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Prognosis 5

Intracerebral hemorrhage (ICH) is a subtype of stroke that results from spontaneous nontraumatic bleeding into the parenchyma of the brain. ICH accounts for ≈10% to 15% of all strokes and carries a disproportionately high risk of early death and long-term disability.1 Evidence for optimal treatment of ICH has lagged behind that for ischemic stroke, and con- sequently, metrics specific to ICH care have not been widely promulgated.

However, numerous more recent studies and clinical trials of various medical and surgical interventions for ICH have been published and form the basis of evidence-based guidelines for the management of ICH that have been devel- oped by the American Heart Association (AHA)/American Stroke Association (ASA) and other international organiza- Thus, the translation of these guidelines into action- able performance measures is a priority to improve the delivery of care and to improve outcomes for patients with ICH.

A clinical performance measure is defined by the Agency for Healthcare Research and Quality as “a mechanism for assessing the degree to which a provider competently and safely delivers the appropriate clinical services to the patient within the optimal time period.”5 Performance measures are being increasingly used for quality improvement, exter- nal reporting, regulatory oversight by hospital and program accreditation groups, and possibly pay-for-performance pro- Performance measures differ from guidelines in that most rigorous guidelines describe a desirable treatment or pro- cess of care that is derived from a review of existing medical evidence using standardized criteria and levels of evidence.7 However, guidelines traditionally do not take the next step of describing specifically how their implementation will be assessed in a quantitative way in order to assess compliance.

Rigorous performance measures often take the strongest high- est-level guidelines and provide a method for directly measur- ing and reporting them with the goal of improving healthcare In addition to being evidence-based, they need to be developed with attention to feasibility and whether they are actionable and clearly interpretable.9 In 2014, the AHA/ASA published “Clinical Performance Measures for Adults Hospitalized With Acute Ischemic This document outlined 15 proposed performance measures for acute ischemic stroke created with the use of a standardized methodology for performance measure Clinical Performance Measures for Adults Hospitalized With Intracerebral Hemorrhage Performance Measures for Healthcare Professionals From the American Heart Association/American Stroke Association J. Claude Hemphill III, MD, MAS, FAHA, Chair; Opeolu M. Adeoye, MD, MS, FAHA; David N. Alexander, MD, FAHA; Anne W. Alexandrov, PhD, AGACNP-BC, ANVP-BC, CCRN; Sepideh Amin-Hanjani, MD, FAHA; Mary Cushman, MD, MSc, FAHA; Mary G. George, MD, MSPH, FAHA*; Peter D. LeRoux, MD; Stephan A. Mayer, MD; Adnan I. Qureshi, MD; Jeffrey L. Saver, MD, FAHA; Lee H. Schwamm, MD, FAHA; Kevin N. Sheth, MD, FAHA; David Tirschwell, MD, MSc, FAHA; on behalf of the AHA/ASA Stroke Performance Oversight Committee © 2018 American Heart Association, Inc. Stroke is available at https://www.ahajournals.org/journal/str DOI: 10.1161/STR.0000000000000171 *The findings and conclusions in this manuscript are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

TheAmerican HeartAssociation makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. This performance measure report was approved by the American Heart Association Science Advisory and Coordinating Committee on January 16, 2018, and the American Heart Association Executive Committee on February 22, 2018.

A copy of the document is available at http://professional.heart. org/statements by using either “Search for Guidelines & Statements” or the “Browse by Topic” area. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com. A Data Supplement is available with this article at https://www.ahajournals.org/doi/suppl/10.1161/STR.0000000000000171. The American Heart Association requests that this document be cited as follows: Hemphill JC 3rd, Adeoye OM, Alexander DN, Alexandrov AW, Amin-Hanjani S, Cushman M, George MG, LeRoux PD, Mayer SA, Qureshi AI, Saver JL, Schwamm LH, Sheth KN, Tirschwell D; on behalf of the AHA/ASA Stroke Performance Oversight Committee.

Clinical performance measures for adults hospitalized with intracerebral hemorrhage: performance measures for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2018;49:e243–e261. doi: 10.1161/ STR.0000000000000171. The expert peer review of AHA-commissioned documents (eg, scientific statements, clinical practice guidelines, systematic reviews) is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://professional.heart.org/statements. Select the “Guidelines & Statements” drop-down menu, then click “Publication Development.” Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association.

Instructions for obtaining permission are located at http://www.heart.org/HEARTORG/General/Copyright- Permission-Guidelines_UCM_300404_Article.jsp. A link to the “Copyright Permissions Request Form” appears on the right side of the page. AHA/ASA Performance Measures development that has been used for other AHA cardiovas- cular performance measure sets.11,12 These ICH performance measures represent the next AHA/ASA stroke-specific mea- sure set and were developed with this same methodology.

The present document on ICH follows that ischemic stroke document substantially, borrowing wording when appro- priate to ensure similarity and harmonization across AHA/ ASA performance measure approaches.10 The process was overseen by the AHA/ASA Stroke Performance Oversight Committee and coordinated by an independent volunteer writing group of medical professionals from different spe- cialties with assistance from theAHA/ASA professional staff. The primary purpose of these ICH Performance Measures is to promote adherence to guideline-recommended care.

Methods The process used by the AHA/ASA ICH Performance Measure Writing Group was adapted from the methodology developed jointly by the American College of Cardiology and AHA for the development of performance measures for cardiovascular The writing group was tasked by the AHA to develop performance measures related to emergency department and inpatient care of adults (≥18 years of age) hospitalized with ICH as the principal admitting condition. The group first determined the definition of ICH and the care period to be covered by the performance measures.

