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. 2022 Dec 13;328(22):2242–2251. doi: 10.1001/jama.2022.21893

Table 3. Post Hoc Analysis of the Relative Risk of Achieving a Clinically Meaningful Change in WOMAC Pain Score.

Follow-up time No./total (%) with significant pain reduction of ≥2 pointsa Absolute risk difference, % (95% CI) Risk ratio (95% CI)b P valuec
Diet and exercise Attention control
6 mo 181/343 (52.8) 145/324 (44.8) 8 (0.45-15.6) 1.17 (1.00-1.35) .045
18 mo 198/329 (60.2) 157/316 (49.7) 10.5 (2.9-18.1) 1.20 (1.04-1.38) .01

Abbreviation: WOMAC, Western Ontario and McMaster Universities Osteoarthritic Index.

a

The minimum clinically important difference for pain is 1.6 (calculated as half the SD) on a 0- to 20-point scale.24 This post hoc analysis is at the individual patient level, in which only whole numbers are possible. The 2-point criterion was recommended by the Osteoarthritis Research Society International as a moderate intervention response.37

b

Relative risk of achieving a clinically meaningful change in pain, defined as a decrease in pain of 2 points or more on the Likert WOMAC pain scale (range, 0-20). Estimated by a generalized estimating equation model fit with contrasts for group comparisons at 6-and 18- month follow-up adjusted for baseline pain scores. The risk (ie, benefit) of achieving a significant decrease in pain increases from 6- to 18-month follow-up and is significantly greater in the diet and exercise group compared with the attention control group.

c

Test of the risk ratio under the null hypothesis that the risk ratio = 1.0.