Burkhardt 2010.
Methods | Randomised clinical trial, multicentre in 15 primary care practices in the Hanover, Germany area | |
Participants |
Inclusion criteria: Adults with upper or lower ARIs in primary care Exclusion criteria: Treatment with antibiotics during the previous 2 weeks, chronic liver disease, major surgery that had required hospitalisation during the last 4 weeks, autoimmune or systemic disorders, dialysis, medullary C‐cell carcinoma and other inflammatory diseases Included in this analysis: 550 out of 571 randomised participants; 21 post randomisation exclusions (2 withdrew consent, 1 due to loss of sample, 15 with autoimmune, inflammatory, or systemic disease, 2 with advanced liver disease, 1 with prior use of antibiotics) |
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Interventions | Guiding antibiotic decisions in primary care with initial measurement only Algorithm used in this study: PCT value < 0.25 µg/L indicated that a relevant bacterial infection of the respiratory tract is unlikely. |
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Outcomes |
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Notes |
Funding: B·R·A·H·M·S AG, Germany Follow‐up: Fixed period of 28 days Registration: NCT00827060 and NCT00688610 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated Quote: "Baseline adaptive randomisation was realised through a web‐based randomisation data bank (IOMTech GmbH, Berlin, Germany), which had been programmed specifically for that purpose." |
Allocation concealment (selection bias) | Low risk | Central randomisation Quote: "In the central laboratory, the web‐based randomisation of the patient into the PCT group or the control group took place." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label trial where physicians knew to which group participants had been assigned and where PCT levels were only communicated in the intervention arm |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Structured interviews by blinded personnel |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up for mortality: 546/550 (99%) |
Selective reporting (reporting bias) | Low risk | Outcomes correspond to study protocol. |
Other bias | Low risk | 87% adherence to PCT algorithm in PCT group |