Orthopaedic & Rheumatologic Institute Outcomes

Transcription

1 Orthopaedic & Rheumatologic Institute 215 Outcomes

2 Measuring Outcomes Promotes Quality Improvement

3 Measuring and understanding outcomes of medical treatments promotes quality improvement. Cleveland Clinic has created a series of Outcomes books similar to this one for its clinical institutes. Designed for a physician audience, the Outcomes books contain a summary of many of our surgical and medical treatments, with a focus on outcomes data and a review of new technologies and innovations. The Outcomes books are not a comprehensive analysis of all treatments provided at Cleveland Clinic, and omission of a particular treatment does not necessarily mean we do not offer that treatment. When there are no recognized clinical outcome measures for a specific treatment, we may report process measures associated with improved outcomes. When process measures are unavailable, we may report volume measures; a relationship has been demonstrated between volume and improved outcomes for many treatments, particularly those involving surgical and procedural techniques. In addition to these institute-based books of clinical outcomes, Cleveland Clinic supports transparent public reporting of healthcare quality data. The following reports are available to the public: Joint Commission Performance Measurement Initiative (qualitycheck.org) Centers for Medicare and Medicaid Services (CMS) Hospital Compare (HospitalCompare.hhs.gov), and Physician Compare (medicare.gov/physiciancompare) Cleveland Clinic Quality Performance Report (clevelandclinic.org/qpr) Our commitment to transparent reporting of accurate, timely information about patient care reflects Cleveland Clinic s culture of continuous improvement and may help referring physicians make informed decisions. We hope you find these data valuable, and we invite your feedback. Please send your comments and questions via to: OutcomesBooksFeedback@ccf.org or scan here. To view all of our Outcomes books, please visit clevelandclinic.org/outcomes.

4 Dear Colleague: Welcome to this 215 Cleveland Clinic Outcomes book. Every year, we publish Outcomes books for 14 clinical institutes with multiple specialty services. These publications are unique in healthcare. Each one provides an overview of medical or surgical trends, innovations, and clinical data for a particular specialty over the past year. We are pleased to make this information available. Cleveland Clinic uses data to manage outcomes across the full continuum of care. Our unique organizational structure contributes to our success. Patient services at Cleveland Clinic are delivered through institutes, and each institute is based on a single disease or organ system. Institutes combine medical and surgical services, along with research and education, under unified leadership. Institutes define quality benchmarks for their specialty services and report on longitudinal progress. All Cleveland Clinic Outcomes books are available in print and online. Additional data are available through our online Quality Performance Report (clevelandclinic.org/qpr). The site offers process measure, outcome measure, and patient experience data in advance of national and state public reporting sites. Our practice of releasing annual outcomes books has become increasingly relevant as healthcare transforms from a volume-based to a value-based system. We appreciate your interest and hope you find this information useful and informative. Sincerely, Delos M. Cosgrove, MD CEO and President

5 what s inside Chairman s Letter 4 Institute Overview 5 Quality and Outcomes Measures Orthopaedics Overview 6 Adult Total Shoulder Arthroplasty for Osteoarthritis 21 Adult Total Hip Arthroplasty for Osteoarthritis 24 Adult Total Hip Resurfacing for Osteoarthritis 26 Adult Unilateral Total Knee Arthroplasty for Osteoarthritis 28 Orthopaedic Surgical Quality Improvement 3 Infection 69 Pericarditis 72 Retroperitoneal Fibrosis 73 Fibromyalgia 74 Institute Patient Experience 76 Cleveland Clinic Implementing Value-Based Care 78 Innovations 84 Contact Information 88 About Cleveland Clinic 9 Resources 92 Spinal Disease 32 Sports Medicine 4 Rheumatology Overview 46 Rheumatoid Arthritis 49 Psoriatic Arthritis 52 Progressive Systemic Sclerosis 54 Prefer an e-version? Visit clevelandclinic.org/outcomesonline, and we ll remove you from the hard copy mailing list and you when next year s books are online. Gout 57 Osteoarthritis 6 Reversible Cerebral Vasoconstriction Syndrome 61 Osteoporosis 62 Transplant 67 Immunodeficiency 68

6 Chairman s Letter Dear Colleagues, Thank you for your interest in the 215 Outcomes for Cleveland Clinic s Orthopaedic & Rheumatologic Institute. Here we provide an overview of our ongoing efforts to measure our patients health and functional outcomes following the full range of surgical procedures and nonsurgical treatments. Our institute is committed to the best outcomes for patients, and we continually strive to make advancements. 215 was a productive year for us. Our standout advancements included: In our NIH-funded Open Knee(s) project, along with our biomedical engineering colleagues, breaking new ground by using crowdsourcing to advance simulations and simulationbased knee modeling A study of MLB pitchers that found low-degree retroversion was a significant predictor of severe injuries, suggesting that retroversion measurements may one day help assess injury risk in pitchers in the big leagues and beyond Our 2,th hip resurfacing procedure, along with our 25,th total hip replacement Establishment of three care paths (for osteoporosis, full-thickness rotator cuff repairs, and anterior cruciate ligament reconstruction) to standardize treatment, reduce variability, and improve outcomes Creation of a Psoriatic Disease Biobank and helping to develop the first published guidelines for management of comorbidities in psoriasis and psoriatic arthritis We welcome your feedback, questions, and ideas for collaboration. Please contact me via at OutcomesBooksFeedback@ccf.org and reference the Orthopaedic & Rheumatologic Institute Outcomes book in your message. Sincerely, Joseph Iannotti, MD, PhD Chairman, Orthopaedic & Rheumatologic Institute 4 Outcomes 215

7 Institute Overview This year s Outcomes book profiles the clinical outcomes of patients treated by the institute s caregivers in 215. Patients with the most complex clinical problems from around the nation and the world come to the Orthopaedic & Rheumatologic Institute for care and expert opinions. These outcomes contributed to Cleveland Clinic s ranking among the nation s top 2 rheumatology programs and top 3 orthopaedics programs in U.S. News & World Report s America s Best Hospitals survey for The institute comprises Orthopaedic Surgery, Rheumatic and Immunologic Diseases, and Musculoskeletal Physical Medicine and Rehabilitation. Current full-time faculty include 55 orthopaedic surgeons (52 orthopaedic, 3 spine), 26 rheumatologists, 12 musculoskeletal radiologists, 7 podiatrists, 1 sports and exercise medicine primary physicians, 2 nonoperative orthopaedists, and 2 physiatrists (PM&R physicians). The institute also is dedicated to the cultivation of knowledge and innovation through basic, translational, and clinical research. One of its missions is to educate and train residents and fellows as well as colleagues at Cleveland Clinic and beyond, contributing to the fields of orthopaedics and rheumatology. Total clinic visits 465,535 Total surgeries 21,5 Total 215 musculoskeletal and rheumatology funding basic, translational, and clinical research $5,2,781 Orthopaedic & Rheumatologic Institute 5

8 Orthopaedics Overview Adult Shoulder Surgery, Procedure Yearly Volume Average Age, Years Males/ Females, % Length of Stay, Days Discharged Home, % Open Surgery Total shoulder arthroplasty /48 58/ Osteoarthritis /45 61/ Other reasons /66 35/ Reverse total shoulder arthroplasty /64 43/ Hemiarthroplasty /45 73/ Revision of total shoulder arthroplasty /47 6/ Rotator cuff repair /43 64/ Capsulorrhaphy /28 76/ Biceps tenodesis /23 83/ Fracture treatment /48 55/ Proximal humerus /69 28/ Clavicle /24 77/ Other treatment /43 59/ Arthroscopic Surgery Rotator cuff repair /38 62/ Capsulorrhaphy /26 68/ Biceps tenodesis /37 67/ SLAP repair /19 76/ Subacromial decompression /42 59/ Debridement /38 56/ Other treatment /38 61/ SLAP = superior labrum from anterior to posterior Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed Yearly Volume: number of surgeries performed per year Average Age, Years: average patient age Males/Females, %: males-to-females ratio Length of Stay, Days: average length of stay in days for inpatient surgeries Discharged Home, %: percentage of patients who were discharged home or to home care 6 Outcomes 215

9 Procedure In-Hospital Mortality, % 3-Day Readmission Rate, % 3-Day Reoperation Rate, % 9-Day Infection Rate, % Preop Function 9-Day Postop Function Open Surgery Total shoulder arthroplasty Osteoarthritis Other reasons Reverse total shoulder arthroplasty Hemiarthroplasty Revision of total shoulder arthroplasty Rotator cuff repair Capsulorrhaphy Biceps tenodesis Fracture treatment Proximal humerus Clavicle Other treatment Arthroscopic Surgery Rotator cuff repair Capsulorrhaphy Biceps tenodesis SLAP repair Subacromial decompression Debridement Other treatment SLAP = superior labrum from anterior to posterior Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed In-Hospital Mortality, %: rate of patient mortality prior to discharge from the hospital encounter during which surgery occurred 3-Day Readmission Rate, %: rate of readmission as an inpatient for any reason to a Cleveland Clinic hospital within 3 days of discharge 3-Day Reoperation Rate, %: rate of reoperation on the same joint within 3 days of discharge 9-Day Infection Rate, %: rate of infection within 9 days of surgery Preop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to arm problems prior to surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) 9-Day Postop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to arm problems 9 days after surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) Orthopaedic & Rheumatologic Institute 7

10 Orthopaedics Overview Adult Hand and Upper Extremity Surgery, Procedure Yearly Volume Average Age, Years Males/ Females, % Length of Stay, Days Discharged Home, % Open Surgery Total elbow arthroplasty /77 13/ Ulnar nerve neuroplasty at elbow /44 55/ Elbow tenotomy /53 58/ Distal bicep repair /4 95/ Carpal tunnel release /63 42/ Without distal radial fracture /63 42/ With distal radial fracture /73 16/ Wrist arthrodesis /37 58/ Hand arthroplasty /79 26/ Palmar fasciectomy /25 78/ De Quervain's release /81 13/ Trigger finger release /63 39/ Finger arthrodesis /67 32/ Finger amputation /31 65/ Fracture treatment /54 43/ Humeral shaft /66 34/ Distal humerus /62 39/ Radial head /62 58/ Proximal ulna /58 39/ Radial or ulnar shaft /51 49/ Distal radius /75 22/ Scaphoid /38 65/ Hand or finger /31 72/ Mass excision /62 35/ Other treatment /43 55/ Arthroscopic Surgery Elbow treatment /18 75/ Wrist treatment /52 55/ Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed Yearly Volume: number of surgeries performed per year Average Age, Years: average patient age Males/Females, %: males-to-females ratio Length of Stay, Days: average length of stay in days for inpatient surgeries Discharged Home, %: percentage of patients who were discharged home or to home care 8 Outcomes 215

11 Procedure In-Hospital Mortality, % 3-Day Readmission Rate, % 3-Day Reoperation Rate, % 9-Day Infection Rate, % Preop Function 9-Day Postop Function Open Surgery Total elbow arthroplasty Ulnar nerve neuroplasty at elbow Elbow tenotomy Distal bicep repair Carpal tunnel release Without distal radial fracture With distal radial fracture Wrist arthrodesis Hand arthroplasty Palmar fasciectomy De Quervain's release Trigger finger release Finger arthrodesis Finger amputation Fracture treatment Humeral shaft Distal humerus Radial head Proximal ulna Radial or ulnar shaft Distal radius Scaphoid Hand or finger Mass excision Other treatment Arthroscopic Surgery Elbow treatment Wrist treatment Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed In-Hospital Mortality, %: rate of patient mortality prior to discharge from the hospital encounter during which surgery occurred 3-Day Readmission Rate, %: rate of readmission as an inpatient for any reason to a Cleveland Clinic hospital within 3 days of discharge 3-Day Reoperation Rate, %: rate of reoperation on the same joint within 3 days of discharge 9-Day Infection Rate, %: rate of infection within 9 days of surgery Preop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to arm problems prior to surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) 9-Day Postop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to arm problems 9 days after surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) Orthopaedic & Rheumatologic Institute 9

12 Orthopaedics Overview Adult Hip Surgery, Procedure Yearly Volume Average Age, Years Males/ Females, % Length of Stay, Days Discharged Home, % Open Surgery Hip resurfacing /27 91/ Total hip arthroplasty /54 45/ Osteoarthritis /55 44/ Rheumatoid arthritis /8 29/ Avascular necrosis /44 59/ Other reasons (eg, fracture) /61 39/ Conversion to total hip arthroplasty /51 48/ Hemiarthroplasty /64 34/ Revision of total hip arthroplasty /53 5/ Infection /44 53/ Other reasons /55 49/ Treatment of hip or pelvis fracture /67 38/ Other treatment /54 44/ Arthroscopic Surgery Treatment of labral tear /68 28/ Without osteoarthritis /68 27/ With osteoarthritis /63 47/ Other treatment Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed Yearly Volume: number of surgeries performed per year Average Age, Years: average patient age Males/Females, %: males-to-females ratio Length of Stay, Days: average length of stay in days for inpatient surgeries Discharged Home, %: percentage of patients who were discharged home or to home care 1 Outcomes 215

13 Procedure In-Hospital Mortality, % 3-Day Readmission Rate, % 3-Day Reoperation Rate, % 9-Day Infection Rate, % Preop Function 9-Day Postop Function Open Surgery Hip resurfacing Total hip arthroplasty Osteoarthritis Rheumatoid arthritis Avascular necrosis Other reasons (eg, fracture) Conversion to total hip arthroplasty Hemiarthroplasty Revision of total hip arthroplasty Infection Other reasons Treatment of hip or pelvis fracture Other treatment Arthroscopic Surgery Treatment of labral tear Without osteoarthritis With osteoarthritis Other treatment Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed In-Hospital Mortality, %: rate of patient mortality prior to discharge from the hospital encounter during which surgery occurred 3-Day Readmission Rate, %: rate of readmission as an inpatient for any reason to a Cleveland Clinic hospital within 3 days of discharge 3-Day Reoperation Rate, %: rate of reoperation on the same joint within 3 days of discharge 9-Day Infection Rate, %: rate of infection within 9 days of surgery Preop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to leg problems prior to surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) 9-Day Postop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to leg problems 9 days after surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) Orthopaedic & Rheumatologic Institute 11

14 Orthopaedics Overview Adult Knee Surgery, Procedure Yearly Volume Average Age, Years Males/ Females, % Length of Stay, Days Discharged Home, % Open Surgery Unilateral total knee arthroplasty /62 38/ Osteoarthritis /62 38/ Rheumatoid arthritis /78 18/ Avascular necrosis /81 3/ Other reasons /52 52/ Bilateral total knee arthroplasty /59 48/ Partial knee arthroplasty /54 46/ Revision of total knee arthroplasty /57 43/ Infection /47 54/ Other reasons /6 38/ Treatment of periarticular knee fracture /63 32/ Other treatment /48 56/ Arthroscopic Surgery ACL reconstruction /38 61/ Meniscectomy /46 53/ Meniscus injury without osteoarthritis /42 59/ Meniscus injury with osteoarthritis /49 49/ Other reasons /56 48/ Meniscus repair /36 7/ Chondroplasty /56 41/ Other treatment /54 47/ ACL = anterior cruciate ligament Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed Yearly Volume: number of surgeries performed per year Average Age, Years: average patient age Males/Females, %: males-to-females ratio Length of Stay, Days: average length of stay in days for inpatient surgeries Discharged Home, %: percentage of patients who were discharged home or to home care 12 Outcomes 215

15 Procedure In-Hospital Mortality, % 3-Day Readmission Rate, % 3-Day Reoperation Rate, % 9-Day Infection Rate, % Preop Function 9-Day Postop Function Open Surgery Unilateral total knee arthroplasty Osteoarthritis Rheumatoid arthritis Avascular necrosis Other reasons Bilateral total knee arthroplasty Partial knee arthroplasty Revision of total knee arthroplasty Infection Other reasons Treatment of periarticular knee fracture Other treatment Arthroscopic Surgery ACL reconstruction Meniscectomy Meniscus injury without osteoarthritis Meniscus injury with osteoarthritis Other reasons Meniscus repair Chondroplasty Other treatment ACL = anterior cruciate ligament Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed In-Hospital Mortality, %: rate of patient mortality prior to discharge from the hospital encounter during which surgery occurred 3-Day Readmission Rate, %: rate of readmission as an inpatient for any reason to a Cleveland Clinic hospital within 3 days of discharge 3-Day Reoperation Rate, %: rate of reoperation on the same joint within 3 days of discharge 9-Day Infection Rate, %: rate of infection within 9 days of surgery Preop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to leg problems prior to surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) 9-Day Postop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to leg problems 9 days after surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) Orthopaedic & Rheumatologic Institute 13

