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An International Standard Set of Patient-Centered Outcome Measures After Stroke

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An International Standard Set of Patient-Centered Outcome Measures After Stroke Original Contribution An International Standard Set of Patient-Centered Outcome Measures After Stroke Joel Salinas, MD, MBA; Sara M. Sprinkhuizen, PhD, MSc; Teri Ackerson, SCRN, BSN; Julie Bernhardt, PT, PhD; Charlie Davie, MD; Mary G. George, MD, MSPH; Stephanie Gething, Dip COT, MSc; Adam G. Kelly, MD; Patrice Lindsay, RN, PhD; Liping Liu, MD; Sheila C.O. Martins, MD, PhD; Louise Morgan, MSN, CPHQ; Bo Norrving, MD, PhD; Gerard M. Ribbers, MD, PhD; Frank L. Silver, MD; Eric E. Smith, MD, MPH; Linda S. Williams, MD; Lee H. Schwamm, MD Background and Purpose—Value-based health care aims to bring together patients and health systems to maximize the ratio of quality over cost. To enable assessment of healthcare value in stroke management, an international standard set of patient-centered stroke outcome measures was defined for use in a variety of healthcare settings. Methods—A modified Delphi process was implemented with an international expert panel representing patients, advocates, and clinical specialists in stroke outcomes, stroke registers, global health, epidemiology, and rehabilitation to reach consensus on the preferred outcome measures, included populations, and baseline risk adjustment variables. Results—Patients presenting to a hospital with ischemic stroke or intracerebral hemorrhage were selected as the target population for these recommendations, with the inclusion of transient ischemic attacks optional. Outcome categories recommended for assessment were survival and disease control, acute complications, and patient-reported outcomes. Patient-reported outcomes proposed for assessment at 90 days were pain, mood, feeding, selfcare, mobility, communication, cognitive functioning, social participation, ability to return to usual activities, and health-related quality of life, with mobility, feeding, selfcare, and communication also collected at discharge. One instrument was able to collect most patient-reported subdomains (9/16, 56%). Minimum data collection for risk adjustment included patient demographics, premorbid functioning, stroke type and severity, vascular and systemic risk factors, and specific treatment/care-related factors. Conclusions—A consensus stroke measure Standard Set was developed as a simple, pragmatic method to increase the value of stroke care. The set should be validated in practice when used for monitoring and comparisons across different care settings. (Stroke. 2016;47:00-00. DOI: 10.1161/STROKEAHA.115.010898.) Key Words: outcome ◼ outcome and process assessment ◼ patient-centered outcomes research ◼ quality improvement ◼ stroke ◼ stroke care Received July 18, 2015; final revision received September 29, 2015; accepted October 16, 2015. From the International Consortium of Health Outcomes Measurement, Cambridge, MA (J.S., S.M.S.); Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston (J.S., L.H.S.); American Heart Association/American Stroke Association (AHA/ASA), Liberty Hospital, MO (T.A.); The Florey Institute of Neuroscience and Mental Health, Melbourne, Victoria, Australia (J.B.); UCLPartners Academic Health Science Network, Royal Free London NHS Foundation Trust, London, United Kingdom (C.D.); Division for Heart Disease and Stroke Prevention, U.S. Centers for Disease Control and Prevention, Atlanta, GA (M.G.G.); Aneurin Bevan University Health Board, Wales, United Kingdom (S.G.); University of Rochester Medical Center, NY (A.G.K.); Heart and Stroke Foundation of Canada, World Stroke Organization, Ottawa, Ontario, Canada (P.L.); Capital Medical University, Beijing Tiantan Hospital, Beijing, China (L.L.); Hospital Moinhos de Vento, National Stroke Registry, Brazilian Stroke Society, Porto Alegre, Brazil (S.C.O.M.); AHA/ASA, Dallas, TX (L.M.); Department of Clinical Sciences, Neurology, Lund University, Lund, Sweden (B.N.); Swedish Stroke Register (Riksstroke), Umeå, Sweden (B.N.); Erasmus University MC, Rijndam Rehabilitation Center, Rotterdam, The Netherlands (G.M.R.); Ontario Stroke Registry, University of Toronto, Toronto, Ontario, Canada (F.L.S.); Hotchkiss Brain Institute and Department of Clinical Neurosciences, University of Calgary, Calgary, Canada (E.E.S.); VA HSR&D Stroke QUERI, Indiana University School of Medicine, Indianapolis (L.S.W.); AHA/ASA Get With The Guidelines-Stroke Registry (L.H.S.); Paul Coverdell National Acute Stroke Registry (L.H.S.); Stroke Joint Commission (L.H.S.); and Primary and Comprehensive Stroke Center Certification Programs (L.H.S.). Guest Editor for this article was Giuseppe Lanzino, MD. The online-only Data Supplement is available with this article at http://stroke.ahajournals.org/lookup/suppl/doi:10.1161/STROKEAHA. 