Role of health technology assessment in pharmaceutical market access in developed countries

Introduction and use of a health technology in a health care setting has clinical, economic, as well as organizational, social-cultural, legal and ethical impacts. Health Technology Assessment (HTA) is a multidisciplinary field that addresses these impacts, considering healthcare context as well as available alternatives. HTA mainly aims to inform policy and clinical decision making. While systematically evaluating the effects of the health technology, HTA addresses direct and intended effects as well as the indirect and unintended effects. It is a multidisciplinary field with well-developed systematic processes and method

Recent Advances in Health Biotechnology During Pandemic

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which emerged in 2019, cut the epoch that will make profound fluctuates in the history of the world in social, economic, and scientific fields. Urgent needs in public health have brought with them innovative approaches, including diagnosis, prevention, and treatment. To exceed the coronavirus disease 2019 (COVID-19) pandemic, various scientific authorities in the world have procreated advances in real time polymerase chain reaction (RT-PCR) based diagnostic tests, rapid diagnostic kits, the development of vaccines for immunization, and the purposing pharmaceuticals for treatment. Diagnosis, treatment, and immunization approaches put for- ward by scientific communities are cross-fed from the accrued knowledge of multidisciplinary sciences in health biotechnology. So much so that the pandemic, urgently prioritized in the world, is not only viral infections but also has been the pulsion in the development of novel approaches in many fields such as diagnosis, treatment, translational medicine, virology, mi- crobiology, immunology, functional nano- and bio-materials, bioinformatics, molecular biol- ogy, genetics, tissue engineering, biomedical devices, and artificial intelligence technologies. In this review, the effects of the COVID-19 pandemic on the development of various scientific areas of health biotechnology are discussed

Validity and reliability of Turkish translation of S-LANSS questionnaire

YÖK Tez ID: 243218S-LANSS Ölçeği, (S-LANSS) Bennett ve ark. tarafından ağrının tespiti ve tanımlanması için geliştirilmiş, 7 sorudan oluşan bir kendini değerlendirme ölçeğidir. S-LANSS skalası nöropatik ağrıyla nosiseptif ağrıyı birbirinden ayırmada yardımcı olmaktadır. Bu çalışmada kronik ağrılı hastalarda S-LANSS' ın Türkçe' ye uyarlamasının, geçerlilik ve güvenilirliğinin değerlendirilmesi amaçlanmıştır. Kırıkkale Üniversitesi Tıp Fakültesi Nöroloji polikliniğine kronik ağrı yakınması ile başvuran toplam 244 hasta değerlendirilmeye alındı. Hastaların ağrıları öncelikle ağrı konusunda uzman bir hekim tarafından medikal öykü, klinik muayene, elektromyografi ve sinir ileti hızları çalışmaları, laboratuar incelemeleri ve görüntüleme yöntemlerine göre nöropatik ve nosiseptif ağrı gruplarına ayrıldı. İzin ve çeviri sürecinin ardından, güvenilirlik ölçümlerin değişmezliği test-tekrar test tekniği ile değerlendirilmiştir. Ayrıca güvenilirlik iç tutarlılığı Cronbach alfa güvenilirlik katsayısı kullanılarak değerlendirilmiştir. Geçerlilik student t ve gruplar arasında karşılaştırma Mann Whitney testi kullanılarak değerlendirilmiştir. Nöropatik ağrı tanısında duyarlılık ve özgüllük değerlendirildi.S-LANSS ağrı skorundan aldıkları puanlar açısından nöropatik ve nosiseptif ağrı grupları arasında istatistiksel olarak anlamlı fark saptandı. Test-tekrar test uygulamasında istatistiksel olarak anlamlı fark saptanmadı. S-LANSS ağrı skorunun 1. ve 2. uygulamasında maddeler arası güvenilirlik katsayıları (Cronbach alfa değeri) 0,74 olarak hesaplandı. S-LANSS her bir sorusu korelasyon katsayıları sırayla 1, 2, 3, 4, 5, 6 ve 7. Sorular için sırayla r=0,98, 0,96, 0,94, 0,95, 0,97, 0,95 ve 0,89 olarak saptandı. Nöropatik ağrı tanısında 1. Uygulamada özgüllük % 80,4, duyarlılık % 74,5, genel ortalama % 77 ve ikinci uygulamada özgüllük % 80,4, duyarlılık % 70,8, genel ortalama % 75 olarak saptandı. Bu çalışma S-LANSS ağrı skalasının Türkçe versiyonunun nöropatik ağrı ayırıcı tanısında geçerli ve güvenilir olduğunu göstermektedir.S-LANSS is 7-item self-reported scale developed by Bennett et al. to detect and distinguish nociceptive pain from neuropathic pain. The aim of this study is to adapt the S-LANSS into Turkish and to test its validity and reliability in chronic pain patients. We enrolled 244 chronic pain patients who admitted for the Neurology Department of Kırıkkale University, Faculty of Medicine in our study. Patients were diagnosed as neuropathic or nociceptive pain based on medical history, physical examination, electromyography and nerve conduction studies, laboratory examinations, and imaging techniques. Discriminate analysis was use to diagnose the neuropathic pain as sensitivity and specifity. Total S-LANSS score were different statistically between neuropathic and nociceptive pain patients in both first and second S-LANSS applications (p<0,001). S-LANSS score Cronbach?s alpha coefficients for all of the patients who were included into the study were 0,74 for the first trial and 0,73 for the second trial. The statistical correlation coefficients for questions 1, 2, 3, 4, 5, 6, 7 items of S-LANSS were r=0,98, 0,96, 0,94, 0,95, 0,97, 0,95 and 0,89, respectively. These results showed that S-LANSS is validated in divergent direction. The specificity and sensitivity, overall of the scale were found to be 80,4%, 74,5% and 77,0%, and 80,4%, 70,8% and 75,0%, respectively. These results suggest a high validity level for the Turkish version of the LANSS Pain Scale.The Turkish version of S-LANSS seems to be reliable and valid differential diagnostic measure of neuropathic pain in chronic pain patients

