multiple comparisons
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Autori v retrospektivní analýze hodnotili vliv gravidity, porodu a poporodního období u 47 pacientek s již probíhající či nově vzniklou roztroušenou sklerózou mozkomíšní (RSM) na změny v klasifikaci „Expanded disability status scale" (EDSS) a na četnost relapsů. Pacientky byly hodnoceny ve dvou skupinách - ve skupině s relabující-remitující formou a ve skupině se sekundárně chronickoprogresivní formou. V souboru pacientek s relabující-remitující formou onemocnění došlo k atakovitému zhoršení neurologického nálezu u 69,7 %. V těhotenství byl průběh onemocnění stabilizován, většina relapsů (91,3 %) se vyskytia v poporodním 6měsíčním období. Relaps rate za 24 měsíců před graviditou byl 2,0 (1,0/rok), za sledované období těhotenství + 6 měsíců po porodu po přepočtení na 12 měsíců byl 0,6/rok. U pacientek se sekundárně progresivní formou onemocnění ke zhoršení nálezu během gravidity nedošlo. V poporodním období za období 6 měsíců jsme prokázali progresi u 53,9 % a to průměrně o 0,9 stupně v EDSS. Nález se posléze stabilizoval a po přeléčení se upravil do původního stavu před graviditou u 71,5 %, v 28,5 % po 6 měsících poporodního období bylo zhoršení nálezu trvalé.
In a retrospective study the authors have analyzed the influence of pregnancy and 6-month postpartum period upon the changes in Expanded Disability Status Scale (EDSS) and on the frequency of attacks in a set of 47 patients suffering from multiple sclerosis (MS). According to clinical course, the patients were divided into two groups with remitting-relapsing (RR) and secondary progressive (SP) course, and assessed separately. In the group with RR course, relapses during pregnancy and post-partum were observed in 69.7 % of cases. Most of relapses (91.3 %) appeared during puerperium while the course during pregnancy wai comparatively stable (8.7 % of relapses). Relapse rate during 24 months before pregnancy was 1.0 attacks/year in comparison with 0.6 attacks/year during 9 months of pregnancy and 6 months after delivery. No worsening was observed in the group with SP course during pregnancy while progression during 6-month period after delivery was found in 53.9 % of patiens (the average worsening of EDSS was 0.9 points). In 71.5 % of these cases, the course then stabilised and remitted into pre-delivery state.
- MeSH
- chronicko-progresivní roztroušená skleróza MeSH
- imunologická tolerance fyziologie MeSH
- komplikace těhotenství MeSH
- lidé MeSH
- postnatální péče MeSH
- progrese nemoci MeSH
- relabující-remitující roztroušená skleróza MeSH
- retrospektivní studie MeSH
- těhotenství MeSH
- Check Tag
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
Neurology, ISSN 0028-3878 vol. 49, no. 2, suppl. 2, 1997
82 s. : il., tab. ; 28 cm
- MeSH
- epidemiologické studie MeSH
- rizikové faktory MeSH
- roztroušená skleróza epidemiologie etiologie MeSH
- shluková analýza MeSH
- studie případů a kontrol MeSH
- Publikační typ
- sborníky MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- neurologie
BACKGROUND: In relapsing-remitting multiple sclerosis (RRMS) the most common treatment strategy has been to start with low-moderate efficacy disease modifying therapy (LE-DMT) and to escalate to more efficacious treatments in cases of breakthrough disease activity. However, recent evidence suggests a better outcome in patients commencing with moderate-high efficacy DMT (HE-DMT) immediately after clinical onset. OBJECTIVE: The aim of this study is to compare disease activity and disability outcomes in patients treated with the two alternative strategies using the Swedish and Czech national multiple sclerosis registries, taking advantage of the fact that the relative frequency of each strategy differs markedly between these two countries. METHODS: Adult RRMS patients who initiated their first-ever DMT between 2013 and 2016 and were included in the Swedish MS register were compared with a similar cohort from the MS register of the Czech Republic using propensity score overlap weighting as a balancing method. The main outcomes of interest were time to confirmed disability worsening (CDW), time to achieve an expanded disability status scale (EDSS) value of 4, time to relapse, and time to confirmed disability improvement (CDI). To support the results, a sensitivity analysis focusing solely on patients from Sweden starting with HE-DMT and patients from the Czech Republic starting with LE-DMT was performed. RESULTS: In the Swedish cohort, 42% of patients received HE-DMT as initial therapy compared to 3.8% of patients in the Czech cohort. The time to CDW was not significantly different between the Swedish and Czech cohorts (p-value 0.2764), with hazard ratio (HR) of 0.89 and a 95% confidence interval (CI) of 0.77-1.03. Patients from the Swedish cohort exhibited better outcomes for all remaining variables. The risk of reaching EDSS 4 was reduced by 26% (HR 0.74, 95%CI 0.6-0.91, p-value 0.0327), the risk of relapse was reduced by 66% (HR 0.34, 95%CI 0.3-0.39, p-value <0.001), and the probability of CDI was three times higher (HR 3.04, 95%CI 2.37-3.9, p-value <0.001). CONCLUSION: The analysis of the Czech and the Swedish RRMS cohorts confirmed a better prognosis for patients in Sweden, where a significant proportion of patients received HE-DMT as initial treatment.
