OP56 Are Therapeutic Positioning Reports Driving Pharmaceutical Reimbursement Outcomes In Spain?

2019 ◽  
Vol 35 (S1) ◽  
pp. 13-14
Author(s):  
Raquel Fernandez Dacosta ◽  
Andrea Berardi ◽  
Richard Macaulay
Keyword(s):  
Alternative Treatment ◽  
Statistical Tests ◽  
Treatment Options ◽  
Marketing Authorization ◽  
Market Approval ◽  
Health Products ◽  
Chi Squared ◽  
Autonomous Regions ◽  
The Impact

IntroductionFollowing marketing authorization in Spain, new medicines are assessed by the Inter-Ministerial Pricing Commission for Pharmaceuticals (CIPM), which provides reimbursement recommendations with a maximum ex-factory price. However, there are 17 autonomous regions, which can make distinct reimbursement decisions. To drive consistency, the Spanish Agency for Medicines and Health Products has issued national Therapeutic Positioning Reports (TPRs) for new medicines since 2012. Since November 2017, CIPM recommendations have been published monthly, giving the opportunity to analyze the impact of TPRs on the speed and outcome of CIPM decisions, which this research evaluates.MethodsPublicly-available CIPM and TRP decisions were identified from www.msssi.gob.es and www.aemps.gob.es, respectively. Marketing authorization dates were identified from www.ema.europa.eu or www.aemps.gob.es (10 March 2007-11 February 2018). Pearson's chi-squared and Mann-Whitney U statistical tests were performed using R.ResultsOne hundred and ninety-three drug-indication pairings with an associated TPR were identified. The majority (62% [120/193]) were recommended as alternative treatment options with only 19 percent (36/193) deemed to be superior and 19 percent (37/193) not recommended. One hundred and eight CIPM recommendations were identified across seven monthly reports, issued a mean of 12.2 months after market approval, 59 percent (64/108) were positive and 41 percent (44/108) were negative recommendations. There were 34 drug-indication pairings with both CIPM and TPR recommendations available. Of these, 24 percent, 56 percent and 21 percent had TPR outcomes of ‘superior’, ‘alternative’ and ‘not recommended’, respectively and 71 percent and 29 percent had positive and negative CIPM outcomes. Drug-indication pairings with ‘negative’ TPRs were significantly more likely to have negative CIPMs than those with either ‘alternative’ or ‘superior’ TPRs (71% vs. 19%, respectively, χ2 = 5.16, p = 0.02) and were more likely to experience significantly longer delays to CIPM recommendation (23.9 vs. 13.5 months, respectively, U = 50, p = 0.03).ConclusionsDrug-indication pairings with ‘positive’ and ‘alterative’ TPR outcomes are associated with significantly better and faster CIPM recommendations than those with ‘not recommended’ TPR outcomes

Abstract P277: The Impact of Implementing the SNIS Recommendations for the Care of Emergent Neurointerventional Patients in the Setting of COVID-19 on Patients Undergoing Mechanical Thrombectomy

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Benjamin Atchie ◽  
Stephanie Jarvis ◽  
Kristin Salottolo ◽  
Alicia Bennett ◽  
Christian Burrell ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Tests ◽  
The Novel ◽  
Exact Test ◽  
Icu Discharge ◽  
Chi Squared ◽  
Pre Treatment ◽  
Novel Coronavirus ◽  
High Level ◽  
The Impact

