Primary outcome: IPSS at 12 months
LUTS, Prostate
SENSITIVITY, SECONDARY, PROSTATE, INCONTINENCE
Overall, 915 participants (85.0% of those randomised) provided primary outcome data, of whom 887 provided sufficient baseline data to be included in the analysis. Some improvement in LUTS occurred at 12 months in both arms, but this was greater in the intervention arm (difference in IPSS −1.81 (95% confidence interval −2.66 to −0.95), P<0.001) after adjustment for baseline values and minimisation variables (Analyses of treatment effectiveness on patient reported primary outcome and secondary outcomesB-IPQ=Brief Illness Perception Questionnaire; ICC=intraclass correlation; CI=confidence interval; ICIQ-UI-SF=International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form; IPSS=International Prostate Symptom Score; NE=not estimable; SD=standard deviation.Higher scores for IPSS, ICIQ-UI-SF, IPSS quality of life, and B-IPQ reflect more severe symptoms, greater impact on quality of life, or participants’ poorer perception of their LUTS.Adjusted for baseline scores and minimisation variables.Number of participants in each arm providing non-missing outcome data except in repeated measures analysis of IPSS (six and 12 months) where this reflects the number of repeated measures of IPSS in each arm.Analysed using mixed effect multilevel linear model (individuals (level 1) nested within general practices (level 2)) adjusting for individual level baseline outcome measure and practice level variables used in the randomisation.Analysed using a repeated measures linear mixed model (IPSS at six and 12 months (level 1), nested within participants (level 2) and nested within general practices (level 3)) adjusting for individual level baseline IPSS and practice level variables used in the randomisation.A planned sensitivity analysis accounting for clustering by nurse or healthcare assistant had little effect on the primary outcome results (difference −1.79 (95% confidence interval −2.53 to −1.06), P=0.004), nor did excluding three participants who were found to be ineligible after follow-up began (difference −1.81 (−2.65 to −0.96), P<0.001) or adjusting for whether the outcome data were collected during the covid-19 pandemic (difference −1.89 (−2.69 to −1.09), P<0.001). Imputation of missing data also yielded comparable results to the complete case analysis (Sensitivity analysis comparing results of ITT analysis of complete cases with ITT analyses, with missing IPSS data imputedCI=confidence interval; IPSS=International Prostate Symptom Score; SD=standard deviation ITT=intention to treat; MICE=multiple imputation by chained equations; SD=standard deviation.Analysis adjusted for baseline IPSS and minimisation variables.Data are imputed using IPSS at baseline and six months, treatment arm, practice size, centre, and deprivation (index of multiple deprivation). To allow for clustering in Stata, imputations were performed separately for each practice.