Reflex epilepsy seizures triggered by sexual intercourse; two case reports

Reflex epilepsy is a condition in which seizures can be triggered habitually by an external stimulus or, less commonly, by internal mental processes. The seizures triggered by visual stimuli are common types of the reflex epilepsy. Epileptic seizures induced by sexual orgazm and somotosensory stimuli are very rare in the literature. In this study two cases of reflex epilepsy which have been triggered by sexual orgazm are reported

Evaluation and Expressions of some cytokines from primordial follicle to antral follicle

Bu çalışmada farklı yaş gruplarındaki ratlarda BFGF ve İGF1 markerlerinin sağ ve sol ovaryumlardaki immünohistokimyasal ekspresyonu incelendi ve dişi ratların yaşları arasındaki ilişki değerlendirildi. Çalışmamızda 21 adet 250-300 gr ağırlığında Sprague-Dawley türü dişi sıçan kullanıldı. A Grubu 4 günlük, B Grubu 1 aylık ve C Grubu ise 3,5 aylık dişi sıçanlardan oluşturuldu. Sıçanlar Ksilazin/ Rompun anestezisi altında sakrifiye edildi, sağ ve sol ovaryumları çıkarıldı ve laboratuar deneyleri için 6 adet deney grubu oluşturuldu. Tüm ovaryumlar % 10'luk formaldehitte tespit edildi. 2 günlük tespitten sonra rutin histolojik takip yapıldı ve elde edilen parafin bloklardan 5 mikron kalınlığında kesitler alındı. Bu parafin kesitlere BFGF ve İGF1 immünohistokimyasal boyamalar yapıldı. Bu markerlerin ovaryumlardaki ekspresyonları ve dişi ratların yaşları arasındaki ilişki değerlendirildi. Çalışmamızda BFGF yaş gruplarına göre azalan bir ekspresyon sergilemiştir BFGF primordiyal ve erken folikül gelişimi için önemli gözükmektedir. İGF1 ekspresyonunda ise anlamlı bir istatistiksel değişme olmamıştır. Daha kapsamlı hücre kültürü çalışmaları gerekmektedir.Immunohistochemical expression of IGF1 and BFGF were examined at right and left ovarian in different age groups for this study.Twenty one old female Sprague Dawley rats weighing 250 to 300 g were used The rats were divided into three groups each. Group A, Group B and Group C were consisted from 4 days1 monyh and 3.5 month female rats respectively. Rats were sacrificed under anesthesia, the right and left ovaries removed and six experimental groups were consisted for laboratory experiments. All ovaries were fixed in 10% formaldehyde for two days. 4 micron sections were obtained from paraffin blocks. IGF1 and BFGF immunohistochemical stainings were performed to these paraffin sections. The association between the ages of female rats and the expression of two markers in ovaries were evaluated. BFGF showed a decreasing expression according to age groups in this study. BFGF seem to be important for the development of primordial and early follicles. There was not a statistically significant change in the expression of IGF1. More extensive cell culture studies are required

