BACKGROUND: Daratumumab, an anti-CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma. Data are needed regarding the use of daratumumab for high-risk smoldering multiple myeloma, a precursor disease of active multiple myeloma for which no treatments have been approved. METHODS: In this phase 3 trial, we randomly assigned patients with high-risk smoldering multiple myeloma to receive either subcutaneous daratumumab monotherapy or active monitoring. Treatment was continued for 39 cycles, for 36 months, or until confirmation of disease progression, whichever occurred first. The primary end point was progression-free survival; progression to active multiple myeloma was assessed by an independent review committee in accordance with International Myeloma Working Group diagnostic criteria. RESULTS: Among the 390 enrolled patients, 194 were assigned to the daratumumab group and 196 to the active-monitoring group. With a median follow-up of 65.2 months, the risk of disease progression or death was 51% lower with daratumumab than with active monitoring (hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.67; P<0.001). Progression-free survival at 5 years was 63.1% with daratumumab and 40.8% with active monitoring. A total of 15 patients (7.7%) in the daratumumab group and 26 patients (13.3%) in the active-monitoring group died (hazard ratio, 0.52; 95% CI, 0.27 to 0.98). Overall survival at 5 years was 93.0% with daratumumab and 86.9% with active monitoring. The most common grade 3 or 4 adverse event was hypertension, which occurred in 5.7% and 4.6% of the patients in the daratumumab group and the active-monitoring group, respectively. Adverse events led to treatment discontinuation in 5.7% of the patients in the daratumumab group, and no new safety concerns were identified. CONCLUSIONS: Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring. No unexpected safety concerns were identified. (Funded by Janssen Research and Development; AQUILA ClinicalTrials.gov number, NCT03301220.).

• MeSH
• doba přežití bez progrese choroby MeSH
• dospělí MeSH
• doutnající mnohočetný myelom * diagnóza   mortalita   terapie   MeSH
• injekce subkutánní MeSH
• Kaplanův-Meierův odhad MeSH
• lidé středního věku MeSH
• lidé MeSH
• mnohočetný myelom * diagnóza   epidemiologie   prevence a kontrola   MeSH
• monoklonální protilátky * aplikace a dávkování   škodlivé účinky   MeSH
• pozorné vyčkávání * statistika a číselné údaje   MeSH
• progrese nemoci MeSH
• protinádorové látky * aplikace a dávkování   škodlivé účinky   MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

BACKGROUND: The current requirement is to establish the preoperative diagnosis accurately as possible and to achieve an adequate extent of surgery. The aim of this study was to define the preoperative clinical and molecular genetic risks of malignancy in indeterminate thyroid nodules (Bethesda III and IV) and to determine their impact on the surgical strategy. METHODS: Prospectively retrospective analysis of 287 patients provided the basis of preoperative laboratory examination, sonographic stratification of malignancy risks and cytological findings. Molecular tests focused on pathogenic variants of genes associated with thyroid oncogenesis in cytologically indeterminate nodules (Bethesda III and IV). The evaluation included clinical risk factors: positive family history, radiation exposure and growth in size and/or number of nodules. RESULTS: Preoperative FNAB detected 52 cytologically indeterminate nodules (28.7%) out of 181 patients. Postoperative histopathological examination revealed malignancy in 12 cases (23.7%) and there was no significant difference between Bethesda III and IV categories (P=0.517). Clinical risk factors for malignancy were found in 32 patients (61.5%) and the presence of at least one of them resulted in a clearly higher incidence of malignancy than their absence (31.3% vs. 10.0%, respectively). Pathogenic variants of genes were detected in 12/49 patients in Bethesda III and IV, and in 4 cases (33.3%) thyroid carcinoma was revealed. The rate of malignancies was substantially higher in patients with pathogenic variants than in those without (33.3% vs. 16.2%, respectively). CONCLUSIONS: Our experience implies that molecular genetic testing is one of several decision factors. We will continue to monitor and enlarge our patient cohort to obtain long-term follow-up data.

