Periods Of Non-use Research Articles

Safety and efficacy results for the segesterone acetate ethinyl estradiol (SA/EE) contraceptive vaginal ring

Objectives: We aimed to determine efficacy and safety of a contraceptive vaginal ring releasing an average daily dose of 150 mcg segesterone acetate (SA; formerly known as Nestorone®) and 15 mcg ethinyl estradiol (EE). This ring is designed for a year of use with women following a 21/7 regimen. It does not require refrigeration before dispensing or during periods of nonuse.

Nonoccupational Exposure of Agricultural Area Residents to Pesticides: Pesticide Accumulation and Evaluation of Genotoxicity.

Although many studies related the toxic effects of pesticides on agricultural workers, little research has been done about agricultural area residents. The purpose of this work was to monitor the presence of pesticides, as well as their genotoxic and cytotoxic potential, in humans with blood samples collected from control and intensive agricultural areas in the Thrace region. Pesticide accumulations were determined by LC-MS/MS. Cytotoxicity and genotoxicity were analyzed by comet assay, and the effect of pesticide accumulation on oxidative stress, DNA repair, and molecular chaperone response were analyzed by qRT-PCR assays in the human blood samples. The agricultural area residents had a significantly higher concentration of pesticides than those in the control area at all three sampling times, and the total pesticide amounts were 4.3 and 10 times significantly higher in blood sampled in the pesticide use period (August 2015 and 2016, respectively) than in the nonuse period (November 2015). The results showed that the pesticide level in blood during the use period led to oxidative stress, DNA damage (mean comet length and % tail DNA), and unfolded/misfolded protein response. Particularly, in pesticide use season, difference between these parameters was found statistically significant with comparison to control. Our results indicate that individuals residing around a monoculture rice farming area comprise an at-risk group as a result of increased genotoxicity evidenced in human blood. We suggest that biological monitoring efforts should be used to control nonoccupational exposures to pesticides and thus safeguard the health of agricultural area residents.

Lambretta vrooming away: Italian Supreme Court rules that mark can be revoked for non-use even if it is still well-known

Scooters India Ltd v Brand Concern BV, Corte di Cassazione (Italian Supreme Court), First Chamber, judgment of 28 March 2017, No 7970/17 The ltalian Supreme Court has ruled that for a well-known trade mark to be revoked for non-use, the only condition is lack of genuine use during the statutory period; whether, due to its well-known character, the mark is still in the minds of consumers is not a relevant factor when deciding on a revocation request. Article 24(1) of the Italian Intellectual Property Code (IPC) lists two grounds of revocation of trade marks for non-use: i) if, within five years from the date of the registration, the mark is not used by the rightholder in relation to the products for which the mark is registered; ii) if the use of the mark is suspended for a continuous period of five years. Before the enactment of the IPC revocation for non-use was governed by Article 42(1) of the Royal Decree 929/1942. That provision was similar to the one in the IPC but not in relation to the length of the relevant non-use period. The original text of Article 42(1) of the Royal Decree 929/1942 provided, in fact, for a non-use period of three years. This period was subsequently extended by Legislative Decree 480/1992 to five years as is currently required by the IPC.

Retention of Assessment Center Rater Training

Abstract. The purpose of this research was to examine frame-of-reference (FOR) training retention in an assessment center (AC) rater training context. In this study, we extended Gorman and Rentsch’s (2009) research showing FOR training effects on performance schemas by examining the effects immediately after training and again after a two-week nonuse period. We examined the retention effects of FOR training on performance ratings and on performance schema accuracy. The results indicated that the FOR training condition, compared to a control condition, yielded performance ratings and performance schemas more similar to expert ratings and to an expert schema, respectively. FOR training also had positive effects on ratings and performance schema accuracy assessed two weeks after training. These results support and extend the theory of FOR training, which posits that the instructed theory of performance replaces the preexisting rater schemas ( Lievens, 2001 ), and they contribute to the research on FOR training within AC contexts.

