LYME DIAGNOSTIC STUDY Part I. Initial Screening Form

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1 LYME DIAGNOSTIC STUDY Part I. Initial Screening Form Thank you for your interest in this study which aims to improve diagnostic testing for Lyme disease. The CDC estimates that 300,000 people are diagnosed with Lyme disease each year. This is a major public health problem. By participating in this study, you are joining our effort to improve the public health of our nation. These questions will help us to determine whether you are eligible to participate in our Lyme Diagnostic Study. There are four main groups of participants (age 18 89) we seek: LYME New onset early Lyme disease (ie, Lyme rash) that has not yet been treated with antibiotics New onset later stage Lyme disease that has not yet been treated with antibiotics o (e.g., arthritis, meningitis, facial nerve palsy) NON LYME (who have never had a tick borne disease & haven t had a tick bite in the last 6 months) Healthy individuals Medically ill with another clearly defined non Lyme illness This public health study will require a blood draw and about 20 minutes of your time to complete questionnaires. There are two sets of questionnaires: a) Part 1. Screening Form (the ones that follow this page take about 15 minutes to complete) b) Part 2. The Study Questionnaires. You complete these after signing the consent form. Part 2 takes about 5 10 minutes. These provide us with more information about you and give us essential contact information so we can make sure you can get the lab test results and the gift card. This study is co sponsored by the Lyme & Tick borne Diseases Research Center at Columbia University and Boulder Diagnostics in Colorado. Any questions you have about the study can be answered by our Columbia Lyme Center research staff (to whom you can be immediately connected by phone at ) and/or by your health care provider. If you think you may be interested in participating, please complete the following questions. Please try to answer each question, even if you do not think it is related to you at this time. Do not leave any questions blank. Try to complete as much as you can yourself, but if you need help, please ask. Thank you! Page 1 of 10 Office Staff Member Initials :

2 Today s DATE: \ \ Current Age: years Sex: Male Female Ethnic background: White (non Hispanic) Black (non Hispanic) Hispanic Asian/Pacific Islander/American Indian/Alaskan Native Not specified Other: Marital Status: Single (never married) Married/Living with partner Divorced/Separated Widowed Are you able to read English well? Yes No Current Employment Status (check all that apply): Employed full time for pay Temporarily out of work Employed at least half time for pay Unemployed more than 6 months Homemaker Retired Full time student Receiving Public Assistance Part time student Disabled Other: Your Highest Education: partial high school or less (and never got GED) completed high school or GED some college (less than 4 years) or technical school training completed 4 year college degree completed post college degree (master s, PhD, MD/OD/DMD/JD, other: ) Why did you come to your health care provider today? (please circle choice) a) Suspected Lyme disease b) Another illness that is unrelated to Lyme disease: (state which: ) c) Feeling sick and not sure why d) Annual or routine wellness visit/physical check up Worst Current symptoms: 1) 2) 3) 4) 5) 6) If you are ill (for any reason), approximately when did you first notice symptoms of your current illness (estimate)? a) Over the last 7 days b) 2 4 weeks ago c) 1 3 months ago d) 4 6 months ago e) 7 12 months ago f) more than one year ago How did your current illness start? a) slowly over months or years b) gradually over weeks c) suddenly over days Can you recall the last time you felt well? If yes, what date? / Have you been exposed to an area where there is Lyme disease? If yes, where? Have you had a bad flu like illness in the last 6 months? Have you been treated with antibiotics for more than 1 day in the last 2 weeks? Your current weight: lbs Current height: feet inches Page 2 of 10 Office Staff Member Initials :

