BACKGROUND: Perianal fistulas of Crohn's disease (CD) create a significant burden on patients' lives. However, the efficacy and safety of adipose-derived mesenchymal stem cell treatment are contradicting, and real-world evidence is lacking. AIMS: To examine the usability of darvadstrocel therapy in managing perianal CD. METHODS: We enrolled patients with CD and perianal fistulas in this retrospective multicenter study. The primary outcome was perianal clinical remission (defined as all treated fistulas closed) at weeks 26 and 52. Secondary outcomes were clinical response rates (≥ 1 fistulas closed), perianal activity (PDAI), patient satisfaction, and adverse events. Data were recorded at baseline and weeks 12, 26 and 52. Prediction of primary outcomes was performed by logistic regression. RESULTS: Overall, among 223 patients (male/female ratio: 0.48), perianal clinical remission was achieved in 78.2% and 62.3% until weeks 26 and 52. Baseline PDAI score (OR 0.75), number of fistulas (OR 0.28) and the number of weeks after preparation for surgery (OR 0.98) were associated with treatment failure. The clinical response rates were 84.8% and 79.8% at weeks 26 and 52. Improvement of subjective perianal symptoms was achieved in 77.8% and 78.4% of patients, respectively. Adverse events occurred in 13.5% of patients; perianal abscesses and proctalgia were the most frequently reported. CONCLUSION: Effectiveness data were higher than in clinical trials. The safety profile was reassuring, and patients' satisfaction was high. Appropriate patient selection, fistula preparation and expertise may help to achieve treatment success.
- MeSH
- Crohnova nemoc * terapie komplikace MeSH
- dospělí MeSH
- indukce remise MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- rektální píštěl * terapie etiologie MeSH
- retrospektivní studie MeSH
- spokojenost pacientů MeSH
- transplantace mezenchymálních kmenových buněk * metody škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
OBJECTIVES: To report the clinical outcomes of the VictoTM (Promedon, Cordoba, Argentina) adjustable artificial urinary sphincter (AUS) implantation in a cohort of patients with severe urinary incontinence (UI) after prostate surgery. PATIENTS AND METHODS: This study enrolled patients with UI following prostate surgery who underwent a Victo implantation between May 2018 and December 2023. Patients were prospectively evaluated at baseline, and at 3 and 12 months after device activation, and thereafter annually. The 24-h pad-weight test (24hPWT) was used to assess severity of UI, while the Patient Global Impression of Improvement (PGI-I) and patient satisfaction according to a Likert scale were used to measure patient-reported outcomes. RESULTS: A total of 96 patients with a median (interquartile range [IQR]) age of 68 (65-72) years were included in the final analysis. The median (IQR) follow-up was 3 (1-4) years. In all, 10 patients completed the 5-year follow-up. After the treatment, we observed a significant reduction in 24hPWT by the median of 83% (P < 0.001) at 3 months and by a median of 79% (P < 0.001) at 3 years. According to the PGI-I, a total of 87%, 92%, 87%, 81%, 83%, and 50% (five of 10) of patients rated their condition/incontinence as 'very much improved', 'much improved' or 'little improved' at 3 months, 1-, 2-, 3-, 4-, and 5-year follow-up visits, respectively. The proportion of patients, who were 'very satisfied' or 'satisfied' with the treatment outcome was 79%, 80%, 75%, 69%, 80%, and 60% (six of 10) at 3 months, 1-, 2-, 3-, 4-, and 5-years, respectively. There were a total of 13 (14%) device failures during the follow-up period. CONCLUSION: In conclusion, our data suggest that Victo AUS significantly reduces the severity of UI after prostate surgery and provides a reasonably high patient-reported satisfaction with treatment outcomes at mid-term follow-up.
- MeSH
- inkontinence moči * chirurgie terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace MeSH
- prospektivní studie MeSH
- prostatektomie * škodlivé účinky MeSH
- senioři MeSH
- spokojenost pacientů MeSH
- umělý močový svěrač * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
Článek se zaměřuje na komunikační strategie pro neurology při rozhovoru s pacienty s roztroušenou sklerózou (RS) při zhoršení jejich zdravotního stavu. Sdělování špatných zpráv je obtížné a často nedostatečně pokryté lékařským vzděláním, což může vést k citovému odpoutání lékařů od pacientů a syndromu vyhoření. Cílené školení komunikačních dovedností zlepšuje vztah lékař-pacient. Doporučené komunikační strategie posilující compliance zahrnují: přípravu prostředí, strukturovaný průběh rozhovoru, zjištění informovanosti pacienta, budování terapeutického vztahu, upřímné a empatické sdělení diagnózy, srozumitelnou edukaci o léčebném postupu a využití multidisciplinarity. Zásadní je i péče o vzdělávání lékařů a psychické zdraví týmu.
