<p>1</p><p>Title</p><p>Establishing Clinical Severity for PROMIS® Measures in Adult Patients with Rheumatic Diseases </p><p>Authors</p><p>Vivek Nagaraja, MD1,2; Constance Mara, PhD3; Puja P. Khanna MD, MPH1,4; Rajaie Namas MD1; Amber Young </p><p>MD1,2; David A Fox MD1; Timothy Laing MD1; William J. McCune MD1; Carol Dodge OTRL, CHT1; Debra </p><p>Rizzo1; Maha Almackenzie MD5; Dinesh Khanna, MD, MS1,2</p><p>Institutional affiliations:</p><p>1 Division of Rheumatology, University of Michigan, Ann Arbor, MI</p><p>2 University of Michigan Scleroderma Program, University of Michigan, Ann Arbor, MI </p><p>3 Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH</p><p>4 Ann Arbor Veterans Affairs Medical Center Ann Arbor, MI </p><p>5 Department of Medicine, University of Toledo, Toledo, OH</p><p>Corresponding Author: </p><p>Dinesh Khanna, MD MS</p><p>Division of Rheumatology, University of Michigan</p><p>300 North Ingalls Building, Room 7C27, Ann Arbor, MI 48109-5422</p><p>Phone 734-936-5561 / Fax 734-763-1253</p><p>Email: [email protected]</p><p>Supplementary material: Case vignettes</p><p>A. PHYSICAL FUNCTION CASE VIGNETTES 2</p><p>Vignette 1</p><p>Mrs. Pratt is a 45-year-old woman with rheumatoid arthritis. In the past 7-days– </p><p>• Her health did not limit her from lifting and carrying groceries • She was able to do chores such as vacuuming or yard work without any difficulty • She was able to cut her food using eating utensils without any difficulty • She was able to carry a laundry basket up a flight of stairs without any difficulty • Her health did not limit her in doing strenuous activities such as backpacking, skiing, playing tennis, bicycling or jogging</p><p>Vignette 2</p><p>Ms. Chamberlin is a 40-year-old woman with lupus. In the past 7-days– </p><p>• She was able to step up and down curbs without any difficulty • She was able to open previously opened jars without any difficulty • She was able to carry a laundry basket up a flight of stairs without any difficulty • She was able to put on a shirt or blouse without any difficulty • She was able to turn a key in a lock with a little difficulty</p><p>Vignette 3 </p><p>Mr. Baker is a 75-year-old man with osteoarthritis. In the past 7-days,</p><p>• His health did not limit him in bathing or dressing himself • He was able to exercise for an hour without any difficulty • He was able to open a can with a hand can opener without any difficulty • His health limited him a little in bending, kneeling, and stooping • He was able to put on and take off a coat or jacket with a little difficulty</p><p>Vignette 4</p><p>Ms. Brown is a 65-year-old woman with rheumatoid arthritis. In the past 7-days,</p><p>• She was able to go up and down stairs at a normal pace without any difficulty • She was able to open previously opened jars with a little difficulty • She was able to open and close a zipper with a little difficulty • She was able to put on and take off a coat or jacket with a little difficulty • She was able to turn a key in a lock with some difficulty</p><p>Vignette 5</p><p>Mr. Miller is a 40-year-old man with psoriatic arthritis. In the past 7-days,</p><p>• He was able to use a hammer to pound a nail with a little difficulty • He was able to stand for short periods of time with a little difficulty 3</p><p>• He was able to run at a fast pace for two miles with a little difficulty • He was able to open a new milk carton with some difficulty • His health somewhat limited him in getting in and out of the bathtub</p><p>Vignette 6:</p><p>Mrs. Wilson is a 50-year-old woman with myositis. In the past 1-week,</p><p>• She was able to kneel on the floor with a little difficulty • She was able to use her hands, such as for turning faucets, using kitchen gadgets, or sewing with some difficulty • She was able to turn from side to side in bed with some difficulty • She was able to climb up 5 flights of stairs with some difficulty • She had much difficulty wiping herself after using the toilet</p><p>Vignette 