• MeSH
• dospělí MeSH
• genetické testování MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory štítné žlázy * genetika   MeSH
• retrospektivní studie MeSH
• rizikové faktory MeSH
• senioři MeSH
• tenkojehlová biopsie MeSH
• uzly štítné žlázy * genetika   patologie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Advances in paediatric type 1 diabetes management and increased use of diabetes technology have led to improvements in glycaemia, reduced risk of severe hypoglycaemia, and improved quality of life. Since 1993, progressively lower HbA1c targets have been set. The aim of this study was to perform a longitudinal analysis of HbA1c, treatment regimens, and acute complications between 2013 and 2022 using data from eight national and one international paediatric diabetes registries. METHODS: In this longitudinal analysis, we obtained data from the Australasian Diabetes Data Network, Czech National Childhood Diabetes Register, Danish Registry of Childhood and Adolescent Diabetes, Diabetes Prospective Follow-up Registry, Norwegian Childhood Diabetes Registry, England and Wales' National Paediatric Diabetes Audit, Swedish Childhood Diabetes Registry, T1D Exchange Quality Improvement Collaborative, and the SWEET initiative. All children (aged ≤18 years) with type 1 diabetes with a duration of longer than 3 months were included. Investigators compared data from 2013 to 2022; analyses performed on data were pre-defined and conducted separately by each respective registry. Data on demographics, HbA1c, treatment regimen, and event rates of diabetic ketoacidosis and severe hypoglycaemia were collected. ANOVA was performed to compare means between registries and years. Joinpoint regression analysis was used to study significant breakpoints in temporal trends. FINDINGS: In 2022, data were available for 109 494 children from the national registries and 35 590 from SWEET. Between 2013 and 2022, the aggregated mean HbA1c decreased from 8·2% (95% CI 8·1-8·3%; 66·5 mmol/mol [65·2-67·7]) to 7·6% (7·5-7·7; 59·4mmol/mol [58·2-60·5]), and the proportion of participants who had achieved HbA1c targets of less than 7% (<53 mmol/mol) increased from 19·0% to 38·8% (p<0·0001). In 2013, the aggregate event rate of severe hypoglycaemia rate was 3·0 events per 100 person-years (95% CI 2·0-4·9) compared with 1·7 events per 100 person-years (1·0-2·7) in 2022. In 2013, the aggregate event rate of diabetic ketoacidosis was 3·1 events per 100 person-years (95% CI 2·0-4·8) compared with 2·2 events per 100 person-years (1·4-3·4) in 2022. The proportion of participants with insulin pump use increased from 42·9% (95% CI 40·4-45·5) in 2013 to 60·2% (95% CI 57·9-62·6) in 2022 (mean difference 17·3% [13·8-20·7]; p<0·0001), and the proportion of participants using continuous glucose monitoring (CGM) increased from 18·7% (95% CI 9·5-28·0) in 2016 to 81·7% (73·0-90·4) in 2022 (mean difference 63·0% [50·3-75·7]; p<0·0001). INTERPRETATION: Between 2013 and 2022, glycaemic outcomes have improved, parallel to increased use of diabetes technology. Many children had HbA1c higher than the International Society for Pediatric and Adolescent Diabetes (ISPAD) 2022 target. Reassuringly, despite targeting lower HbA1c, severe hypoglycaemia event rates are decreasing. Even for children with type 1 diabetes who have access to specialised diabetes care and diabetes technology, further advances in diabetes management are required to assist with achieving ISPAD glycaemic targets. FUNDING: None. TRANSLATIONS: For the Norwegian, German, Czech, Danish and Swedish translations of the abstract see Supplementary Materials section.

• MeSH
• diabetes mellitus 1. typu * epidemiologie   krev   farmakoterapie   MeSH
• dítě MeSH
• glykovaný hemoglobin * analýza   MeSH
• hypoglykemie epidemiologie   MeSH
• hypoglykemika * terapeutické užití   MeSH
• kojenec MeSH
• krevní glukóza * analýza   MeSH
• lidé MeSH
• longitudinální studie MeSH
• mladiství MeSH
• předškolní dítě MeSH
• registrace * statistika a číselné údaje   MeSH
• regulace glykemie statistika a číselné údaje   metody   MeSH
• výsledek terapie MeSH
• Check Tag
• dítě MeSH
• kojenec MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• předškolní dítě MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

xMonitorace glukózy pomocí kontinuálních monitorů u pacientů s diabetem je v současné době běžným standardem v managementu kompenzace a léčby diabetu. Senzory se staly běžnou součástí života pacientů. Kromě záznamů běžných dní našich pacientů se diabetolog může setkat i se zcela nestandardním záznamem. Takový záznam analyzuje i následující kazuistika, která popisuje případ mladého muže s diabetes mellitus 1. typu, který měl v době tragické události aplikovaný glukózový senzor.

