ResearchPad - original-research-article https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Evaluation of performance-enhancing drugs seized by Israeli enforcement agencies 2012–2017: implications for policy and regulatory change]]> https://www.researchpad.co/article/elastic_article_12747 Illicit performance-enhancing substances are used mostly by athletes to enhance performance in sports, and by bodybuilders to gain muscle and body mass. Among performance-enhancing substances, the most common and known substances are anabolic-androgenic steroids, which are associated with a range of short and long-term adverse medical and psychiatric effects.While the sale and distribution of performance-enhancing substances are considered criminal offenses per the Israeli local pharmacy ordinance, the use and personal possession of these substances are not. Presently, the Division of Enforcement and Inspection of the Israel Ministry of Health cooperates with police and customs agents in performance-enhancing substance-related enforcement activities, which chiefly include seizures carried out at suspicious sites. Moreover, the Division of Enforcement and Inspection provides professional guidance, lab analysis services, and expert opinions on the toxicological and pharmaceutical nature of products seized.This paper presents a contemporary sub-analysis of registered seizures of performance-enhancing substances carried-out by Israel enforcement agencies. The main aim of this analysis is to characterize current patterns of performance-enhancing substances, thus providing the possibility of better assessment of current enforcement and health policy.MethodsA sub-analysis of 712 seizures of performance-enhancing substances seized by Israeli enforcement authorities during a six-year period ranging from January 2012 to December 2017.ResultsThis study demonstrates that Israel faces a challenge regarding the importation and distribution of illicit performance-enhancing substances. The most common substances seized were anabolic androgenic steroids (N = 539). Most seizures were carried out in the central mail processing sites, (38.4%), followed by seizures in private premises such as homes and warehouses (29.6%). Significant differences were found between anabolic-androgenic steroids and other substances, relating to place and year of seizure. Among seizures with known sources (N = 355), the most frequent geographic region given as the source of substances was Eastern Europe (47.6%), followed by East Asia (24.8%), West Asia (19.4%), and Western Europe (5.9%). Bulgaria was the country with the highest frequency of seizures (N = 71) followed by Jordan (N = 45), Thailand (N = 37) and Moldova (N = 36). Significant regional differences were found based on the variables of gender, place of seizure, and type of substance. The most frequent month of seizures was August (N = 129), followed by July (N = 119), and June (N = 118).ConclusionsWhile data analysis focused on the supply side of the performance-enhancing substances market, the high number of seizures of performance-enhancing substances in Israel represents evidence of the existence of a high demand and a large consumer base for these products. Consequently, there is a need for developing further enforcement, treatment, and prevention policies that do not currently exist in Israel. Policymakers should consider prioritizing law enforcement action and incentivizing intelligence sharing to monitor suspected shipment sources and specific points of entry. Additionally, the results demonstrate that there is a need in reforming the penal law to discourage the use of performance-enhancing substances. Similar measures have already been applied in countries like Spain, Italy, and Belgium. Furthermore, policy-makers should consider enhancing health ministry agencies with a higher enforcement capacity by giving them further investigative and inquiry authority. Due to the troubling magnitude of the phenomenon, policymakers should also prioritize educational and prevention strategies. ]]> <![CDATA[Academic benchmarks for leaders in Otolaryngology - Head &amp; Neck Surgery: a Canadian perspective]]> https://www.researchpad.co/article/elastic_article_12024 The present study summarizes the demographics, subspecialty training, and academic productivity of contemporary leaders in Canadian Otolaryngology – Head & Neck Surgery (OHNS) training programs across Canada.MethodsDemographic data regarding chairpersons (CPs) and program directors (PDs) were obtained from publicly-available faculty listings and online sources, and included employment institution, residency training, fellowship training status, gender, and years of post-graduate experience. Research productivity was measured using the h-index and number of publications, obtained from Scopus. Characteristics of CPs and PDs were compared using statistical analysis.ResultsCross-sectional data was obtained from a total of 27 CPs and PDs from 13 accredited OHNS training programs across Canada active on July 1, 2019. All academic leaders completed at least 1 year of fellowship training. Head and neck oncology represented 77% of CPs and 59% of academic leaders overall, while pediatric otolaryngology represented 43% of PDs. Females represented 11% of academic leaders. There was a significant association between location of residency training and employment, with 56% (15/27) of physicians working where they had trained (p = 0.001, Fisher’s exact test; φ = 2.63, p = 0.001). On average, individuals with a graduate (Master’s) degree had a significantly higher H-index (17.7 vs 7.4, p = 0.001) and greater number of publications (106 vs. 52, p = 0.02). Compared to PDs, CPs had a significantly higher average h-index score (14.5 vs. 8.14, p = 0.04) and accrued more years of post-graduate experience (29.7 vs. 21.3 years, p = 0.008). There were no differences in the proportions of CPs and PDs with graduate degrees. There appeared to be a decline in research productivity beginning 3 years after academic appointment.ConclusionsThis cross-sectional overview of academic leaders in Canadian OHNS programs demonstrates the following key findings: 1) all leaders completed fellowship training; 2) head and neck surgical oncology was the most common fellowship training subspecialty; 3) leaders were likely to be employed at the institution where they