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01.12.2011 | Research article | Ausgabe 1/2011 Open Access

BMC Medical Research Methodology 1/2011

Baseline characteristics and patient reported outcome data of patients prescribed etanercept: web-based and telephone evaluation

Zeitschrift:
BMC Medical Research Methodology > Ausgabe 1/2011
Autoren:
Alan G Wade, Gordon M Crawford, Neil Pumford, Volker Koscielny, Susan Maycock, Alex McConnachie
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1471-2288-11-91) contains supplementary material, which is available to authorized users.

Competing interests

AW has no competing interests. He is a Director of the company "Patients Direct" which has been funded by Pfizer to setup and undertake the work described in this manuscript.
GC has no competing interests. He is a Director of the company "Patients Direct" which has been funded by Pfizer to setup and undertake the work described in this manuscript.
NP is an employee of Patients Direct.
VK is an employee of Pfizer UK.
SM is an employee of Pfizer UK.
AMcC has no competing interests.

Authors' contributions

AW was involved in the conception, design, set up, acquisition of data, analysis and interpretation of data, reviewing drafts of the manuscript and approval of final version. GC was involved in the conception, design, set up, acquisition of data, analysis and interpretation of data, reviewing drafts of the manuscript and approval of final version. NP was involved in acquisition of data, data verification, designing data reports, analysis and interpretation of data, designing the manuscript content, reviewing drafts of the manuscript and approval of final version. VK was involved in the conception, design, set up, interpretation of data, reviewing drafts of the manuscript and approval of final version. SM was involved in the conception, design, set up, interpretation of data, reviewing drafts of the manuscript and approval of final version. AMcC was involved in the data extraction, data cleaning, designing data reports, analysis and statistical interpretation of data, reviewing drafts of the manuscript and approval of final version.

Abstract

Background

The anti-TNF inhibitor, etanercept is administered as a once or twice weekly subcutaneous injection for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis (JIA). Limited data from the patients' perspective are available on the use of biologics in the treatment of these chronic conditions and this evaluation was designed to collect data from patients who had been prescribed etanercept for the first time. This manuscript describes the self-reported baseline characteristics and health-related quality of life of patients prior to treatment. Follow-up data will be reported separately.

Methods

Patients throughout the United Kingdom prescribed etanercept were invited to participate in an evaluation of their condition and treatment using a data collection tool consisting of a web-based system supplemented by telephone reporting (PROBE). Outcome measures reported at baseline included demographic data, the condition being treated, previous treatment with biologic agents and current and previous medications. Questions modified from standard, validated quality of life questionnaires such as EQ-5D were incorporated and patients made a global assessment of the severity of their own illness using the CGI-S scale.

Results

A total of 344 patients/carers/parents participated in the evaluation at baseline, 290 (84%) by online questionnaire and 54 (16%) by telephone. Overall, the study population had a mean age of 53 years, was predominantly female (62%) and 20% had been previously treated with a biologic agent. A total of 191 (56%) patients were receiving treatment with etanercept for rheumatoid arthritis, 44 (13%) for psoriatic arthritis, 43 (13%) for ankylosing spondylitis, 35 (10%) for psoriasis, 9 (3%) for known juvenile idiopathic arthritis (JIA) and 22 (6%) for another condition/patient unsure/missing response. All patients were prescribed the 50 mg weekly dose of etanercept except for 1 patient with JIA (40 mg) dose and 2 patients with psoriasis (100 mg). Thirty-eight percent of patients with rheumatoid arthritis were not receiving treatment with methotrexate.

Conclusions

The baseline characteristics and health-related quality of life of first time users of etanercept can be adequately described using self-reported patient data collected using an online questionnaire with a telephone option (PROBE).
Zusatzmaterial
Additional File 1: Word document Breakdown of telephone, internet and all responses on baseline characteristics. (DOC 341 KB)
12874_2010_605_MOESM1_ESM.DOC
Additional File 2: Word document Breakdown of question completion by telephone, internet and all respondents. (DOC 175 KB)
12874_2010_605_MOESM2_ESM.DOC
Authors’ original file for figure 1
12874_2010_605_MOESM3_ESM.bmp
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