Kristoffersen 2009
| Methods | Randomised clinical trial, multicentre, 3 hospitals in Denmark | |
| Participants |
Inclusion criteria: hospitalised patients with suspected pneumonia (no X‐ray confirmation); quote: "The assessment of eligibility (i.e. the clinical diagnosis) was made by the admitting physician and was based on medical history and physical examination." Exclusion criteria: not meeting the diagnostic criteria Included in this analysis: 210 out of 223 randomised patients: 13 post randomisation exclusions (3 no procalcitonin testing, 6 not meeting inclusion criteria, 4 withdrew informed consent) |
|
| Interventions | Guiding antibiotic decisions in CAP patients with initial values only Algorithm used in this study: physicians were not asked to wait for procalcitonin results before initiating antimicrobial therapy; therefore, procalcitonin values were, in most cases, used to motivate either cessation or continuation of already initiated treatments. Discontinuation of AB treatment was recommended if procalcitonin at admission was below 0.25 µg/L, despite delays in test results |
|
| Outcomes |
|
|
| Notes |
Funding: The Danish Medical Research Council and the Danish Lung Association provided financial support Follow‐up: until hospital discharge Registration: NCT00415753 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation scheme |
| Allocation concealment (selection bias) | Low risk | Central randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label trial where physicians knew in which group patients were and where procalcitonin levels were only communicated in the intervention arm |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Non‐blinded study members |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up for mortality: 210/210 (100% until discharge) |
| Selective reporting (reporting bias) | Low risk | No selective reporting (oral verification with first author) |
| Other bias | Unclear risk | 59% adherence to procalcitonin algorithm in procalcitonin group |