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Table 1 Primary and secondary objectives and outcome measures

From: General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial

  Objectives Outcome measures Time point(s) of evaluation of this outcome measure
Primary To determine whether the addition of a CRP POCT (with training on test use and advice on interpretation) to usual care for managing AECOPD leads to a reduction in antibiotic consumption for AECOPD compared to usual care alone Antibiotic consumption (any consumption of antibiotics for AECOPD vs. no consumption of antibiotics for AECOPD) First 4 weeks post randomisation
Primary To determine whether the addition of a CRP POCT (with training on test use and advice on interpretation) to usual care for managing AECOPD leads to a reduction in antibiotic consumption for AECOPD without negatively impacting on COPD health status compared to usual care alone Recovery in terms of COPD health status as assessed using the Clinical COPD Questionnaire (CCQ) total scores 2 weeks post randomisation
Secondary To assess the effect of using a CRP POCT for AECOPD in primary care on: Prevalence of potentially pathogenic bacteria (including S. pneumoniae, Haemophilus spp. and Enterobacteriacae) cultured from sputum at 4 weeks and the proportion of bacteria that are resistant 4 weeks post-randomisation
   Prevalence of commensal organisms cultured from throat swabs at 4 weeks and proportion of bacteria that are resistant 4 weeks post randomisation
   COPD health status over time measured using the CCQ total score At weeks 1, 2 and 4 post randomisation
   CCQ symptoms domain At weeks 1, 2 and 4 post randomisation
   CCQ function state domain At weeks 1, 2 and 4 post randomisation
   CCQ mental state domain At weeks 1, 2 and 4 post randomisation
   Total antibiotic consumption (number of days antibiotics consumed for AECOPD/any reason) First 4 weeks post randomisation
   Health utility measured using the EuroQol-5D (EQ-5D) At weeks 1, 2 and 4 and at month 6 post randomisation
   All-cause antibiotic consumption During the first 4 weeks post randomisation
   Antibiotic prescribing At the index consultation
   Antibiotic prescribing During the first 4 weeks post randomisation
   Use of other COPD treatments including orally administered steroids During the first 4 weeks post randomisation
   Adverse effects potentially attributable to antibiotics prescribed for the exacerbation During the first 4 weeks post randomisation
   Primary and secondary care consultations, including hospitalisations At week 4 and month 6
   Costs (total NHS cost) and cost-effectiveness At month 6
   Incidence of pneumonia (measured by patient and GP report) At week 4 and month 6
   Disease-specific, health-related quality of life over time measured using the CRQ-SAS (dyspnoea, fatigue, emotion function, mastery and total scores) At month 6
  1. AECOPD acute exacerbation of chronic obstructive pulmonary disease, CCQ Clinical COPD Questionnaire, CRP C-reactive protein point-of-care test, POCT point-of-care test, CRQ-SAS Chronic Respiratory Disease Questionnaire, self-administered, standardised, GP general practitioner