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Table 1 Relationships between objectives, outcomes, measures and hypotheses

From: A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol

Objective Hypothesis Outcome Measure Visit
To assess the effectiveness of early intervention by a GP-practice nurse partnership, in patients newly identified as having COPD Early intervention by a GP–practice nurse partnership will improve outcomes for patients with COPD, compared with usual care Improvement in disease related quality of life St George’s Respiratory Questionnaire (SGRQ) [52] 1,2,3
    COPD Assessment Test (CAT) 1,2,3
   Improved smoking cessation rates Participation in smoking cessation program; quit rates (self-report) 1,2,3
    Validation of smoking cessation (where applicable) by carbon monoxide analysis 1,3
   Improved compliance with COPD immunisation recommendations Influenza and pneumococcal vaccination status (self-reported) 1,3
   Improved prescribing and use of medications for COPD Audit of prescribing against COPD-X guidelines 1,2,3
    Inhaler technique score using published checklists [43] 1,3
   Increased referral for pulmonary rehabilitation Completion of pulmonary rehabilitation (self-reported) 1,2,3
   Increase in disease related knowledge COPD knowledge questionnaire score [54] 1,3
   Improved general health status General health status question (using preliminary question from SGRQ) [52]. 1,2,3
   Slower decline in lung function Post-bronchodilator FEV1 1,3
To assess the acceptability and feasibility of team-based vs conventional management of patients with COPD   Improved team-work between GP and practice nurse Collaborative Practice Scale, VAS scale for team management of COPD End of study
   Barriers and facilitators to team-work management of COPD Process measures relating to GP and PN visits. 1, 2, 3
    Semi-structured interviews with GPs, PNs, patients End of study