16 Orthopaedics Overview Adult Foot and Ankle Surgery, Procedure Yearly Volume Average Age, Years Males/ Females, % Length of Stay, Days Discharged Home, % Open Surgery Total ankle arthroplasty /46 44/ Ankle arthrodesis /48 63/ Osteoarthritis /5 63/ Rheumatoid arthritis /67 / Traumatic injury /45 64/ Other reasons /42 67/ Achilles tendon treatment /3 63/ Acute rupture repair /22 76/ Chronic reconstruction /58 37/ Foot arthrodesis /63 37/ Osteoarthritis /64 38/ Rheumatoid arthritis /63 / Deformity /65 24/ Other reasons /59 47/ Flat foot or cavus foot correction /82 22/ Big toe arthrodesis /79 21/ Osteoarthritis /79 16/ Rheumatoid arthritis /91 / Deformity /78 26/ Other reasons /56 22/ Cheilectomy /67 41/ Bunion correction /9 13/ Hammertoe correction /79 25/ Bunion and hammertoe correction /91 6/ Fracture treatment /54 46/ Tibia or fibula /45 52/ Ankle /64 41/ Foot or toes /51 44/ Amputation /37 74/ Below knee /37 71/ Foot /33 78/ Toes /4 72/ Excision of leg or ankle tumor /58 39/ Excision of foot or toe tumor /67 36/ Other treatment /6 45/ Arthroscopic Surgery 5 4 Osteochondritis dissecans lesion repair /48 4/ Other treatment /56 32/ Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. 14 Column descriptions: Procedure: type of surgical procedure performed Yearly Volume: number of surgeries performed per year Average Age, Years: average patient age Males/Females, %: males-to-females ratio Length of Stay, Days: average length of stay in days for inpatient surgeries Discharged Home, %: percentage of patients who were discharged home or to home care Outcomes 215

17 Procedure In-Hospital Mortality, % 3-Day Readmission Rate, % 3-Day Reoperation Rate, % 9-Day Infection Rate, % Preop Function 9-Day Postop Function Open Surgery Total ankle arthroplasty Ankle arthrodesis Osteoarthritis Rheumatoid arthritis Traumatic injury Other reasons Achilles tendon treatment Acute rupture repair Chronic reconstruction Foot arthrodesis Osteoarthritis Rheumatoid arthritis Deformity Other reasons Flat foot or cavus foot correction Big toe arthrodesis Osteoarthritis Rheumatoid arthritis Deformity Other reasons Cheilectomy Bunion correction Hammertoe correction Bunion and hammertoe correction Fracture treatment Tibia or fibula Ankle Foot or toes Amputation Below knee Foot Toes Excision of leg or ankle tumor Excision of foot or toe tumor Other treatment Arthroscopic Surgery Osteochondritis dissecans lesion repair Other treatment Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Adult patients are aged 18 or older. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed In-Hospital Mortality, %: rate of patient mortality prior to discharge from the hospital encounter during which surgery occurred 3-Day Readmission Rate, %: rate of readmission as an inpatient for any reason to a Cleveland Clinic hospital within 3 days of discharge 3-Day Reoperation Rate, %: rate of reoperation on the same joint within 3 days of discharge Orthopaedic & Rheumatologic Institute 9-Day Infection Rate, %: rate of infection within 9 days of surgery Preop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to leg problems prior to surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) 9-Day Postop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to leg problems 9 days after surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) 15

18 Orthopaedics Overview Pediatric Shoulder and Hand/Upper Extremity Surgery, Procedure Yearly Volume Average Age, Years Males/ Females, % Length of Stay, Days Discharged Home, % Open Shoulder Surgery Capsulorrhaphy /24 1/ Treatment of shoulder fracture /15 88/ Other treatment Arthroscopic Shoulder Surgery Capsulorrhaphy /24 68/ SLAP repair /19 68/ Other treatment Open Hand/UE Surgery Trigger finger release /53 4/ Fracture treatment /34 62/ Humeral shaft /48 41/ Distal humerus Radial head Proximal ulna Radial or ulnar shaft /34 64/ Distal radius /29 75/ Scaphoid /11 1/ Hand or finger /26 72/ Mass excision /59 43/ Other treatment /38 65/ Arthroscopic Hand/UE Surgery 5 4 SLAP = superior labrum from anterior to posterior, UE = upper extremity Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Pediatric patients are younger than 18 years. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed Yearly Volume: number of surgeries performed per year Average Age, Years: average patient age Males/Females, %: males-to-females ratio Length of Stay, Days: average length of stay in days for inpatient surgeries Discharged Home, %: percentage of patients who were discharged home or to home care 16 Outcomes 215

19 Procedure In-Hospital Mortality, % 3-Day Readmission Rate, % 3-Day Reoperation Rate, % 9-Day Infection Rate, % Preop Function 9-Day Postop Function Open Shoulder Surgery Capsulorrhaphy Treatment of shoulder fracture Other treatment Arthroscopic Shoulder Surgery Capsulorrhaphy SLAP repair Other treatment Open Hand/UE Surgery Trigger finger release Fracture treatment Humeral shaft Distal humerus Radial head Proximal ulna Radial or ulnar shaft Distal radius Scaphoid Hand or finger Mass excision Other treatment Arthroscopic Hand/UE Surgery SLAP = superior labrum from anterior to posterior, UE = upper extremity Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Pediatric patients are younger than 18 years. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed In-Hospital Mortality, %: rate of patient mortality prior to discharge from the hospital encounter during which surgery occurred 3-Day Readmission Rate, %: rate of readmission as an inpatient for any reason to a Cleveland Clinic hospital within 3 days of discharge 3-Day Reoperation Rate, %: rate of reoperation on the same joint within 3 days of discharge 9-Day Infection Rate, %: rate of infection within 9 days of surgery Preop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to arm problems prior to surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) 9-Day Postop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to arm problems 9 days after surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) Orthopaedic & Rheumatologic Institute 17

20 Orthopaedics Overview Pediatric Hip, Knee, and Foot/Ankle Surgery, Procedure Yearly Volume Average Age, Years Males/ Females, % Length of Stay, Days Discharged Home, % Open Hip Surgery Treatment of hip or pelvis fracture 6 3 Other treatment /54 57/ Arthroscopic Hip Surgery 36 3 Open Knee Surgery Treatment of periarticular knee fracture /19 77/ Other treatment /51 41/ Arthroscopic Knee Surgery ACL reconstruction /52 43/ Meniscectomy /36 66/ Meniscus repair /35 91/ Chondroplasty /45 38/ Other treatment /53 24/ Open Foot/Ankle Surgery Flat foot or cavus foot correction /49 81/ Fracture treatment /3 73/ Tibia or fibula /27 81/ Ankle /39 69/ Foot or toes /31 61/ Excision of leg or ankle tumor /47 7/ Excision of foot or toe tumor /5 75/ Other treatment /5 47/ Arthroscopic Foot/Ankle Surgery 5 6 ACL = anterior cruciate ligament Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Pediatric patients are younger than 18 years. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed Yearly Volume: number of surgeries performed per year Average Age, Years: average patient age Males/Females, %: males-to-females ratio Length of Stay, Days: average length of stay in days for inpatient surgeries Discharged Home, %: percentage of patients who were discharged home or to home care 18 Outcomes 215

21 Procedure In-Hospital Mortality, % 3-Day Readmission Rate, % 3-Day Reoperation Rate, % 9-Day Infection Rate, % Preop Function 9-Day Postop Function Open Hip Surgery Treatment of hip or pelvis fracture Other treatment Arthroscopic Hip Surgery Open Knee Surgery Treatment of periarticular knee fracture Other treatment Arthroscopic Knee Surgery ACL reconstruction Meniscectomy Meniscus repair Chondroplasty Other treatment Open Foot/Ankle Surgery Flat foot or cavus foot correction Fracture treatment Tibia or fibula Ankle Foot or toes Excision of leg or ankle tumor Excision of foot or toe tumor Other treatment Arthroscopic Foot/Ankle Surgery ACL = anterior cruciate ligament Data reflect outcomes of care provided by Cleveland Clinic physicians irrespective of practice location, including Cleveland Clinic main campus, Cleveland Clinic northeast Ohio regional hospitals, and Cleveland Clinic Florida. Pediatric patients are younger than 18 years. A dash indicates that insufficient data were available to calculate the measure with reasonable accuracy. Column descriptions: Procedure: type of surgical procedure performed In-Hospital Mortality, %: rate of patient mortality prior to discharge from the hospital encounter during which surgery occurred 3-Day Readmission Rate, %: rate of readmission as an inpatient for any reason to a Cleveland Clinic hospital within 3 days of discharge 3-Day Reoperation Rate, %: rate of reoperation on the same joint within 3 days of discharge 9-Day Infection Rate, %: rate of infection within 9 days of surgery Preop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to leg problems prior to surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) 9-Day Postop Function: how much physical activities (eg, daily activities, housework, work outside the home, and exercising) are free of limitations due to leg problems 9 days after surgery; scores range from (extreme limitations, low function) to 1 (no limitations, high function) Orthopaedic & Rheumatologic Institute 19

22 Orthopaedics Overview Percentage of Primary and Revision Total Hip Arthroplasties Performed at Cleveland Clinic Hospitals 215 Surgeries (%) Primary THA Revision THA 4 2 N = CC Main Campus 721 CC Florida 538 Other CC Locations 42 Lutheran 259 Euclid 253 Lakewood 174 CC = Cleveland Clinic, THA = total hip arthroplasty At Cleveland Clinic main campus and Cleveland Clinic Florida, 27% and 15%, respectively, of all total hip arthroplasty surgeries performed are revisions. Conversely, all other Cleveland Clinic hospitals individually perform < 6%. Approximately 6% of all total hip arthroplasty revision surgeries across Cleveland Clinic health system are performed at Cleveland Clinic main campus. Percentage of Primary and Revision Total Knee Arthroplasties Performed at Cleveland Clinic Hospitals 215 Surgeries (%) Primary TKA Revision TKA 4 2 N = CC Main Campus 824 Euclid 581 Other CC Locations 474 Lutheran 47 CC Florida 4 Lakewood 348 CC = Cleveland Clinic, TKA = total knee arthroplasty At Cleveland Clinic main campus, Cleveland Clinic Florida, and Lakewood Hospital, 26%, 14%, and 12%, respectively, of all total knee arthroplasty surgeries performed are revisions. Conversely, all other Cleveland Clinic hospitals individually perform < 8%. Approximately 5% of all total knee arthroplasty revision surgeries across Cleveland Clinic health system are performed at Cleveland Clinic main campus. 2 Outcomes 215

23 Adult Total Shoulder Arthroplasty for Osteoarthritis Shoulder-Related Pain 1 Year After Surgery Shoulder-Related Function 1 Year After Surgery Patients (%) 1 8 > 3 MCID a 1 3 MCID Patients (%) 1 8 > 3 MCID a 1 3 MCID N = Improving Worsening N = Improving Worsening On average, 91% of patients reported a clinically important improvement in shoulder-related pain after 1 year, while 1% reported worsening (8% showed no detectable change in shoulder-related pain). On average, 91% of patients reported a clinically important improvement in shoulder-related function after 1 year, while 1% reported worsening (8% showed no detectable change in shoulder-related function). Shoulder-related pain and function are measured using a modified Penn Shoulder Score (PSS) questionnaire. Data are derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed during the indicated years. ªMCID refers to the minimal clinically important difference and is estimated here as one-half of the SD of patient-reported data 1 year after surgery. For shoulder-related pain, the MCID is 12. (N = 387) on a scale from (extreme pain) to 1 (no pain). For shoulder-related function, the MCID is 13.6 (N = 368) on a scale from (extreme limitations) to 1 (no limitations). Orthopaedic & Rheumatologic Institute 21

24 Adult Total Shoulder Arthroplasty for Osteoarthritis Arm-Related Physical Function 1 Year After Surgery Whole-Body Physical Function 1 Year After Surgery Patients (%) 1 8 > 3 MCID a 1 3 MCID Patients (%) 1 8 > 3 MCID a 1 3 MCID N = Improving Worsening N = Improving Worsening On average, 87% of patients reported a clinically important improvement in arm-related physical function after 1 year, while 3% reported worsening (1% showed no detectable change in arm-related physical function). On average, 54% of patients reported a clinically important improvement in whole-body physical function after 1 year, while 1% reported worsening (36% showed no detectable change in whole-body physical function). Arm-related physical function is measured using the Review of Musculoskeletal System (ROMS) questionnaire. Whole-body physical function is measured using the Veterans RAND 12 (VR-12) questionnaire. Data are derived from patient selfreported scores collected during office visits up to 6 months before and 1 year after surgeries performed during the indicated years. ªMCID refers to the minimal clinically important difference and is estimated here as one-half of the SD of patient-reported data 1 year after surgery. For arm-related physical function, the MCID is 1.6 (N = 528) on a scale from (extreme limitations) to 1 (no limitations). For whole-body physical function, the MCID is 5. (N = 449) on a norm-based scale where 5 represents the mean score of a nonpatient control group and every 1 units represents 1 SD from the mean. 22 Outcomes 215

25 Analysis of Synovial Fluid Cytokine Profiles in the Diagnosis of Periprosthetic Joint Infections of the Shoulder Improved diagnosis of shoulder periprosthetic joint infection (PJI) can lead to better decision-making regarding treatment in revision surgery. The utility of synovial fluid cytokine analysis for diagnosis of shoulder PJI was evaluated. Synovial fluid levels of 9 cytokines [interleukin-6 (IL-6), granulocyte macrophage colony-stimulating factor (GM-CSF), IL-1β, IL-12, IL-2, IL-8, interferon-gamma (IFN-γ), IL-1, tumor necrosis factor-alpha (TNF-α)] were measured using an immunoassay technique from 75 cases of revision shoulder arthroplasty. Synovial IL-6, GM-CSF, IFN-γ, IL-1β, IL-2, IL-8, and IL-1 were significantly elevated in cases classified as infected. Individually, IL-6, IL-1β, IL-8, and IL-1 showed the best combination of sensitivity and specificity for predicting infection, while a combined predictive model consisting of IL-6, TNF-α, and IL-2 showed better diagnostic test characteristics than any individual cytokine alone. Synovial fluid cytokine analysis was more effective than routine perioperative testing in diagnosis of shoulder PJI and could be developed into a predictive tool to determine the probability of PJI in patients undergoing revision shoulder arthroplasty. Synovial Fluid Cytokine Diagnostic Test Characteristics for Infection (N = 75) November 212 February 215 Cytokine AUC a Optimal Cutoff (pg/ml) Sensitivity Specificity PPV NPV LR+ LR IL GM-CSF IFN-γ IL-1β IL IL IL IL TNF-α Combined b AUC = area under the curve, LR+ = positive likelihood ratio, LR = negative likelihood ratio, NPV = negative predictive value, PPV = positive predictive value a AUC, optimal cutoff, sensitivity, specificity, PPV, NPV, LR+, and LR were determined from receiver operating characteristic analysis of individual cytokines and combined cytokine analysis. b Combined represents the diagnostic test characteristics of a 3-cytokine (IL-6, TNF-α, IL-2) model found to have the optimal predictive power. Orthopaedic & Rheumatologic Institute 23

26 Adult Total Hip Arthroplasty for Osteoarthritis Hip-Related Pain 1 Year After Surgery Patients (%) 1 Hip-Related Function 1 Year After Surgery Patients (%) > 3 MCID a 1 3 MCID 8 6 > 3 MCID a 1 3 MCID N = Improving Worsening N = Improving Worsening On average, 92% of patients reported a clinically important improvement in hip-related pain after 1 year, while 1% reported worsening (7% showed no detectable change in hip-related pain). On average, 9% of patients reported a clinically important improvement in hip-related function after 1 year, while 1% reported worsening (9% showed no detectable change in hip-related function). Hip-related pain and function are measured using a modified Hip dysfunction and Osteoarthritis Outcome Score (HOOS) questionnaire. Data are derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed during the indicated years. ªMCID refers to the minimal clinically important difference and is estimated here as one-half of the SD of patient-reported data 1 year after surgery. For hip-related pain, the MCID is 11.9 (N = 1133) on a scale from (extreme pain) to 1 (no pain). For hip-related function, the MCID is 12.5 (N = 1142) on a scale from (extreme limitations) to 1 (no limitations). 24 Outcomes 215

