465 Unmasking the prevalence of cardiac amyloidosis in the real world: first insights from the phase 2 of active study, an Italian nationwide survey

Aims Clinicians needs to identify patients with cardiac amyloidosis (CA) at an early stage, due to the availability of disease modifying therapies. Some echocardiographic findings may rise the suspicion of CA, also in patients with mild or no symptoms, addressing second level diagnostic tests. To investigate the prevalence of CA in consecutive patients ≥55 years undergoing clinically indicated, routine transthoracic echocardiogram (TTE) in Italy with echocardiographic signs suggestive of CA. Methods and results This is a prospective multicentric study conducted in Italy. It comprises two phases: 1) an observational phase consisting in a national survey on prevalence of possible echocardiographic red flags of CA in consecutive patients ≥55 years undergoing routine TTE (previously published) and 2) a CA diagnostic phase. Preliminary results of phase 2 are herein presented. Patients that in the phase 1 presented a CA-suggestive TTE (i.e. at least one red flag of CA in hypertrophic, non-dilated left ventricles) were re-evaluated for a cardiological visit. Those who consented to proceed in the study, underwent clinical evaluation, blood and urine tests and scintigraphy with bone tracer. Diagnosis of transthyretin related-CA (TTR-CA) was made in presence of Grades 2–3 Perugini uptake at scintigraphy and absence of monoclonal protein. The study was registered at ClinicalTrials.gov (#NCT04738266). Of the 5315 screened echocardiograms, 381 exams (7.2%) were classified as AC-suggestive. Two-hundred-twelve of the 381 patients with a CA-suggestive TTE underwent phase 2 study. Main reasons for the 169 non-entering patients into the phase 2 were death (n = 53) and refusal to participate (n = 85). Sixty-five of these 212 patients (31%; 17% considering also the 169 non-entering patients into the phase 2) had a diagnosis of CA. Finally, TTR-CA was diagnosed in 53 (25%) and AL-CA in 12 (5.7%) patients. Conclusions Among a cohort of consecutive unselected patients ≥55 years with echocardiographic findings suggestive of CA, the real prevalence of CA ranged from 17 up to 31%. Although TTR-CA was predominant, AL-CA was diagnosed in a significant amount of cases. TTE has a fundamental role in screening patients, raising the suspicion of CA and orienting diagnostic work-up for CA.

Reproductive Services and Conscience-Based Refusals in Obstetrics and Gynecology Training

Purpose: Professional bodies such as the American College of Obstetrics and Gynecology recognize the impact of conscience-based decisions. The first time such decisions affect patients and providers is in residency. Our study sought to determine the attitudes of program directors towards various conscience-based refusals in potential applicants to obstetrics and gynecology programs. Method: An eight-question survey was sent to 279 directors of U.S. obstetrics and gynecology residencies in 2019. The survey proposed hypothetical conscientious refusals of common aspects of obstetric and gynecology practice. The survey asked respondents to categorize their reaction to these choices and choose from a list of factors which could modify their reaction. Univariate analysis and multivariate logistic regression were performed. Results: 97 program directors (35%) responded. A majority of PDs reported that the inability to prescribe or counsel on birth control, to provide methotrexate, to counsel on abortion, or to clearly enumerate refusals was impossible to work around, likely to lower an applicant’s rank, not compatible with training, or not good for patients; collectively, these responses were grouped as “negative reactions” (73–99%). Female program directors had more negative reactions to applicants who refused to prescribe birth control (aOR 15.8, 95% CI 1.7–99.5) and counsel on abortion (aOR 3.6, 95% CI 1.2–10.8). Directors from different locations and program types did not have significantly different responses. A few program directors identified that academic strength could mitigate otherwise negatively-viewed choices. Illustrative comments of directors’ attitudes are provided. Conclusions: Program directors agree that conscientious refusal to participate in certain activities is problematic for obstetrics and gynecology residency. There are very few subjective or regional differences on this stance, and few aspects of an application modify directors’ reactions.

