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The Alberta Rapport Team Data Collection Form for the Study of Biologic Agents in Rheumatoid Arthritis

Welcome!

The purpose of this important questionnaire is to monitor the long-term safety and effectiveness of new biologic agents for the treatment of rheumatoid arthritis.

We have made every effort to keep this survey brief for your convenience. Although some of the questions may seem similar, each one has been tested and carefully selected to provide necessary information. Thus, it is important that you give the best answer you can to every question. If you have a problem answering any question, please note your problem beside the question and / or ask for help. Medications can sometimes have lasting effects so it will be important for us to find out how you are doing in the future, even if you have stopped your biologic agent or have switched to a new medication.

The information that you provide is confidential. Your answers will be combined with the answers of other patients and reported in such a way that you cannot be identified.

We truly appreciate your valued contribution and look forward to working with you to answer some of the important questions that we all share regarding biologic agents!

Initials:
ID#:

BACKGROUND INFORMATION

This information will be used to determine whether the safety or effectiveness of biologic agents depends on a person’s age or other characteristics.

To be completed at the FIRST visit only:

1. What is your date of birth?
2. What is your gender?
3. What is your ethnic origin?	My mother is: My father is:
4. How many years of school have you completed?

To be completed at each visit:

1. What is your height? (feet / inches):
2. What is your weight? (pounds):
3. Are you:
4. Please give the full name of the doctor currently providing your arthritis care:

5. What is your present marital status?
6. With whom do you currently live? (please check all that apply)
	Alone With spouse or partner With child(ren) With parent(s) With other relatives Withe friends or roommates Nursing or convalescent home Paid live-in help

OTHER MEDICAL CONDITIONS

The following is a list of common problems. Please indicate if you currently have the problem in the first column. If you do not have the problem, skip to the next problem.

If you do have the problem, please indicate in the second column if you receive medications or some other type of treatment for the problem. For example, if you have high blood pressure that is under good control with medication, you should circle “yes” in columns 1 and 2.

In the third column indicate if the problem limits any of your activities.

Finally, indicate all medical conditions that are not listed under “other medical problems” at the end of the page.


PROBLEM	No	Yes	No	Yes	No	Yes
Heart disease	N	Y	N	Y	N	Y
Heart failure/fluid on the lungs.	N	Y	N	Y	N	Y
High blood pressure	N	Y	N	Y	N	Y
Lung disease	N	Y	N	Y	N	Y
Diabetes	N	Y	N	Y	N	Y
Ulcer or stomach disease	N	Y	N	Y	N	Y
Kidney disease	N	Y	N	Y	N	Y
Liver disease	N	Y	N	Y	N	Y
Anemia or other blood disease	N	Y	N	Y	N	Y
Cancer	N	Y	N	Y	N	Y
Depression	N	Y	N	Y	N	Y
Osteoarthritis, degenerative arthritis	N	Y	N	Y	N	Y
Back pain	N	Y	N	Y	N	Y
Other medical problems (please write in below):	N	Y	N	Y	N	Y
	N	Y	N	Y	N	Y
	N	Y	N	Y	N	Y

HEALTH-RELATED QUALITY OF LIFE

This next set of questions asks about your views on your health. This information will track how you feel and how well you are able to do your usual activities. Answer every question by marking the answer as indicated. If you are unsure about how to answer a question, please give the best answer you can.

1.	In general, would you say your health is:

2.	Compared to one year ago, how would you rate your health in general now?

3.	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much?

Activities		Yes, Limited a Lot	Yes, Limited a Little	No, Not Limited at All
a.	Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
b.	Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
c.	Lifting or carrying groceries
d.	Climbing several flights of stairs
e.	Climbing one flight of stairs
f.	Bending, kneeling or stooping
g.	Walking more than a mile
h.	Walking several blocks
i.	Walking one block
j.	Bathing or dressing yourself

4.	During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?

		Yes	No
a.	Cut down on the amount of time you spent on work or other activities
b.	Accomplished less than you would like
c.	Were limited in the kind of work or other activities
d.	Had difficulty performing the work or other activities (i.e. it took extra effort)
5.	During the past 4 weeks, have you had any of the following problems with your work or other regular activities as a result of any emotional problems (such as feeling depressed or anxious)?
		Yes	No
a.	Cut down on the amount of time you spent on work or other activities
b.	Accomplished less than you would like
c.	Didn’t do work or other activities as carefully as usual?