27 Leg-Related Physical Function 1 Year After Surgery Patients (%) 1 Whole-Body Physical Function 1 Year After Surgery Patients (%) > 3 MCID a 1 3 MCID 8 6 > 3 MCID a 1 3 MCID N = Improving Worsening N = Improving Worsening On average, 77% of patients reported a clinically important improvement in leg-related physical function after 1 year, while 5% reported worsening (18% showed no detectable change in leg-related physical function). On average, 67% of patients reported a clinically important improvement in whole-body physical function after 1 year, while 7% reported worsening (26% showed no detectable change in whole-body physical function). Leg-related physical function is measured using the Review of Musculoskeletal System (ROMS) questionnaire. Whole-body physical function is measured using the Veterans RAND 12 (VR-12) questionnaire. Data are derived from patient selfreported scores collected during office visits up to 6 months before and 1 year after surgeries performed during the indicated years. ªMCID refers to the minimal clinically important difference and is estimated here as one-half of the SD of patient-reported data 1 year after surgery. For leg-related physical function, the MCID is 2. (N = 2164) on a scale from (extreme limitations) to 1 (no limitations). For whole-body physical function, the MCID is 5.7 (N = 277) on a norm-based scale where 5 represents the mean score of a nonpatient control group and every 1 units represents 1 SD from the mean. Orthopaedic & Rheumatologic Institute 25

28 Adult Total Hip Resurfacing for Osteoarthritis Hip-Related Pain 1 Year After Surgery Patients (%) 1 Hip-Related Function 1 Year After Surgery Patients (%) > 3 MCID a 1 3 MCID 8 6 > 3 MCID a 1 3 MCID N = Improving Worsening N = Improving Worsening On average, 95% of patients reported a clinically important improvement in hip-related pain after 1 year, while 1% reported worsening (4% showed no detectable change in hip-related pain). On average, 95% of patients reported a clinically important improvement in hip-related function after 1 year, while 1% reported worsening (4% showed no detectable change in hip-related function). Hip-related pain and function are measured using a modified Hip dysfunction and Osteoarthritis Outcome Score (HOOS) questionnaire. Data are derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed during the indicated years. ªMCID refers to the minimal clinically important difference and is estimated here as one-half of the SD of patient-reported data 1 year after surgery. For hip-related pain, the MCID is 1.1 (N = 573) on a scale from (extreme pain) to 1 (no pain). For hip-related function, the MCID is 1.5 (N = 569) on a scale from (extreme limitations) to 1 (no limitations). 26 Outcomes 215

29 Leg-Related Physical Function 1 Year After Surgery Patients (%) 1 Whole-Body Physical Function 1 Year After Surgery Patients (%) > 3 MCID a 1 3 MCID 8 6 > 3 MCID a 1 3 MCID N = Improving Worsening N = Improving Worsening On average, 85% of patients reported a clinically important improvement in leg-related physical function after 1 year, while 3% reported worsening (12% showed no detectable change in leg-related physical function). On average, 75% of patients reported a clinically important improvement in whole-body physical function after 1 year, while 4% reported worsening (21% showed no detectable change in whole-body physical function). Leg-related physical function is measured using the Review of Musculoskeletal System (ROMS) questionnaire. Whole-body physical function is measured using the Veterans RAND 12 (VR-12) questionnaire. Data are derived from patient selfreported scores collected during office visits up to 6 months before and 1 year after surgeries performed during the indicated years. ªMCID refers to the minimal clinically important difference and is estimated here as one-half of the SD of patient-reported data 1 year after surgery. For leg-related physical function, the MCID is 1.6 (N = 174) on a scale from (extreme limitations) to 1 (no limitations). For whole-body physical function, the MCID is 6. (N = 834) on a norm-based scale where 5 represents the mean score of a nonpatient control group and every 1 units represents 1 SD from the mean. Orthopaedic & Rheumatologic Institute 27

30 Adult Unilateral Total Knee Arthroplasty for Osteoarthritis Knee-Related Pain 1 Year After Surgery Knee-Related Function 1 Year After Surgery Patients (%) 1 8 > 3 MCID a 1 3 MCID Patients (%) 1 8 > 3 MCID a 1 3 MCID N = Improving Worsening N = Improving Worsening On average, 85% of patients reported a clinically important improvement in knee-related pain after 1 year, while 2% reported worsening (13% showed no detectable change in knee-related pain). On average, 82% of patients reported a clinically important improvement in knee-related function after 1 year, while 2% reported worsening (16% showed no detectable change in knee-related function). Knee-related pain and function are measured using a modified Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire. Data are derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed during the indicated years. ªMCID refers to the minimal clinically important difference and is estimated here as one-half of the SD of patient-reported data 1 year after surgery. For knee-related pain, the MCID is 12. (N = 1994) on a scale from (extreme pain) to 1 (no pain). For knee-related function, the MCID is 12.2 (N = 196) on a scale from (extreme limitations) to 1 (no limitations). 28 Outcomes 215

31 Leg-Related Physical Function 1 Year After Surgery Whole-Body Physical Function 1 Year After Surgery Patients (%) 1 8 > 3 MCID a 1 3 MCID Patients (%) 1 8 > 3 MCID a 1 3 MCID N = Improving Worsening N = Improving Worsening On average, 74% of patients reported a clinically important improvement in leg-related physical function after 1 year, while 6% reported worsening (2% showed no detectable change in leg-related physical function). On average, 59% of patients reported a clinically important improvement in whole-body physical function after 1 year, while 1% reported worsening (31% showed no detectable change in whole-body physical function). Leg-related physical function is measured using the Review of Musculoskeletal System (ROMS) questionnaire. Whole-body physical function is measured using the Veterans RAND 12 (VR-12) questionnaire. Data are derived from patient self-reported scores collected during office visits up to 6 months before and 1 year after surgeries performed during the indicated years. ªMCID refers to the minimal clinically important difference and is estimated here as one-half of the SD of patient-reported data 1 year after surgery. For leg-related physical function, the MCID is 1.8 (N = 3984) on a scale from (extreme limitations) to 1 (no limitations). For whole-body physical function, the MCID is 5.6 (N = 2949) on a norm-based scale where 5 represents the mean score of a nonpatient control group and every 1 units represents 1 SD from the mean. Orthopaedic & Rheumatologic Institute 29

32 Orthopaedic Surgical Quality Improvement The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP ) objectively measures and reports risk-adjusted surgical outcomes based on a defined sampling and abstraction methodology. These outcomes data reflect Cleveland Clinic s overall orthopaedic surgery ACS NSQIP performance benchmarked against 478 participating sites. Orthopaedic Surgery Outcomes July 214 June 215 Outcome N Observed Rate (%) Expected Rate (%) 3-day mortality a.5 3-day morbidity Pneumonia a.64 Deep vein thrombosis/pulmonary embolism b.98 Urinary tract infection Surgical site infection Return to operating room Readmission b 4.51 a Identified as a statistical outlier (lower than expected) by the ACS NSQIP hierarchical model b Identified as a statistical outlier (higher than expected) by the ACS NSQIP hierarchical model In addition to overall orthopaedic surgery ACS NSQIP outcomes data, data specific to total knee arthroplasty (TKA) and total hip arthroplasty (THA) are provided. TKA performance is benchmarked against 124 participating sites; THA performance is benchmarked against 99 sites. Total Knee Arthroplasty Outcomes July 214 June 215 Outcome N Observed Rate (%) Expected Rate (%) 3-day morbidity Pneumonia 417. a.39 Deep vein thrombosis/pulmonary embolism b 1.29 Urinary tract infection Sepsis Return to operating room Readmission a Identified as a statistical outlier (lower than expected) by the ACS NSQIP hierarchical model b Identified as a statistical outlier (higher than expected) by the ACS NSQIP hierarchical model 3 Outcomes 215

33 Total Hip Arthroplasty Outcomes July 214 June 215 Outcome N Observed Rate (%) Expected Rate (%) 3-day mortality day morbidity Cardiac event Pneumonia Unplanned intubation Deep vein thrombosis/pulmonary embolism b.71 Urinary tract infection 344. a.93 Surgical site infection Sepsis b.39 Return to operating room Readmission b 4.95 a Identified as a statistical outlier (lower than expected) by the ACS NSQIP hierarchical model b Identified as a statistical outlier (higher than expected) by the ACS NSQIP hierarchical model Source: facs.org/quality-programs/acs-nsqip Primary Total Hip Arthroplasty and/or Total Knee Arthroplasty Inpatient Complications All-Cause 3-Day Readmissions April 212 March 215 July 212 June 215 Percent Cleveland Clinic National rate a Complications Readmissions N = a Source: medicare.gov/hospitalcompare CMS calculates elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) outcomes measures based on Medicare claims and enrollment information. The most recent risk-adjusted data available from CMS are shown. Although Cleveland Clinic s THA/TKA complications and readmissions rates are slightly lower than the US national rates, CMS ranks Cleveland Clinic s performance on each as no different than the respective US national rate. To further reduce avoidable readmissions, Cleveland Clinic is focused on optimizing transitions from hospital to home or postacute facility. Specific initiatives have been implemented to ensure effective communication, education, and follow-up. Orthopaedic & Rheumatologic Institute 31

34 Spinal Disease The Center for Spine Health provides comprehensive care for a continuum of spinal disorders. Comprehensive care includes medical management, physical therapy, surgical interventions, minimally invasive injection procedures, specialized exercise programs, acupuncture, osteopathic manipulation, and referral to an in-house functional restoration program, all intended to maximize return to participation in vocational, family, and recreational activities. The Center for Spine Health consists of surgeons, all board-certified in either neurosurgery or orthopedic surgery, and medical specialists board-certified in various fields that include rheumatology, physical medicine and rehabilitation, neurology, internal medicine, sports medicine, pain medicine, psychiatry, and psychology. Cervical Myelopathy Change in Functional Status Following Cervical Decompression With Fusion for Myelopathy Surgical Dates: May 7, 214 June 24, 215 Patients (%) Improved Stable Worsened 4 2 N = EQ-5D Score 18 PDQ Score 9 PHQ-9 Score 24 In patients undergoing cervical decompression for myelopathy, among those with EuroQol (EQ-5D ) scores < 1 (N = 18), 37% noted improvement and 7% worsened in health-related quality of life. In those with baseline impairment of physical function, defined as Pain Disability Questionnaire (PDQ) score > 16, 4% noted improvement after surgery and 12% worsened. In those with at least moderate depressive symptoms, defined as a score 1 on the Patient Health Questionnaire (PHQ-9) prior to treatment, 25% noted improvement in depressive symptoms. Median duration of follow-up after surgery was 48 days (range, 9 449). In this and subsequent graphs, clinically meaningful change was defined as a change of half a standard deviation, 1 or a total point change of.11, based on 212 Neurological Institute data, for the EQ-5D, a total point change of > 16 for the PDQ, and a change of 5 points for the PHQ-9. 2 References 1. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 23 May;41(5): Löwe B, Unützer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the Patient Health Questionnaire-9. Med Care. 24 Dec;42(12): Outcomes 215

35 Change in Functional Status Following Cervical Decompression Without Fusion for Myelopathy Surgical Dates: May 5, 214 June 23, 215 Patients (%) N = EQ-5D Score 83 PDQ Score 66 PHQ-9 Score 12 Improved Stable Worsened Among patients undergoing cervical decompression without fusion for cervical myelopathy and who had EQ-5D < 1, 32% noted improvement, 47% remained stable, and 2% worsened in health-related quality of life. Among patients with baseline impairment of physical function (PDQ > 16), 35% noted improvement after surgery and 22% worsened. Among patients who had at least moderate depressive symptoms (PHQ-9 1) prior to surgery, 58% remained stable and 33% worsened in depressive symptoms. Median duration of follow-up after surgery was 45 days (range, 5 38). Cervical Disc Herniation Change in Functional Status Following Cervical Decompression With Fusion for Cervical Disc Herniation Surgical Dates: May 14, 214 June 23, 215 Patients (%) N = EQ-5D Score 8 PDQ Score 6 PHQ-9 Score 17 Improved Stable Worsened In patients who underwent cervical fusion for symptoms of cervical disc herniation, 41% of those with EQ-5D < 1 noted improvement and 14% noted worsening in health-related quality of life. In those with baseline impairment of physical function (PDQ > 16), 45% noted improvement after surgery and 18% worsened. In those with at least moderate depressive symptoms (PHQ-9 1) prior to treatment, 65% remained stable and 24% worsened in depressive symptoms. Median duration of follow-up after surgery was 59 days (range, ). Orthopaedic & Rheumatologic Institute 33

36 Spinal Disease Change in Functional Status Following Cervical Decompression Without Fusion for Cervical Disc Herniation Surgical Dates: June 6, 214 June 15, 215 Patients (%) Improved Stable Worsened 4 2 N = EQ-5D Score 3 PDQ Score 25 PHQ-9 Score 5 In patients who underwent cervical decompression without fusion for symptoms of cervical disc herniation, 33% of those with EQ-5D < 1 noted improvement and 17% noted worsening in health-related quality of life. In those with baseline impairment of physical function (PDQ > 16), 24% noted improvement after surgery and 16% worsened. In those with at least moderate depressive symptoms (PHQ-9 1) prior to treatment, 1% remained stable in depressive symptoms. Median duration of follow-up after surgery was 5 days (range, ). 34 Outcomes 215

37 Lumbar Spinal Disease Surgical Treatment Spinal stenosis results in narrowing of the spinal canal, which often causes leg pain that can impair walking, standing, and many aspects of daily function. For symptomatic patients, the goal of surgery is to decompress the spinal canal to eliminate neural compression and relieve leg pain; this may or may not require instrumented fusion of the operated levels. Change in Functional Status Following Lumbar Decompression With Fusion for Spinal Stenosis Surgical Dates: May 1, 214 June 25, 215 Patients (%) Improved Stable Worsened 4 2 N = EQ-5D Score 391 PDQ Score 321 PHQ-9 Score 96 Among patients undergoing lumbar decompression with fusion for symptomatic spinal stenosis, 99% had baseline EQ-5D < 1; 47% noted improvement and 15% worsened in health-related quality of life after surgery. Of the patients who had baseline impairment of physical function (PDQ > 16), 45% noted improvement after surgery and 17% worsened. Among patients reporting at least moderate depressive symptoms (PHQ-9 1) prior to surgery, 11% noted improvement and 9% worsened in depressive symptoms. Median duration of follow-up was 48 days after surgery (range, 6 394). Orthopaedic & Rheumatologic Institute 35

38 Spinal Disease Change in Functional Status Following Lumbar Decompression Without Fusion for Spinal Stenosis Surgical Dates: May 1, 214 June 24, 215 Patients (%) N = EQ-5D Score 161 PDQ Score 14 PHQ-9 Score 44 Improved Stable Worsened Among patients undergoing lumbar decompression without fusion for symptomatic spinal stenosis, 99% had baseline EQ-5D < 1; 43% noted improvement and 11% worsened in health-related quality of life after surgery. Of the patients who had baseline impairment of physical function (PDQ > 16), 52% noted improvement after surgery and 8% worsened. Among patients reporting at least moderate depressive symptoms (PHQ-9 1) prior to surgery, 16% noted improvement and 82% remained stable in depressive symptoms. Median duration of follow-up was 5 days after surgery (range, 6 428). Change in Functional Status Following Lumbar Decompression Without Fusion for Disc Herniation Surgical Dates: May 7, 214 June 23, 215 Patients (%) N = EQ-5D Score 79 PDQ Score 68 PHQ-9 Score 15 Improved Stable Worsened Among patients undergoing lumbar decompression without fusion for symptomatic lumbar disc herniation, 1% had baseline EQ-5D < 1; 43% noted improvement and 11% worsened in healthrelated quality of life after surgery. All patients had baseline impairment of physical function defined as PDQ > 16, and 5% noted improvement after surgery while 12% worsened. Among the 19% of patients reporting at least moderate depressive symptoms (PHQ-9 1) prior to surgery, 27% noted improvement and 7% worsened in depressive symptoms. Median duration of followup was 45 days after surgery (range, 7 213). 36 Outcomes 215

39 Spinal Injections (Nonsurgical Treatment) Change in Functional Status Following Lumbar Spinal Injections for Disc Herniation Treatment Dates: Jan. 6 June 29, 215 Patients (%) N = EQ-5D Score 327 PDQ Score 293 PHQ-9 Score 63 Improved Stable Worsened Among patients undergoing lumbar spinal injection for symptomatic lumbar disc herniation, 1% had baseline EQ-5D < 1; 38% noted improvement and 13% worsened in healthrelated quality of life after injection. Of the 96% of patients who had baseline impairment of physical function (PDQ > 16), 38% noted improvement after injection while 12% worsened. Among the 36% of patients reporting at least moderate depressive symptoms (PHQ-9 1) prior to injection, 11% noted improvement and 6% worsened in depressive symptoms. Median duration of follow-up was 32 days after injection (range, 1 311). Orthopaedic & Rheumatologic Institute 37

