PROMs in Carotid Artery Revascularisation Munira Essat Sc

PROMs in Carotid Artery Revascularisation Munira Essat Sc. HARR, University of Sheffield, UK Co-authors: Ahmed Aber 1, Patrick Phillips 1, Edith Poku 1, Helen Buckley Woods 1, Aoife Howard 1, Simon Palfreyman 2, Eva Kaltenthaler 1, , Georgina Jones 3, Jonathan Michaels 1 1 University of Sheffield, UK; 2 University of Alberta, Canada; 3 Leeds Beckett University, UK

2 Funding / Disclaimer • This work presents independent research funded by the UK National Institute for Health Research (NIHR) under the Programme Grants for Applied Research programme (Project ID: RP‐PG‐ 1210‐ 12009) • The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA Programme, NICE, NIHR, NHS or the UK Department of Health 19/10/2021 © The University of Sheffield

3 Background • Carotid artery disease (CAD) is the narrowing of one or both of the carotid arteries due to plaque build-up and can increase the risk of stroke • Patients with severely narrowed or blocked arteries may undergo a procedure (endarterectomy, angioplasty or stenting) to open the arteries and prevent stroke 19/10/2021 © The University of Sheffield

4 • Patient-reported outcome measures (PROMs) are self-completed questionnaires which provide a way to measure the impact of a disease and its associated treatments on the Qo. L from the patients’ perspective • Generic • Disease-specific • Preference-based 19/10/2021 © The University of Sheffield

5 • PROMs used alongside clinical outcome measures provide information that helps to inform: • • Disease management Therapeutic choices Reimbursement decisions Health policy Source: http: //cardiovisual. com/category/heart-health-curated-articles/curated-articles-doctorpatient-communication/ • No recommended PROMs for use in patients undergoing carotid artery revascularisation 19/10/2021 © The University of Sheffield

6 Review objectives • Identify PROMs that have been: • Developed and/or validated in patients with CAD undergoing revascularisation • Assess their psychometric properties • Examine suitability for clinical and research use 19/10/2021 © The University of Sheffield

7 Inclusion criteria Population Participants with a diagnosis of CAD who need, have had, or are undergoing revascularisation Intervention Any treatment procedure indicated for CAD e. g. carotid endarterectomy, carotid artery stenting and angioplasty Outcomes Study Type PROMs (including generic, disease-specific, preferencebased, functional and symptoms) used to assess Qo. L in patients with CAD undergoing revascularisation Any Language English 19/10/2021 © The University of Sheffield

8 Methods • 8 databases were searched (inception to 02/17) • Two-stage search approach: • Stage 1: searches undertaken to identify all relevant PROM terms used in CAD • Stage 2: incorporated PROM terms identified in stage 1 with the preliminary search strategy and a methodological search filter for finding studies on measurement properties 19/10/2021 © The University of Sheffield

9 Evaluation of PROMs • Reliability- measures are reproducible and consistent over time in patients with a stable condition • Validity- instrument measures what it is supposed to measure • Responsiveness- instrument detects meaningful change over time if a change truly exist • Acceptability- the degree to which the instrument is acceptable to the patients 19/10/2021 © The University of Sheffield

10 Results • 1, 670 citations identified • Five studies (reporting on six PROMs) were included: • SF-36, EQ-5 D, HADS, DHI, Quality of life for CAD scale, and Disease-specific PROM for CAD 19/10/2021 © The University of Sheffield

11 Study and patient characteristics Author, year (Country) Stolker 2010 (SAPPHIRE Trial, USA) Cohen 2011 (CREST Trial, USA & Canada) Attigah 2011 (Germany) Design Diagnosis (Sample size) RCT Reported PROM(s) Treatment Symptomatic and EQ-5 D CEA versus asymptomatic carotid SF-36 CAS in high stenosis (high risk) (N=310) Disease-specific PROM risk patients RCT Symptomatic and SF-36 CEA versus asymptomatic carotid stenosis Disease-specific PROM CAS (N=2, 502) Cohort Symptomatic and HADS Local study asymptomatic carotid stenosis EQ-5 D anaesthetic (N=102) in CEA Hsu 2014 Cohort Symptomatic and SF-36 CAS (Taiwan) study asymptomatic carotid stenosis DHI (N=61) Ivanova 2015 Before- Asymptomatic carotid Quality of life for CAD CEA (Latvia) after artery stenosis (N=120) study BMT, best medical therapy; CAS, carotid artery stenting; CEA, carotid endarterectomy; 19/10/2021 © The University of Sheffield

Psychometric properties of included PROMs Internal consistency Test re-test Reliability Content validity Construct validity Responsiveness Acceptability 0 0 ? 0 0 0 0 +/+/0 + + 0 0 0 0 +/? + 0 0 0 - 0 0 ? ? + + 0 0 +/- 0 0 0 0 ? 0 SF-36 Cohen 2011 Stolker 2010 Hsu 2014 EQ-5 D Stolker 2010 Attigah 2011 Disease-Specific PROM Cohen 2011 Stolker 2011 Quality of life for CAD Ivanova 2015 Dizziness Handicap Inventory Hsu 2014 0 Hospital Anxiety and Depression Scale Attigah 2011 0 Psychometric and operational criteria: 0, Not reported/ no evaluation completed; -, Not in favour; -/+, Weak evidence; +, In favour; ? Methodology questionable 19 -Oct-21 © The University of Sheffield

13 Implication of results • Quality of the instruments were variable • Lacked rigorous psychometric validation in CAD patients • Unable to recommend a specific PROM for use in patients with CAD undergoing revascularisation 19/10/2021 © The University of Sheffield

14 Conclusions • There is a lack of valid, reliable and responsive instruments to measure PROs following carotid artery revascularisation • The development and validation of a new PROM for this patient population is warranted 19/10/2021 © The University of Sheffield

15 References • Attigah N, Kutter J. Assessment of patients' satisfaction in carotid surgery under local anaesthesia by psychometrical testing-a prospective cohort study. Eur J Vasc Endovasc Surg 2011; 41(1): 76 -82. • Cohen DJS. Health-related quality of life after carotid stenting versus carotid endarterectomy: Results from CREST (Carotid Revascularization Endarterectomy versus Stenting Trial). J Am Coll Cardiol 2011; 58(15): 1557 -1565. • Hsu LC, Chang FC, Teng MMH, Chern CM, Wong WJ. Impact of carotid stenting in dizzy patients with carotid stenosis. J Chin Med Assoc. 2014; 77(8): 403 -408. • Ivanova P, Kikule I, Zvirgzdins V, Krievins D. Quality of life assessment for asymptomatic high-grade carotid stenosis patients before and after carotid endarterectomy. Gazzetta Medica Italiana Archivio per le Scienze Mediche 2015; 174(12): 33 -42. • Stolker JM, Mahoney EM, Safley DM, Pomposelli FB, Yadav JS, Cohen DJ. Healthrelated quality of life following carotid stenting versus endarterectomy: results from the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at HIgh Risk for Endarterectomy) trial. JACC Cardiovas Inter. 2010; 3: 515 -523. 19/10/2021 © The University of Sheffield

16 Thank you! Email: m. essat@sheffield. ac. uk 19/10/2021 © The University of Sheffield