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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