A systematic review and meta-analysis of the clinimetric properties of the core outcome measurement instruments for clinical effectiveness trials of nutritional and metabolic interventions in critical illness (CONCISE)

Davies, T. W.; Kelly, E.; van Gassel, R. J. J.; van de Poll, M. C. G.; Gunst, J.; Casaer, M. P.; Christopher, K. B.; Preiser, J. C.; Hill, A.; Gundogan, K.; Reintam-Blaser, A.; Rousseau, A.-F.; Hodgson, C.; Needham, D. M.; Schaller, S. J.; McClelland, T.; Pilkington, J. J.; Sevin, C. M.; Wischmeyer, P. E.; Lee, Z. Y.; Govil, D.; Chapple, L.; Denehy, L.; Montejo-González, J. C.; Taylor, B.; Bear, D. E.; Pearse, R. M.; McNelly, A.; Prowle, J.; Puthucheary, Z. A.

doi:10.1186/s13054-023-04729-7

Critical Care

Table 2 Key characteristics of included studies

From: A systematic review and meta-analysis of the clinimetric properties of the core outcome measurement instruments for clinical effectiveness trials of nutritional and metabolic interventions in critical illness (CONCISE)

Author, Year, Location	n	Gender M/F	Age mean ± SD or median [IQR]	Outcome Measure	Setting	Severity of illness APACHE ± SD or median [IQR]	ICU LOS (days) mean ± SD or median [IQR]	Timepoints of assessment for outcome of interest
Abd-El-Gawad et al., 2013, Egypt [55]	65	42/23	70 ± 11	KI	General ICU	NR	11 ± 8	1 month prior to ICU admission
Ali et al., 2008, USA [64]	136	65/71	58 ± 16	HGS	General ICU	66 ± 27	ICUAW 21 ± 19, non-ICUAW 12 ± 10	Ventilator day 5
Alison et al., 2012, Australia [28]	173	104/69	57 ± 16	SF-36 PF, 6MWT	Post ICU clinic	19 ± 10	9 ± 8	Post hospital discharge (weeks 1, 8, 26)
Bakhru et., 2018, USA [29]	36	19/17	65 [IQR 28]	SPPB, SF-36 PF, SF-36 PCS, HGS	General ICU, Post ICU clinic	29 [IQR 8.0]	NR	Post hospital discharge [30 days]
Baldwin et al., 2013, Australia [65]	17	10/7	78 [46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82]	HGS	General ICU	20 ± 5	18 [12,13,14,15,16,17,18,19,20,21]	ICU admission (day 13)
Bo et al., 2003, Italy [56]	659	352/307	77 ± 8	KI	General ICU	13 ± 5	7 ± 6	2 weeks prior to ICU admission
Broslawski et al.,1995, USA[63]	45	24/21	77 ± 8	KI	General ICU	19 ± 8	7 ± 8	6 months after ICU discharge
Bruno et al., 2022, Global [62]	2359	1670/689	Non-frailty/disability 75 ± 4, Frailty or disability 77 ± 6, Frailty & Disability 78 ± 5	KI	General ICU (COVID)	NR SOFA: Non-frailty/disability 5, Frailty or disability 6, Frailty & disability 8	NR	Prior to ICU admission
Chiang et al., 2006, Taiwan [51]	32	24/8	Control 79 [73,74,75,76,77,78,79,80,81,82, 84], Treatment 75 [63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80]	BI	Post ICU clinic	NR	NR	NR
Chan et al., 2015, Global [30]	651	368/226	Between 48–59	SF-36 PF, 6MWT	General ICU	Between 19–84	Between 9–19	NR
Chan et al., 2016, Global [50]	306	157/149	ATLOS = 48 ± 15, ICAP = 46 ± 13	SPPB – 4 m gait speed	General ICU	ATLOS = 25 ± 8, ICAP = 24 ± 8	ATLOS = 14 ± 11, ICAP = 18 ± 18	36-, 48-, and 60- month ICU follow up
Chan et al., 2017, Global [40]	233	123/110	ATLOS = 48 ± 14, ICAP = 49 ± 15	SF-36 PCS, 6MWT	General ICU	ATLOS = 25 ± 8 ICAP = 24 ± 8	ATLOS = 15 ± 12, ICAP = 18 ± 17	6, 12 months post ICU follow up