The effect of context based approach supported by 5E learning model on 7th grade students' achievements, retention and attitude on the unit 'light'

Bu çalışmanın amacı 7.sınıf fen bilimleri dersi Işık ünitesinde öğrencilerin başarılarına, bilgilerinin kalıcılığına ve fen dersine karşı olan tutumlarına 5E ile desteklenmiş bağlam temelli yaklaşımın (BT+5E) etkisini incelemektir. Çalışma öntest- sontest- kontrol gruplu yarı deneysel bir çalışmadır. Ayrıca bağlam temelli yaklaşımın ve 5E öğretim modelinin de aynı bağımsız değişkenler üzerindeki etkisi ayrı ayrı incelenmiştir. Bunun için çalışma üç deney bir kontrol grubundan oluşan 100 öğrenci ile yürütülmüştür. Deney grubu 1 de dersler bağlam temelli yaklaşıma (BT) göre, deney grubu 2de 5E öğretim modeli (5E) ile, deney grubu 3te 5E ile desteklenmiş bağlam temelli yaklaşımla, kontrol grubunda geleneksel öğretim yöntemi ile işlenmiştir. Çalışma grupları için ayrı ayrı ders materyalleri geliştirilmiştir. Çalışmada cinsiyet bağımsız değişkenin bağımlı değişkenler üzerindeki etkisi ve Mantıksal Düşünme Yetenek Testi (MDYT) puanları ile öğrencilere uygulanan testlerin sonuçları arasındaki ilişki de incelenmiştir. Araştırma Ankara da bir devlet okulunda 2012- 2013 eğitim öğretim yılı bahar döneminde 6 haftada tamamlanmıştır. Öğrencilere ön test olarak Işık Önbilgi Testi (IÖT), Işık Başarı Testi (IBT), Fen Tutum Ölçeği(FTÖ) ve Mantıksal Düşünme Yetenek Testi (MDYT) uygulanmıştır. 4 grupta uygulamalar tamamlandıktan sonra son test olarak IBT ve FTÖ uygulanmıştır. Son testlerin uygulanmasından yaklaşık bir ay sonra IBT testi kalıcılık için tekrar uygulanmıştır. Çalışmadan elde edilen veriler SPSS 18.0 programında Tek yönlü ANOVA, İlişkili Örneklemler t-Testi, ANCOVA ve Pearson Korelasyonu ile analiz edilmiştir. Sonuçlar.05 anlamlılık düzeyinde değerlendirilmiştir. Verilerin analizine göre öğrenci başarısını ve fen dersine olan tutumlarını artırmada en etkili yöntemin BT+5E, kalıcılıkta ise 5E olduğu görülmüştür. Cinsiyetin başarı, tutum ve kalıcılık üzerinde etkili olmadığı da bulunmuştur. Ayrıca başarı ve kalıcılıkla mantıksal düşünme yeteneğinin ilişkili olduğu sonucuna ulaşılmıştır. Çoklu karşılaştırma testlerine göre de yöntemlerin bağımlı değişkenler üzerindeki etkisi sıralanmıştır. Çalışmanın bundan sonraki araştırmalara rehberlik edeceği alan yazına bir katkıda bulunacağı düşünülmektedir.The aim of this study to examine the effect of context based approach supported by 5E learning model (CB+5E) on 7th grade class students' achievement, retention and attitude of the unit of Light. In this experimental study; pre-test and post-test control group design was used. The effect of 5E learning model and context based approach also were examined on the same independent variables separately. Therefore this research was carried out using 3 experimental groups and 1 control group, a total of 100 students. In the experimental group 1 lessons were carried out with context based approach, in the experimental group 2 lessons were carried out by 5E learning model, in the experimental group 3 lessons were carried out with the context based approach supported by 5E learning model and in the control group lessons were carried out with traditional methods. The different course materials have been separetely developed for each working group. In this study, both the effect of gender on the dependent variable and the relationship between Logical Thinking Ability Test (LTAT) scores and the results of the tests which applied to students was investigated. Research was completed in 6 weeks during spring term of 2012 - 2013 academic year in a public school in Ankara. Light Prior Knowledge Test (LPT), Light Achievement Test (LAT), Science Attitude Scale (SAS) and Logical Thinking Ability Test (LTAT) were applied to the students as a pre test. LAT and SAS were applied as final tests after the completion of the experimental practice for the 4 groups. One month later, the students were given LAT test, the results of which shaped the retention analysis. Data was analysed by One-Way ANOVA, Paired Sample t-Test, ANCOVA and Pearson Correlation using SPSS 18.0 programme. Results were evaluated at .05 level of significance. According to the analysis of results, it was observed that CB+5E (Context based approach supported by 5E) is the most effective method to enhance students' achievement and to improve their attitudes toward science and 5E learning model is the most effective method for retention of learned information. It has been concluded that gender is not effective on the students' achievement, attitude and retention. It also has been found that success and retention of learned information is associated with logical thinking ability. The impact of the methods on the dependent variables are listed according to the results of multiple comparison tests. It is thought that this study will be a guide for new studies and will contribute to the literature