Group members then reviewed existing AHA/ASA guidelines relevant to ICH for suitability for con- version to performance measures on the basis of the strength of guideline recommendation and evidence base, feasibility of data collection, reliability for comparison across hospitals, and potential to improve patient outcome. Specific guideline rec- ommendations selected were then converted into performance measures by specifying eligible patients through specific inclu- sion and exclusion criteria and the measure numerator and denominator that would allow quantitative reporting of aggre- gate data.

Previously existing performance measures that might apply to ICH that were already developed or endorsed by the National Quality Forum (NQF) or other groups such as the Centers for Disease Control and Prevention (CDC) or The Joint Commission (TJC) were also reviewed, and when possible, an attempt was made to harmonize these new AHA/ASA ICH performance measures with those already endorsed. Draft ICH performance measures were released for public comment.After the close of the public comment period, these comments were reviewed by the writing group, and the performance measures were revised as deemed appropriate.

New measures deserve pilot testing before widespread adoption. Structure and Membership of the Writing Group The writing group was selected by the AHA/ASA Stroke Performance Oversight Committee and was designed to include a diverse set of experienced clinicians with expertise in both the guideline-concordant management of ICH and performance measure development. Represented specialties included vascular neurology, neurosurgery, neurocritical care, neuroendovascular care, physical medicine and rehabilitation, cardiology, hematology, emergency medicine, public health, and nursing. AHA staff members provided administrative assistance and direction for the process but were not involved directly in selecting the specific performance measures.

Work was conducted via multiple confidential conference calls and e-mail; in-person writing group meetings did not occur. Disclosure of Relationships With Industry All members of the writing group were volunteers who donated their time and efforts without monetary or other com- pensation. Writing group members were required to disclose in writing all financial relationships with industry relevant to this topic according to standard AHA reporting policies. Definition of ICH ICH was defined as spontaneous bleeding into the paren- chyma of the brain not caused by trauma.

There are multiple different causes for ICH, including hypertension, coagulopa- thy, underlying vascular anomalies, sympathomimetic drugs of abuse, and cerebral amyloid angiopathy. These perfor- mance measures are meant to apply to the same condition described in the AHA/ASA “Guidelines for the Management of Spontaneous Intracerebral Hemorrhage.”2 Thus, intracra- nial hemorrhage that is caused by an initial arterial or venous infarct does not apply, nor does intraparenchymal hemorrhage that occurs as a result of trauma or of treatment with tissue- type plasminogen activator.

These performance measures also do not apply to acute ischemic stroke or subarachnoid hemor- rhage, which are the subject of other current or future docu- ments. In addition, these performance measures are intended for patients for whom the principal reason for hospital admis- sion is ICH. Patients who are admitted to the hospital for another reason (eg, acute myocardial infarction) and develop an ICH during hospitalization are excluded.

Although these patients should generally be treated according to the ICH guidelines, concerns of the writing group about the feasibility of case ascertainment, diagnosis attribution, and data reliabil- ity led to exclusion of these patients from documented assess- ment with these performance measures. Table 1 includes a list of International Classification of Diseases, 10th Revision, Table 1.

ICD-10-CM Principal Diagnosis Codes for Eligible Patients With an ICH Diagnosis I61.0 Nontraumatic ICH in hemisphere, subcortical I61.1 Nontraumatic ICH in hemisphere, cortical I61.2 Nontraumatic ICH in hemisphere, unspecified I61.3 Nontraumatic ICH in brainstem I61.4 Nontraumatic ICH in cerebellum I61.5 Nontraumatic ICH, intraventricular I61.6 Nontraumatic ICH, multiple localized I61.8 Other nontraumatic ICH I61.9 Nontraumatic ICH, unspecified I62.9 Nontraumatic intracranial hemorrhage, unspecified ICD-10-CM indicates International Classification of Diseases, 10th Revision, Clinical Modification; and ICH, intracerebral hemorrhage.

Adapted from the Centers for Medicare and Medicaid Services ICD-10 Assessment and Maintenance Toolkit.13 Hemphill et al Performance Measures for ICH e245 Clinical Modification principal diagnosis codes for eligible patients with an ICH diagnosis in whom these performance measures are considered applicable. Dimensions of Care The acute hospital inpatient setting for the primary treatment of a patient with ICH was chosen as the setting for assessment of these performance measures.

As with acute ischemic stroke, it is recognized that there are multiple dimensions of care for ICH, including the prehospital setting, the emergency depart- ment, rehabilitation, and outpatient care directed at primary and secondary prevention.

Most other stroke-related performance measures (such as those from TJC,13 AHA’s Get With The the the CDC’s Paul Coverdell National Acute Stroke Program,15 and the AHA/ASA ischemic stroke ) have used the inpatient setting for this purpose because it represents a well-identified period of care that generally has good documentation of patient parameters and administered treatments as part of the medical record.16 However, it is recognized that there are elements relevant to the care of patients with ICH that are not sufficiently captured by the use of the inpatient setting such as administration of longer- term rehabilitation and interventions focusing on prevention such as long-term blood pressure control.

The writing group discussed the feasibility of assessment of performance measures in various settings and felt that restricting the dimension of care to the acute inpatient setting was a reasonable compromise for this first set of ICH performance measures. It was felt important that all hospitals involved in the acute care of patients with ICH should be considered under these performance measures; thus, they apply to hospitals that might transfer a patient with ICH after initial assessment or receive that patient in transfer after initial stabilization at another acute care hospital.

In addition, it would be most desirable for performance measures to be directly linked to patient-specific outcomes as opposed to processes of care.17 Outcomes can be intermediate- term or acute outcomes (eg, development of pneumonia during the inpatient setting) or long-term outcomes (eg, functional out- come at 6 months after ICH or recurrence of ICH in the years after the initial event). The ability to use outcomes as opposed to processes of care in these performance measures was a sub- stantial part of the discussion by the writing group.