The article focuses on communication strategies for neurologists when talking to multiple sclerosis (MS) patients as their diagnosis deteriorates. Breaking of bad news is difficult and often insufficiently covered in medical education, which can lead to emotional detachment of physicians from patients and burnout. Targeted communication skills training improves the physician-patient relationship. Recommended communication strategies to enhance the compliance include: preparation of the environment, structured interview process, ascertaining the patient's awareness, building a therapeutic relationship, honest and empathetic communication of the diagnosis, understandable education about the treatment procedure and the use of multidisciplinarity. It is also essential to take care of the physicians education and the team and physicians mental wellbeing.
BACKGROUND: Although there is growing evidence of the association between gender and early diagnosis of preclinical Alzheimer's disease, little attention has been given to the enrolment ratio of men and women in clinical trials and data reporting. METHODS: This study aims to analyze gender differences in sociodemographic factors associated with the willingness to participate in clinical trials and undergo specific procedures in the context of an Alzheimer's disease prevention research cohort. 2544 cognitively unimpaired participants from the ALFA parent cohort (age 45-75 years) of the Barcelonaβeta Brain Research Center were contacted through a structured phone call to determine their willingness to participate in Alzheimer's disease clinical trials and undergo trial-related procedures (magnetic resonance imaging, lumbar puncture, positron emission tomography, and cognitive assessment). Sociodemographic data on education, occupational attainment, civil and caregiver status were gathered. Stepwise logistic regression models were performed in order to study the interaction between gender and sociodemographic factors in the willingness to participate in clinical trials and to undergo clinical trial-related procedures. RESULTS: 1,606 out of the 2,544 participants were women (63.1%). Women were significantly younger and had lower educational attainment compared with men. In addition, women were more likely to be caregivers, single and unemployed. Women showed a significantly lower willingness than men to participate in a clinical trial (p = 0.003) and to undergo a lumbar puncture (p < 0.001). Single women were less willing to participate in clinical trials than single men (p = 0.041). Regarding clinical trial-related procedures, women with higher years of education were significantly less willing to undergo a lumbar puncture (p = 0.031). CONCLUSION: We found gender differences regarding the sociodemographic factors that predict the willingness to participate in clinical trials and to undergo clinical trial-related procedures. Our results highlight the urgent need to design recruitment strategies accounting for gender-related factors, particularly those related to marital status and education.
- MeSH
- Alzheimerova nemoc * psychologie MeSH
- klinické zkoušky jako téma * psychologie MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- pohlavní dimorfismus MeSH
- senioři MeSH
- sexuální faktory MeSH
- stupeň vzdělání MeSH
- výběr pacientů MeSH
- zapojení pacienta psychologie statistika a číselné údaje MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
Ofatumumab představuje první plně humánní anti-CD20 monoklonální protilátku, vyvinutou pro subkutánní autoaplikaci v měsíčních intervalech. Je určen k terapii aktivní relabující-remitující RS (RR-RS) a u pacientů se známkami nepříznivé prognózy nemoci ho lze uplatnit v první linii léčby. V registračních klinických studiích prokázal jasnou superioritu oproti teriflunomidu a data z extenzí klinických hodnocení potvrzují jeho setrvalou účinnost, příznivý bezpečnostní profil i vysokou míru adherence pacientů k léčbě. Z pohledu pacienta se jedná o atraktivní možnost terapie vysoce účinným lékem s jednoduchou podkožní aplikací v domácím prostředí, bez nutnosti premedikace. Ofatumumab splňuje předpoklady moderní farmakoterapie a je jedním z průlomových přípravků, který může významně zlepšit prognózu pacientů s RR-RS.
Ofatumumab represents the first fully human anti-CD20 monoclonal antibody, developed for subcutaneous self-administration once a month. It is indicated for the treatment of active relapsing-remitting multiple sclerosis (RR-MS) and can be used as a first-line therapy in patients with negative prognostic factors suggestive of an unfavorable disease course. Ofatumumab demonstrated clear superiority over teriflunomide in registration clinical trials and long-term data from open-label extension studies which confirmed its sustained efficacy, favorable safety profile, and also a high level of patient compliance. From the patient‘s point of view, it is an attractive treatment option with a high-efficacy drug that is easy to administer via subcutaneous injection at home, requiring no premedication. Ofatumumab meets the requirements of modern pharmacotherapy and is one of the breakthrough drugs that can significantly improve the prognosis of patients with RR-MS.
