Mixed methods study to develop the content validity and the conceptual framework of the electronic patient-reported outcome measure for vascular conditions

Abstract

ObjectiveThe aim of this paper is to describe the stages undertaken to generate the items and conceptual framework of a new electronic personal assessment questionnaire for vascular conditions.DesignA mixed methods study: First a survey of vascular clinicians was completed to identify the most common conditions treated in vascular clinics and wards. Quantitative systematic reviews were done to identify validated patient-reported outcome measures (PROMs) for direct inclsuion in the new instrument. However, due to scarcity of validated PROMs, the items of the new instrument were mainly based on a large qualitative study of patients and systematic reviews of the qualitative evidence . This was followed by a quantitative clinicians’ consensus study and, finally, a qualitative face validity study with patients.ParticipantsVascular patients participated in the primary qualitative study and the face validity study. In the qualitative study, 55 patients were interviewed, and for the face validity, 19 patients gave feedback. Twelve clinicians completed the survey and 13 completed two cycles of the clinicians’ consensus study.ResultsThe items and scales in the electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS) were generated based on the results of five systematic reviews evaluating existing PROMs for possible inclusion in ePAQ-VAS, five systematic reviews of qualitative evidence, a primary qualitative study involving 55 patients and clinicians’ input. One hundred and sixty-eight items were initially generated, of which 59 were eliminated by the expert panel due to repetition. The instrument was divided into one generic and three disease-specific sections (abdominal aortic aneurysm, carotid artery disease and lower limb vascular conditions). In each section, items were grouped together into putative scales. Fifty-five items were grouped across eight scales; the remaining items were kept as individual items, because of relevance to service users.ConclusionsThis multidimensional electronic questionnaire covers the most common vascular conditions. This is particularly important for patients presenting with mixed symptoms or multiple conditions. This tool captures symptomatology, health related quality of life (HRQoL) and other clinically relevant data, such as experience with services and comorbidities.

Electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS): development and validity

“…First, systematic literature reviews of existing outcome measures and qualitative evidence were conducted 7 -11,21-24 . Second, clinicians involved in the care of vascular patients were invited to list the key issues, symptoms and impact of these conditions 20 . Third, semistructured interviews were conducted with five vascular patient groups (PAD, AAA, CAD, VLU and VV).…”

Configuration of vascular services: a multiple methods research programme

“…Identified signs, symptoms and impact of the conditions were then mapped and tabulated to see which themes were relevant to which condition and where the similarities and differences lay. 179 Pain and mobility were the most commonly reported domains by participants with PAD. The extent to which they had an impact on HRQoL was associated with the severity, age expectations and social support.…”

“…178 Based on the work reported above, the Steering Committee employed an iterative process to incorporate evidence from the systematic reviews of qualitative studies, the qualitative study and the clinicians' consensus study, as recommended by the FDA, 176 to develop the initial item pool for the ePAQ-VAS. 179 A draft instrument was then adjusted based on further service users' input and review by the steering committee.…”

“…The effect size and standardised response mean were measured for all of the relevant scales of the ePAQ-VAS (Table 12). 179 Substudy: EuroQol-5 Dimensions, five-level version, utility values…”

A look to the future: Pandemic-induced digital technologies in vascular surgery

“…Electronic data capture systems can also be designed for direct patient entry, permitting large-scale data collection of patient-reported outcome measures and patient-reported experience measures [78] . These data can be used for clinical research, quality improvement, or to tailor the next step in a protocolized treatment algorithm for individual patients.…”