Measuring Quality in Arthritis Care: The Arthritis Foundation s Quality Indicator Set for Osteoarthritis

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1 Arthritis & Rheumatism (Arthritis Care & Research) Vol. 51, No. 4, August 15, 2004, pp DOI /art , American College of Rheumatology ORIGINAL ARTICLE Measuring Quality in Arthritis Care: The Arthritis Foundation s Quality Indicator Set for Osteoarthritis JAMES N. PENCHARZ 1 AND CATHERINE H. MACLEAN 2 Objective. To develop a comprehensive set of explicit process measures to assess the quality of health care for osteoarthritis and to describe the scientific evidence that supports each measure. Methods. Through a comprehensive literature review, we developed potential quality measures and a summary of existing data to support or refute the relationship between the processes of care proposed in the indicators and relevant clinical outcomes. The proposed measures and literature summary were presented to a multidisciplinary panel of experts in arthritis and pain. The panel rated each proposed measure for its validity as a measure of health care quality. Results. Among 22 measures proposed for osteoarthritis, the expert panel rated 14 as valid measures of health care quality. Conclusion. Sufficient scientific evidence and expert consensus exist to support a comprehensive set of measures to assess the quality of heath care for osteoarthritis. These measures can be used to gain an understanding of the quality of care for patients with osteoarthritis. KEY WORDS. Osteoarthritis; Quality indicators; Patient safety. INTRODUCTION Osteoarthritis (OA) is the most common form of arthritis (1). It is a degenerative joint disease that affects 12% of the general population, with prevalence increasing with age. Between 60% and 70% of individuals aged 65 years or older show radiographic changes consistent with OA, and about half of these meet classification criteria for the disease by reporting joint pain or stiffness (2). Pain and disability are the most common consequences of OA joint damage (3). Consequently, the therapeutic goals for OA are to improve patients joint pain and function (4). Although efficacious therapies exist to achieve this goal, some barriers, such as medication toxicities and Supported by a contract from the Arthritis Foundation to RAND. Mr. Pencharz s work supported by a graduate student scholarship from the Canadian Arthritis Network and a grant from the Arthritis Health Professions Association. 1 James N. Pencharz, BScKin, MSc: Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada and RAND, Santa Monica, California; 2 Catherine H. MacLean, MD, PhD: RAND, Santa Monica, California and University of California Los Angeles. Address correspondence to Catherine H. MacLean, MD, PhD, RAND, 1700 Main Street, M-23C, Santa Monica, CA maclean@rand.org. Submitted for publication November 17, 2002; accepted in revised form April 25, behavior change (e.g., exercise, weight loss), may limit their effectiveness. Little is known about the quality of care for patients with OA. Previous studies on the management of OA suggest that utilization of recommended and efficacious interventions varies according to physician type (5,6). Furthermore, surveys of physicians indicate variation in clinicians knowledge, perceptions, and attitudes about the management of OA (7 10). One objective of the Arthritis Foundation Quality Indicator Project is to develop a set of quality indicators that could be used to measure quality of care for OA. On the basis of a comprehensive literature review, a set of process indicators to assess the quality of health care for individuals with OA was developed. This article reviews the evidence on which the indicators are based. METHODS The methods for developing these quality indicators, including the literature review and expert panel consideration, are detailed in a previous article (11). Briefly, we searched for and reviewed guidelines for the treatment of OA and existing quality measures for OA. Based on this review, we developed a preliminary set of quality measures for OA aiming to cover the domains of prevention, characterization of disease severity, diagnosis, 538

2 Measuring Quality in Arthritis Care: Osteoarthritis 539 Table 1. The Arthritis Foundation s quality indicators for osteoarthritis Topic area Physical examination Pain and functional assessment Education Exercise Weight loss Assistive devices Pharmacologic therapy Surgery Radiographs Quality indicator 1. IF a patient is begun on a drug treatment for joint pain, arthritis, or arthralgia, THEN evidence that the affected joint was examined should be documented. 2. IF a patient is diagnosed with symptomatic osteoarthritis of the knee or hip, THEN his or her pain should be assessed annually and when new to a practice. 3. IF a patient is diagnosed with symptomatic osteoarthritis of the knee or hip, THEN his or her functional status should be assessed annually and when new to a practice. 4. IF a patient has had a diagnosis of symptomatic osteoarthritis of the knee or hip for 3 months, THEN education about the natural history, treatment, and self management of osteoarthritis should have been given or recommended at least once. 5. IF an ambulatory patient has had a diagnosis of symptomatic osteoarthritis of the knee or hip for 3 months AND has no contraindication to exercise and is physically and mentally able to exercise, THEN a directed or supervised muscle strengthening or aerobic exercise program should have been prescribed at least once and reviewed at least once per year. 6. IF an individual is overweight (as defined by body mass index of 27 kg/m 2 ), THEN the individual should be advised to lose weight annually. 7. IF a patient has symptomatic osteoarthritis of the knee or hip and is overweight (as defined by body mass index of 27 kg/m 2 ), THEN the patient should be advised to lose weight at least annually AND the benefit of weight loss on the symptoms of osteoarthritis should be explained to the patient. 8. IF a patient has symptomatic osteoarthritis of the knee or hip and has been overweight (as defined by body mass index of 27 kg/m 2 ) for 3 years, THEN the patient should receive referral to a weight loss program. 9. IF a patient has had symptomatic osteoarthritis of the knee or hip and reports difficulty walking to accomplish activities of daily living for more than three months, THEN the patient s walking ability should be assessed for need for ambulatory assistive devices. 