Abstract
BackgroundPatient-reported Outcomes (PROs) capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Electronic PRO data capture (ePRO) with software packages to administer questionnaires, storing data, and presenting results has facilitated PRO assessment in hospital settings. Compared to conventional paper-pencil versions of PRO instruments, ePRO is more economical with regard to staff resources and time, and allows immediate presentation of results to the medical staff.The objective of our project was to develop software (CHES – Computer-based Health Evaluation System) for ePRO in hospital settings and at home with a special focus on the presentation of individual patient’s results.MethodsFollowing the Extreme Programming development approach architecture was not fixed up-front, but was done in close, continuous collaboration with software end users (medical staff, researchers and patients) to meet their specific demands. Developed features include sophisticated, longitudinal charts linking patients’ PRO data to clinical characteristics and to PRO scores from reference populations, a web-interface for questionnaire administration, and a tool for convenient creating and editing of questionnaires.ResultsBy 2012 CHES has been implemented at various institutions in Austria, Germany, Switzerland, and the UK and about 5000 patients participated in ePRO (with around 15000 assessments in total). Data entry is done by the patients themselves via tablet PCs with a study nurse or an intern approaching patients and supervising questionnaire completion.DiscussionDuring the last decade several software packages for ePRO have emerged for different purposes. Whereas commercial products are available primarily for ePRO in clinical trials, academic projects have focused on data collection and presentation in daily clinical practice and on extending cancer registries with PRO data. CHES includes several features facilitating the use of PRO data for individualized medical decision making. With its web-interface it allows ePRO also when patients are home. Thus, it provides complete monitoring of patients‘physical and psychosocial symptom burden.
Highlights
Patient-reported Outcomes (PROs) capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice
An important issue related to electronic administration of PRO instruments is the equivalence of scores derived from electronic and from paper-pencil questionnaires
This is in line with a report of the ISPOR Electronic PRO data capture (ePRO) Good Research Practices Task Force report that states, that minor modifications of questionnaire design are not likely to introduce response bias or to impact psychometric properties [10]
Summary
Patient-reported Outcomes (PROs) capturing e.g., quality of life, fatigue, depression, medication side-effects or disease symptoms, have become important outcome parameters in medical research and daily clinical practice. Since the 1990s there has been growing awareness of the importance to complement the traditional physicianrated assessment of the patients’ health status by an assessment made by the patients themselves, so-called patient-reported outcomes (PROs)[1,2,3,4] These PROs include physical and psychosocial symptoms (e.g., sideeffects, quality of life (QOL), gastrointestinal symptoms, fatigue, pain, anxiety, and depression). A meta-analysis by Gwaltney et al [9] suggests that psychometric properties are rather invariant across modes of administration and scores do not differ substantially This is in line with a report of the ISPOR ePRO Good Research Practices Task Force report that states, that minor modifications of questionnaire design are not likely to introduce response bias or to impact psychometric properties [10]. A comprehensive theoretical overview on factors potentially affecting comparability of scores and questioning score equivalence is given by Robling et al [11]
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