Introduction: As a result of the novel coronavirus 2019 (COVID-19) pandemic, the Society for Neurointerventional Surgery (SNIS) issued guidelines for patient management during COVID-19. Specifically, they suggested intubating COVID-19 positive or those with unknown COVID-19 status prior to emergent endovascular thrombectomy, cohorting by COVID-19 status, early ICU discharge, and postponing elective cases. We sought to determine how the implementation of SNIS guidelines affected outcomes for patients with ischemic stroke. Methods: This was a retrospective cohort study comparing ischemic stroke patients who were treated with thrombectomy admitted during the COVID-19 pandemic 4/1/20-6/30/20 “COVID-19 peak” to patients admitted 4/1/19-6/30/19 “2019”. Statistical tests used for analysis included Kruskal-Wallis, chi-squared and Fisher’s exact test. Results: The proportion of patients treated with thrombectomy was not significantly different, 23% in 2019 vs. 24% during the COVID-19 peak, p=0.67. There were 112 patients treated with thrombectomy: 57 (51%) in 2019, 55 (49%) during the COVID-19 peak. No patients treated with thrombectomy were positive for COVID-19, but 27 (49%) were tested. The median age was 69 for those treated in 2019 and 69 for those during the COVID-19 peak, p=0.44. Patients were similar in sex, race, and comorbidities. The time from onset to arrival was also statistically similar, p=0.19. In 2019, 16% received tPA compared to 9% during the COVID-19 peak, p=0.28. The median time to groin puncture was significantly shorter in 2019, 38 minutes, than during the COVID-19 peak, 44 minutes, p=0.01. The recanalization rate and mRS were similar between groups, p=0.06, and p=0.91, respectively. Conclusions: After implementing the SNIS guidelines, including pre-treatment intubation, we observed a significantly longer time to groin puncture. Anecdotally, the increased observed was remarkably small given the changes to care and did not negatively impact patient outcomes. This suggests that hospitals managing patients efficiently can implement changes in response to COVID-19 and continue high level of care without impacting outcomes. Therefore, we recommend following the SNIS guidelines to prevent the spread of COVID-19.

Surgery for Lung Cancer and the Consequences for the Swallow

2016 ◽  
Vol 1 (13) ◽  
pp. 162-168
Author(s):  
Pippa Hales ◽  
Corinne Mossey-Gaston
Keyword(s):  
Lung Cancer ◽  
Treatment Options ◽  
Vocal Cord Palsy ◽  
Subsequent Treatment ◽  
Physiological Reserve ◽  
Palliative Phase ◽  
And Function ◽  
The Impact ◽  
Swallow Function

Lung cancer is one of the most commonly diagnosed cancers across Northern America and Europe. Treatment options offered are dependent on the type of cancer, the location of the tumor, the staging, and the overall health of the person. When surgery for lung cancer is offered, difficulty swallowing is a potential complication that can have several influencing factors. Surgical interaction with the recurrent laryngeal nerve (RLN) can lead to unilateral vocal cord palsy, altering swallow function and safety. Understanding whether the RLN has been preserved, damaged, or sacrificed is integral to understanding the effect on the swallow and the subsequent treatment options available. There is also the risk of post-surgical reduction of physiological reserve, which can reduce the strength and function of the swallow in addition to any surgery specific complications. As lung cancer has a limited prognosis, the clinician must also factor in the palliative phase, as this can further increase the burden of an already compromised swallow. By understanding the surgery and the implications this may have for the swallow, there is the potential to reduce the impact of post-surgical complications and so improve quality of life (QOL) for people with lung cancer.

An influence of social isolation on the level of physical activity as well as on well-being and mental state of people during the coronavirus COVID-19 pandemic

2019 ◽  
Vol 129 (4) ◽  
pp. 127-131
Author(s):  
Agnieszka Parfin ◽  
Krystian Wdowiak ◽  
Marzena Furtak-Niczyporuk ◽  
Jolanta Herda
Keyword(s):  
Physical Activity ◽  
Social Isolation ◽  
Small Sample Size ◽  
Statistical Tests ◽  
Population Group ◽  
Well Being ◽  
Small Sample ◽  
Subjective Well Being ◽  
Tract Infections ◽  
The Impact

AbstractIntroduction. The COVID-19 is the name of an infectious disease caused by a new strain of coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). It was first diagnosed in December 2019 in patients in Wuhan City, Hubei Province, China. The symptoms are dominated by features of respiratory tract infections, in some patients with a very severe course leading to respiratory failure and, in extreme cases to death. Due to the spread of the infection worldwide, the WHO declared a pandemic in March 2020.Aim. An investigation of the impact of social isolation introduced due to the coronavirus pandemic on selected aspects of life. The researchers focused on observing changes in habits related to physical activity and their connections with people’s subjective well-being and emotional state.Material and methods. The study was carried out within the international project of the group „IRG on COVID and exercise”. The research tool was a standardized questionnaire.Results. Based on the data collected and the analysis of the percentage results, it can be observed that the overwhelming majority of people taking up physical activity reported a better mood during the pandemic. However, statistical tests do not confirm these relationships due to the small sample size.Conclusions. Isolation favours physical activity. Future, in-depth studies, by enlarging the population group, are necessary to confirm the above observations.