Ultimately, consideration of feasibility of measurement and harmonization with existing performance measures from other organizations (especially those measures that are NQF endorsed) weighed substantially in the decisions on which performance measures to put forth and how they should be structured.

Literature Review The primary source for review of potential performance mea- of Spontaneous Intracerebral Hemorrhage.”2 AHA/ASA “Guidelines for Adult Stroke Rehabilitation and Recovery” were also reviewed.18 In addition, other documents of existing performance measures or quality metrics were reviewed to assess whether there were current performance measures developed for ischemic stroke or ICH that should be considered for inclusion and harmonization.

The AHA/ASA “Metrics for Measuring Quality of Care in Comprehensive Stroke Centers” and “Clinical Performance Measures for Adults Hospitalized With Acute Ischemic Stroke” were reviewed for potential measures that would apply to ICH and should be considered for inclusion.10,19 Currently active per- formance measures from other organizations, including TJC, the CDC’s Paul Coverdell National Acute Stroke Program, NQF, AHA’s Get With The Guidelines–Stroke, the American Medical Association-convened Physician Consortium for Performance Improvement, the Centers for Medicare & Medicaid Services Hospital Inpatient Quality Reporting Program, and NQF, were reviewed specifically in terms of whether measures analogous to those proposed here existed in other performance measurement sets currently in use and, if so, to consider harmonization across them when appropriate.

Selection and Development of Performance Measures The process for the selection and development of these ICH performance measures used an approach from the AHA/ASA Stroke Performance Oversight Committee similar to that used for the 2014 AHA/ASA ischemic stroke performance mea- Only Class I (high consensus for benefit) and Class III (high consensus for harm) recommendations according to the AHA/ASA criteria for recommendations and classification of Levels of Evidence were considered candidates for develop- ment into performance measures (Supplemental Tables 2 and correspondence to review all Class I and III recommendations from the 2015 AHA/ASA ICH guidelines for suitability to develop into performance measures.

Potentially applicable metrics from the AHA/ASA “Metrics for Measuring Quality of Care in Comprehensive Stroke Centers” manuscript were also added to the list for consideration.19 Standard criteria for performance measure development were determined before initial review and were derived from principles set forth previ- ously by theAHA and theAmerican College of Cardiology.11,12 These criteria included (1) likelihood that measure adherence would result in improved patient outcomes; (2) interpretabil- ity; (3) actionability; (4) precise numerator and denominator that could be defined; (5) reliability; (6) validity; and (7) fea- sibility for implementation.

On the basis of the writing group discussion and voting, if a specific guideline recommendation was felt not to meet the above criteria, then it was not moved forward for development as a potential performance measure. From this list of potential performance measures, sub- groups of the writing group developed formal measurement set specifications in draft form for each potential performance measure. These specifications included numerator, denomi- nator, period of assessment, data sources, rationale and spe- cific recommendations from which it was derived, method of reporting, and challenges to implementation.

Each writing group member participated in the development of at least 2 draft performance measures. Subsequent teleconferences were held in which each of these drafts was reviewed by the writ- ing group with input designed to improve the measurement set specifications before voting by the writing group. During these teleconferences, existing performance measures from other organizations as described previously were reviewed with special attention given to NQF-endorsed measures. Draft measurement set specifications were revised when deemed appropriate in order to harmonize with existing measures.

Each measure was then voted on for inclusion or exclu- sion with a standardized ballot form that included a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) on various aspects concerning suitability for submission as a performance measure. The ballots allowed measures to be rated separately on these various dimensions: evidence-based, inter- pretable, actionable, design of numerator and denominator, reli- ability, validity, and feasibility for implementation, as well as an overall assessment. Ballots were then reviewed and discussed on follow-up conference calls for consensus among the writing group for ultimate inclusion in the performance measure set.

Review and Endorsement In February 2017, the ICH performance measures document underwent a 30-day public comment period, during which AHA members and other healthcare professionals had an opportunity to review and comment on the measurement set specifications for each of the 9 specific performance measures proposed. Relevant healthcare organizations and professional societies were alerted to the publication of the document and encouraged to comment. Numerous comments were received, which were reviewed by the writing group via e-mail and in teleconference to determine whether changes to a specific measure should be made.

When deemed appropriate, these changes were made before the development of this final manuscript describing the ICH performance measures. Peer review of this manuscript was then conducted by reviewers selected by the AHA. After peer review and appropriate revi- sions, these ICH performance measures were approved by the AHA Science Advisory and Coordinating Committee and the AHA Executive Committee. They should be considered valid until either updated or rescinded by the AHA/ASA Stroke Performance Oversight Committee.

Performance Measures for Adults Hospitalized With ICH Patient Population and Care Period The patient population is patients with spontaneous ICH, as defined in Definition of ICH in the Methods section, and the care period is the acute hospitalization for diagnosis and management of new ICH, from emergency department arrival at an acute care hospital to discharge from acute care.

For patients who are initially seen at 1 hospital (in the emer- gency department or hospital intensive care unit or ward) and transferred to another hospital, care at both hospitals is eli- gible for assessment with these performance measures based on the measures that would be relevant for the extent of care delivered at each respective hospital. The performance mea- sures were not designed for use for elective admissions (eg, evaluation or management of vascular anomalies such as arteriovenous malformations or cavernous malformations) or for inpatient ICH in which stroke occurred after hospital admission for another reason.

Accordingly, these admission types are excluded from the measure denominators, as they are for current NQF-endorsed ICH measures. The writing group agreed that it is appropriate to exclude admissions with length of stay >120 days, as is done in the NQF-endorsed ICH measures, to avoid double counting patients when generating quarterly reports. ICH may be identified by discharge International Classification of Diseases codes (as required by TJC), pro- spective or retrospective surveillance of admission logs by the hospital team, or a combination (as allowed by AHA’s Get With The Guidelines–Stroke).

