Development and validation of the Swedish national stroke register Riksstroke's questionnaires in patients at 3 and 12 months after stroke: a qualitative study.

OBJECTIVES: Because healthcare and community organisations and treatment methods are always changing, continuous changes might also be needed in questionnaires that register patient-reported outcomes (PRO) and patient-reported experiences (PRE) of healthcare interventions and community support. Thus, the aim of this study was to test the content and face validity, including the readability, of two questionnaires used by the Swedish national stroke register Riksstroke to register PRO and PRE at 3 and 12 months poststroke.

DESIGN: Clinicians' and patients' knowledge and experiences of current care, rehabilitation, community support and functioning after stroke as well as comments noted regarding the content and layout of the questionnaires were retrieved in focus-groups with expert clinicians and in patient interviews analysed with content analysis. A workgroup of experts with experience in stroke care, rehabilitation and research repeatedly revised the questionnaires regarding content, layout and consistency throughout the validation process.

PARTICIPANTS: The participants included allied healthcare professionals, nurses and physicians with extensive experience of working with stroke care and rehabilitation (expert clinicians) as well as patients who had suffered a stroke 3 or 12 months earlier and who were purposefully selected among those who had completed and returned the 3-month questionnaire.

SETTING: Expert clinicians met at their work place in focus-groups. Patients were interviewed where they resided, that is, in their home or nursing home, including rural, town and city areas in Sweden.

RESULTS: Based on clinical expertise and comments from the patients (n=47), the questionnaires were revised and then found to be valid in terms of content validity and face validity, including readability.

CONCLUSIONS: The present evaluation emphasises the need for testing aspects of validity, including readability, of questionnaires addressing PRO and PRE and for the recurrent revision of such questionnaires in order to maintain their validity in a society undergoing constant change.