10. IF a patient has a diagnosis of osteoarthritis and reports difficulties with nonambulatory activities of daily living, THEN the patient s functional ability with problem tasks should be assessed for need of nonambulatory assistive devices to aid with problem tasks. 11. IF a nonnarcotic pharmacologic therapy is initiated to treat osteoarthritis pain of mild or moderate severity, THEN acetaminophen should be the first drug used, unless there is a documented contraindication to use. 12. IF oral pharmacologic therapy for osteoarthritis is changed from acetaminophen to a different oral agent, THEN there should be evidence that the patient has had a trial of maximum dose acetaminophen (suitable for age/comorbidities). 13. IF a patient with severe symptomatic osteoarthritis of the knee or hip has failed to respond to nonpharmacologic and pharmacologic therapy, THEN the patient should be offered referral to an orthopedic surgeon. 14. IF a patient has hip or knee osteoarthritis AND has worsening complaints accompanied by a progressive decrease in activities AND no previous radiograph during the preceding 3 months, THEN a knee or hip radiograph should be performed within 3 months. and treatment. The preliminary indicators were reviewed and modified by an external advisory board of senior clinicians. We performed a comprehensive literature review for evidence to support or refute each of the proposed indicators. A structured search identified 2,058 titles from which abstracts and articles relevant to this report were identified. Additional evidence was extracted from the reference lists of identified articles, clinical practice guidelines for OA, the authors own extensive files from previous related work (12,13), and comments from expert external reviewers. The guidelines, existing quality indicators, and evidence to support or refute each indicator were summarized in a monograph; in instances where there was no evidence to support a proposed indicator, this was stated. A multidisciplinary expert panel comprised of nationally recognized experts discussed and rated the validity of each of the proposed measures based on the evidence presented in the monograph and their expert opinion using a modification of the RAND/UCLA Appropriateness Method (14). In total, 22 potential indicators were rated by the expert panel, including 18 preliminary indicators and an additional 4 indicators that were proposed by the expert panel. RESULTS Of the 22 total potential quality indicators, 14 were judged to be valid measures of quality for OA by the expert panel (Table 1). A summary of the evidence about the relationship between the process of care described in each indicator and relevant health outcomes is provided below for each of the indicators judged to be valid by the expert panel. Quality indicator 1. Physical examination for diagnosis.

3 540 Pencharz and MacLean IF a patient is begun on a drug treatment for joint pain, arthritis, or arthralgia, THEN evidence that the affected joint was examined should be documented BE- CAUSE physical examination is necessary to diagnose the etiology of the pain correctly and to evaluate response to drug therapy. Supporting evidence. The literature review identified no clinical or observational studies that demonstrated the necessity of examining the joints and periarticular structures to correctly diagnose OA. Given the very high prevalence of OA in the elderly, it is likely that most elderly patients who complain of joint pain have OA. However, patients with soft tissue injuries and occult fractures may complain of the same symptoms as patients with OA. Both the American College of Rheumatology (ACR) (4) and the American Board of Family Practice (ABFP) (15) recommend examination of the joints and periarticular structures in patients who complain of joint pain. Quality indicator 2. Initial and annual functional status assessment. IF a patient has a diagnosis of symptomatic osteoarthritis of the knee or hip, THEN his or her functional status should be assessed upon diagnosis OR introduction into a new practice AND should be assessed annually BECAUSE this information should direct therapeutic decisions. Supporting evidence. The literature review identified no clinical or observational studies that evaluated the relationship between functional assessment and clinical decision making. However, because improving function is 1 of the 2 primary goals in the treatment of osteoarthritis (4), it would seem that assessing this parameter is essential to clinical decision making. Assessment of function is implicitly recommended by the ACR (4) in their guidelines for OA. The ABFP (15) specifically recommends assessing functional status during the evaluation of patients with arthritis. Quality indicator 3. Initial and annual pain assessment. IF a patient has a diagnosis of symptomatic osteoarthritis of the knee or hip, THEN his or her pain should be assessed upon diagnosis OR introduction into a new practice AND should be assessed annually BECAUSE this information should direct therapeutic decisions. Supporting evidence. The literature review identified no clinical or observational studies that evaluated the relationship between pain and clinical decision making. However, because improvement of pain is 1 of the 2 primary goals in the treatment of OA (4), it would seem that assessing this parameter is essential to clinical decision making. Assessment of pain is implicitly recommended by the ACR (4) in their guidelines for OA. The ABFP (15) specifically recommends assessing pain during the evaluation of patients with arthritis. Quality indicator 4. Patient education. IF a patient has had a diagnosis of symptomatic osteoarthritis of the knee or hip for 3 months, THEN education about the natural history, treatment, and self management Table 2. Pooled effect sizes for patient education controlled trials among patients with arthritis* Pooled pain effect size (95% CI) Pooled disability effect size (95% CI) All studies 0.17 ( 0.31, 0.65) 0.03 ( 0.41, 0.47) OA studies 0.16 ( 0.69, 1.02) 0.0 ( 0.61, 0.61) RA studies 0.16 ( 0.18, 0.50) 0.18 ( 0.27, 0.63) * Adapted from Superio-Cabuslay et al (17). 