Full imputation data set

Vasiliki Orgeta; Phuong Leung; Lauren Yates; Sujin Kang; Zoe Hoare; Catherine Henderson; Chris Whitaker; Alistair Burns; Martin Knapp; Iracema Leroi; Esme D Moniz-Cook; Stephen Pearson; Stephen Simpson; Aimee Spector; Steven Roberts; Ian T Russell; Hugo de Waal; Robert T Woods; Martin Orrell

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Orgeta V, Leung P, Yates L, et al. Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Southampton (UK): NIHR Journals Library; 2015 Aug. (Health Technology Assessment, No. 19.64.)

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Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial.

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Appendix 6Full imputation data set

The tables presented here indicate the results for the data if the multiple imputation model had been used to impute the data for all 356 participants at each time point. Various methodologies for different types of missing data (e.g. death vs. ill health) have not been taken into account as the number of each of these circumstances was minimal and would have limited impact on the results of any imputation method. Ten imputation sets were created to establish a robust adjustment to the data missing from each time point.

TABLE 52

The pooled means (and 95% CIs) of the multiple imputations comparing the iCST and TAU for person with dementia outcomes at week 26 after adjusting for the baseline outcome measures

Person with dementia outcome measure	iCST (N = 180)	TAU (N = 176)	Pooled MD	95% CI of pooled MD	p-value
ADAS-Cog	22.16	22.61	–0.45	–1.95 to 1.05	0.56
QoL-AD	37.74	37.71	0.03	–1.94 to 2.00	0.98
DEMQOL	93.23	93.57	–0.34	–2.48 to 1.80	0.76
NPI [P]	10.52	9.80	0.72	–1.85 to 3.29	0.58
GDS-15	3.45	3.33	0.12	–0.34 to 0.58	0.61
QCPR total	56.59	55.21	1.38	–0.16 to 2.92	0.08
QCPR (warmth)	33.48	32.83	0.65	–0.31 to 1.61	0.18
QCPR (criticism and conflict)	23.06	22.43	0.63	–0.26 to 1.52	0.17
MMSE	18.98	19.68	–0.7	–1.44 to 0.04	0.07
BADLS [P]	13.38	13.47	–0.09	–1.40 to 1.22	0.89
QoL-AD [P]	31.27	31.03	0.26	–0.91 to 1.38	0.69
DEMQOL [P]	99.05	97.94	1.11	–1.16 to 3.38	0.34

: MD, mean difference; NPI, Neuropsychiatric Inventory; [P], Proxy rated measure.

TABLE 53

The pooled means (and 95% CIs) of the multiple imputations comparing the iCST and TAU for person with dementia outcomes at week 13 after adjusting for the baseline outcome measures

Carer outcome measure	iCST (N = 180)	TAU (N = 176)	Pooled MD	95% CI of pooled MD	p-value
ADAS-Cog	22.24	22.00	0.24	–1.37 to 1.85	0.77
QoL-AD	38.28	38.20	0.08	–0.85 to 1.01	0.86
DEMQOL	90.99	91.41	–0.42	–2.65 to 1.81	0.71
NPI [P]	13.41	14.52	–1.11	–3.24 to 1.02	0.31
GDS-15	3.43	3.42	0.01	–0.54 to 0.57	0.96
QCPR total	56.27	55.16	1.12	–0.13 to 2.36	0.08
QCPR (warmth)	33.72	33.43	0.29	–0.59 to 1.17	0.52
QCPR (criticism and conflict)	22.49	21.86	0.63	–0.06 to 1.32	0.08
MMSE	20.06	20.01	0.05	–0.70 to 0.80	0.89
BADLS [P]	12.96	13.18	–0.22	–1.45 to 1.01	0.73
QoL-AD [P]	32.56	31.76	0.80	–0.31 to 1.92	0.16
DEMQOL [P]	101.57	100.58	0.99	–1.22 to 3.2	0.38

: MD, mean difference; NPI, Neuropsychiatric Inventory; [P], Proxy rated measure.

TABLE 54

The pooled means (and 95% CIs) of the multiple imputations comparing the iCST and TAU for carer outcomes at week 26 after adjusting for the baseline outcome measures

Carer outcome measure	iCST (N = 134)	TAU (N = 139)	MD	95% CI of MD	p-value
SF-12 PCS	47.80	46.99	0.81	–1.18 to 2.80	0.43
SF-12 MCS	46.84	47.52	–0.68	–2.82 to 1.47	0.54
HADS total	10.56	10.67	–0.12	–1.39 to 1.16	0.86
HADS (anxiety)	6.04	5.97	0.07	–0.74 to 0.88	0.87
HADS (depression)	4.63	4.83	–0.20	–0.83 to 0.43	0.53
EQ-5D health state today	75.33	74.90	0.42	–3.03 to 3.88	0.81
EQ-5D calculated utility value^a	0.79	0.74	0.05	0.01 to 0.09	0.02
RS-14	82.83	82.05	0.78	–1.23 to 2.80	0.45
NPI (carer distress)	3.79	3.78	0.01	–0.45 to 0.47	0.97
QCPR total	58.20	58.67	–0.46	–1.79 to 0.87	0.50
QCPR (warmth)	34.38	34.44	–0.06	–0.74 to 0.62	0.87
QCPR (criticism and conflict)	23.88	24.25	–0.38	–1.21 to 0.46	0.38

: MD, mean difference; NPI, Neuropsychiatric Inventory; RS-14, Resilience Scale-14 items.
a: Significant difference at 5% level.

TABLE 55

The pooled means (and 95% CIs) of the multiple imputations comparing the iCST and TAU for carer outcomes at week 13 after adjusting for the baseline outcome measures

Carer outcome measure	iCST (N = 180)	TAU (N = 176)	MD	95% CI of MD	p-value
SF-12 PCS	49.95	50.14	–0.19	–1.59 to 1.22	0.80
SF-12 MCS	46.28	47.08	–0.80	–2.48 to 0.88	0.35
HADS total	11.27	11.01	0.26	–0.74 to 1.27	0.61
HADS (anxiety)	6.84	6.58	0.26	–0.41 to 0.92	0.45
HADS (depression)	4.58	4.60	–0.02	–0.51 to 0.47	0.93
EQ-5D health state today	74.91	74.56	0.35	–3.00 to 3.70	0.84
EQ-5D calculated utility value	0.80	0.78	0.02	–0.01 to 0.06	0.21
RS-14	81.37	81.75	–0.38	–2.00 to 1.25	0.65
NPI (carer distress)	3.14	3.04	0.10	–0.32 to 0.52	0.64
QCPR total	58.05	58.21	–0.16	–1.66 to 1.34	0.84
QCPR (warmth)	34.76	35.54	–0.77	–1.61 to 0.06	0.07
QCPR (criticism and conflict)	23.30	22.67	0.64	–0.26 to 1.53	0.16

: MD, mean difference; NPI, Neuropsychiatric Inventory; RS-14, Resilience Scale-14 items.

Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Orgeta 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.

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Orgeta V, Leung P, Yates L, et al. Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Southampton (UK): NIHR Journals Library; 2015 Aug. (Health Technology Assessment, No. 19.64.) Appendix 6, Full imputation data set.
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