HAQ Instructions (ARAMIS) 6-30-09

1The Health Assessment Questionnaire (HAQ) © and the Improved HAQ © (formerly called the PROMIS HAQ) Stanford University School of Medicine Division of Immunology & Rheumatology (Revised June 2009) This document describes the classic (“Legacy”) Health Assessment Questionnaire and the Improved HAQ (formerly called the PROMIS HAQ), their history, administration and scoring conventions, and provides information regarding user permission. The Heath Assessment Questionnaire (HAQ) The HAQ was originally developed three decades ago by James F. Fries, MD, and colleagues at Stanford University. Conceived to represent a model of patient-oriented outcome assessment, the HAQ is one of the first instruments to measure patient reported outcomes (PRO). The HAQ is widely used throughout the world. It has been administered in rheumatic disease studies, HIV/AIDS patients, normal aging cohorts, and in population-based studies, including the follow-up to the National Health and Nutrition Examination Survey (NHANES). We refer you to reviews in 1992, 1996, and 2003 (see references), which examine the HAQ’s history and document its reliability, validity, and applicability in multiple settings and languages. The HAQ has been validated in patients with a wide variety of rheumatic diseases, including rheumatoid arthritis, osteoarthritis, juvenile rheumatoid arthritis, lupus, scleroderma, ankylosing spondylitis, fibromyalgia, and psoriatic arthritis. However, the HAQ has been and can be administered in diverse disciplines and in different cultures without any impact on its reliability or validity with properly designed adaptations. The HAQ has played a major role in numerous areas, such as in the prediction of successful aging, inversion of the therapeutic pyramid in rheumatoid arthritis (RA), 2 quantification of NSAID gastropathy, development of risk factor models for osteoarthrosis, and examination of mortality risks in RA. The HAQ has become a de facto mandated outcome measure for clinical trials in rheumatoid arthritis and some other diseases. Although it has sometimes been characterized as a disease-specific instrument rather than having been adjudicated on the basis of its structure, content, and history, the HAQ should be considered generic rather than disease-specific. THE HAQ’S TWO VERSIONS - THE 2-PAGE (SHORT) HAQ-DI AND THE FULL HAQ The HAQ has been administered primarily in one of two versions, the 2-page or short HAQ-DI (Disability Index) or the Full HAQ. The 2-page HAQ-DI has received the widest attention, the most frequent use, and is the most cited version. It assesses the extent of a patient’s functional ability. It is commonly called “the HAQ”, and consists of the HAQ- DI, along with the HAQ Pain Visual Analog Scale (VAS), and the Patient Global Health VAS. These are core items that have not changed since the HAQ’s inception. The Full HAQ is a multi-dimensional instrument. It contains five sections which address generic health dimensions, or the “5 Ds”: (1) disability; (2) discomfort; (3) drug toxicity; (4) health care utilization and cost (“dollars”); and (5) death. It also includes supplemental items on demographics, lifestyle, and health behaviors. Other than the HAQ-DI and the pain and patient global health scales, the additional items on the full HAQ are used primarily by the Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS) to address research areas of interest. Items are tailored and modified as required to address specific hypotheses or research questions. RELIABILITY AND VALIDITY OF THE HAQ-DI The HAQ-DI is sensitive to change and is a good predictor of future disability and costs. It has demonstrated reliability and validity in different languages and contexts. Test- retest correlations range from 0.87 to 0.99. Correlations between interview and questionnaire format range from 0.85 to 0.95. Validity has been demonstrated in literally hundreds of studies. There is consensus that the HAQ-DI possesses face and content validity. Correlations between questionnaire or interview scores and task performance range from 0.71 to 0.95 demonstrating criterion validity. The construct/convergent validity, predictive validity, and sensitivity to change have also been established in numerous observational studies and clinical trials. The HAQ-DI has also demonstrated a high level of convergent validity based on the pattern of correlations with other clinical and laboratory measures. 