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. 2017 Oct 12;2017(10):CD007498. doi: 10.1002/14651858.CD007498.pub3

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)
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.
Outcomes
  • days with impairment during everyday life or leisure activities, or both, due to the infection of the respiratory tract within the first 14 days according to self assessment

  • revisit to the physician's office with a respiratory tract infection within 28 days

  • number of days with antibiotic‐induced side effects

  • antibiotic use

  • change of antibiotics within 28 days

  • participants with any symptoms of ongoing or relapsing infection at 28 days

  • all‐cause mortality

  • hospitalisation

Notes Funding: B·R·A·H·M·S AG, Germany
Follow‐up: Fixed period of 28 days
Registration: NCT00827060 and NCT00688610
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