Response to the Comment by Cirasino L and Semeraro S: "Need to direct immune thrombocytopenia therapy towards shared goals" Direct and indirect comparisons to determine the first choice for newly diagnosed primary immune thrombocytopenia in adults.
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ABSTRACT:
SUBMITTER: Arai Y
PROVIDER: S-EPMC6058780 | biostudies-literature | 2018 Jun
REPOSITORIES: biostudies-literature
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Response to the Comment by Cirasino L and Semeraro S: "Need to direct immune thrombocytopenia therapy towards shared goals" Direct and indirect comparisons to determine the first choice for newly diagnosed primary immune thrombocytopenia in adults.
Arai Yasuyuki Y Jo Tomoyasu T Matsui Hiroyuki H Kondo Tadakazu T Takaori-Kondo Akifumi A
Haematologica 20180601 6
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Project description:Excess aldosterone is an important contributor to hypertension and cardiovascular disease. Conversely, low circulating aldosterone causes salt wasting and hypotension. Aldosterone activates mineralocorticoid receptors (MRs) to increase epithelial sodium channel (ENaC) activity. However, aldosterone may also stimulate the thiazide-sensitive Na(+)-Cl(-) cotransporter (NCC). Here, we generated mice in which MRs could be deleted along the nephron to test this hypothesis. These kidney-specific MR-knockout mice exhibited salt wasting, low BP, and hyperkalemia. Notably, we found evidence of deficient apical orientation and cleavage of ENaC, despite the salt wasting. Although these mice also exhibited deficient NCC activity, NCC could be stimulated by restricting dietary potassium, which also returned BP to control levels. Together, these results indicate that MRs regulate ENaC directly, but modulation of NCC is mediated by secondary changes in plasma potassium concentration. Electrolyte balance and BP seem to be determined, therefore, by a delicate interplay between direct and indirect mineralocorticoid actions in the distal nephron.
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Project description:ObjectiveTo investigate the agreement between direct and indirect comparisons of competing healthcare interventions.DesignMeta-epidemiological study based on sample of meta-analyses of randomised controlled trials. Data sources Cochrane Database of Systematic Reviews and PubMed. Inclusion criteria Systematic reviews that provided sufficient data for both direct comparison and independent indirect comparisons of two interventions on the basis of a common comparator and in which the odds ratio could be used as the outcome statistic.Main outcome measureInconsistency measured by the difference in the log odds ratio between the direct and indirect methods.ResultsThe study included 112 independent trial networks (including 1552 trials with 478,775 patients in total) that allowed both direct and indirect comparison of two interventions. Indirect comparison had already been explicitly done in only 13 of the 85 Cochrane reviews included. The inconsistency between the direct and indirect comparison was statistically significant in 16 cases (14%, 95% confidence interval 9% to 22%). The statistically significant inconsistency was associated with fewer trials, subjectively assessed outcomes, and statistically significant effects of treatment in either direct or indirect comparisons. Owing to considerable inconsistency, many (14/39) of the statistically significant effects by direct comparison became non-significant when the direct and indirect estimates were combined.ConclusionsSignificant inconsistency between direct and indirect comparisons may be more prevalent than previously observed. Direct and indirect estimates should be combined in mixed treatment comparisons only after adequate assessment of the consistency of the evidence.
| S-EPMC3156578 | biostudies-literature
Project description:BackgroundImmune thrombocytopenia (ITP) has been reported following COVID-19 vaccination. After index case fatalities, there was concern among patients both with and without a prior history of ITP in Australia.ObjectivesTo describe treatment outcomes of ITP after COVID-19 vaccination and compare relapsed vs historical pre-COVID-19 ITP cohorts.MethodsWe collected ITP cases in Australia within 6 weeks of receiving any COVID-19 vaccination as part of primary vaccination (up to October 17, 2021). Second, we reviewed platelet charts in a historical ITP cohort to determine whether platelet variability was distinct from relapsed ITP after vaccination.ResultsWe report on 50 patients (37 de novo, 13 relapsed ITP) vaccinated from March 22, 2021, to October 17, 2021. Although there was 1 fatality, bleeding was otherwise mostly minor: (70% WHO bleeding grade <2). De novo ITP was more likely after AstraZeneca ChAdOx1 nCoV-19 (89%) than Pfizer BNT162b2 (11%). Most patients responded quickly (median, 4 days; complete response, 40 of 45 [89%]). In the historical cohort, only 6 of 47 patients exhibited platelet variability (>50% decrease and platelets <100 × 109/L), but median platelet nadir was significantly higher than vaccination relapse (27 vs 6 × 109/L, P =.005).ConclusionITP was more frequently reported after AstraZeneca ChAdOx1 nCoV-19 than Pfizer BNT162b2 vaccination. Standard ITP treatments remain highly effective for de novo and relapsed ITP (96%). Although thrombocytopenia can be severe after vaccination, bleeding is usually mild. Despite some sampling bias, our data do not support a change in treatment strategies for patients with ITP after vaccination.