40 Spinal Disease Surgical Complications Surgical Site Infection Rates for Spinal Surgery Infections per 1 Cases N = New protocols introduced in 212 to reduce surgical site infections include nasal staphylococcus surveillance and decolonization protocols, an updated perioperative scrub protocol, new rules restricting operating room traffic and updating operating room table preparation, and new wound closure recommendations. The most recent overall postoperative infection rates in the Spine Center of 1.9% for 214 and 1.5% for 215 compare favorably with available published data ranging from 1.4% to 11%. 1,2 N = spinal surgeries with available infection surveillance data. References 1. Smith JS, Shaffrey CI, Sansur CA, Berven SH, Fu KM, Broadstone PA, Choma TJ, Goytan MJ, Noordeen HH, Knapp DR Jr, Hart RA, Donaldson WF 3rd, Polly DW Jr, Perra JH, Boachie-Adjei O; Scoliosis Research Society Morbidity and Mortality Committee. Rates of infection after spine surgery based on 18,419 procedures: a report from the Scoliosis Research Society Morbidity and Mortality Committee. Spine. 211 Apr 1;36(7): Schimmel JJ, Horsting PP, de Kleuver M, Wonders G, van Limbeek J. Risk factors for deep surgical site infections after spinal fusion. Eur Spine J. 21 Oct;19(1): Outcomes 215

41 3-Day Postoperative Mortality Rate Following Spinal Surgery (N = 3178) 215 Mortality Rate (%) Cleveland Clinic NSQIP 1 Medicare 2 The 3-day postoperative mortality rate following spinal surgery in 215 was.3%, compared with a rate of.3% for the National Surgical Quality Improvement Program (NSQIP) 1 database and a rate of.4% for the Medicare database. 2 Postoperative Venous Thromboembolism Rate Following Spinal Surgery (N = 198) 215 Postoperative VTE Rate (%) N = Q1 283 Q2 25 VTE = venous thromboembolism Q3 253 Number of VTE 1 Q Ongoing surveillance of postoperative complications, such as postoperative venous thromboembolism, and prompt implementation of quality improvement efforts help to ensure that patients return home safely after surgery. The graph shows perioperative pulmonary embolism or deep vein thrombosis per 1 surgical discharges for patients aged 18 years and older who underwent spine surgery. Cases with a principal diagnosis of pulmonary embolism or deep vein thrombosis, or with a secondary diagnosis of pulmonary embolism or deep vein thrombosis present on admission, were excluded from analysis. References 1. Schoenfeld AJ, Ochoa LM, Bader JO, Belmont PJ Jr. Risk factors for immediate postoperative complications and mortality following spine surgery: a study of 3475 patients from the National Surgical Quality Improvement Program. J Bone Joint Surg Am. 211 Sep 7;93(17): Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 21 Apr 7;33(13): Orthopaedic & Rheumatologic Institute 39

42 Sports Medicine Concussion is a type of mild traumatic brain injury caused by a bump, blow, or jolt to the head that can present with a variety of symptoms. Cleveland Clinic s Concussion Center continues to be a leader in the evaluation and management of patients with concussion. In an effort to optimize community-based sports concussion care, the Concussion Center developed and implemented standardized methods of reporting, evaluating, and managing concussion injury in youth and high school athletes. The following outcomes highlight sports concussion care using the Concussion Center s highly integrated, multidisciplinary approach. Incident Reporting The collection and reporting of head injury details (eg, symptoms, date, time, location of injury, and action taken) facilitates the collaboration of care between athletic trainers on the sideline and physicians in the hospital or office. The development and deployment of the Concussion Incident Report module to a mobile device, ipad, or iphone allows athletic trainers, who are typically the first medical personnel to evaluate an injured athlete, to track head injury details. Additional assessment modules are utilized to objectively characterize aspects of cognitive and motor status. 4 Outcomes 215

43 Incident Reporting Over Time Assessments 3, 25, 2, 15, Baseline Follow-up Incident reports Incident Reports , Q1 Q2 Q3 Q4 214 Q1 Q2 Q3 Q4 215 The graph illustrates the historical use of the Cleveland Clinic Concussion (C3) Application and the Incident Report (IR) after the pilot phase. Collectively, both the preseason baseline and in-season follow-up assessments increased dramatically from the beginning of 214 through the conclusion of the fall 215 sports season. The Concussion Center is currently analyzing both baseline and postinjury data for this data set. As shown by the red line, the number of IRs dramatically increased starting in July 214, after all Cleveland Clinic athletic trainers received education on its use. The remainder of the reported outcomes will focus on the IR as it provides data that will guide process improvement, facilitate patient hand-offs, and allow calculation of injury rates for communication to community partners. Orthopaedic & Rheumatologic Institute 41

44 Sports Medicine Concussion Rates by Sport and Venue for High School Athletes (N = 595) 215 Cleveland Clinic National 1 Sport Game/Event (%) Practice (%) Total (%) [Number] Game/Event (%) Practice (%) Total (%) Football [24] Boys ice hockey [28] Boys soccer [44] Boys wrestling [59] Boys basketball [38] Boys swimming/diving Girls soccer [98] Girls basketball [67] Girls gymnastics..2.2 [1] Cheerleading [1] Girls volleyball [34] Girls swimming/diving [12] The rates of concussion IRs were higher in competition than in practice for all sports, except cheerleading and swimming/ diving, in the Cleveland Clinic patient population, and the overall rates of observed concussions among girls soccer, basketball, and volleyball were higher compared with a national sample. 1 The presence of Cleveland Clinic high school athletic trainers at soccer, basketball, and volleyball practices and competitions likely improved detection. Increased popularity of soccer, as well as community education and awareness of concussion signs and symptoms, may contribute to greater incidence among these athletes. Reference 1. Marar M, McIlvain NM, Fields SK, Comstock RD. Epidemiology of concussions among United States high school athletes in 2 sports. Am J Sports Med. 212 Apr;4(4): Outcomes 215

45 Distribution of Football-Associated Concussions by Position and Venue (N = 197) 215 Number of Concussions Game Practice 1 Offensive Line Defensive Line Linebacker Wide Receiver Running Back Quarterback Cornerback Safety Special Teams Fullback Tight End Kick Returner Kicker To better understand how position played in football may affect concussion rates, patients with concussion were evaluated based on position played and venue where injured. High school athletes reported 24 concussions while playing football, which is consistent with prior reports of the associated increased incidence of concussion in football players. 1 Among the 197 concussions with position and venue data available, 52.3% of football-related concussions occurred on offense, 42.1% on defense, and 5.6% on special teams (includes kicker and kick returner). Offensive and defensive linemen accounted for 36% of concussions. Linemen account for nearly one-half of football positions on the field. Wide receivers accounted for 12.2% of all concussions, despite making up approximately 9.1% of the positions on the field. The rates of concussion IRs were higher in competition than in practice for all positions, except linemen, which may reflect the cumulative effect of repetitive subconcussive impacts at the line of scrimmage. Reference 1. Marar M, McIlvain NM, Fields SK, Comstock RD. Epidemiology of concussions among United States high school athletes in 2 sports. Am J Sports Med. 212 Apr;4(4): Orthopaedic & Rheumatologic Institute 43

46 Sports Medicine Same-Day Incident Reports: Action Taken After Concussion (N = 232) 215 Action Taken After Head Injury Percent (Number) Sent to locker room 4.9 (95) Remained on sideline 26.7 (62) Sent home immediately with parent/family member 11.2 (26) Returned to play; did not report initial symptoms 4.3 (1) Sent to ED with family 1.7 (4) Sent to ED with backboard via ambulance.9 (2) Returned to play after evaluation; no signs of concussion.4 (1) Other 13.8 (32) ED = emergency department The immediate action following the identification of or evaluation for a concussion is critical in terms of preventing a more serious injury as a result of an immediate subsequent blow to the head. As shown in the table, most athletes were sent to the locker room with a certified athletic trainer or other appropriate personnel, or remained on the sideline. Ten athletes did not report their symptoms until after the game, citing various reasons (eg, being unaware of symptoms, desire to keep playing). Unfortunately, 2.6% exhibited more concerning signs and symptoms and were sent to a local emergency department for a more thorough evaluation. Among student-athletes who were removed from play and evaluated at the time of injury, 1 was returned to play after it was determined that there was no concussion. The IRs show 13.8% of athletes (N = 32) for whom further information was not available, revealing shortcomings in data collection methods and an opportunity for improvement during the upcoming year. 44 Outcomes 215

47 Return-to-Play and Return-to-School Reporting In addition to incident reporting, a critical aspect of understanding the outcomes of concussion care involves monitoring the progression of exertional recovery along the pathway to return-to-play (RTP) after concussion. Consensus guidelines recommend a 6-phase graduated RTP protocol of exertional recovery after concussion, from initial rest (Phase 1) to eventual RTP (Phase 6). 1 The development and deployment of the Concussion RTP module to a mobile device, ipad, or iphone allows athletic trainers, who typically supervise the graduated exertional recovery protocol, to closely monitor and document the progress of each individual student-athlete. Impact of Sports Concussion on School Days Missed (N = 515) August December 215 Concussion RTP Module Data Percent of student-athletes with school days missed 21.4% (N = 11) Average school days missed (N = 11) 3.4 days In fall 215, the RTP module was used for 515 student-athletes. In addition to monitoring the exertional recovery aspects of RTP, athletic trainers using the Concussion RTP module document the days missed from school by student-athletes. Among the 515 student-athletes, 11 missed a total of 369 full or partial days from school, for an average of 3.4 days of school missed per student-athlete. Increasing deployment of the Concussion RTP module will allow a deeper understanding of the impact of sports concussion on both return-to-school and return-to-play after concussion among high school and collegiate athletes. These data will be useful in providing patients with realistic expectations related to the projected number of days they may be absent from school and sport. Further, having these data will facilitate interactions with school administrators and school counselors to ensure appropriate accommodations are provided for the student-athlete. Reference 1. McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorák J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 212. Br J Sports Med. 213 Apr;47(5): Orthopaedic & Rheumatologic Institute 45

48 Rheumatology Overview Patient Visit Volumes Since the beginning of the BIOLOGIC SUMMITS in 25, this local meeting has grown into an international event. In 215, more than 4 attendees gathered in Cleveland. More impressively, each SUMMIT has been repurposed and posted at ccfcme. org/rheumcme and is available free to all. The R. J. Fasenmyer Center for Clinical Immunology has issued more than 4, hours of continuing medical education credit for this remarkable meeting. The R. J. Fasenmyer Center continues to sponsor an ongoing program in basic and clinical immunology designed for rheumatologists, holding its fourth annual boot camp (Basic and Clinical Immunology for the Busy Clinician) in Hollywood, Florida, for nearly 1 practitioners Total Visits (in Thousands) N = ,11 Volume of New Rheumatoid Arthritis Patient Visits Number of Patients N = , , , , Outcomes 215

49 Most Common Conditions Treated in 215 a Condition Volume Rheumatoid arthritis 4712 Osteoporosis 317 Connective tissue diseases 347 Osteoarthritis 2651 Vasculitis 2141 Chronic pain syndromes 1763 Fibromyalgia 1262 Inflammatory arthritis 635 Bursitis 611 Psoriatic arthritis 63 Gout 56 Ankylosing spondylitis 42 Polymyalgia rheumatica 47 Total 21,865 Volume of Visits of Patients With Rare Disorders in 215 Diagnosis Volume Giant cell arteritis 41 Common variable immunodeficiency 155 Sarcoidosis 142 Familial Mediterranean fever 111 Takayasu disease 83 Behcet syndrome 7 Cerebral arteritis 16 Hypermobility syndrome 16 Mononeuritis multiplex 16 Ehlers-Danlos syndrome 12 Inclusion body myositis 12 Erythema nodosum 5 Total 148 ªExcludes Cleveland Clinic family health centers Volume of New Granulomatosis With Polyangiitis (Wegener s) Patient Visits Number of Patients N = Orthopaedic & Rheumatologic Institute 47

50 Rheumatology Overview Volume of Medication Infusions Cleveland Clinic Main Campus Outpatient Medication Intravenous immunoglobulin (Gammagard ) Infliximab (Remicade ) Rituximab (Rituxan ) Abatacept (Orencia ) Zoledronic acid (Reclast ) Tocilizumab (Actemra ) Belimumab (Benlysta ) Pegloticase (Krystexxa ) Cyclophosphamide (Cytoxan ) Methylprednisolone (Solu-Medrol ) Ibandronate (Boniva ) Volume of New Psoriatic Arthritis Patient Visits Number of Patients N = Outcomes 215

51 Rheumatoid Arthritis Percentage of Rheumatoid Arthritis Patients Taking Disease-Modifying Antirheumatic Drug Therapy (N = 19,197) Percentage of Newly Diagnosed Patients With Rheumatoid Arthritis Starting Biologic DMARDs Who Had Tuberculosis Testing (N = 37) Percent Cleveland Clinic target N = Percent N = Cleveland Clinic target American College of Rheumatology guidelines recommend that rheumatoid arthritis patients be treated with diseasemodifying antirheumatic drug (DMARD) therapy. More than 99% of rheumatoid arthritis patients who were seen in the Department of Rheumatology at least 2 times during the years were treated with DMARD therapy. Reasons for not prescribing DMARD therapy for the small percentage of patients not on DMARDs included disease remission, refusal of treatment, and contraindications to DMARD therapy. In any given year, 92% to 95% of patients were on a DMARD. DMARDs = disease-modifying antirheumatic drugs The 212 Update of the 28 American College of Rheumatology (ACR) Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis 1 recommends tuberculosis (TB) screening before using biologic agents to identify latent TB infection (LTBI). The ACR recommends the tuberculin skin test or interferon-γ release assays as the initial test in all rheumatoid arthritis patients starting biologic agents, regardless of risk factors for LTBI. In 213, 91% (73 of 81), in 214, 93% (12 of 19), and in 215, 96% (112 of 117) of patients had TB testing. Reference 1. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, Moreland LW, O Dell J, Winthrop KL, Beukelman T, Bridges SL Jr, Chatham WW, Paulus HE, Suarez-Almazor M, Bombardier C, Dougados M, Khanna D, King CM, Leong AL, Matteson EL, Schousboe JT, Moynihan E, Kolba KS, Jain A, Volkmann ER, Agrawal H, Bae S, Mudano AS, Patkar NM, Saag KG. 212 update of the 28 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 212 May;64(5): Orthopaedic & Rheumatologic Institute 49

52 Rheumatoid Arthritis Percentage of Rheumatoid Arthritis Patients Treated With Methotrexate Who Were Prescribed Folic Acid (N = 5644) Infusion Reactions in Patients Treated With Biologic and Nonbiologic Therapies in a Rheumatology Infusion Center Percent Cleveland Clinic target N = Percent (N = 2826) 214 (N = 2835) 215 (N = 334) Methotrexate is an effective and frequently used medication for the treatment of rheumatoid arthritis. Long-term therapy is usually required for effective treatment. Methotrexate side effects are a common reason for discontinuation. A Cochrane Review 1 of 6 randomized controlled trials demonstrated that concomitant use of folic acid reduced gastrointestinal toxicity, abnormal transaminase elevation, and patient withdrawal symptoms from methotrexate with no reduction in efficacy. Use of folic acid should be considered in all patients with rheumatoid arthritis. More than 85% of patients were prescribed folic acid; a chart review of a subset of patients who did not receive a folic acid prescription showed frequent use of over the counter folic acid preparations. Reference 1. Shea B, Swinden MV, Tanjong Ghogomu E, Ortiz Z, Katchamart W, Rader T, Bombardier C, Wells GA, Tugwell P. Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis. Cochrane Database Syst Rev. 213 May 31;5:CD Mild Moderate Severe The Rheumatology Infusion Center administered 2826 infusions in 213, 2835 infusions in 214, and 334 infusions in 215 (main campus only). Both biologic and nonbiologic medications were used to treat a large number of rheumatic diseases. Infusion reactions can be serious complications and require established protocols to guarantee appropriate premedication, infusion rates, and treatment for drug reactions to ensure patient safety. In 213, reactions occurred in 48 of 2826 infusions (1.7%), and were mild in 19, moderate in 28, and severe in 1 infusion. In 214, reactions occurred in 5 of 2835 infusions (1.8%), and were mild in 5, moderate in 43, and severe in 2 infusions. In 215, reactions occurred in 36 of 334 infusions (1.2%), and were mild in 1, moderate in 29, and severe in 6 infusions. Only 7 patients were not able to complete the infusions (.23%) in 213, 214, and Outcomes 215