The impact of a physician’s recommendation and gender on informed decision making: A randomized controlled study in a simulated decision situation

2020 ◽  
Author(s):  
Marie Eggeling ◽  
Anna Meinhardt ◽  
Ulrike Cress ◽  
Joachim Kimmerle ◽  
Martina Bientzle
Keyword(s):  
Decision Making ◽  
Cruciate Ligament ◽  
Treatment Options ◽  
General Information ◽  
Treatment Preference ◽  
Controlled Study ◽  
Treatment Preferences ◽  
Hypothetical Scenario ◽  
And Gender ◽  
The Impact

Objective: This study examined the influence of physicians’ recommendations and gender on the decision-making process in a preference-sensitive situation. Methods: N = 201 participants were put in a hypothetical scenario in which they suffered from a rupture of the anterior cruciate ligament (ACL). They received general information on two equally successful treatment options for this injury (surgery vs. physiotherapy) and answered questions regarding their treatment preference, certainty and satisfaction regarding their decision, and attitude toward the treatment options. Then participants watched a video that differed regarding physician’s recommendation (surgery vs. physiotherapy) and physician’s gender (female vs. male voice and picture). Afterward, they indicated again their treatment preference, certainty, satisfaction, and attitude, as well as the physician’s professional and social competence.Results: Participants changed their treatment preferences in the direction of the physician’s recommendation (P<.001). Decision certainty (P<.001) and satisfaction (P<.001) increased more strongly if the physician’s recommendation was congruent with the participant’s prior attitude than if the recommendation was contrary to the participant’s prior attitude. Finally, participants’ attitudes toward the recommended treatment became more positive (surgery recommendation: P<.001; physiotherapy recommendation: P<.001). We found no influence of the physician’s gender on participants’ decisions, attitudes, or competence assessments.Conclusion: This research indicates that physicians should be careful with recommendations when aiming for shared decisions, as they might influence patients even if the patients have been made aware that they should take their personal preferences into account. This could be particularly problematic if the recommendation is not in line with the patient’s preferences.

scholarly journals Assessing the Impact of Attendance Modality on the Learning Performance of a Course on Machines and Mechanisms Theory

Mathematics ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 558
Author(s):  
David Valiente ◽  
Héctor Campello-Vicente ◽  
Emilio Velasco-Sánchez ◽  
Fernando Rodríguez-Mas ◽  
Nuria Campillo-Davo
Keyword(s):  
Statistical Tests ◽  
Group Testing ◽  
Test Group ◽  
Historical Record ◽  
Team Work ◽  
University Education ◽  
Learning Performance ◽  
Control Group ◽  
Face To Face ◽  
The Impact

University education approaches related to the field of science, technology, engineering and mathematics (STEM), have generally particularized on teaching activity and learning programs which are commonly understood as reoriented lessons that fuse theoretic concepts interweaved with practical activities. In this context, team work has been widely acknowledged as a means to conduct practical and hands-on lessons, and has been revealed to be successful in the achievement of exercise resolution and design tasks. Besides this, methodologies sustained by ICT resources such as online or blended approaches, have also reported numerous benefits for students’ active learning. However, such benefits have to be fully validated within the particular teaching context, which may facilitate student achievement to a greater or lesser extent. In this work, we analyze the impact of attendance modalities on the learning performance of a STEM-related course on “Machines and Mechanisms Theory”, in which practical lessons are tackled through a team work approach. The validity of the results is reinforced by group testing and statistical tests with a sample of 128 participants. Students were arranged in a test group (online attendance) and in a control group (face-to-face attendance) to proceed with team work during the practical lessons. Thus, the efficacy of distance and in situ methodologies is compared. Moreover, additional variables have also been compared according to the historical record of the course, in regards to previous academic years. Finally, students’ insights about the collaborative side of this program, self-knowledge and satisfaction with the proposal have also been reported by a custom questionnaire. The results demonstrate greater performance and satisfaction amongst participants in the face-to-face modality. Such a modality is prooven to be statistically significant for the final achievement of students in detriment to online attendance.

