219 Low-dose-CT versus X-ray in patients suspected of pulmonary disease Outcomes In the ULDCT group 896/1160 (77.2%) of the SF-12 questionnaires were returned (830 complete, 66 incomplete) versus 824/1151 (71.6%) for CXR (776 complete, 48 incomplete). There were only minor differences in baseline characteristics between responders and non-responders (Supplementary Tables S3 and S4). Functional health measured by the mean PCS score was 37.0 (SD: 11.1, 95% CI: 36.2 to 37.8) in the ULDCT group compared to 35.9 (SD: 10.6, 95% CI: 35.2 to 36.7) in the CXR group, a difference of 1.1 points (95% lower CI: 0.003) and demonstrating non-inferiority of ULDCT (Figure 2, Figure S2). A sensitivity analysis including 109 imputed PCS scores of partially incomplete questionnaires showed results similar to the primary analysis, with a mean PCS score 36.9 in the ULDCT group (n=892) versus 35.9 in the CXR group (n=823), a difference of 1.0 (one-sided 95% lower CI: -0.06). Additional sensitivity analyses did not produce substantially different findings (Supplementary text S3, Figure 2). In 66/2378 patients who gave permission for follow-up (2.8%; 30 ULDCT, 36 CXR) insufficient follow-up data were available to assign the day 28 diagnosis, leaving 1161 ULDCT and 1151 CXR patients. With ULDCT, more patients had a day 28 diagnosis of CAP and asthma exacerbation, while patients in the CXR group more often had a day 28 diagnosis of congestive heart failure (Table 3). At day 28, 26 ULDCT patients (2.2%; 95% CI: 1.0 to 3.0) and four CXR patients (0.3%; 95% CI: 0.0 to 1.0) were in follow-up because of clinically relevant incidental findings (absolute difference 1.8; 95% CI: 1.0 to 2.7). Of these, three ULDCT patients and two CXR patients were lost to follow-up. Mental health measured by the mean MCS score for ULDCT was 46.2 (95% CI: 44.5 to 46.0) versus 45.2 (95% CI: 45.5 to 46.9) for CXR, a mean difference of 1.0 (95% CI: -0.1 to 2.0). Mortality rates within 28 days were 2.6% for ULDCT and 3.0% for CXR, resulting in an absolute risk difference of 0.4% (95% CI: -0.9% to 1.7%). Figure 2. Equivalence plot of the Physical Component summary Scale (PCS) scores of the short form (SF)-12 questionnaires. Confidence interval primary analysis: 0.003 to 2.13 (difference is 1.1), confidence interval imputed data: -0.06 to 2.10 (difference is 1.0). 9
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