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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