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Table 3 Outcome measurements

From: Opioids in patients with COPD and refractory dyspnea: literature review and design of a multicenter double blind study of low dosed morphine and fentanyl (MoreFoRCOPD)

 

Measurement

Frequency of measurement

Primary outcome measure

  

Change in mean dyspnea sensation

Numeric rating scale [26]

Once daily in patient diary

Secondary outcome measures

  

Change in worst dyspnea sensation

Numeric rating scale [26]

Once daily in patient diary

Change in Health-Related Quality of Life

CCQ [27]

Once daily in patient diary

CRQ [28]

During each study visit

CRQ-mastery domain

During each study visit

HADS-A [29]

Open en named side effects

During each study visit

Once daily in patient diary and asked during study visits

Anxiety

Side effects

Change in hypercapnia, HCO3 and pH

Change in sleep quality

Patient preference

Continued opioid use

Capillary blood gas analysis

Numeric rating scale [30]

Asked during the final study visit

Asked 3 months after the end of study

During each study visit

Once daily in patient diary

Once

Once

  1. CCQ clinical COPD questionnaire, CRQ chronic respiratory questionnaire, HADS-A hospital anxiety and depression scale—anxiety subscale