THE IMAGE OF THE CONFESSIONAL OTHERS: OLD-BELIEVERS WANDERERS IN THE ORAL HISTORY OF THE UPPER PECHORA AND UDORA KOMI-ZYRYANS

Образы «других» являются неотъемлемой частью фольклорной картины мира, играя значимую роль в (само) идентификации этнических и конфессиональных групп. В ходе непосредственного общения формируются народные представления о конфессиональных особенностях «других», выделяется набор признаков, маркирующих их в качестве таковых. В статье рассматривается формирование и трансформация представлений о конфессиональном «другом» в моноэтничной поликонфессиональной среде на примере староверов-странников, проживавших в Удорском и Троицко-Печорском районах Республики Коми. Источниковой базой исследования послужили архивные данные и полевые материалы фольклорно-этнографических экспедиций, проходивших в начале 2000-х гг. Появление староверов-странников, позиционировавших себя как хранителей «истинной веры» и стремившихся максимально ограничить контакты с иноверцами, стало толчком для выделения этой группы в качестве конфессиональных «других». На верхней Печоре, на момент проведения исследований, страннические общины существовали; здесь сохранялась идеологическая конфронтация между разными группами верующих, что нашло отражение в различных локальных номинациях странников. На Удоре, где последователи странников исчезли в 1970-е гг., повсеместно использовался экзоконфессионим, не имевший оценочных коннотаций. Определяющее влияние на формирование представлений о странниках как о «других» оказали их религиозные практики. Ключевым показателем, характеризующим суть вероучения в глазах конфессиональных соседей, равно как и самих странников, стало «бегство от мира» — полный отказ от участия в государственной и общественной жизни, от любого взаимодействия с иноверцами. Не менее значимыми для системы представлений о данной группе были особенности погребальной обрядности (тайные похороны удорских странников) и крещения (крещение в пожилом возрасте). Закрытость повседневной и ритуальной жизни странников способствовала распространению слухов, компенсировавших отсутствие информации. Изменение исторических реалий (исчезновение удорских странников, изменение возрастного состава общин) вело к изменениям и коррективам существовавших представлений. The images of the Others are an integral part of the folklore worldview, also they play a significant role in the (self) identification of ethnic and confessional groups. Folk ideas about the confessional characteristics of the Others, as well as a set of features that allowed to mark them as the Others are formed in the course of direct communication. The article examines the formation and transformation of ideas about a confessional Other in a mono-ethnic and poly-confessional environment, using the example of Old-Believers Wanderers who lived in the Udorskii and Troitsko-Pechorskii districts of the Komi Republic. The article based on the archival data and field materials of folklore and ethno-graphic’ expeditions that took place in the early 2000s. The emergence of Wanderers, who were positioning themselves as keepers of the «true faith», and striving to limit contacts with non-Wanderers as much as possible, became the impetus for singling out this group as confessional Others. On the upper Pechora, where at the time of our research Wanderer’s communities existed, the ideological confrontation between different groups of believers were still persisted, that was reflected in various local nomination of Wanderers. On Udora, where the followers of the Wanderers disappeared in the 1970s, an outer nomination of this confessional group was widely used, which had no evaluative connotations. Their religious practices had a decisive influence on the formation of perceptions of the Wanderers as Others. The key indicator that characterizes the essence of the religion of the Wanderers in the eyes of their confessional neighbors, as for Wanderers themselves, was «flight from the world» – a complete refusal to participate in state and social life, and to have any interaction with representatives of the other faith. No less significant for the system of ideas about this group were the features of the funeral rituals (secret funerals of Udora’ Wanderers) and ritual of baptism (baptism in old age). The closedness of the daily and ritual life of the Wanderers contributed to the spread of rumors, which compensated the lack of information. Objective changes of the reality (the disappearance of Wanderers communities of Udora, the change in the age structure of the communities) led to changes and adjustments of the existing ideas.

Voluntary and Involuntary Nonadherence: Terminology for Labeling Patient Participation

The descriptions and labels healthcare providers place upon patients can greatly determine the quality and availability of the healthcare they receive. When that patient is given the label nonadherent or noncompliant within healthcare, it can have a detrimental impact on the patient. But patient adherence is a more complicated issue than can be express with a binary determination; is or is not, yes or no. Therefore, additional terminology should be utilized to properly convey the patient’s participation status when the patient does not fully engage in care. This paper proposes the implementation of additional qualifying language: involuntary nonadherence and voluntary nonadherence. Involuntary nonadherence is defined as when the patient desires to participate in care but is unable to do so because of factors outside of his/her control. These could involve inadequate means of transportation, difficulties with schedule flexibility, etc. These patients are demonstrating nonadherence by current standards but would participate if circumstances allowed – outside pressures are influencing the decision to be nonadherent. Contrast that with voluntary nonadherence, defined as when the patient gives informed refusal to participate, and the patient is fully able to participate but actively chooses not to. This additional qualifying language could ensure protection for patients from being labeled and potentially dismissed due to circumstances outside of their control.

