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Table 3 Patient and carer baseline and outcome measures for BIS Phase III RCT

From: Study Protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

Baseline characteristic/outcome Instrument/measure
PATIENT  
Patient breathlessness Numerical Rating Scale (NRS) for breathlessness [23] at worst/average over last 24 hours/now; modified Borg [24] at rest and on exertion & identification of activity that makes breathlessness worst
Patient distress due to breathlessness
(primary outcome measure)
NRS for distress due to breathlessness (after Corner et al 1995 [25])
Patient quality of life Chronic Respiratory Questionnaire [26]
EQ-5D [27]
Patient anxiety & depression Hospital Anxiety and Depression Scale [28]
Patient use of other services CSRI [29]
Patient social functioning No. of times patient goes out of the house (weekly average since last interview)
Patient experience of breathlessness & expectations of BIS/satisfaction & outcome of BIS Brief qualitative interview:
t1 - experience of breathlessness & expectations of BIS
t3/t5 - satisfaction and outcome of BIS
CARER  
Carer's assessment of patient's breathlessness Numerical Rating Scale (NRS) for breathlessness [23] at worst/average over last 24 hours/now; modified Borg [24] at rest and on exertion & identification of activity that makes breathlessness worst
Carer distress due to patient's breathlessness NRS adapted for carer for distress to carer due to patient's breathlessness
Carer quality of life EQ-5D [27]
Carer anxiety & depression Hospital Anxiety and Depression Scale [28]
Carer's social functioning No. of times carer goes out of the house (weekly average since last interview)
Caregiver burden Burden Interview [30]
Caregiver Appraisal Scale [31]
Carer experience of breathlessness & expectations of BIS/satisfaction & outcome of BIS Brief qualitative interview:
t1 - experience of breathlessness & expectations of BIS
t3/t5 - satisfaction and outcome of BIS