Literature DB >> 9389222

Clinical trials in rheumatoid arthritis: methodological suggestions for assessing radiographs arising from the GRISAR Study. Gruppo Reumatologi Italiani Studio Artrite Reumatoide.

R Ferrara1, F Priolo, M Cammisa, L Bacarini, A Cerase, G Pasero, G F Ferraccioli, O D Alberighi, A Antonellini, E Marubini.   

Abstract

OBJECTIVES: The three x ray assessors of the GRISAR study (blinded to treatment) gave consensual erosion and damage scores to the baseline and 12 month radiographs of 284 rheumatoid arthritis (RA) patients using three different methods: single readings (blinded as to patient and chronological sequence of the x rays), paired readings (blinded as to sequence), and chronologically ordered paired readings. The aim was to evaluate which of these reading procedures is the most appropriate for clinical trials.
METHODS: The progression of the scores obtained using each procedure was compared by means of descriptive statistics, principal components analysis, and intra-patient correlation coefficients of pairs of methods. Bootstrap estimates of the variance of the difference in the means of two equally sized random samples were calculated to evaluate the power of the statistical analysis performed to assess the possible treatment effect for both paired and chronological reading methods.
RESULTS: (a) The standard deviations of the paired and chronological readings were similar, but that of the single readings was higher. (b) The knowledge that two x rays were of the same patient accounted for a sizeable proportion of the between method variability. (c) Agreement was satisfactory between the paired and chronological methods for both scores but, between them and the single readings, it was modest for erosions and poor for damage. (d) The bootstrap estimate of the variance of the difference was smaller for the paired than the chronological method, possibly giving it greater power to test treatment effect.
CONCLUSIONS: These results suggested that paired readings were the most suitable for evaluating the progression of joint damage in the GRISAR study.

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Year:  1997        PMID: 9389222      PMCID: PMC1752270          DOI: 10.1136/ard.56.10.608

Source DB:  PubMed          Journal:  Ann Rheum Dis        ISSN: 0003-4967            Impact factor:   19.103


  12 in total

Review 1.  Radiographic assessment of disease progression in rheumatoid arthritis.

Authors:  A C Brower
Journal:  Rheum Dis Clin North Am       Date:  1991-08       Impact factor: 2.670

Review 2.  Use of the radiograph to measure the course of rheumatoid arthritis. The gold standard versus fool's gold.

Authors:  A C Brower
Journal:  Arthritis Rheum       Date:  1990-03

3.  Radiographic evaluation of rheumatoid arthritis and related conditions by standard reference films.

Authors:  A Larsen; K Dale; M Eek
Journal:  Acta Radiol Diagn (Stockh)       Date:  1977-07

Review 4.  Plain X-rays in rheumatoid arthritis: overview of scoring methods, their reliability and applicability.

Authors:  D M van der Heijde
Journal:  Baillieres Clin Rheumatol       Date:  1996-08

5.  Assessment of radiologic progression in rheumatoid arthritis. A randomized, controlled trial.

Authors:  J F Fries; D A Bloch; J T Sharp; D J McShane; P Spitz; G B Bluhm; D Forrester; H Genant; P Gofton; S Richman
Journal:  Arthritis Rheum       Date:  1986-01

6.  Methods of assessing radiographic change in rheumatoid arthritis.

Authors:  H K Genant
Journal:  Am J Med       Date:  1983-12-30       Impact factor: 4.965

7.  How many joints in the hands and wrists should be included in a score of radiologic abnormalities used to assess rheumatoid arthritis?

Authors:  J T Sharp; D Y Young; G B Bluhm; A Brook; A C Brower; M Corbett; J L Decker; H K Genant; J P Gofton; N Goodman
Journal:  Arthritis Rheum       Date:  1985-12

Review 8.  Radiographic methods of assessment (scoring) of rheumatic disease.

Authors:  J J Kaye
Journal:  Rheum Dis Clin North Am       Date:  1991-08       Impact factor: 2.670

9.  Hand radiography of 200 patients with rheumatoid arthritis repeated after an interval of one year.

Authors:  A Larsen; J Thoen
Journal:  Scand J Rheumatol       Date:  1987       Impact factor: 3.641

10.  Biannual radiographic assessments of hands and feet in a three-year prospective followup of patients with early rheumatoid arthritis.

Authors:  D M van der Heijde; M A van Leeuwen; P L van Riel; A M Koster; M A van 't Hof; M H van Rijswijk; L B van de Putte
Journal:  Arthritis Rheum       Date:  1992-01
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  9 in total

1.  Radiographic assessment of hip osteoarthritis progression: impact of reading procedures for longitudinal studies.

Authors:  G R Auleley; B Giraudeau; M Dougados; P Ravaud
Journal:  Ann Rheum Dis       Date:  2000-06       Impact factor: 19.103

Review 2.  Interpreting radiographic data in rheumatoid arthritis.

Authors:  P A Ory
Journal:  Ann Rheum Dis       Date:  2003-07       Impact factor: 19.103

3.  Radiography as primary outcome in rheumatoid arthritis: acceptable sample sizes for trials with 3 months' follow up.

Authors:  K Bruynesteyn; R Landewé; Sj van der Linden; D van der Heijde
Journal:  Ann Rheum Dis       Date:  2004-03-22       Impact factor: 19.103

Review 4.  Radiographic scoring methods as outcome measures in rheumatoid arthritis: properties and advantages.

Authors:  S Boini; F Guillemin
Journal:  Ann Rheum Dis       Date:  2001-09       Impact factor: 19.103

5.  Scoring of radiographic progression in randomised clinical trials in ankylosing spondylitis: a preference for paired reading order.

Authors:  A Wanders; R Landewé; A Spoorenberg; K de Vlam; H Mielants; M Dougados; S van der Linden; D van der Heijde
Journal:  Ann Rheum Dis       Date:  2004-08-05       Impact factor: 19.103

Review 6.  Prevention or retardation of joint damage in rheumatoid arthritis: issues of definition, evaluation and interpretation of plain radiographs.

Authors:  Maarten Boers; Désirée M F M van der Heijde
Journal:  Drugs       Date:  2002       Impact factor: 9.546

7.  Blinding images to sequence in osteoarthritis: evidence from other diseases.

Authors:  D T Felson; M C Nevitt
Journal:  Osteoarthritis Cartilage       Date:  2008-11-01       Impact factor: 6.576

8.  Inter-rater reliability of the radiographic assessment of simple bone cysts.

Authors:  S Cho; R Yankanah; P Babyn; J Stimec; A S Doria; D Stephens; J G Wright
Journal:  J Child Orthop       Date:  2019-04-01       Impact factor: 1.548

9.  Deep learning-based automatic-bone-destruction-evaluation system using contextual information from other joints.

Authors:  Kazuki Miyama; Ryoma Bise; Satoshi Ikemura; Kazuhiro Kai; Masaya Kanahori; Shinkichi Arisumi; Taisuke Uchida; Yasuharu Nakashima; Seiichi Uchida
Journal:  Arthritis Res Ther       Date:  2022-10-03       Impact factor: 5.606

  9 in total

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