The views of science teachers about engineering design skills

Bilim ve teknolojide ilerlemek için araştıran, sorgulayan ve günlükhayatta karşılaştığı problemlere çözüm bulmaya çalışan bireyleryetiştirmek eğitim kurumlarına düşen başlıca görevlerden birisidir. Buamaç doğrultusunda eğitim programları güncellenmektedir. En son 2018yılında güncellenen Fen Bilimleri Öğretim Programına önceki öğrenmealanlarına ek olarak öğrencilerin yenilikçi (inovatif) düşünmelerinisağlamak amacıyla mühendislik ve tasarım becerileri dâhil edilmiştir. Buçalışmanın amacı Fen Bilimleri öğretmenlerinin 2018 yılında güncellenenFen Bilimleri Dersi Öğretim Programında yer alan mühendislik ve tasarımbecerileri ile ilgili görüşlerini ortaya çıkarmaktır. Bu amaç doğrultusunda11 Fen Bilimleri öğretmeninden mühendislik ve tasarım becerilerikonusundaki görüşlerini almak üzere katılımcı görüş formu toplanmıştır.Öğretmenlerin görüş formuna yazdıkları cevaplar betimsel analiz yöntemiile analiz edilerek sonuçlar betimsel olarak sunulmuştur. Genel olarakçalışmaya katılan öğretmenlerin “mühendislik ve tasarım becerileri”hakkında bir eğitim almadıkları ve bu konuda bilgi sahibi olmadıklarıgörülmüştür. Öğretmenlerin kendi istek ve ilgileri doğrultusunda bukonuda bilgi sahibi oldukları da çalışma sonucunda görülmüştür.Çalışmada öğrencilerden önce kendilerinin bu konuda bilgi ve tecrübeyeihtiyaç duyduklarını belirten öğretmenlerin ortak görüşü ise öncelikleöğretmenlere bu konuda eğitim verilmesi yönündedir. Öğretmenlerinmühendislik ve tasarım becerilerini uygulayabilmeleri için lisanstanitibaren bu konuda bilgi ve tecrübe kazandıracak eğitimlerin olmasıgerektiğini belirtmişlerdir. Yine öğretmenler, mühendislik ve tasarımbecerisinin öğrencilerin akademik gelişimi açısından faydalı olabileceğini belirtmişlerdir. Genel olarak mühendislik ve tasarım becerilerininmüfredata ilave edilmesi konusunda öğretmenlerin olumlu görüşe sahipoldukları ancak bu konuda eğitim almadıkları için kendilerini yetersizhissettikleri görülmüştür.It is one of the main duties of educational institutions to educateindividuals who are researching, questioning and seeking solutions to theproblems they face in daily life to advance in science and technology. Forthis reason training programs are being updated. The Science EducationCurriculum, recently updated in 2018, includes to previous learningareas engineering and design skills to provide students with innovativethinking. The aim of this study is to reveal the opinions of scienceteachers about the engineering and design skills included in the ScienceEducation Curriculum updated in 2018. For this purpose, a participantopinion form was collected from 11 science teachers to get their opinionson engineering and design skills. The answers written by the teachers inthe opinion form were analyzed with the method of descriptive analysisand the results were presented descriptively. In general, it has beenobserved that the teachers who participated in the study did not geteducated on "engineering and design skills" and that they do not have theknowledge on this subject. It is also seen that the teachers haveknowledge about this subject in the direction of their desire and interest.In this study, teachers stated that they need knowledge and experiencebefore their students and their common opinion is that the teachersshould be educated on this subject firstly. Teachers have stated that theyneed to be educated from the university onwards to gain knowledge andexperience in order to be able to apply the engineering and design skills.Again, teachers have indicated that engineering and design skills may bebeneficial to the students' academic development. In general it has beenseen that, teachers have a positive opinion about the addition ofengineering and design skills to curriculum, but they feel insufficientbecause of not get educated on this subject