Glucose monitoring using continuous monitors in patients with diabetes is currently a common standard in the management of diabetes control and treatment. Sensors have become a common part of patients’ lives. In addition to the recorded data of the patients’ ordinary days, a diabetologist may also encounter a completely non-standard data record. Such a record is analysed in the following case report, which describes the case of a young man with type 1 diabetes mellitus who had a glucose sensor applied at the time of the tragic event.

V kazuistike analyzujeme využitie kontinuálneho monitoringu glykémií na prevenciu hypoglykémií u 43-ročnej pacientky s latentným autoimunitným diabetes mellitus 1. typu s krátkym trvaním ochorenia a vysokou citlivosťou na podanie inzulínu a zvažujeme možnosti spomalenia deštrukcie beta buniek pankreasu.

n this case report, we analyse the use of continuous glucose monitoring to prevent hypoglycaemia in a 43-year-old patient with latent autoimmune diabetes mellitus type 1 with short disease duration and high sensitivity to insulin administration, and we consider options for slowing down the destruction of pancreatic beta cells.

Cíl: Cílem naší práce bylo popsat epidemiologickou situaci výskytu rotavirových gastroenteritid (RG) a vliv očkování na hospitalizaci pro RG v České republice (ČR) v letech 2018–2023. Metody: Byla provedena deskriptivní analýza anonymizovaných případů RG hlášených pod kódem A08.0 v systému pro hlášení infekčních onemocnění (ISIN) v České republice v letech 2018–2023. K analýze binárních proměnných byl použit chí-kvadrát test. Vliv očkování na hospitalizaci byl hodnocen pomocí logistické regrese s odds ratio (OR) a 95 % intervalu spolehlivosti. Použity byly programy Excel, STATA a Datawrapper GmbH. Incidence onemocnění byla přepočítána na 100 000 obyvatel. Výsledky: Ve sledovaném období bylo v ČR hlášeno celkem 26 303 případů RG (v rozmezí 1 811–7 483 ročně), což odpovídá průměrné roční incidenci 41,0 (rozmezí 16,9–69,6) na 100 000 obyvatel. Padesát jedna procent případů se vyskytlo u žen. Průměrná roční specifická incidence podle pohlaví byla srovnatelná. Případy se vyskytly u osob 0–101letých (medián 3 roky, mezikvartilové rozpětí [IQR] 1–8 let). Maximální počty případů byly zaznamenány v měsících březen až červen, přičemž v pandemických letech 2020 a 2021 byly celkové počty případů nižší, a tedy i sezonnost byla vyjádřena méně. Průměrná roční specifická incidence byla nejvyšší v krajích Vysočina, Jihočeském a Olomouckém. Hospitalizováno bylo 18 693 (71,1 %) případů RG, nejvíce případů ve věkové skupině 1–4 roky (34,7 %) a 5–9 let (11,9 %). Údaje o očkování byly dostupné pro 21 142 osob s RG, z nich 304 (1,4 %) osob bylo vykázáno jako očkováno. Riziko hospitalizace pro RG bylo u očkovaných osob statisticky významně nižší (p < 0,001) než u neočkovaných. Nahlášeno bylo celkem 27 epidemií RG, v největší bylo zaznamenáno 152 případů. Jako import bylo hlášeno 226 případů onemocnění. Závěr: Po zahájení očkování proti RG v ČR bylo očekáváno snížení počtu onemocnění, hospitalizací a úmrtí pro tato onemocnění. Nicméně významný dopad očkování na zátěž RG dosud v ČR pozorován není a domníváme se, že hlavním důvodem je nadále nízká proočkovanost proti RG v ČR. Doporučujeme proto zařadit toto dobrovolné očkování mezi očkování hrazená zdravotními pojišťovnami a zároveň apelujeme na časnou komunikaci vhodnosti očkování mezi praktickým lékařem pro děti a dorost a rodiči dětí.