Exploring willingness to participate in future Human Infection Studies in Lusaka, Zambia: A nested qualitative exploratory study

Human Infection Studies (HIC) involve intentional infection of volunteers with a challenge agent or pathogen with the aim of understanding and developing vaccines as well as understanding the disease pathophysiology in a well-controlled environment. Though Africa carries the highest burden of vaccine-preventable diseases, the region is only now being primed to conduct HIC relevant to its population. Given the imminent introduction of HIC in Zambia, we sought to understand potential participants’ willingness to volunteer for such studies. We used a qualitative exploratory approach to understand the potential participants’ perceptions on willingness to participate in HIC using the example of typhoid. Healthy adults, recruited using random selection and purposive sampling from higher learning institutions in Lusaka, participated in 15 in-depth interviews (IDIs) and 5 Focus Group Discussions (FGDs) respectively. Participants considered typhoid a serious disease with potential for life-long consequences and death. After sharing audio-visual materials introducing the concepts of HIC, some participants expressed open willingness to participate or alternatively the need to consult parents and professors, and expressed fear of death and illness. Though willing to be quarantined for up to six months, participants expressed concerns regarding separation from family and duties, having insufficient information to decide, inadequate access to care, severe disease, life-long injury or side-effects, death, and vaccine failure. These concerns along with possibility of underlying conditions that compromise individual immunity, competing priorities, parental refusal, and distrust of study or vaccine efficacy could lead to refusal to participate. Reasons for willingness to participate included monetary compensation, altruism and being part of a team that comes up with a vaccine. Though afraid of deliberate typhoid infection, potential participants are willing to consider participation if given adequate information, time to consult trusted persons, compensation and assurance of adequate care.

THE GREEK MOVEMENT AGAINST VACCINATION IN GREECE AND THE POTENTIAL SIDE-EFFECTS OF COVID-19 VACCINES

The history of the anti-vaccination movement is long. It does not have a long tradition in Greece. However, from the beginning of COVID-19 and even before a vaccine was discovered, a significant portion of Greeks categorically stated their refusal to participate in vaccination despite the deadly consequences of the virus. This is mainly due to the misinformation they have received and the fact that they believed various conspiracy theories that start with the dangers of vaccines and go as far as the belief that COVID-19 does not exist. These beliefs, in addition to being untrue, also carry a great danger. The more people who refuse to be vaccinated because they think they are doing some kind of resistance, the harder it will be to achieve the collective immunity needed to fight COVID-19. The benefits of vaccination in preventing and protecting against communicable diseases do not only concern the vaccinated population, but, through the immunity of the community, the benefits extend to the whole population, as the transmission of diseases is limited and even people who are not vaccinated are protected such as pregnant women, immunocompromised individuals, and newborns. <p> </p><p><strong> Article visualizations:</strong></p><p><img src="/-counters-/edu_01/0778/a.php" alt="Hit counter" /></p>

Hydroxychloroquine For Prophylaxis Of COVID-19 In Health Workers: A Randomized Clinical Trial.

Health care workers are at high risk of being infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). Our aim is to evaluate the efficacy and safety of hydroxychloroquine (HCQ) for prophylaxis of COVID19 in health personnel exposed to patients infected by SARS-COV-2. Methods: Double-blind randomized, placebo-controlled single center clinical trial. Included subjects were health care workers caring for severe COVD19 patients. Main outcome was time to symptomatic SARS-CoV2 infection. Results: 127 subjects with a confirmed baseline negative RT-PCR SARS-CoV2 test were included in the trial, 62 assigned to HCQ and 65 to placebo. One subject (1.6%) in the HCQ group and 6 (9,2%) subjects in the placebo group developed COVID-19. (Log Rank test p = 0.09). No severe COVID19 cases were observed. The study was suspended because of a refusal to participate and losses to follow up after several trials reported lack of effectiveness of hydroxychloroquine in hospitalized patients with COVID-19. Conclusion: Although the number of symptomatic infections in health personnel was lower in the HCQ group, the difference was not statistically significant. The trial is underpowered due to the failure to complete the estimated sample size.