| S-EPMC9744687 | biostudies-literature
Project description:IntroductionImmune-mediated inflammatory diseases including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondylarthritis (nr-axSpA), atopic dermatitis (AD), ulcerative colitis (UC), and Crohn's disease (CD) pose a substantial burden on patients and their quality of life. Upadacitinib is an orally administered, selective, and reversible Janus kinase inhibitor indicated for seven conditions, but data on its safety versus other active treatments are limited. A systematic literature review of indirect and direct treatment comparisons of randomized controlled trials (RCTs) was conducted to assess the safety profile of upadacitinib.MethodsMEDLINE, Embase, and Cochrane Library databases were searched for indirect and direct treatment comparisons of RCTs that (1) included licensed upadacitinib dosages; (2) studied any of the seven conditions; (3) reported any adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, major adverse cardiovascular event, venous thromboembolism, malignancies, infections or serious infections, and death; and (4) were published between January 2018 and August 2022.ResultsA total of 25 studies were eligible for inclusion. SAEs, AEs leading to discontinuation, and any AEs were commonly studied. RA was the most studied condition, followed by AD and UC. Most studies (16/25, 64%) reported no statistically significant difference in the studied safety outcomes between upadacitinib and other active treatments (e.g., tumor necrosis factor blockers, interleukin receptor antagonists, integrin receptor antagonists, T cell co-stimulation modulator), or placebo (placebo ± methotrexate or topical corticosteroids). Other studies (9/25, 36%) reported mixed results of no statistically significant difference and either statistically higher (8/25, 32%) or lower rates (1/25, 4%) on upadacitinib.ConclusionMost studies suggested that upadacitinib has no statistically significant difference in the studied safety outcomes compared to active treatments or placebo in patients with RA, PsA, AS, AD, UC, and CD. A few studies reported higher rates, but findings were inconsistent with limited interpretation.
| S-EPMC10838816 | biostudies-literature
Project description:ObjectiveTo describe rank reversal as a source of inconsistent interpretation intrinsic to indirect comparison (Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epi 1997;50:683-91) of treatments and to propose best practice.MethodsWe prove our main points with intuition, examples, graphs, and mathematical proofs. We also provide software and discuss implications for research and policy.ResultsWhen comparing treatments by indirect means and sorting them by effect size, three common measures of comparison (risk ratio, risk difference, and odds ratio) may lead to vastly different rankings.ConclusionsThe choice of risk measure matters when making indirect comparisons of treatments. The choice should depend primarily on the study design and the conceptual framework for that study.
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Project description:Pregnancy rate is a major determinant of population dynamics of wild ungulates and of productivity of livestock systems. Allocation of feeding resources, including stocking rates, prior to and during the breeding season is a crucial determinant of this vital rate. Thus, quantification of effects and interaction among multiple factors that affect pregnancy rate is essential for management and conservation of pasture-based systems. Pregnancy rate of 2982 heifers and primiparous cows was studied as a function of animal category, average daily gain during the breeding season, stocking rate, pasture type and body weight at the beginning of the breeding season. Data were obtained from 43 experiments conducted in commercial ranches and research stations in the Pampas region between 1976 and 2015. Stocking rate ranged from 200 to 464 kg live weight ha-1, which brackets values for most of the grazinglands in similar regions. Age at breeding was 14-36 months (24.6±7.5 months); initial breeding weights were 129-506 kg and 194-570 kg for heifers and primiparous cows. Pregnancy rate was modeled with an apriori set of explanatory variables where proximate variables (breed, body weight at start of breeding, weight gain during breeding and category) were included first and subsequently modeled as functions of other variables (pasture type, supplementation and stocking rate). This modeling approach allowed detection of direct and indirect effects (through nutrition and body weight) of factors that affect pregnancy rate. Bos taurus breeds (N = 1058) had higher pregnancy rate than B. Taurus x B. indicus crossbreed (N = 1924) females. Pregnancy rate of heifers and primiparous cows grazing in natural grasslands decreased with increasing stocking rate, but no effect of stocking rate was detected in cultivated and improved pastures. Pregnancy rate increased with increasing average daily gain during the breeding season. Use of cultivated or improved natural pastures promotes higher pregnancy rate, as well as allows an increase in stocking rate at the regional level. Body weight at the start of the breeding season is the primary determinant of pregnancy rates in heifer and primiparous cows.
