Additional data tables

Chris A Rogers; Katie Pike; Helen Campbell; Barnaby C Reeves; Gianni D Angelini; Alastair Gray; Doug G Altman; Helen Miller; Sian Wells; David P Taggart; on behalf of the CRISP investigators

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Rogers CA, Pike K, Campbell H, et al.; on behalf of the CRISP investigators. Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial). Southampton (UK): NIHR Journals Library; 2014 Jul. (Health Technology Assessment, No. 18.44.)

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Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial).

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Appendix 2Additional data tables

Withdrawals

TABLE 20

Details of withdrawals

Allocation	Time of withdrawal	Time from randomisation to withdrawal (days)	Consent withdrawn by	Reason for withdrawal	Received surgery
ONCABG	Pre surgery	0	Patient	No reason given	No
ONCABG	Pre surgery	21	Clinician	Surgery no longer required, patient and surgeon agreed medical treatment other than surgery	No
ONCABG	Pre surgery	31	Clinician	Not willing for data to be used	No
OPCABG	Pre surgery	1	Clinician	Decided to treat medically	No
OPCABG	Pre surgery	2	Clinician	Patient no longer being considered for surgery as not symptomatic	No
OPCABG	Pre surgery	4	Patient	Patient withdrew without knowing allocation, wanted to be operated on by the surgeon met in clinic	Yes^a
OPCABG	Pre surgery	50	Clinician	Not willing for data to be used	No

a: The patient was happy for data collection and follow-up to continue; therefore, this patient remained in the analysis cohort.

The European Quality of Life-5 Dimensions responses

TABLE 21

Preoperative EQ-5D responses by type of questionnaire

Domain	Levels	Three-level EQ-5D		Five-level with five descriptors EQ-5D		Five-level with three descriptors EQ-5D
Domain	Levels	Randomised to OPCABG (n = 14)	Randomised to ONCABG (n = 16)	Randomised to OPCABG (n = 18)	Randomised to ONCABG (n = 13)	Randomised to OPCABG (n = 16)	Randomised to ONCABG (n = 19)
Mobility	No problems walking about	7	8	10	3	9	10
	Slight problems walking about	–	–	5	1	0	1
	Some problems walking about	7	8	2	5	7	7
	A lot of problems walking about	–	–	0	4	0	0
	Confined to bed	0	0	1	0	0	1
Self-care	No problems with self-care	12	13	17	11	15	16
	Slight problems washing or dressing	–	–	0	0	0	1
	Some problems washing or dressing	2	3	0	2	1	1
	A lot of problems washing or dressing	–	–	1	0	0	0
	Unable to wash or dress	0	0	0	0	0	1
Usual activities^a	No problems with usual activities	5	7	10	6	8	7
	Slight problems with usual activities	–	–	4	2	1	1
	Some problems with usual activities	8	7	3	5	5	8
	A lot of problems with usual activities	–	–	0	0	0	0
	Unable to perform usual activities	0	2	1	0	2	3
Pain/discomfort^b	No pain or discomfort	5	7	5	4	10	10
	Slight pain or discomfort	–	–	9	4	1	1
	Moderate pain or discomfort	8	7	4	4	3	7
	A lot of pain or discomfort	–	–	0	0	1	0
	Extreme pain or discomfort	1	2	0	1	0	1
Anxiety/depression^c	Not anxious or depressed	9	10	11	5	11	13
	Slightly anxious or depressed	–	–	6	6	1	0
	Moderately anxious or depressed	3	6	1	1	3	2
	Very anxious or depressed	–	–	0	0	0	0
	Extremely anxious or depressed	2	0	0	1	1	3

a: One patient with missing data (three-level: in the OPCABG group).
b: One patient with missing data (five-level with three descriptors: in the OPCABG group).
c: One patient with missing data (five-level with three descriptors: in the ONCABG group).
: Missing data: two patients did not attempt to complete the EQ-5D (three-level: one in the OPCABG group; five-level with five descriptors: one in the ONCABG group).

