OMERACT-OARSI Initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited.

Pham, Thuy T.; Heijde, Desirée van der; Altman, Roy D.; Anderson, Jennifer J.; Bellamy, Nicholas; Hochberg, Marc C.; Simon, Lee S.; Strand, Vibeke; Woodworth, T.; Dougados, Maxime

doi:10.1016/j.joca.2004.02.001

Cited by 720 publications

(660 citation statements)

References 6 publications

Supporting

Mentioning

626

Contrasting

Unclassified

Order By: Relevance

“…In order to use the cutoff, an underlying assumption was that the group's baseline WOMAC score was normally distributed, so this was assessed to examine the assumption of normality. In conjunction with the cutoff, the Relative Change Index was used to ensure that the degree of change in WOMAC score between baseline and 12-month followup was large enough to exceed that of (19) are high improvement in pain or in function of Ն50% and an absolute change of Ն20, and, if the patient does not fulfill them, improvement in Ն2 of the 3 following: pain of Ն20% and an absolute change of Ն10, function of Ն20% and an absolute change of Ն10, and patient's global assessment of Ն20% and an absolute change of Ն10.…”

Section: Methodsmentioning

confidence: 99%

“…From an examination of the literature, we have identified 4 broad approaches that can be used to assess whether an individual with OA is a responder or a nonresponder to an intervention: return to normal (17,18), the Outcome Measures in Rheumatology Clinical Trials (OMERACT)-Osteoarthritis Research Society International (OARSI) responder criteria (19), the minimum important difference (MID) (20), and the minimum clinically important difference (MCID) (21)(22)(23). It was not possible to calculate the MCID in this study due to the lack of a suitable external anchoring question.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Patient‐reported outcomes one year after primary hip replacement in a European Collaborative Cohort

Judge¹,

Cooper²,

Williams³

et al. 2010

Arthritis Care & Research

133

View full text Add to dashboard Cite

Results. On average, there was a large improvement in WOMAC scores 12 months after surgery, but whereas some patients improved, others got worse. The OMERACT-OARSI method classified 85.7% of patients as responders, MID 70.1%, and return to normal 64.1%. In general, each approach classified the same groups of patients as responding to THR. Based on total WOMAC score, patients who were younger, morbidly obese, employed, and better educated were more likely to respond to THR, but the effects were attenuated after adjustment for confounding, with only the effect of education remaining important. Conclusion. The overall average response to THR was good, but ϳ14 -36% of patients did not improve, or were worse, 12 months postsurgery. Although the OMERACT-OARSI criteria were originally designed for use in clinical drug trials, they performed well in classifying patient response 12 months post-THR. Further research is required to understand the determinants of patient outcomes following THR.

show abstract

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Patient‐reported outcomes one year after primary hip replacement in a European Collaborative Cohort

Judge¹,

Cooper²,

Williams³

et al. 2010

Arthritis Care & Research

133

View full text Add to dashboard Cite

show abstract

“…These three domains are considered core criteria for combination to present the results of changes after treatment as a single outcome variable for clinical trials [19].…”

Section: Measurementsmentioning

confidence: 99%

Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study

et al. 2010

View full text Add to dashboard Cite

The objective is to determine if pain and disability outcomes of patients treated with neural mobilisation differ for sub-classifications of low back and leg pain (LB&LP). Radiating leg pain is a poor prognostic factor for recovery in patients with LBP. To improve outcome, a new pathomechanism-based classification system was proposed: neuropathic sensitization (NS), denervation (D), peripheral nerve sensitization (PNS) and musculoskeletal (M). Seventy-seven patients with unilateral LB&LP were recruited. Following classification, all subjects were treated seven times with neural mobilisation techniques. A successful outcome was defined as achieving a minimal clinically important change in pain intensity (11-point numerical rating scale), physical function (Roland Morris disability questionnaire) and global perceived change (7-point Likert scale: from 1 = ''completely recovered'' to 7 = ''worse than ever''). The proportion of responders was significantly greater in PNS (55.6%) than the other three groups (NS 10%; D 14.3% and M10%). After adjusting for baseline differences, mean magnitude of improvement of the outcome measures were significantly greater in PNS compared to the other groups. Patients classified as PNS have a more favourable prognosis following neural mobilisation compared to the other groups.