3 Have you ever had a Lyme Vaccine? (if yes, how many years ago? (years)) Is your immune system currently markedly suppressed? Don t know Have you taken steroids (nasal, skin, or pill) (e.g., prednisone or other agents) in the last month? Do you have any allergies? If yes, specify: If Female, are you: a) pre puberty b) post puberty (not menopausal) c) in pre/peri menopause d) post menopausal A. PLEASE TELL US ABOUT ALL MEDICATIONS YOU HAVE TAKEN OVER THE LAST MONTH Name of Medication Reason for Medication # of Days Taken Are you still taking it? B. Have you ever been medically ill or psychiatrically ill in your lifetime? If yes, please circle each category of disease or disorder that you ve had, name it, & then indicate if you had it in the last 6 months and when in your life this problem first occurred. If your condition is not listed, please add to Other. If more than one condition exists, please specify the most problematic ones. Please circle each category of disease or disorder below that you ve ever had Specify Name of Diagnoses or Disorders Cardiovascular/Hypertension Pulmonary Gastrointestinal Urologic Genital Endocrine (e.g., Diabetes, Thyroid) Neurologic Hematologic/Blood Cancer Dermatologic Rheumatologic (Joints/Muscles) Autoimmune Disease Infectious (e.g., HIV, Hepatitis) Fibromyalgia Chronic Fatigue Syndrome Mood Disorder (e.g. Depression) Anxiety Disorder (e.g,. Panic, OCD) Sleep Apnea or Narcolepsy Obesity Mononucleosis Migraine Headaches Other Disorder/Condition Other Disorder/Condition In the last 6 months, have you required treatment or sought help for this? What year was this first a problem? Page 3 of 10 Office Staff Member Initials :

4 Have you had any symptoms or signs of illness in the last month? If yes, please circle Y for yes or N for no to indicate whether you ve had any of the following symptoms General Symptoms? Muscle and Joint Symptoms? Face/Head Symptoms? Y N Fever of 100 or greater Y N Muscles aches in upper body Y N Facial weakness or palsy Y N Large or tender lymph nodes Y N Muscle aches in lower body Y N Facial pain or odd sensations Y N Marked Fatigue Y N Muscle aches nearly all over Y N Irregular Heart rhythm Y N Back pain Y N Eyes: Double Vision Y N Cough Y N Eyes: Vision change less clear Y N Runny nose Y N Joint pain in arms Y N Eyes: Hyper Sensitivity to Light Y N Diarrhea Y N Joint pain in legs Y N Eyes: inflammation or redness Y N Nausea and/or vomiting Y N Joint pain that moves around Y N Flu like symptoms/malaise Y N Joint swelling in 1 or both knees Y N Ears: Hyper sensitivity to Sound Y N Sweats and/or chills Y N Joint swelling elsewhere Y N Ears: Loss of hearing Neurologic Symptoms? Dermatologic a new rash? Y N Headaches (Moderate to severe) Y N New rash is round or oval Y N Neck Stiffness or pain Y N New rash is 2 inches in size or more Y N Dizziness/Light headed Y N Balance problems on walking Y N New rash is very itchy or painful Y N Drooling/can t close eyelids/facial palsy Y N New rash started small and got bigger over time Y N Numbness/Tingling in extremities Y N More than one rash has appeared Y N Shooting or stabbing pains Y N New rash developed after a known tick bite Y N Memory Problems or brain fogginess Y N Other type of rash Y N Changes in vision or hearing Y N Weakness in your legs or arms C. Health Habit 1. On average, how much have you exercised over the last month? a) None b) less than 1x/week c) 1 3x/week d) 4 6x/week e) daily 2. On average, over the last month, how many cigarettes have you smoked (not electric cigs.)? a) None b) less than ½ pack per day c) ½ to 1 pack per day d) More than 1 pack per day 3. On average, how often have you drunk alcohol or smoked marihuana over the last month? a) None b) less than 1x/week c) 1 3x/week d) 4 6x/week e) daily D. Compared to one year ago, how would you rate your health in general now? (circle one letter) 1. Much better now than one year ago 2. Somewhat better now than one year ago 3. About the same now as one year ago 4. Somewhat worse now than one year ago 5. Much worse now than one year ago E. History of Prior Illness: Over the course of your whole life (including the last 3 months): How many times have you been medically hospitalized (not just overnight in the ER)? >5x How many times have you been psychiatrically hospitalized (not just overnight in the ER)? >5x How many times have you had major surgery? >5x Page 4 of 10 Office Staff Member Initials :