95% CI 95% confidence interval; OA osteoarthritis; RA rheumatoid arthritis. Effect size weighted according to sample size. Values are based on effect sizes calculated separately for each treatment group. of osteoarthritis should have been given or recommended at least once BECAUSE this education will improve patient knowledge about the disease and its treatments, selfefficacy, pain, and functional ability. Supporting evidence. The literature search identified 2 published meta-analyses of the effectiveness of patient education on pain and disability among individuals with arthritis (16,17). The more recent meta-analysis included articles published between 1966 and 1993 (17). We conducted a supplementary literature search between the years 1993 and 2002, which identified 12 additional randomized controlled trials (RCTs) or controlled clinical trials (CCTs) applicable to this indicator (18 29). Superio-Cabuslay and colleagues (17) identified 13 controlled trials of patient education, 10 of which included patients with OA exclusively or predominantly. To standardize outcome measures, the authors calculated the standard gain difference as a measure of effect size. The effect size estimates were calculated to ensure that positive values indicated that the intervention group experienced greater improvement than the control group. The pooled study effect size was an average of all the study effect sizes, weighted by sample size. In this meta-analysis, the education interventions had small to moderate nonsignificant effects (i.e., crossing the null) on pain and function (Table 2). For the 2 trials published before and the 10 trials published after, but not included in the Superio-Cabuslay meta-analysis, we calculated standardized mean difference (SMD) effect sizes (Hedge s adjusted g), if the necessary components were reported within the published article. Positive effect sizes indicate an intervention group advantage over the control group. Among the 4 studies (22,26,27,29) that reported self efficacy, 3 had statistically significant effect sizes (22,26,27). The effect sizes for these trials ranged from moderate (SMD 0.73, 95% confidence interval [95% CI] ) (29) to large (SMD 7.34, 95% CI ) (22). Similarly, of the 6 studies reporting results on arthritis (19,24,25,27,28) or medication knowledge (26), all 6 reported statistically significant improvements in the intervention group s knowledge compared with the control group. The effect sizes for these trials were large and ranged from 0.88 (95% CI ) (27) to 4.16 (95% CI ) (19). In contrast, only 2 of 10 trials reported statistically significant improvement in the intervention group s function

4 Measuring Quality in Arthritis Care: Osteoarthritis 541 compared with the control group. The effect sizes for these trials were 0.36 (95% CI ) (20) and 0.44 (95% CI ) (19). Similarly, only 2 of the 9 trials reported a statistically significant improvement in the intervention group s pain compared with the control group. The effect sizes for these trials were 0.38 (95% CI ) (19) and 0.56 (95% CI ) (22). The ACR (4,30), the ABFP (14), and the American Pain Society (APS) (31) guidelines for the treatment of osteoarthritis cite education as a nonpharmacologic treatment option. The Assessing Care of Vulnerable Elders (ACOVE) Quality Indicators for Management of Osteoarthritis contain patient education indicators for 2 separate patient populations: incident OA ( 6 months) and prevalent OA ( 12 months) (12). Quality indicator 5. Exercise for patients with knee and hip osteoarthritis. IF an ambulatory patient has had a diagnosis of symptomatic osteoarthritis of the knee or hip for 3 months AND has no contraindications to exercise and is physically and mentally able to exercise, THEN a directed or supervised muscle strengthening or aerobic exercise program should have been prescribed at least once and reviewed at least once per year BECAUSE directed or supervised exercise programs improve functional ability and reduce pain. Supporting evidence. The literature search identified a recently completed systematic review, which included 11 trials that evaluated the effectiveness of therapeutic exercise for patients with knee and hip OA in improving pain and self-reported disability (32). Effect sizes for these outcomes could be calculated for 7 of these studies. The effect size calculated was Hedge s g statistic for continuous data. Among the 6 studies that evaluated the effect of exercise on pain, 4 demonstrated statistically significant positive effect sizes (95% CIs not crossing null value) with small to medium effect sizes. Five studies reported on patients function. Four of these studies had statistically significant positive effect sizes that were small, medium, or large. In the fifth study, the effect size was negative. We also identified an additional 10 clinical trials (33 42) that have been published since van Baar and colleagues completed their systematic literature search (32). We calculated the SMD for those trails that included the necessary components within the published manuscript. Five of the 8 of the trials reporting results on patientreported disability (33 36,38 40,42) showed statistically significant improvements in the intervention group compared with the control group (34,35,38 40). These improvements are evidenced by effect sizes that ranged from small (39) to large (34). All but 1 of the trials (34) reported results on patientreported pain. Five of the trials reported statistically significant improvements in the intervention group compared with the control group (33,35,38 40). These improvements are evidenced by effect sizes that ranged from moderate (40) to large (35). The ACR, the ABFP (15), the American Academy of Orthopedic Surgeons (AAOS) (43), the American Geriatrics Society (44), the APS (31), and the Philadelphia Panel evidence-based guidelines (45) recommend exercise for the treatment of osteoarthritis of the knee and hip. The ACOVE Quality Indicators for Management of Osteoarthritis contain exercise indicators for 2 separate patient populations: incident OA ( 6 months) and prevalent OA ( 12 months) (4,12). Quality indicator 6. Weight loss to prevent incident knee or hip osteoarthritis. IF an individual is overweight (as defined by body mass index of 27 kg/m 2 ) (46), THEN the individual should be advised to lose weight annually BECAUSE weight loss reduces the risk of developing symptomatic knee and hip osteoarthritis. Supporting evidence. We