Cíl studie: Cílem tohoto článku je přehled základních metod biostatistického designu a statistickéanalýzy.Typ studie: Přehledný článek.Název a sídlo pracoviště: Gynekologicko-porodnická klinika 1. LF UK a Nemocnice na Bulovce, Praha.Předmět studie: Medicínský výzkum vyžaduje komplexitu několika speciálních znalostí a schopností:lékařské praxe, biologického chápání a schopnosti biostatistické expertízy. Tento článekdiskutuje o metodách biostatického designu a analýzy ve světle názorných klinických a zdravotnickýchpříkladů.
Objective: The purpose of this review is to discuss basic methods of the biostatistical study designand analysis.Design: A review article.Setting: OBGYN clinic, 1st Medical Faculty, Charles University, Teaching Hospital Bulovka, Prague.Subject: The medical research requires the complexity of special skills, including medical practice,biological understanding and biostatistical expertise. The following article discusses methods ofthe biostatistical study design and analysis using synoptical clinical and health examples.
2nd ed. ix, 237 s.
Katetrová renální denervace (RDN) byla považována za nadějnou metodu pro léčbu rezistentní hypertenze a počet výkonů se celosvětově stále navyšoval. Doposud byly publikovány s rozdílnými výsledky pouze dvě randomizované studie, které hodnotí efekt této intervence oproti medikamentózní léčbě. Proto jsou nutné další pečlivě designované srovnávací studie. Studie PRAGUE-15 byla navržena jako otevřená prospektivní randomizovaná multicentrická studie srovnávající účinek RDN s intenzifikovanou medikamentózní léčbou u pacientů s rezistentní hypertenzí. Pacienti randomizovaní do medikamentózní větve budou užívat v léčbě spironolacton, pokud k tomu nebudou žádné kontraindikace. Primární cílový ukazatel studie byl stanoven jako změna hodnot systolického a diastolického tlaku během 24hodinového ambulantního monitorování krevního tlaku (ABPM) mezi vstupní hodnotou a šestiměsíční kontrolou. V tomto článku popisujeme design a metodiku studie. Zásadní pro tuto studii je hodnocení změn krevního tlaku pomocí ABPM, nezávislé hodnocení a užívání spironolactonu v medikamentózní léčbě.
Catheter-based renal denervation (RDN) was considered as a promising method for treatment of resistant hypertension and was increasingly being used worldwide. However, there are equivocal results from only two randomized trials studying the effect of such intervention. Thus, additional data from properly designed long-term comparative trials are needed. The PRAGUE-15 trial is designed as an open, prospective, randomized multicenter trial comparing RDN versus intensified medical treatment in patients with resistant hypertension. Patients randomized to the medical treatment group will receive spironolactone in the absence of contraindications. The primary endpoint will be changes in systolic and diastolic pressure during ambulatory blood pressure monitoring (ABPM) from baseline to 6 months. Herein, we describe the trial design and methodology. The strengths of the trial include ABPM (as the objective endpoint), independent outcomes assessment, and therapeutic use of spironolactone.
- MeSH
- Patient Compliance MeSH
- Blood Pressure Monitoring, Ambulatory MeSH
- Denervation MeSH
- Hypertension * diagnosis drug therapy surgery MeSH
- Catheter Ablation * MeSH
- Clinical Trials as Topic * methods MeSH
- Humans MeSH
- Multicenter Studies as Topic methods MeSH
- Prospective Studies MeSH
- Randomized Controlled Trials as Topic methods MeSH
- Spironolactone therapeutic use MeSH
- Patient Selection MeSH
- Research Design * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
- Comparative Study MeSH
Contributions to nephrology ; Vol. 19
249 s. : il.