The risk of hospitalized infection following initiation of biologic agents versus methotrexate in the treatment of juvenile idiopathic arthritis.

BackgroundIn the present study, we compared the incidence of hospitalized infection among children with juvenile idiopathic arthritis (JIA) following initiation of treatment with biologic agents versus methotrexate (MTX).MethodsWe used national Medicaid claims data from 2000 through 2010 to create cohorts of children with JIA who were new users of tumor necrosis factor inhibitors (TNFi), anakinra, and MTX (without concurrent biologic agent use) as defined by a 6-month baseline period of nonuse. Because most anakinra users have systemic juvenile idiopathic arthritis (SJIA), we used claims to identify MTX users who likely had SJIA. Among TNFi users, concurrent MTX use was a time-varying covariate. The study outcome was a primary hospital discharge diagnosis of infection. We calculated adjusted hazard ratios (aHRs) to compare infection rates between biologic agents and MTX.ResultsWe identified 3075 new MTX users (160 with SJIA), 2713 new TNFi users, and 247 new anakinra users. There was no increased risk of infection associated with TNFi monotherapy versus MTX (aHR 1.19, 95 % CI 0.72–1.94) or with TNFi + MTX combination therapy versus MTX (aHR 1.23, 95 % CI 0.69–2.17). Baseline high-dose oral glucocorticoid use (≥10 mg/day of prednisone) was associated with infection (aHR 2.03 [95 % CI 1.21–3.39] versus no oral glucocorticoid). Anakinra was associated with infection versus MTX (aHR 3.53 95 % CI 1.83–6.82), but less so compared with MTX users with SJIA (aHR 2.69, 95 % CI 0.82–8.82).ConclusionsNeither TNFi monotherapy nor TNFi + MTX combination therapy was significantly associated with hospitalized infection compared with MTX. Anakinra was significantly associated with infection, but there was likely residual confounding by disease phenotype.

Association between statins and infections among patients with diabetes: a cohort and prescription sequence symmetry analysis.

PurposeA previous meta‐analysis of randomized trials did not confirm findings from observational studies that suggested that statins reduce the risk of infection. However, animal experiments indicate that statins may be more effective in reducing the risk and/or the severity of infection among patients with diabetes. Hence, we evaluated the effect of statins on antibiotic prescriptions (a proxy for infections) among patients with drug‐treated type 2 diabetes using two confounding‐reducing observational designs.MethodsWe conducted a prescription sequence symmetry analysis and a cohort study using the IADB.nl pharmacy prescription database. For the prescription sequence symmetry analysis, a sequence ratio was calculated. The matched cohort study, comparing the time to first antibiotic prescription between periods that statins are initiated and non‐use periods, was analyzed using stratified Cox regression.ResultsPrescription sequence symmetry analysis of 4684 patients with drug‐treated type 2 diabetes resulted in an adjusted sequence ratio of 0.86 (95% confidence interval [CI]: 0.81 to 0.91). Corresponding figures for the cohort analysis comparing 9852 statin‐initiation with 4928 non‐use periods showed similar results (adjusted hazard ratio: 0.88, 95%CI: 0.83 to 0.95).ConclusionsThese findings suggest that statins are associated with a reduced risk of infections among patients with drug‐treated type 2 diabetes. © 2016 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Adverse drug events in older hospitalized adults: Implications for nursing practice

Dry mouth is common in elderly patients. However, the use of saliva substitute has been limited due to its inedibility. This study investigated the efficacy of oral moisturizing jelly (OMJ), a novel edible saliva substitute. A pre-post design was conducted in 118 elderly patients diagnosed with hypertension and/or diabetes mellitus. After using OMJ, signs and symptoms of dry mouth were compared with baseline data. The properties of saliva were compared between the OMJ use and non-use periods. The use of OMJ for 2 weeks significantly reduced symptoms of dry mouth, while the use for 1 month reduced the signs of xerostomia, prevented the decline of salivary pH(s) and improved buffering capacities. OMJ was equally effective in patients taking 1 to 2 and 3 to 7 medications. Furthermore, 65% of patients preferred OMJ over a commercial product. OMJ could be new edible saliva substitute for elderly patients suffering from dry mouth.Clinicaltrials.gov ID: NCT02317172.