3 The HAQ-DI is designed to assess the patient’s USUAL abilities using their usual equipment over the past week. Some patients have questioned whether their responses should reflect a particularly good or bad time, which may be out of the time frame requested, because they feel that their response may be missing those times when their functional ability changes. However, by repeating the HAQ at specific and regular time intervals (ARAMIS administers the HAQ every 6 months), patterns of function can be examined. Inquiring about these activities only when patients are feeling particularly good or bad would result in inaccurate and biased data. ADMINISTRATION The Full and the 2-page HAQ are usually self-administered. However, either one can be administered face-to-face in a clinical setting or in a telephone interview by a trained interviewer, Both have been validated in these settings. In ARAMIS, the questionnaire is mailed to patients every six months. They are asked to complete it without additional instructions. The Full HAQ takes 20 to 30 minutes to complete. The 2-page HAQ or the Improved HAQ can be completed in approximately five minutes. Patients usually find the instruments self-explanatory. Clarification is seldom required. STRUCTURE – HAQ-DI The HAQ-DI is composed of 20 items in 8 categories (Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities [IADL} – also see Figure at end of this document). Items were developed to be mutually exclusive and collectively exhaustive of activities related to physical functioning. Each category has at least two sub-category questions. Within each category, patients report the amount of difficulty they have in performing the specific sub-category items. There are four response options ranging from No Difficulty to Unable to Do, scored 0-3. HANDLING RESPONSES Patients should respond to items using their own frame of reference. Thus, the ratings, No, Some, Much, or Unable, are deliberately not operationalized. For example, if a 4 patient asks what “Some” means, an appropriate response would be “Whatever you think ‘Some’ means to you”. When a sub-category item does not apply, e.g., when a patient does not shampoo their hair (perhaps they have no hair), they should give the response that would represent the ability they believe they would have had they been able to attempt the activity. When a patient uses aids or devices (e.g., crutches, jar openers, etc.), then they answer the question based on their usual equipment or way of performing the activity. If they have no difficulty with a sub-category item when using aids/devices (see below for discussion of aids/devices), then they mark the “no difficulty” column. In scoring, the use of aids/devices results in an adjusted score for that item (see below). Improperly Marked Items: When a patient makes a mark between two response options, then the score is the closest one. When it is directly between two response options, use the higher number. Items Left Blank: When all sub-category items in a category are left blank, or when more than one response is given, then follow up with the patient is required. Note: A HAQ-DI score cannot be calculated validly when there are scores for less than six of the eight categories. SCORING The HAQ-DI’s scoring conventions allow for the computation of two disability indices: 1. The Standard HAQ-DI, the preferred and traditional scoring method, which takes into account the use of aids/devices. 2. The Alternative Disability Index, which does not. In any event, a patient must have a score for at least six of the eight categories. Otherwise a HAQ-DI score cannot be validly computed. Computing the Standard HAQ-DI Score (With Aids/Devices): There are three steps: 1. Sum the 8 category scores by using the highest sub-category score from each category. 5  For example, in the category ARISING there are three sub-category items. A patient responds with a 1, 2, and 0, respectively; the category score is 2. 2. Adjust for use of aids/devices and/or help from another person when indicated. The Table below identifies the Aid/Devices companion variable for each HAQ-DI category.  Adjust the score for a category by increasing a zero or a one to a two.  If a patient's highest score for that sub-category is a two it remains a two, and if a three, it remains a three. 