International Classification of Diseases, 10th Revision, Clinical Modification codes for ICH are shown in Table 1. The choice of method of case ascer- tainment and diagnosis via administrative billing codes versus chart review may depend on many registry-specific factors, including available resources, and the writing group endorses either method as a valid means of case ascertainment. Brief Summary of the Measurement Set Table 2 shows the AHA/ASA performance measure set for adults hospitalized with ICH. The set consists of 9 measures.

This includes several measures that are already endorsed as ICH performance measures by other organizations, some that are analogous to measures already endorsed by others but revised either to make them directly relevant to ICH (venous thromboembolism prophylaxis) or to harmonize with isch- emic stroke measures (2 dysphagia measures), and 3 new measures.

For example, 2 measures are currently already endorsed by the NQF, and 3 have analogous measures that are similar to NQF-endorsed measures but were revised for this ICH measure set.20 Two are currently part of TJC Primary and Comprehensive Stroke Center criteria, and 1 measure is similar to a Comprehensive Stroke Center criteria measure but revised. Two measures are either identical or analogous to the CDC’s Paul Coverdell NationalAcute Stroke Program measures. Three are identical to measures in the AHA/ASA ischemic stroke performance measure set.

The Discussion provides additional comments on the measures, including the limitations of some of the current measures, opportunities for improvement, and rec- ommendations for implementation and field testing. Appendix Table A1 provides full specifications for each measure. Data Collection The process whereby data are collected for reporting of per- formance measures influences data quality, cost of assessment, and ultimately the ways that the data can be used. To maximize the reliability of data capture, a prospectively designed report form should be used.

The move of hospitals and healthcare systems to electronic health records means that some data ele- ments can be automatically captured through these systems. Some data elements (eg, laboratory results or medications dis- pensed) have highly structured elements in electronic health records that facilitate automatic data abstraction, whereas other data elements (eg, baseline severity score or performance of a swallowing screen) are captured in less structured for- mats or require prospective addition of standardized elements to narrative admission and progress notes to increase compli- ance and to facilitate data abstraction.

Capturing and verifying the accuracy of these elements and other crucial clinical data Hemphill et al Performance Measures for ICH e247 (eg, a contraindication to a process) may still require manual chart review and abstraction. Regardless of how the data are collected, the reliability of data abstraction methods used in performance measure assessment should be validated by inde- pendent review of a subset of cases consisting of manual chart review (in the case of electronically derived performance data) or independent abstracter review (in the case of chart review– based performance data).

To avoid bias and to ensure accurate numerators and denominators for reporting of overall hospital compliance with these performance measures, we recommend that data should be collected on all consecutive patients rather than a convenience sample. Discussion The goal of this project has been to develop an ICH-specific performance measure set derived from high-level recommen- dations from evidence-based guidelines. These performance measures are based principally on the AHA/ASA guidelines for management of spontaneous ICH and were developed with the use of standardized prespecified criteria delineated by the AHA and American College of Cardiology for overall performance measure development.

Each performance mea- sure derives directly from a Level I or Level III recommenda- tion from the 2015 AHA/ASA ICH guidelines, although in several instances the specific wording and construction of the performance measures were revised or enhanced to harmonize with existing performance measures in use from other orga- nizations, to align with similar measures for ischemic stroke that reasonably apply across all stroke subtypes, and to allow formal measurement for reporting purposes.

The purpose of these performance measures is to improve the quality of care for patients with ICH by providing hospitals, stroke teams, and regulatory bodies with a way to directly measure and potentially benchmark this quality of care. The writing group, through its internal discussions and deliberations, understands that many domains of care important to the patient with ICH are not represented specifically by a performance measure because of the lack of AHA/ASA Class I or Class III rec- ommendations for a specific aspect of treatment.

However, concordance with current guideline-recommended care is strongly encouraged even in the absence of a specific perfor- mance measure linked to all aspects of care. It is hoped that this proposed ICH performance measure set will provide an initial toolkit for assessing quality of care and that it will be revised and expanded as evidence-based care for ICH expands. These performance measures are designed for use within hospitals in the United States.

They may be useful in other countries as well, either as directly assessed performance mea- sures or as an example by which other countries may assess appropriate ICH performance measures optimized for their own system of care.

When adoption outside the United States is considered, it is appropriate to consider the relevance of the specific aspects of each performance measure to local context and modify if needed.21 In addition, these performance mea- sures are intended to complement similar existing efforts by other organizations and regulatory bodies in the United States given that the overall goals of improving ICH quality of care and being able to measure this quality are similar across groups.

This is why significant effort was made to harmonize these performance measures with other existing measures, espe- cially when these earlier measures had been endorsed by the NQF. When the writing group felt that an existing performance measure was not optimal, the relevant performance measure was made according to writing group specifications, and this divergence is described in more detail later. Finally, it is recog- nized that all 9 of these proposed performance measures assess process and not patient outcome directly.

The writing group spent a substantial amount of time discussing whether patient outcomes could be used rather than process, and this was the initial desire for several of the original drafts of performance measure specification sets. Examples of this could include less hematoma expansion with timely coagulopathy reversal, lower pneumonia rates from dysphagia screening, and improved functional outcome from rehabilitation services. However, a Table 2. AHA/ASA Performance Measure Set for Hospitalized Patients With ICH No.