trained; 4) a Master’s degree may be associated with increased research productivity; 5) there is a potential risk of decreased productivity after appointment to a leadership position; and 6) women are underrepresented in academic leadership roles. ]]> <![CDATA[Determinants of self-reported adherence to inhaler therapy in patients with chronic obstructive pulmonary disease]]> https://www.researchpad.co/article/elastic_article_11617 Adherence to therapy is crucial for COPD patients, since non-adherence leads to worse quality of life, increased health-care expenditure and poor clinical outcome. The aim of this study was to identify the main determinants of suboptimal adherence to therapy in a cohort of COPD patients.MethodsGeneral information (age, BMI, smoking, comorbidities, education, life style), lung function, exacerbations, symptoms and COPD treatment were collected. Adherence to therapy was assessed by self-reported 4-item Morisky Medication Adherence Scale (MMAS-4), and was related to anthropometric, socio/economic and health status data, obtained by questionnaires (COPD Assessment Test, CAT; Treatment Satisfaction Questionnaire, HRQoL; Katz Index of Independence of Daily Living Activities, Lawton Instrumental Activities of Daily Living Scale).Results136 COPD patients were studied (age 72±8 yrs; 73.5% men; BMI 28.5±7.4 kg/m2; FEV1 53.5±19.0 % predicted). Nearly half of the patients (46.3%) had suboptimal adherence to therapy (score >0) and, as compared to those with optimal adherence, had higher prevalence of women and coronary artery disease, heavier smoking history and worse CCQ overall score. The results of multivariate analysis showed that the determinants of suboptimal adherence were female sex (OR 4.339, 95%CI 1.509-12.474, p=0.006), amount of pack/years smoked (OR 1.947, 95%CI 1.141-3.323, p=0.015), higher CCQ overall score (OR 3.318, 95%CI 1.050-9.892, p=0.049) and higher education (OR 2.758, 95%CI 1.083-7.022, p=0.033). Adherence was better in patients assuming triple inhaler therapy.ConclusionsSuboptimal adherence is frequent among COPD patients, particularly in women, heavy smokers and subjects with high educational level. Interventions to improve adherence should be especially addressed to patients with these characteristics. ]]> <![CDATA[Community Vs. hospital HIV testing sites in Jerusalem, Israel - who’s tested and who’s at risk?]]> https://www.researchpad.co/article/elastic_article_9350 After decades of constant increase in HIV diagnoses among men who have sex with men (MSM), a gradual decrease has been reported in recent years. Timely detection of HIV leads to early treatment and behavioral changes which decrease further transmissions. This cross-sectional study aimed to assess demographic and behavioral characteristics of individuals who were tested for HIV in Jerusalem, Israel.MethodsThis study compared individuals who were tested at Hadassah AIDS Center (HAC) with those tested at the Jerusalem Open House (JOH) - an LGBTQ community center. Participants completed anonymous questionnaires regarding their demographic, HIV-testing history, and sexual behaviors. High-risk sexual behavior (HRSB) was defined as a diagnosis of sexually transmitted disease or condomless anal/vaginal sex during the last year.ResultsAmong 863 participants, 104 (12.1%) were tested in HAC and 759 (87.9%) in JOH. Of those, 19 (18.3%) and 227 (29.9%) were HRSB, respectively. Two MSM were tested positive in JOH. JOH received more MSM, HRSB and individuals who were previously tested for HIV, while HAC received more migrants and health-care workers. HRSB-participants were more commonly younger, males, non-Jewish, with lower income, previously tested for HIV, reported more sexual partners, payed for sex or used drugs.ConclusionsMSM and HRSB-individuals were more likely to be tested in JOH, while migrants and health-care workers in HAC, possibly due to the geographic location, reputation and specific atmosphere. In order to encourage HIV-tests among HRSB and non-Jews, additional interventions should be employed, including outreach activities, extending opening hours and reducing testing costs should be employed. ]]> <![CDATA[Creating an Age-Friendly Public Health System]]> https://www.researchpad.co/article/elastic_article_8823 The public health system in America—at all levels—has relatively few specialized initiatives that prioritize the health and well-being of older adults. And when public health does address the needs of older adults, it is often as an afterthought. In consultation with leaders in public health, health care, and aging, an innovative Framework for an Age-Friendly Public Health System (Framework) was developed outlining roles that public health could fulfill, in collaboration with aging services, to address the challenges and opportunities of an aging society.Research Design and MethodsWith leadership from Trust for America’s Health and The John A. Hartford Foundation, the Florida Departments of Health and Elder Affairs are piloting the implementation of this Framework within Florida’s county health departments and at the state level. The county health departments are expanding data collection efforts to identify older adult needs, creating new alliances with aging sector partners, coordinating with other agencies and community organizations to implement evidence-based programs and policies that address priority needs, and aligning efforts with the age-friendly communities and age-friendly health systems movements.Results, and Discussion and ImplicationsThe county health departments in Florida participating in the pilot are leveraging the Framework to expand public health practice, programs, and policies that address health services and health behaviors, social, and economic factors and environmental conditions that allow older adults to age in place and live healthier and more productive lives. The model being piloted in Florida can be tailored to meet the unique needs of each community and their older adult population. ]]> <![CDATA[Provision of immediate postpartum intrauterine contraception after vaginal birth within a public maternity setting: Health services research evaluation]]> https://www.researchpad.co/article/elastic_article_7141 Expanding access to postpartum intrauterine contraception (PPIUC) can reduce unintended pregnancies and short inter‐pregnancy