Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life
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Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life in edentulous patients Lena Ring*1,2, Stefan Höfer1,3, Frank Heuston4, David Harris5 and Ciaran A O'Boyle1 Address: 1Department of Psychology, Royal College of Surgeons in Ireland, Mercer Street Lower, Dublin 2, Ireland, 2Dept of Pharmacy, BMC, Box 580, 751 23 Uppsala, Sweden, 3Department of Medical Psychology and Psychotherapy, Medical University Innsbruck, Innsbruck, Austria, 4Department of Restorative Dentistry & Periodontology, Dublin Dental Hospital, Dublin 2, Ireland and 5The School of Dental Sciences, Trinity College, Dublin 2, Ireland Email: Lena Ring* - [email protected]; Stefan Höfer - [email protected]; Frank Heuston - [email protected]; David Harris - [email protected]; Ciaran A O'Boyle - [email protected] * Corresponding author
Published: 07 September 2005 Health and Quality of Life Outcomes 2005, 3:55
doi:10.1186/1477-7525-3-55
Received: 11 March 2005 Accepted: 07 September 2005
This article is available from: http://www.hqlo.com/content/3/1/55 © 2005 Ring et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract Background: Quality of life (QoL) is now established as an important outcome for evaluating the impact of disease, and for assessing the efficacy of treatments. However, individuals change with time and the basis on which they make a QoL judgement may also change, a phenomenon increasingly referred to as response shift. Here, the individual may change his or her internal standards, values, and/or conceptualization on the target construct as a result of external factors such as a treatment or a change in health status. This has important implications for assessing the effects of treatments as a change in QoL may reflect a response shift, a treatment effect, or a complex combination of both. In this study, we used an individualised quality of life (IQoL) measure, the SEIQoL, together with a then-test to determine whether response shift would influence the measurement of treatment efficacy in edentulous patients. Methods: Data are reported here for the first phase of a randomised controlled clinical trial designed to assess the impact, on IQoL, of implant supported dentures compared with high quality conventional dentures. IQoL was measured using the SEIQoL-DW in 117 patients (mean age 64.8; 32% male) at baseline (T1) and 3 months (T2) after receiving high quality conventional dentures. The work was carried out in dental teaching hospitals in Dublin and Belfast. Results: Unadjusted SEIQoL index scores revealed no significant impact of treatment at three months (baseline: 75.0; 3 months: 73.2, p = .33, n.s.). However, the then-test at 3 months revealed that patients retrosp
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