6.	During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors, or groups?

7.	How much bodily pain have you had during the past 4 weeks?

8.	During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?

9.	These questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4 weeks–
		All the time	Most of the time	A good bit of the time	Some of the time	A little bit of the time	None of the time
a.	Did you feel full of pep?	1	2	3	4	5	6
b.	Have you been a very nervous person?	1	2	3	4	5	6
c.	Have you been so down in the dumps that nothing could cheer you up?	1	2	3	4	5	6
d.	Have you felt calm and peaceful?	1	2	3	4	5	6
e.	Did you have a lot of energy?	1	2	3	4	5	6
f.	Have you felt downhearted and blue?	1	2	3	4	5	6
g.	Did you feel worn out?	1	2	3	4	5	6
h.	Have you been a happy person?	1	2	3	4	5	6
i.	Did you feel tired?	1	2	3	4	5	6


10.	During the past 4 weeks, how much has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)?

11.	How TRUE or FALSE is each of the following statements for you?
		Definitely true	Mostly true	Don't know	Mostly false	Definitely false
a.	I seem to get sick a little easier than other people	1	2	3	4	5
b.	I am as healthy as anybody I know	1	2	3	4	5
c.	I expect my health to get worse	1	2	3	4	5
d.	My health is excellent	1	2	3	4	5

CLINICAL HEALTH ASSESSMENT QUESTIONNAIRE (CLINHAQ)

We are interested in learning how your illness affects your ability to function in daily life.

Please check the response which best describes your usual abilities OVER THE PAST WEEK:

		Without Any Difficulty	With Some Difficulty	With Much Difficulty	Unable to do
DRESSING & GROOMING Are you able to:
-	Dress yourself, including shoelaces & buttons?
-	Shampoo your hair?
ARISING Are you able to:
-	Stand up from a straight chair?
-	Get in & out of bed?
EATING Are you able to:
-	Cut your meat?
-	Lift a full cup or glass to your mouth?
-	Open a new milk carton?
WALKING Are you able to:
-	Walk outdoors on flat ground?
-	Climb up five steps?
-	Walk two miles?
-	Participate in sports & games as you would like?
-	Get a good night's sleep?
-	Deal with feelings of anxiety or being nervous?
-	Deal with feelings of depression or feeling blue?

Please check any AIDS OR DEVICES that you usually use for any of these activities:

Cane (W) Walker (W) Built up or special utensils (E)

Crutches (W) Wheelchair (W) Special or built up chair (A)

Devices used for dressing (button hook, zipper pull, long handled shoe horn) (D)

Other (specify):

Please check any categories for which you usually need HELP FROM ANOTHER PERSON:

Dressing and Grooming Eating

Arising Walking

How much pain have you had because of your illness IN THE PAST WEEK?

No pain					Severe pain
0	1	2	3	4	5	6	7	8	9	10

When you awakened in the morning OVER THE LAST WEEK, did you feel stiff?

If yes, please write the number of minutes or hours until you are as limber as you will be for the day.

Please check the response which best describes your usual abilities OVER THE PAST WEEK:
		Without Any Difficulty	With Some Difficulty	With Much Difficulty	Unable to do
HYGIENE Are you able to:
-	Wash and dry your body?
-	Take a tub bath?
-	Get on and off the toilet?
REACH Are you able to:
-	Reach and get down a 5 pound object (such as a bag of sugar) from just above your head?
-	Bend down to pick up clothing from the floor?
GRIP Are you able to:
-	open car doors?
-	Open jars which have been previously opened?
-	Turn faucets on and off?
ACTIVITIES Are you able to:
-	Run errands and shop?
-	Get in and out of a car?
-	Do chores such as vacuuming or yard work?

Please check any AIDS OR DEVICES that you usually use for any of these activities:

Bathtub bar (H) Long handled appliances in bathroom (H)

Raised toilet seat (H) Jar opener for jars previously opened (G)

Long-handled appliances for reach (R)

Other (specify):

Please check any categories for which you usually need HELP FROM ANOTHER PERSON:

Hygiene Gripping and opening things

Reach Errands and chores

How much trouble have you had with your stomach (i.e. nausea, heartburn, bloating, pain etc) IN THE PAST WEEK?

No stomach problems					Severe stomach problems
0	1	2	3	4	5	6	7	8	9	10

How much of a problem has fatigue or tiredness been for you IN THE PAST WEEK?