3. Divide the summed category scores by the number of categories answered (must be a minimum of 6) to obtain a HAQ-DI score of 0-3 (3=worst functioning). Companion Aids/Devices Items for HAQ-DI Categories HAQ-DI Category Companion Item Dressing & Grooming Devices used for dressing (button hook, zipper pull, long handled shoe horn etc.) Arising Built up or special chair Eating Built up or special utensils Walking Cane walker, crutches Hygiene Raised toilet seat, bathtub seat, bathtub bar Long handled appliances in bathroom Reach Long handled appliances for reach Grip Jar opener (for jars previously opened Notes about Aids/Devices: The assignment of devices to particular disability categories assumes that the devices are used only for their intended purposes, e.g., when a patient indicates that they use a cane, it is presumed that the cane is used as an aid in walking. However, it is possible that patient uses the cane as an aid in performing other activities. For example, the patient may check off the cane listed at the bottom of the page (or write “cane” under the “other” option) and then write a little note in the margin stating that the cane is also used on a regular basis to help them rise out of a chair and to rise off of the toilet. In such a case, the variables should be scored a “1” to reflect the patient’s use of a cane in these three areas of functioning. If unsure whether the patient is using one of the devices specified above for the purpose for which it is designed, the patient should be called for clarification. 6 When there are devices entered in the “Other” section or notes written next to an item, they are considered as being used for any of the stated categories. Permanent adaptations of the person’s environment (e.g., changing faucets in the bathroom or kitchen, using fabric hook and loop closures on clothing) should also be counted as aids/devices. In ARAMIS, few patients have reported “other” items, and when they have, it has usually been either a duplicate of an aid/device already listed, or they have listed something that does not count (e.g., a wrist splint).Thus, it is usually acceptable to exclude the “Other” option, if desired. Computing the Alternative HAQ-DI Score (Without Aids/Devices) The Standard scoring method is preferred and the most common. However, there are circumstances where the alternative score would be preferable, such as when an investigator’s goal is to increase the use of aids/devices. If aids/devices were taken into account, scoring would be biased, and findings would indicate that the study increased HAQ disability scores. There are two steps in computing the alternative HAQ-DI: 1. Sum the scores for each category, ignoring scoring for aids/devices. 2. Divide by the number of categories answered (minimum of 6 required). This yields a score of 0-3 (3=worst disability). 7 The Improved HAQ © (formerly called the PROMIS HAQ) The Improved HAQ (formerly called the PROMIS HAQ) is the first substantial revision of the HAQ-DI since its inception three decades ago. We have revised its name to avoid confusion with official instruments of the Patient Reported Outcomes Measurement Information System (PROMIS). Please see the PROMIS website (http://www.nihpromis.org) for information about the PROMIS Physical Function item bank and short forms and the PROMIS Assessment Center sm . Background The Improved HAQ evolved from its parent, the original Health Assessment Questionnaire Disability Index (HAQ-DI). In the mid-2000s, in collaboration with QualityMetric, Inc. we became one of the six primary research sites in the Patient Reported Outcome Measurement Information System (PROMIS) (www.nihpromis.org ). PROMIS is a component of the National Institutes of Health (NIH) Roadmap Initiative aimed at improving PROs and promoting their broader use by the private and public sectors. Its goal is to improve the quality and efficiency of clinical research; in part by reducing sample sizes required in clinical trials. The Improved HAQ came about in conjunction with our work with PROMIS and followed standardized PROMIS protocols for item development. Original HAQ-DI items underwent qualitative and quantitative psychometric processes to improve their measurement properties. Qualitative evaluation involved a stepwise process that included expert review, patient surveys, focus groups, and cognitive interviewing. Items were then rewritten, field tested, and quantitatively assessed using advanced psychometric methodology. Findings from these analyses indicated that an item was clearer when written in the present tense without a time frame and with more response options. We rewrote original HAQ-DI items by deleting the one-week time frame, retaining the present tense 8 capability framework (“Are you able to ...”),and increasing the response option set from the original four choices (“Without any difficulty; with some difficulty; with much difficulty; and unable to do”) to five by adding “with a little difficulty”. Results of analyses showed that the addition of the fifth response option decreased the number of responses to “without any difficulty”, thereby reducing ceiling