scholarly journals Protein Tyrosine Kinases: Their Roles and Their Targeting in Leukemia

Cancers ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 184
Author(s):  
Kalpana K. Bhanumathy ◽  
Amrutha Balagopal ◽  
Frederick S. Vizeacoumar ◽  
Franco J. Vizeacoumar ◽  
Andrew Freywald ◽  
...  
Keyword(s):  
Growth Factor ◽  
Protein Kinase ◽  
Tyrosine Kinase ◽  
Protein Kinases ◽  
Tyrosine Kinases ◽  
Treatment Options ◽  
Growth Factor Receptor ◽  
Tyrosine Protein Kinase ◽  
Mesenchymal Epithelial Transition Factor ◽  
The Impact

Protein kinases constitute a large group of enzymes catalysing protein phosphorylation and controlling multiple signalling events. The human protein kinase superfamily consists of 518 members and represents a complicated system with intricate internal and external interactions. Protein kinases are classified into two main families based on the ability to phosphorylate either tyrosine or serine and threonine residues. Among the 90 tyrosine kinase genes, 58 are receptor types classified into 20 groups and 32 are of the nonreceptor types distributed into 10 groups. Tyrosine kinases execute their biological functions by controlling a variety of cellular responses, such as cell division, metabolism, migration, cell–cell and cell matrix adhesion, cell survival and apoptosis. Over the last 30 years, a major focus of research has been directed towards cancer-associated tyrosine kinases owing to their critical contributions to the development and aggressiveness of human malignancies through the pathological effects on cell behaviour. Leukaemia represents a heterogeneous group of haematological malignancies, characterised by an uncontrolled proliferation of undifferentiated hematopoietic cells or leukaemia blasts, mostly derived from bone marrow. They are usually classified as chronic or acute, depending on the rates of their progression, as well as myeloid or lymphoblastic, according to the type of blood cells involved. Overall, these malignancies are relatively common amongst both children and adults. In malignant haematopoiesis, multiple tyrosine kinases of both receptor and nonreceptor types, including AXL receptor tyrosine kinase (AXL), Discoidin domain receptor 1 (DDR1), Vascular endothelial growth factor receptor (VEGFR), Fibroblast growth factor receptor (FGFR), Mesenchymal–epithelial transition factor (MET), proto-oncogene c-Src (SRC), Spleen tyrosine kinase (SYK) and pro-oncogenic Abelson tyrosine-protein kinase 1 (ABL1) mutants, are implicated in the pathogenesis and drug resistance of practically all types of leukaemia. The role of ABL1 kinase mutants and their therapeutic inhibitors have been extensively analysed in scientific literature, and therefore, in this review, we provide insights into the impact and mechanism of action of other tyrosine kinases involved in the development and progression of human leukaemia and discuss the currently available and emerging treatment options based on targeting these molecules.

scholarly journals Exploring Residents’ Perceptions of the Socio-Cultural Benefits of Tourism Development in the Mountain Area

Societies ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 83
Author(s):  
Iulia C. Muresan ◽  
Rezhen Harun ◽  
Felix H. Arion ◽  
Ava Omar Fatah ◽  
Diana E. Dumitras
Keyword(s):  
Positive Attitude ◽  
Statistical Tests ◽  
Tourism Development ◽  
Principal Component ◽  
Local Communities ◽  
Three Dimensions ◽  
Development Economic ◽  
Mountain Area ◽  
Sustainable Tourism Development ◽  
The Impact

Development of tourism affected the socio-cultural environment of many destinations. Previous studies have focused more on analyzing the impact of tourism on all three dimensions of sustainable development (economic, environment and socio-cultural); therefore, the present paper examines tourism development’s impact with regard to the socio-cultural benefits that enhance sustainable tourism development. A survey based on a questionnaire was employed in June 2018 in a mountain village in Cluj County, Romania. The collected data were analyzed using principal component analysis, and several statistical tests were conducted. The results indicated that the respondents have a positive attitude towards tourism development and socio-cultural perceived benefits. Older people and those running a business tend to perceive more positively the benefits of tourism development. The findings of the research could contribute to future development strategies, as it is well known that supporting local communities influences the success of tourism destination.