Fatigue is no problem					Fatigue is a major problem
0	1	2	3	4	5	6	7	8	9	10

Considering ALL THE WAYS THAT YOUR ILLNESS AFFECTS YOU, rate how you are doing

Very well					Very poor
0	1	2	3	4	5	6	7	8	9	10

How much of a problem has sleep (i.e., resting at night) been for you IN THE PAST WEEK?

Sleep is no problem					Sleep is a major problem
0	1	2	3	4	5	6	7	8	9	10

QUALITY OF LIFE

By placing a check-mark in one box in each group below, please indicate which statements best describe your own state of health today.

Mobility
	I have no problems in walking about
	I have some problems in walking about
	I am confined to bed

Self-Care
	I have no problems with self-care
	I have some problems washing or dressing myself
	I am unable to wash or dress myself

Usual Activities(e.g. work, study, housework, family or leisure activities)
	I have no problems with performing my usual activities
	I have some problems with performing my usual activities
	I am unable to perform my usual activities

Pain / Discomfort
	I have no pain or discomfort
	I have moderate pain or discomfort
	I have extreme pain or discomfort

Anxiety / Depression
	I am not anxious or depressed
	I am moderately anxious or depressed
	I am extremely anxious or depressed

RESOURCE USE IN RHEUMATOID ARTHRITIS

Your contribution in improving our understanding of the costs of rheumatoid arthritis is very important, as only you can assess the effect of the disease on your daily activities and the health care resources that you require.

Please note that the time period for which we estimate costs differs among the questions included below. Most questions refer to the past six months , but some questions refer to the past 3 months or the past month .

Please indicate only those expenses that refer to your rheumatoid arthritis . If you have visited a doctor or taken drugs because of another problem (e.g. a cold), do not include that visit. This is very important!

HOSPITAL SERVICES

Inpatient stays

Please indicate whether and how many times during the last 6 months you have been hospitalized (i.e. spent at least one night at the hospital), because of your rheumatoid arthritis.

Have you been hospitalized during the last 6 months?	Yes	No
If so, how many times have you been hospitalized?	times
How many days in total have you spent in hospital?	Days
During any of these stays, did you require an operation?	Yes	No
If so, please indicate what operation(s) you required	Hip replacement
	Knee replacement
	Other surgery

Day Surgery

Please indicate how many times during the last 6 months you had outpatient surgery (i.e. no overnight stay) because of your rheumatoid arthritis. Do not include visits to the outpatient clinic (see question 1.3).

Have you had day surgery during the last 6 months?	Yes	No
If so, how many times?	Times
If so, please indicate what operation(s) you had

Outpatient attendance

Please indicate whether and how many times during the last 6 months you have attended an outpatient clinic because of your rheumatoid arthritis.

Have you attended an outpatient clinic to see a hospital doctor during the last 6 months?	Yes		No
If yes, what specialty clinic and how many times?	Rheumatology		times
	Orthopedics		times
	Ophthalmology		times
	Gastroenterology		times
	General		times
	Emergency		times
	Other		times

Have you had any X-rays in the last 6 months?	Yes	No
If so, please indicate how many times.	Times
Have you had bone scan in the last 6 months?	Yes	No
Have you had an MRI in the last 6 months?	Yes	No
Have you had a CT scan in the last 6 months?	Yes	No

COMMUNITY AND OTHER SERVICES

Visits

Please indicate whether and how many times during the past 3 months you have used these services because of your rheumatoid arthritis.

How many times have you been to visit your Family doctor?		times
How many times did you go for blood tests?		times
How many times have you visited the Physiotherapist?		times
How many times have you visited an Occupational Therapist?		times
How many times have you visited the Chiropractor?		times
How many times have you had acupuncture?		times
How many times have you had massage sessions?		times
How many times did you see another health professional?		times

Other Community Services

Please indicate whether and how many times during the past 3 months you have used community services (e.g. home care, nursing care, Meals on Wheels etc.) because of your rheumatoid arthritis.

Have your received help from community services during the past 3 months?	Yes	No
How many times have you received Meals on Wheels	times
Have community or district nurses visited you?	times
Have Social Service personnel visited you?	times
Have you required help with other services during the past 3 months?
Did you require home help?	Hours/week
Did you require child care?	Hours/week
Did you require other services? (specify)	Hours/week
Did you have to pay yourself for any these services?	Yes	No
If yes, approximately how much did these services cost you per week?	$

Investments

Please indicate whether, during the past 3 months , you bought any special aids or devices, or made any investments (e.g. changes in your home or car), because of your rheumatoid arthritis.