5 Over the last 3 months: How many times have you been to the Emergency Room in the last 3 months? >5x How many times have you been to an urgent care center in the last 3 months? >5x How many days in the last 3 months have you been hospitalized overnight for any reason? >5 How many visits to any health care provider have you made in the last 3 months? (not including ER visits, urgent care, or follow up visits for this study) F. History of Lyme Disease 1. PAST: Have you ever been diagnosed with Lyme disease before? Not sure If you had it in the past, which type of Lyme disease did you have? (check each one that applies) Lyme Rash Lyme Facial Palsy Cardiac Lyme Lyme Arthritis Lyme Meningitis Cognitive Lyme Lyme Flu like Symptoms Lyme Shooting/Stabbing pains Other: 2. TREATMENT: How many separate times have you been treated for Lyme? When did you finish your last course of antibiotics for Lyme disease? / / Duration: How many days of antibiotics did you get for your most recent Lyme? days Which antibiotic were you given most recently? Doxycycline amoxicillin Other: All together, please estimate the amount of prior antibiotic treatment for all episodes of Lyme disease: Oral antibiotics (mons) IV antibiotics: (mons) Intramuscular antibiotics (Mos) 3. Have you ever had a Lyme rash diagnosed by a MD or nurse? not sure If yes, when? / / 4. CURRENT: Do you think you might have Lyme disease now? Not sure If yes or not sure, when did you think your current illness first started? / / Is this a new case of Lyme disease for you? Not sure If new, which of the following have you recently developed? (check the box to the left of all that apply) A new tick bite (that you saw attached to your skin) A new unexplained rash New onset Facial nerve palsy (Bell s palsy) New onset swollen or painful joints (arthritis) New other symptom: New bad headaches & stiff neck (meningitis) New flu like symptoms New shooting or stabbing pains New Mental confusion or memory loss Other: If you may have Lyme disease now, have you received antibiotics for this episode? If yes, specify Name of antibiotic # of days of antibiotic taken (days) When did you take your last dose of antibiotic? / / 5. TESTING: Have you ever had a Lyme test? Not sure i. If yes, when was your most recent Lyme test: / /. ii. Please give the results of this recent test: positive negative equivocal don t know iii. Have you ever had a positive Lyme test? Don t know If yes, when: / / Page 5 of 10 Office Staff Member Initials :

6 G. IMPACT OF SYMPTOMS ON YOUR LIFE. Please circle one number below for each time point of the scale. PLEASE CIRCLE A NUMBER FOR HOW MUCH SYMPTOMS AFFECT YOUR LIFE NOW Currently symptoms disrupt my work/school work: Currently symptoms disrupt my social life/leisure activities : Currently symptoms disrupt my family life/home responsibilities: ****************************************************************************************** HAS THERE BEEN AT LEAST 1 MONTH IN THE LAST 3 MONTHS WHEN YOU FUNCTIONED BETTER THAN NOW? If yes, then PLEASE CIRCLE A NUMBER FOR HOW MUCH SYMPTOMS AFFECTED YOUR LIFE DURING THAT BEST MONTH During my best month of the last three, symptoms disrupted my work/school work: During my best month of the last three, symptoms disrupted my social life/leisure activities : During my best month of the last 3, symptoms disrupted my family life/home responsibilities: How many days of lost productivity did you have in the past month due to physical or mental illness? Page 6 of 10 Office Staff Member Initials :

7 SYMPTOMS. During the past 7 days, how much have you been bothered by any of the following problems? Check box as New only if the symptom started to bother you for the first time in the last 1 2 months. Check Not New if your current symptom started to bother you more than 2 months ago. Rate bother for the past 7 days Not at all A little bit Somewhat Quite a bit much Rate if New or Not 1. Stomach or bowel problems New Not New 2. Chest Pain or Shortness of Breath New Not New 3. Dizziness New Not New 4. Trouble sleeping New Not New 5. Feeling tired or having low energy New Not New 6. Pain in your arms, legs, or joints New Not New 7. Back Pain New Not New 8. Headaches New Not New 9. Stiff or painful neck New Not New 10. Muscle aches or pains almost all over New Not New 11. Joint swelling, tenderness or pain New Not New 12. Generalized weakness (malaise) New Not New 13. Feeling feverish New Not New 14. Sweats and/or chills New Not New 15. Nausea and/or vomiting New Not New 16. Feeling worse after normal exertion New Not New 17. Sleeping too little (<5 hours) New Not New 18. Sleeping too much (>9 hours) New Not New 19. Trouble falling or staying asleep New Not New 20. Not feeling rested on awakening New Not New 21. Weakness of arms, legs, or hands New Not New 22. Unpleasant numbness or tingling New Not New 23. Shooting, stabbing or burning pains New Not New 24. Atypical skin or muscle twitching New Not New 25. Facial muscle palsy/eyelid weakness New Not New 26. Problems with balance New Not New 27. Discomfort with normal light stimuli New Not New 28. Discomfort with normal sound stimuli New Not New 29. Feeling irritable, joyless, or sad New Not New 30. Feeling panicky or anxious New Not New 31. Trouble finding words or names New Not New 32. Trouble with memory New Not New 33. Slower speed of thinking (brain fog) New Not New 34. Trouble focusing or multi tasking New Not New If any of the above symptoms caused you significant impairment in work, social, or family functioning, please indicate the number(s) of each of the most impairing symptom(s) below: # # # #_ # _# # Page 7 of 10 Office Staff Member Initials :

