10.1002/jmrs.530

Clin Oral Implants Res. 2021 Sep 22. doi: 10.1111/clr.13841. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim was to evaluate the role of resorbable membranes applied over customized titanium meshes related to soft tissue healing and bone regeneration after vertical/horizontal bone augmentation.

MATERIALS AND METHODS: Thirty patients with partial edentulism of the maxilla/mandible, with vertical/horizontal reabsorption of the alveolar bone, and needing implant-supported restorations, were randomly divided into two groups: Group A was treated using only custom-made meshes (Mesh-); Group B using custom-made meshes with cross-linked collagen membranes (Mesh+). Data collection included: surgical and healing complications, “pseudo-periosteum” thickness, bone density, planned bone volume (PBV), regenerated bone volume (RBV), regeneration rate (RR), vertical bone gain (VBG), and implant survival in regenerated areas. Statistical analysis was performed between the 2 study groups using a significance level of α=0.05.

RESULTS: Regarding the healing complications, the non-inferiority analysis proved to be inconclusive despite the better results of group Mesh+ (13%) compared to group Mesh- (33%); Estimated value -1.13 CI-95% from -0.44 to 0.17. Superiority approach confirmed the absence of significant differences (p=0.39). RBV were 803.27mm³ and 843.13mm³ , respectively; and higher RR was observed in group Mesh+ (82.3%) compared to Mesh- (74.3%), although this value didn’t reach a statistical significance (p=0.44). All 30 patients completed the study, receiving 71 implants; 68 out of them were clinically stable and in function.

CONCLUSION: the results showed that customized meshes alone don’t appear to be inferior to customized meshes covered by cross-linked collagen membranes in terms of healing complication rates and regeneration rates, although superior results were observed in group Mesh+ compared to group Mesh- for all variables.

PMID:34551168 | DOI:10.1111/clr.13841

Int J Clin Pract. 2021 Sep 22:e14915. doi: 10.1111/ijcp.14915. Online ahead of print.

ABSTRACT

BACKGROUND: Although biologic agents are very effective, solid data proving they are safer than other therapies in psoriasis are still lacking.

METHODS: A total of 289 psoriatic patients were followed for 30 months; of which number 118 were treated with topical agents alone, 112 received biologic agents, and the remaining 59 patients were on non-biologic systemic agents. The rates of adverse events in these groups were recorded and statistically analyzed.

RESULTS: Patients treated with biologic agents had higher rates of adverse events (p=0.017), including overall infections (p=0.003), respiratory infections (p<0.001), renal, urinary (p<0.001), musculoskeletal, connective tissue (p<0.001, and p=0.021) and oral cavity-related (p=0.046) disorders. Except for the incidence of infections, all the above adverse events occurred more often in our study than in clinical trials. The occurrence of serious adverse events was p=0.066, with the incidence of serious infections being p=0.164. Unlike patients on topical therapy and non-biologic systemic agents, patients treated with biologic agents were forced to discontinue their therapies (p=0.001). The Psoriasis Area Severity Index (PASI) and Body Surface Area (BSA) scores were the lowest among patients on biologic agents.

CONCLUSION: While biologic agents were the most effective therapies, they were associated with higher rates of treatment discontinuation and adverse events in comparison with other forms of therapy.

PMID:34551188 | DOI:10.1111/ijcp.14915

Public Health Nurs. 2021 Sep 22. doi: 10.1111/phn.12972. Online ahead of print.

ABSTRACT

OBJECTIVE: The study was conducted to determine the vaccination rates and related factors among the elderly.

DESIGN: Cross-sectional study.

SAMPLE: This study was conducted with 984 elderly people living in a province in western Turkey.

MEASUREMENTS: The single-stage cluster sampling method was used in the sample selection. The descriptive statistics, the chi-square analysis, the Mann-Whitney U test and the logistic regression analysis for the multivariate analysis were used to evaluate the data.