intervals; however, provision across Europe is limited. Our aim was to determine the feasibility, clinical outcomes and patient satisfaction of providing immediate PPIUC after vaginal birth using a health services research model.Material and methodsPhased introduction of PPIUC across two Lothian maternity hospitals; all women intending vaginal birth during the study period without a contraindication to use of the method were eligible to receive PPIUC. Midwives and obstetric doctors were trained in vaginal PPIUC insertion using Kelly forceps. Women received information antenatally and had PPIUC insertion of either a levonorgestrel intrauterine system or a copper intrauterine device within 48 hours of vaginal birth. Follow‐up was conducted in‐person at 6 weeks postpartum and by telephone at 3, 6 and 12 months. Primary outcomes were: uptake, complications (infection, uterine perforation), expulsion and patient satisfaction at 6 weeks; and method of continuation up to 12 months. Secondary outcomes included hazard ratio for expulsion adjusted for demographic and insertion‐related variables.ResultsUptake of PPIUC was 4.6% of all vaginal births; 465/447 (96.1%) of those requesting PPIUC successfully received it and most chose a levonorgestrel intrauterine system (73%). At 6 weeks postpartum, the infection rate was 0.8%, there were no perforations and 98.3% of women said they would recommend the service. The complete expulsion rate was 29.8% (n = 113) and most had symptoms (n = 79). Of the additional 121 devices removed, 118 were because of partial expulsion. The rate of complete/partial expulsion was higher for insertions by midwives compared with those by doctors. The re‐insertion rate after expulsion/removal was 87.6% and method continuation at 12 months was 79.6%.ConclusionsRoutine PPIUC at vaginal birth is feasible. Complications were extremely rare. High expulsion rates may be observed in early stages of service introduction and with inexperienced providers. Re‐insertion and therefore longer‐term continuation rates of intrauterine contraception were very high. In settings with low rates of attendance for interval postpartum intrauterine contraception insertion, PPIUC could be a useful intervention to prevent unintended and closely spaced pregnancies. ]]> <![CDATA[Human milk sIgA antibody in relation to maternal nutrition and infant vulnerability in northern Kenya]]> https://www.researchpad.co/article/elastic_article_6597 The maternal buffering hypothesis posits that human lactation biology can buffer milk against the mild-to-moderate malnutrition that occurred routinely in evolutionary history through the mobilization of maternal body reserves. This perspective may provide insights for understanding human milk immune content variation, such as milk sIgA, which protects infants’ intestines from microbial colonization and prevents diarrheal disease.ObjectiveTo investigate how maternal delivery of sIgA to milk may vary in a way that can buffer milk against maternal malnutrition, while taking into consideration infants’ varying needs for immune protection across age or by sex.MethodologyA cross-sectional study analyzed archived milk specimens from breastfeeding mothers in Ariaal communities of northern Kenya surveyed during the 2006 Horn-of-Africa drought. Multiple regression models for ln-transformed sIgA were constructed using maternal nutrition, infant age/sex and their interactions as predictors. Maternal nutrition variables included iron-deficiency anemia (IDA), vitamin A deficiency (VAD) and mid-upper arm circumference (MUAC). Infant vulnerability was considered high in young age and/or male sex.Results and implicationsMilk sIgA did not significantly differ by maternal IDA. Milk sIgA increased with infant age and maternal MUAC (n = 202). Significant interactions were observed between infant age and maternal VAD and between infant sex and maternal MUAC, such that milk sIgA content was low for younger infants particularly among VAD mothers, while among mothers with low MUAC, sIgA was lower for male infants. Results imply that mothers’ ability to deliver/buffer milk sIgA may be lowered when nutritional stress is combined with high infant vulnerability to infection.Lay SummaryHuman milk sIgA antibody content was low for younger infants among vitamin A deficient mothers. Among mothers with small arm-circumference, milk sIgA was lower for sons. Double burden of raising young or male infants with high needs for immune protection and being malnourished, might lower maternal sIgA delivery to milk. ]]> <![CDATA[Comparison of the Efficacy and Safety of Adalimumab (Humira) and the Adalimumab Biosimilar Candidate (HS016) in Chinese Patients with Active Ankylosing Spondylitis: A Multicenter, Randomized, Double-Blind, Parallel, Phase III Clinical Trial]]> https://www.researchpad.co/article/elastic_article_6119 The aim of this study was to evaluate the efficacy and safety of the biosimilar candidate of adalimumab (HS016) compared with adalimumab (Humira) for the treatment of active ankylosing spondylitis.MethodsA multicenter, randomized, double-blind, parallel, positive control, phase III clinical trial was conducted at 28 locations in China. Patients with active ankylosing spondylitis were randomized in a 2:1 ratio to subcutaneously receive 40 mg of either HS016 or adalimumab every other week for 24 weeks. The primary endpoint was to achieve at least a 20% improvement (ASAS20) in patients at 24 weeks according to the Assessment of Spondyloarthritis International Society criteria. The secondary endpoint included other efficacy assessment parameters, health evaluations, safety, pharmacokinetic, and immunogenicity parameters.ResultsFollowing the random assignment of 648 patients into HS016 (n = 416) and adalimumab (n = 232) groups, no significant difference was found in the ASAS20 response rates at 24 weeks between the HS016 (364/416, 87.5%) and adalimumab (209/232, 90.1%) treatments and the difference between the response rates (− 2.59%; 90% confidence interval [CI] − 6.77 to 1.60) was within the predefined equivalence margin (± 15%). There were also no significant differences when the secondary endpoints were compared (all p > 0.05). Similarly, the rates of treatment-emergent adverse events (TEAEs) were not significantly different between the two groups, with most TEAEs being mild to moderate. Only nine