Influence of oral moisturizing jelly as a saliva substitute for the relief of xerostomia in elderly patients with hypertension and diabetes mellitus

Dry mouth is common in elderly patients. However, the use of saliva substitute has been limited due to its inedibility. This study investigated the efficacy of oral moisturizing jelly (OMJ), a novel edible saliva substitute. A pre-post design was conducted in 118 elderly patients diagnosed with hypertension and/or diabetes mellitus. After using OMJ, signs and symptoms of dry mouth were compared with baseline data. The properties of saliva were compared between the OMJ use and non-use periods. The use of OMJ for 2 weeks significantly reduced symptoms of dry mouth, while the use for 1 month reduced the signs of xerostomia, prevented the decline of salivary pH(s) and improved buffering capacities. OMJ was equally effective in patients taking 1 to 2 and 3 to 7 medications. Furthermore, 65% of patients preferred OMJ over a commercial product. OMJ could be new edible saliva substitute for elderly patients suffering from dry mouth.Clinicaltrials.gov ID: NCT02317172.

Defining success with HIV pre-exposure prophylaxis: a prevention-effective adherence paradigm.

Clinical trial data have shown that oral pre-exposure prophylaxis (PrEP) is efficacious when taken as prescribed; however, PrEP adherence is complex and must be understood within the context of variable risk for HIV infection and use of other HIV prevention methods. Different levels of adherence may be needed in different populations to achieve HIV prevention, and the optimal methods for achieving the necessary adherence for both individual and public health benefits are unknown. Guidance for PrEP use must consider these questions to determine the success of PrEP-based HIV prevention programs. In this article, we propose a new paradigm for understanding and measuring PrEP adherence, termed prevention-effective adherence, which incorporates dynamic HIV acquisition risk behaviors and the use of HIV alternative prevention strategies. We discuss the need for daily PrEP use only during periods of risk for HIV exposure, describe key issues for measuring and understanding relevant behaviors, review lessons from another health prevention field (i.e., family planning), and provide guidance for prevention-effective PrEP use. Moreover, we challenge emerging calls for sustained, near perfect PrEP adherence regardless of risk exposure and offer a more practical and public health-focused vision for this prevention intervention.

Actual drawing of histological images improves knowledge retention

Medical students have to process a large amount of information during the first years of their study, which has to be retained over long periods of nonuse. Therefore, it would be beneficial when knowledge is gained in a way that promotes long-term retention. Paper-and-pencil drawings for the uptake of form-function relationships of basic tissues has been a teaching tool for a long time, but now seems to be redundant with virtual microscopy on computer-screens and printers everywhere. Several studies claimed that, apart from learning from pictures, actual drawing of images significantly improved knowledge retention. However, these studies applied only immediate post-tests. We investigated the effects of actual drawing of histological images, using randomized cross-over design and different retention periods. The first part of the study concerned esophageal and tracheal epithelium, with 384 medical and biomedical sciences students randomly assigned to either the drawing or the nondrawing group. For the second part of the study, concerning heart muscle cells, students from the previous drawing group were now assigned to the nondrawing group and vice versa. One, four, and six weeks after the experimental intervention, the students were given a free recall test and a questionnaire or drawing exercise, to determine the amount of knowledge retention. The data from this study showed that knowledge retention was significantly improved in the drawing groups compared with the nondrawing groups, even after four or six weeks. This suggests that actual drawing of histological images can be used as a tool to improve long-term knowledge retention.

Time dependence of risks and benefits in pediatric primary prevention implantable cardioverter-defibrillator therapy.