RESULTS: It was determined that 45.6% of the elderly were vaccinated after the age of 65 and the most frequently administered vaccines were influenza (41.3%), pneumococcal (10.9%), and tetanus (5.5%) vaccines. Higher vaccination rates were determined in the following demographics, namely by 1.8-fold (95% CI, 1.4-2.4) in those living in urban areas, by 2.6-fold (95% CI, 1.8-3.9) in those with high school or higher education, by 1.5-fold (95% CI, 1.0-2.5) in those who did not work, by 1.7-fold (95% CI, 1.3-2.3) in those with chronic diseases and by 2-fold (95% CI, 1.1-3.4) in those who fulfilled their physical own needs themselves.

CONCLUSION: This study showed that more than half of the elderly did not receive any vaccinations in old age. The vaccination rates of the elderly were associated with many factors.

PMID:34551144 | DOI:10.1111/phn.12972

Clin Oral Implants Res. 2021 Sep 22. doi: 10.1111/clr.13851. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare peri-implant clinical and radiographic parameters between hydrophilic and hydrophobic narrow dental implants in patients with mandibular implant overdentures for 1 year.

MATERIALS AND METHODS: In a randomized, double-blind, split-mouth study with a 1-year follow-up, sixteen edentulous participants received two narrow-diameter implants in the anterior mandibular region with 2 types of surfaces: hydrophobic (Neoporos surface, NS) and hydrophilic (Acqua surface, AS). During the osseointegration period and after loading with mandibular implant overdentures, the outcomes monitored were i) peri-implant health: early healing index (EHI), visible plaque index (VPI), calculus presence (CP), peri-implant inflammation (PI), probing depth (PD), bleeding on probing (BOP); ii) implant stability quotient (ISQ), iii) crestal bone loss (CBL) and bone level change (BLC); and iv) implant success and survival rates.

RESULTS: The PD in NS implants decreased by 31.78% between 15 and 30 days, while a similar reduction (-31.28%) occurred in the 3^rd month in the AS group. The ISQ also decreased significantly during the 1^st month in both groups: -10.95% after 7 days in the NS group and -7.46% after 15 days in the AS group. At 12 months, statistically significance differences were not observed, however, the AS surface presented 50.6% smaller CBL and 41.3% smaller BLC values. The success and survival rates were 62.5% for AS implants and 87.5% for NS implants.

CONCLUSION: Narrow diameter implants with hydrophilic and hydrophobic surfaces loaded with mandibular implant overdentures showed no differences in peri-implant healing, stability, and peri-implant bone remodelling in the 1^st year of follow-up.

PMID:34551146 | DOI:10.1111/clr.13851

Laryngoscope. 2021 Sep 22. doi: 10.1002/lary.29863. Online ahead of print.

ABSTRACT

OBJECTIVES/HYPOTHESIS: To reanalyze the growth trajectory and assess longitudinal changes of children undergoing adenotonsillectomy (AT) versus watchful waiting (WW) enrolled in the Childhood Adenotonsillectomy Trial (CHAT) study and to determine if an AT increases the risk of obesity in children.

STUDY DESIGN: Reanalysis of prospective cohort investigation.

METHODS: The study analyzed publicly available data from CHAT, including 3 months visit data not previously included in a prior publication. Statistical comparisons and mixed-effects modeling were done using age- and sex-specific BMI expressed as a percentage of the 95th percentile (%BMIp95). P < .05 was considered significant.

RESULTS: Children in the AT group, especially if underweight at baseline, had an increased rate of weight gain, with 100% of underweight children in the AT group becoming normal weight compared to 20% for WW. However, the rate of weight gain, as measured by the %BMIp95 trajectory for both AT and WW groups, was not significantly different when baseline weight status and obstructive sleep apnea (OSA) resolution were accounted for. Comparisons of %BMIp95 between treatment groups at baseline, 3- and 7-month follow-up visits also failed to identify statistically significant differences (P > .05). Overall for the entire cohort, resolution of OSA was associated with a decreased weight trajectory (P < .001).

CONCLUSIONS: AT compared to WW is not associated with an increased risk of excessive weight gain. Otolaryngologists should be aware of this updated analysis when discussing AT surgical outcomes with families.