severe cases were found, including seven within the HS016 group, three (0.7%) of which were tuberculosis cases. Plasma concentrations of HS016 and adalimumab from weeks 12 to 14 were similar during the steady-state period and steady-state maximal concentration (Cmax,ss) was equivalent for HS016 (7356.6 ng/mL) and adalimumab (7600.3 ng/mL). The accumulated proportion of patients with positive human anti-human antibodies (HAHAs) at week 24 was 326/412 (79.1%) in the HS016 group and 183/229 (79.9%) in the adalimumab group (p > 0.05), while the accumulated proportion of patients with positive neutralizing antibody (NAb) tests were 72/412 (17.5%) in the HS016 group and 43/229 (18.8%) in the adalimumab group (p > 0.05).ConclusionHS016 resembled adalimumab in efficacy and safety over the 24-week treatment period.Trial registration numberChiCTR1900022520.Electronic supplementary materialThe online version of this article (10.1007/s40259-020-00408-z) contains supplementary material, which is available to authorized users. ]]> <![CDATA[An Open-Label Phase 1 Study to Determine the Effect of Lenvatinib on the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Patients with Advanced Solid Tumors]]> https://www.researchpad.co/article/elastic_article_6106 Lenvatinib is a multikinase inhibitor that inhibits enzyme activity but induces gene expression of cytochrome P450 3A4 (CYP3A4), an important enzyme for drug metabolism. We evaluated the impact of lenvatinib on CYP3A4 using midazolam as a probe substrate in patients with advanced solid tumors. The primary objective was to determine the pharmacokinetic effects of lenvatinib on midazolam, and the secondary objective was to assess the safety of lenvatinib.MethodsThis multicenter, open-label, nonrandomized, phase 1 study involved patients with advanced cancer that progressed after treatment with approved therapies or for which no standard therapies were available.ResultsCompared with baseline, coadministration of lenvatinib decreased the geometric mean ratio of the area under the concentration–time curve for midazolam on day 1 to 0.914 (90% confidence interval [CI] 0.850–0.983) but increased it on day 14 to 1.148 (90% CI 0.938–1.404). Coadministration of lenvatinib also decreased the geometric mean ratio of the maximum observed concentration for midazolam on day 1 to 0.862 (90% CI 0.753–0.988) but increased it on day 14 to 1.027 (90% CI 0.852–1.238). There was little change in the terminal elimination phase half-life of midazolam when administered with lenvatinib. The most common treatment-related adverse events were hypertension (20.0%), fatigue (16.7%), and diarrhea (10.0%).ConclusionsCoadministration of lenvatinib had no clinically relevant effect on the pharmacokinetics of midazolam, a CYP3A4 substrate. The adverse events were consistent with the known safety profile of lenvatinib, and no new safety concerns were identified.ClinicalTrials.Gov IdentifierNCT02686164. ]]> <![CDATA[Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin<sup>®</sup> with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology]]> https://www.researchpad.co/article/elastic_article_6091 A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties as well as nonclinical and clinical outcomes.ObjectivesThe aim was to assess the analytical similarity between the trastuzumab biosimilar HLX02 and Europe-sourced Herceptin® (EU-Herceptin®) and China-sourced Herceptin® (CN-Herceptin®) following a quality-by-design (QbD) quality study and tier-based quality attribute evaluation.MethodsA panel of highly sensitive and orthogonal methods, including a novel Fc gamma receptor IIIa (FcγRIIIa) affinity chromatography technique that enables quantitative comparison of glycan effects on effector function, was developed for the assessment. To ensure the full product variability was captured, ten batches of HLX02 were compared with 39 RP batches with expiry dates from August 2017 to March 2021.ResultsThe extensive three-way similarity assessment demonstrated that HLX02 is highly similar to the RPs. Furthermore, the %afucose, %galactose, and FcγRIIIa affinity of the RPs were observed to first decrease and then return to the original level in relation to their expiry dates, and the RP batches can be subgrouped by their FcγRIIIa affinity chromatograms. HLX02 is demonstrated to be more similar to the RPs of the high FcγRIIIa affinity group.ConclusionBesides having an overall high analytical similarity to both EU-Herceptin® and CN-Herceptin®, HLX02 is more similar to Herceptin® with high FcγRIIIa affinity, a result that demonstrates the power of the novel FcγRIIIa affinity chromatography technology in biosimilarity evaluation.Electronic supplementary materialThe online version of this article (10.1007/s40259-020-00407-0) contains supplementary material, which is available to authorized users. ]]> <![CDATA[Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study]]> https://www.researchpad.co/article/elastic_article_6068 The aim was to compare outcomes in adult patients with inflammatory bowel disease (IBD) who switched to infliximab-dyyb with those who remained on reference product (RP) infliximab in the United States (US) in a retrospective, propensity score-matched, non-inferiority cohort trial.MethodsThis study was a retrospective, non-inferiority study conducted within a US integrated healthcare system and included adult patients with a confirmed diagnosis of Crohn’s disease or ulcerative colitis. A 1:1 propensity score matching was utilized to match patients who switched to infliximab-dyyb during the period April 2016–March 2018 to patients who remained on RP infliximab. The non-inferiority margin was set at + 10% of the upper limit. The primary outcome was a composite measure of disease worsening requiring acute care after the index date of switching to infliximab-dyyb or continuing RP infliximab. Disease worsening requiring acute care was defined as any IBD-related emergency room visit, hospitalization, or surgery. The secondary outcome was the composite measure of disease worsening requiring acute care or treatment failure. A switch to another biologic or tofacitinib was a proxy for treatment failure. All patients were followed for up to 9 months.ResultsAfter propensity score matching, the matched cohort included 1409 patients in the infliximab-dyyb group and 1409 patients in the RP