53 Biomarkers of Nitric Oxide and Endothelial Dysfunction in Patients With Rheumatoid Arthritis µmol/l.8.7 Control (N = 244) Rheumatoid arthritis (N = 119) (ADMA + SDMA)/MMA Arg-MI (P <.1) Control (N = 244) Rheumatoid arthritis (N = 119) ADMA (P <.1) SDMA (P <.1) ADMA = asymmetric dimethylarginine, Arg-MI = arginine methylation index, MMA = N-monomethylarginine, SDMA = symmetric dimethylarginine Cardiovascular (CV) diseases are the major contributor to increased morbidity and mortality observed in patients with rheumatoid arthritis (RA). Traditional CV risk factors do not completely explain the elevated CV risks in RA patients. Specific biomarkers of nitrative stress that impair nitric oxide production have been recently shown to be associated with increased CV risks. These biomarkers include asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA), and N-monomethylarginine (MMA). Plasma levels of these L-arginine analogues were measured by mass spectrometry in 119 RA patients and 244 controls. Elevated levels were found of ADMA, SDMA, and arginine methylation index [arg-mi, the ratio of (ADMA + SDMA)/MMA] in RA patients (P <.1). Statin and disease-modifying antirheumatic drug therapy did not alter the levels of these biomarkers in the plasma. Orthopaedic & Rheumatologic Institute 51

54 Psoriatic Arthritis 52 Percentage of Psoriatic Arthritis Patients Taking Disease- Modifying Antirheumatic Drug Therapy (N = 2537) Percent Cleveland Clinic target N = American College of Rheumatology guidelines recommend that psoriatic arthritis patients be treated with diseasemodifying antirheumatic drug (DMARD) therapy. More than 99% of psoriatic arthritis patients who were seen in the Department of Rheumatology at least 2 times during the years were treated with DMARD therapy. Reasons for not prescribing DMARD therapy for the small percentage of patients not on DMARDs included disease remission, refusal of treatment, and contraindications to DMARD therapy. In any given year, between 88% and 93% of patients were on a DMARD. Treatment Patterns in Psoriatic and Rheumatoid Arthritis: Use of Biologic DMARDs Percent Biologic Only Nonbiologic Only Both DMARDs = disease-modifying antirheumatic drugs Rheumatoid arthritis (N = 22,634) Psoriatic arthritis (N = 2985) Neither A comparison was made of DMARD treatment patterns for rheumatoid arthritis (RA) and psoriatic arthritis (PsA). Nonbiologic DMARDs are oral agents (methotrexate, leflunomide, azathioprine, sulfasalazine), while biologic DMARDs are subcutaneous or intravenous medications and are monoclonal antibodies targeting inflammatory cytokines or cells (tumor necrosis factors, IL-1, B-cell). A majority of RA and PsA patients received DMARD therapy in any given year (93% RA; 91% PsA). More patients with PsA received biologic plus nonbiologic DMARD combination therapy (2% RA; 29% PsA). Treatment patterns differed with nonbiologic DMARD monotherapy used in 68% of RA patients vs 37% of PsA patients. RA patients rarely (5%) received biologic DMARD monotherapy, which was provided to 25% of PsA patients. These outcomes represent DMARD therapy utilization in patients with RA and PsA seen at an academic health center, but may not be representative of general treatment patterns across the US because of clinical factors resulting in selection bias. These outcomes may provide valuable data on practice patterns that may inform clinical trials, decision-making in biologic choice, and differences in response to agents commonly used in RA and PsA treatment. Outcomes 215

55 Percentage of Newly Diagnosed Patients With Psoriatic Arthritis Starting Biologic DMARDs Who Had Tuberculosis Testing (N = 57) Percent Cleveland Clinic target Patients With Tuberculosis Testing DMARDs = disease-modifying antirheumatic drugs The 212 Update of the 28 American College of Rheumatology (ACR) Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents 1 recommends tuberculosis (TB) screening before using biologic agents to identify latent TB infection (LTBI). The ACR recommends the tuberculin skin test or interferon-γ release assays as the initial test in all patients starting biologic agents, regardless of risk factors for LTBI. One hundred percent (57 of 57) of newly diagnosed psoriatic arthritis patients in 213 and 214 had TB testing. In 215, 97% (3 of 31) of patients had TB testing. Reference 1. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, Moreland LW, O Dell J, Winthrop KL, Beukelman T, Bridges SL Jr, Chatham WW, Paulus HE, Suarez-Almazor M, Bombardier C, Dougados M, Khanna D, King CM, Leong AL, Matteson EL, Schousboe JT, Moynihan E, Kolba KS, Jain A, Volkmann ER, Agrawal H, Bae S, Mudano AS, Patkar NM, Saag KG. 212 update of the 28 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 212 May;64(5): Percentage of Psoriatic Arthritis Patients Treated With Methotrexate Who Were Prescribed Folic Acid (N = 776) Percent Cleveland Clinic target N = Methotrexate is an effective and frequently used medication for the treatment of psoriatic arthritis. Long-term therapy is usually required for effective treatment. Methotrexate side effects are a common reason for discontinuation. A Cochrane Review 1 of 6 randomized controlled trials in rheumatoid arthritis demonstrated that concomitant use of folic acid reduced gastrointestinal toxicity, abnormal transaminase elevation, and patient withdrawal symptoms from methotrexate with no reduction in efficacy. This recommendation is likely to apply to methotrexate use in other conditions such as psoriatic arthritis. In 215, more than 87% of patients with psoriatic arthritis were prescribed folic acid; a chart review of a subset of patients who did not receive a folic acid prescription showed frequent use of over the counter preparations. Reference 1. Shea B, Swinden MV, Tanjong Ghogomu E, Ortiz Z, Katchamart W, Rader T, Bombardier C, Wells GA, Tugwell P. Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis. Cochrane Database Syst Rev. 213 May 31;5:CD951. Orthopaedic & Rheumatologic Institute 53

56 Progressive Systemic Sclerosis Percentage of Patients With Progressive Systemic Sclerosis Who Obtained Pulmonary Function Testing and Echocardiograms (N = 98) Pulmonary Function Testing (%) Cleveland Clinic target The American College of Rheumatology provided guidelines for detection of pulmonary hypertension (PH) in connective tissue diseases, including progressive systemic sclerosis (PSS). 1 The key recommendation stated that all patients with PSS should be screened for PH with pulmonary function tests (PFTs), including single-breath diffusing capacity for carbon monoxide; transthoracic echocardiogram (echo); and measurement of N-terminal protein natriuretic peptide (NTproBNP), performed annually. The percentage N = of patients who had PFTs and echos in the year of the clinic visit plus the previous year ranged from 54% to 68% between 211 and 215. Echocardiogram (%) Cleveland Clinic target A chart review of 2 patients who did not obtain a PFT every year (5 PFTs, years ) showed that 1 patient had morphea, 1 patient had PFTs performed outside Cleveland Clinic, 16 patients had 1 to 4 PFTs, and only 2 of 2 patients (1%) had no PFTs performed. A chart review of 2 patients who did not obtain an echo every year (5 echos, years ) showed that 18 patients had 1 to 4 echos, 1 patient had a diagnosis N = of systemic lupus erythematosus not PSS, and only 1 of 2 patients (5%) had no echo. The great majority of patients had a PFT or echo performed during the 5-year period, although yearly tests were achieved in around 5% of patients. Reference 1. Khanna D, Gladue H, Channick R, Chung L, Distler O, Furst DE, Hachulla E, Humbert M, Langleben D, Mathai SC, Saggar R, Visovatti S, Altorok N, Townsend W, FitzGerald J, McLaughlin VV; Scleroderma Foundation and Pulmonary Hypertension Association. Recommendations for screening and detection of connective tissue disease-associated pulmonary arterial hypertension. Arthritis Rheum. 213 Dec;65(12): Outcomes 215

57 Percentage of Scleroderma Patients With Gastroesophageal Reflux Disease Treated With Antisecretory Medications (N = 364) Percent Antisecretory Agent Cleveland Clinic target The American Gastroenterological Association Institute Medical Position Panel 1 recommends antisecretory drugs for the treatment of patients with gastroesophageal reflux disease syndromes (GERD), based on their ability to heal esophagitis and provide symptomatic relief. In these uses, proton pump inhibitors are more effective than histamine 2 receptor antagonists, which are more effective than placebo. This recommendation is graded A, strongly recommended based on good evidence that it improves important health outcomes. During 214 and 215, 93.4% of patients with progressive systemic sclerosis and GERD were on antisecretory medications. Reference 1. Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 28 Oct;135(4): Mycophenolate and the Frequency of Endoscopic Therapy for Gastric Antral Vascular Ectasia in Patients With Progressive Systemic Sclerosis (N = 48) Procedure Rate per Year (Therapeutic Endoscopies) N = No Immunosuppressive Therapy 19 Immunosuppressive Therapy (P =.9) 29 Mycophenolate Therapy (P =.13) 14 Gastric antral vascular ectasia (GAVE) is often a cause of upper gastrointestinal bleeding in patients with progressive systemic sclerosis (PSS). Bleeding often requires therapeutic endoscopic intervention. The role of immunosuppressive therapy in the treatment of GAVE has not been established. During the past 1 years, 48 patients with GAVE and PSS were identified. The rate per year of endoscopic intervention for the 29 patients treated with immunosuppressive therapies was compared with the 19 never treated. The rate of endoscopies per year was 1.37 for untreated patients (112.8 person years),.51 for those on immunosuppressive agents (P =.9; 51.2 person years), and.25 for patients treated with mycophenolate (MP) (P =.13). In patients with frequent therapeutic endoscopies, MP may reduce the need for endoscopic procedures. Orthopaedic & Rheumatologic Institute 55

58 Progressive Systemic Sclerosis Pulmonary Arterial Hypertension in Patients With Anti-PM-Scl Antibody (N = 42) Interstitial Lung Disease in Patients With Anti-PM-Scl Antibody (N = 42) Percent Number of Patients Prevalence PAH PAH cohort PAH with ILD PAH no ILD SSc (historical) SSc Cohorts N = ILD 23 NSIP Fibrotic 13 NSIP Cellular 6 Organizing Pneumonia 2 UIP 1 Bronchiolitis 1 ILD = interstitial lung disease, PAH = pulmonary arterial hypertension, SSc = systemic sclerosis Patients with anti-pm-scl antibody (PM-Scl) can present with several phenotypes, including polymyositis, dermatomyositis, systemic sclerosis (SSc), scleromyositis, or sclera-dermatomyositis. Pulmonary arterial hypertension (PAH) occurs in progressive systemic sclerosis (PSS), but the incidence in patients with PM-Scl has not been rigorously examined. All patients with PAH were diagnosed by right heart catheterization (RHC). Forty-two patients with PM-Scl were reviewed. Five patients (11.9%) had RHCconfirmed PAH: 3 (7.1%) with interstitial lung disease (ILD) and 2 (4.8%) without ILD. The prevalence of PAH in SSc from published cohorts 1 is 6.3% (range,.6% to 8.6%). The prevalence of PAH in nondisease controls is <.1%. Reference 1. Koschik RW 2nd, Fertig N, Lucas MR, Domsic RT, Medsger TA Jr. Anti-PM-Scl antibody in patients with systemic sclerosis. Clin Exp Rheumatol. 212 Mar-Apr;3(2 Suppl 71):S ILD = interstitial lung disease, NSIP = nonspecific interstitial pneumonia, UIP = usual interstitial pneumonia All patients had high resolution computed tomography scans (HRCT). Nonspecific interstitial pneumonia was the most common HRCT-based subtype of interstitial lung disease. CT Score Total CT Score (P =.14) CT = computed tomography Inflammation Score (P =.4) Initial Follow-Up Fibrosis Score (P =.63) All patients received immunosuppressive therapy. At a mean of 36 months there was no change in total computed tomography score, although there was a trend for progression of the fibrosis score (P =.63). 56 Outcomes 215

59 Gout Percentage of Gout Patients Treated With Urate-Lowering Therapy Who Reached Target Uric Acid Level (N = 226) Patients (%) mg/dl mg/dl Uric Acid Level > 7. mg/dl % 12.% 12.9% % 13.% 13.9% Patients in this cohort had a diagnosis of gout, had at least 2 visits with a Cleveland Clinic rheumatologist, and were prescribed a uric acid-lowering agent (allopurinol or febuxostat). The recommended target uric acid level was 6. mg/dl. Between 73.1% and 75.1% of patients had a uric acid level of 6. mg/dl between 21 and 215, demonstrating successful treatment to reach the target level. Additionally, 12.% to 13.% of patients had a uric acid level between 6.1 mg/dl and 7. mg/dl, demonstrating acceptable levels. Between 12.9% and 13.9% of patients did not achieve target levels, with uric acid levels > 7. mg/dl. The percentage of patients who achieved target plus acceptable uric acid levels remains relatively stable, with no improvement in the percentage meeting target levels ( vs ). Substantial numbers of patients do not achieve target uric acid levels and are undertreated with urate-lowering therapy. Defined systems approaches will be needed to improve treatment in gout patients. Orthopaedic & Rheumatologic Institute 57

60 Gout Percentage of Tophaceous Gout Patients Treated With Urate-Lowering Therapy Who Reached Target Uric Acid Level (N = 152) Patients (%) mg/dl mg/dl > 7. mg/dl Uric Acid Level % 8.2% 12.2% % 9.2% 1.5% Patients in this cohort had a diagnosis of tophaceous gout, had at least 2 visits with a Cleveland Clinic rheumatologist, and were prescribed a uric acidlowering agent (allopurinol or febuxostat). The recommended target uric acid level was 6. mg/dl. Between 79.6% and 8.3% of patients had a uric acid level of 6. mg/dl between 21 and 215, demonstrating successful treatment to reach the target level. Additionally, 8.2% to 9.2% of patients had a uric acid level between 6.1 mg/dl and 7. mg/dl, demonstrating acceptable levels. Between 1.5% and 12.2% of patients did not achieve target levels, with uric acid levels > 7. mg/dl. The percentage of patients who achieved target plus acceptable uric acid levels remains relatively stable, with no improvement in the percentage meeting target levels ( vs ). The percentage of patients with tophaceous gout who reached uric acid levels < 6. mg/dl was somewhat greater than for the entire gout cohort; however, substantial numbers of patients are undertreated with urate-lowering therapy. 58 Outcomes 215

61 Uric Acid Levels After Pegloticase Infusions in Gout Patients (N = 181) Number of Infusions by Year Infusions sua Checked sua < 6. mg/dl sua = serum uric acid Pegloticase (Krystexxa ) is a pegylated uricase indicated for the treatment of chronic gout in adult patients resistant to conventional therapy. It is given as an IV infusion every 2 weeks. Anaphylaxis and immune reactions can occur and are based on formation of antibodies. The antibodies result in a loss of effect of the drug, which has been shown to precede the reactions in 91% of cases. Typically, uric acid levels fall below 1 mg/dl; with loss of effect, uric acid levels are higher. This has led to the recommendation that a uric acid level be checked before each infusion. Treatment should be discontinued if uric acid rises to 6. mg/dl or greater on 2 consecutive tests. In 213, 34 pegloticase infusions were performed in 5 patients; serum uric acid was checked prior to infusion in all cases and was < 6. mg/dl in all tests. No infusion reactions occurred. In 214, 7 pegloticase infusions were performed in 7 patients; 68 had their serum uric acid level checked, and 66 were < 6. mg/dl. In the 2 with uric acid levels > 6. mg/dl, pegloticase was discontinued. In 215, 77 pegloticase infusions were performed in 9 patients; serum uric acid was checked prior to infusion in all patients, and 76 were < 6. mg/dl. In the 1 test with uric acid level > 6. mg/dl, pegloticase was discontinued. Number of Gout Patients Treated With Pegloticase Who Had G6PD Testing (N = 21) Patients (%) G6PD = glucose-6-phosphate dehydrogenase Glucose-6-phosphate dehydrogenase (G6PD) levels should be checked prior to pegloticase infusion because of the risk for hemolysis in G6PD-deficient patients; 1% of patients in 213, 214, and 215 had G6PD testing. Orthopaedic & Rheumatologic Institute 59