Implantable cardioverter defibrillators (ICDs) used to prevent sudden cardiac arrest in children not only provide appropriate therapy in 25% of patients but also result in a significant incidence of inappropriate shocks and other device complications. ICDs placed for secondary prevention have higher rates of appropriate therapy than those placed for primary prevention. Pediatric patients with primary prevention ICDs were studied to determine time-dependent incidence of appropriate use and adverse events. A total of 140 patients aged <21 years (median age, 15 years) at first ICD implantation at Boston Children's Hospital (2000-2009) in whom devices were placed for primary prevention were retrospectively identified. Demographics and times to first appropriate shock; adverse events (including inappropriate shock, lead failure, reintervention, and complication); generator replacement and follow-up were noted. During mean follow-up of 4 years, appropriate shock occurred in 19% patients and first adverse event (excluding death/transplant) occurred in 36%. Risk of death or transplant was ≈1% per year and was not related to receiving appropriate therapy. Conditional survival analysis showed rates of appropriate therapy and adverse events decrease soon after implantation, but adverse events are more frequent than appropriate therapy throughout follow-up. Primary prevention ICDs were associated with appropriate therapy in 19% and adverse event in 36% in this cohort. The incidence of both first appropriate therapy and device-related adverse events decreased during longer periods of follow-up after implantation. This suggests that indications for continued device therapy in pediatric primary prevention ICD patients might be reconsidered after a period of nonuse.

Prehospital Mass-Casualty Triage Training—Written Versus Moulage Scenarios: How Much Do EMS Providers Retain?

The aim of this study was to assess the effectiveness of written and moulage scenarios using video instruction for mass-casualty triage by evaluating skill retention at six months post intervention. Prehospital personnel were instructed in the START method of mass-casualty triage using a video. Moulage and written testing were completed by each participant immediately after instruction and at six months post instruction. There was a significant decrease in performance between initial and six-month testing, indicating skill decay and loss of retention of triage skills after an extended nonuse period. There were no statistically significant differences between written and moulage testing results at either initial testing or at six months. Prior skill level did not influence test performance on the type of testing conducted or long-term retention of triage skills. These data confirm the skill deterioration associated with an infrequently used triage method. Further research to more precisely define triage criteria, as well as the ability to apply the criteria in a clinical setting and to rapidly identify patients at risk for morbidity/mortality is needed.

Clinical Case Study Review

This manuscript describes a case in which, based on clinical observations, we hypothesize that a change in a cochlear implant recipient's electrode impedance and performance was attributed to a change in the recipient's physiology rather than a device failure. Of particular note was the finding that electrode impedances decreased after a period of nonuse of the implant as well as after steroid treatment. Retrospective single-subject case study review. Outpatient clinic. This paper describes outcomes for a 75-year-old male cochlear implant user. A change in electrode impedance and a decrease in speech recognition were addressed through cochlear implant programming, periods of nonuse of the implant, provision of steroids, and bilateral cochlear implantation. The primary measures of interest were serial assessment of electrode impedance and speech recognition. Secondary measures included assessment of implant stimulation levels and electrophysiologic responses. Electrode impedances decreased (improved) after a period of nonuse of the implant as well as after provision of steroid treatment. Recipient performance also improved but did not return to baseline levels. Atypical fluctuations in electrode impedance were observed with periods of CI use and nonuse. Additionally, after a 10-month period of constant fluctuation of electrode impedances with atypical morphology, electrode impedances stabilized to normal levels with a typical morphology within 3 days of steroid treatment. Given these observations, we hypothesized that the change in this recipient's electrode impedance as well as the decrease in this implant recipient's performance may be attributed to his physiology rather than to the device failure. Changes in electrode impedance accompanied by a decrease in this patient's performance were successfully addressed by a period of nonuse of the implant, provision of steroids, and an increase in the pulse width of the biphasic pulsatile signal used for stimulation. It should be noted that the results of this case are anecdotal in nature and may not apply to all cochlear implant recipients experiencing electrode impedance changes and/or deterioration in performance.