Aim: To describe the epidemiological situation of rotavirus gastroenteritis (RVGE) and the impact of vaccination on hospitalization for RVGE in the Czech Republic in 2018–2023. Methods: A descriptive analysis was performed of anonymized RVGE cases reported under code A08.0 to the Infectious Diseases Reporting System (ISIN) in the Czech Republic in 2018–2023. The Chi-square test was used to analyse binary variables. The effect of vaccination on hospitalization was assessed using logistic regression with odds ratio (OR) and 95% confidence interval. Excel, STATA, and Datawrapper GmbH programs were used. The incidence of the disease was calculated per 100,000 population. Results: In the monitored period, a total of 26,303 RVGE cases were reported in the Czech Republic (range 1,811–7,483 per year), which corresponds to an average annual incidence of 41.0 (range 16.9–69.6) per 100,000 population. Fifty-one percent of cases occurred in women. The average annual sex-specific incidence rates were comparable. Patients were aged 0–101 years (median 3 years, interquartile range [IQR] 1–8 years). The maximum numbers of cases were recorded in the months of March to June. In the pandemic years 2020 and 2021, the overall numbers of cases were lower, and therefore the seasonality was less expressed. The average annual specific incidence was highest in the Vysočina, South Bohemian and Olomouc Regions. A total of 18,693 (71.1%) cases of RVGE were hospitalized, most of them in the age groups 1–4 years (34.7%) and 5–9 years (11.9%). Vaccination data were available for 21,142 individuals with RVGE, of whom 304 (1.4%) were reported as vaccinated. The risk of hospitalization for RVGE was statistically significantly lower (p < 0.001) in vaccinated than in unvaccinated individuals. A total of 27 RVGE outbreaks were reported, with the largest one involving 152 cases. Two hundred and twenty-six cases were classified as imported. Conclusions: After the introduction of RVGE vaccination in the Czech Republic, a reduction in RVGE cases, hospitalizations, and deaths was expected. However, a significant impact of vaccination on the RVGE burden has not yet been observed in the country. The main reason continues to be low RVGE vaccine coverage. We therefore recommend including this voluntary vaccination in the schedule covered by health insurance and also call for early communication of the appropriateness of such vaccination between the paediatric/adolescent medicine practitioners and children’s parents.

WHAT IS KNOWN ON THE SUBJECT: Missed, rationed or unfinished nursing care represents a global problem that jeopardizes the provision of quality and safe care. This phenomenon is frequently observed in adult, paediatric and child healthcare facilities and various care units. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE: The findings of this review contribute valuable information to inform evidence-based practices, foster organizational improvements and ultimately optimize the overall quality of care in psychiatric healthcare settings. In addition, the review illuminates the far-reaching consequences of care on both patient and nurse outcomes, emphasizing the urgent need for tailored strategies to mitigate these effects. WHAT ARE THE IMPLICATIONS FOR PRACTICE: Based on the synthesis of the literature, a thorough and continuous assessment of patient care needs in the physical, psychological and social domains is needed, primarily utilizing standardized instruments designed for psychiatric settings to ensure a comprehensive understanding of unmet needs. Based on identified unmet needs, nurses should develop individualized care plans and tailor interventions to address them. In addition, nurse managers must adopt and implement regular monitoring mechanisms to track the prevalence of unmet care needs and at the same time establish reporting systems that capture the proportion of unmet needs, allowing timely interventions and adjustments to care delivery. Lastly, nurse managers must not only emphasize the importance of ethical care practices and dignity-focused interventions but also educate healthcare providers, especially nurses, on the potential threats to patient dignity arising from unmet care needs. ABSTRACT: INTRODUCTION: Despite frequent observations of unmet care needs in acute care adult settings, there are a limited number of studies that focus on investigating this phenomenon in the psychiatric setting. AIM: To synthesize the existing empirical research on unmet care needs in psychiatric healthcare settings. METHODS: The search was carried out in August 2023 in four scientific databases, PubMed, ProQuest, Web of Science and OVID Nursing, based on their institutional availability. The search produced 1129 studies. The search and retrieval process reflected the recommendations of the Preferred Reporting Items for systematic reviews and meta-analyses. RESULTS: This review included 14 studies investigating unmet care needs in the psychiatric healthcare setting. Unmet care needs included three domains: physical, psychological and social. The analysis of the factors revealed factors related to the characteristics of the organization, nurse and patient. DISCUSSION: The classification of unmet needs provides a comprehensive understanding of the various challenges facing people in psychiatric healthcare settings. IMPLICATION FOR PRACTICE: Identified factors that influence the occurrence of unmet care needs will help prevent the occurrence of unmet care needs and timely assessment. The resolution of needs helps to achieve patient and nurse outcomes, increase the quality of care provided and patient satisfaction in a psychiatric healthcare setting.

