[Abstract] How to secure better outcomes for everybody in asthma management: the international-medicines use review health technology assessment (international-MUR HTA)

Aims: This project is looking at the development and application of the novel tool (International–Medicines-Use-Review-Health-Technology-Assessment; International-MUR HTA) in community practice that for the first time is able to meet better asthma control and secure added value service in asthma management. More specifically it allows to: evaluate the quality of care delivered in terms of economic impact (for patient-provider-society), health outcomes and patient benefits; collect real-world evidence and evaluate longterm effect of care; provide different stakeholders with evidence-based information that would help formulate health policies in community practice that are safe, effective, patient-focused and cost-effective, balancing access to innovation and cost containment. Crucially, the tool can also support the delivery of a cost-effective and cost-saving intervention for asthma patients based on the success of the Italian-Medicines-Use-Review (I-MUR) trial [1]. Methods: Evidence from the Italian-Medicine-Use-Review (I-MUR) trial showed that the I-MUR intervention provided by the community pharmacists in asthma is effective, cost-saving and cost-effective.1 The trial allowed to model a novel framework (International-MUR-HTA) that would enable to routinely deliver the intervention, but also collect and analyse patient relevant data on its clinical-effectiveness, quality-of-life and cost-effectiveness. I-MUR-HTA was discussed within three expert-panel discussions including policy-makers, commissioners, academics, healthcare-professionals and patientrepresentatives in Italy,2 UK3 and Brussels/Europe.4 The current plan includes testing the use of the tool in RW environment across European regions. Results: Evidence collected from the expert discussions confirmed that International-MUR-HTA information is relevant to meet current NICE target for cost-effective service delivery and this is what is needed to support the evaluation of innovative effective and cost-effective health policies and promote their implementation across nations. Its implementation is underway and real-world pilots are planned to take place in different European regions. Conclusion: the International-MUR-HTA appears to be an innovative tool to promote active patient involvement into policy-decision-making and community service implementation

Novel pharmacist-led intervention secures the minimally important difference (MID) in Asthma Control Test (ACT) score: better outcomes for patients and the healthcare provider

Introduction: A key priority in asthma management is achieving control. The Asthma Control Test (ACT) is a validated tool showing a numerical indicator which has the potential to provide a target to drive management. A novel pharmacist-led intervention recently evaluated and introduced in the Italian setting with a cluster randomised controlled trial (C-RCT) showed effectiveness and cost-effectiveness. This paper evaluates whether the intervention is successful in securing the minimally important difference (MID) in the ACT score and provides better health outcomes and economic savings. Methods: Clinical data were sourced from 816 adult patients with asthma participating in the C-RCT. The success of the intervention was measured looking at the proportion of patients reaching MID in the ACT score. Different levels of asthma control were grouped according to international guidelines and graded using the traffic light rating system. Asthma control levels were linked to economic (National Health Service (NHS) costs) and quality-adjusted life years outcomes using published data. Results: The median ACT score was 19 (partially controlled) at baseline, and 20 and 21 (controlled) at 3-month and 6-month-follow up, respectively (p<0.01). The percentage of patients reaching MID at 3 and 6 months was 15.8% (129) and 19.9% (162), respectively. The overall annual NHS cost savings per 1000 patients attached to the shift towards the MID target were equal to €346 012 at 3 months and increased to €425 483 at 6 months. Health utility gains were equal to 35.42 and 45.12 years in full health gained, respectively. Discussion: The pharmacist-led intervention secured the MID in the ACT score and provided better outcomes for both patients and providers

Analiza czynników klinicznych, biologicznych i położniczych wpływających na decyzję o usunięciu mięśniaka macicy w trakcie cięcia cesarskiego