The Effect of Distributed Practice on Immediate Posttraining, and Long-Term Performance on a Complex Command-and-Control Simulation Task

Using 192 paid participants who trained on a command-and-control microworld simulation, we examined the comparative effectiveness of two distributed practice schedules in enhancing performance at the end of training as well as after an 8-week nonuse period. Longer interstudy intervals (10 hr of practice over 2 weeks) led to higher levels of skill at the end of training and after nonuse than shorter interstudy intervals (10 hr of practice over 1 week). The study begins to address gaps in the skill retention literature by using a cognitively complex task and an extended nonuse interval. The primary implication of our findings is that scheduling longer interstudy practice intervals is a viable means of enhancing immediate posttraining performance and promoting long-term skill retention for cognitively complex tasks.

A Survey of SCI Individuals Who Use a Ferti CareR Personal Vibrator: Reproduction, Bladder Program, Spasticity and Quality of Life

Introduction: For individuals with spinal cord injury, the Ferti Care R Personal vibrator can be applied to the genitalia for reproductive health and orgasm. In addition, reports of vibratory effects on spasticity and bladder inhibition have been reported. However, there is no reported owner survey for the devices home-use, either benefits or problems.Methods: 122 SCI individuals (69% response rate) who had been using the device for 2 to more than 4 years completed a mailed survey which included a wide range of device related questions.Results: Respondents were primarily males (90%) between 20 and 60 years old. Seventy-two percent had cervical or upper thoracic injury and 56% had complete injuries; 91% are using the device currently, but 48% have periods of nonuse. They were using it for orgasm (ejaculation, 84%) and sexual activity (68%). Most respondents also perceived improvement since starting to use the device in health areas including: overall health (70%), quality of life (96%), leg spasticity (80%), sleeping (65%), decreased urinary incontinence episodes (71%) and decreased rate of urinary tract infections (57%). Help with having 22 children was reported by 14 owners. Problems with use included few or no erections (77%), skin problems (13%), and needing medication for high blood pressure during use (10%). Conclusions: This is the first survey of use and nonuse of a vibrator by individuals with SCI. High percentages of respondents reported benefit in areas of sexual health, quality of life, spasticity relief and bladder inhibition. Problems with use were limited. Thus, vibratory therapy should be considered further in SCI rehabilitation programs as well as for continued outcomes research.

USE OF FORMOTEROL IN THE TREATMENT OF STUTTERING. A PILOT STUDY

Stuttering is a serious health and social problem that can distinctively affect not only the mental development of an individual but also his life possibilities, including social fulfilment and his general life prospects. The etiology of stuttering is however unknown and that is why it is not possible to treat it causally. This pilot study takes into account the hypothesis of bronchial constriction as a negative factor in stuttering and investigates the effect of the long-acting bronchodilator formoterol fumarate on stuttering in 42 patients. Patients were divided in 2 groups - A (school children and juveniles) and B (adults 18-25 resistant to other treatment). The medicine was administered once a day in the morning in a dose of 12 microg for the total period of 6 months. The prime outcome parameter - severity of stuttering - was evaluated using the ordinary scale (McGill Pain Questionnaire). The evaluation was done by an examining physician during visits to the centres and by the patients themselves (in cases of the youngest with the assistance of a parent) in a daily diary. A non-parametric pair test (Wilcoxon signed rank test) was used to compare the average marks in the whole set of patients. During the six moth period of administration of Foradil the speech fluency improved. The average number of dysfluent words decreased from 10.5 +/- 1.3 to 6.6 +/-0.97. The average mark of speech fluency evaluated by the physicians between the period of non use of Foradil and the six month period after the use of Foradil improved from 2.95 +/- 0.76 to 1.95 +/- 0.56 (as proved by the chi-square test, p<0.0001). The evaluation of speech fluency of balbuties uses the logopedic practices. Other clinical evaluations of speech fluency are not known.