62 Osteoarthritis Differences in Quality of Life After Bariatric Surgery Compared With Nonsurgical Weight Loss in Osteoarthritis Patients (N = 67) SF-36 Score a Year 1 Year P = Physical Functioning.4.11 General Health.1.34 Physical Health Summary Energy/Fatigue <.1.28 SF-36 = Short Form Health Survey a Range, 1, = maximum disability, 1 = no disability Obesity is a strong, but potentially modifiable, risk factor for development and progression of knee osteoarthritis (OA). The benefits of massive weight loss, as seen after bariatric surgery, have not been well studied in the OA population. The study objective was to examine whether massive weight loss in obese patients following bariatric surgery is associated with improved OA symptoms as measured through quality of life (QOL), compared with medical management alone. A total of 15 Cleveland Clinic patients who were included in the Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial (27 211) were screened for clinical and radiographic evidence of OA. The STAMPEDE trial examined the effects of bariatric surgery vs medical management alone in obese patients with diabetes. The patients were randomized into 1 of 3 groups: 5 received sleeve gastrectomy; 5 received Roux-en-Y gastric bypass (1 patients in the surgical arm); and 5 patients were managed medically. QOL scores were collected at baseline and at 12, 24, and 36 months following intervention. OA was defined by physician diagnosis and/or radiographic evidence of OA (joint space narrowing and osteophytes) of the hip, knee, ankle, or foot. The change in 12- and 36-month postintervention Short Form Health Survey (SF-36) scores between the surgical group and the medically managed group were compared. Sixty-seven patients defined the OA cohort and had baseline and follow-up data available for review; 49 patients were in the surgical group, and 18 patients were in the medical group. There was a statistically significant difference in body mass index (BMI) change, at 12 months postintervention, between the bariatric surgery patients and the medically managed (BMI, 9.12 and 2.24, respectively). In the graph above, each pair of bars represents the difference in SF-36 score improvement between surgical weight loss and nonsurgical weight loss patients at 1 year and 3 years. There was a significantly greater improvement in the surgical group compared with the medical group in SF-36 domains of physical functioning, general health, overall physical health, and energy/fatigue scores. At 3 years postintervention, although improvements were preserved, only the general health category sustained statistical significance. 6 Outcomes 215

63 Reversible Cerebral Vasoconstriction Syndrome Plasma Endothelin-1 Levels in Reversible Cerebral Vasoconstriction Syndrome (N = 7) E-1 Level (pg/ml) Ictal Resolution Healthy matched controls All Patients E-1 = endothelin-1 Ictal vs Radiographic Resolution Resolution vs Healthy Matched Controls Reversible cerebral vasoconstriction syndrome (RCVS) comprises a group of diverse conditions characterized by reversible multifocal narrowing of the cerebral arteries with no evidence of vasculitic brain pathology. RCVS is associated at presentation with acute-onset, severe, recurrent headaches, often termed thunderclap. Endothelin-1 (E-1) is a potent vasoconstrictor that was found to be increased during the acute (ictal) phase of RCVS vs healthy matched controls. Fourteen paired blood samples from 7 patients were drawn during the ictal and resolution phase. E-1 levels were significantly higher in the ictal phase than in the resolution phase (2.63 vs pg/ml, P =.37). For patients whose radiographs showed complete resolution of vasospasm (N = 4), the difference in E-1 levels was greater (2.317 vs pg/ml, P =.4). E-1 levels in the resolution phase in RCVS patients were not different (1.522 vs pg/ml, P =.312) from those of sex- and age-matched controls. These results suggest a major role for E-1 in the pathogenesis of RCVS. Orthopaedic & Rheumatologic Institute 61

64 Osteoporosis Percentage of Osteoporosis Patients Started on Denosumab Who Received Continued Therapy at Specified Intervals Patients (%) months ± 3 days 6 months ± 6 days 6 months ± 9 days 2 N = Second Dose 966 Third Dose 687 Fourth Dose 468 Fifth Dose 31 Sixth Dose 189 Denosumab (Prolia ) is an injectable medication for patients with low bone mass who are at high risk for fracture. Once treatment is started, current guidelines recommend treatment at 6-month intervals; 15% of patients never received a second dose of medication. For those who continued denosumab at each dosing interval, compliance within the 3-, 6-, and 9-day intervals increased over time, rising from 7% within a 3-day window with the second dose to 79.9% at the sixth dose. Systematic methods to monitor drug dosing at recommended intervals are needed to improve compliance with established guidelines. Percentage of Osteoporosis Patients Started on Denosumab Who Received a Second Dose of Denosumab at Specified Intervals (N = 966) Adherence to an oral bisphosphonate regimen is Patients (%) poor, with < 5% of patients on therapy at 1 year. Adherence to an injectable medication regimen is a 1 6 months ± 3 days function of patient acceptance and systems measures 8 6 months ± 6 days in clinical practice to ensure patient scheduling. Of 6 months ± 9 days patients receiving their first dose of denosumab, 824 (85.3%) received a second dose of medication. 4 Dosing interval for denosumab is every 6 months 2 (18 days), and delays may reduce efficacy; 7.4% of patients received their second dose within 21 days, 79.6% within 24 days, and 85.3% within Second Dose 27 days. Of patients not receiving a second dose of denosumab, approximately 2% received another osteoporosis medication. 62 Outcomes 215

65 Percentage of Patients Treated With Denosumab Who Had Vitamin D and Calcium Testing Prior to Treatment (N = 4232) Patients (%) Days Prior to Infusion Serum calcium Vitamin D Denosumab has been associated with hypocalcemia, which is more common in patients with preinjection hypocalcemia and vitamin D deficiency. A serum calcium and vitamin D test is suggested within the preceding year to reduce the risk of hypocalcemia: 79.8% and 9.9% of patients had serum calcium testing in the preceding 18 and 365 days, respectively, while 73.8% and 88.1% of patients had vitamin D testing in the preceding 18 and 365 days, respectively. Percentage of Osteoporosis Patients Started on Zoledronic Acid Who Received Continued Therapy at Specified Intervals Patients (%) year ± 3 days 1 year ± 6 days 1 year ± 9 days 2 N = Second Dose 1138 Third Dose 556 Fourth Dose 146 Zoledronic acid (Reclast ) is a medication for patients with low bone mass who are at high risk for fracture. Once treatment is started, current guidelines recommend treatment at 1-year intervals. Delays in treatment may result in loss of effect. After initiation of therapy with zoledronic acid, a second dose was administered to 58.3% of patients at 1 year ± 3 days, to 7.8% within 1 year ± 6 days, and to 76.9% within 1 year ± 9 days. Of those who received a second dose, a third dose was administered to 79.1% of patients within 1 year ± 9 days. Of those who received a third dose, a fourth dose was administered to 79.7% of patients within 1 year ± 9 days. Systematic methods to monitor drug dosing at recommended intervals are needed to improve compliance with established guidelines. Orthopaedic & Rheumatologic Institute 63

66 Osteoporosis Percentage of Osteoporosis Patients Started on Zoledronic Acid Who Received a Second Dose at Specified Intervals (N = 1426) Patients (%) Second Dose 1 year ± 3 days 1 year ± 6 days 1 year ± 9 days Adherence to oral bisphosphonate medication is poor, with < 5% of patients on therapy at 1 year. Adherence with an infusible medication is a function of patient acceptance and systems measures in practice to ensure patient scheduling. Of 1426 patients receiving their first dose of zoledronic acid, 76.9% received a second dose of medication at 1 year ± 9 days. Of the patients not receiving a second dose of zoledronic acid, approximately 25% were changed to another osteoporosis medication. Percentage of Patients Treated With Zoledronic Acid Who Had Renal Function Testing Prior to Infusion (N = 5199) Patients (%) Days Prior to Infusion Zoledronic acid infusion for osteoporosis is not recommended for patients with a glomerular filtration rate 35 ml/min. During the period , 96.3% of patients had renal function testing with a creatinine level and estimated glomerular filtration rate within 365 days prior to infusion. A chart survey of 2 patients who did not have an estimated glomerular filtration rate in the electronic medical record revealed that all 2 had labs done outside Cleveland Clinic, which were documented in the chart prior to zoledronic acid infusion. 64 Outcomes 215

67 Percentage of Patients Treated With Zoledronic Acid Who Had Vitamin D Testing Prior to Infusion (N = 5169) Patients (%) Days Prior to Infusion Zoledronic acid infusion for osteoporosis may be associated with hypocalcemia after infusion. Patients with hypovitaminosis D are at high risk for hypocalcemia. Obtaining a vitamin D level is considered standard of care for patients prior to infusion. More than 91% of patients undergoing infusion had a vitamin D level measured within 365 days before infusion. Percentage of Patients on Glucocorticoids Treated With Osteoporosis Medications (N = 331) Patients (%) FRAX < 1% FRAX 1% 2% FRAX > 2% Days After DXA DXA = dual energy x-ray absorptiometry, FRAX = World Health Organization Fracture Risk Assessment Tool American College of Rheumatology guidelines for glucocorticoid-induced osteoporosis (GIO) recommend treatment based on duration and dose of steroid therapy and absolute fracture risk for major osteoporotic fractures using the FRAX tool (World Health Organization Fracture Risk Assessment Tool). Treatment is recommended for most patients with a 1-year absolute fracture risk of major osteoporotic fractures 1%. National Osteoporosis Foundation guidelines in the US recommend treatment if the FRAX 1-year risk is 2%. Patients on glucocorticoids for > 9 days were examined by absolute fracture risk categories for major osteoporotic fractures. In patients with a 1-year risk for fracture 2%, 57.7%, 64.5%, and 7% were on therapy for GIO at 9, 18, and 365 days, respectively. Orthopaedic & Rheumatologic Institute 65

68 Osteoporosis Percentage of Patients With Low Bone Mass (T-Score 2.5) and High Fracture Risk by FRAX Who Were Treated With Osteoporosis Medications Patients (%) (N = 317) (N = 424) (N = 436) (N = 55) Days After DXA DXA = dual energy x-ray absorptiometry, FRAX = World Health Organization Fracture Risk Assessment Tool Current guidelines recommend treatment of patients with low bone mass, with a T-score 2.5 at the hip or lumbar spine, or patients who have a 1-year absolute fracture risk as calculated by FRAX of 2% for major osteoporotic fracture or 3% for hip fracture. Patients were reviewed who were not on treatment at the time of a bone density scan and had low bone mass or high fracture risk, who were then placed on therapy for osteoporosis with medications (bisphosphonates, denosumab, raloxifene, and teriparatide). For the period , more than 8% of patients were placed on medication within 9 days, with small increases in treatment after that time up to 365 days. For the periods , , , and , treatment rates have trended higher. Cleveland Clinic s dual energy x-ray absorptiometry (DXA) registry enrolled its first patient in 29. The ability to combine bone density registry data with the World Health Organization s FRAX 1-year absolute fracture risk, osteoporosis medications, and glucocorticoid use has created a powerful tool for quality improvement and outcomes. A collaboration with the University of Alabama will combine DXA registries and allow linkage of patients with Medicare claims data. Enrollment in Cleveland Clinic s DXA registry through 215 totals more than 62, patients. 66 Outcomes 215

69 Transplant Percentage of Cardiac Transplant Patients Who Had a DXA Scan Percent N = DXA = dual energy x-ray absorptiometry Cleveland Clinic target Glucocorticoid use is associated with bone loss and fractures. The 21 American College of Rheumatology guidelines on glucocorticoidinduced osteoporosis recommend a DXA scan for patients on glucocorticoid therapy for 3 months or more. Cardiac transplant recipients receive glucocorticoids for more than 3 months after surgery to prevent organ rejection. Fewer than 15% of transplant patients had DXA scans before or within 6 months after transplant in 21. Collaboration between the Transplant and Osteoporosis centers since 21 has significantly improved the frequency of DXA scans in cardiac transplant patients before or within 6 months after transplant surgery. Between 84% and 96% of cardiac transplant patients since 21 have had bone evaluation with DXA scan. Percentage of Lung Transplant Patients Who Had a DXA Scan Percent N = Cleveland Clinic target Lung transplant recipients receive glucocorticoids for more than 3 months after surgery to prevent organ rejection. Collaboration between the Transplant and Osteoporosis centers since 21 has resulted in a continued high frequency of DXA scans in lung transplant patients before or within 6 months after transplant surgery. Between 92% and 96% of lung transplant patients since 21 have had bone evaluation with DXA scan. DXA = dual energy x-ray absorptiometry Orthopaedic & Rheumatologic Institute 67

70 Immunodeficiency Percentage of CVID Patients Who Meet Diagnostic, Evaluation, and Treatment Guidelines Patients (%) (N = 5) 213 (N = 26) 215 (N = 83) Cleveland Clinic target Low IgG and Low IgA or IgM B-Cell Subset Vaccination Testing PFT or CT LFT and Creatinine Immunoglobulin Treatment Trough IgG > 5 mg/dl CT = computed tomography, CVID = common variable immunodeficiency, IgA = immunoglobulin A, IgG = immunoglobulin G, IgM = immunoglobulin M, LFT = liver function tests, PFT = pulmonary function testing The diagnosis of common variable immunodeficiency (CVID) requires low levels of IgG, low IgA or IgM, and poor response to vaccines. Replacement immunoglobulin therapy is recommended regardless of infectious history, and expert consensus suggests that trough levels be > 5 mg/dl to prevent infections. Pulmonary function testing (PFT) or a computed tomography (CT) scan of the chest, liver function tests (LFT), and creatinine levels are recommended as yearly follow-up testing. B-cell subsets are recommended at the time of diagnosis because of their value in predicting the clinical course. These current guidelines are based on expert panel recommendations formulated through the Immune Deficiency Foundation as well as published recommendations of experts in the field. 68 Outcomes 215

71 Infection Percentage of Patients With HIV/AIDS Who Obtained Lab Tests per Recommended Guidelines (N = 85) Patients (%) Cleveland Clinic target Rapid Plasma Reagin Yearly Hepatitis B/C Screen at Baseline Patients with HIV/AIDS should have a rapid plasma reagin for syphilis yearly and screening for hepatitis B and C at the baseline visit. All patients had hepatitis screening at baseline, and 85% to 1% had screening for syphilis during These outcomes are based on guidelines prepared by the National Committee for Quality Assurance, HIV Medicine Association, Infectious Diseases Society of America, and HIV/AIDS Workgroup, and are the standard of care for HIV patients. Percentage of Patients With HIV/AIDS Who Obtained Lab Tests per Recommended Guidelines (N = 85) Patients (%) Viral Load < 4 Copies/mL Viral Load < 4 Copies/mL All Tests Tuberculosis Testing Cleveland Clinic target Patients with HIV/AIDS should have testing for tuberculosis at the baseline visit; 74% of patients in the cohort had tuberculosis testing in 213, 88% in 214, and 1% in 215. The goal of treatment is viral suppression to a level < 4 copies/ml: 94% of patients had a documented viral load < 4 copies/ ml in 213, 99% in 214, and 95% in 215; 68% of patients had a viral load < 4 copies/ml on every test in 213, 91% in 214, and 95% in 215. Tuberculosis testing and frequent measures of viral load have improved during These outcomes are based on guidelines prepared by the National Committee for Quality Assurance, HIV Medicine Association, Infectious Diseases Society of America, and HIV/AIDS Workgroup, and are the standard of care for HIV patients. Orthopaedic & Rheumatologic Institute 69

72 Infection Herpes Zoster and the Risk for Ischemic Stroke in Patients With Autoimmune Disease (N = 5,929) Rate per 1 Patient Years Incidence Rate Ratio months 24 6 months Incidence Rate/Ischemic Stroke Months vs Months 1 Month vs 24 6 Months Herpes zoster (HZ) is an opportunistic infection caused by the varicella-zoster virus. It often occurs in patients on immunosuppressive therapies. The risk of stroke has been reported to increase after HZ infection, but little is known about risk in patients with autoimmune diseases. Patients were identified from Medicare data (26 212) who had a hospital discharge with diagnosis code for HZ or who received a drug for HZ as an outpatient. Patients also had to have a diagnosis of ankylosing spondylitis, inflammatory bowel disease, psoriasis or psoriatic arthritis, or rheumatoid arthritis. The outcome of interest was hospitalization for ischemic stroke (HIS); 5,929 patients were identified. The crude incidence rate for HIS was 9.8/1 patient years (PY) within 6 months vs 8.7/1 PY in years 2 6. The incidence rate ratio for HIS was 1.3 in the first 6 months vs months, and 1.5 in the first month vs 24 6 months. Patients with autoimmune diseases who have incident HZ have a 5% increase in stroke risk in the first month after infection. 7 Outcomes 215