Chan et al., 2018, Global [31]	120	57/63	50 ± 15	SF-36 PF, 6MWT	General ICU	86 ± 28	15 ± 11	6, 12 months post onset ARDS
Chrispin et al., 1997, UK [32]	166	113/53	62 [59,60,61,62,63,64]	SF-36 PF	General ICU	10 [8,9,10,11]	1	ICU discharge
Clini et al., 2011, Italy [57]	77	46/31	75 ± 7	KI	Ventilator weaning unit	12 ± 4	51 [12–115]	Prior to admission to weaning unit [24 days]
Costigan et al., 2019, Canada [44]	40	19/21	62 ± 17	STS	Mixed ICU	20 [14,15,16,17,18,19,20,21,22,23,24,25,26,27,28]	7 [4,5,6,7,8,9,10,11,12]	ICU discharge
Cottereau et al., 2015, France [66]	84	45/39	66 [53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79]	HGS	General ICU	NR	13 [7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24]	At the time of SBT
Daubin et al., 2011, France [58]	100	65/35	79 ± 3	KI	General ICU	24 [18,19,20,21,22,23,24,25,26,27,28,29,30]	NR	ICU admission
de Azevedo et al., 2021, Brazil [41]	181	99/82	66 ± 19	SF-36 PCS	Mixed ICU	NR. SAPS 53 [44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68]	32	3, 6 months post randomisation
Denehy et al., 2014, Australia/USA [39]	177	113/64	60 [49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72]	STS, SF-36 PCS, 6MWT	General ICU	19 [16,17,18,19,20,21,22,23]	8 [6,7,8,9,10,11,12,13,14]	Post ICU discharge [3 months]
dos Reis et al., 2022, Brazil [52]	122	62/60	56 [47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66]	BI	General ICU	21 ± 8	7 [5,6,7,8,9,10,11]	ICU discharge (± 24 h)
Fan et al., 2014, USA [67]	222	123/99	49 [40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58]	HGS	Home/post ICU clinic	23 [19,20,21,22,23,24,25,26,27,28]	14 [10,11,12,13,14,15,16,17,18,19,20,21,22,23]	Post hospital discharge (3, 6, 12 & 24 months)
Hermans 2012, Belgium [68]	75	38/32	59 [52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71]	HGS	Mixed ICU	NR	22 [15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30]	Not specified
Heyland et al., 2000, Canada [33]	30	16/14	62 ± 14	SF-36 PF, SF-36 PCS	General ICU	22 ± 6	12 ± 9	Post ICU discharge [1 year]
Kaarola et al., 2004, Finland [34]	1099	659/440	54 [41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65]	SF-36 PF	General ICU	14 [9,10,11,12,13,14,15,16,17,18]	2 [1,2,3,4,5,6]	1–6 years post discharge from ICU
Kawakami et al., 2021, Japan [42]	192	125/67	74 [64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81]	SF-36 PCS	Mixed ICU	23 [18,19,20,21,22,23,24,25,26,27,28]	7 [5,6,7,8,9,10,11,12,13,14]	Baseline, 6 months post ICU
Khoudri et al., 2007, Morocco [35]	145	79/66	38 ± 17	SF-36 PF	General ICU	14 ± 6	9 ± 7	3 months post ICU discharge
Lee et al., 2012, USA [69]	107	59/48	61 ± 18	HGS	Mixed ICU	15 ± 9	5 [3,4,5,6,7,8,9,10]	48 h after admission (or when able, median time 3 days)
Melo et al., 2019, Brazil [46]	96	48/48	62 ± 1	STS	General ICU	SAPS 32 ± 9	5 ± 2	Discharge from ICU to ward [3 times on the same day]
Melo et al., 2022, Brazil [47]	142	75/67	51 [43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64]	STS	General ICU	SAPS 40 [36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57]	3 [2,3,4,5]	ICU Discharge
Mohamed-Hussein et al., 2018, Egypt [70]	34	18/16	61 ± 12	HGS	Respiratory ICU	NR	10 ± 9	First 24 h after recovery from sedation, repeated every 24 h for 5 days