infliximab group. The overall mean age (± standard deviation) was 47.7 ± 17.0 years, 50.9% of patients were of male gender, and 51.8% of patients had Crohn’s disease, while the remainder of the cohort had ulcerative colitis. There were 144 patients (10.2%) in the infliximab-dyyb group and 245 patients (17.4%) in the RP infliximab group who experienced disease worsening requiring acute care (P < 0.01 for non-inferiority). There were 347 patients (24.6%) in the infliximab-dyyb group who experienced disease worsening requiring acute care or treatment failure compared to 375 patients (26.6%) who remained on RP infliximab (P < 0.01 for non-inferiority).ConclusionThere was no increased risk of (1) disease worsening requiring acute care or (2) disease worsening requiring acute care or treatment failure in patients with IBD who switched from RP infliximab to infliximab-dyyb when compared to patients who remained on RP infliximab in this US population. Infliximab-dyyb is an option for patients with IBD who need to use RP infliximab. ]]> <![CDATA[Effects of DTL electrode position on the amplitude and implicit time of the electroretinogram]]> https://www.researchpad.co/article/N0e98d302-10c2-4dd6-b00c-93007a339b3c This study sought to investigate whether there is an optimal position of the Dawson, Trick, and Litzkow (DTL) electrodes when measuring the full-field electroretinogram (ERG) for monitoring purposes.MethodsIn 200 uveitis patients, an extended light-adapted (LA) ERG protocol was measured twice, incorporating the International Society for Clinical Electrophysiology of Vision standards. First, a LA ERG was measured with the DTL in the lower lid position (LLP) and thereafter in the fornix position. Differences in amplitudes and implicit times of a-waves, b-waves, and the 30 Hz peak were investigated. Intraclass correlation coefficients (ICCs) as well as coefficients of variation (CoV) were calculated, to assess both reliability and relative variability between the two DTL positions.ResultsImplicit times showed no statistically significant differences between the two DTL positions. As expected, amplitudes at the different stimulus strengths were 1.12–1.19 higher in the LLP, but there were no significant differences in the CoV between the two DTL positions. The ICC was high for the b-wave and 30 Hz flicker response (0.842–0.979), but lower for the a-wave, especially for amplitudes (0.584–0.716).ConclusionsFor monitoring purposes in patients, we conclude that based on relative variability, no position is preferable above the other. However, because in most diseases amplitudes are decreased, the LLP may be chosen because it yields higher amplitudes. Whatever the choice, it is important to ensure that the DTL position remains stable during an ERG recording.Electronic supplementary materialThe online version of this article (10.1007/s10633-019-09733-3) contains supplementary material, which is available to authorized users. ]]> <![CDATA[Attitudes, knowledge, and preferences of the Israeli public regarding the allocation of donor organs for transplantation]]> https://www.researchpad.co/article/N26e517c2-f84a-4238-9199-8656537fc723 There is a stark disparity between the number of patients awaiting deceased-donor organ transplants and the rate at which organs become available. Though organs for transplantation are assumed to be a community resource, and the organ supply depends on public willingness to donate, current allocation schemes do not explicitly incorporate public priorities and preferences. This paper seeks to provide insights regarding the Israeli public’s preferences regarding criteria for organ (specifically, kidney) allocation, and to determine whether these preferences are in line with current allocation policies.MethodsA market research company administered a telephone survey to 604 adult participants representing the Jewish-Israeli public (age range: 18–95; 50% male). The questionnaire comprised 39 questions addressing participants’ knowledge, attitudes, and preferences regarding organ donation and criteria for organ allocation, including willingness to donate.ResultsThe criteria that respondents marked as most important in prioritizing waitlist candidates were maximum medical benefit (51.3% of respondents) and waiting time (21%). Donor status (i.e., whether the candidate is registered as an organ donor) was ranked by 43% as the least significant criterion. Most participants expressed willingness to donate the organs of a deceased relative; notably, they indicated that they would be significantly more willing to donate if organ allocation policies took their preferences regarding allocation criteria into account. Unlike individuals in other countries (e.g., the UK, the US, and Australia) who responded to similar surveys, Israeli survey respondents did not assign high importance to the candidate’s age (24% ranked it as the least important factor). Interestingly, in some cases, participants’ declared preferences regarding the importance of various allocation criteria diverged from their actual choices in hypothetical organ allocation scenarios.ConclusionsThe findings of this survey indicate that Israel’s citizens are willing to take part in decisions about organ allocation. Respondents did not seem to have a strict definition or concept of what they deem to be just; yet, in general, their preferences are compatible with current policy. Importantly, participants noted that they would be more willing to donate organs if their preferences were integrated into the allocation policy. Accordingly, we propose that allocation systems must strive to respect community values and perceptions while maintaining continued clinical effectiveness. ]]> <![CDATA[Wisdom Once Gained Is Not Easily Lost: Implicit Theories About Wisdom and Age-Related Cognitive Declines]]> https://www.researchpad.co/article/Ndac50045-6209-407c-befb-c05832136779 Most people agree that cognitive capabilities are an integral component of wisdom and its development. However, a question that has received less attention is whether people view maintaining cognitive capabilities as a necessary prerequisite for maintaining wisdom.Research Design and MethodsThis study used a mixed-methods approach to evaluate people’s views about the relationship between age-related cognitive declines, Alzheimer’s disease (AD), and wisdom. Our final