effects. This process resulted in HAQ-DI items with better structure, clarity, and reliability. The Improved HAQ contains the same 20 items as the original HAQ-DI. The Figure at the end of this document gives a visual comparison of the two instruments. Overall, its items are clearer, simpler, more clearly understood, assessed more quickly, have less floor and ceiling effects, have greater information content, smaller measurement errors, and are more reliable with better face and content validity and better responsiveness than their original HAQ-DI counterparts. We also reduced aids/devices from 21 to 4 and found that there is no significant effect on scores. We have initially set the scoring scale at 0-100 for ease in computation. However, we continue to investigate alternative scoring algorithms. The figure below shows the comparison of information content between an original HAQ-DI item and an Improved HAQ item (black triangles), which contains five instead of four response options. The scale has zero set at the mean of a normal population, and each integer represents one standard deviation from that mean. The height of the curve above the standard error of zero represents the item information content. The information content of the Improved HAQ item (black triangles) is spread more broadly, meaning that it provides information across a greater range of function. The data show relevant improvements for the Improved HAQ item with respect to measurement range and peak information. 0.00 2.00 4.00 6.00 8.00 -4.00 -3.00 -2.00 -1.00 0.00 1.00 2.00 Theta I t e m i n f o r m a t i o n 9 We recently compared internet with mailed administrations of the original HAQ-DI with the Improved HAQ. We studied response rates, instrument scores, data validity, and sensitivity to change at one year in a group of RA and osteoarthritis participants. We found that the HAQ-DI and the Improved HAQ were similar relative to completion rates and instrument scores, and that they measured the same constructs. Both instruments were sensitive to change, although the Improved HAQ was more responsive than the HAQ-DI after one year. (manuscript under review). Use of the Improved HAQ in clinical research is encouraged, with the understanding that data collected from that use will contribute further to knowledge about the validity of these measures. STRUCTURE – Improved HAQ The Improved HAQ is comprised of the same contextual 20 items contained in the HAQ- DI. All items are better than their original counterparts in all attributes; hence, the Improved HAQ is more reliable, valid, and sensitive to change than the HAQ-DI. We recommend its use in all instances where the HAQ-DI would have been used except in studies in progress where baseline measurements used the HAQ-DI. Modifications in wording from the HAQ-DI were made from findings in item analyses. The items do not contain a time frame, are written in the present tense, and have five response options (the HAQ-DI contains four). Patients respond from 0-4, with 4=worst functioning. In contrast to the HAQ-DI, items in the Improved HAQ are not grouped by physical function category. Rather than listings of aids/devices or assistance as in the HAQ-DI, the Improved HAQ uses four questions asking about use of aids/devices or assistance. The Improved HAQ instrument also includes the HAQ pain and patient global health scales. They are handled as described below. ADMINISTRATION As with the HAQ-DI, patients should use their own frame of reference when responding to items. Thus, the terms None, A Little, Some, Much, or Unable, are deliberately not operationalized. For example, when a patient asks what “Some” means, an appropriate 10 response would be “Whatever ‘Some’ means to you”. When an item does not apply to a patient, e.g., they don’t shampoo their hair (perhaps they have no hair), they give the response that would represent the ability they believe they would have had they attempted the activity. HANDLING RESPONSES Improperly Marked Items. When a patient’s mark is between the response columns, then the score is the closest one. If it’s directly between, use the higher number. Items Left Blank. When more than one response to an item is given, then follow-up with the patient is required. Note: An Improved HAQ score cannot be calculated validly if there are responses to fewer than 15 of the 20 items. SCORING The Improved HAQ results in a score from 0-100 and is computed as follows: 1. Each item is scored a 0, 1, 2, 3, or 4. 2. If any of the aids/devices items are answered “yes”, then first adjust the score. If it is a 0, 1, or 2 for any of the associated items (see below for listing) the score for that item is raised to a 3 before computing a score. An item scored 4 remains a 4. 