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The Development and Validation of a Patient-Reported Outcome Measure of Health-Related Quality of Life in Locally Recurrent Rectal Cancer

Harji, Deena Pravin (2017) The Development and Validation of a Patient-Reported Outcome Measure of Health-Related Quality of Life in Locally Recurrent Rectal Cancer. PhD thesis, University of Leeds.

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Abstract

Background The impact of locally recurrent rectal cancer (LRRC) on health-related quality of life (HrQoL) is poorly understood. The overall aim of the project was to develop and validate a patient reported outcome measure (PROM) to assess HrQoL in LRRC in patients in the UK and Australia. This thesis reports on the initial development of the LRRC-QoL and the results from the interim psychometric analysis from the UK cohort. Methods An international, three phase, mixed methodological study was conducted. Phase I consisted of two systematic reviews and a qualitative study consisting of a series of focus groups. Phase II consisted of the development and pre-testing of the provisional PROM; The Locally Recurrent Rectal Cancer Quality of Life Measure (The LRRC-QoL). Phase III assessed the psychometric properties of the LRRC-QoL including scale structure, reliability and validity. Results Phase I: Relevant HrQoL themes were identified; symptoms, sexual function, psychological impact, role functioning, healthcare services, future perspective. These themes were operationalised into a conceptual framework and reviewed by an expert panel prior to the development of a provisional version of the LRRC-QoL. Phase II: A total of 27 cognitive interviews were undertaken to pre-test the LRRC-QoL. The measure underwent three revisions in both population cohorts. The final version of the LRRC-QoL ready for psychometric testing consisted of 32 questions organised into 5 scales. Phase III: Eighty patients participated in the UK validation study. The final scale structure consisted of healthcare services, psychological impact, sexual function, pain, urostomy-related symptoms, lower limb symptoms, stoma related issues, sexual interest and urinary symptoms. The reliability of the LRRC-QoL was good, with Cronbach’s Alpha and Intraclass correlation values of >0.7 for the majority of the scales. The LRRC-QoL was unable to demonstrate the properties of convergent validity and known-groups comparison sufficiently. Conclusions The LRRC-QoL is the first measure to be developed exclusively in patients with LRRC. The scale structure of the LRRC-QoL is robust. Further work is required including the completion of the psychometric validation in Australia and the confirmation of reliability and validity in an independent sample.

Item Type: Thesis (PhD)
Keywords: locally recurrent rectal cancer, quality of life, patient reported outcomes
Academic Units: The University of Leeds > Faculty of Medicine and Health (Leeds) > Institute of Molecular Medicine (LIMM) (Leeds) > Section of Clinical Trials Research Unit (Leeds)
Depositing User: Miss Deena Harji
Date Deposited: 06 Nov 2017 12:04
Last Modified: 06 Nov 2017 12:04
URI: http://etheses.whiterose.ac.uk/id/eprint/18378

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