115.010898/-/DC1. Correspondence to Lee H. Schwamm, MD, Vice Chairman, Department of Neurology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114. E-mail [email protected] © 2015 The Authors. Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made. Stroke is available at http://stroke.ahajournals.org DOI: 10.1161/STROKEAHA.115.010898 Downloaded from http://stroke.ahajournals.org/1 by guest on January 26, 2016 2 Stroke January 2016 he global stroke epidemic continues to increase, with a Core Principles Tdisproportionate burden present and increasing among In reviewing candidate measures, the panel’s decision to include or low-income countries.1 There is an urgent need for better exclude elements from the Standard Set was governed by a set of strategies to deliver efficient and effective care, while reduc- guiding principles, which were unanimously adopted by the panel at the onset of the process. These included emphasizing or prioritiz- ing disparities between countries, because of the societal ing (1) pragmatism over idealism; (2) completeness in data collec- burden posed by stroke. A proposed strategy for improving tion over breadth of areas surveyed; (3) measures that can also be quality of care involves measuring the value-based health care collected through retrospective abstraction; (4) instruments that are given to patients.2 In this framework, value is defined as the perpetually freely available and ideally with a digital platform; (5) instruments made of modular subunits that permit recombination of total benefit gained by a patient relative to the cost of obtain- elements; and (6) measures robust to comparison in both low- and ing that benefit (ie, health outcomes divided by the cost to high-income countries and with available cost utility values to calcu- achieve those outcomes).3 Defining condition-specific mea- late measures of cost-effectiveness. surable outcomes that are meaningful to patients is critical to this equation. Outcomes can be broken into the broad catego- Results ries of survival, disease control, complications of treatment, Condition Scope and long-term quality of life. The importance of each can vary The Standard Set was developed for evaluation of adult from patient to patient.4 Despite existing efforts in the area patients (age ≥18 years) presenting to a hospital with isch- of patient-reported outcome measures (PROMs) to quantify emic stroke (IS) or intracerebral hemorrhage (ICH). This stroke outcomes accurately using validated instruments, there scope of IS and ICH covers >90% of the global burden of is significant variability across instruments and domains, incident stroke with high diagnostic reliability based on epide- and no agreement about which critical measures should miological studies performed worldwide at varied proportions 5–8 be routinely captured. To define a set of global standards between countries.10,11 Inclusion of both IS and ICH is needed for measuring outcomes that matter most to stroke patients, to create a global model for stroke and allows a greater focus an international expert panel was assembled representing on uniformly capturing stroke severity (an essential predictor patients, advocates, and clinician experts in stroke outcomes, of outcome). registers, global health, epidemiology, and rehabilitation. Subarachnoid hemorrhage (SAH) was excluded from case entry because of the substantially different course of treatment Methods and outcomes in patients with SAH. Although SAH is more Assembling the Expert Panel likely to be distinguished from IS or ICH based on clinical pre- The primary aim of this expert consensus group was to define the sentation and age, differentiating between ISH and ICH in set- Stroke Standard Set, a minimum set of outcomes and risk adjust- tings where imaging technologies are not available would require ment variables that are highest priority to collect for all patients inferential (rather than definite) classification based on proxy hospitalized with stroke and designed to be able to be measured in variables. Given heterogeneity in SAH case ascertainment, as any country within an existing register or as a free-standing set. The well as the markedly different nature of SAH management, and working group was created and coordinated by the International impact on outcomes, not including SAH in the initial Standard Consortium for Health Outcomes Measurement (ICHOM, http:// www.ICHOM.org), a nonprofit organization focused on the devel- Set was favored. Future working groups
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