3. Sum the 20 items and divide by 20 to yield an average score from 0 to 4. Multiply by 25 to convert the score to 0-100. Alternative Scoring Methods Two alternative scoring methods are being evaluated in parallel and offer some advantages. Ultimately, we will recommend the method that is most sensitive to change. 1. Using all 20 items, divided into 8 categories. After #1 above average the highest items in each of the 8 categories, then multiply by 25. 2. Using 16 items, 8 categories. 11 The following items are deleted from the 20-item Improved HAQ to comprise a 16-item HAQ: (1) stand up from an armless straight chair (2) cut your food using eating utensils (3) walk a block on flat ground (4) reach and get down a 5-pound object from above your head. After completing step 1 above, average the highest items in each of the 8 categories, then multiply by 25. Aids/Devices The table below shows the Improved HAQ’s four aids/devices items with their companion Improved HAQ items and associated HAQ-DI categories. There are no associated aids/devices question for Improved HAQ items #2, 4, 5 -7, 10, 11, 14-17 ,19, or 20 (See HAQ instrument). Improved HAQ Aids/Devices Items Companion Improved HAQ Items Associated HAQ-DI Category(ies) 1. To get around, do you usually need a cane, crutches, walker, wheelchair, or help from another person? 8, 9, 1 Walking 2. To stand up from a sitting position, do you usually need a special chair, a raised toilet seat, or help from another person? 3,12 Arising Hygiene 3. To get dressed, do you usually need a buttonhook, zipper pull or other gadget, or help from another person? 1 Dressing/ Grooming 4. To reach something, do you usually use long-handled appliances or help from another person? 13 Reach Hygiene 12 USER PERMISSION The HAQ-DI and the Improved HAQ are copyrighted to insure that they will be used unmodified to preserve the validity of results and contribute to standardization of assessment across studies. However, both are considered to be in the public domain, with the request that users cite relevant articles(s) in their publications (see references at the end of this document). There is no charge from Stanford for permission to use the HAQ-DI or the Improved HAQ. However, other groups which have independently translated the HAQ may charge for their use. Permission from PROMIS is not needed to use the Improved HAQ. 13 FIGURE. Content and Configuration Comparison of the HAQ-DI and The Improved HAQ Items common to the HAQ-DI and the Improved HAQ 1. Dress yourself, including shoelaces and buttons? 2. Shampoo your hair? 3. Stand up from a straight chair 4. Get in and out of bed 5. Cut your own meat? 6. Lift a full cup or glass to your mouth? 7. Open a new milk carton? 8. Walk outdoors on flat ground? 9. Climb up five steps? 10. Wash and dry your body? 11. Take a tub bath? 12. Get on and off the toilet? 13. Reach and get down a 5 pound object (such as a bag of sugar) from above your head? 14. Bend down to pick up clothing from the floor? 15. Open car doors? 16. Open previously opened jars 17. Turn faucets on and off? 18. Run errands and shop? 19. Get in and out of a car? 20. Do chores such as vacuuming or yard work? Instrument HAQ-DI Improved HAQ Time Frame (past tense) Over the past week, are you able to… (present tense) Are you able to… Response Options (n=4) Without any difficulty, With some difficulty, With much difficulty, Unable to do (n=5) Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do Aids/Devices (n=21) Please check any categories for which you usually need help from another person: 1. Dressing and grooming 2. Eating 3. Walking 4. Arising Please check any aids or devices that you usually use: 5. Devices used for dressing (button hook, zipper pull, etc.), 6. Built up or special utensils 7. Crutches 8. Cane 9. Walker 10. Wheelchair 11. Special or built up chair 12. Raised toilet seat 13. Long-handled appliances for reach 14. Bathtub seat 15. Bathtub bar 16. Long-handled appliances in bathroom 17. Jar opener (for jars previously opened) Please check any categories for which you usually need help from another person: 18. Hygiene 19. Reach 20. Gripping and opening things 21. Errands and chores (n=4) For each of the following questions, please answer by placing an “X” in the appropriate box: [Response options - Yes/No] 1. To get around, do you usually need a cane, crutches, walker, wheelchair, or help from another person? 2. To stand up from a sitting position, do you usually need a special chair, a raised toilet seat, or help from another person? 