- Klíčová slova
- ofatumumab,
- MeSH
- adherence k farmakoterapii MeSH
- antigeny CD20 škodlivé účinky terapeutické užití MeSH
- humanizované monoklonální protilátky * škodlivé účinky terapeutické užití MeSH
- imunosupresiva terapeutické užití MeSH
- injekce subkutánní MeSH
- klinická studie jako téma MeSH
- lidé MeSH
- relabující-remitující roztroušená skleróza farmakoterapie MeSH
- Check Tag
- lidé MeSH
Aterosklerózou podmíněná kardiovaskulární onemocnění (ASKVO) představují hlavní příčinu morbidity a mortality nejen v České republice, ale také globálně. Ze jejich hlavní, tedy kauzální rizikový faktor (RF) je považován cholesterol nesený částicemi obsahujícími apolipoprotein B (apoB), tj. převážně částicemi LDL. Jakkoli je věnována stále větší pozornost inovativním léčebným postupům, ukazuje se, že za nedostatečnou kontrolou dyslipidemie (DLP) stojí často nonadherence k léčbě či (bohužel) lékařská inercie. Cílem multicentrické retrospektivní průřezové studie bylo zmapování kontroly DLP a léčebných strategií ve skupině pacientů ve vysokém či velmi vysokém kardiovaskulárním (KV) riziku, a to na pracovištích ambulantních kardiologů/internistů. Celkem bylo do studie zařazeno 450 pacientů – 80 % ve velmi vysokém KV-riziku a 12,7 % v KV-riziku vysokém; zbylá procenta zaujímali chybně zařazení probandi. Pouze 19,4 % velmi vysoce KV-rizikových nemocných, respektive 28,1 % vysoce rizikových, dosahovalo cílových hodnot LDL-cholesterolu (LDL-C). Více než 60 % ošetřujících kardiologů (navzdory doporučeným postupům) preferovalo pomalou (opatrnou) titraci dávky hypolipidemik; pouze 17 % kliniků indikovalo promptní úpravu zavedené terapie (navýšení dávky, změnu preparátu či přidání dalšího léku) k dosažení redukce LDL-C. Překvapujícím zjištěním bylo, že přes 60 % lékařů bylo spokojeno s dosavadní léčbou, a to i přes to, že nebylo dosaženo cílových hodnot lipidových parametrů. Je zřejmá velmi pozvolná (bohužel neuspokojivá) penetrace doporučených postupů do klinické praxe. Lze tedy předpokládat, že při maximálním využití v současnosti dostupných léčebných možností bude u velké části pacientů docíleno uspokojivé kontroly DLP, a to s minimem dalších nákladů.
Atherosclerotic cardiovascular diseases (ASCVD) are the leading cause of morbidity and mortality not only in the Czech Republic but also globally. Cholesterol carried by apolipoprotein B (apoB)-containing particles, i.e. predominantly LDL particles, is considered to be their major, i.e. causal, risk factor (RF). Although increasing attention is being paid to innovative therapies, it appears that nonadherence to treatment or (unfortunately) medical inertia is often behind the lack of control of dyslipidemia (DLP). The aim of this multicenter retrospective cross-sectional study was to map DLP control and treatment strategies in a group of patients at high or very high cardiovascular (CV) risk, in outpatient cardiologists/internists’ offices. A total of 450 patients were enrolled in the study-80% at very high CV risk and 12.7% at high CV risk; the remaining percentages were misclassified probands. Only 19.4% and 28.1% of the very high CV-risk and high-risk patients, respectively, achieved target LDL-cholesterol (LDL-C) levels. More than 60% of the treating cardiologists (despite recommended practices) preferred slow (cautious) dose titration of hypolipidemic agents; only 17% of clinicians indicated prompt modification of established therapy (dose increase, change of preparation, or addition of another drug) to achieve LDL-C reduction. A surprising finding was that over 60% of clinicians were satisfied with the current treatment, despite not achieving target lipid parameters. A very slow (unfortunately unsatisfactory) penetration of the recommended procedures into clinical practice is evident. Thus, it can be assumed that with maximum use of currently available treatment options, satisfactory control of DLP will be achieved in a large proportion of patients with minimal additional costs.