8 GLOBAL HEALTH AND LIFE SATISFACTION. Please respond to each item by marking one box per row. Excellent Good [4] Good 1. In general would you say your health is 2. In general, would you say your quality of life is. 3. In general, how would you rate your physical health? In general, how would you rate your mental health, including your mood and your ability to think? In general, how would you rate your satisfaction with your social activities and relationships? In general, please rate how well you carry out your usual social activities and roles. (This includes activities at home, at work and in your community, and responsibilities as a parent, child, spouse, employee, friend, etc.) [3] Fair [2] Poor [1] 7. To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair?... Completely Mostly [4] Moderately [3] A Little [2] Not At All [1] In the Past 7 Days. Never Rarely Sometimes Often Always 8. How often have you been bothered by emotional problems such as feeling anxious, depressed or irritable? How would you rate your fatigue on average?... [4] [3] None Mild [4] Moderate [3] [2] Severe [2] [1] Severe [1] 10. How would you rate your pain on average?... No Pain Worst Imaginable Pain Page 8 of 10 Office Staff Member Initials :

9 PHYSICAL FUNCTION. (Please respond to each question or statement by marking one box per row.) In the Past 7 Days 1. Are you able to do chores such as vacuuming or yard work? 2. Are you able to do up and down stairs at a normal pace? Are you able to go for a walk of at least 15 minutes?.. 4. Are you able to run errands and shop? How much do your physical health problems now limit your usual physical activities (such as walking or climbing stairs)?... Without any Difficulty Not at all With a little difficulty [4] little With some difficulty [3] Somewhat With much difficulty [2] Quite A lot Unable to do [1] Cannot do 6. Does your health now limit you in doing moderate work around the house like vacuuming, sweeping floors or carrying in groceries? 7. Does your health now limit you in lifting or carrying groceries?. 8. Does your health now limit you in doing heavy work around the house like scrubbing floors, or lifting or moving heavy furniture?... FATIGUE. Please respond to each question or statement by marking one box per row. In the Past 7 Days Never [1] Rarely [2] Sometimes [3] Often [4] Always 1. How often did you feel tired? How often did you experience extreme exhaustion? How often did you run out of energy? How often did your fatigue limit you at work (include work at home)? How often were you too tired to think clearly? How often were you too tired to take a bath or shower? How often did you have enough energy to exercise strenuously?... Page 9 of 10 Office Staff Member Initials :

10 SLEEP. Please respond to each question or statement by marking one box per row. In the Past 7 Days Poor Poor [4] Fair [3] Good [2] Good [1] 1. My sleep quality was... Not at all A little bit [4] Somewh at [3] Quite a bit [2] Much [1] 2. My sleep was refreshing I had a problem with my sleep 4. I had difficulty falling asleep My Sleep was restless. 6. I tried hard to get to sleep PAIN. Please respond to each question or statement by marking one box per row. In the Past 7 Days 1. How much did pain interfere with your day to day activities?... Not at all [1] A little bit [2] Somewhat [3] Quite a bit [4] Much 2. How much did pain interfere with work around the home? How much did pain interfere with your ability to participate in social activities? How much did pain interfere with your enjoyment of life? How much did pain interfere with the things you usually do for fun? How much did pain interfere with your enjoyment of social activities?... Page 10 of 10 Office Staff Member Initials :