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. Author manuscript; available in PMC: 2019 Sep 7.
Published in final edited form as: N Engl J Med. 2019 Mar 7;380(10):905–914. doi: 10.1056/NEJMoa1810642

Table 3.

Patient Safety Outcomes.*

Outcome Flexible Programs
(N = 32)
Standard Programs
(N = 31)
Difference in Change
(95% CI)
Primary outcome
30-day mortality
 Trial yr (%) 12.5 12.2 0.3
 Pretrial yr (%) 12.6 12.7 −0.1
 Difference in percentage points −0.1 −0.5 0.4 (−∞ to 0.9)
Secondary outcomes
Readmission or death at 7 days
 Trial yr (%) 16.9 16.6 0.3
 Pretrial yr (%) 16.6 16.7 0.0
 Difference in percentage points 0.3 −0.1 0.3 (−∞ to 1.0)
Readmission or death at 30 days
 Trial yr (%) 29.9 29.3 0.7
 Pretrial yr (%) 29.8 29.7 0.1
 Difference in percentage points 0.1 −0.4 0.5 (−∞ to 1.3)
Patient safety indicators
 Trial yr (%) 0.9 0.7 0.2
 Pretrial yr (%) 1.0 0.7 0.2
 Difference in percentage points −0.1 −0.1 <0.1 (−∞ to 0.2)
Prolonged length of hospital stay§
 Trial yr (%) 63.2 61.2 2.0
 Pretrial yr (%) 63.0 61.4 1.5
 Difference in percentage points 0.3 −0.2 0.5 (−∞ to 1.6)
Payment in 2016 dollars
 Trial yr 25,139 23,199 1940
 Pretrial yr 23,882 21,870 2012
 Relative difference (%) 0.7 0.5 0.3 (−∞ to 0.6)
*

All listed values are means.

One-sided 95% confidence intervals (CIs) were calculated to complement tests of noninferiority. If the upper limit of the confidence interval for the value in the flexible programs minus that in the standard programs was less than the noninferiority margin of 1 percentage point, an outcome in the flexible programs was deemed to be noninferior to that in the standard programs. Confidence intervals have not been adjusted for multiple testing, so inferences drawn from the intervals may not be reproducible.

Patient safety indicators include rates of pressure ulcers, iatrogenic pneumothorax, bloodstream infection from a central venous catheter, hip fracture, hemorrhage or hematoma, physiologic or metabolic derangement, respiratory failure, pulmonary embolism or deep-vein thrombosis, sepsis, and accidental puncture or laceration. Details are provided in Table S4 in the Supplementary Appendix.

§

A prolonged length of hospital stay is defined as a length of stay that exceeded the point at which the rate of discharge typically begins to decrease. Details regarding the number of days defining prolonged length of stay for each condition are provided in Table S5 in the Supplementary Appendix.

For clarity, the mean dollars in the trial year and pretrial year are listed without the use of log transformation. Because payment data are skewed, log-transformed dollars were used to calculate the relative percent differences for each program, which were then aggregated to each trial group. The associated 95% confidence interval was again based on log-transformed dollars. Formulas for this calculation are provided in Sections S1 and S2 in the Supplementary Appendix.