- MeSH
- adherence k farmakoterapii statistika a číselné údaje MeSH
- dyslipidemie etiologie farmakoterapie MeSH
- hypolipidemika terapeutické užití MeSH
- kardiovaskulární nemoci * etiologie farmakoterapie MeSH
- LDL-cholesterol * krev účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- rizikové faktory kardiovaskulárních chorob MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- klinická studie MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
BACKGROUND: Telerehabilitation is a practical option for individuals with multiple sclerosis (MS) to engage in sustained physical activity without -visiting a rehabilitation facility. The aim of this systematic review was to evaluate the feasibility, effectiveness, safety, and adherence of exercise-based telerehabilitation as compared with usual care for MS patients. METHODS: A comprehensive literature search adhering to PRISMA guidelines was conducted, focusing on studies published in English since 2000. The systematic review protocol was registered in PROSPERO. The selection process involved strict criteria, including studies focusing on people with MS, telerehabilitation centred on regular exercise, a control group receiving usual care, valid exercise testing, and adherence to randomized controlled trial principles. Methodological quality was assessed using the TESTEX tool, ensuring rigour in study design and reporting. RESULTS: Among the 281 records screened, 10 studies met the criteria. Telerehabilitation interventions varied in format and outcomes were assessed using diverse exercise tests and questionnaires. Despite variations, the studies collectively demonstrated promising feasibility and safety, with minimal withdrawals and minor adverse events. Effectiveness varied, with 5 out of 10 studies showing significant improvements in the intervention group. Adherence rates ranged from 38% to 100%. CONCLUSION: In most of the assessed aspects, telerehabilitation is comparable to regular centre-based rehabilitation.
- MeSH
- adherence pacienta MeSH
- cvičení * MeSH
- lidé MeSH
- roztroušená skleróza * rehabilitace MeSH
- telerehabilitace * MeSH
- terapie cvičením * metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- systematický přehled MeSH
- MeSH
- adherence pacienta psychologie MeSH
- COVID-19 psychologie MeSH
- infekce dýchací soustavy * psychologie MeSH
- lidé MeSH
- pacienti hospitalizovaní psychologie MeSH
- postakutní syndrom COVID-19 psychologie MeSH
- psychoterapie * metody MeSH
- úzkost etiologie patologie terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH
BACKGROUND: Remote measurement technology (RMT) involves the use of wearable devices and smartphone apps to measure health outcomes in everyday life. RMT with feedback in the form of data visual representations can facilitate self-management of chronic health conditions, promote health care engagement, and present opportunities for intervention. Studies to date focus broadly on multiple dimensions of service users' design preferences and RMT user experiences (eg, health variables of perceived importance and perceived quality of medical advice provided) as opposed to data visualization preferences. OBJECTIVE: This study aims to explore data visualization preferences and priorities in RMT, with individuals living with depression, those with epilepsy, and those with multiple sclerosis (MS). METHODS: A triangulated qualitative study comparing and thematically synthesizing focus group discussions with user reviews of existing self-management apps and a systematic review of RMT data visualization preferences. A total of 45 people participated in 6 focus groups across the 3 health conditions (depression, n=17; epilepsy, n=11; and MS, n=17). RESULTS: Thematic analysis validated a major theme around design preferences and recommendations and identified a further four minor themes: (1) data reporting, (2) impact of visualization, (3) moderators of visualization preferences, and (4) system-related factors and features. CONCLUSIONS: When used effectively, data visualizations are valuable, engaging components of RMT. Easy to use and intuitive data visualization design was lauded by individuals with neurological and psychiatric conditions. Apps design needs to consider the unique requirements of service users. Overall, this study offers RMT developers a comprehensive outline of the data visualization preferences of individuals living with depression, epilepsy, and MS.
- MeSH
- deprese * psychologie MeSH
- dospělí MeSH
- epilepsie * psychologie MeSH
- kvalitativní výzkum * MeSH
- lidé středního věku MeSH
- lidé MeSH
- mobilní aplikace MeSH
- nositelná elektronika MeSH
- pacientova volba psychologie statistika a číselné údaje MeSH
- roztroušená skleróza * psychologie MeSH
- senioři MeSH
- telemedicína MeSH
- vizualizace dat MeSH
- zjišťování skupinových postojů * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