did not identify any randomized or controlled clinical trails evaluating the relationship between weight loss among overweight individuals and incident knee OA. We identified numerous observational, case-control or cross-sectional studies evaluating this relationship (47 55), which we have summarized in Table 3. These studies demonstrate correlations between present elevated body mass index (BMI) and increased risk of having symptomatic (odds ratio [OR] per 1 unit increase in BMI among women: 1.16, 95% CI ) or radiographic OA (OR per 1 unit increase in BMI for tibiofemoral joint osteophytes: 1.63, 95% CI ) (49,50). They also demonstrate that elevated baseline BMI increases the odds of developing knee OA during followup (54,55). We also identified 3 studies that investigated the relationship between weight loss among overweight individuals and incident knee OA. The Framingham knee osteoarthritis study (47) used a historic cohort analysis to demonstrate that women who lost 2 units of BMI during 10 years of followup had an adjusted OR of 0.46 (95% CI ) for developing symptomatic knee OA during that time. Next, Felson and colleagues (51) investigated the impact of weight change on the development of radiographic OA among a cohort of individuals without knee OA over an 8-year followup period. They found that a 10-lb weight gain was correlated with an increased odds of developing knee OA (OR 1.4, 95% CI ). This finding was significant among women (OR 1.6, 95% CI ) but not among men (OR 0.9, 95% CI ). Weight loss (i.e., 5 lb) did not significantly reduce the participants odds of developing knee OA during followup (OR 0.5, 95% CI ). Shiozaki and colleagues (53) followed the impact of weight changes on the development and progression of knee OA among 608 women over 14 years. They found that individuals in the highest BMI quintile (BMI kg/m 2 ) at baseline had a significant increased risk of developing incident radiographic knee OA (relative risk [RR] 3.60, 95% CI ). Interestingly, if individuals lost 2 or more units of BMI during followup, their risk of developing or having radiographic progression of knee OA was reduced by 20% (RR 0.81, 95% CI ). We did not identify any studies investigating the relationship between weight loss among overweight individ-

5 542 Pencharz and MacLean Table 3. Summary of studies investigating the influence of obesity on the incidence of knee or hip OA* Author (ref.), year Population and study design Findings Felson et al (47), 1992 Spector et al (48), women, without OA at baseline, enrolled in an observational cohort with biennial examinations, including BMI At 18 th biennial exam, the presence or absence of symptomatic knee OA was determined 1.26 ( ) for baseline BMI Year of onset of symptomatic OA determined by patient self report at 18 th biennial exam 1.11 ( ) for weight gain 0.46 ( ) for weight loss 58 women with unilateral knee OA Clinical assessment, including BMI calculation and radiographs taken of both knees at baseline and 24-month followup Adjusted odds ratio for developing symptomatic knee OA over the past 10 years per 2 units of BMI (95% CI) Baseline BMI was the most important factor associated with incidence of OA in the contralateral knee RR 4.69 ( ) for BMI 26 kg/m 2 Radiographs scored for presence of OA and severity of OA disease RR 2.50 ( ) for BMI kg/m 2 Hochberg et al Cross-sectional cohort of 465 men and 275 women Adjusted odds ratio of having current knee OA (49), 1995 Clinical assessment, including BMI and radiographs to determine the presence of knee OA Per 1 unit change in BMI (male): 1.17 ( ) Per 1 unit change in BMI (female): 1.16 ( ) Cicuttini et al (50), 1996 Felson et al (51), 1997 Cross-sectional twin study, 329 twin pairs Clinical assessment, including BMI calculation and radiographs Twins discordant on the presence of knee OA (i.e., 1 twin has knee OA, the other does not) compared according to BMI 598 individuals enrolled in an observational cohort with biennial examinations, including weight and BMI determination At 22 nd biennial exam, the incidence of knee OA was determined among those with no knee OA at 18 th biennial exam using radiographic criteria of Kellegren and Lawrence grade 2 Adjusted odds of developing tibiofemoral joint osteophytes per 1 unit increase in BMI 1.63 ( ) Adjusted odds of developing patellofemoral joint osteophytes per 1 unit increase in BMI 1.32 ( ) Adjusted odds of incident knee OA per 10-lb change in weight from baseline to followup Everyone: 1.4 ( ) Males: 0.9 ( ) Females: 1.6 ( ) Adjusted odds of incident knee OA Gaining 5 lb: 3.8 ( ) Losing 5 lb: 0.5 ( ) Cooper et al Case-control study evaluation of Adjusted odds of having hip OA by BMI tertile (52), cases with hip OA on waiting list for total joint replacement 24.5 kg/m age-matched controls from general population (excluded patients with previous hip surgery kg/m ( ) 28.0 kg/m ( ) Shiozaki et al Prospective cohort of 608 Japanese women followed for 14 years Relative risk of incident knee OA by BMI quintile (53), 1999 Clinical assessments including BMI calculation and radiographs taken at baseline and at 7- and 14-years followup kg/m 2 : 0.78 ( ) Individuals grouped into 5 BMI quintiles kg/m 2 : 1.53 ( ) kg/m 2 : 1.00 (reference) kg/m 2 : 1.79 ( ) kg/m 2 : 3.60 ( ) Relative risk of incident knee OA or progression 2-unit BMI increase: 1.05 ( ) Gelber et al (54), 1999 Cooper et al (55), 2000 Prospective cohort of 1,132 men initiated in 1947 BMI recorded between ages of 20 and 49 years Incidence of knee OA highest among the highest BMI category ( 24.7 kg/ m 2 ) for each 10-year age group (P 0.001) Incidence of knee or hip OA determined using mailed questionnaire and corroborated by physician Incidence of hip OA increased across changes in BMI categories 0.3 kg/ m 2, kg/m 2, 2.3 kg/m 2 (P 0.05) Prospective cohort of 354 individuals from a large general practice in Great Britain followed for 5 years Baseline clinical assessment determined the presence or absence of knee OA, including radiographs and BMI At followup a clinical assessment was performed to determine incidence or progression of knee OA, using radiographs Adjusted odds of incident radiographic knee OA ( grade 2) by baseline BMI group 22.7 kg/m 2 : 1.00 (reference) kg/m 2 : 6.6 ( ) 25.4 kg/m 2 : 18.3 ( ) *OA osteoarthritis; BMI body mass index; 95% CI 95% confidence interval; RR relative risk. P 0.05.