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Project description: Not available
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Project description:ObjectiveAn increasing number of studies indicate that autophagy plays an important role in the pathogenesis of spinal cord injury, and that regulating autophagy can enhance recovery from spinal cord injury. However, the effect of regulating autophagy and whether autophagy is detrimental or beneficial after spinal cord injury remain unclear. Therefore, in this study we evaluated the effects of autophagy regulation on spinal cord injury in rats by direct and indirect comparison, in an effort to provide a basis for further research.Data sourceRelevant literature published from inception to February 1, 2018 were included by searching Wanfang, CNKI, Web of Science, MEDLINE (OvidSP), PubMed and Google Scholar in English and Chinese. The keywords included "autophagy", "spinal cord injury", and "rat".Data selectionThe literature included in vivo experimental studies on autophagy regulation in the treatment of spinal cord injury (including intervention pre- and post-spinal cord injury). Meta-analyses were conducted at different time points to compare the therapeutic effects of promoting or inhibiting autophagy, and subgroup analyses were also conducted.Outcome measureBasso, Beattie, and Bresnahan scores.ResultsOf the 622 studies, 33 studies of median quality were included in the analyses. Basso, Beattie, and Bresnahan scores were higher at 1 day (MD = 1.80, 95% CI: 0.81-2.79, P = 0.0004), 3 days (MD = 0.92, 95% CI: 0.72-1.13, P < 0.00001), 1 week (MD = 2.39, 95% CI: 1.85-2.92, P < 0.00001), 2 weeks (MD = 3.26, 95% CI: 2.40-4.13, P < 0.00001), 3 weeks (MD = 3.13, 95% CI: 2.51-3.75, P < 0.00001) and 4 weeks (MD = 3.18, 95% CI: 2.43-3.92, P < 0.00001) after spinal cord injury with upregulation of autophagy compared with the control group (drug solvent control, such as saline group). Basso, Beattie, and Bresnahan scores were higher at 1 day (MD = 6.48, 95% CI: 5.83-7.13, P < 0.00001), 2 weeks (MD = 2.43, 95% CI: 0.79-4.07, P = 0.004), 3 weeks (MD = 2.96, 95% CI: 0.09-5.84, P = 0.04) and 4 weeks (MD = 4.41, 95% CI: 1.08-7.75, P = 0.01) after spinal cord injury with downregulation of autophagy compared with the control group. Indirect comparison of upregulation and downregulation of autophagy showed no differences in Basso, Beattie, and Bresnahan scores at 1 day (MD = -4.68, 95% CI: -5.840 to -3.496, P = 0.94644), 3 days (MD = -0.28, 95% CI: -2.231-1.671, P = 0.99448), 1 week (MD = 1.83, 95% CI: 0.0076-3.584, P = 0.94588), 2 weeks (MD = 0.81, 95% CI: -0.850-2.470, P = 0.93055), 3 weeks (MD = 0.17, 95% CI: -2.771-3.111, P = 0.99546) or 4 weeks (MD = -1.23, 95% CI: -4.647-2.187, P = 0.98264) compared with the control group.ConclusionRegulation of autophagy improves neurological function, whether it is upregulated or downregulated. There was no difference between upregulation and downregulation of autophagy in the treatment of spinal cord injury. The variability in results among the studies may be associated with differences in research methods, the lack of clearly defined autophagy characteristics after spinal cord injury, and the limited autophagy monitoring techniques. Thus, methods should be standardized, and the dynamic regulation of autophagy should be examined in future studies.
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Project description:Platelet autoantibody (PA) testing has previously shown poor sensitivity for immune thrombocytopenia (ITP) diagnosis, but no previous study used both 2011 American Society of Hematology (ASH) guidelines for ITP diagnosis and 2012 International Society on Thrombosis and Haemostasis (ISTH) PA testing recommendations. We therefore performed a comprehensive retrospective study of PA testing in adult patients with ITP strictly applying these criteria. Of 986 PA assays performed, 485 assays in 368 patients met criteria and were included. Sensitivity and specificity of a positive test result for diagnosis of active ITP (n = 228 patients) were 90% and 78%, respectively. Sensitivity and specificity of a negative test result for clinical remission (n = 61 assays) were 87% and 91%. Antibodies against both glycoprotein IIb (GPIIb)/IIIa and GPIb/IX were required for the presence of antibodies against GPIa/IIa in patients with ITP. Logistic regression analysis revealed that more positive autoantibodies predicted more severe disease (relative to nonsevere ITP, relative risk ratio for severe ITP and refractory ITP was 2.27 [P < .001] and 3.09 [P < .001], respectively, per additional autoantibody); however, serologic testing did not meaningfully predict treatment response to glucocorticoids, intravenous immunoglobulin, or thrombopoietin receptor agonists. Sixty-four patients with ITP had multiple PA assays performed longitudinally: all 10 patients achieving remission converted from positive to negative serologic results, and evidence for epitope spreading was observed in 35% of patients with ongoing active disease. In conclusion, glycoprotein-specific direct PA testing performed using ISTH recommendations in patients meeting ASH diagnostic criteria is sensitive and specific for ITP diagnosis and reliably confirms clinical remission. More glycoproteins targeted by autoantibodies predicts for more severe disease.
| S-EPMC6960466 | biostudies-literature