73 Infection Rate in HIV Patients Who Received TNF-α Inhibitor Therapy for Autoimmune Disease (N = 23) Incidence per 1 Patient Years Overall VL > 5 Copies/mL VL 5 Copies/mL TNF-α = tumor necrosis factor-alpha, VL = viral load Few HIV-infected patients have been treated with tumor necrosis factor (TNF-α) inhibitor therapy for autoimmune diseases refractory to conventional therapies. Serious infection episodes (SIE) were evaluated in 23 HIV patients (26 treatment episodes) from Cleveland Clinic and 3 other centers (Brigham and Women s Hospital, Johns Hopkins Hospital, and University of Miami Hospital) treated with TNF agents (etanercept = 16, adalimumab = 6, and infliximab = 4). Subsets of patients were examined based on CD4 cell counts and viral load. Individuals provided 86.7 patient years of follow-up. Two patients (8.7%) had SIE, which resulted in an incidence rate of 2.3 per 1 patient years (95% confidence interval [CI], ). CD4+ cell counts were 29 and 84, respectively, at the time of the SIE. The incidence rate was 3.28 (95% CI, ) for patients with viral loads > 5 copies/ml and 2.8 (95% CI, ) for patients with viral load 5 copies/ml, suggesting that patients with higher viral loads are at increased risk for infection. This study suggests that TNF-α therapy in patients with HIV may have reasonable rates of SIE in the range of those observed in registry databases of HIV patients. Orthopaedic & Rheumatologic Institute 71

74 Pericarditis Azathioprine Use in Patients With Idiopathic Recurrent Pericarditis (N = 13) Prednisone Dose (mg) Number of Flares 25 2 Before azathioprine After azathioprine Before azathioprine After azathioprine Prednisone Dose (Mean) (P <.3 for Difference) Flares in 6 Months (P =.1 for Difference) Idiopathic recurrent pericarditis (IRP) recurs at a rate of 3% to 5% within 2 months of diagnosis and treatment, with 5% of patients on treatment for 5 years for continued symptoms. Standard treatment includes colchicine, nonsteroidal antiinflammatory medications, and glucocorticoids (GCs). Azathioprine (AZA) was evaluated as a steroid-sparing agent in 13 patients with IRP. The outcomes were the mean dose and cumulative dose of GCs in the 6 months before AZA initiation and the 6 months after. In addition, the number of flares was assessed in the 6 months before and after AZA initiation. Mean GC dose was 21 mg before and 13 mg after AZA initiation (P =.3), and cumulative dose was 44 mg in the 6 months before AZA initiation and 2229 mg in the 6 months after (P =.12). The number of flares averaged 3 in the 6 months before AZA initiation and.3 in the 6 months after (P =.1). Use of AZA resulted in a significant decrease in GC use, both mean dose and cumulative dose, and also reduced the number of flares of IRP. 72 Outcomes 215

75 Retroperitoneal Fibrosis Comparison of IgG4 and Non-IgG4 Related Retroperitoneal Fibrosis Syndrome (N = 33) Number of Patients N = IgG4+ 6 IgG4 = immunoglobulin G4 Non-IgG4 27 Retroperitoneal fibrosis is a rare disease characterized by progressive expansion of fibroinflammatory tissue in the periaortic region, resulting in abdominal pain, back pain, hydronephrosis, and renal failure. Between 28% and 58% of patients in previous series had biopsies with plasma cells that stain positive for IgG4. Only 17% of (6 of 33) patients at Cleveland Clinic were IgG4+. Percent IgG4+ Non-IgG4 P = Glucocorticoids.74 Initial Stent.3 Recurrent Stent 1. Ureterolysis.56 Imaging Improved Imaging Resolved IgG4 = immunoglobulin G4 There were no significant differences between IgG4+ and non-igg4 patients in treatment or outcomes for glucocorticoid use, rate of initial stent, need for recurrent stent, and ureterolysis surgeries. Improved or resolved imaging was also no different between the 2 groups. The change in creatinine levels was not different between the 2 groups: 1.2 mg/dl for non-igg4 patients vs.4 mg/dl for IgG4+ patients. Orthopaedic & Rheumatologic Institute 73

76 Fibromyalgia Benefits of a Multidisciplinary Educational Program for Patients With Fibromyalgia (N = 56) Score Before After PSEQ (P <.3) MHLC (P <.1) MHLC = Multidimensional Health Locus of Control (range, 18), PSEQ = Pain Related Self-Efficacy Questionnaire (range, 6) Fibromyalgia (FM) is a biopsychosocial disorder with a prevalence of 2% to 4% in the general population. Patients who met the 21 American College of Rheumatology criteria for FM were enrolled in a brief (3.5 hours) educational program that included discussion about clinical, pathophysiologic, and therapeutic aspects of FM. Components of the program included exercise instruction, orientation to the cognitive behavioral model of pain and stress (which uses problemfocused and action-oriented strategies to address behaviors that are based on prior conditioning and cannot be controlled through rational thought), information about psychosocial contributors to chronic pain, family education, and introduction to relaxation techniques. Patients completed the Pain Related Self-Efficacy Questionnaire (PSEQ) 1 and Multidimensional Health Locus of Control (MHLC) 2 scale before and immediately after the program. Of 77 patients meeting FM criteria, 56 agreed to fill out both questionnaires before and after the intervention. After the brief intervention, both PSEQ and MHLC were significantly improved, demonstrating that the program impacted patients confidence in their ability to manage FM and reduce external attributions to their disease. References 1. Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 27 Feb;11(2): Wallston KA, Stein MJ, Smith CA. Form C of the MHLC scales: a condition-specific measure of locus of control. J Pers Assess Dec;63(3): Outcomes 215

77 Effect of Narcotic Use in Patients With Fibromyalgia Cohort (N = 23) Percent 5 4 Narcotic use (N = 92) No narcotic use (N = 138) Employment College Fewer patients were employed who used narcotic medication (31.5% vs 48.6%), and they were less likely to have a college degree (23.4% vs 41.7%). Score Narcotic use (N = 92) No narcotic use (N = 138) FIQ PHQ-9 HAQ-DI FIQ = Fibromyalgia Impact Questionnaire, HAQ-DI = Health Assessment Questionnaire Disability Index, PHQ-9 = Patient Health Questionnaire The Fibromyalgia Impact Questionnaire (FIQ) assesses FM symptoms, including pain and fatigue. The Patient Health Questionnaire (PHQ-9) evaluates depression; scores 5 are suggestive of depression. The Health Assessment Questionnaire Disability Index (HAQ-DI) is a measure of functional status for common activities of daily living (scale, 3: = no difficulty, 3 = unable to do). Patients on narcotics have more pain and fatigue, depression, and a greater disability index. Health Care Utilization (Number per Patient) 14 Narcotic use (N = 92) 12 No narcotic use (N = 138) Medications Surgeries Physician Visits Narcotic use characterized a group of patients who had increased health needs, including number of medications used, surgeries, and number of physician visits in preceding 6 months. Orthopaedic & Rheumatologic Institute 75

78 Patient Experience Orthopaedic & Rheumatologic Institute Keeping patients at the center of all that we do is critical. Patients First is the guiding principle at Cleveland Clinic. Patients First is safe care, high-quality care, in the context of patient satisfaction, and high value. Ultimately, our caregivers have the power to impact every touch point of a patient s journey, including their clinical, physical, and emotional experience. We know that patient experience goes well beyond patient satisfaction surveys. Nonetheless, by sharing the survey results with our caregivers and the public, we constantly identify opportunities to improve how we deliver exceptional care. Outpatient Office Visit Survey Orthopaedic & Rheumatologic Institute CG-CAHPS Assessment a Percent Best Response (N = 1,253) 215 (N = 2,774) CG-CAHPS 214 database average (all practices) b 2 Appointment Access (% Always) c Doctor Communication (% Yes, Definitely) d Doctor Rating (% 9 or 1) 1 Scale Clerical Staff (% Yes, Definitely) d Test Results Communication (% Yes) e a In 213, Cleveland Clinic began administering the Clinician and Group Practice Consumer Assessment of Healthcare Providers and Systems surveys (CG-CAHPS), standardized instruments developed by the Agency for Healthcare Research and Quality (AHRQ) and supported by the Centers for Medicare & Medicaid Services for use in the physician office setting to measure patients perspectives of outpatient care. b Based on results submitted to the AHRQ CG-CAHPS database from 3962 practices in 214 c Response options: Always, Usually, Sometimes, Never d Response options: Yes, definitely; Yes, somewhat; No e Response options: Yes, No Source: Press Ganey, a national hospital survey vendor 76 Outcomes 215

79 Inpatient Survey Orthopaedic & Rheumatologic Institute HCAHPS Overall Assessment Best Response (%) Hospital Rating (% 9 or 1) 1 Scale Recommend Hospital (% Definitely Yes) b a Based on national survey results of discharged patients, January 214 December 214, from 4172 US hospitals. medicare.gov/hospitalcompare b Response options: Definitely yes, Probably yes, Probably no, Definitely no 214 (N = 63) 215 (N = 61) National average all patients a The Centers for Medicare & Medicaid Services requires United States hospitals that treat Medicare patients to participate in the national Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, a standardized tool that measures patients perspectives of hospital care. Results collected for public reporting are available at medicare.gov/ hospitalcompare. HCAHPS Domains of Care a Best Response (%) (N = 63) 215 (N = 631) National average all patients b Discharge Information % Yes Care Transition % Strongly Doctor Communication Nurse Communication Pain Management Room Clean % Always Agree New Medications Communication (Options: Always, Usually, Sometimes, Never) Responsiveness to Needs a Except for Room Clean and Quiet at Night, each bar represents a composite score based on responses to multiple survey questions. b Based on national survey results of discharged patients, January 214 December 214, from 4172 US hospitals. medicare.gov/hospitalcompare Source: Press Ganey, a national hospital survey vendor, 215 Quiet at Night Orthopaedic & Rheumatologic Institute 77

80 Cleveland Clinic Implementing Value-Based Care Overview Cleveland Clinic health system uses a systematic approach to performance improvement while simultaneously pursuing 3 goals: improving the patient experience of care (including quality and satisfaction), improving population health, and reducing the cost of healthcare. The following measures are examples of 215 focus areas in pursuit of this 3-part aim. Throughout this section, Cleveland Clinic refers to the academic medical center or main campus, and those results are shown. Real-time data are leveraged in each Cleveland Clinic location to drive performance improvement. Although not an exact match to publicly reported data, more timely internal data create transparency at all organizational levels and support improved care in all clinical locations. Improve the Patient Experience of Care Cleveland Clinic Overall Inpatient Mortality Ratio O/E Ratio Q1 Cleveland Clinic Cleveland Clinic target Q2 Q3 Q4 Q1 Q2 Q3 Q Source: Data from the Vizient Clinical Data Base/Resource Manager TM used by permission of Vizient. All rights reserved. Cleveland Clinic s observed/expected (O/E) mortality ratio outperformed its internal target derived from the Vizient 215 risk model. Ratios less than 1. indicate mortality performance better than expected in Vizient s risk adjustment model. Cleveland Clinic Central Line-Associated Bloodstream Infection Rate 215 Rate per 1 Line Days Q1 Q2 215 Cleveland Clinic has implemented several strategies to reduce central line-associated bloodstream infections (CLABSIs), including a central-line bundle of insertion, maintenance, and removal best practices. Focused reviews of every CLABSI occurrence support reductions in CLABSI rates. Q3 Q4 78 Outcomes 215

81 Cleveland Clinic Postoperative Pulmonary Embolism or Deep Vein Thrombosis Risk-Adjusted Rate Cleveland Clinic Hospital-Acquired Pressure Ulcer Prevalence (Adult) Rate per 1 Patients Percent Cleveland Clinic NDNQI 5 th percentile (academic medical centers) 4 2 Cleveland Clinic Cleveland Clinic target 2 1 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q Source: Data from the Vizient Clinical Data Base/Resource Manager TM used by permission of Vizient. All rights reserved. Improved screening, risk adjustment, and prevention strategies have supported Cleveland Clinic s continued improvement with respect to perioperative pulmonary embolism and deep vein thrombosis (AHRQ Patient Safety Indicator 12). Embolism/thrombosis prevention remains a safety priority for Cleveland Clinic. Source: Data reported from the National Database for Nursing Quality Indicators (NDNQI ) with permission from Press Ganey. A pressure ulcer is an injury to the skin that can be caused by pressure, moisture, or friction. These sometimes occur when patients have difficulty changing position on their own. Cleveland Clinic caregivers have been trained to provide appropriate skin care and regular repositioning help while taking advantage of special devices and mattresses to reduce pressure for high-risk patients. In addition, they actively look for hospital-acquired pressure ulcers and treat them quickly if they occur. Orthopaedic & Rheumatologic Institute 79

82 Cleveland Clinic Implementing Value-Based Care Keeping patients at the center of all that we do is critical. Patients First is the guiding principle at Cleveland Clinic. Patients First is safe care, high-quality care, in the context of patient satisfaction, and high value. Ultimately, our caregivers have the power to impact every touch point of a patient s journey, including their clinical, physical, and emotional experience. We know that patient experience goes well beyond patient satisfaction surveys. Nonetheless, by sharing the survey results with our caregivers and the public, we constantly identify opportunities to improve how we deliver exceptional care. Outpatient Office Visit Survey Cleveland Clinic CG-CAHPS Assessment a Best Response (%) (N = 167,53) 215 (N = 227,599) CG-CAHPS 214 database average (all practices) b Appointment Access (% Always) c a In 213, Cleveland Clinic began administering the Clinician and Group Practice Consumer Assessment of Healthcare Providers and Systems surveys (CG-CAHPS), standardized instruments developed by the Agency for Healthcare Research and Quality (AHRQ) and supported by the Centers for Medicare & Medicaid Services for use in the physician office setting to measure patients perspectives of outpatient care. b Based on results submitted to the AHRQ CG-CAHPS database from 3962 practices in 214 c Response options: Always, Usually, Sometimes, Never d Response options: Yes, definitely; Yes, somewhat; No e Response options: Yes, No Source: Press Ganey, a national hospital survey vendor Specialty Care Primary Care Doctor Communication (% Yes, Definitely) d (% Always) c Doctor Rating (% 9 or 1) 1 Scale Clerical Staff (% Yes, Definitely) d Test Results Communication (% Yes) e 8

83 Inpatient Survey Cleveland Clinic HCAHPS Overall Assessment Best Response (%) HCAHPS Domains of Care a Best Response (%) 1 8 Hospital Rating (% 9 or 1) 1 Scale Recommend Hospital (% Definitely Yes) c a At the time of publication, 215 ratings have not been reported by the Centers for Medicare & Medicaid Services and ratings are not adjusted for patient mix. b Based on national survey results of discharged patients, January 214 December 214, from 4172 US hospitals. medicare.gov/hospitalcompare c Response options: Definitely yes, Probably yes, Probably no, Definitely no 214 (N = 1,369) 215 (N = 9966) a National average all patients b The Centers for Medicare & Medicaid Services requires United States hospitals that treat Medicare patients to participate in the national Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, a standardized tool that measures patients perspectives of hospital care. Results collected for public reporting are available at medicare.gov/ hospitalcompare. 214 (N = 1,369) 215 (N = 9966) b National average all patients c Discharge Information % Yes Care Transition % Strongly Doctor Communication Nurse Communication Pain Management Room Clean % Always Agree New Medications Communication (Options: Always, Usually, Sometimes, Never) Responsiveness to Needs Quiet at Night a Except for Room Clean and Quiet at Night, each bar represents a composite score based on responses to multiple survey questions. b At the time of publication, 215 ratings have not been reported by the Centers for Medicare & Medicaid Services and ratings are not adjusted for patient mix. c Based on national survey results of discharged patients, January 214 December 214, from 4172 US hospitals. medicare.gov/hospitalcompare Source: Centers for Medicare & Medicaid Services, 214; Press Ganey, a national hospital survey vendor, 215 Orthopaedic & Rheumatologic Institute 81

84 Cleveland Clinic Implementing Value-Based Care Focus on Value Cleveland Clinic has developed and implemented new models of care that focus on Patients First and aim to deliver on the Institute of Medicine goal of Safe, Timely, Effective, Efficient, Equitable, Patient-centered care. Creating new models of Value-Based Care is a strategic priority for Cleveland Clinic. As care delivery shifts from fee-for-service to a population health and bundled payment delivery system, Cleveland Clinic is focused on concurrently improving patient safety, outcomes, and experience. What does this new model of care look like? Integrated Care Model Retail Venues Home Community-Based Organizations Care System Outpatient Clinics Independent Physician Offices Ambulatory Diagnosis & Treatment MyChart Postacute Facilities Rehabilitation Facilities Hospitals The Cleveland Clinic Integrated Care Model (CCICM) is a value-based model of care, designed to improve outcomes while reducing cost. It is designed to deliver value in both population health and specialty care. The patient remains at the heart of the CCICM. The blue band represents the care system, which is a seamless pathway that patients move along as they receive care in different settings. The care system represents integration of care across the continuum. Critical competencies are required to build this new care system. Cleveland Clinic is creating disease- and condition-specific care paths for a variety of procedures and chronic diseases. Another facet is implementing comprehensive care coordination for high-risk patients to prevent unnecessary hospitalizations and emergency department visits. Efforts include managing transitions in care, optimizing access and flow for patients through the CCICM, and developing novel tactics to engage patients and caregivers in this work. Measuring performance around quality, safety, utilization, cost, appropriateness of care, and patient and caregiver experience is an essential component of this work. 82 Outcomes 215

85 Improve Population Health Cleveland Clinic Accountable Care Organization Measure Performance 215 National Percentile Ranking 9th 8th 7th 6th Tobacco Screening Heart Failure Ischemic Vascular Disease Falls Screening Diabetes Hypertension Pneumonia Vaccination BMI Screening Influenza Vaccination Coronary Artery Disease Colorectal Cancer Screening Breast Cancer Screening Reduce the Cost of Care Cleveland Clinic Health System Orthopaedic Surgery Cost per Case Development and implementation of care paths has improved outcomes and care coordination while reducing unnecessary variations in clinical practice. These efficiencies have reduced the total cost of care. The Total Joint Arthroplasty care paths that were implemented in 213 have led to year-over-year reductions in the cost per case for these procedures. Additional cost reductions were experienced in 215 as these care paths were refined and sustained. Change in Cost per Case Percent Total Hip Arthroplasty Total Knee Arthroplasty 4th Depression Screening Blood Pressure Screening -5 As part of Cleveland Clinic s commitment to population health and in support of its Accountable Care Organization (ACO), these primary care ACO measures have been prioritized for monitoring and improvement. Cleveland Clinic is improving performance in these measures by enhancing care coordination, optimizing technology and information systems, and engaging primary care physicians and specialists directly in the improvement work. These pursuits are part of Cleveland Clinic s overall strategy to transform care in order to improve health and make care more affordable Orthopaedic & Rheumatologic Institute 83

86 Innovations OME (OrthoMiDaS Episode of Care) With orthopaedics accounting for 2% to 3% of all US healthcare dollars and reimbursement moving toward a value-based model, the accurate measurement of patient-reported functional outcomes in a cost effective, scientifically valid, and scalable manner is increasingly a critical factor in ensuring patients receive both high quality and high value care. Cleveland Clinic s orthopaedics specialists developed OME (OrthoMiDaS Episode of Care), a research outcomes evaluation system that builds on 14 years of experience from the NIH-funded Multicenter Orthopaedic Outcomes Network cohort study, the expertise of more than 2 orthopaedic surgeons, the skills of expert statisticians and programmers, and the robustness of the Research Electronic Data Capture system extended with custom software. OME utilizes Cleveland Clinic s existing computer infrastructure and clinical workflow to securely and cost effectively collect 3 separate data sets that are critical to measuring, tracking, and evaluating patients pain and functional changes after orthopaedic surgery: patientreported outcome (PRO) measures prior to surgery, surgeonreported procedural details and risk factors immediately following surgery, and PROs 1 year after surgery. All PROs have been scientifically validated and include a general health measure; specific shoulder, knee, and hip measures; and, for athletes, special activity measures. At 1-year follow-up, patients return to work/sport and acceptable symptom states are assessed. OME was implemented in early 215 at Cleveland Clinic s Sports Health Center and has since been scaled to include approximately 27 patients undergoing elective orthopaedic surgeries, with patient and surgeon baseline completion rates of more than 95%. 84 Outcomes 215

87 Patient-Specific Pedicle Screw Placement Guide The patient-specific pedicle screw placement guide is a device that allows surgeons to virtually plan an ideal trajectory for pedicle screw placement at each vertebral level using a computed tomographic (CT) scan. Once the trajectory is determined, a canal is created along the planned axis and attached to an area that interfaces with the patient s posterior lamina. The guide is 3D printed on a rapid prototyping machine in durable polycarbonate for sterilization and intraoperative use. The device can then be placed on the patient s spine, and the canal assists the surgeon in drilling, tapping, and placing the screw in the planned trajectory. Across 3 cadavers operated on by either a resident or a staff surgeon, there was significant improvement in placement of pedicle screws with time to screw placement, pedicle perforation of screws, and need for screw adjustment. Poor outcomes defined to the blinded postoperative CT scan reviewers as neurologic or vascular injury resulting from screw placement were mitigated. These studies showed pedicle screw placement accuracy within 2 mm (99% confidence interval [CI], ) and 7 degrees (95% CI, ) of the planned trajectory. Such accuracy will allow surgeons to optimize chosen screw size and trajectory of screw placement to result in better fixation and fewer clinical hardware failures. Improvement in Outcomes of PSI Technology Compared With That of Standard of Care Freehand Technique and Time to Screw Placement With Placement in 3 Cadavers Image above depicts a set of thoracic pedicle screw placement guides created in a virtual setting for a cadaveric spine using CT based technology; image below shows their realworld counterparts that were 3D printed in polycarbonate. PSI SOC P Value Perforation Adjustment required High likelihood of poor outcome 8.6 Average time to screw placement per level (seconds) ± ± PSI = patient-specific instrumentation, SOC = standard of care Orthopaedic & Rheumatologic Institute 85

88 Innovations Cell X An Integrated Platform for Quantitative Analysis of Stem Cells and for Picking the Cells Needed for Cell Therapy Cell-based therapies and personalized medicine represent the next frontier in medical care. A patient s own cells may be used to regenerate or repair tissue damaged by a disease or injury or used to test for sensitivity to a specific drug. George Muschler, MD, orthopaedic surgeon at Cleveland Clinic s Orthopaedic & Rheumatologic Institute, in collaboration with Parker Hannifin Corporation, has developed a new platform, the Cell X device, which combines high precision imaging and robotic manipulation of cells for use in new therapies and cell-based diagnostics. Precision and automation are essential to the development of new personalized regenerative therapies that are safe, rapid, reliable, and ultimately less costly than current methods of surgical replacement. Cell X Integrated stem cell imaging and picking device Living stem and progenitor cells imaged using Cell X 86 Outcomes 215

89 Sideline Guidelines A Cleveland Clinic Orthopaedic & Rheumatologic Institute research team led by Kurt Spindler, MD, along with experts from Cleveland Clinic s Sports Health Center and other medical institutions, developed a first-of-its-kind application, Sideline Guidelines, designed to help sports medical professionals accurately address athletic injuries on the sidelines. According to the Centers for Disease Control and Prevention, high school sports account for an estimated 2 million injuries, 5, doctor visits, and 3, hospitalizations each year. The app offers a summary of medical information to provide medical professionals with guidelines for diagnosing injuries, assessing an individual athlete s postinjury ability, making return-to-play decisions, and planning training schedules. The searchable format allows providers to quickly access key points to assist in making an informed medical decision. Sideline Guidelines is available from itunes. Orthopaedic & Rheumatologic Institute 87

90 Contact Information Orthopaedic & Rheumatologic Institute Appointments or , ext Orthopaedic & Rheumatologic Institute Referrals 855.REFER.123 ( ) On the Web at clevelandclinic.org/orthorheum Staff Listing For a complete listing of Cleveland Clinic s Orthopaedic & Rheumatologic Institute staff, please visit clevelandclinic.org/staff. Publications Orthopaedic & Rheumatologic Institute staff authored 249 publications in 215. For a complete list, go to clevelandclinic.org/outcomes. Locations For a complete listing of Orthopaedic & Rheumatologic Institute locations, please visit clevelandclinic.org/orthorheum. 88 Outcomes 215

91 Additional Contact Information General Patient Referral 24/7 hospital transfers or physician consults General Information Hospital Patient Information General Patient Appointments or Referring Physician Center and Hotline 855.REFER.123 ( ) Or or visit clevelandclinic.org/refer123 Request for Medical Records or , ext Same-Day Appointments CARE (2273) Global Patient Services/ International Center Complimentary assistance for international patients and families or visit clevelandclinic.org/gps Medical Concierge Complimentary assistance for out-of-state patients and families , ext. 5558, or Cleveland Clinic Abu Dhabi clevelandclinicabudhabi.ae Cleveland Clinic Canada Cleveland Clinic Florida Cleveland Clinic Nevada For address corrections or changes, please call Orthopaedic & Rheumatologic Institute 89

92 About Cleveland Clinic Overview Cleveland Clinic is an academic medical center offering patient care services supported by research and education in a nonprofit group practice setting. More than 34 Cleveland Clinic staff physicians and scientists in 14 medical specialties and subspecialties care for more than 6.6 million patients across the system, performing more than 28, surgeries and conducting more than 64, emergency department visits. Patients come to Cleveland Clinic from all 5 states and more than 18 nations. Cleveland Clinic is an integrated healthcare delivery system with local, national, and international reach. The main campus in midtown Cleveland, Ohio, has a bed hospital, outpatient clinic, specialty institutes, labs, classrooms, and research facilities in 42 buildings on 165 acres. Cleveland Clinic s CMS case-mix index is the second highest in the nation. Cleveland Clinic encompasses more than 15 northern Ohio outpatient locations, including 18 full-service family health centers, 3 health and wellness centers, 9 regional hospitals, an affiliate hospital, and a rehabilitation hospital for children. Cleveland Clinic also includes Cleveland Clinic Florida; Cleveland Clinic Nevada, which includes the Lou Ruvo Center for Brain Health in Las Vegas and urology and nephrology services; Cleveland Clinic Canada; and Sheikh Khalifa Medical City (management contract). Cleveland Clinic Abu Dhabi is a full-service hospital and outpatient center in the United Arab Emirates (UAE), which began offering services in spring 215. Cleveland Clinic is the second-largest employer in Ohio, with more than 49, employees. It generates $12.6 billion of economic activity a year. Cleveland Clinic supports physician education, training, consulting, and patient services around the world through representatives and offices in Canada, the Dominican Republic, El Salvador, Guatemala, Honduras, Panama, Peru, Saudi Arabia, Turkey, and the United Arab Emirates. The Cleveland Clinic Model Cleveland Clinic was founded in 1921 by 4 physicians who had served in World War I and hoped to replicate the organizational efficiency of military medicine. The organization has grown through the years by adhering to the model set forth by the founders. All Cleveland Clinic staff physicians receive a straight salary with no bonuses or other financial incentives. The hospital and physicians share a financial interest in controlling costs, and profits are reinvested in research and education. Cleveland Clinic established family health centers in surrounding communities beginning in the 199s. Cleveland Clinic Florida was established in Marymount Hospital joined Cleveland Clinic in 1995, followed by regional hospitals including Euclid Hospital, Fairview Hospital, Hillcrest Hospital, Lutheran Hospital, Medina Hospital, South Pointe Hospital, and affiliate Ashtabula County Medical Center. In 215, the Akron General Health System joined the Cleveland Clinic health system. Internally, Cleveland Clinic services are organized into patient-centered integrated practice units called institutes, each institute combining medical and surgical care for a specific disease or body system. Cleveland Clinic was also one of the first academic medical centers to establish an Office of Patient Experience to work with institutes to ensure the best outcome and experience for every patient. A Clinically Integrated Network Cleveland Clinic is committed to providing value-based care, and it has grown the Cleveland Clinic Quality Alliance into the nation s second-largest and northeast Ohio s largest clinically integrated network. The network comprises more than 59 physician members, both employees and independent physicians from the community. Led by its physician members, the Quality Alliance strives to improve quality and consistency of care; reduce costs and increase efficiency; and provide access to expertise, data, and experience. 9 Outcomes 215

93 Cleveland Clinic Lerner College of Medicine Lerner College of Medicine is known for its small class sizes, unique curriculum, and full-tuition scholarships for all students. Each new class accepts 32 students who are preparing to be physician investigators. In 216, Cleveland Clinic is building a 165,-square-foot multidisciplinary Health Education Campus as the new home of the Case Western Reserve University (CWRU) School of Medicine and Cleveland Clinic s Lerner College of Medicine, as well as the CWRU School of Dental Medicine, the Frances Payne Bolton School of Nursing, and physician assistant and allied health training programs. Graduate Medical Education In 215, nearly 19 residents and fellows trained at Cleveland Clinic and Cleveland Clinic Florida, which is part of a continuing upward trend. U.S. News & World Report Ranking Cleveland Clinic is consistently ranked among the top hospitals in America by U.S. News & World Report. It has ranked No. 1 in heart care and heart surgery since In 215, 4 of its programs were ranked No. 2 in the nation: gastroenterology and GI surgery, nephrology, rheumatology, and urology. Cleveland Clinic Physician Ratings Cleveland Clinic believes in transparency and in the positive influence of the physician-patient relationship on healthcare outcomes. To continue to meet the highest standards of patient satisfaction, Cleveland Clinic physician ratings, based on nationally recognized Press Ganey patient satisfaction surveys, are published online at clevelandclinic.org/staff. Orthopaedic & Rheumatologic Institute 91

94 Resources Referring Physician Center and Hotline Call us 24/7 for access to medical services or to schedule patient appointments at 855.REFER.123 ( ), or go to clevelandclinic.org/refer123. The free Cleveland Clinic Physician Referral App, available for mobile devices, gives you 1-click access. Available at the App Store or Google Play. Remote Consults Anybody anywhere can get an online second opinion from a Cleveland Clinic specialist through our MyConsult service. For more information, go to clevelandclinic.org/myconsult, myconsult@ccf.org, or call , ext Request Medical Records or , ext Track Your Patients Care Online Cleveland Clinic offers an array of secure online services that allow referring physicians to monitor their patients treatment while under Cleveland Clinic care, as well as access test results, medications, and treatment plans. my.clevelandclinic.org/online-services DrConnect (online access to patients treatment progress while under referred care): ; drconnect@ccf.org or visit clevelandclinic.org/drconnect MyPractice Community (affordable electronic medical records system for physicians in private practice): eradiology (teleradiology consultation provided nationwide by board-certified radiologists with specialty training, within 24 hours or stat): ; starimaging@ccf.org Medical Records Online Patients can view portions of their medical record, receive diagnostic images and test results, make appointments, and renew prescriptions through MyChart, a secure online portal. All new Cleveland Clinic patients are automatically registered for MyChart. clevelandclinic.org/mychart Critical Care Transport Worldwide Cleveland Clinic s fleet of ground and air transport vehicles is ready to transfer patients at any level of acuity anywhere on earth. Specially trained crews provide Cleveland Clinic care protocols from first contact. To arrange a transfer for STEMI (ST-elevation myocardial infarction), acute stroke, ICH (intracerebral hemorrhage), SAH (subarachnoid hemorrhage), or aortic syndrome, call CODE (2633). For all other critical care transfers, call or CME Opportunities: Live and Online Cleveland Clinic s Center for Continuing Education operates the largest CME program in the country. Live courses are offered in Cleveland and cities around the nation and the world. The center s website (ccfcme.org) is an educational resource for healthcare providers and the public. It has a calendar of upcoming courses, online programs on topics in 3 areas, and the award-winning virtual textbook of medicine, The Disease Management Project. Clinical Trials Cleveland Clinic is running more than 22 clinical trials at any given time for conditions including breast and liver cancer, coronary artery disease, heart failure, epilepsy, Parkinson disease, chronic obstructive pulmonary disease, asthma, high blood pressure, diabetes, depression, and eating disorders. Cancer Clinical Trials is a mobile app that provides information on the more than 2 active clinical trials available to cancer patients at Cleveland Clinic. clevelandclinic.org/cancertrialapp 92 Outcomes 215

95 Healthcare Executive Education Cleveland Clinic has programs to teach people from outside the organization how it operates a major medical center. The Executive Visitors Program is an intensive, 3-day behind-the-scenes view of the Cleveland Clinic organization for the busy executive. The Samson Global Leadership Academy is a 2-week immersion in challenges of leadership, management, and innovation taught by Cleveland Clinic leaders, administrators, and clinicians. Curriculum includes coaching and a personalized 3-year leadership development plan. clevelandclinic.org/executiveeducation Consult QD Physician Blog A blog from Cleveland Clinic for physicians and healthcare professionals. Discover the latest research insights, innovations, treatment trends, and more for all specialties. consultqd. clevelandclinic.org Social Media Cleveland Clinic uses social media to help caregivers everywhere provide better patient care. Millions of people currently like, friend, or link to Cleveland Clinic social media including leaders in medicine. Facebook for Medical Professionals facebook.com/cmeclevelandclinic Follow us on Connect with us on LinkedIn Clevelandclinic.org/MDlinkedin Orthopaedic & Rheumatologic Institute 93