Objectives: Myomas in pregnancy are associated with a significantly higher risk for cesarean section (CS). Cesarean myomectomy (CM), i.e. myomectomy during cesarean section, has been the source of much debate and was considered relatively contraindicated for many years. However, some authors advise to perform routine myomectomy during CS. The aim of our study was to determine factors influencing the intraoperative decision to perform CM. Material and methods: A total of 185 patients with uterine myomas, who delivered by caesarean section during a 5-year period, were included in the study - 102 patients underwent CM (study group) and 83 women underwent CS without myomectomy (control group). Clinical and obstetric data were recorded and processed for analysis. Using non-parametric correlation methods, we investigated the influence of different variables on the decision to perform CM. Results: No differences were recorded between the two groups in terms of parity, fetal presentation, gestational age, number of previous laparotomies, and previous myomectomy, presence of diabetes and hypertension, indications and type of CS. Significant differences were detected in type and location of the myomas, contrary to their number and size, where no significant differences were registered. Conclusions: The most significant predictors of CM included age, surgical experience and type of myomas. CM is generally performed by experienced surgeons and in younger women. Also, it is more often performed in patients affected by pedunculated and subserosal myomas, and less frequent in case of intramural and multiple myomas.Cel pracy: Mięśniaki macicy w ciąży są związane z istotnie wyższym ryzykiem cięcia cesarskiego (CS). Miomektomia podczas cięcia cesarskiego (CM) jest źródłem wielu debat a przez wiele lat była uznana za przeciwwskazaną. Aczkolwiek niektórzy autorzy zalecają rutynową miomektomię podczas cięcia cesarskiego. Celem naszego badania jest określenie czynników wpływających na decyzję o miomektomii podczas cięcia cesarskiego. Materiał i metoda: Do badania włączono 185 pacjentek z mięśniakami macicy, które miały wykonane cięcie cesarskie w czasie 5 letniej obserwacji – 102 pacjentki przeszły miomektomię podczas cięcia cesarskiego (grupa badana) a 83 miały wykonane cięcie cesarskie bez miomektomii (grupa kontrolna). Analizie poddano dane kliniczne i położnicze. Przy pomocy testów nieparametrycznych zbadano wpływ różnych zmiennych na decyzję o cięciu cesarskim. Wyniki: Nie znaleziono różnic pomiędzy dwiema grupami pod względem rodności, położenia płodu, wieku ciążowego, liczby uprzednio wykonanych laparotomii oraz miomektomii, obecności cukrzycy lub nadciśnienia, wskazań do cięcia cesarskiego oraz rodzaju wykonanego cięcia cesarskiego. Istotne różnice dotyczyły typu i lokalizacji mięśniaków, w przeciwieństwie do liczby i rozmiaru, które nie miały znaczenia. Wnioski: Na wykonanie miomektomii podczas cięcia cesarskiego największy wpływ miały wiek, doświadczenie operatora i rodzaj mięśniaka. CM jest wykonywana przez doświadczonych chirurgów i u młodszych kobiet. Również miomektomia podczas cięcia cesarskiego częściej jest przeprowadzana na uszypułowanych i podsurowicówkowych mięśniakach a rzadziej w przypadku śródściennych i mnogich mięśniaków

Concepts and Thoughts about Modern Uterine Intramural and Subserosal Myomectomy

Myomectomy is the main conservative uterine operation of modern gynecology, as the percentage of patient with myomas is ever increasing. In the last century, this operation was performed by “open†technique, then, with the advent of minimally invasive technologies, it is passed to the endoscopic method. Thus, hysteroscopy and laparoscopy, until the modern robotically assisted surgery were introduced or the removal of uterine myomas. Many of the concepts of traditional surgery, in light of modern scientific evidences, were revisited, since the myomectomy have been evaluated from the morphological-functional side. Therefore, with the forthcoming endocrinal biological discoveries, myomectomy has slowly changed the technical and surgical planning. Many limits have been widely surpassed, up to the possibility of applying this method even in older women, over 45 in which is critical of the uterus preservation for assisted procreation. In the last century, considering to perform a myomectomy in a 45-47 year old woman with myomas was an unlikely thought; nowadays, with the methods of assisted reproductive technique, many reproductive limits have been largely overcome, until the menopausal pregnancy. This clinical opinion is based on biologic anatomic morphological evidences, which allowed knowing better the consequences of uterine myomectomy within the capabilities of the uterus after myomectomy