scholarly journals Characteristics of visits and predictors of admission from a paediatric emergency room in Saudi Arabia

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mohammad H. Al-Qahtani ◽  
Abdullah A. Yousef ◽  
Bassam H. Awary ◽  
Waleed H. Albuali ◽  
Mohammed A. Al Ghamdi ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Hospital Admission ◽  
Hospital Admissions ◽  
Binary Logistic Regression ◽  
Total Sample ◽  
Age Group ◽  
Chi Squared ◽  
Improper Use ◽  
Level Shifts ◽  
The Impact

Abstract Background The Emergency Repartment (ER) is one of the most used areas in healthcare institutions. Problems with over utilisation and overcrowding have been reported worldwide. This study aims at examining the characteristics of paediatric ER visits, the rate of hospital admissions and its associated predictors at King Fahd Hospital of the University in the Eastern Province of Saudi Arabia. Methods This is a retrospective, medical record-based study. Variables included gender, age group, nationality, complaints, Triage level, shifts and seasons. Descriptive statistics were reported as frequencies/percentages. P-values were obtained through a Chi-Squared test while unadjusted and adjusted odds ratios were estimated by binary logistic regression, where admission was considered as the outcome. Results The total number of paediatric patients included was 46,374, and only 2.5% were admitted. Males comprised 55.4% while females comprised 44.6%. The most common age group were toddlers, and 92.4% of the total sample were Saudis. The most common complaint was fever (26.9%) followed by respiratory symptoms (24.9%). Only 7 patients (0.02%) were classified as triage I (Resuscitation), and most were triage IV (Less urgent) (71.0%). Most visits occurred during the winter months. Adjusted ORs showed that neonates had higher odds of admission (OR = 3.85, 95%CI = 2.57–5.76). Moreover, those presenting with haematological conditions showed an OR of 65.49 (95%CI = 47.85–89.64), followed by endocrine conditions showing an OR of 34.89 (95%CI = 23.65–51.47). Triage I had a very high odds of admission (OR = 19.02, 95%CI = 2.70–133.76), whereas triage V was associated with a very low odds of admission (OR = 0.30, 95%CI = 0.23–0.38). Conclusions A low rate of hospital admission was found in comparison with other rates worldwide. This was mostly attributed to an alarmingly high number of non-urgent ER visits. This further emphasises the problem with improper use of ER services, as these cases should be more appropriately directed towards primary healthcare centres. Further studies to examine the impact of prioritising patients in the ER based on the identified predictors of hospital admission, in addition to the standard triage system, are suggested.

scholarly journals Role of the Pharmacist in Managing Treatment-Resistant Depression: A Focus on Ketamine

Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 118
Author(s):  
Linda Xing Yu Liu ◽  
Marina Golts ◽  
Virginia Fernandes
Keyword(s):  
Current Practice ◽  
Quality Care ◽  
Treatment Options ◽  
Critical Role ◽  
Transitions Of Care ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Resistant Depression ◽  
Multiple Treatments ◽  
The Impact

The impact of depression is well described in the literature, and it is most prominent in patients who have trialed multiple treatments. Treatment-resistant depression (TRD) is particularly debilitating, and it is associated with significant morbidity and mortality. Despite this, there seems to be therapeutic inertia in adopting novel therapies in current practice. Ketamine is an N-methyl-D-aspartate receptor antagonist and anesthetic agent which has recently been shown to be effective in the management of TRD when administered intravenously or intranasally. The treatments, however, are not easily accessible due to restrictions in prescribing and dispensing, high costs, and the slow uptake of evidence-based practice involving ketamine within the Canadian healthcare system. Given the limited treatment options for TRD, novel approaches should be considered and adopted into practice, and facilitated by a multi-disciplinary approach. Pharmacists play a critical role in ensuring access to quality care. This includes dissemination of evidence supporting pharmacological treatments and facilitating translation into current practice. Pharmacists are uniquely positioned to collaborate with prescribers and assess novel treatment options, such as ketamine, address modifiable barriers to treatment, and triage access to medications during transitions of care. Extending the reach of these novel psychiatric treatments in both tertiary and primary care settings creates an emerging role for pharmacists in the collaborative effort to better manage treatment-resistant depression.

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