Literature DB >> 15479869

Should contemporary rheumatoid arthritis clinical trials be more like standard patient care and vice versa?

T Pincus1, T Sokka.   

Abstract

The information used by rheumatologists when delivering care to patients with rheumatoid arthritis (RA) is derived mainly from two sources: randomised controlled clinical trials and experience in clinical care. However, these two sources differ significantly because (a) the extensive inclusion and exclusion criteria result in clinical trial participants being recruited from only a minority of patients seen in standard clinical care; (b) assessments in clinical trials are conducted according to standard quantitative measures and indices, while standard clinical care of most patients with RA is generally conducted empirically, without collection of any quantitative data other than laboratory tests to estimate prognosis and document change in status; and (c) although baseline databases of various clinical trials (and observational studies) are 60-90% identical in content, they are not standardised and therefore not amenable to direct comparisons. Strategies to promote similarities between clinical trials and standard clinical care in patients with RA may include: more generalised inclusion criteria; incorporation of quantitative measurement into standard care, easily accomplished by asking each patient to complete a simple questionnaire at each visit to a rheumatologist; and consensus among rheumatologists for databases with standard content and format in clinical care and research involving patients with RA.

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Year:  2004        PMID: 15479869      PMCID: PMC1766773          DOI: 10.1136/ard.2004.028415

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


  75 in total

1.  Listening to the patient: a practical guide to self-report questionnaires in clinical care.

Authors:  F Wolfe; T Pincus
Journal:  Arthritis Rheum       Date:  1999-09

2.  Clinical versus statistical considerations in the design and analysis of clinical research.

Authors:  R I Horwitz; B H Singer; R W Makuch; C M Viscoli
Journal:  J Clin Epidemiol       Date:  1998-04       Impact factor: 6.437

3.  Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group.

Authors:  R Maini; E W St Clair; F Breedveld; D Furst; J Kalden; M Weisman; J Smolen; P Emery; G Harriman; M Feldmann; P Lipsky
Journal:  Lancet       Date:  1999-12-04       Impact factor: 79.321

Review 4.  Measures of activity and damage in rheumatoid arthritis: depiction of changes and prediction of mortality over five years.

Authors:  L F Callahan; T Pincus; J W Huston; R H Brooks; E P Nance; J J Kaye
Journal:  Arthritis Care Res       Date:  1997-12

5.  A practical exercise in reading RA radiographs by the larsen and sharp methods.

Authors:  E T Molenaar; J Edmonds; M Boers; D M van der Heijde; M Lassere
Journal:  J Rheumatol       Date:  1999-03       Impact factor: 4.666

6.  Treatment of active rheumatoid arthritis with leflunomide compared with placebo and methotrexate. Leflunomide Rheumatoid Arthritis Investigators Group.

Authors:  V Strand; S Cohen; M Schiff; A Weaver; R Fleischmann; G Cannon; R Fox; L Moreland; N Olsen; D Furst; J Caldwell; J Kaine; J Sharp; F Hurley; I Loew-Friedrich
Journal:  Arch Intern Med       Date:  1999-11-22

7.  Toward a multidimensional Health Assessment Questionnaire (MDHAQ): assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format.

Authors:  T Pincus; C Swearingen; F Wolfe
Journal:  Arthritis Rheum       Date:  1999-10

8.  A proposed 30-45 minute 4 page standard protocol to evaluate rheumatoid arthritis (SPERA) that includes measures of inflammatory activity, joint damage, and longterm outcomes.

Authors:  T Pincus; R H Brooks; L F Callahan
Journal:  J Rheumatol       Date:  1999-02       Impact factor: 4.666

9.  Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology.

Authors:  F Wolfe; M Lassere; D van der Heijde; G Stucki; M Suarez-Almazor; T Pincus; K Eberhardt; T K Kvien; D Symmons; A Silman; P van Riel; P Tugwell; M Boers
Journal:  J Rheumatol       Date:  1999-02       Impact factor: 4.666

10.  Quantitation of the activity of rheumatoid arthritis. 5. A method for summation of the systemic indices of rheumatoid activity.