6 Measuring Quality in Arthritis Care: Osteoarthritis 543 Table 4. Controlled trials of the effects of weight loss on osteoarthritis symptoms Author (ref.), year N Intervention Control Weight loss advantage in intervention group Improvement in OA symptoms Williams and Foulsham 22 Exercise, appetite suppressant* Exercise only Yes No (57), 1981 Toda et al (58), Appetite suppressant, NSAID NSAID only Yes Yes Huang et al (60), Weight reduction electrotherapy Electrotherapy only Yes Yes Messier et al (59), Exercise, diet counseling Exercise only Yes Yes Toda (61), Diet therapy exercise# Exercise# Yes Yes * Phentermine. Mazindol. Acemetacine. NSAID nonsteroidal antiinflammatory drug. Improvements did not correlated with weight loss. Authors did not correlated improvements with weight loss. # Exercise status could be control, aerobic exercise, or muscle strengthening exercise. uals and incident hip OA. After the expert panel meeting, we did identify a systematic review, including 1 prospective cohort study, 4 case-control studies, and 7 cross-sectional studies, that suggested overweight individuals have 2 times the risk of developing hip OA (56). No guidelines or quality indicators have been developed that recommend weight loss to prevent incident knee or hip OA. Quality indicator 7. Weight loss to reduce symptoms of OA. IF a patient has symptomatic osteoarthritis of the knee or hip and is overweight (as defined by body mass index of 27 kg/m 2 ), THEN the patient should be advised to lose weight at least annually AND the benefit of weight loss on the symptoms of osteoarthritis should be explained to the patient BECAUSE weight loss will improve joint pain and functional ability. Quality indicator 8. Referral to weight loss program. IF a patient has symptomatic osteoarthritis of the knee or hip and has been overweight (as defined by body mass index of 27 kg/m 2 ) for more than 3 years, THEN the patient should receive a referral to a weight loss program BECAUSE the patient may not have the expertise necessary to facilitate weight loss in the face of arthritis. Supporting evidence. The literature review identified 3 observational studies that provide indirect evidence supporting an influence of weight loss on the clinical (47) or radiographic (51,55) progression of knee OA. We also identified 5 controlled studies that directly examined the relationship between weight loss, pain, and disability in overweight individuals with OA (57 61). Table 4 displays the sample size and summary of the treatments provided to the study intervention and control groups. All the trials demonstrated a statistically significant weight loss advantage in the intervention groups compared with the control groups. Two of the trials reported concurrent improvements in OA symptoms (58,59). Two other trials were able to correlate weight loss success with improvements in OA symptoms (60,61). The ACR (4) and APS (31) guidelines for medical management of hip or knee OA recommend weight loss to improve joint pain and function. No quality indicators have been developed that recommend weight loss to improve joint pain or function for prevalent knee or hip OA. Quality indicator 9. Ambulatory assistive devices. IF a patient has a diagnosis of symptomatic osteoarthritis of the knee or hip and reports difficulty walking to accomplish activities of daily living for 3 months, THEN the patient s walking ability should be assessed for need of ambulatory assistive devices BECAUSE these devices will improve walking and help maintain function and independence. Supporting evidence. We did not identify any RCTs or CCTs evaluating the effectiveness of canes among individuals with OA. We were able to identify 1 survey of 144 regular cane users (including 77 patients with self-reported joint problems) (64). Patients reported performing more functional tasks and feeling significantly more confident in their functional ability when using their cane compared with when not using a cane. Sasaki and Yasuda (65) reported that patients who had received insoles and used them had less walking pain and better walking ability than patients who had not received insoles. Maillefert and colleagues (66) recently reported an RCT of 156 patients with medial knee OA. Patients were allocated to use either a 5 laterally wedged insole or a neutral insole. At 6-months followup, the 2 groups reported similar levels of pain and disability but the intervention group had used less nonsteroidal antiinflammatory drugs (NSAIDs) during the past 3 months. We were able to identify only 1 study that biomechanically analyzed walking in people with gonarthrosis. Draper and colleagues (67) demonstrated that patients with a varus deformity, wearing a valgus brace, can improve gait nearly to the point of perfect symmetry. Two research groups have reported on longitudinal studies of patients who used knee braces. At followup, patients in both studies reported less pain, being able to do more ambulatory functional tasks, and having less difficulties with when performing them (68,69). One research group had conducted an RCT of knee brac-