Comparison of the Levels of Anxiety, Depression and Hopelessness of Patients with Epilepsy and Healthy Individuals

OBJECTIVE: Epilepsy is characterized by sudden seizures and loss of control in patients; it leads to constantly be under stress. Psychiatric disorders, particularly depressive disorders are more frequent in patients with epilepsy than in the whole of society. In this study; we aimed to compare depression,anxiety and desperation levels between epileptic patients and healthy ones. METHODS: 34 patients and 34 healthy controls were enrolled to the study. Demographic features of all subjects were also recorded. Neurologic examination, Electroencephalography (EEG) and cranial magnetic resonance imaging(MRI) of patients were also evaluated. State-Trait Anxety Inventory (STAI) is for anxiety, Beck Depression Inventory (BDE) is for depression, Beck Hopelessness Scale (BUO) is for hopelessness were evaluated. RESULTS: Epileptic patients were with mean age of 24.56 ± 8.49, healthy subjects were with the mean age 27.44 ± 5.66 years. 13 of patients were female(38.2%) and 21 patients were male(%38.2) in all groups.There was no significant difference about demographic features(p>0.05). When continuous and instant anxiety levels of epileptic and healthy groups were compared, no significant difference was observed between instant anxiety levels(p> 0.05); but there was difference between continuous anxiety levels (p <0.05). Also, hopelessness and depression levels were similar between groups (p<0.05). CONCLUSION: The results of the study showed that depression, anxiety and hopelessness levels were higher in epileptic patients when compared to healthy people. In addition, patients with seizure control with less drug use will reduce the level of trait anxiety was concluded

Methylprednisolone 100 mg Tablet Formulation With Pea Protein: Experimental Approaches Over Intestinal Permeability and Cytotoxicity

Objective: This study was carried out to transform the hydrolyzed pea protein into a pharmaceutical tablet form by masking methylprednisolone. Significance: This study provides some crucial contributions in showing how functional excipients such as pea protein, which are generally used in food industries, can be used in pharmaceutical product formulations and their effects. Methods: Methylprednisolone was formulated using spray drying technology. Design Expert Software (Version 13) was used for the statistical analysis. The in vitro cytotoxic effects for NIH/3T3 mouse fibroblast cells were investigated by XTT cell viability assay. HPLC was used to analyze the Caco-2 permeability studies and dissolution tests. Results: The optimum formulation was evaluated against the reference product by performing cytotoxicity and cell permeability studies. According to our test results, Papp (apparent permeability) values of Methylprednisolone were measured around 3 10-6 cm/s and Fa (fraction absorbed) values around 30%. These data indicate that Methylprednisolone HCl has ‘moderate permeability’ and our study confirmed that it could have belonged to BCS Class II-IV since both low solubility and moderate permeability. Conclusion: The findings offer valuable information to guide and inform the use of pea protein in pharmaceutical formulations. Significant effects on methylprednisolone tablet formulation designed with the philosophy of quality by design (QbD) of pea protein have been demonstrated by both in vitro and cell studies

Comparison of the anticancer effect of microalgal oils and microalgal oil-loaded electrosprayed nanoparticles against PC-3, SHSY-5Y and AGS cell lines

Many of the bioactive substances used in pharmaceutical industry are easily affected by temperature, light and oxygen, and are easily degraded during storage and processing, and exhibit poor adsorption properties during digestion, which limits their direct use. Microalgae are rich in oils which have antimicrobial properties and antioxidants that attract attention in both food and pharmaceutical sectors in recent years. Studies to encapsulate bioactive compound-rich microalgae oils with nanotechnological approaches to improve the physical and chemical stability are relatively new, and it is promising to apply these approaches for pharmaceutical purposes. In this study, cytotoxic effects of oil extracts of Botryococcus braunii and Microcystis aeruginosa and their oil-loaded nanoparticles on L929 cell line, PC-3 prostate cell line, SHSY-5Y neuroblastoma cell line and AGS gastric adenocarcinoma cell line were investigated. The obtained extracts were found to have no cytotoxic effect on L929 cells. However, they showed cytotoxic effect on cancer cells. As for the nanoparticles; a gradual release was determined and the stability of the nanoparticle structure was shown. In the light of obtained findings, it was considered that nanoparticles produced with oil extracts of microalgae which have bioactive substances, have potential to be evaluated especially in pharmaceutical and cosmetic fields