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Open Access Research

Are treatment benefits in neuropathic pain reflected in the self assessment of treatment questionnaire?

Ingela Wiklund1*, Stefan Holmstrom2, Malcolm Stoker2, Kathleen W Wyrwich3 and Mary Devine3

Author Affiliations

1 United BioSource Corporation, 26-28 Hammersmith Grove, W6 7HA, London, UK

2 Astellas Pharma Global Development, Elisabethhof 19, PO Box 108, 2350 AC, Leiderdorp, The Netherlands

3 United BioSource Corporation, 7101 Wisconsin Ave, Suite 600, 20814, Bethesda, MD, USA

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Health and Quality of Life Outcomes 2013, 11:8  doi:10.1186/1477-7525-11-8

Published: 18 January 2013

Abstract

Background/objective

The Self Assessment of Treatment (SAT) questionnaire was developed to reflect key patient reported outcomes of Neuropathic Pain (NP) treatments. This study aimed to understand how patients perceived the relevance and ease of understanding of the questions in the SAT and to recommend modifications based on patient and clinician interviews.

Methods

Semi-structured interviews were conducted with clinicians and NP patients to provide information regarding treatment attributes and the impact of pain. Patients were debriefed on the SAT, a 5-item scale evaluating pain, activity level, quality of life (QoL) and satisfaction with treatment (recommend treatment and undergo treatment again). The SAT has a recall period reflecting back to the start of treatment. The qualitative analysis software ATLAS.ti 5.0 was used to analyze patient transcripts. Changes to the SAT were integrated into the questionnaire for a second round of debriefing interviews.

Results

Three NP clinicians and 44 patients (20 painful diabetic neuropathy, 16 HIV-associated neuropathy and 8 post herpetic neuralgia) with a mean age of 60.3 (12.3) years and an even gender distribution were interviewed. Patient treatment experience included anticonvulsants (73%), antidepressants (34%), opioids (25%), and topical medications (41%). Pain descriptors and treatment attributes were similar across the three NP groups. Pain relief was judged the most important treatment attribute, followed by ability to undertake activities. Sleep improvement was another important attribute. Activity limitations and QOL were perceived as too broad and non-specific, and were split into 3 concepts each (activity limitations was split into self care, daily and physical activities and QOL was split into sleep, emotions, and social function). A 7-day recall period was introduced. The item stem and response options were made consistent, and a baseline and follow-up questionnaires were developed (except for the satisfaction items) to enable monitoring onset of treatment benefit and change over time.

Conclusions

The content validity of the revised SAT was improved by the qualitative research, and NP treatment benefits are reflected in a more consistent fashion by the changes. Baseline and follow-up versions make it possible to perform assessments of change over time.

Keywords:
Neuropathic pain; Content validity; Self assessment; Questionnaire