Method | Description | No. and Type of Studies with References | Feasibility | Truth | Within-group Discrimination (ES) | Between-group Discrimination (estimate or statistic with p-value) |
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Patient global assessment of response to treatment (PGART; 5–point numerical scale) | 0 = excellent, 1 = very good, 2 = good, 3 = fair and 4 = poor response to treatment | Total: 4; controlled*: 4 (17, 20, 27, 42); observational: 0 *Navarra and Schlesinger references were posthoc analysis of Rubin and Schumacher studies | Inexpensive, no training required, no specialist equipment required, acceptable to patients | High face validity. Low PGART scores were associated with reductions in tenderness and pain scores over Days 2–5 (17, 20). Unable to calculate correlation coefficients with available information. Patients with both monoarticular and oligoarticular disease had a clinical response, but the response was greater in those with monoarticular disease, p < 0.001 (42). Good construct validity: significant differences in pain scores between patients categorized into None/fair vs Good/Excellent based on responses to PGART (p< 0.0001) (27). Baseline assessment of disease severity not captured using this measure. | All articles reported significant reduction in PGART scores over time. In an RCT comparing etoricoxib (ETO) and indomethacin (IND), the least squares mean change (95% CI) from baseline to Days 2–8 was 1.42 (1.20 to 1.65) for ETO and 1.33 (1.10 to 1.56) for IND (17). In another RCT comparing ETO and IND, the least square mean change (95% CI) from baseline to the mean of Days 2–5 was 1.58 (1.37–1.79) for ETO, and 1.70 (1.48–1.92) for IND (20). ES could not be calculated from available data. | In 2 RCT comparing ETO and IND, there was no difference between the least square mean difference in PGART scores between the ETO and IND groups (17, 20). |
PGART 5–point descriptive scale | Excellent, good, exceptable, slight, poor response to treatment | Total: 2; controlled: 2 (13, 18); observational: 0 | Inexpensive, no training required, no specialist equipment required, acceptable to patient | High face validity. Excellent and good PGART responses were accompanied by reductions in pain, tenderness, swelling and erythema (18) and C-reactive protein (13). Unable to calculate correlation coefficients with available information. Baseline assessment of disease severity not captured using this measure. | In an RCT of canakinumab (CAN) vs triamcinolone acetonide (TA), good or excellent response to treatment reported in 88.8% patients receiving CAN 150 mg after 72 h and in 92.6% after 7 days, and in 53.5% patients receiving TA after 72 h and in 55.3% after 7 days (13). ES could not be calculated from available data. | In an RCT of CAN vs TA, good or excellent response to treatment was observed more often in patients receiving any CAN dose compared with TA; at 72 h OR 2.0 (p = 0.02) and at 7 days OR 2.3 (p = 0.01) (13). In another RCT of CAN vs TA, CAN 150 mg was associated with significantly better responses compared with T, OR favoring CAN 150 mg vs TA = 4.0, p = 0.002 (18). |
Patient global assessment (PGA) of overall condition | 1 = very good; 2 = good; 3 = fair; 4 = poor and 5 = very poor | Total 3; controlled: 2 (24, 25); observational: 1 (61) | Inexpensive, no training required, no specialist equipment required, acceptable to patients | High face validity. Improvements in PGA were accompanied by similar reductions in pain, tenderness and swelling (24, 25, 61). Unable to calculate correlation coefficients with available information. | All articles reported in PGA scores over time. In a clinical trial of etodolac (ETD) and naproxen (NAP), the mean scores at baseline and on Days 2, 4, and 7 were 4.3, 3.2, 2.3, and 1.8, respectively, for ETD, and 4.0, 3.5, 2.7 and 2.1 for NAP, p < 0.05 for both groups at each timepoint compared with baseline (24). In another clinical trial of ETD and NAP, no patients described their condition as good or very good at baseline. At the last study visit (Days 3–7), good or very good condition was reported by 76% in the ETD group and 81% NAP group (25). p value not reported. ES could not be calculated from available data. | In the 2 RCT of ETD and NAP, there was no significant difference between the 2 treatment groups in the PGA scores over time (24, 25). |
RCT: randomized controlled trial.