Performance Measure NQF Endorsed CDC PCNASR/AHA GWTG-Stroke TJC CMS HIQRP AHA Ischemic Stroke Performance Measure New Measure 1 Baseline severity score   2 Coagulopathy reversal o 3 Venous thromboembolism prophylaxis o o o o o 4 Admission unit  5 Dysphagia screen: assessment o o  6 Dysphagia screen: management o o  7 Long-term blood pressure treatment  8 Assessed for rehabilitation      9 Avoid corticosteroids   indicates identical measure present in other measurement set; o, analogous but not identical measure present in other measurement set; AHA, American Heart Association; ASA, American Stroke Association; CDC, Centers for Disease Control and Prevention; CMS, Centers for Medicare & Medicaid Services; GWTG-Stroke, Get With The Guidelines–Stroke; HIQRP, Hospital Inpatient Quality Reporting Program; ICH, intracerebral hemorrhage; NQF, National Quality Forum; PCNASR, Paul Coverdell National Acute Stroke Registry; and TJC, The Joint Commission.

gap remains between many processes of care derived from evi- dence-based guidelines and performance metrics that meet the various criteria such as feasibility, interpretability, and ability to be reliably and directly measured in the context of current stroke care. Consequently, most if not all current and endorsed ICH and ischemic stroke performance measures target pro- cesses of care.

The writing group felt that as the field of quality assessment and performance measurement moves forward in stroke, priority should be placed on piloting outcome assess- ment for various performance measures with the goal of future transition from process measurement to patient-based outcome measurement. What follows is a brief discussion of each per- formance measure with a focus on unique or potentially con- troversial issues in its development.

The recommendation for a baseline severity score in all patients with acute ICH was new in the 2015 AHA/ASA ICH guidelines and was considered as a metric for Comprehensive Stroke Centers in the 2011 AHA/ASA recommendations. Numerous baseline severity scores for ICH exist,22–24 with the general goal of their use being to improve communication and risk stratification in terms of the patient’s clinical condition and not to attempt to provide a precise numeric prognostic estimate. The ICH score is the most widely used and validated score for baseline severity stratification.

Whether to require a specific baseline severity score (such as the ICH score22 ) or to allow any of a variety of existing severity scores (such as the FUNC [Functional Outcome in Patients with Primary Intracerebral the Glasgow Coma Scale score, the National Institutes of Health Stroke Scale score, or others as chosen by a specific hospital or individual physician) was a point of discussion for these performance measures and the 2015 ICH guidelines themselves.

TJC requires a baseline ICH severity score as part of its metrics for Comprehensive Stroke Centers, and the ICH score is the only severity score used in this context. This TJC performance measure is endorsed by the NQF. Thus, the writing group felt that harmonization with the existing NQF-endorsed measure was a high priority in order to reduce heterogeneity and to improve standardization of care. This approach was largely affirmed by others during the public comment period.

Components of the ICH score and 1 straight- forward method of calculating ICH hematoma volume can be found in work by Hemphill et al22 and Kothari et al.25 The performance measure for reversal of coagulopathy follows from the 2015 AHA/ASA ICH guidelines Class I rec- ommendation for discontinuation of vitamin K antagonists in patients with acute ICH with an elevated international nor- malized ratio and administration of therapy to replace vitamin K–dependent clotting factors.

The 2015 ICH guidelines do not provide a Class I recommendation as to whether to use prothrombin complex concentrates or fresh-frozen plasma and do not specify a time frame in which therapy must be administered.

The optimal therapy and timing for vitamin K antagonist reversal in acute ICH have received notable atten- tion in the time since the literature review for the 2015 ICH Although a recent clinical trial sug- gested superiority of prothrombin complex concentrates over the writing group felt that the level of existing recommendations and available data best supported that, to meet this performance measure, the administration of either was acceptable. TJC has an existing Comprehensive Stroke Center metric about this topic.

However, the writing group felt that the absence of any time frame for administra- tion did not appropriately reflect quality because treatment with prothrombin complex concentrates or fresh-frozen plasma at a time point outside the hyperacute period was not the intended approach and meeting the metric by treat- ing many hours after ictus was not reflective of quality care.

Thus, initiation within 90 minutes of emergency department presentation (door-to-needle time) was chosen for this perfor- mance measure because it combines the expected time frame for the initial head computed tomography in stroke evaluation with treatment timing from a recent clinical trial of coagu- lopathy reversal. Although this new door-to-needle time for the initiation of coagulopathy reversal requires piloting, it is expected that high compliance will be achieved now and that future revisions will target a shorter door-to-needle time of 60 minutes, analogous to that for acute ischemic stroke.

Per the recommendation in the 2015 ICH guidelines, intravenous vitamin K must also be administered to meet this performance measure. The fact that this measure applies to the present- ing hospital (or a transfer-receiving hospital if therapy was not started at the initial hospital) was considered important because it emphasizes that just transferring a patient with ICH is insufficient to meet certain performance measures that per- tain to early aspects of care.

This measure deserves pilot test- ing, and it is reasonable for additional data such as type of treatment (prothrombin complex concentrates or fresh-frozen plasma) and time to international normalized ratio correction to be recorded. Again, public comment was generally support- ive of the requirement of an early time frame for treatment. The 2015 ICH guidelines did not include a Class I recommen- dation for reversal of newer anticoagulant agents such as dabi- gatran, rivaroxaban, or apixaban. Thus, the writing group felt that a specific performance measure should not be developed at this time.

However, this is an important issue for future guideline and performance measure updates. Venous thromboembolism prophylaxis exists as a mea- sure for patients with ICH in the CDC’s Paul Coverdell National Acute Stroke Program and is an NQF-endorsed measure. An analogous performance measure is present in the AHA/ASA ischemic stroke performance measures that allows the use of anticoagulant medications or mechanical devices to meet the measure. For ICH, the use and optimal timing of anticoagulant medications remain without Class I recommendations.