• MeSH
• duševní poruchy terapie   MeSH
• lidé MeSH
• ošetřovatelství v psychiatrii * normy   MeSH
• služby péče o duševní zdraví normy   MeSH
• zdravotnické služby - potřeby a požadavky MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

High specification mattresses periodically redistribute pressure using alternating air cells, offloading tissues. This study aimed to evaluate the effects of alternating air pressure gradients on sacral tissue physiology. This randomised cross-over study recruited 15 healthy participants to test the three mattress settings (fast cycle, normal cycle, and slow cycle). Participants were asked to adopt supine, lateral, and high sitting (head of bed at 40°) postures, whilst transcutaneous tissue gas tensions and interface pressures at the sacrum were continuously monitored. Comparison between mattress settings and postures showed no statistical difference (p > 0.05) between peak pressure index values at the sacrum for each air inflation cycle speed setting. By contrast, a significantly higher sacral (p < 0.05) contact area was observed for high sitting. During high sitting, ischemic responses during both fast and normal air inflation cycle speed settings were recorded. During the slow air inflation cycle speed, most participants (60%-100%) showed high levels of perfusion. The present study identified a main effect of posture on interface pressure and perfusion over the sacrum. The alternating mattress speed influenced local tissue perfusion, with the greatest changes in tissue oxygenation occurring in a high-speed setting.

• MeSH
• dekubity * prevence a kontrola   MeSH
• design vybavení MeSH
• dospělí MeSH
• klinické křížové studie MeSH
• lidé MeSH
• lůžka * MeSH
• mladý dospělý MeSH
• postura těla * fyziologie   MeSH
• tlak vzduchu * MeSH
• zdraví dobrovolníci pro lékařské studie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

• MeSH
• diabetes mellitus 2. typu * diagnóza   MeSH
• lidé MeSH
• selfmonitoring glykemie metody   MeSH
• Check Tag
• lidé MeSH

Úvod a cíl: Obstrukční spánková apnoe (OSA) představuje v současnosti stále častěji zmiňovaný problém, a to nejen kvůli rostoucímu počtu diagnostikovaných případů, ale také díky novým poznatkům o její patofyziologii a zdravotních důsledcích. Článek si klade za cíl poskytnout přehled poznatků a nových informací z aktuální odborné literatury, týkajících se konzervativní terapie OSA u dospělých pacientů, se zaměřením na použití mandibulárního protraktoru (MAD). Metodika: Pro zpracování článku byly využity databáze PubMed, Scopus, Google Scholar a Ebsco. Byly shrnuty klíčové informace a výsledky z jednotlivých studií. Výsledky: V současné době se na téma OSA a MAD publikuje stále více odborných článků. Neexistují však žádná přesná doporučení a postupy v návrhu aparátu, typu použitého aparátu ani režimu používání, proto je třeba v této problematice dalšího výzkumu. Závěr: Přestože trvalý přetlak v dýchacích cestách (continuous positive airway pressure – CPAP) zůstává nejúčinnější formou léčby, MAD nabízejí slibnou alternativu pro některé pacienty, kteří CPAP netolerují. Z přehledu také vyplývá, že je zapotřebí dalších studií, které by prozkoumaly dlouhodobou účinnost a bezpečnost MAD při léčbě OSA.

Introduction and aim: Obstructive sleep apnoea (OSA) is nowadays an increasingly recognized health issue, not only due to the rising number of diagnosed cases but also because of new knowledge about its pathophysiology and health consequences. This article aims to provide a review of the current literature and new information regarding conservative therapy of OSA in adult patients, with a focus on the use of mandibular advancement devices (MADs). Methods: Databases PubMed, Scopus, Google Scholar, and Ebsco were used for literature search. Key information and results from individual studies were summarized. Results: Currently, an increasing number of scientific articles are being published on OSA and MAD. However, there are no precise recommendations and guidelines regarding the design of the appliance, the type of appliance used or the mode of use, so further research is needed on this topic. Conclusion: Although continuous positive airway pressure (CPAP) remains the most effective form of treatment, MADs offer a promising alternative for patients who are unable to tolerate CPAP. Our review also suggests that further studies are needed to evaluate the long-term efficacy and safety of MADs in the management of OSA.

• MeSH
• lidé MeSH
• obstrukční spánková apnoe * diagnóza   komplikace   terapie   MeSH
• okluzní dlahy MeSH
• polysomnografie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• přehledy MeSH