PROMs in Carotid Artery Revascularisation Munira Essat ScHARR, University of Sheffield, UK Co-authors: Ahmed Aber1, Patrick Phillips1, Edith Poku1, Helen Buckley Woods1, Aoife Howard1, Simon Palfreyman2, Eva Kaltenthaler1,, Georgina Jones3, Jonathan Michaels1   1 University of Sheffield, UK; 2University of Alberta, Canada; 3 Leeds Beckett University, UK

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 12/11/2018 © The University of Sheffield

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 12/11/2018 © The University of Sheffield

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 QoL from the patients’ perspective Generic Disease-specific Preference-based 12/11/2018 © The University of Sheffield

PROMs used alongside clinical outcome measures provide information that helps to inform: Disease management Therapeutic choices Reimbursement decisions Health policy No recommended PROMs for use in patients undergoing carotid artery revascularisation Source: http://cardiovisual.com/category/heart-health-curated-articles/curated-articles-doctor-patient-communication/ 12/11/2018 © The University of Sheffield

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 12/11/2018 © The University of Sheffield

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 PROMs (including generic, disease-specific, preference-based, functional and symptoms) used to assess QoL in patients with CAD undergoing revascularisation Study Type Any Language English 12/11/2018 © The University of Sheffield

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 12/11/2018 © The University of Sheffield

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 12/11/2018 © The University of Sheffield

Results 1,670 citations identified Five studies (reporting on six PROMs) were included: SF-36, EQ-5D, HADS, DHI, Quality of life for CAD scale, and Disease-specific PROM for CAD 12/11/2018 © The University of Sheffield

Study and patient characteristics Author, year (Country) Design Diagnosis (Sample size) Reported PROM(s) Treatment Stolker 2010 (SAPPHIRE Trial, USA) RCT Symptomatic and asymptomatic carotid stenosis (high risk) (N=310) EQ-5D SF-36 Disease-specific PROM CEA versus CAS in high risk patients Cohen 2011 (CREST Trial, USA & Canada) Symptomatic and asymptomatic carotid stenosis (N=2,502) CEA versus CAS Attigah 2011 (Germany) Cohort study Symptomatic and asymptomatic carotid stenosis (N=102) HADS Local anaesthetic in CEA Hsu 2014 (Taiwan) Symptomatic and asymptomatic carotid stenosis (N=61) DHI CAS Ivanova 2015 (Latvia) Before- after study Asymptomatic carotid artery stenosis (N=120) Quality of life for CAD CEA BMT, best medical therapy; CAS, carotid artery stenting; CEA, carotid endarterectomy; 12/11/2018 © The University of Sheffield

Psychometric properties of included PROMs Internal consistency Test re-test Reliability Content validity Construct validity Responsiveness Acceptability SF-36 Cohen 2011 +/- + Stolker 2010 - Hsu 2014 ? EQ-5D   Attigah 2011 Disease-Specific PROM Cohen 2011 Stolker 2011 Quality of life for CAD Ivanova 2015 Dizziness Handicap Inventory Hospital Anxiety and Depression Scale Psychometric and operational criteria: 0, Not reported/ no evaluation completed; -, Not in favour; -/+, Weak evidence; +, In favour; ? Methodology questionable 12-Nov-18 © The University of Sheffield

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 12/11/2018 © The University of Sheffield

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 12/11/2018 © The University of Sheffield

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(1-2):33-42. Stolker JM, Mahoney EM, Safley DM, Pomposelli FB, Yadav JS, Cohen DJ. Health-related 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. 12/11/2018 © The University of Sheffield

Email: m.essat@sheffield.ac.uk Thank you! Email: m.essat@sheffield.ac.uk 12/11/2018 © The University of Sheffield