7 544 Pencharz and MacLean ing in patients with varus gonarthrosis. Kirkley and colleagues (70) reported that at 6-months followup, the patients who had received the unloader brace had significantly lower levels of pain and disability than the controls who had received medical care only. The ACR (4) and APS (31) guidelines for medical management of hip or knee OA recommend the use of assistive devices in some patients to improve joint pain and stiffness. No quality indicators have been developed that recommend assistive devices for knee or hip OA. Quality indicator 10. Activities of daily living assistive devices. IF a patient has a diagnosis of osteoarthritis and reports difficulties with nonambulatory activities of daily living, THEN the patient s functional ability with problem tasks should be assessed for need of nonambulatory assistive devices to aid with problem tasks BECAUSE these devices will improve function and independence. Supporting evidence. Our literature review did not identify any RCTs or CCTs that evaluated the effectiveness of activities of daily living (ADL) assistive devices. However, we did identify 2 studies investigating ADL assistive device use among OA patients. Mann and colleagues (62) performed a survey of 66 patients with arthritis. They found that although patients all used 10 devices each, patients with more severe disease used their physical disability devices more regularly. About 90% of patients were satisfied with their ADL assistive devices. Klinger and Spaulding (63) surveyed use of assistive devices and ADL in 30 patients with lower limb OA. The percentages of participants who used assistive devices at least once a month varied: grab bars (50%), cane (47%), long sponge (20%), raised toilet seats (17%), long shoehorn (17%), tub seat (17%), walker (13%), and long reacher (7%). Participants who used these devices regularly reported being able to maintain participation in valued ADLs more often than participants who reported not using these devices regularly (P 0.05). Quality indicator 11. Initial pharmacologic therapy. IF nonnarcotic pharmacologic therapy is initiated to treat osteoarthritis pain of mild or moderate severity, THEN acetaminophen should be the first drug used, unless there is a documented contraindication to use BECAUSE acetaminophen achieves pain relief comparable to an NSAID (nonselective and selective) and is less toxic. Quality indicator 12. Maximum dosage of acetaminophen. IF oral pharmacologic therapy for osteoarthritis is changed from acetaminophen to a different oral agent, THEN there should be evidence that the patient has had a trial of maximum-dose acetaminophen (suitable for age and comorbidities) BECAUSE acetaminophen may achieve pain relief comparable to an NSAID (nonselective and selective) and is less toxic. Supporting evidence. We identified 3 trials that compared the efficacy of acetaminophen and nonselective NSAIDs in the treatment of osteoarthritis and 1 trial that compared the efficacy of acetaminophen and selective NSAIDs. In 1 double-blind study (71), 184 patients with OA of the knee were randomly assigned to receive acetaminophen, 4,000 mg/day; ibuprofen, 1,200 mg/day; or ibuprofen, 2,400 mg/day. At 4-weeks followup, despite improvement by all 3 groups, no statistically significant differences were found between treatment groups on any outcome variables, except rest pain (i.e., improved in the patients treated with ibuprofen 1,200 mg/day compared with the acetaminophen group). A post-hoc analysis of this trial demonstrated that greater baseline pain correlated with greater pain relief in all study groups (72). The analysis also suggested that among the patients with highest levels of baseline pain, the ibuprofen 2,400 mg/day treatment had significantly improved rest pain compared with the other groups. However, this finding was not sustained when adjustments for multiple comparisons were made. A 4-week RCT comparing the efficacy of naproxen 750 mg/day to acetaminophen 2,600 mg/day among patients with OA showed significant rest pain improvements in the naproxen group compared with the acetaminophen group (73) Pain on motion, 50-foot walk time, and physician assessment were not different between groups. A recent randomized, double blind, cross-over trial compared the efficacy of combination diclofenac/misoprostol, 75 mg/200 g twice daily, and acetaminophen, 4,000 mg/ day, in 218 patients with OA (74). Improvements in pain and function were similar among patients with mild osteoarthritis, but favored the diclofenac/misoprostol combination for patients with moderate or severe OA (P 0.001). In an editorial that reviewed each of the above 3 studies (75), it was noted that although 2 of the studies (71,73) did not find a statistically significant difference in pain relief between the acetaminophen and NSAID groups, the effect size of treatment between groups was similar across all 3 trials (71,73,74). For each of the studies, the effect size demonstrated modest efficacy of NSAIDs compared with acetaminophen. This editorial suggests that combination small sample and small effect sizes may partly explain why statistically significant differences between the effects of acetaminophen and NSAIDs on pain and disability were found in the earlier studies. We identified a double blind, randomized controlled trial that compared rofecoxib 12.5 mg/day, rofecoxib 25 mg/day, celecoxib 200 mg/day, and acetaminophen 4,000 mg/day (76). Outcomes assessed at 6 days and 6 weeks demonstrated that the magnitude of improvement on all measures was greater for rofecoxib 25 mg/day than for acetaminophen. However only walking pain at 6 days demonstrated a significant improvement in the celecoxib group compared with the acetaminophen group. Numerous studies have demonstrated that selective and nonselective NSAIDs are associated with increased risk of gastrointestinal bleeding (77 81). A few observational studies have reported an association between acetaminophen and gastrointestinal bleeding (82,83). Renal toxicity has been reported for NSAIDs, though it is less common than gastrointestinal toxicities (84 91). A few observational studies have reported an association between acet-