7:</p><p>Ms. Taylor is a 55-year-old woman with lupus. In the past 7-days, </p><p>• She was able to transfer from a bed to a chair and back with some difficulty • She was able to kneel on the floor with some difficulty • She was able to walk a block on flat ground with some difficulty • She was able to reach into a low cupboard with much difficulty • Her health limited her quite a lot, in participating in active sports such as swimming, tennis, or basketball</p><p>Vignette 8:</p><p>Mr. Martin is a 58-year-old man with recurrent gout. In the past 7-days,</p><p>• His health somewhat limited him in climbing several flights of stairs • He was able to run five miles with much difficulty • He was able to bend or twist his back with much difficulty • He was able to put on a shirt with much difficulty • He was able to lift 10 pounds above his shoulder with much difficulty </p><p>Vignette 9:</p><p>Mr. Lee is a 48-year-old man with recurrent gout. In the past 7-days,</p><p>• His health limited him quite a lot, in doing heavy work around the house like scrubbing floors, or lifting or moving heavy furniture • He was able to stand up from an armless straight chair with much difficulty • He was able to stand for one hour with much difficulty • He was unable to exercise hard for half an hour 4</p><p>• He was unable to pull heavy objects (10 pounds) towards himself</p><p>Vignette 10:</p><p>Mrs. Torres is a 52-year-old woman with Rheumatoid arthritis. In the past 7-days,</p><p>• She was able to exercise hard for half an hour with much difficulty • She was able to step up and down curbs with much difficulty • She was unable to dry her back with a towel • She was unable to move a chair from one room to another • She was unable to turn a key in a lock</p><p>Vignette 11:</p><p>Ms. Cook is a 58-year-old woman with Rheumatoid arthritis. In the past 7-days,</p><p>• She was able to squat and get up with much difficulty • She was unable to run or jog for two miles • She was unable to pull on trousers • She was unable to peel fruit • She was unable to get in and out of a car</p><p>Vignette 12:</p><p>Ms. Collins is a 38-year-old woman with Rheumatoid arthritis. In the past 7-days,</p><p>• She was unable to get in and out of the bathtub • She was unable to climb up 5 flights of stairs • She was unable to run five miles • She was unable to lift a full cup or glass to her mouth • She was unable to trim her fingernails</p><p>B. PAIN INTERFERNCE VIGNETTES</p><p>Vignette 1</p><p>Mrs. Smith is a 35-year-old woman with rheumatoid arthritis. In the past 7-days, her joint pain – </p><p>• Did not interfere with her enjoyment of life • Did not interfere with her ability to concentrate • Did not make her feel depressed • Did not interfere with her household chores • Did not prevent her from walking more than 1-mile 5</p><p>Vignette 2</p><p>Ms. Payne is a 40-year-old woman with lupus. In the past 7-days, her overall pain – </p><p>• Interfered a little bit with her day to day activities • Did not interfere with her relationships with other people • Felt like it was a little bit of a burden to her • Did not restrict her social life to her home • Did not prevent her from standing for more than 30 minutes</p><p>Vignette 3:</p><p>Mr. Stone is a 75-year-old man with osteoarthritis. In the past 7-days, his joint pain – </p><p>• Has somewhat been distressing him often • Has not been severe enough that he could think of nothing else • Makes him feel a little bit anxious • Makes him avoid social activities a little bit, because it may make him hurt more • Did not interfere with his ability to remember things</p><p>Vignette 4:</p><p>Ms. Lopez is a 65-year-old woman with rheumatoid arthritis. In the past 7-days, her joint pain – </p><p>• Interfered a little bit with her ability to remember things • Did not keep her from getting into a standing position • Somewhat made her feel emotionally tense • Felt like quite a bit of burden to her • Somewhat interfered with work around the home</p><p>Vignette 