- MeSH
- Animals, Laboratory MeSH
- Research Design MeSH
- Publication type
- Conference Proceedings MeSH
- Conspectus
- Experimentální medicína
- NML Fields
- nefrologie
- urologie
VÝCHODISKA: Požadavek hodnotit účinnost a úspěšnost realizovaných drogových politik se stává běžnou součástí schvalovaných protidrogových strategii v EU. Jednotlivé země stojí před otázkou vhodného způsobu evaluace svých národních strategii a/nebo akčních plánů a otázka evaluační metodiky se tak stává diskutovaným tématem v odborných kruzích. Také Česká republika evaluovala na přelomu let 2009 a 2010 Národní strategii protidrogové politiky na období 2005–2009. CÍLE: Článek popisuje výzkumný design, metody a shrnuje hlavní výsledky projektu, jehož cílem bylo vyhodnotit českou protidrogovou politiku v uplynulém období pěti let. METODIKA: Evaluace české protidrogové politiky vycházela z teoretického modelu zjednodušeného politického cyklu. Zaměřila se na fáze formulování, implementování a pak hodnotila výsledky protidrogové politiky. Při hodnocení byla použita kombinace různých kvalitativních a kvantitativních metod sběru a analýzy dat od analýzy dokumentů a semistrukturovaného rozhovoru přes dotazníkové šetření po SWOT analýzu v pracovních skupinách a analýzu epidemiologických dat. VÝSLEDKY: Podařilo se popsat úroveň a stav dosažení jednotlivých strategických cílů v širších souvislostech – evaluace identifikovala možné faktory, které mohly dosažení strategických cílů ovlivnit, a to ve fázi formulování i ve fázi implementace protidrogové politiky. Ukázalo se, že charakter a potenciál aktivit, které byly obsaženy v akčním plánu, a rovněž úspěšnost implementace těchto aktivit koresponduje s úrovní dosažení strategických cílů, k jejichž dosažení dané aktivity přispívaly. ZÁVĚRY: Získané zkušenosti a výsledky evaluace jsou příspěvkem k odborné diskusi na téma zkoumání a hodnocení protidrogové politiky. Evaluace poskytla zpětnou vazbu k jednotlivým fázím tvorby a realizace protidrogové politiky, k vývoji a výsledkům české protidrogové politiky v letech 2005–2009. Přinesla také nové podněty k uvažování o protidrogové politice a k přípravě strategických dokumentů v budoucnu.
BACKGROUND: The recognition of the need to evaluate the efficacy and efficiency of national drug policies has become an integrated part of approved drug policy documents. Countries face the issue of adequate evaluations of their national drug strategies/programmes and/or action plans; the issue of appropriate design and methodology is a topic for discussion among researchers and policy analysts. The Czech Republic was also confronted with this issue when evaluating its National Drug Policy Strategy for the Period 2005–2009 at the turn of 2010. AIMS: This article describes the research design, methods, and main findings of the evaluation of the Czech drug policy in the last five years. METHODOLOGY: The Czech drug policy evaluation was based on a (simplified) policy cycle model. It focused on the phase of the formulation of drug policy documents, their implementation and subsequently on the outcomes of the drug policy. Different methods of data collection and analysis were used with respect to the focus (of the individual segments) of evaluation: document analysis, semi-structured interviews, questionnaire surveys, SWOT analysis in working groups and analysis of epidemiological data sets. FINDINGS : The evaluation succeeded in describing the level and status of the accomplishment of the strategic goals in broader terms: the evaluation identified factors which may have had an influence on the achievement of the strategic goals during both the formulation and implemen- tation of the drug policy. The results indicate that the nature and potential of the activities incorporated in the action plan and their successful implementation correspond with the level of fulfilment of the strategic goals, the achievement of which they were intended to contribute to. CONCLUSIONS : The lessons learned during the evaluation process, together with the evaluation findings, contribute to the debate on research into the drug policy and its evaluation. The evaluation provided qualitative feedback on the formulation phase of the drug policy and its implementation, development and outcomes in the period 2005–2009. It also provided input facilitating reflection on the drug policy and the development of drug policy documents in the future.
- Keywords
- hodnocení politiky, národní strategie a akční plán protidrogové politiky, aktéři protidrogové politiky, design evaluace, metody hodnocení politik,
- MeSH
- Evaluation Studies as Topic MeSH
- Humans MeSH
- Substance-Related Disorders prevention & control MeSH
- Program Development MeSH
- Data Collection methods MeSH
- Preventive Health Services trends MeSH
- Government Programs utilization MeSH
- Policy Making MeSH
- Health Policy trends legislation & jurisprudence MeSH
- Check Tag
- Humans MeSH
This study is focused on reliability of assessing fundamental aquatic skills in preschool children. They are still not able to swim at least 10 meters independently, and therefore, they must be tested by several fundamental aquatic motor tasks. The degree of task accomplishment is evaluated by a group of experienced independent raters. It is insufficient to present only inter-rater reliability as information about reliability of test scores because different aquatic tasks are also one of the sources of measurement error. In the present paper, the generalizability theory (GT) is introduced as an appropriate tool for solving such a situation. It extended the classical reliability theory by recognizing and estimating measurement error arisen from more than one source. The whole measurement procedure was repeated after two weeks. The raters displayed very consistent ratings. The generalizability coefficient (which is equivalent to the reliability coefficient in classical test theory) equals .96 and .91 for relative and absolute interpretation of test scores, respectively. In this case, the occasion facet was considered as fixed.