Needham et al., 2014, USA [36]	203	100/103	48 ± 15	SF-36 PF, 6MWT	Post ICU clinic	85 ± 25	14 ± 11	12 months after ALI onset
O'Grady et al., 2022, Global [45]	451	278/173	Between 60–66	STS	General ICU	Between 19–24	9 [7,8,9,10,11]	ICU discharge, hospital discharge
Parry et al., 2015, Australia [49]	66	40/26	58 ± 17	6MWT	General ICU	21 ± 7	8 [5,6,7,8,9,10,11,12,13,14,15]	Awakening, Discharge
Parry, Berney et al., 2015, Australia [71]	60	35/25	69 [49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77]	HGS	General ICU	22 [18,19,20,21,22,23,24,25,26,27,28,29]	12 [8,9,10,11,12,13,14,15,16,17,18,19,20]	Awakening
Parry et al., 2021, Australia [13]	60	35/25	69 [49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77]	6MWT, HGS	General ICU	22	12 [8,9,10]	Day of awakening
Puthucheary et al., 2020, Germany [37]	159	107/49	61 [43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72]	SF-36 PF, SF-36 PCS	General ICU	NR	28 [10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48]	6, 12, 24 months
Rosa et al., 2020, Brazil [48]	32	14/18	59 [38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68]	6MWT	Post ICU clinic	NR	7 [4,5,6,7,8,9,10,11]	Post ICU discharge (4 months)
Sacanella et al., 2009, Spain [53]	230	140/90	75 ± 6	BI, IADL	General ICU	20 ± 6	12 ± 12	ICU admission
Shahbazi et al., 2021. Iran [73]	109	58/51	61 ± 14	GLIM	General ICU (COVID)	15 ± 4	NR	First 48 h following ICU admission
Theilla et al., 2021. Israel [74]	84	58/26	51 ± 21	GLIM	General ICU	21 ± 8	7 ± 10	First 24 h following ICU admission
Tripathy et al., 2014, India [59]	109	80/29	75 ± 8	KI	Post ICU clinic	19 ± 7	7 ± 3	Baseline, 28 days post-admission and 12 months post-hospital discharge
Van Der Schaaf et al., 2008, Netherlands [54]	69	43/26	60 [19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71]	BI, HGD	General ICU	16 [12,13,14,15,16,17,18,19,20]	7 [5,6,7,8,9,10,11,12,13,14,15,16,17]	Post ICU discharge (3–5 days)
Vest et al., 2011, USA [60]	309	145/164	75 ± 9	KI	General ICU	24 ± 6	5 ± 6	One month and one year after ICU discharge
Weinert et al., 1997, USA [43]	24	16/8	40 ± 12	SF-36 PCS	General ICU	NR Lung injury score 2 ± 1	NR	6 months post-acute lung injury
Wischmeyer, 2017, USA [38]	125	60/65	111 ± 18	SF-36 PF, SF-36 PCS, 6MWT	General ICU	21 ± 7	18 [8,9,10,11,12,13,14,15,16,17,18]	3–6 months post-randomisation
Wu et al., 1995, USA [61]	2313	1295/1018	62	KI	General ICU	NR	NR	2 months post ICU admission

APACHE acute physiology and chronic health evaluation; ARDS = Acute Respiratory Distress Syndrome; BI Barthel index, GLIM global leadership initiative on malnutrition, HGS hand grip strength, IADL instrumental activities of daily living, ICU intensive care unit, ICUAW ICU acquired weakness, IQR inter quartile range, KI katz index, LOS length of stay, NR Not reported, SAPS simplified acute physiology score, SBT spontaneous breathing trial, SF-36 PCS short form-36 physical component score, SF-36 PF short form-36 physical functioning, SOFA sequential organ failure assessment, SPPB short physical performance battery, STS Sit-to-stand, 6MWT 6-min walk test

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