- MeSH
- dospělí MeSH
- lidé MeSH
- recidiva MeSH
- registrace MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie epidemiologie MeSH
- roztroušená skleróza * farmakoterapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Švédsko MeSH
BACKGROUND: In the absence of evidence from randomised controlled trials, observational data can be used to emulate clinical trials and guide clinical decisions. Observational studies are, however, susceptible to confounding and bias. Among the used techniques to reduce indication bias are propensity score matching and marginal structural models. OBJECTIVE: To use the comparative effectiveness of fingolimod vs natalizumab to compare the results obtained with propensity score matching and marginal structural models. METHODS: Patients with clinically isolated syndrome or relapsing remitting MS who were treated with either fingolimod or natalizumab were identified in the MSBase registry. Patients were propensity score matched, and inverse probability of treatment weighted at six monthly intervals, using the following variables: age, sex, disability, MS duration, MS course, prior relapses, and prior therapies. Studied outcomes were cumulative hazard of relapse, disability accumulation, and disability improvement. RESULTS: 4608 patients (1659 natalizumab, 2949 fingolimod) fulfilled inclusion criteria, and were propensity score matched or repeatedly reweighed with marginal structural models. Natalizumab treatment was associated with a lower probability of relapse (PS matching: HR 0.67 [95% CI 0.62-0.80]; marginal structural model: 0.71 [0.62-0.80]), and higher probability of disability improvement (PS matching: 1.21 [1.02 -1.43]; marginal structural model 1.43 1.19 -1.72]). There was no evidence of a difference in the magnitude of effect between the two methods. CONCLUSIONS: The relative effectiveness of two therapies can be efficiently compared by either marginal structural models or propensity score matching when applied in clearly defined clinical contexts and in sufficiently powered cohorts.
- MeSH
- fingolimod hydrochlorid terapeutické užití MeSH
- imunologické faktory terapeutické užití MeSH
- imunosupresiva terapeutické užití MeSH
- lidé MeSH
- natalizumab terapeutické užití MeSH
- recidiva MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie MeSH
- roztroušená skleróza * farmakoterapie MeSH
- tendenční skóre MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
Cíl: Zjistit, zda existuje asociace mezi (–6)A/G a M235T polymorfizmy genu pro angiotenzinogen (ATG) a vnímavostí k roztroušené skleróze a/nebo formou tohoto onemocnění. Soubor a metodika: Celkem 195 nepříbuzných pacientů (49 mužů, 146 žen) s diagnózou roztroušené sklerózy a 126 zdravých kontrol bylo genotypizováno pro dva ATG polymorfizmy metodou polymerázové řetězové reakce s následnou restrikční analýzou. Konečné výsledky byly získány pomocí těchto statistických testů: Fisherův exaktní test, chí-kvadrát a Holmova testu mnohonásobného srovnání. Pro další statistické zpracování bylo využito programu Statistica, verze 8.0 (StratSoft, Inc., Tulsa, OK, USA). Výsledky: Neprokázali jsme statisticky signifikantní rozdíl v genotypové či alelické distribuci pro zkoumané polymorfizmy mezi skupinou nemocných a kontrolními osobami. Ve skupině pacientů se sice dvojnásobní homozygoti MMGG vyskytovali méně často (p = 0,029; OR = 0,57; CI 0,33–0,98), ale přepočtem pomocí Holmova testu výsledky pozbyly signifikance (pcorr = 0,17). Nenalezli jsme statisticky významné rozdíly v distribuci genotypů mezi pacienty s rozdílnými formami onemocnění. Závěr: Naše studie neprokázala, že by (–6)A/G a M235T ATG polymorfizmy měly vliv na vnímavost k roztroušené skleróze, ani že by asociovaly s různými formami tohoto onemocnění.