TABLE 22

Four- to 8-week postoperative EQ-5D responses by type of questionnaire

Domain	Levels	Three-level EQ-5D		Five-level (5 descriptors) EQ-5D		Five-level (3 descriptors) EQ-5D
Domain	Levels	Randomised to OPCABG (n = 14)	Randomised to ONCABG (n = 15)	Randomised to OPCABG (n = 17)	Randomised to ONCABG (n = 12)	Randomised to OPCABG (n = 15)	Randomised to ONCABG (n = 18)
Mobility	No problems walking about	8	6	12	7	11	13
	Slight problems walking about	–	–	3	2	0	1
	Some problems walking about	6	9	2	1	4	4
	A lot of problems walking about	–	–	0	1	0	0
	Confined to bed	0	0	0	1	0	0
Self-care	No problems with self-care	14	13	15	11	14	17
	Slight problems washing or dressing	–	–	2	0	0	1
	Some problems washing or dressing	0	2	0	1	1	0
	A lot of problems washing or dressing	–	–	0	0	0	0
	Unable to wash or dress	0	0	0	0	0	0
Usual activities	No problems with usual activities	9	6	13	4	4	7
	Slight problems with usual activities	–	–	2	5	3	3
	Some problems with usual activities	5	8	1	3	8	8
	A lot of problems with usual activities	–	–	1	0	0	0
	Unable to perform usual activities	0	1	0	0	0	0
Pain/discomfort	No pain or discomfort	7	9	12	4	7	10
	Slight pain or discomfort	–	–	4	8	3	2
	Moderate pain or discomfort	7	5	1	0	5	6
	A lot of pain or discomfort	–	–	0	0	0	0
	Extreme pain or discomfort	0	1	0	0	0	0
Anxiety/depression^a	Not anxious or depressed	12	12	13	9	13	12
	Slightly anxious or depressed	–	–	3	1	0	1
	Moderately anxious or depressed	2	3	1	1	2	2
	Very anxious or depressed	–	–	0	0	0	1
	Extremely anxious or depressed	0	0	0	1	0	0

a: Two patients with missing data (five-level with three descriptors: in the ONCABG group).
: Missing data: seven patients did not attempt to complete the EQ-5D (three-level: one in the OPCABG group and one in the ONCABG group; five-level with five descriptors: one in the OPCABG group and two in the ONCABG group; five-level with three descriptors: one in the OPCABG group and one in the ONCABG group).

TABLE 23

EQ-5D visual analogue scale responses by type of questionnaire

Questionnaire	Preoperative		4–8 weeks postoperative		MD (95% CI)
Questionnaire	Randomised to OPCABG	Randomised to ONCABG	Randomised to OPCABG	Randomised to ONCABG	MD (95% CI)
Three-level EQ-5D
n	13	16	14	15
Mean (SD)	68 (15)	62 (17)	76 (16)	66 (16)	10 (–2 to 22)
Five-level (five descriptor) EQ-5D
n	18	13	17	12
Mean (SD)	69 (17)	71 (15)	77 (16)	74 (12)	3 (–7 to 14)
Five-level (three descriptor) EQ-5D
n	16	19	15	18
Mean (SD)	69 (16)	66 (18)	76 (10)	73 (16)	3 (–6 to 13)

TABLE 24

Quality-of-life responses at 1-year follow-up

Quality-of-life measure	Randomised to OPCABG (n = 5)	Randomised to ONCABG (n = 2)
Rose and CCS angina class
Rose angina
No angina	4	0
Grade I	1	1
Grade II	0	1
CCS class
Asymptomatic	5	1
Grade I	0	0
Grade II	0	1
Grade III	0	0
Grade IV	0	0
EQ-5D categorical responses
Mobility
No problems walking about	3	1
Slight problems walking about	0	0
Some problems walking about	1	1
A lot of problems walking about	1	0
Confined to bed	0	0
Self-care
No problems with self-care	4	2
Slight problems washing or dressing	0	0
Some problems washing or dressing	1	0
A lot of problems washing or dressing	0	0
Unable to wash or dress	0	0
Usual activities
No problems with usual activities	3	1
Slight problems with usual activities	0	0
Some problems with usual activities	2	1
A lot of problems with usual activities	0	0
Unable to perform usual activities	0	0
Pain/discomfort
No pain or discomfort	2	1
Slight pain or discomfort	0	0
Moderate pain or discomfort	2	1
A lot of pain or discomfort	0	0
Extreme pain or discomfort	1	0
Anxiety/depression
Not anxious or depressed	4	2
Slightly anxious or depressed	0	0
Moderately anxious or depressed	1	0
Very anxious or depressed	0	0
Extremely anxious or depressed	0	0

: Continuous data:
: EQ-5D single summary index data were collected for five patients, responses were: OPCABG group –0.02, 0.8, 1 and 1; ONCABG group 0.69.
: EQ-5D visual analogue scale data were collected for six patients, responses were: OPCABG group 35, 74, 75 and 75; ONCABG group 70 and 70.
: CROQ core total scores were calculated for seven patients, responses were: OPCABG group 42.4, 52.6, 54.7, 55.2 and 55.9; ONCABG group: 34.5 and 54.1.

Copyright © Queen’s Printer and Controller of HMSO 2014. This work was produced by Rogers et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK262160

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Rogers CA, Pike K, Campbell H, et al.; on behalf of the CRISP investigators. Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial). Southampton (UK): NIHR Journals Library; 2014 Jul. (Health Technology Assessment, No. 18.44.) Appendix 2, Additional data tables.
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Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial).

Appendix 2Additional data tables

Withdrawals

TABLE 20

The European Quality of Life-5 Dimensions responses

TABLE 21

TABLE 22

TABLE 23

TABLE 24

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