LEVEL OF EVIDENCE: 2 Laryngoscope, 2021.

PMID:34551129 | DOI:10.1002/lary.29863

Headache. 2021 Sep 22. doi: 10.1111/head.14206. Online ahead of print.

ABSTRACT

OBJECTIVE: This post hoc analysis in patients medically diagnosed with chronic migraine (CM) and medication-overuse headache (MOH) evaluated reductions in the use of acute headache medication (AHM) and sustained changes in the diagnostic status of CM and MOH following eptinezumab treatment in the PROMISE-2 study.

BACKGROUND: Eptinezumab, a monoclonal antibody that inhibits calcitonin gene-related peptide, is approved in the United States for the preventive treatment of migraine. A previous analysis showed that eptinezumab reduced monthly migraine days and was well tolerated in the subgroup of PROMISE-2 patients diagnosed with both CM and MOH.

METHODS: The phase 3, double-blind, placebo-controlled PROMISE-2 study (NCT02974153) randomized adults with CM to eptinezumab 100 mg, 300 mg, or placebo (administered intravenously every 12 weeks for up to two doses). MOH was prospectively diagnosed at screening by trained physicians based on 3 months of medication history and International Classification of Headache Disorders-3β criteria. This post hoc analysis evaluated changes in total and class-specific days of AHM usage, the percentage of patients using AHM at or above MOH diagnostic thresholds, and the percentage of patients experiencing monthly headache and migraine day frequency below diagnostic thresholds for MOH and/or CM.

RESULTS: In PROMISE-2, 431/1072 (40.2%) patients with CM were diagnosed with MOH (eptinezumab 100 mg, n = 139; 300 mg, n = 147; placebo, n = 145) and were included in this analysis. Total monthly AHM use decreased from 20.6 days/month at baseline to 10.6 days/month over 24 weeks of treatment (49% decrease) with eptinezumab 100 mg, from 20.7 to 10.5 days/month (49% decrease) with eptinezumab 300 mg, and from 19.8 to 14.0 days/month (29% decrease) with placebo. Numerically greater decreases from baseline with eptinezumab were also observed for individual drug classes. In each study month, the percentages of patients who were below MOH thresholds were numerically higher for both eptinezumab doses compared with placebo, as were the percentages of patients experiencing headache and migraine frequency below CM thresholds. Of patients with available data across the entire treatment period, 29.0% (58/200) of patients treated with eptinezumab stopped meeting and remained below diagnostic thresholds for both CM and MOH during Weeks 1-24, as well as 6.3% (6/96) of patients who received placebo.

CONCLUSIONS: Across 24 weeks of treatment, eptinezumab reduced AHM use in patients diagnosed with CM and MOH. More than one-fourth (29%) of patients treated with eptinezumab did not meet the diagnostic thresholds for either CM or MOH for the entire treatment period.

PMID:34551130 | DOI:10.1111/head.14206

Clin Pharmacol Ther. 2021 Sep 22. doi: 10.1002/cpt.2425. Online ahead of print.

ABSTRACT

Clinicians and patients often try a treatment for an initial period to inform longer-term therapeutic decisions. A more rigorous approach involves N-of-1 trials. In these single-patient crossover trials, typically conducted in patients with chronic conditions, individual patients are given candidate treatments in a double-blinded, random sequence of alternating periods to determine the most effective treatment for that patient. However, to date, these trials are rarely done outside of research settings and have not been integrated into general care where they could offer substantial benefit. Designating this classical, N-of-1 trial design as Type 1, there also are new and evolving uses of N-of-1 trials that we designate as Type 2. In these, rather than focusing on optimizing treatment for chronic diseases when multiple approved choices are available, as is typical of Type 1, a Type 2 N-of-1 trial tests treatments designed specifically for a patient with a rare diseases, to facilitate personalized medicine. While the aims differ, both types face the challenge of collecting individual-patient evidence using standard, trusted, widely accepted methods. To fulfill their potential for producing both clinical and research benefits, and to be available for wide use, N-of-1 trials will have to fit into the current healthcare ecosystem. This will require generalizable and accepted processes, platforms, methods, and standards. This also will require sustainable value-based arrangements among key stakeholders. In this article, we review opportunities, stakeholders, issues, and possible approaches that could support general use of N-of-1 trials and deliver benefit to patients and the healthcare enterprise. To assess and expand the benefits of N-of-1 trials, we propose multi-stakeholder meetings, workshops, and the generation of methods, standards, and platforms that would support wider availability and the value of N-of-1 trials.