8 Measuring Quality in Arthritis Care: Osteoarthritis 545 aminophen and renal insufficiency (92 95), although this risk is generally considered low (96). See the previously published analgesic quality indicators article for a larger discussion of these issues (81). The ACR osteoarthritis guidelines (4) state that although a number of patients may fail to obtain adequate relief even with full doses of acetaminophen, this drug merits a trial as initial therapy, based on its overall cost, efficacy, and toxicity profile. In patients with knee OA with moderate-to-severe pain... [a] prescription of an NSAID merits consideration as an alternate initial therapeutic approach. The ABFP advocates acetaminophen as the first-line pharmacologic agent for treating OA (15). The APS recommends acetaminophen as the first-line pharmacologic therapy in patients with mild OA (31). Quality indicator 13. Referral for surgical assessment. IF a patient with severe symptomatic osteoarthritis of the knee or hip has failed to respond to nonpharmacologic and pharmacologic therapy, THEN the patient should be offered referral to an orthopedic surgeon BECAUSE osteotomy or total joint replacement may reduce pain, improve functional status, and improve quality of life. Supporting evidence. The literature review identified a meta-analysis of 130 studies with a combined 9,879 patients (two-thirds had OA, and one-third had rheumatoid arthritis) that reported patient outcomes after tricompartmental total knee replacement (TKR) (97). On average, these patients had a 100% improvement in global rating after surgery. Depending on the type of prosthesis used, between 86% and 92% of patients reported a good or excellent outcome rating. The mean complication rate was 18.1%, and the mean mortality rate per year of followup was 1.5%. One study compared outcomes of TKR among the very elderly with those among young elders (98). Fifty consecutive patients age 80 years or older undergoing TKR were compared with 50 patients age years who had the same diagnosis and were undergoing the same type of surgery. A composite score of clinical and functional measures showed no difference between age groups at any point in the 2-year followup. Another report systematically identified 20 articles that evaluated health-related quality of life (HRQOL) after total hip replacement (THR) (99). Each of the 20 studies demonstrated beneficial and often dramatic improvement in HRQOL after elective THR. Other studies report mortality rates following THR of between 0.34% (100) and 0.4% (101). The infection rate following primary THR has been reported at 0.25% (102,103). Both the ACR (4,104) and AFBP (105) recommend referral to an orthopedic surgeon for further evaluation and possible joint replacement if response to medical therapy for OA of the knee or hip is inadequate. The National Institutes of Health consensus statement on total hip replacement states that hip replacement is an option for nearly all patients with diseases of the hip that cause chronic discomfort and significant functional impairment (106). The clinical policies of the AAOS list pain and functional disability and nonresponsiveness to medical treatment as indications for knee and hip replacement surgery (43,107). Quality indicator 14. Radiographs. IF a patient has hip or knee osteoarthritis AND has worsening complaints accompanied by a progressive decrease in activities AND no previous radiograph during the preceding 3 months, THEN a knee or hip radiograph should be performed within 3 months BECAUSE radiographs will help to define the extent of the osteoarthritis and rule out other causes of pain and functional limitation, including fracture and avascular necrosis. Supporting evidence. The literature review did not identify any studies that assess the effect of obtaining knee or hip radiographs on clinical decision making. DISCUSSION Based on scientific evidence and the consensus of a multidisciplinary panel of experts, the 14 explicit process measures we present here have been rated as valid measures of health care quality for OA. Although OA is a highly prevalent disease, little attention has previously been paid to the quality of the health care delivered for this disease. We know from a single study that assessed the appropriateness of drugs prescribed that quality may be suboptimal (108). However, little is known about performance on the processes of care that are detailed in the indicator set we present here. The indicators we present cover many aspects of arthritis care ranging from prevention to joint replacement. However, it should be noted that the indicators selected by our process do not necessarily represent recommendations for optimal care. Instead, they should be construed as minimally acceptable standards. Although we were able to find solid evidence to support a link between the processes of care described in the indicator and meaningful patient outcomes for some of the indicators, no such evidence exists for others. For some of these indicators, the processes of care have been assumed to be so essential to care that clinical trails assessing their importance have not been, and probably never will be, performed. For example, indicators 2 and 3 require the assessment of pain and functional status annually. Although we could find no data that demonstrates a direct link between assessing these parameters and clinical outcomes, the expert panel rated this indicator as a valid measure of quality because assessment of these parameters is necessary to direct therapy. In summary, we present 14 explicit process measures that, after rigorous review, were rated as valid measures of health care quality for osteoarthritis by a multidisciplinary panel of experts. Although future research must first address the feasibility of applying these measures to different data sources, they can potentially be used to compare care provided by different health care providers, different health care delivery systems, and to compare the changes in care over time. Also they may ultimately be used to document and improve the quality of care for individuals with OA.

