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Original research
Mixed methods study to develop the content validity and the conceptual framework of the electronic patient-reported outcome measure for vascular conditions
  1. Ahmed Aber1,
  2. Patrick Phillips1,
  3. Elizabeth Lumley1,
  4. Stephen Radley2,
  5. Steven M Thomas1,3,
  6. Shah Nawaz3,
  7. Georgina Jones4,
  8. Jonathan Michaels1
  9. UK Vascular PROMs Group
    1. 1ScHARR, The University of Sheffield, Sheffield, UK
    2. 2Jessop Wing, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
    3. 3Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
    4. 4Leeds Social Sciences School, Leeds Beckett University, Leeds, UK
    1. Correspondence to Dr Ahmed Aber; a.aber{at}


    Objective The 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.

    Design A 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.

    Participants Vascular 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.

    Results The 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.

    Conclusions This 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.

    • patient reported outcome measures
    • vascular surgery
    • electronic health record (EHR)
    • quality in health care
    • qualitative research
    • mixed methods

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:

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    • Collaborators UK Vascular PROMs Group: Alison Abbott; Ayman Badawy; Nasim Akhtar; Faisal, Alam; Wissam Al-Jundi; Matthew Armon; Lukla Biasi; Matt Bown; Bruce Campbell; Tommaso Donati; Tony Fox; Andrew Gordon; Linda Hands; Gary Hicken; Peter Holt; Shelley Jackson; Brenda King; Talia Lea; Greg McMahon; John Mosley; Sanjay Patel; Gaynor Radley; Harjeet Rayt; Rob Sayers; and Paul Tisi.

    • Contributors JM, GJ, AA and SR designed the study. AA, PP, EL, SR and GJ performed the analysis of the data and theme generation. ST and SN helped with consensus study and qualitative study recruitment. AA wrote the paper, and all authors reviewed and edited the paper. All authors approved the manuscript.

    • Funding This manuscript presents independent research funded by the National Institute for Health Research under the Programme Grants for Applied Research (RP-PG-1210–12009).

    • Competing interests SR is a shareholder in ePAQ Systems Ltd, an NHS spin-out technology company, the majority shareholder being Sheffield Teaching Hospitals.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Ethics approval Ethical approval was obtained from Yorkshire & Humber NRES committee – Bradford Leeds (REC Number: 14/YH/1117) on 25 September 2014.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement No data are available.