Authors:  J LANSBURY
Journal:  Am J Med Sci       Date:  1956-09       Impact factor: 2.378

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  16 in total

Review 1.  Swedish registers to examine drug safety and clinical issues in RA.

Authors:  J Askling; C M Fored; P Geborek; L T H Jacobsson; R van Vollenhoven; N Feltelius; S Lindblad; L Klareskog
Journal:  Ann Rheum Dis       Date:  2006-01-13       Impact factor: 19.103

2.  Effectiveness of anti-tumor necrosis factor agents in the treatment of rheumatoid arthritis: observational study.

Authors:  Anna D'Souza; Brian L Meissner; Boxiong Tang; R Scott McKenzie; Catherine T Piech
Journal:  Am Health Drug Benefits       Date:  2010-07

3.  Biologic therapies and infections in the daily practice of three Italian rheumatologic units: a prospective, observational study.

Authors:  Paola Cipriani; Onorina Berardicurti; Francesco Masedu; Francesca D'Onofrio; Luca Navarini; Piero Ruscitti; Nicola Maruotti; Domenico Paolo Emanuele Margiotta; Vasiliki Liakouli; Paola Di Benedetto; Francesco Carubbi; Marco Valenti; Francesco Paolo Cantatore; Antonella Afeltra; Roberto Giacomelli
Journal:  Clin Rheumatol       Date:  2016-10-25       Impact factor: 2.980

4.  Biologicals in rheumatology: Austrian experiences from a rheumatic outpatient clinic.

Authors:  C Duftner; C Dejaco; H Larcher; M Schirmer; M Herold
Journal:  Rheumatol Int       Date:  2008-05-27       Impact factor: 2.631

5.  Acupuncture for symptom management of rheumatoid arthritis: a pilot study.

Authors:  Hyangsook Lee; Ji-Young Lee; Yun-Ju Kim; Sehyun Kim; Changshik Yin; Jae-Ho Khil; Kirok Kwon; Sun-Mi Choi; Hyejung Lee; Hi-Joon Park
Journal:  Clin Rheumatol       Date:  2008-01-10       Impact factor: 2.980

6.  Health care costs of rheumatoid arthritis: A longitudinal population study.

Authors:  Mark Tatangelo; George Tomlinson; J Michael Paterson; Edward Keystone; Nick Bansback; Claire Bombardier
Journal:  PLoS One       Date:  2021-05-06       Impact factor: 3.240

7.  Is three selected parameters adequate to monitor rheumatoid arthritis?

Authors:  S Chandrashekara; M Syed; R Swapna
Journal:  Clin Rheumatol       Date:  2006-10-07       Impact factor: 3.650

8.  Impact of concomitant DMARD therapy on adherence to treatment with etanercept and infliximab in rheumatoid arthritis. Results from a six-year observational study in southern Sweden.

Authors:  Lars Erik Kristensen; Tore Saxne; Jan-Ake Nilsson; Pierre Geborek
Journal:  Arthritis Res Ther       Date:  2006       Impact factor: 5.156

9.  Increased Cardiovascular Events and Subclinical Atherosclerosis in Rheumatoid Arthritis Patients: 1 Year Prospective Single Centre Study.

Authors:  Piero Ruscitti; Paola Cipriani; Francesco Masedu; Silvio Romano; Onorina Berardicurti; Vasiliki Liakouli; Francesco Carubbi; Paola Di Benedetto; Saverio Alvaro; Maria Penco; Marco Valenti; Roberto Giacomelli
Journal:  PLoS One       Date:  2017-01-19       Impact factor: 3.240

10.  Rituximab in clinical practice: dosage, drug adherence, Ig levels, infections, and drug antibodies.

Authors:  Jon Thorkell Einarsson; Max Evert; Pierre Geborek; Tore Saxne; Maria Lundgren; Meliha C Kapetanovic
Journal:  Clin Rheumatol       Date:  2017-10-04       Impact factor: 2.980

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