1. 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

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
12/11/2018
© 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
12/11/2018
© 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 QoL from the patients’ perspective
Generic
Disease-specific
Preference-based
12/11/2018
© 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
No recommended PROMs for use in patients undergoing carotid artery revascularisation
Source:
12/11/2018
© 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
12/11/2018
© 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
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

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
12/11/2018
© 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
12/11/2018
© The University of Sheffield

10. 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

11. 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

12. 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

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
12/11/2018
© 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
12/11/2018
© 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):
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):
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:
12/11/2018
© The University of Sheffield

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