Aim: To investigate whether there is an association between (–6)A/G a M235T polymorphisms of angiotensinogen (ATG) and susceptibility to multiple sclerosis and/or the course of the disease. Materials and methods: A total of 195 patients (49 men and 146 women) with multiple sclerosis (MS) and 126 healthy controls were investigated for two angiotensinogen polymorphisms using PCR and restriction analysis. The data were analysed with the support Statistica software, version 8.0 (StratSoft, Inc., Tulsa, OK, USA) and using the Fisher’s, Chi-squared and Holm’s tests. Results: We observed no significant differences in genotype or allelic distribution between groups of patients and control subjects for tested ATG polymorphisms. Double homozygotes MMGG were less frequent in the group of MS patients (p = 0.029, Odds ratio = 0.57, CI 0.33–0.98). However, using the Holm’s test for multiple comparisons, the results lacked statistical significance (pcorr= 0.17). We did not find significant differences either in genotype distribution or in allele frequencies among MS patients with the different disease courses. Conclusions: Our study did not find an association between (–6)A/G a M235T polymorphisms of ATG and susceptibility to multiple sclerosis or the course of this disease.
- Klíčová slova
- renin-angiotenzinový systém, angiotenzinogen, polymorfizmus,
- MeSH
- angiotensinogen genetika krev MeSH
- chronicko-progresivní roztroušená skleróza genetika MeSH
- dospělí MeSH
- financování organizované MeSH
- genotyp MeSH
- genotypizační techniky MeSH
- lidé středního věku MeSH
- lidé MeSH
- polymerázová řetězová reakce MeSH
- polymorfismus genetický genetika MeSH
- relabující-remitující roztroušená skleróza genetika MeSH
- renin-angiotensin systém genetika MeSH
- restrikční mapování MeSH
- statistika jako téma MeSH
- studie případů a kontrol MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
Již koncem roku 2014 byla publikována mezinárodní myelomovou pracovní skupinou nová diagnostická kritéria. Zejména změny u mnohočetného myelomu (MM) a jeho tzv. „smoldering“ formy jsou tak zásadní, že s jejich uveřejněním nebylo možné čekat na další vydání celkových doporučení. Proto Česká myelomová skupina zareagovala vydáním doplňku č. 2 svých guidelines. Cílem tohoto článku je seznámit čtenáře s nově doporučenými kritérií pro diagnostiku MM včetně jejich srovnání s kritérii předchozími.
The new diagnostic criteria was published by the International myeloma working group at the end of 2014 already. Particularly changes in multiple myeloma (MM) and its “smoldering” form are so fundamental that we could not wait with their publication to the next release of overall recommendations. Therefore Czech Myeloma Group responded by issuing Supplement no. 2 of its guidelines. The aim of this article is to introduce the newly recommended criteria for the diagnosis of MM, including a comparison with the previous criteria
BACKGROUND: Simultaneous comparisons of multiple disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS) over an extended follow-up are lacking. Here we emulate a randomised trial simultaneously comparing the effectiveness of six commonly used therapies over 5 years. METHODS: Data from 74 centres in 35 countries were sourced from MSBase. For each patient, the first eligible intervention was analysed, censoring at change/discontinuation of treatment. The compared interventions included natalizumab, fingolimod, dimethyl fumarate, teriflunomide, interferon beta, glatiramer acetate and no treatment. Marginal structural Cox models (MSMs) were used to estimate the average treatment effects (ATEs) and the average treatment effects among the treated (ATT), rebalancing the compared groups at 6-monthly intervals on age, sex, birth-year, pregnancy status, treatment, relapses, disease duration, disability and disease course. The outcomes analysed were incidence of relapses, 12-month confirmed disability worsening and improvement. RESULTS: 23 236 eligible patients were diagnosed with RRMS or clinically isolated syndrome. Compared with glatiramer acetate (reference), several therapies showed a superior ATE in reducing relapses: natalizumab (HR=0.44, 95% CI=0.40 to 0.50), fingolimod (HR=0.60, 95% CI=0.54 to 0.66) and dimethyl fumarate (HR=0.78, 95% CI=0.66 to 0.92). Further, natalizumab (HR=0.43, 95% CI=0.32 to 0.56) showed a superior ATE in reducing disability worsening and in disability improvement (HR=1.32, 95% CI=1.08 to 1.60). The pairwise ATT comparisons also showed superior effects of natalizumab followed by fingolimod on relapses and disability. CONCLUSIONS: The effectiveness of natalizumab and fingolimod in active RRMS is superior to dimethyl fumarate, teriflunomide, glatiramer acetate and interferon beta. This study demonstrates the utility of MSM in emulating trials to compare clinical effectiveness among multiple interventions simultaneously.