5:</p><p>Mr. Smith is a 40-year-old man with psoriatic arthritis. In the past 7-days, his joint pain – </p><p>• Somewhat made it difficult for him to take in new information • Interfered quite a bit with his ability to participate in leisure activities • Somewhat made him feel depressed • Made it quite a bit difficult for him to fall asleep • Very much prevented him from walking more than 1-mile</p><p>Vignette 6:</p><p>Mrs. Vanderbilt is a 50-year-old woman with myositis. In the past 1-week, her muscle pain – </p><p>• Somewhat prevented her from sitting for more than 10-minutes • Restricted quite a bit of her social life to her home • Made her feel anxious quite a bit 6</p><p>• Very much interfered with doing her tasks away from home [eg: getting groceries] • Very much interfered in her ability to do household chores</p><p>Vignette 7:</p><p>Ms. Espinoza is a 55-year-old woman with lupus. In the past 7-days, her chest pain – </p><p>• Was quite severe that she could think of nothing else • Quite often prevented her from sitting for more than 10-minutes • Made it very difficult to fall asleep • Very often made her avoid social activities because it might make her hurt more • Very often was distressing to her</p><p>Vignette 8:</p><p>Mr. Romano is a 58-year-old man with recurrent gout. In the past 7-days, his joint pain due to gout – </p><p>• Interfered very much with his day-to-day activities • Interfered very much with his ability to work [including work at home] • Was very distressing to him • Made it very difficult to fall asleep • Very often kept him from socializing with others</p><p>C. SLEEP DISTURBANCE VIGNETTES</p><p>Vignette 1</p><p>Mrs. Reed is a 45-year-old woman with rheumatoid arthritis. In the past 7-days,</p><p>• She always got enough sleep • She was very much satisfied with her sleep • Her sleep was very much refreshing • She did not feel lousy when she woke up • She did not have a problem with her sleep</p><p>Vignette 2</p><p>Ms. Peterson is a 40-year-old woman with lupus. In the past 7-days, </p><p>• She did not feel sad at bedtime • She did not have trouble getting into a comfortable position to sleep • She did not try hard to get to sleep • A little bit of stress disturbed her sleep • She tossed and turned, a little bit, at night 7</p><p>Vignette 3</p><p>Mr. Baker is a 75-year-old man with osteoarthritis. In the past 7-days,</p><p>• He never had trouble staying asleep • He never had trouble sleeping • He woke up and had a little bit of trouble falling back to sleep • He was a little bit afraid he would not get back to sleep after waking up • He felt a little bit worried at bedtime</p><p>Vignette 4</p><p>Ms. Brown is a 65-year-old woman with rheumatoid arthritis. In the past 7-days,</p><p>• She has been a little bit satisfied with her sleep • Her sleep was a little bit refreshing • She felt a little bit lousy when she woke up • She had a little bit of problem with her sleep • She sometimes got enough sleep</p><p>Vignette 5</p><p>Ms. Miller is a 40-year-old woman with psoriatic arthritis. In the past 7-days,</p><p>• She had a little bit of problem with her sleep • It was often easy for her to fall asleep • She somewhat had difficulty falling asleep • She sometimes layed in bed for hours waiting to fall asleep • She sometimes woke up too early and could not fall back asleep.</p><p>Vignette 6:</p><p>Mrs. Wilson is a 50-year-old woman with myositis. In the past 1-week,</p><p>• She somewhat worried about not being able to fall asleep • She somewhat felt worried at bedtime • She somewhat had trouble stopping her thoughts at bedtime • She somewhat felt sad at bedtime • She somewhat had trouble getting into a comfortable position to sleep</p><p>Vignette 7:</p><p>Ms. Taylor is a 55-year-old woman with lupus. In the past 7-days, </p><p>• She sometimes got enough sleep • She was somewhat satisfied with her sleep • She somewhat thinks her sleep was refreshing 8</p><p>• She very much felt lousy when she woke up • She very much had a