816 infection control & hospital epidemiology july 2018, vol. 39, no. 7 Randomization


Randomization sequence was generated without blocking or stratification using Research Randomizer version 4.0 soft- ware.6 Reporting assignments were placed into serially num- bered, sealed, opaque envelopes by the investigators.


Blinding


The study was not blinded. Attending physicians were aware of reporting assignment, and investigators were aware of report- ing assignment before assessing diagnosis and adverse events. Patients were not aware of the study.


Statistical Methods


All specimens randomized and reported were included in the intention-to-treat (ITT) analysis. Specimens inappropriately included were excluded from the per-protocol (PP) analysis. The proportion of appropriate treatment was compared using 2-sided Pearson χ2 test with SPSS version 23.0 software (IBM, Armonk, NY). An adjusted analysis was not performed. Cost was calculated as the difference in antibiotic cost and length of hospital stay for the episode.


Ethics


The protocol was approved by the Provincial Health Research Ethics Board on June 30, 2016 (reference #2016157). Physician consent requirement was waived because the intervention posed no more than minimal risk to participants. A letter was sent to all inpatient physicians informing them about the study prior to recruitment, and a debrief meeting, offering an opportunity to withdraw physician participation, was pro- vided. The patient consent requirement was waived because physicians were the research subjects.


results


Participant flow is illustrated in Figure 1. We assessed 286 consecutive positive urine cultures between January 3, 2017, and March 27, 2017. Among them, 176 were excluded because they did not meet the inclusion criteria. Baseline data are provided in Table 1. The 2 groups were comparable in mean age and gender. However, the modified reporting arm had more UTIs (20 of 55 [36.3%] vs 14 of 55 [25.4%]; P = .219). Of 110 positive urine cultures, 76 (69.1%) represented ASB rather than UTI.


Numbers Analyzed


In total, 110 specimens were randomized and reported and included in the ITT analysis. Overall, 4 specimens were ran- domized to modified reporting (ie, 1 collected from catheter, 1 duplicate, 1 on treatment, and 1 culture negative). Another 2 specimens randomized to standard reporting (ie, 2 duplicates)


did not follow protocol and were excluded from the PP ana- lysis. The final PP analysis included 104 specimens.


Outcomes and Estimation


The proportion of appropriate treatment was higher in the modified arm than in the standard arm in the ITT analysis: 44 of 55 (80.0%) versus 29 of 55 (52.7%), respectively (absolute difference = −27.3%; RR, 0.42; P = .002; number needed to report for benefit, 3.7). The PP analysis had a similar result: 42 of 53 (79.2%) in the modified arm versus 26 of 51 (51.0%) in the standard arm (absolute difference, −28.2%; RR, 0.42; P = .002; number needed to report for benefit, 3.5). The overall difference in proportion of appropriate treat-


ment was based on a change in the proportion of treatment of ASB, not on a change in the proportion of treatment of UTI. The rate of treatment of ASB was reduced from 24 of 41 (58.5%) in the standard arm to 10 of 35 (37.1%) in the modified arm (P = .016) (Table 2).


Ancillary Analyses


Among specimens in the PP analysis randomized to modified reporting, the physician called the laboratory to request the complete report in 14 of 53 cases (26.4%). The proportion of appropriate treatment in cases when the physician did call the laboratory was 10 of 14 (71.4%), and in cases when the phy- sician did not call the lab, it was 32 of 39 (82.0%; P = .41). These results suggest that a crossover from modified reporting to standard reporting did not reduce the benefit of the mod- ified reporting.


Harms


Untreated UTI was more frequent in the standard reporting arm: 2 of 14 (14.3%) in the standard reporting arm versus 2 of 20 (10.0%) in the modified reporting arm (P = .37) (Table 2). There were 3 bacteremia cases: 2 in the standard reporting


arm (both treated UTI) and 1 in the modified reporting arm (treated UTI). All bacteremias occurred in blood cultures collected at the time of admission to hospital, prior to treat- ment. None were considered to have been related to the study intervention (Supplementary Table 1). There were 3 deaths, 1 in the standard reporting arm (untreated ASB) and 2 in the modified reporting arm (1 untreated ASB and 1 treated UTI). None were considered related to the study intervention (Supplementary Table 2). Complete data were available for 72-hour safety assessment


for 109 of 110 patients (1 discharged during follow-up). Complete data were available for 7-day safety assessment for 107 of 110 patients (there were 3 deaths during follow-up). At 72 hours, features of SIRS were uncommon in both arms, with no discernible trend when arms were compared (Sup- plementary Table 3). At 7 days, new symptoms were observed


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120  |  Page 121  |  Page 122  |  Page 123  |  Page 124  |  Page 125  |  Page 126  |  Page 127  |  Page 128  |  Page 129  |  Page 130  |  Page 131  |  Page 132  |  Page 133  |  Page 134  |  Page 135  |  Page 136  |  Page 137  |  Page 138  |  Page 139  |  Page 140  |  Page 141  |  Page 142  |  Page 143  |  Page 144