Results
tuberculosis, death, silicosis, diabetes
MULTIDRUG-RESISTANT TUBERCULOSIS, EVENT, TUBERCULOSIS, SECONDARY, SILICOSIS, EVENTS, EXTRAPULMONARY TUBERCULOSIS, DIABETES
Between Jan 26, 2017, and April 3, 2019, 15 257 patients were assessed for eligibility and 3074 were enrolled (Trial profileParticipants could have met more than one exclusion criterion. *Extrapulmonary tuberculosis, diabetes, or silicosis.Baseline characteristicsData are n, n (%), n/N (%), or median (IQR). Percentages are overall, ignoring clustering. CNY=Chinese yuan renminbi. NA=not applicable.By health-care worker.1909 (71%) of 2686 patients were male, 777 (29%) were female, the median age was 44 years (IQR 29–58), and 1675 (62%) had sputum smear-positive tuberculosis (Using multiple imputation for missing outcomes, 239 (16%; geometric mean of cluster-level event rate based on mean of 25 imputations) of 1388 patients in the control group and 224 (16%) of 1298 in the intervention group had a primary composite outcome event. There was no evidence of a difference in the risk of the primary composite outcome between groups (adjusted RR 1·01, 95% CI 0·73 to 1·40, p=0·95; adjusted risk difference 0·7%, 95% CI –4·5 to 5·9%). Results were similar in unadjusted, complete case, and per-protocol analyses (Primary and secondary outcomes, excluding adherenceData are n/N (%) or RR (95% CI); p value unless otherwise stated. All analyses were in the intention-to-treat population. All comparisons are intervention group versus control group. RR=risk ratio.Number of events in number of participants, ignoring cluster; percentages are the geometric mean of the cluster-level risk or rate of an event.Calculated using multiple imputation; values shown by group are the imputation-mean of total number of events and geometric mean of cluster-level proportion of events; all other outcomes used complete cases.Rate difference reported between the groups in those with a successful treatment outcome; adjusted analysis not completed because of the small number of events.In those with a positive smear at the start of treatment.Prespecified subgroup analysis did not show significant differences in the risk of the primary composite outcome between groups by clinic type, patient age, education level, sex, or household expenditure (Subgroup analyses of primary composite outcome in the intention-to-treat populationCNY=Chinese yuan renminbi. RR=risk ratio.Most primary composite outcome events were due to death, loss to follow-up, treatment failure, or switch to multidrug-resistant tuberculosis treatment, which had similar percentages between the groups (203 events [14%; geometric mean] in 1350 patients in the control group Patients in the intervention group were 64% less likely to miss more than 20% of treatment doses in a month (geometric mean 0·9 months [16%] of 6·0 months per person in the intervention group Secondary outcomes of medication adherence and process measuresData are n/N (%) unless otherwise stated. All comparisons are intervention group versus control group.Adherence outcomes summarised by patient, taking the arithmetic mean within cluster, then the geometric mean between clusters (1306 in the control group and 1261 in the intervention group contributed to the analysis of adherence outcomes).Before any change in management in the intervention group.Post-hoc sensitivity analyses for the primary outcome and secondary adherence outcomes were consistent with the primary analyses (Most patients in the control group reported self-administering treatment (943 [68%] of 1388 patients), and only 10% (138) were supervised by a health-care worker, although this differed widely by cluster (Before any change in patient management in the intervention group, patients in both groups had similar contact with the township and village doctor between clinic visits (mean 2·5 visits [SD 0·8] per month in the control group 