Table 5.
Cross-sectional perspective: SF–36 Physical Function outcome (N = 16 077)*
| Effect | Description | Time = 0 | Time = 3.5 y | Time = 6.5 y | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Estimate (95% CI) | Effect ratio† | P‡ | Estimate (95% CI) | Effect ratio† | P‡ | Estimate (95% CI) | Effect ratio† | P‡ | ||
| Intercept | On-average entry Physical Functioning score | 90.69 (90.08 to 91.30) | – | <.001 | 90.69 (90.08 to 91.30) | – | <.001 | 90.69 (90.08 to 91.30) | – | <.001 |
| Time | Time in y; time = 0 at first 6-mo visit | 0 | – | – | −4.18 (−4.77 to −3.59) | – | <.001 | −7.77 (−8.87 to −6.67) | – | <.001 |
| Age | Age (in y) at randomization | −0.25 (−0.29 to −0.21) | – | <.001 | −0.54 (−0.58 to −0.50) | – | <.001 | −0.78 (−0.84 to −0.72) | – | <.001 |
| Finasteride§ | Treatment arm; finasteride = 1, placebo = 0 | 0.07 (−0.28 to 0.42) | 0.01 | .71 | −0.21 (−0.60 to 0.18) | −0.02 | .30 | −0.45 (−1.04 to 0.14) | −0.05 | .13 |
| Black race | Yes = 1, no = 0 | −0.93 (−1.81 to −0.05) | −0.10 | .04 | −1.23 (−2.27 to −0.19) | −0.14 | .02 | −1.49 (−3.08 to 0.10) | −0.17 | .07 |
| Other race | Not black, not non-Hispanic white: yes = 1, no = 0 | −1.09 (−2.36 to 0.18) | −0.12 | .09 | −0.75 (−2.28 to 0.78) | −0.08 | .34 | −0.46 (−2.85 to 1.93) | −0.05 | .71 |
| Body mass index | Body mass index at enrollment, (weight in kg)/(height in m)2, 18.5–24.9kg/m2 is considered normal | −0.29 (−0.33 to −0.25) | – | <.001 | −0.46 (−0.50 to −0.42) | – | <.001 | −0.61 (−0.69 to −0.53) | – | <.001 |
| Current smoker | Indicator, current smoker at enrollment: yes = 1,no = 0 | −2.34 (−2.97 to −1.71) | −0.26 | <.001 | −4.06 (−4.80 to −3.32) | −0.45 | <.001 | −5.53 (−6.67 to −4.39) | −0.62 | <.001 |
| Physical Function | SF–36 Physical Functioning score at enrollment (scale: 0–100): higher score = better functioning | 5.00 (4.84 to 5.16) | – | <.001 | 4.70 (4.52 to 4.88) | – | <.001 | 4.44 (4.20 to 4.68) | – | <.001 |
| Vitality|| | SF–36 Energy/Vitality score at enrollment (0–100): higher score = more energy | 0.89 (0.73 to 1.05) | – | <.001 | 1.29 (1.11 to 1.47) | – | <.001 | 1.63 (1.36 to 1.90) | – | <.001 |
| Bodily Pain|| | SF–36 Bodily Pain Scale at enrollment (0–100): higher score = less pain | 0.97 (0.87 to 1.07) | – | <.001 | 0.96 (0.84 to 1.08) | – | <.001 | 0.94 (0.76 to 1.12) | – | <.001 |
| Education level¶ | At enrollment: 3 levels | 0.52 (0.36 to 0.68) | – | <.001 | 0.72 (0.54 to 0.90) | – | <.001 | 0.89 (0.64 to 1.14) | – | <.001 |
| Marital status¶ | At enrollment: 2 levels | 0.92 (0.41 to 1.43) | 0.10 | <.001 | 1.59 (1.00 to 2.18) | 0.18 | <.001 | 2.16 (1.26 to 3.06) | 0.24 | <.001 |
| MET-hours of walking | At enrollment | 0.03 (0.03 to 0.03) | – | <.001 | 0.04 (0.02 to 0.06) | – | <.001 | 0.05 (0.03 to 0.07) | – | <.001 |
| Diabetes | Indicator, diabetes at enrollment: yes = 1, no = 0 | −1.31 (−2.05 to−0.57) | −0.15 | <.001 | −4.94 (−5.80 to −4.08) | −0.55 | <.001 | −8.06 (−9.37 to −6.75) | −0.90 | <.001 |
| Hypertension | Indicator, hypertension at enrollment: yes = 1, no = 0 | −0.73 (−1.12 to−0.34) | −0.08 | <.001 | −1.55 (−2.00 to −1.10) | −0.17 | <.001 | −2.26 (−2.93 to −1.59) | −0.25 | .01 |
| Mental Health|| | SF–36 Mental Health score at enrollment (0–100): higher score = better mental health | −0.60 (−0.76 to−0.44) | – | <.001 | −0.87 (−0.96 to −0.56) | – | <.001 | −1.01 (−1.18 to−0.60) | – | <.001 |
| AUA Symptom Index | AUA SymptomIndex at enrollment (0–35): higher score = worse urinary symptoms | −0.69 (−0.94 to −0.44) | – | <.001 | 0.87 (−1.16 to −0.58) | – | <.001 | −1.01 (−1.46 to−0.56) | – | <.001 |
| Sexual Activity Scale|| | Sexual Activity Scale score at enroll- ment (0–100): higher score = more sexual dysfunction | −0.30 (−0.40 to −0.20) | – | <.001 | −0.40 (−0.50 to −0.30) | – | <.001 | −0.49 (−0.65 to−0.33) | – | <.001 |
| Leg pain | Leg pain at enrollment: yes = 1, no = 0 | −2.57 (−3.04 to −2.10) | −0.29 | <.001 | −3.09 (−3.64 to −2.54) | −0.35 | <.001 | −3.54 (−4.36 to−2.72) | −0.45 | <.001 |
| Congestive heart failure | Congestive heart failure at enrollment: yes = 1, no = 0 | −5.64 (−7.97 to −3.31) | −0.63 | <.001 | −4.76 (−7.56 to −1.96) | −0.53 | <.001 | −4.01 (−8.40 to0.38) | −0.45 | .07 |
* CI = confidence interval; – = not applicable; SF–36 = Health Survey Short Form–36; MET = metabolic equivalent; AUA = American Urological Association.
† Ratio of effect estimate to σβ0, the SD of the random intercept term. Effect ratios are not calculated for continuous variables.
‡ Two-sided t-test.
§ The finasteride effects shown in the table are those expected for the “typical” man having the median Physical Functioning score at enrollment. The impact of finasteride depends on the enrollment Physical Functioning score and varies from a 1-point benefit (for those with the maximum Physical Functioning score at enrollment) to a 1-point deficit (for those with the minimum Physical Functioning score at enrollment). This variation is statistically significant but negligible in real terms.
‖ Estimate represents the expected effect on the Physical Functioning score of a 10-point difference in this covariate at enrollment.
¶ See Table 4 for variable categories.