PMID:34551122 | DOI:10.1002/cpt.2425

Allergy. 2021 Sep 22. doi: 10.1111/all.15107. Online ahead of print.

ABSTRACT

BACKGROUND: IgG2 responses are associated with repeated antigen exposure and display highly mutated variable domains. A recent study highlighted a role of IgG2+ memory B cells and allergen-specific IgG2 levels after a 3^rd consecutive pre-seasonal sublingual allergen immunotherapy (AIT) with grass pollen tablet. Herein, we aim to explore changes in allergen-specific IgG2 in individuals undergoing house dust mite immunotherapy (HDM-AIT) and explore whether the interrelationship with other humoral responses (i.e. IgG4 and IgE) may discriminate between high and low responders.

METHODS: Levels of serum D. pteronyssinus- and D. farinae-specific IgG2, IgG4 and IgE antibodies were measured by ELISA or ImmunoCap in a sub-group of individuals enrolled in a randomized, double-blind, placebo-controlled, sublingual AIT study evaluating the safety and efficacy of a 300 IR HDM tablet.

RESULTS: After 1-year sublingual AIT, HDM-specific serum IgG2 responses increase mostly in high versus low responders and are distinctive according to the clinical benefit. Higher correlation between HDM-specific IgG2, IgE and/or IgG4 responses are seen in subjects benefiting the most from HDM-AIT as indicated by changes in Average Total Combined Scores. More strikingly, statistically significant correlation between HDM-specific IgG2 and IgE responses are only observed in individuals stratified as high responders.

CONCLUSIONS: We provide evidence for coordinated serum immune responses upon AIT in HDM-allergic subjects exhibiting high clinical benefit when compared with low responders. Assessing HDM-specific IgE, IgG2 and IgG4 in serum could be used as follow-up combined markers to support decision as to AIT continuation and/or adaptation.

PMID:34551124 | DOI:10.1111/all.15107

Sleep. 2021 Sep 22:zsab232. doi: 10.1093/sleep/zsab232. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Increased phase synchronization in electroencephalography (EEG) bands might reflect the activation of compensatory mechanisms of cognitive decline in people with neurodegenerative diseases. Here, we investigated whether altered large-scale couplings of brain oscillations could be linked to the balancing of cognitive decline in a longitudinal cohort of people with idiopathic rapid eye-movement sleep behavior disorder (iRBD).

METHODS: We analyzed 18 patients (17 males, 69.7±7.5 years) with iRBD undergoing high-density EEG (HD-EEG), presynaptic dopaminergic imaging, and clinical and neuropsychological assessments at two time points (time interval 24.2±5.9 months). We thus quantified the HD-EEG power distribution, orthogonalized amplitude correlation and weighted phase lag index at both time points and correlated them with clinical, neuropsychological and imaging data.

RESULTS: Four patients phenoconverted at follow-up (three cases of parkinsonism and one of dementia). At the group level, neuropsychological scores decreased over time, without reaching statistical significance. However, alpha phase synchronization increased and delta amplitude correlations decreased significantly at follow-up compared to baseline. Both large-scale network connectivity metrics were significantly correlated with neuropsychological scores but not with sleep quality indices or presynaptic dopaminergic imaging data.

CONCLUSIONS: These results suggest that increased alpha phase synchronization and reduced delta amplitude correlation may be considered electrophysiological signs of an active compensatory mechanism of cognitive impairment in people with iRBD. Large-scale functional modifications may be helpful biomarkers in the characterization of prodromal stages of alpha-synucleinopathies.

PMID:34551110 | DOI:10.1093/sleep/zsab232