Uterine Fibroids Management In Asymptomatic Women

Uterine myomas or fibroids represent the most common pathology in female genital tract. There are marked differences by race in both prevalence and incidence. Pathogenesis of fibroids is still unclear. Several risk factors have been identified, ranging from genetic predisposition to variable lifestyles, with recurrence in positive family history for fibroids. Although most of them are asymptomatic, they may cause abnormal uterine bleeding and pelvic pain, and are associated with several pregnancy-related complications, spontaneous abortion, preterm delivery, and cesarean delivery. Moreover, fibroids are associated with several adverse reproductive outcomes and in 10% of infertility case. These fibroids related problems can negatively impact daily living and quality of life. Frequently, the diagnosis is incidental and the treatment is based on symptoms and patient’ wishes, depending on age, numbers and fibroid’ size, woman's fertility plans and risk of malignancy. Because of the high estimated prevalence and costs associated with treatments, the direct and indirect costs of uterine fibroids are substantial. This manuscript reviews the current literature on uterine fibroids, focusing on updated researches on fibroid management in asymptomatic women. Unfortunately, from the data examined, there is no univocity of diagnosis and treatment, thus, further large studies are need to define the management of asymptomatic fibroids

Post-Cesarean Section Hemorrage Treated by a Collagen Patch Coated with the Human Coagulation Factors

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VP164 Applying health technology assessment to pharmacy: the Italian-Medicine-Use-Review-Health Technology Assessment

There is a lack of Health-Technology-Assessment (HTA) tools in pharmacy practice and the collection of real-world-evidence (RWE) in community pharmacy to populate longer-term-disease-progression-modelling (1). This project is looking at the development and application of a novel Patient-Reported-Outcome- Measure (PROM) in community pharmacy that can enable: the evaluation of the quality of care delivered from the patient perspective in terms of economic impact, patient health outcomes and ‘utilities’; the collection of RWE and evaluate long-term effect of care; to provide different stakeholders with unique evidence-based information that help formulate health policies in community pharmacy that are safe, effective, patient-focused and cost-effective, balancing access to innovation and cost containment. Evidence from the Italian-Medicine-Use-Review (I-MUR) trial (2) showed that the I-MUR intervention provided by community pharmacists to asthma patients is effective, cost-saving and cost-effective (3). The trial allowed to model a framework (I-MUR-HTA) that would enable to routinely deliver the intervention, but also collect and analyse PROM data on its clinical-effectiveness, quality-of-life and cost-effectiveness. I-MUR-HTA was discussed within three expert-panel discussions including policy-makers, commissioners, academics, healthcare-professionals and patient-representatives in Italy, United Kingdom and Europe. Current plan include testing the use of the tool in the real world environment. Evidence collected from the panel discussions confirmed that I-MUR-HTA evidence-based information is relevant to meet current National-Health-Care-System plans and this is what is needed to support the evaluation of innovative effective and cost-effective health policies and promote their implementation across nations. Current Italian law on pharmacy services provides the appropriate institutional framework to regulate the introduction of I-MUR-HTA across the territory. Its implementation is underway and a real-world pilot is planned to take place in Italy. I-MUR-HTA appears to be an innovative tool to promote active patient involvement into policy-decision-making and pharmacy-service

Uterine fibroids - clinical presentation and complications

Fibroids are the most common benign tumors of the genital organs in women of childbearing age. In some women, fibroids can be present for years without any symptoms and then are discovered accidentally during a gynecological examination. In others, they can cause significant morbidity and necessitate the need for multiple surgical procedures. The scope of this clinical review is to provide information about the clinical data as well as the complications of uterine fibroids and their clinical presentation. The most common symptoms that may occur in women with uterine fibroids include: bleeding (menometrorrhagia, metrorrhagia or intermenstrual bleeding), pain, symptoms of compression of adjacent structures, changed appearance of the abdomen and infertility. Complications of uterine fibroids include: venous thromboembolism, torsion of pedunculated fibroids, acute urinary retention and renal insufficiency, vaginal and intraabdominal bleeding, mesenteric vein thrombosis and gangrene of the intestine. Complications of uterine fibroids fibroids are rare and though they may cause significant morbidity, and rarely, mortality, which indicates the need for further research in this area. Accurate diagnosis is an essential prerequisite for the evaluation of therapeutic options, especially recently, when medical and numerous non-invasive treatment options have become available