problem with her sleep</p><p>Vignette 8:</p><p>Mr. Martin is a 58-year-old man with recurrent gout. In the past 7-days,</p><p>• It was sometimes not easy for him to fall asleep • He somewhat had difficulty falling asleep • He always laid in bed for hours waiting to fall asleep • He always woke up too early and could not fall back asleep • He very much felt physically tense at bedtime</p><p>Vignette 9:</p><p>Mr. Lee is a 48-year-old man with recurrent gout. In the past 7-days,</p><p>• He somewhat tried hard to get to sleep • Stress disturbed his sleep very much • He very much tossed and turned at night • He always had trouble staying asleep • He always woke up and had trouble falling back to sleep</p><p>Vignette 10:</p><p>Mrs. Torres is a 52-year-old woman with rheumatoid arthritis. In the past 7-days,</p><p>• She very much felt physically tense at bedtime • She very much worried about not being able to fall asleep • She very much felt worried at bedtime • She very much had trouble stopping her thoughts at bedtime • She very much felt sad at bedtime</p><p>D. DEPRESSION CASE VIGNETTES</p><p>Vignette 1</p><p>Mrs. Sanders is a 40-year-old woman with rheumatoid arthritis. In the past 7-days, due to her arthritis – </p><p>• Never felt worthless • Never felt depressed • Never had trouble making decisions • Never felt ignored by other people • Never felt emotionally exhausted 9</p><p>Vignette 2</p><p>Ms. Pringle is a 35-year-old woman with lupus. In the past 7-days, due to her overall pain she – </p><p>• Never felt feel helpless • Rarely felt sad • Rarely felt disappointed in herself • Never felt upset for no reason • Never felt guilty</p><p>Vignette 3:</p><p>Mr. Stinger is a 75-year-old man with osteoarthritis. In the past 7-days, due to his joint pain he – </p><p>• Rarely had trouble feeling close to people • Rarely felt disappointed in himself • Never felt that he was not needed • Rarely felt depressed • Never felt that his life was empty</p><p>Vignette 4:</p><p>Ms. Lopez is a 65-year-old woman with rheumatoid arthritis. In the past 7-days, due to her joint pain she – </p><p>• Felt a little worthless • Felt a little that nothing could cheer her up • Somewhat withdrew from other people • Felt a little that she wanted to give up on everything • Did not feel that she had no reason for living</p><p>Vignette 5:</p><p>Mr. Hartnup is a 40-year-old man with psoriatic arthritis. In the past 7-days, due to his joint pain he – </p><p>• Somewhat felt that he was not needed • Somewhat felt lonely • Felt a little that he had no reason for living • Somewhat felt ignored by people • Somewhat felt that his life was empty </p><p>Vignette 6:</p><p>Mrs. Johnson is a 50-year-old woman with myositis. In the past 1-week, due to her muscle weakness she– </p><p>• Somewhat felt that nothing could cheer her up • Somewhat felt hopeless • Felt quite discouraged about the future 10</p><p>• Found that things in her life were quite overwhelming • Felt quite emotionally exhausted</p><p>Vignette 7:</p><p>Ms. Jimenez is a 55-year-old woman with lupus. In the past 7-days, due to her chest pain she – </p><p>• Felt quite helpless • Quite often felt that she was not as good as other people • Felt very discouraged about the future • Quite often felt that nothing was interesting • Quite often felt that she had no reason for living</p><p>Vignette 8:</p><p>Mr. Romano is a 58-year-old man with recurrent gout. In the past 7-days, due his joint pain he – </p><p>• Felt very helpless • Very much withdrew from other people • Quite often had trouble making decisions • Felt very pessimistic • Very much found that things in his life were overwhelming</p><p>Vignette 9:</p><p>Mr. Clarke is a 76-year-old man with history of polymyalgia rheumatica. In the past 7-days, due to worsening shoulder and hip pain, he – </p><p>• Felt very helpless • Very much felt that nothing could cheer him up • Very much felt like a failure • Felt very disappointed with himself • Had very much trouble making decisions</p>