sample of 1,519 adults ranged in age from 18 to 86.ResultsThe majority of participants stated that wisdom could be present even in people with significant age-related cognitive declines or with AD. In the qualitative responses, common justifications for this were (a) that even people with severe AD can still exhibit wise behaviors during lucid moments, (b) that wisdom is an immutable characteristic that is impossible to lose, and (c) that wisdom maintenance and cognitive capability maintenance are separate constructs.Discussion and ImplicationsAlthough prior research has examined implicit theories about the role of cognition in the development of wisdom, this is the first study to examine implicit theories about whether cognitive declines lead to wisdom declines. The results suggest that most people hold essentialist beliefs about wisdom, viewing it as a fixed and unchangeable trait rather than as a malleable skill. ]]> <![CDATA[Patient-ventilator asynchrony in conventional ventilation modes during short-term mechanical ventilation after cardiac surgery: randomized clinical trial]]> https://www.researchpad.co/article/N44014a4f-19a5-46a3-bcc7-8d88369b05f0 Studies regarding asynchrony in patients in the cardiac postoperative period are still only a few. The main objective of our study was to compare asynchronies incidence and its index (AI) in 3 different modes of ventilation (volume-controlled ventilation [VCV], pressure-controlled ventilation [PCV] and pressure-support ventilation [PSV]) after ICU admission for postoperative care.MethodsA prospective parallel randomised trialin the setting of a non-profitable hospital in Brazil. The participants were patients scheduled for cardiac surgery. Patients were randomly allocated to VCV or PCV modes of ventilation and later both groups were transitioned to PSV mode.ResultsAll data were recorded for 5 minutes in each of the three different phases: T1) in assisted breath, T2) initial spontaneous breath and T3) final spontaneous breath, a marking point prior to extubation. Asynchronies were detected and counted by visual inspection method by two independent investigators. Reliability, inter-rater agreement of asynchronies, asynchronies incidence, total and specific asynchrony indexes (AIt and AIspecific) and odds of AI ≥10% weighted by total asynchrony were analysed. A total of 17 patients randomly allocated to the VCV (n=9) or PCV (n=8) group completed the study. High inter-rated agreement for AIt (ICC 0.978; IC95%, 0,963-0.987) and good reliability (r=0.945; p<0.001) were found. Eighty-two % of patients presented asynchronies, although only 7% of their total breathing cycles were asynchronous. Early cycling and double triggering had the highest rates of asynchrony with no difference between groups. The highest odds of AI ≥10% were observed in VCV regardless the phase: OR 2.79 (1.36-5.73) in T1 vs T2, p=0.005; OR 2.61 (1.27-5.37) in T1 vs T3, p=0.009 and OR 4.99 (2.37-10.37) in T2 vs T3, p<0.001.ConclusionsThere was a high incidence of breathing asynchrony in postoperative cardiac patients, especially when initially ventilated in VCV. VCV group had a higher chance of AI ≥10% and this chance remained high in the following PSV phases. ]]> <![CDATA[Efficacy, Tolerability, and Safety of Concentrated Intranasal Midazolam Spray as Emergency Medication in Epilepsy Patients During Video-EEG Monitoring]]> https://www.researchpad.co/article/N2b7b433c-f8f9-4f8a-94a3-9c7a47ab0613 An efficient, well tolerated, and safe emergency treatment with a rapid onset of action is needed to prevent seizure clusters and to terminate prolonged seizures and status epilepticus.ObjectivesThis study aimed to examine the efficacy, tolerability, and safety of intranasal midazolam (in-MDZ) spray in clinical practice.MethodsIn this retrospective, multicenter observational study, we evaluated all patients with peri-ictal application of in-MDZ during video-EEG monitoring at the epilepsy centers in Frankfurt and Marburg between 2 014 and 2017. For every patient, we analyzed the recurrence of any seizure or generalized tonic–clonic seizures after index seizures with and without in-MDZ administration. Treatment-emergent adverse events (TEAEs) were also evaluated.ResultsIn-MDZ was used in 243 patients with epilepsy (mean age 35.5 years; range 5–76 years; 46.5% female) for treatment of 459 seizures. A median dose of in-MDZ 5 mg (i.e., two puffs; range 2.5–15 mg) was administered within a median time from EEG seizure onset until in-MDZ application of 1.18 min [interquartile range (IQR) 1.27], while median time from clinical seizure onset until in-MDZ administration was 1.08 min (IQR 1.19). In-MDZ was given within 1 min after EEG seizure onset in 171 seizures. An intraindividual comparison of seizures with and without application of in-MDZ was feasible in 171 patients, demonstrating that in-MDZ reduced the occurrence of any (Cox proportional-hazard model p < 0.001) and generalized tonic–clonic seizure (Cox proportional-hazard model p = 0.0167) over a period of 24 h. The seizure-free timespan was doubled from a median of 5.0 h in controls to a median of 10.67 h after in-MDZ administration. We additionally clustered in-MDZ administrations for the 119 patients who received in-MDZ more than once, comparing them with the index cases without in-MDZ. Even when considering subsequent seizures with in-MDZ administration, a patient receiving in-MDZ is still half as likely to incur another seizure in the upcoming 24 h as compared with when the same patient does not receive in-MDZ (hazard ratio 0.50; 95% CI 0.42–0.60; p < 0.01). In-MDZ was well tolerated without major adverse events. The most common side effects were irritation of the nasal mucosa [37 cases (8.1%)], prolonged sedation [26 cases (5.7%)], and nausea and vomiting [12 cases (2.6%)]. A decline in oxygen saturation was measured after 78 seizures (17%).ConclusionWe conclude that in-MDZ is a safe and efficient treatment option to prevent short-term recurrence of seizures. In-MDZ can be administered very quickly by trained staff within 1–2 min after seizure onset. No major cardiocirculatory or respiratory adverse events were observed. ]]> <![CDATA[A Practical Methodology for Improving the Aging-Friendliness of Communities: Case Studies from Three U.S. Communities]]> https://www.researchpad.co/article/N2c0a9a40-fec1-49a4-87f4-47aa94e10077