Qui a le droit d’étudier le genre et comment ? Réflexions sur le point de vue situé et la catégorisation du sexe à partir d’une enquête par méthodes mixtes sur les trans’

Who Has the Right to Study Gender and How ? Reflections on the Situated Point of View and the Categorisation of Sex Based on a Mixed Method Study of Trans People. Trans people are often reticent when it comes to research. Looking back over a mixed method study, this article analyses the causes of this phenomenon. There are two main reasons for trans people’s distrust. The first relates to expert opinion and more specifically the point of view of professional experts, insofar as trans people have often already been objectivized by non-trans medical and legal experts. The second concerns the categorisation of sex. Some people do not recognise themselves in the man/woman binary applied by professional experts. However, the trans population is heterogeneous: criticism and refusal to participate were more common with certain social profiles than others, varying according to sex assigned at birth, age, generation, and level of education. By paying attention to this plurality, this article provides avenues for allowing researchers to navigate the trans field and also contributes to reflections on the situated point of view and the categorisation of sex in the social sciences.

647 The Superhero in You: Engaging Pediatric Patients in Therapeutic Exercises

Introduction Engaging pediatric burn survivors in necessary range of motion exercises can be challenging. For younger children, difficulty understanding the reasoning behind prescribed exercises, fear and anxiety can all lead to refusal to participate. Traditional rote range of motion exercises do not engage the child’s sense of curiosity and adventure and seem more like medicine than play. We have developed a range of motion exercise program based on well-known superhero actions. For children who need to address active wrist extension and digit extension, they become “Iron Man” (Example included), “Hulk Smash” lets us work on grip and active composite flexion while becoming “Spiderman” encourages digit isolation. “Superman”, “Wonder Woman” and “Batman” allow utilization of total body movements but can be focus on shoulder flexion or abduction and cross body movements. Methods Traditional superhero movements were assessed to determine similarity to traditional therapy exercises. Exercises were drawn with the extremities performing the desired movements. Pediatric patients are introduced to these exercises and encouraged to act out the superhero movements with therapist directing the desired end range and directionality of movements. Results These characters are well known and loved by pediatric patients. In many instances, a fearful patient may become an active therapy participant through these engaging activities. Goal attainment becomes more fun and less when children are engaged in a purposeful play task. Caregivers can carry these exercises well beyond the therapy session to encourage day long exercise which is essential for contracture prevention and remediation. A recent feedback comment from the parent of a 4-year-old burn survivor specifically focused on these exercises. “Absolutely phenomenal. The therapist did “superhero” moves with my son and got him to open and close his hands. I was so relieved that the movement was normal” Conclusions Modifying instruction methods to include familiar and fun techniques can increase therapy participation and can decrease the fear experienced by young burn survivors when faced with moving an injured extremity.

Excluded versus included patients in a randomized controlled trial of infections caused by carbapenem-resistant Gram-negative bacteria: relevance to external validity

Background Population external validity is the extent to which an experimental study results can be generalized from a specific sample to a defined population. In order to apply the results of a study, we should be able to assess its population external validity. We performed an investigator-initiated randomized controlled trial (RCT) (AIDA study), which compared colistin-meropenem combination therapy to colistin monotherapy in the treatment of patients infected with carbapenem-resistant Gram-negative bacteria. In order to examine the study’s population external validity and to substantiate the use of AIDA study results in clinical practice, we performed a concomitant observational trial. Methods The study was conducted between October 1st, 2013 and January 31st, 2017 (during the RCTs recruitment period) in Greece, Israel and Italy. Patients included in the observational arm of the study have fulfilled clinical and microbiological inclusion criteria but were excluded from the RCT due to receipt of colistin for > 96 h, refusal to participate, or prior inclusion in the RCT. Non-randomized cases were compared to randomized patients. The primary outcome was clinical failure at 14 days of infection onset. Results Analysis included 701 patients. Patients were infected mainly with Acinetobacter baumannii [78.2% (548/701)]. The most common reason for exclusion was refusal to participate [62% (183/295)]. Non-randomized and randomized patients were similar in most of the demographic and background parameters, though randomized patients showed minor differences towards a more severe infection. Combination therapy was less common in non-randomized patients [31.9% (53/166) vs. 51.2% (208/406), p = 0.000]. Randomized patients received longer treatment of colistin [13 days (IQR 10–16) vs. 8.5 days (IQR 0–15), p = 0.000]. Univariate analysis showed that non-randomized patients were more inclined to clinical failure on day 14 from infection onset [82% (242/295) vs. 75.5% (307/406), p = 0.042]. After adjusting for other variables, non-inclusion was not an independent risk factor for clinical failure at day 14. Conclusion The similarity between the observational arm and RCT patients has strengthened our confidence in the population external validity of the AIDA trial. Adding an observational arm to intervention studies can help increase the population external validity and improve implementation of study results in clinical practice. Trial registration The trial was registered with ClinicalTrials.gov, number NCT01732250 on November 22, 2012.