However, the use of pneumatic compres- sion devices on the day of hospital admission is a Class I rec- ommendation from the 2015 AHA/ASA ICH guidelines and is required to successfully meet this performance measure. For purposes of harmonization with analogous performance measures from other groups, use of pneumatic compression devices on day 0 (admission day) or day 1 of hospitalization is considered acceptable. Three measures in this ICH performance measure set are identical to those in theAHA/ASA ischemic stroke measure set. They relate to dysphagia screening and rehabilitation services.

All 3 of these measures derive from an independent Class I rec- ommendation in the 2015AHA/ASA ICH guidelines. However, these are also issues that generally apply to all stroke patients, Hemphill et al Performance Measures for ICH e249 and this factored significantly into the writing group’s delib- erations on whether to draft entirely independent and unique performance measures on these topics for ICH or to consider whether the existing performance measures on these topics should be adopted for ICH.

In the 2014 AHA/ASA ischemic stroke performance measures, there is extensive discussion of the challenges and controversies concerning the use of dyspha- gia screening as a performance measure.10 In that document, the decision was made to create 2 dysphagia measures, 1 mea- sure for screening within 24 hours of hospital admission and 1 measure that requires passing of a dysphagia screen before oral intake. As of this writing, NQF endorses a measure for dyspha- gia screening before oral intake, but it does not specify a time or require that the dysphagia screen is passed.

The ICH perfor- mance measure writing group extensively discussed the exist- ing controversies in dysphagia screening and ultimately felt that harmonization with the 2 measures from the ischemic stroke set made the most sense.

Similarly, the writing group recognized that the performance measure requiring assessment for rehabili- tation is associated with high compliance already and does not specify the type of rehabilitation services provided.29 Even so, the writing group felt it was important to have a performance measure that pertained to rehabilitation services because this is a Class I recommendation in the ICH guidelines, and harmo- nization with the ischemic stroke set was prioritized given that there were no ICH-specific rehabilitation recommendations that superseded this. Three new ICH-specific performance measures are pro- posed as part of this measure set.

These new measures deserve pilot testing to assess feasibility and reliability. The new measures relate to hospital admission unit, long-term blood pressure management, and corticosteroid use for intracranial pressure management. It is recognized that for ICH specifi- cally, improved outcomes are seen in patients who are man- aged in a specialized hospital neurological intensive care unit or stroke unit.

It appears that this effect is in addition to the impact of any 1 specific targeted intervention and may indi- cate that hospital units such as these create a milieu in which overall care is optimized.30–32 Although there is not an exist- ing analogous performance measure from other organizations, TJC requires that certified Primary and Comprehensive Stroke Centers have such hospital units. To avoid failing this measure in this ICH performance measure set, hospitals that do not have such units are required to transfer patients in the emer- gency setting to another hospital with these capabilities.

This emphasizes the importance of stroke systems of care. A poten- tial challenge related to the implementation of this measure is verification of expertise in such hospital units. The 2015 AHA/ ASA ICH guidelines do not provide specifics for how this can be assessed; TJC indicates that specialized training, includ- ing certification in an educational course such as Emergency Neurological Life Support,33 would be a potential indicator.

Hypertension is the most common cause of ICH, and the 2015 AHA/ASA ICH guidelines contain a new prevention- focused recommendation for the initiation of blood pressure control immediately after ICH onset.1,2 The related new perfor- mance measure does not apply to specific targets or agents for acute blood pressure control in patients with ICH in the emer- gency department or intensive care unit. Rather, it focuses on the initiation of blood pressure treatment during the inpatient setting with the goal of improving long-term blood pressure management for purposes of secondary prevention.

The writ- ing group ideally preferred a measure that directly assessed achieving long-term blood pressure control as an outpatient after ICH. However, development of this into a performance measure was not considered feasible or actionable at this time because of the often limited information on outpatient records and the challenge of following up with patients who may be seen in different healthcare systems. Thus, this new perfor- mance measure requires that patients with ICH are prescribed a pharmacological antihypertensive treatment at the time of hospital discharge or have a documented blood pressure indi- cating that they do not have hypertension.

As a new perfor- mance measure, pilot testing is warranted, and it is hoped that, with the advance of electronic medical records, a future per- formance measure might target documentation of long-term compliance and control. The new AHA definition of hyperten- sion as a blood pressure >130/80 mmHg was incorporated as the target for initiation of treatment.34 Corticosteroids are not recommended for treating elevated intracranial pressure or cerebral edema in patients with ICH.2 There is limited information on the extent to which this still occurs.

Some members of the writing group felt this was a rare occurrence and thus a performance measure focusing on this was likely to have very high compliance already. However, other members were concerned that there was still substan- tial use. Pilot testing during initial implementation may help clarify this. Note that the goal of this performance measure is zero use, and the wording of the measurement set reflects this. A potential challenge is identifying clear documentation in the medical record for an alternative reason (eg, asthma exacerba- tion) if corticosteroids are administered.

Conclusions Nine performance measures are proposed as part of this initial AHA/ASA clinical performance measure set for adults hospi- talized with ICH. Six either are existing performance measures that are NQF endorsed (n=2) or have analogous performance measures through other organizations or related disease pro- cesses (n=4). These 6 measures are endorsed for immediate use. Three new measures are proposed, and it is recommended that they be implemented now but also that pilot testing occur during this implementation in case revisions are desirable to improve their feasibility, actionability, and reliability.

Many more issues were considered for performance measures but did not meet the criteria for inclusion in this set (Supplemental Table 1). In addition, the writing group recognizes that there are many issues that might be desirable in performance mea- sures but do not currently meet the high evidence standards (Class I or III recommendations) required for consideration.

Quality assessment and performance measure implementation in stroke are still at an early stage, and it is hoped that future advancement of the evidence base for ICH care and broader experience with testing and implementation of performance measures will lead to revisions and expansions with the ulti- mate goal of improving the care of patients with ICH and stroke in general. Appendix Table A1. ICH Performance Measures 1.