Abstract

Background and Objectives

In this paper, we present a series of three case studies to illustrate an innovative and practical approach to improving the aging-friendliness of communities. These three communities used the AdvantAge Initiative to “listen” to the voices of older adults in their communities and to identify and prioritize aging-related issues. This approach was developed by the Center for Home Care Policy and Research at the Visiting Nurse Service of New York (VNSNY), the largest not-for-profit home health care organization in the United States, and has been implemented in over 60 communities throughout the United States. The methodology involves tools such as conceptual frameworks, survey questionnaires, focus groups, and technical assistance to help stakeholders interpret data and find solutions to identified issues.

Research Design and Methods

We interviewed VNSNY program staff and community partners involved in three AdvantAge Initiative projects that commenced at varying time points: Memphis and Shelby County, Tennessee (2012); New York City’s Chinatown neighborhood (2006); and the state of Indiana (2008). We also collected and reviewed secondary materials associated with these projects (e.g., meeting notes from community planning meetings, annual reports from grant recipients, press coverage).

Results

In this case study, we begin by providing an overview of the AdvantAge Initiative framework and the AdvantAge Initiative key indicators. We then present a more in-depth look at the three communities and how they approached and implemented the AdvantAge Initiative.

Discussion and Implications

These case studies demonstrate that this methodology may be implemented in diverse communities and geographic locations. By looking at the longer-term outcomes and by comparing the strategies employed by each community, we see that communities, regardless of size, can bring stakeholders together to promote health and implement meaningful changes that make the community a better place to live for older adults and their families.