- MeSH
- dimethyl fumarát terapeutické užití MeSH
- fingolimod hydrochlorid terapeutické užití MeSH
- glatiramer acetát terapeutické užití MeSH
- imunosupresiva terapeutické užití MeSH
- interferon beta terapeutické užití MeSH
- lidé MeSH
- natalizumab terapeutické užití MeSH
- recidiva MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie MeSH
- roztroušená skleróza * farmakoterapie MeSH
- těhotenství MeSH
- Check Tag
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
Bone mineral density (BMD) is an important indicator of bone health, particularly in patients with conditions such as multiple myeloma. This study aims to compare three methodologies for quantifying BMD in vertebral regions affected by lytic lesions: two using data from conventional CT with different corrections for tissue composition, and one using data acquired on a dual-energy CT system. Method 1 is based on conventional CT with corrections using reference values for muscle and fat, Method 2 uses conventional CT with corrections based on the measured CT values of paraspinal muscle, and Method 3 is based on dual-energy CT. The Wilcoxon signed-rank test was used for statistical comparison, as the dataset did not follow a normal distribution. The results indicated significant differences between Methods 1 and 2 for BMD in regions of interest (ROIs) within lytic lesions, while no significant differences were found for other comparisons in this group. For vertebrae affected by multiple myeloma, significant differences were found between Methods 1 and 2, and Methods 2 and 3, but not between Methods 1 and 3. In healthy vertebrae, a significant difference was found only between Methods 2 and 3. When all ROIs were combined, significant differences were found between Methods 1 and 2, and Methods 2 and 3, with no difference between Methods 1 and 3. Future research will focus on objectively assessing the accuracy of these methods by comparing their results with a calibration phantom.
OBJECTIVE: Pathology in multiple sclerosis is not homogenously distributed. Recently, it has been shown that structures adjacent to CSF are more severely affected. A gradient of brain tissue involvement was shown with more severe pathology in periventricular areas and in proximity to brain surfaces such as the subarachnoid spaces and ependyma, and hence termed the "surface-in" gradient. Here, we study whether (i) the surface-in gradient of periventricular tissue alteration measured by T1 relaxometry is already present in early multiple sclerosis patients, (ii) how it differs between early and progressive multiple sclerosis patients, and (iii) whether the gradient-derived metrics in normal-appearing white matter and lesions correlate better with physical disability than conventional MRI-based metrics. METHODS: Forty-seven patients with early multiple sclerosis, 52 with progressive multiple sclerosis, and 92 healthy controls were included in the study. Isotropic 3D T1 relaxometry maps were obtained using the Magnetization-Prepared 2 Rapid Acquisition Gradient Echoes sequence at 3 T. After spatially normalizing the T1 maps into a study-specific common space, T1 inter-subject variability within the healthy cohort was modelled voxel-wise, yielding a normative T1 atlas. Individual comparisons of each multiple sclerosis patient against the atlas were performed by computing z-scores. Equidistant bands of voxels were defined around the ventricles in the supratentorial white matter; the z-scores in these bands were analysed and compared between the early and progressive multiple sclerosis cohorts. Correlations between both conventional and z-score-gradient-derived MRI metrics and the Expanded Disability Status Scale were assessed. RESULTS: Patients with early and progressive multiple sclerosis demonstrated a periventricular gradient of T1 relaxation time z-scores. In progressive multiple sclerosis, z-score-derived metrics reflecting the gradient of tissue abnormality in normal-appearing white matter were more strongly correlated with disability (maximal rho = 0.374) than the conventional lesion volume and count (maximal rho = 0.189 and 0.21 respectively). In early multiple sclerosis, the gradient of normal-appearing white matter volume with z-scores > 2 at baseline correlated with clinical disability assessed at two years follow-up. CONCLUSION: Our results suggest that the surface-in white matter gradient of tissue alteration is detectable with T1 relaxometry and is already present at clinical disease onset. The periventricular gradients correlate with clinical disability. The periventricular gradient in normal-appearing white matter may thus qualify as a promising biomarker for monitoring of disease activity from an early stage in all phenotypes of multiple sclerosis.
- MeSH
- bílá hmota * diagnostické zobrazování patologie MeSH
- chronicko-progresivní roztroušená skleróza patologie MeSH
- lidé MeSH
- magnetická rezonanční tomografie metody MeSH
- mozek diagnostické zobrazování patologie MeSH
- roztroušená skleróza * diagnostické zobrazování patologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH