Comparison of intervention versus standard care for primary and secondary outcomesa
| Category | Flexicult n (%) | Standard care n (%) | Odds ratio | 95% CI | ICC | ||
|---|---|---|---|---|---|---|---|
| Concordant antibiotic usage | Yes | Primary outcome | |||||
| UTI + antibiotic + sensitive | 58 (23.0) | 67 (27.3) | |||||
| No UTI + no antibiotic | 41 (16.3) | 41 (16.7) | |||||
| Total | 99 (39.3) | 108 (44.1) | |||||
| No | UTI + antibiotic + resistant | 5 (2.0) | 10 (4.1) | 0.84 | 0.58 to 1.20 | 0.02 | |
| UTI + No antibiotic | 12 (4.8) | 17 (6.9) | |||||
| No UTI + antibiotic | 136 (54.0) | 110 (44.9) | |||||
| Total | 153 (60.7) | 137 (55.9) | |||||
| Concordant antibiotic usage sensitivity: Flexicult b | Secondary analyses of primary outcome | ||||||
| 99 (39.4) | 108 (44.1) | 0.84 | 0.58 to 1.20 | n/a | |||
| Concordant antibiotic prescribing sensitivity: initial consultationc | 98 (33.1) | 114 (38.5) | 0.79 | 0.57 to 1.11 | 0.01 | ||
| Antibiotic prescribing at initial consultation | Secondary outcomes | ||||||
| 267 (82.4) | 282 (88.4) | 0.56 | 0.35 to 0.88 | 0.46 | |||
| Prescribed to guidelines at initial consultationd | 156 (58.9) | 166 (59.5) | 0.99 | 0.67 to 1.45 | 0.67 | ||
| Drug type and duratione | UTI-specific and 1–3 days | 182 (69.2) | 185 (67.8) | (ref) | n/a | ||
| UTI-specific and >3 days | 50 (19.0) | 57 (20.9) | 1.15 | 0.71 to 1.87 | |||
| Broad spectrum and 1–3 days | 0 (0.0) | 0 (0.0) | (empty) | ||||
| Broad spectrum and >3 days | 31 (11.8) | 31 (11.4) | 1.00 | 0.58 to 1.75 | |||
| Patient enablement (dichotomised) | 171 (70.1) | 177 (69.7) | 0.99 | 0.66 to 1.48 | n/a | ||
| Antibiotic consumed (day 3) | 217 (79.2) | 200 (76.6) | 1.24 | 0.81 to 1.89 | 0.24 | ||
| Antibiotic consumed (during 2 weeks) | 234 (85.1) | 217 (81.6) | 1.38 | 0.87 to 2.19 | 0.33 | ||
| New antibiotic prescribed (within 2 weeks) | 33 (10.3) | 30 (9.7) | 1.11 | 0.65 to 1.89 | n/a | ||
| Re-consultation (within 2 weeks) | 41 (12.9) | 41 (13.2) | 0.99 | 0.62 to 1.60 | n/a | ||
| Hospital stay (within 2 weeks) | 3 (0.9) | 4 (1.3) | Numbers too small for analysis | ||||
| Microbiologically confirmed UTI (at 2 weeks) | 20 (8.7) | 20 (9.2) | 0.94 | 0.49 to 1.81 | n/a | ||
| Stool sample resistance (at 2 weeks) | Ciprofloxacin | 33 (22.4) | 34 (24.5) | 0.96 | 0.54 to 1.71 | 0.396 | |
| Extended-spectrum beta-lactamases | 12 (8.2) | 8 (5.8) | 1.35 | 0.53 to 3.46 | n/a | ||
| Gentamicin | 16 (10.9) | 9 (6.5) | 1.75 | 0.74 to 4.42 | n/a | ||
| Carbapenem | 0 (0.0) | 1 (0.7) | Numbers too small for analysis | ||||
| Recurrence (within 3 months) | 54 (17.0) | 69 (22.3) | 0.72 | 0.48 to 1.07 | n/a | ||
| Duration of all symptoms | Median (IQR) | Median (IQR) | HR | 95% CI | ICC | ||
| 8.0 (5.0–14.0) | 8.0 (5.0–14.0) | 1.02 | 0.83 to 1.25 | n/a | |||
| Duration of moderately bad symptoms | 4.0 (2.0–6.0) | 4.0 (2.0–6.0) | 0.98 | 0.82 to 1.17 | n/a | ||
| Overall urinary symptom burden (AUC over 2 weeks)f | Mean (SD) | Mean (SD) | MD | 95% CI | ICC | ||
| 39.5 (36.56) | 38.2 (34.56) | 0.99 | 0.84 to 1.19 | n/a | |||
↵a For these analyses, the denominator depends on the amount of relevant data available, which is not always 324 and 319 for Flexicult (intervention) and Standard Care respectively. As stated in the results section, the denominators for this analysis are 252 and 245 for Flexicult (intervention) and Standard Care respectively.
↵b UTI and antibiotic resistance defined by the clinician’s reading of the Flexicult plate.
↵c Antibiotic prescribed at initial consultation or, if available, the antibiotic prescribed after reading the Flexicult plate.
↵d Prescribed to guidelines (England and Wales: trimethoprim, 3 days; nitrofurantoin, 3 days; Spain: fosfomycin, 1 day; nitrofurantoin, 7 days; the Netherlands: nitrofurantoin, 5 days; fosfomycin, 1 day; trimethoprim, 3 days) based on prescription made at the initial consultation. This excludes those who did not receive a prescription and those for which the prescribed drug is unknown.
↵e As a multinomial model, relative risk ratios, rather than odds ratios, are given.
↵f Effect/95% CI are back-transformed from a natural log transformation. AUC = area under the curve. ICC = intracluster correlation coefficient. HR = hazard ratio. IQR = interquartile range. n/a = not applicable. MD = mean difference. SD = standard deviation. UTI = urinary tract infection.