Baseline Severity Score: Percentage of patients with ICH in whom a baseline severity score is measured and a total score is recorded as part of initial evaluation on arrival at the hospital Numerator Patients in whom an initial severity score is measured and a total score recorded within 6 h of hospital arrival. If an intracranial procedure is performed within 6 h of arrival, the severity score must be measured before this procedure. The ICH score should be used as the baseline severity score.

Denominator Included patients: All patients with ICH Excluded patients: <18 y of age Patients who arrive at hospital >48 h after last known well time Length of stay >120 d Clear documentation for comfort care/palliative care measures established before hospital arrival Period of Assessment First 6 h after hospital arrival Sources of Data Prospective flowsheet, retrospective medical record review, electronic medical record Rationale Baseline clinical evaluation is part of the standard care of every patient with ICH.

Measurement of a validated standardized severity score is important for prioritizing interventions, such as intensive care unit admission and surgical intervention, is the main determinant of short-term and long-term prognosis, facilitates communication of stroke severity between survivors, and is essential for risk adjustment to monitor provider and hospital care outcomes. The ICH score is selected for use because it is the most commonly used validated baseline severity score and is required by TJC in its analogous measure. Source for Recommendation From the 2015 AHA/ASA “Guidelines for the Management of Spontaneous Intracerebral Hemorrhage” 1.

A baseline severity score should be performed as part of the initial evaluation of patients with ICH (Class I; Level of Evidence B). Method of Reporting Per patient: documentation of whether a severity score was measured and a total score was recorded as part of the initial evaluation on arrival at the hospital Per patient population: percentage of patients in whom a severity score was measured and a total score was recorded as part of the initial evaluation on arrival at the hospital Challenges to Implementation Training in ICH score calculation may be needed to produce the most reliable results.

Measuring an intracerebral-specific score, such as the ICH score, within 6 h of arrival may be challenging for hospitals without an on-site stroke team, as opposed to a more general measure such as the GCS (which is a component of the ICH score). When hematoma volume is measured as part of a baseline severity score, a validated measure (such as the ABC/2 calculation method) should be used. This requires training. Analogous Measures Endorsed by Other Organizations Identical measure used by TJC (CSTK-03) and endorsed by NQF (No.

2866) AHA indicates American Heart Association; ASA, American Stroke Association; CSTK, Comprehensive Stroke; GCS, Glasgow Coma Score; ICH, intracerebral hemorrhage; NQF, National Quality Forum; and TJC, The Joint Commission. Hemphill et al Performance Measures for ICH e251 Appendix. Continued 2.

Coagulopathy Reversal: Percentage of patients with ICH and an INR >1.4 resulting from warfarin treatment who receive therapy to replace vitamin K–dependent clotting factors within 90 min of ED presentation and who also receive intravenous vitamin K* Numerator Patients with an INR >1.4 resulting from warfarin treatment who receive therapy to replace vitamin K–dependent clotting factors within 90 min of ED presentation and who also receive intravenous vitamin K* Denominator Included patients: Patients with ICH with known onset (or last known well) within 12 h of ED presentation Known or presumed current warfarin use Excluded patients: <18 y of age Documented contraindication to treatment with an anticoagulant reversal agent Clear documentation for comfort care/palliative care measures established before hospital arrival Length of stay >120 d Enrolled in a clinical trial that would affect the use of anticoagulant reversal agents Use of nonwarfarin anticoagulants Elevated INR not resulting from warfarin (eg, liver disease) Hospital transfer from another presenting ED where therapy to replace vitamin K–dependent clotting factors was already started Period of Assessment Initial 90 min after ED arrival Sources of Data Prospective flowsheet, retrospective medical record review, electronic medical record, pharmacy records Rationale Coagulopathy, specifically that resulting from the vitamin K antagonist warfarin, is a significant risk factor for hematoma expansion in ICH, and outcome is worsened in these patients.

Time to correction of an elevated INR caused by warfarin has been related to amount of hematoma expansion. Prothrombin complex concentrates and fresh-frozen plasma decrease the INR and quickly reverse the anticoagulant effect of warfarin. Vitamin K is needed to ensure that coagulopathy does not return after the effect of initial reversal has passed.

Source for Recommendations From the 2015 AHA/ASA “Guidelines for the Management of Spontaneous Intracerebral Hemorrhage” Patients with ICH whose INR is elevated because of vitamin K antagonist should have their vitamin K antagonist withheld, receive therapy to replace vitamin K–dependent factors and correct the INR, and receive intravenous vitamin K (Class I; Level of Evidence C). Recombinant factor VIIa does not replace all clotting factors, and although the INR may be lowered, clotting may not be restored in vivo; therefore, recombinant factor VIIa is not recommended for vitamin K antagonist reversal in ICH (Class III; Level of Evidence C).

Method of Reporting Per patient: documentation of administration of therapy to replace vitamin K–dependent clotting factors within 90 min of arrival to the presenting ED Per patient population: percentage of patients treated with therapy to replace vitamin K–dependent clotting factors within 90 min of arrival to the presenting ED Challenges to Implementation Documentation of time of symptom onset or last known well is not always recorded for ICH. Initiation of coagulopathy reversal agent does not necessarily guarantee adequate INR correction.

Analogous Measures Endorsed by Other Organizations Analogous measure used by TJC (CSTK-04) AHA indicates American Heart Association; ASA, American Stroke Association; CSTK, Comprehensive Stroke; ED, emergency department; ICH, intracerebral hemorrhage; INR, international normalized ratio; and TJC, The Joint Commission. *Acceptable therapies to meet the 90-minute door-to-needle time metric include prothrombin complex concentrate (preferable) or fresh-frozen plasma (acceptable). Treatment with vitamin K alone is not acceptable to meet this measure. However, to meet this performance measure, intravenous vitamin K must also be given. A specific time for the vitamin K administration is not delineated.