9 546 Pencharz and MacLean REFERENCES 1. Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum 1998;41: Hawker G. Epidemiology of arthritis and osteoporosis. 1st ed. Toronto: Institute for Clinical Evaluative Sciences (ICES); Felson DT, Lawrence RC, Dieppe PA, Hirsch R, Helmick CG, Jordan JM, et al. Osteoarthritis: new insights. Part 1: the disease and its risk factors. Ann Intern Med 2000;133: American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee. Arthritis Rheum 2000;43: Mazzuca SA, Brandt KD, Katz BP, Dittus RS, Freund DA, Lubitz R, et al. Comparison of general internists, family physicians, and rheumatologists managing patients with symptoms of osteoarthritis of the knee. Arthritis Care Res 1997;10: Katz JN, Solomon DH, Schaffer JL, Horsky J, Burdick E, Bates DW. Outcomes of care and resource utilization among patients with knee or shoulder disorders treated by general internists, rheumatologists, or orthopedic surgeons. Am J Med 2000;108: Holt WS, Mazzuca SA. Prescribing behaviors of family physicians in the treatment of osteoarthritis. Fam Med 1992;24: Hochberg MC, Perlmutter DL, Hudson JI, Altman RD. Preferences in the management of osteoarthritis of the hip and knee: results of a survey of community-based rheumatologists in the United States. Arthritis Care Res 1996;9: Mamlin LA, Melfi CA, Parchman ML, Gutierrez B, Allen DI, Katz BP, et al. Management of osteoarthritis of the knee by primary care physicians. Arch Fam Med 1998;7: Glazier RH, Dalby DM, Badley EM, Hawker GA, Bell MJ, Buchbinder R, et al. Management of common musculoskeletal problems: a survey of Ontario primary care physicians. CMAJ 1998;158: MacLean CH, Saag, KG, Solomon DH, Morton SC, Sampsel S, Klippel JH. Measuring Quality in Arthritis Care: Methods for Developing the Arthritis Foundation s Quality Indicator Set. Arthritis Rheum 2004;51: MacLean CH. Quality indicators for the management of osteoarthritis in vulnerable elders. Ann Intern Med 2001;135: Pencharz JN, Grigoriadis E, Jansz GF, Bombardier C. A critical appraisal of clinical practice guidelines for the treatment of lower-limb osteoarthritis. Arthritis Res 2002;4: Shekelle PG, MacLean CH, Morton SC, Wenger NS. Assessing the care of vulnerable elders: methods for developing quality indicators. Ann Intern Med 2001;135: American Board of Family Practice. Osteoarthritis reference guide. 7th ed. Lexington (KY): American Board of Family Practice; Mullen P, Laville E, Biddle A, Lorig K. Efficacy of psychoeducational interventions on pain, depression, and disability in people with arthritis: a meta-analysis. J Rheumatol 1987;14: Superio-Cabuslay E, Ward M, Lorig K. Patient education interventions in osteoarthritis and rheumatoid arthritis: a meta-analytic comparison with nonsteroidal antiinflammatory drug treatment. Arthritis Care Res 1996;9: Calfas KJ, Kaplari RM, Ingram RE. One-year evaluation of cognitive-behavioral intervention in osteoarthritis. Arthritis Care Res 1992;5: Simeoni E, Bauman A, Stenmark J, O Brien J. Evaluation of a community arthritis program in Australia: dissemination of a developed program. Arthritis Care Res 1995;8: Mazzuca SA, Brandt KD, Katz BP, Chambers M, Byrd D, Hanna M. Effects of self-care education on the health status of inner-city patients with osteoarthritis of the knee. Arthritis Rheum 1997;40: Lorig KR, Sobel DS, Stewart AL, Brown BW, Bandura A, Ritter P, et al. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care 1999; 37: Barlow JH, Turner AP, Wright CC. A randomized controlled study of the arthritis self-management programme in the UK. Health Educ Res 2000;15: Solomon DH, Warsi A, Brown-Stevenson T, Farrell M, Gauthier S, Mikels D, et al. Does self-management education benefit all populations with arthritis? A randomized controlled trial in a primary care physician network. J Rheumatol 2002;29: Maggs, FM, Jubb, RW, Kemm JR. Single-blind randomized controlled trial of an educational booklet for patients with chronic arthritis. Br J Rheumatol 1996;35: Branch VK, Lipsky K, Nieman T, Lipsky PE. Positive impact of an intervention by arthritis patient educators on knowledge and satisfaction of patients in a rheumatology practice. Arthritis Care Res 1999;12: Edworthy SM, Devins GM, Aaron S, Alderdice C, Atkinson M, Zubieta A, et al. Improving medication adherence through patient education distinguishing between appropriate and inappropriate utilization. J Rheumatol 1999;26: Hopman-Rock M, Westhoff MH. The effects of a health educational and exercise program for older adults with osteoarthritis of the hip or knee. J Rheumatol 2000;27: Cohen JL, van Houten Sauter S, DeVellis RF, DeVellis BM. Evaluation of arthritis self-management courses led by laypersons and by professionals. Arthritis Rheum 1986;29: Keefe FJ, Caldwell DS, Baucom D, Salley A, Robinson E, Timmons K, et al. Spouse-assisted coping skills training in the management of knee pain in osteoarthritis: long-term follow-up results. Arthritis Care Res 1999;12: American College of Rheumatology Ad Hoc Committee on Clinical Guidelines. Guidelines for the initial evaluation of the adult patient with acute musculoskeletal symptoms. Arthritis Rheum 1996;39: American Pain Society. Guideline for the management of pain in osteoarthritis, rheumatoid arthritis, and juvenile chronic arthritis: 2. Glenview (IL): American Pain Society; Van Baar ME, Assendelft WJJ, Dekker J, Oostendorp RAB, Bijlsma WJ. Effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review of randomized clinical trials. Arthritis Rheum 1999;42: Baker KR, Nelson ME, Felson DT, Layne JE, Sarno R, Roubenoff R. The efficacy of home based progressive strength training in older adults with knee osteoarthritis: a randomized controlled trial. J Rheumatol 2001;28: Deyle GD, Henderson NE, Matekel RL, Ryder MG, Garber MB, Allison SC. Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med 2000;132: Fransen M, Crosbie J, Edmonds J. Physical therapy is effective for patients with osteoarthritis of the knee: a randomized controlled clinical trial. J Rheumatol 2001;28: Halbert J, Crotty M, Weller D, Ahern M, Silagy C. Primary care-based physical activity programs: effectiveness in sedentary older patients with osteoarthritis symptoms. Arthritis Rheum 2001;45: Mangione KK, McCully K, Gloviak A, Lefebvre I, Hofmann M, Craik R. The effects of high-intensity and low-intensity cycle ergometry in older adults with knee osteoarthritis. J Gerontol A Biol Sci Med Sci 1999;54:M Maurer BT, Stern AG, Kinossian B, Cook KD, Schumacher HR Jr. Osteoarthritis of the knee: isokinetic quadriceps exercise versus an educational intervention. Arch Phys Med Rehabil 1999;80: O Reilly SC, Muir KR, Doherty M. Effectiveness of home