During the past 3 months, have you bought any assistive devices for your rheumatoid arthritis, or made any investments (e.g. changes in your home or car)?	*Yes*	No
If yes, please list what they were, how much they cost and whether you paid for them yourself, in full or partly.
	Cost ($)		Amount paid yourself ($)

Over-the-counter drugs

During the past month, have you bought any medicine over-the-counter for your rheumatoid arthritis (non-prescription or alternative medicines)?	*Yes*	No
If yes, please list the name of the product(s) you bought during the past month and the price you paid.
	$
	$
	$
	$
	$

Daily Activities

The following questions refer to your ability to perform your usual daily activities, and help that you may have needed from friends and relatives, during the past month.

Were there days, during the past month, where you were not able to undertake your normal activities, such as housework, gardening, shopping?	*Yes*	No
If yes, how many days?	days
And how many hours on average during such days?	hours

During the past month, did you require help from your family or from your friends to care for you, or help you with your normal activities?	*Yes*	No
If yes, during how many days?	days
And for how many hours per day on average?	hours

On average over the past month, how many hours per week have you received health care for your Rheumatoid Arthritis? hours

ILLNESS-RELATED EMPLOYMENT HISTORY

1.	What is your current work status?
2.	Over your working life, what has been your main occupation?
	(Please be specific. For example, math teacher, civil engineer, car salesperson.)
3.	Before you were diagnosed with rheumatoid arthritis, were you in paid work?
	If yes, how many hours per week, on average did you work?	hours per week.
4.	Over the last 3 months, how many hours a week, on average, did you spend on UNPAID work (i.e. non- leisure activities for which you do not get paid, such as household chores, shopping, or caring for children)	hours per week (OR hours per month)
If you are CURRENTLY EMPLOYED in paid work, please answer questions 5 TO 9. If not, skip to questions 10 & 11.
5.	What is your current occupation? (Again, please be specific.)
6.	How many days over the last 6 months were you unable to work because of your arthritis?	days.
7.	Over the last 6 months, have you changed your general working hours (e.g. full-time vs. half-time) because of your arthritis?
	If yes, by how many hours per week have you reduced?	hours per week
	If yes, was your income reduced?
	If yes, by how much per month?	$/month
8.	On average, how many hours per week did you spend in paid work over the last 6 months?	hours per week (OR hours per month, if applicable)
9.	Did you change jobs over the last 6 months because of a change in your health?
If you are NOT CURRENTLY EMPLOYED, please answer questions 10 & 11
10.	Did you stop working permanently or retire early because of your arthritis?
	If yes, in what year?
11.	Did you stop working permanently or retire early because of another medical reason?
	If yes, in what year?

USE OF MEDICATIONS FOR RHEUMATOID ARTHRITIS

The table below contains a list of medications used to treat rheumatoid arthritis. Please indicate whether you have EVER taken each drug at any time in the past. If you have taken the drug for any length of time DURING THE LAST 6 MONTHS, please enter the dose you are currently taking or, if the drug has been stopped, enter the usual dose that you took and the reason the medication was stopped.

		IF DRUG TAKEN IN THE LAST 6 MONTHS:		If DRUG STOPPED, Reason(s) for stopping:
MEDICATION	Have you EVER taken this drug?	# of months on drug in past 6 months	Dose (milli-grams) & frequency	Not effective	Side effects	Not sure
Biologic Agents Enbrel (etanercept)	Yes No
Humira (adalimumab)	Yes No
Kineret (anakinra)	Yes No
Remicade (infliximab)	Yes No
Other (specify):	Yes No
Disease Modifying Drugs Aralen (chloroquine)	Yes No
Arava (leflunomide)	Yes No
Auranofin (oral gold)	Yes No
Cuprimine (D-penicillamine)	Yes No
Cytoxan (cyclophosphamide)	Yes No
Gold shots (Myochrysine, Solganol)	Yes No
Imuran (azathioprine)	Yes No
Methotrexate (Rheumatrex)	Yes No
Minocycline (Minocin)	Yes No
Neoral (cyclosporin)	Yes No
Plaquenil (hydroxychloroquine)	Yes No
Salazopyrin (sulfasalazine)	Yes No
Prednisone	Yes No
Antiinflammatories (list below )	Yes No
	Yes No
Stomach protectors (list below )	Yes No
Other(s):	Yes No
	Yes No

ArthritisDoctors.ca

The Alberta Rapport Team Data Collection Form for the Study of Biologic Agents in Rheumatoid Arthritis