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

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