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<![CDATA[Patient satisfaction with primary care physician performance in a multicultural population]]> https://www.researchpad.co/article/N14742f70-241b-40ca-802c-6e9bea8caf3c

Background

A key component of the quality of health care is patient satisfaction, particularly in regard to Primary Care Physician (PCP), which represents the first contact with health care services. Patient satisfaction is associated with ethnic, regional and socio-demographic differences, due to differences in service quality, patient-doctor communication, and the patient’s perceptions. The aim of this study was to evaluate patients’ satisfaction related to primary care physicians’ (PCP) performance and to explore potential differences by ethnicity in a multicultural population.

Methods

A national cross-sectional telephone survey was conducted, among a random sample of the Israeli population aged ≥25 years. Satisfaction level from performance of PCP was assessed using a validated questionnaire (30 items; 6 different domains).

Results

The final sample included (n = 827 Jews; n = 605 Arabs, mean age 54.7(±14.9). In the adjusted logistic regression models, Arabs reported lower general satisfaction related to PCPs’ performance as compared to Jews (adjusted odds ratio (AOR), 0.63; (95% CI: 0.40–0.98). Arabs reported lower satisfaction related to PCPs’ performance across the following domains: communication skills (AOR, 0.42; 95% CI, 0.22–0.82); interpersonal manners (AOR, 0.37; 95% CI, 0.24–0.58); and time spent with the patients (AOR, 0.60; 95% CI, 0.43–0.85).

Conclusions

Jews and Arabs were very satisfied with PCPs’ performance. However, there are ethnic differences in the extent of satisfaction level related to the performance of PCP. Satisfaction from PCPs’ performance may be achieved by improving the communication skills of the PCP, encouraging interpersonal interaction between the PCP and the patient, and devoting more time to the patient during the visits.

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<![CDATA[Molecular Detection of Human Metapneumovirus and Human Bocavirus on Oropharyngeal Swabs Collected from Young Children with Acute Respiratory Tract Infections from Rural and Peri-Urban Communities in South India]]> https://www.researchpad.co/article/N3161d110-bcaf-489f-8618-35762a79594f

Background

Acute respiratory tract infections (ARTIs) are one of the major causes of morbidity and mortality among young children in developing countries. Information on the incidence of human metapneumovirus (hMPV) and human bocavirus (HBoV) infections in developing countries, especially among rural children, is very limited.

Objectives

This study was conducted to identify whether these viruses were associated with ARTI among children ≤5 years of age in rural and peri-urban populations in South India.

Methods

The study was cross-sectional with prospective sample collection. Oropharyngeal swabs were collected from children ≤5 years of age presenting with ARTI. None of the children in this study were known to have any immunosuppressive conditions. The two viruses, hMPV and HBoV, were identified using semi-nested polymerase chain reaction (PCR) assays and one-step PCR assays, respectively. The lower limits of detection of hMPV and HBoV were 6.69 × 105 plasmid copies and 5.77 × 103 plasmid copies, respectively, per 5 μL PCR reaction input.

Results

The frequency of hMPV infection in children was higher than that of HBoV infection. The different frequencies of hMPV in patients in various age groups with upper and lower respiratory tract infections were compared, and the variance was found to be insignificant. In the 38 children who were hMPV positive, the majority (73.7 %) were from rural communities. The overall hMPV-positive rate was higher in the rural population than in the peri-urban population, but the difference was statistically insignificant. The youngest age at which hMPV-positive status was recorded was 5 months.

Conclusion

This study demonstrated that hMPV was associated with a significant number (i.e. >10 %) of ARTIs in children in South India, whereas a relatively smaller number of HBoV infections was observed.

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<![CDATA[Molecular Detection of Streptococcus pyogenes by Strand Invasion Based Amplification Assay]]> https://www.researchpad.co/article/Nefd23bcb-6f7a-4765-a535-396b8ef58c64

Introduction

Streptococcus pyogenes (group A Streptococcus, GAS) is responsible for a variety of highly communicable infections, accounting for 5–15 and 20–30% of sore throat hospital visits in adults and children, respectively. Prompt diagnosis of GAS can improve the quality of patient care and minimize the unnecessary use of antibiotics.

Objective

Our objective was to develop an alternative nucleic acid amplification method for the diagnosis of GAS.

Method

We developed and evaluated a strand invasion based amplification (SIBA) assay to rapidly and specifically detect GAS. The performance of the developed GAS SIBA assay was compared with an established GAS polymerase chain reaction (PCR) assay.

Results

The GAS SIBA assay detected small amounts (ten copies) of S. pyogenes DNA within 13 min. The rapid detection time was achieved in part by optimization of magnesium concentration and reaction temperature. The sensitivity and specificity of the GAS SIBA assay for detection of S. pyogenes from clinical specimens were both 100%, and clinical specimens were detected within ~ 8 min of starting the reaction.

Conclusion

Because the GAS SIBA assay is performed at low and constant temperature, it can be used both in centralized laboratories and for point-of-care testing. Furthermore, given its short detection time and strong analytical performance, the GAS SIBA assay could help to improve patient care and minimize unnecessary prescription of antibiotics.

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