3. To get dressed, do you usually need a buttonhook, zipper pull or other gadget, or help from another person? 4. To reach something, do you usually use long-handled appliances or help from another person? 14 The HAQ Pain Visual Analog Scale (VAS) The he HAQ Pain Scale assesses arthritis-related pain and its severity over the PAST WEEK on a double-anchored VAS (a horizontal line where each end represents opposite ends of a continuum). It obtains data on how arthritis-related pain has USUALLY been over the past week, even though pain may be reported to vary over the course of a day or from day to day. The VAS line is standardized to 15 centimeters in length, which is convenient for the page and the patient. The scale is labeled from zero (no pain) at the left anchor point and 100 (severe pain) at the right anchor point. Patients are instructed to place a vertical mark on the line to indicate the severity of their pain. HANDLING RESPONSES  When a patient writes in a number on the pain scale, or writes a number in addition to making a mark, use the written number, converting it to the corresponding score. In this case, do not measure the mark. For example, if the patient writes “50” on the line, this should be coded as 1.5 (see below for scoring computation).  When a patient records a percentage, multiply the percentage by 3.  When a patient puts more than one mark, the midpoint is used.  When a patient makes a horizontal line below the pain scale, instead of a vertical one, the midpoint of that line is taken. If the line starts at the beginning of the scale, measure to the end of the line not the middle. COMPUTING THE PAIN SCORE Using a metric ruler, from zero to the patient’s mark, measure the distance in centimeters and multiply by 0.2. This converts centimeters into the appropriate metric and yields a score from 0 to 3. For example, if the mark is at 8 centimeters, 8 x 0.2 yields a pain score of 1.6. The table below shows measurement conversions. Alternatively, a 0-100 mm scale may be used, which requires no score conversion. 15 Conversion of Centimeter Measurements to Pain Scores Centimeters  Score Centimeters  Score Centimeters  Score 0 = 0 4.8 - 5.2 = 1.0 10.3 - 10.7 = 2.1 0.1 - 0 .7 = 0.1 5.3 - 5.7 = 1.1 10.8 - 11.2 = 2.2 0.8 - 1.2 = 0.2 5.8 - 6.2 = 1.2 11.3 - 11.7 = 2.3 1.3 - 1.7 = 0.3 6.3 - 6.7 = 1.3 11.8 - 12.2 = 2.4 1.8 - 2.2 = 0.4 6.8 - 7.2 = 1.4 12.3 - 12.7 = 2.5 2.3 - 2.7 = 0.5 7.8 - 8.2 = 1.6 12.8 - 13.2 = 2.6 2.8 - 3.2 = 0.6 8.3 - 8.7 = 1.7 13.3 - 13.7 = 2.7 3.3 - 3.7 = 0.7 8.8 - 9.2 = 1.8 13.8 - 14.2 = 2.8 3.8 - 4.2 = 0 .8 9.3 - 9.7 = 1.9 14.3 - 14.7 = 2.9 4.3 - 4.7 = 0 .9 9.8 - 10.2 = 2.0 14.8 - 15.0 = 3.0 THE HAQ PATIENT GLOBAL VAS The HAQ Patient Global Health VAS is a validated measure of quality of life. Fries and Ramey compared the HAQ Global to the Torrance quality-of-life “feeling thermometer” and found the two scales to be highly correlated (r = -0.676; p<0.001), indicating that both instruments were measuring similar quality of life constructs (see Fries and Ramey 1997). The Global VAS is also a 15-centimeter, double-anchored horizontal scale that starts at 0 (very well) and goes to 100 (very poor). Handling responses and scoring are the same as the Pain Scale (please see above). 16 References Bruce B, Fries JF The Stanford health assessment questionnaire (HAQ): a review of its history, issues, progress, and documentation. J Rheumatol 2003;30(1): 167-178. Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, et al. The patient reported outcomes measurement information system (PROMIS): Progress of an NIH roadmap cooperative group during its first two years. Medical Care 2007;45:S3-S11. Fries JF, Bruce B, Cella D. The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes. Clin Exp Rheumatol 2005;23(5 Suppl 39):S53-7. Fries JF, Bruce B, Cella D. The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes. Clin Exp Rheumatol 2005;23(5 Suppl 39):S53-7. Fries JF, Spitz PW, et al. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23(2): 137-45. Fries JF, Spitz PW, et al. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 1982;9(5): 789-93. Fries, JF, Ramey DR. "Arthritis specific" global health analog scales assess "generic" health related quality-of-life in patients with rheumatoid arthritis. J Rheumatol 1997;24(9): 1697-702. Ramey D, Fries JF, et al. (1995). The Health Assessment Questionnaire 1995 - status and review. quality of life and pharmacoeconomics in clinical trials. S. B. Philadelphia, Lippincott-Raven Publishers: 227-237. Ramey DR, Raynauld JP, et al. The health assessment questionnaire 1992: status and review" Arthritis Care Res 1992;5(3): 119-29.