What Should Be the Topics of a Prospective Study on Ovarian Masses in Children?-Results of a Multicenter Retrospective Study and a Scoping Literature Review.

PURPOSE: to determine management problems of ovarian masses in girls in order to form a baseline for prospective randomized studies of the established topics and quality improvement of our management. MATERIALS AND METHODS: We performed a national analysis of clinical aspects of ovarian masses in girls operated on in Poland, analyzed retrospectively medical files of all consecutive patients aged 0-18 who underwent surgeries for ovarian lesions between 2012 and 2017 at 17 pediatric surgical departments and complemented the analysis with a scoping review of a recent primary research related to ovarian masses in children. RESULTS: The study group comprised 595 patients. Forty-four (7.39%) girls were diagnosed with malignant tumors. The overall preservation rate was 64.54%. The analysis revealed that positive tumor markers (OR = 10.3), lesions larger than 6 cm (OR = 4.17) and solid mass on ultrasound examination (OR = 5.34) are interdependent variables differentiating malignant tumors from non-malignant lesions (X42 = 79.1; p = 0.00000). Our scoping review revealed 10 major branches of research within the topic of ovarian masses in pediatric population. CONCLUSIONS: We have developed an overview of the field with the emphasis on the local environment. Our next step is a multi-institutional prospective study of a quality improvement project implementation based on the obtained knowledge.

Real-world effectiveness of abobotulinumtoxinA (Dysport®) in adults with upper limb spasticity in routine clinical practice: an observational study.

AbobotulinumtoxinA (aboBoNT-A, Dysport®) is used in clinical practice as a well-tolerated and effective therapy for muscle spasticity. AboBoNT-A has been shown to reduce upper and lower limb spastic paresis in clinical trials, demonstrating improvements in muscle tone and limb function. This open-label, multicentre, observational, non-interventional study was the first to investigate aboBoNT-A's efficacy in adult patients with upper limb spasticity (ULS) in routine clinical practice in Poland. All enrolled patients received ≥1 aboBoNT-A injection cycles, per routine clinical practice (full analysis set, FAS), and ≥1 rehabilitation session. Patients attended a baseline visit (V1) and two follow-up visits (V2, V3) for retreatment, depending on the investigator's assessment of individual patient needs, with a mean interval (SD) between injections of 4.4 (1.4) and 4.5 (1.2) months. The primary effectiveness endpoint was patient- and physician-based evaluation using the Clinical Global Impression-Improvement Scale (CGII), a validated 7-point scale (1 = very much improved to 7 = very much worse) relative to baseline. CGI-I has not previously been used as a primary endpoint in studies evaluating ULS. Secondary endpoints included muscle tone in shoulder, elbow, carpal joint, and finger muscles, measured by the Modified Ashworth Scale (MAS), and muscle strength according to the Medical Research Council scale (MRC). Of 108 enrolled patients (FAS), 92 (85.2%) completed the study and 57 (52.8%) were included in the per protocol (PP) population. AboBoNT-A improved patient conditions in 96.4% and 98.6% at V2 and V3 (investigator assessment) and 92.8% and 98.6% (as reported by patient) of patients, respectively. Significant reductions in muscle tone from baseline were observed at both visits (p < 0.0001-0.0077) across muscle groups. Increased muscle strength by cumulative MRC was observed at V2 (p = 0.0566) and V3 (p = 0.0282) versus baseline. Safety was consistent with the known profile of aboBoNT-A. In conclusion, aboBoNT-A treatment is beneficial in patients with post-stroke ULS in routine clinical practice, assessed by patients and investigators.

LanroNET - A Non-Interventional Prospective Study to Assess the Resource Utilisation and Cost of Lanreotide Autogel 120 mg in the Population of Polish Patients with Symptomatic Neuroendocrine Tumours.

Wstep: Celem badania LanroNET byla ocena wykorzystania zasobów medycznych oraz kosztów objawowego leczenia polskich chorych na nowotwory neuroendokrynne z zastosowaniem lanreotydu autogel 120 mg. Material i metody: LanroNET to wieloosrodkowe, nieinterwencyjne, obserwacyjne, prospektywne badanie przeprowadzone w 12 osrod-kach w Polsce. W badaniu uczestniczyli dorosli chorzy na wydzielajace nowotwory neuroendokrynne leczeni lanreotydem autogel 120 mg od przynajmniej 3 miesiecy przed wlaczeniem do badania. Podczas 24-miesiecznej obserwacji rzeczywistej praktyki klinicznej zbierano dane dotyczace wykorzystania zasobów medycznych oraz przebiegu terapii chorych z wydzielajacymi nowotworami neuroendokrynnymi. WYNIKI: W badaniu uczestniczylo 54 chorych na wydzielajace nowotwory neuroendokrynne. Przecietny czas stosowania lanreotydu wynosil 1,7 roku (zakres 0,0-2,2 lata). Badanie ukonczylo 33 pacjentów, najczestsza przyczyna przedwczesnego zakonczenia leczenia (8/16) byla progresja choroby. Calkowity sredni koszt wykorzystanych zasobów bez kosztów farmakoterapii oszacowano na 26 307 zl/EUR 6.030,35 na pacjenta/rok. W czasie badania sredni odstep miedzy wstrzyknieciami lanreotydu wynosil 31,7 dni (6,7). Pod koniec obserwacji, po 24 miesiacach od follow-up, 7 pacjentów stosowalo 42-dniowe odstepy miedzy dawkami. Sredni rzeczywisty koszt lanreotydu autogel 120 mg wyniósl 4216,30 zl/966,49 EUR na pacjenta/28 dni we wspólnej perspektywie platnika i pacjenta i byl nizszy o 554,16 zl/127,02 EUR niz koszt stosowania standardowych 28-dniowych odstepów miedzy dawkami. WNIOSKI: Badanie LanroNET jest pierwszym w Polsce obserwacyjnym dwuletnim badaniem chorych na czynne hormonalnie nowotwo-ry neuroendokrynne zoladkowo-jelitowo-trzustkowe oceniajacym koszty codziennej praktyki klinicznej i koszty leczenia lanreotydem autogel.

Physical and chemical properties and stability of sodium cefazolin in buffered eye drops determined with HPLC method.

The aim of the studies was to analyze the stability of 1% and 5% eye drops containing sodium cefazolin, prepared in citrate buffer of pH 6.11-6.27, which were stored at the temperature of 4 degrees C and 20 degrees C with light protection. The drops were prepared under aseptic conditions by dissolving sodium cefazolin (Biofazolin, IBA Bioton), dry injection form of the drug, in citrate buffer. The viscosity of the drops was increased using polyvinyl alcohol. The drops were preserved with phenylmercuric borate of 0.001% concentration mixed with beta-phenylethyl alcohol of 0.4% concentration in the drops. The concentration of cefazolin was determined at every three days using HPLC method. Besides, the measurements of pH, osmotic pressure and viscosity were performed as well as the organoleptic analysis of the drops (clarity, color, odor). The concentration of cefazolin in 1% drops after the 30-day-storage at the temperature of 4 degrees C, depending on their composition, decreased in the range of 2.17-6.02%. In 5% drops the decrease in cefazolin concentration was similar, i.e., after 30-day-storage at the temperature of 4 degrees C it was 1.62-6.76%. In 1% and 5% drops stored at the temperature of 20 degrees C the stability of the drops determined as the 10% degradation time of cefazolin was in the range of 9-15 days.