Performance of Trickle-Bed Air Biofilter: A Comparative Study of a Hydrophilic and a Hydrophobic Voc

Two lab-scale trickle-bed air biofilters were operated for investigating the difference in performance between a hydrophilic and a hydrophobic volatile organic compound (VOC). Methyl isobutyl ketone (MIBK) and styrene were selected as a model hydrophilic and hydrophobic VOCs, respectively. Effects of loading rates, biofilter re-acclimation, removal profile along biofilter depth, nitrogen consumption, and CO2 production were compared under three operating conditions, namely, backwashing and two non-use periods (starvation and stagnant).

Patterns of heroin, cocaine, and alcohol abuse during long-term methadone maintenance treatment

Individuals' use of heroin, cocaine, and alcohol during long-term methadone maintenance treatment (MMT) was studied. Prospectively collected data from 103 heroin-addicted individuals who were consecutively admitted for MMT and remained 2 years in treatment were evaluated. The patients were assessed every 6 months with a standardized interview. Three longitudinal patterns of drug abuse were identified. A proportion of patients abstained fully from their particular drug use (26% from heroin, 39% from cocaine, and 19% from alcohol); a proportion (39%, 32%, and 47%, respectively) switched between periods of abuse and nonuse of these drugs; and chronic drug users (34%, 28%, and 33%, respectively) continued use, including periods of daily abuse throughout MMT. Different therapeutic interventions may be needed in patients with different longitudinal patterns of additional substance use during MMT.

Evaluation of Trickle-Bed Air Biofilter Performance under Periodic Stressed Operating Conditions as a Function of Styrene Loading

Trickle-bed air biofilters (TBABs) are suitable for treating volatile organic compounds (VOCs) at a significantly high practical loading because of their controlled environmental conditions. The application of TBAB for treating styrene-contaminated air under periodic backwashing and cyclical nonuse periods at a styrene loading of 0.64–3.17 kg chemical oxygen demand (COD)/m3·day was the main focus of this study. Consistent long-term efficient performance of TBAB strongly depended on biomass control. A periodic in situ upflow with nutrient solution under media fluidization, that is, backwashing, was approached in this study. Two different nonuse periods were employed to simulate a shutdown for equipment repair or during weekends and holidays. The first is a starvation period without styrene loading, and the second is a stagnant period, which reflects no flow passing through the biofilter. For styrene loadings up to 1.9 kg COD/m3·day, removal efficiencies consistently above 99% were achieved by conducting a coordinated biomass control strategy, that is, backwashing for 1 hr once per week. Under cyclical nonuse periods for styrene loadings up to 1.27 kg COD/m3·day, stable long-term performance of the biofilter was maintained at more than 99% removal without employing back-washing. No substantial impact of nonuse periods on the biofilter performance was revealed. However, a coordinated biomass control by backwashing subsequently was unavoidable for attaining consistently high removal efficiency at a styrene loading of 3.17 kg COD/m3·day. As styrene loading was increased, reacclimation of the biofilter to reach the 99% removal efficiency following back-washing or the nonuse periods was delayed. After the nonuse periods, the response of the biofilter was a strong function of the biomass in the bed. No significant difference between the effects of the two different nonuse periods on TBAB performance was observed during the study period.

Evaluation of trickle-bed air biofilter performance for MEK removal

A lab-scale trickle-bed air biofilter (TBAB) was operated to evaluate the removal of methyl ethyl ketone (MEK) from waste gas. Three biomass control strategies were investigated, namely, backwashing and two non-use periods (starvation and stagnant). Five volumetric loading rates from 0.70 to 7.04 kg COD/m 3 day were employed. Backwashing once a week removed the excess biomass and obtained long-term, stable performance over 99% removal efficiency for loading rates less than 5.63 kg COD/m 3 day. The two non-use periods could also sustain 99% removal efficiency and could be employed as another means of biomass control for loading rates up to 3.52 kg COD/m 3 day. The non-use periods did not delay the recovery when the loading rate did not exceed 3.52 kg COD/m 3 day. The pseudo-first-order removal rate constant decreased with increase in volumetric loading rate. The effect of non-use periods on removal rate showed apparent transition from positive to negative with the increase in loading rate.