Recombinant factor VIIa is not recommended by the AHA/ASA ICH guidelines and is not acceptable. Appendix. Continued 3.

Venous Thromboembolism Prophylaxis: Percentage of patients with ICH who receive lower limb pneumatic compression on hospital day 0 or 1 Numerator Patients who received VTE prophylaxis using lower limb pneumatic compression on the day of admission (day 0) or the day after admission (day 1) or who have documentation why no pneumatic compression device was used* Denominator Included patients: All patients with ICH Excluded patients: <18 y of age Length of stay <2 d Length of stay >120 d “Comfort measures only” documented on hospital day 0 or 1 Enrolled in a clinical trial that would affect the use of VTE prophylaxis Period of Assessment Hospital day 0 or day 1 Sources of Data Prospective flowsheet, retrospective medical record review, electronic medical record Rationale Pulmonary embolism from DVT accounts for nearly 10% of deaths after stroke.

DVT is common in patients with ICH because of decreased mobility. The CLOTS trials demonstrated that pneumatic compression is superior to the use of graduated compression stockings and that DVT occurrence is reduced, especially in patients with ICH, if pneumatic compression was started as early as the day of hospital admission. Source for Recommendations From the 2015 AHA/ASA “Guidelines for the Management of Spontaneous Intracerebral Hemorrhage” Patients with ICH should have intermittent pneumatic compression for prevention of VTE beginning the day of hospital admission (Class I; Level of Evidence A). 2.

Graduated compression stockings are not beneficial to reduce DVT or improve outcome (Class III; Level of Evidence A). Method of Reporting Per patient: documentation of whether patient received pneumatic compression on hospital day 0 or 1 Per patient population: percentage of patients receiving pneumatic compression on hospital day 0 or 1 Challenges to Implementation Documentation variability in the description of whether pneumatic compression was used Documentation of contraindication to pneumatic compression Analogous Measures Endorsed by Other Organizations Analogous measures endorsed or used by NQF (No.

0434), TJC (STK-1), AHA Ischemic Stroke Performance Measure 1, AHA GWTG–Stroke, CDC PCNASP, and CMS HIQRP AHA indicates American Heart Association; ASA, American Stroke Association; CDC, Centers for Disease Control and Prevention; CLOTS, Clots in Legs or Stockings After Stroke; CMS, Centers for Medicare & Medicaid Services; CSTK, Comprehensive Stroke; DVT, deep venous thrombosis; GWTG–Stroke, Get With The Guidelines– Stroke; HIQRP, Hospital Inpatient Quality Reporting Program; ICH, intracerebral hemorrhage; NQF, National Quality Forum; PCNASP, Paul Coverdell National Acute Stroke program; TJC, The Joint Commission; and VTE, venous thromboembolism.

*Acceptable contraindications to the use of pneumatic compression include any local leg condition in which the sleeves may interfere, such as dermatitis, vein ligation (immediately postoperative), gangrene, recent skin graft, severe peripheral arterial disease, existing DVT, or severe congestive heart failure with pulmonary edema. Hemphill et al Performance Measures for ICH e253 Appendix. Continued 4.

Admission Unit: Percentage of patients with ICH who are admitted to an intensive care unit or dedicated stroke unit with physician and nursing neuroscience acute care expertise Numerator Patients admitted to an intensive care unit or dedicated stroke unit with physician and nursing neuroscience acute care expertise Denominator Included patients: Patients with ICH admitted to an acute care hospital within 24 h of initial symptom identification Excluded patients: <18 y of age Length of stay >120 d Clear documentation for comfort care/palliative care measures established before hospital arrival Period of Assessment Day of hospital admission to hospital Sources of Data Prospective flowsheet, retrospective medical record review, electronic medical record Rationale Patients with ICH are frequently medically and neurologically unstable particularly at the time of initial presentation.

Care of patients with ICH in a dedicated neuroscience intensive care unit is associated with a lower mortality rate. Stroke units have demonstrated improved long-term outcome in randomized trials. Presence of a stroke unit is a required component for Primary and Comprehensive Stroke Center certification by TJC. Source for Recommendation From the 2015 AHA/ASA “Guidelines for the Management of Spontaneous Intracerebral Hemorrhage” Initial monitoring and management of patients with ICH should take place in an intensive care unit or dedicated stroke unit with physician and nursing neuroscience acute care expertise (Class I; Level of Evidence B).

Method of Reporting Per patient: documentation of whether a patient was admitted to an intensive care unit or dedicated stroke unit with physician and nursing neuroscience acute care expertise Per patient population: percentage of patients with ICH admitted to an intensive care unit or dedicated stroke unit with physician and nursing neuroscience acute care expertise Challenges to Implementation Verification of physician and nursing neuroscience care expertise Measure would require hospitals that do not have such an intensive care unit or dedicated stroke unit to transfer the patient with ICH from the ED to a hospital that has this type of intensive care unit or stroke unit.

Analogous Measures Endorsed by Other Organizations For certification, TJC requires Primary Stroke Centers to have a “stroke unit or designated beds for the acute care of stroke patients” and Comprehensive Stroke Centers to have “dedicated neuro-ICU [intensive care unit] beds for complex stroke patients that include staff and licensed independent practitioners with the expertise and experience to provide neuro-critical care 24 hours a day, 7 days a week.” AHA indicates American Heart Association; ASA, American Stroke Association; ED, emergency department; ICH, intracerebral hemorrhage; and TJC, The Joint Commission. Appendix. Continued 5.