REASONS FOR TREATMENT DISCONTINUATION OF BIOLOGICS – DEVELOPMENT AND VALIDATION OF A QUESTIONNAIRE

Author(s)

Meyer-Moock S1, Schiffner-Rohe J2, Kohlmann T3
1Universitätsmedizin Greifswald, Greifswald, Germany, 2Pfizer Deutschland GmbH, Berlin, Germany, 3University Medicine Greifswald, Greifswald, Germany

OBJECTIVES For patients with rheumatoid arthritis (RA) and inadequate response to traditional therapy, treatment with biologics is recommended to reduce disease progression and improve HRQol. Nevertheless, up to 30% of patients stop treatment on their own initiative. Aim of the study is to develop and validate an instrument to assess reasons for treatment discontinuation of biologics in patients with RA.  METHODS We conducted expert interviews with rheumatologists (n=5) to develop a questioning route,  which was used in 2 focus groups with a total of 15 RA patients who dropped out therapy (phase 1). Based on these results a draft questionnaire was developed and pre-tested (phase 2; n=6), resulting in the pilot questionnaire. In the validation phase (phase 3) the questionnaire is completed by approx. 200 patients, with an interim analysis planned after recruitment of half the sample size. Quantitative data analyses will focus on psychometric properties: missing data, floor/ceiling effects, factorial validity, distribution of properties. Patients are recruited at 40 German office based rheumatologists, with 5 patients per center.  RESULTS

The final questionnaire consists of 82 items covering socio-demographic aspects, HRQoL, history of treatment and disease, treatment information, expectations and satisfaction and ”reasons for discontinuation”. Piloting showed that HRQoL, treatment and working-life aspects have impact on treatment discontinuation. Particularly, information about treatment options, patient-doctor relationship and financial burden were addressed. The questionnaire has proven to be feasible in field-test. Validation phase is currently ongoing; results from the interim analysis will be presented. CONCLUSIONS

Interviews with experts and patients demonstrated that treatment discontinuation is triggered by multiple reasons. A targeted developed questionnaire is necessary to identify latent reasons for treatment discontinuation. Furthermore, an “easy-to-use” questionnaire could be used in daily routine to identify patients likely to withdraw treatment and need special patient adherence programs.

This research was funded by Pfizer GmbH.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PMS81

Topic

Patient-Centered Research

Topic Subcategory

Stated Preference & Patient Satisfaction

Disease

Musculoskeletal Disorders

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