Are sample sizes of randomized clinical trials in rheumatoid arthritis too large?

2014 ◽  
Vol 44 (11) ◽  
pp. 1034-1044 ◽  
Author(s):  
Selda Celik ◽  
Yusuf Yazici ◽  
Hasan Yazici
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Sample Sizes

scholarly journals Delphi Expert Parent Study: Factors Needed for 21st Century Pre- and Perinatal Parenting Programs

2019 ◽  
Vol 28 (3) ◽  
pp. 163-179
Author(s):  
Christine L. McKee ◽  
Peta Stapleton ◽  
Aileen M. Pidgeon
Keyword(s):  
Clinical Trials ◽  
21St Century ◽  
Randomized Clinical Trials ◽  
Parenting Programs ◽  
Sample Sizes ◽  
Control Groups ◽  
Delphi Methodology

Using Delphi methodology, the current study utilized a panel of “expert” parents (N = 23 after three rounds) to examine nine content-based and logistical factors perceived to be important when developing pre-and perinatal (PPN) parenting programs for the modern day. The aim was to attain consensus on 235 items generated from literature and panelists. Consensus was reached on 126 items (53.62%). The most notable related to needs-based content, barriers to fathers' attendance, and groups of parents who may benefit most from programs. Consistent with the literature, clarity was not achieved for appropriate timing and length of programs. With the diversity of recommendations, next steps involve developing a range of programs that use randomized clinical trials with control groups, effective sample sizes, and are pre-and posttested.

THE INCIDENCE OF TUBERCULOSIS ACROSS 5 RANDOMIZED CLINICAL TRIALS WITH ABATACEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS

2006 ◽  
Vol 12 (Supplement) ◽  
pp. S43-S44
Author(s):  
Carlos Abud-Mendoza ◽  
L W Moreland ◽  
K Bahrt ◽  
J-C Becker ◽  
R Aranda ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Randomized Clinical Trials

scholarly journals Demographic Characteristics of Participants in Rheumatoid Arthritis Randomized Clinical Trials

2019 ◽  
Vol 2 (11) ◽  
pp. e1914745 ◽  
Author(s):  
Adrienne Strait ◽  
Francine Castillo ◽  
Sonam Choden ◽  
Jing Li ◽  
Evans Whitaker ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Demographic Characteristics

scholarly journals The role of biologic agents in damage progression in rheumatoid arthritis: indirect comparison of data coming from randomized clinical trials

2012 ◽  
Vol 4 (4) ◽  
pp. 213-223 ◽  
Author(s):  
Ennio Giulio Favalli ◽  
Francesca Pregnolato ◽  
Martina Biggioggero ◽  
Pier Luigi Meroni
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Radiographic Progression ◽  
Indirect Comparison ◽  
Biologic Agents ◽  
Mean Difference ◽  
Funnel Plot ◽  
Damage Progression ◽  
Radiographic Score

Objectives: All biologic agents approved for the treatment of rheumatoid arthritis (RA) have been tested versus methotrexate (MTX) for efficacy on damage progression in several randomized clinical trials (RCTs), but direct head-to-head comparisons have never been conducted. The purpose of this investigation is to analyse data coming from main RA RCTs and to perform an indirect comparison. Methods: A systematic review of literature from 1988 to 2011 was conducted. Only randomized, double-blind, controlled, comparative trials, with evaluation of radiographic progression were included. The radiographic score was standardized and mean difference in the percentage of the annual radiographic progression rate was used as the effect measure. Heterogeneity between studies was estimated by I2 test. For each trial, the effect was plotted according to its standard error in a funnel plot. Results: Of 44 potentially relevant trials, 12 RCTs were included in the study. In order to optimize RCTs comparison, studies were stratified in early and late RA group. Main population characteristics were similar in both early and late RA groups, whereas the standardized baseline radiographic score value significantly differs among trials in both early (range 2.7–21.9) and late (range 23.46–75) RA groups. The standardized annual estimated progression is similar across the late RA group. Strong evidence of heterogeneity ( I2 = 97%, p = 0.00001) but no asymmetry of the funnel plot was observed in the early RA group. Total mean difference was −16.28 (95% confidence interval [CI] −24.42 to −8.14). For the late RA group a random model was used ( I2 = 99%, p = 0.00001) and a total mean difference of −39.25 (95% CI −53.77 to −24.73) was found. Conclusions: All biologic agents provide a favourable effect on disease progression both in early and late RA. The significant heterogeneity among various RCTs did not allow an effective comparison of the performance of biologic agents in each study.

scholarly journals Adalimumab in rheumatoid arthritis treatment: a systematic review and meta-analysis of randomized clinical trials

2013 ◽  
Vol 53 (5) ◽  
pp. 419-430
Author(s):  
Marina Amaral de Ávila Machado ◽  
Alessandra Almeida Maciel ◽  
Lívia Lovato Pires de Lemos ◽  
Juliana Oliveira Costa ◽  
Adriana Maria Kakehasi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Rheumatoid Arthritis Treatment

scholarly journals Drug-induced cutaneous vasculitis developing during Etanercept treatment for rheumatoid arthritis

2021 ◽  
Vol 97 (4) ◽  
pp. 113-119
Author(s):  
Maria N. Chamurlieva ◽  
Yulia L. Korsakova ◽  
Stefka G. Radenska-Lopovok ◽  
Tatiana V. Korotaeva
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Tnf Inhibitors ◽  
Cutaneous Vasculitis ◽  
Inflammatory Rheumatic Diseases ◽  
Tnf Inhibitor ◽  
Drug Induced ◽  
Etanercept Treatment ◽  
Increased Risk

Biological disease-modifying anti-rheumatic drugs (bDMARDs) are widely used for the treatment of chronic inflammatory rheumatic diseases. Since the introduction of tumor necrosis factor alpha (TNF-) inhibitors, the treatment of rheumatoid arthritis has been revolutionized. The approach of targeting TNF- has considerably improved the success of the treatment of rheumatoid arthritis. Their effectiveness has been extensively proven in randomized clinical trials and in clinical practice. Randomized clinical trials and post-marketing studies proved that patients undergoing TNF- inhibitors therapy are at increased risk of infectious disease, bacterial, viral, fungal, opportunistic, oncology and skin adverse effects such as psoriasis and angiitis of the skin. In this case report drug-induced cutaneous vasculitis developing during TNF- inhibitor (Etanercept) treatment for rheumatoid arthritis is described.

Randomized clinical trials as reflexive–interpretative process in patients with rheumatoid arthritis: a qualitative study

2015 ◽  
Vol 35 (8) ◽  
pp. 1423-1430 ◽  
Author(s):  
Mercedes de Jorge ◽  
Sonia Parra ◽  
Jenny de la Torre-Aboki ◽  
Gabriel Herrero-Beaumont
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Qualitative Study ◽  
Randomized Clinical Trials
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