show abstract

“…A recent review of 7 trials of HA injection in patients with hip OA (14) included 2 trials (1 uncontrolled study [18] and 1 RCT [15]), in which the proportion of responders was analyzed as an outcome measure (32). In the open-label trial, following a single injection of hylan G-F 20, the proportion of responders 3 months after treatment was 53.6% (18), and in the study by Qvistgaard et al (15), the proportion of responders on day 28 was 53% in the HA group as compared with 44% in the placebo group; responder proportion was not calculated at month 3.…”

Section: Discussionmentioning

confidence: 99%

Effect of hyaluronic acid in symptomatic hip osteoarthritis: A multicenter, randomized, placebo‐controlled trial

Richette¹,

Ravaud²,

Conrozier³

et al. 2009

Arthritis & Rheumatism

106

View full text Add to dashboard Cite

Objective. To evaluate the efficacy and tolerability of a single intraarticular (IA) injection of hyaluronic acid (HA) for the treatment of hip osteoarthritis (OA).Methods. A multicenter, randomized, parallelgroup, placebo-controlled trial was conducted over 3 months. Patients (older than 30 years) with symptomatic hip OA (pain score of >40 mm on a visual analog scale [VAS]) and a Kellgren/Lawrence grade of 2 or 3 were randomly assigned to receive 1 fluoroscopically guided IA injection of HA (2.5 ml) or placebo (2.5 ml). Patients were followed up for 3 months. The main outcome measure was pain score on a VAS (100 mm) at month 3 compared with baseline. Secondary outcome measures were the proportion of responders defined by Osteoarthritis Research Society International criteria; Western Ontario and McMaster Universities Osteoarthritis Index subscores for pain, stiffness, and disability; and patient and physician global assessment. Randomization was computer generated. HA and placebo preparations were placed in numbered identical containers, and syringes were covered with masking tape. Physicians assessing outcomes were blinded with regard to group assignment.Results. Eighty-five patients were randomized to the HA group (n ‫؍‬ 42) or placebo group (n ‫؍‬ 43). Baseline characteristics were similar between the 2 groups. At 3 months, the decrease in pain score did not differ between the HA and placebo groups in the intentto-treat analysis (mean ؎ SD decrease 7.8 ؎ 24.9 mm with HA versus 9.1 ؎ 27.4 mm with placebo; P ‫؍‬ 0.98). The responder rates were 33.3% and 32.6% in the HA and placebo groups, respectively (P ‫؍‬ 0.94). Other secondary end points did not differ between the groups, nor did use of rescue medication or frequency of adverse events.Conclusion. Our findings indicate that a single IA injection of HA is no more effective than placebo in treating the symptoms of hip OA.Osteoarthritis (OA) is the most common type of arthritis and the major cause of disability in elderly populations worldwide. Hip OA is the second most frequent form of OA affecting a large joint, and its prevalence ranges from 3% to 11% in populations older than 35 years (1-3).Current therapies for hip OA include a combination of nonpharmacologic and pharmacologic treatments (4-6). Viscosupplementation is an intraarticular (IA) therapeutic modality that is based on the physiologic importance of hyaluronic acid (HA) in synovial ClinicalTrials.gov identifier: NCT00330135.

show abstract

OMERACT-OARSI Initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited.

Abstract: This data driven and experts' opinion approach is the basis for proposing an optimal simplified set of responder criteria for OA clinical trials. Other studies, using other sets of OA patients, are required in order to further validate this proposed OMERACT-OARSI set of criteria.

Cited by 720 publications

References 6 publications

Patient‐reported outcomes one year after primary hip replacement in a European Collaborative Cohort

Patient‐reported outcomes one year after primary hip replacement in a European Collaborative Cohort

Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study

Effect of hyaluronic acid in symptomatic hip osteoarthritis: A multicenter, randomized, placebo‐controlled trial

Contact Info

Product

Resources

About