- MeSH
- Financing, Organized MeSH
- Evaluation Studies as Topic MeSH
- Humans MeSH
- Locomotion physiology MeSH
- Motor Skills physiology classification MeSH
- Swimming physiology classification MeSH
- Motor Activity physiology MeSH
- Child, Preschool MeSH
- Athletic Performance physiology classification education MeSH
- Statistics as Topic MeSH
- Sports Medicine methods MeSH
- Investigative Techniques MeSH
- Check Tag
- Humans MeSH
- Child, Preschool MeSH
This publication presents the preparation of a certi-fied methodology for in vitrotransdermal absorption test-ing of chemicals and highlights the various pitfalls in their implementation. Vertical diffusion cells (Franz cells) were used to test the dermal absorption of caffeine, benzoic acid, and testosterone across a penetration membrane (porcine ear skin), while the receptor fluid samples were evaluated by HPLC. The designed methodology was certi-fied in 2022 in the Good Laboratory Practice system and will be used at the VUOS Rybitví and at the Medical Faculty of the Charles University in Hradec Králové to assess the dermal absorption of various substances in the environment and occupational surroundings.
- MeSH
- Risk Assessment methods MeSH
- Caffeine analysis metabolism MeSH
- Skin Absorption * drug effects MeSH
- Benzoic Acid analysis metabolism MeSH
- In Vitro Techniques methods instrumentation MeSH
- Testosterone analysis metabolism MeSH
- Research Design MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
This study focuses on the drop foot case related to hyperthyroidism of the ankle joint resulting in the relaxation of the toes during walking. This condition requires treatment using an ankle-foot orthosis. Traditional orthosis techniques lack precision and depend on the skill of the fabricator. This research aims to make a bias in ankle-foot orthosis design and analysis methods, where a complete methodology of numerical design and testing has been proposed using advanced engineering software. A numerical model of the patient's foot was generated and used to design an ankle-foot orthosis model using SolidWorks. The designed model was mechanically analyzed by the finite element method using ANSYS Workbench 16.1 under different static and dynamic loading conditions. The ankle-foot orthosis model was numerically designed and analyzed before the manufacturing process. This is believed to reduce time and material loss and foster the use of numerical models in biomedical applications. This study suggests focusing on the design and analysis of orthoses according to the patient's measurements. This is expected to increase the comfort and raise the level of treatment. Numerical design methods also enable precise manufacturing using computerized devices such as three-dimensional printers.
- MeSH
- Finite Element Analysis MeSH
- Biomechanical Phenomena MeSH
- Walking physiology MeSH
- Computer-Aided Design MeSH
- Equipment Design methods MeSH
- Ankle Joint physiology MeSH
- Humans MeSH
- Gait Disorders, Neurologic * etiology physiopathology therapy MeSH
- Foot Orthoses * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
This review focuses on the latest development of microseparation electromigration methods in capillaries and microfluidic devices with MS detection and identification. A wide selection of 183 relevant articles covers the literature published from June 2012 till May 2014 as a continuation of the review article on the same topic by Kleparnik [Electrophoresis 2013, 34, 70-86]. Special attention is paid to the new improvements in the theory of instrumentation and methodology of MS interfacing with capillary versions of zone electrophoresis, ITP, and IEF. Ionization methods in MS include ESI, MALDI, and ICP. Although the main attention is paid to the development of instrumentation and methodology, representative examples illustrate also applications in the proteomics, glycomics, metabolomics, biomarker research, forensics, pharmacology, food analysis, and single-cell analysis. The combinations of MS with capillary versions of electrochromatography and micellar electrokinetic chromatography are not included.
- MeSH
- Single-Cell Analysis instrumentation methods MeSH
- Food Analysis instrumentation methods MeSH
- Equipment Design MeSH
- Electrophoresis, Capillary instrumentation methods MeSH
- Mass Spectrometry instrumentation methods MeSH
- Humans MeSH
- Metabolomics instrumentation methods MeSH
- Microfluidic Analytical Techniques instrumentation methods MeSH
- Polysaccharides analysis MeSH
- Proteins analysis MeSH
- Animals MeSH
- Check Tag
- Humans MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
A new co-crystal of pharmaceutical active ingredient Apremilast was successfully designed in this work. The discovered co-crystal with benzoic acid significantly improves key properties like the dissolution and stability of an otherwise poorly soluble Apremilast. A crystallization process was developed, which includes efficient solvent selection and ternary phase diagram construction to minimize risks during scale up. To increase efficiency, we propose that both steps be combined into a single methodology based on solubility data. A suitable solvent for the co-crystallization process was selected and ternary phase diagrams were constructed using three different modifications of thermodynamic model of solid-liquid equilibria. Based on the obtained information, the co-crystallization process was scaled-up to 100 mL. This provides a feasible process to produce larger amounts of this promising pharmaceutical solid form of Apremilast necessary for further drug development.
