Table 3.

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

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