A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials

Conroy, Elizabeth J.; Arch, Barbara; Harman, Nicola L.; Lane, J. Athene; Lewis, Steff C.; Norrie, John; Sydes, Matthew R.; Gamble, Carrol

doi:10.1186/s13063-017-2300-1

Trials

Table 2 Trial demographics by journal

From: A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials

			Journal (N in cohort)								Total (N = 264)
			BMJ (N = 16)		NEJM (N = 55)		Lancet (N = 66)		HTA (N = 127)		Total (N = 264)
			n	n/N%	n	n/N%	n	n/N%	n	n/N%	n	n/N%
Trial rationale	Explanatory		0	0.0	0	0.0	5	7.6	2	1.6	7	2.7
	Pragmatic		6	37.5	2	3.6	10	15.2	88	69.3	106	40.2
	Not specified or clear		10	62.5	53	96.4	51	77.3	37	29.1	151	57.2
Funder origin	Asia		0	0.0	1	1.8	3	4.5	0	0.0	4	1.5
	Japan		0	0.0	1	1.8	2	3.0	0	0.0	3	1.1
	South Korea		0	0.0	0	0.0	1	1.5	0	0.0	1	0.4
	Australia		1	6.3	2	3.6	3	4.5	0	0.0	6	2.3
	Australia		1	6.3	2	3.6	2	3.0	0	0.0	4	1.5
	New Zealand		0	0.0	0	0.0	1	1.5	0	0.0	2	0.8
	Europe		14	87.5	21	38.2	40	60.6	127	100.0	202	76.5
	Belgium		0	0.0	1	1.8	0	0.0	0	0.0	1	0.4
	Denmark		3	18.8	2	3.6	0	0.0	0	0.0	5	1.9
	Finland		1	6.3	0	0.0	0	0.0	0	0.0	1	0.4
	France		0	0.0	2	3.6	5	7.6	0	0.0	7	2.7
	Germany		0	0.0	1	1.8	6	9.1	0	0.0	7	2.7
	Ireland		1	6.3	0	0.0	2	3.0	0	0.0	3	1.1
	Netherlands		2	12.5	1	1.8	2	3.0	0	0.0	5	1.9
	Spain		0	0.0	0	0.0	1	1.5	0	0.0	1	0.4
	Sweden		0	0.0	0	0.0	1	1.5	0	0.0	1	0.4
	Switzerland		1	6.3	4	7.3	3	4.5	0	0.0	8	3.0
	United Kingdom		6	37.5	9	16.4	19	28.8	127	100.0	161	61.0
	Other (European Union)		0	0.0	1	1.8	1	1.5	0	0.0	2	0.8
	North America		1	6.3	30	54.5	20	30.3	0	0.0	51	19.3
	Canada		0	0.0	1	1.8	0	0.0	0	0.0	1	0.4
	United States of America		1	6.3	29	52.7	20	30.3	0	0.0	50	18.9
	Not specified		0	0.0	1	1.8	0	0.0	0	0.0	1	0.4
Recruitment setting	Primary		4	25.0	2	3.6	5	7.6	46	36.2	57	21.6
	Secondary only		2	12.5	2	3.6	5	7.6	17	13.4	26	9.8
	Tertiary only		3	18.8	17	30.9	30	45.5	47	37.0	97	36.7
	Secondary or tertiary (not specified)		0	0.0	0	0.0	2	3.0	3	2.4	5	1.9
	Community		7	43.8	4	7.3	2	3.0	15	11.8	28^a	10.6
	Emergency		1	6.3	5	9.1	0	0.0	7	5.5	13	4.9
	Hospice		0	0.0	0	0.0	0	0.0	0	0.0	0	0.0
	Social care		0	0.0	0	0.0	0	0.0	0	0.0	0	0.0
	Other setting		0	0.0	1	1.8	1	1.5	0	0.0	2^b	0.8
	Not clear		0	0.0	32	58.2	22	33.3	9	7.1	63^c	23.9
Trial design	Parallel		13	81.3	48	87.3	59	89.4	103	81.1	233	88.3
	Sequential		0	0.0	1	1.8	1	1.5	1	0.8	3	1.1
	Crossover		0	0.0	1	1.8	2	3.0	5	3.9	9	3.4
	Cluster		2	12.5	0	0.0	2	3.0	11	8.7	15	5.7
	Factorial		1	6.3	5	9.1	2	3.0	7	5.5	15	5.7
Number of trial arms	2		12	75.0	42	76.4	46	69.7	85	66.9	185	70.1
	3		3	18.8	7	12.7	10	15.2	29	22.8	49	18.6
	4		1	6.3	4	7.3	4	6.1	7	5.5	16	6.1
	5		0	0.0	2	3.6	2	3.0	5	3.9	9	3.4
	6 or more		0	0.0	0	0.0	4	6.1	1	0.8	5^d	1.9
Type of intervention ^{e, f}	Pharmaceutical		3	18.8	41	74.5	54	81.8	34	26.8	132	50.0
	Cellular and gene therapy		0	0.0	1	1.8	2	3.0	0	0.0	3	1.1
	Medical device		0	0.0	5	9.1	5	7.6	16	12.6	26	9.8
	Surgery		0	0.0	3	5.5	1	1.5	10	7.9	14	5.3
	Radiotherapy		0	0.0	1	1.8	3	4.5	9	7.1	13	4.9
	Psychological and behavioural		6	37.5	0	0.0	1	1.5	22	17.3	29	11.0
	Physical		2	12.5	2	3.6	0	0.0	10	7.9	14	5.3
	Complimentary		0	0.0	0	0.0	1	1.5	5	3.9	6	2.3
	Resources and infrastructure		1	6.3	1	1.8	1	1.5	19	15.0	22	8.3
	Other		4	25.0	2	3.6	1	1.5	12	9.4	19	7.2
Number of primary outcomes	1		11	68.8	47	85.5	51	77.3	101	79.5	210	79.5
	2		2	12.5	3	5.5	10	15.2	13	10.2	28	10.6
	3		1	6.3	4	7.3	2	3.0	1	0.8	8	3.0
	4 or more		2	12.5	1	1.8	2	3.0	11	8.7	16	6.1
Primary outcome type	Subjective	1 primary outcome	3	18.8	0	0.0	2	3.0	39	30.7	44	16.7
	Subjective	2 + primary outcomes	1	6.3	0	0.0	0	0.0	4	3.1	5	1.9
	Objective	1 primary outcome	6	37.5	46	83.6	46	69.7	53	41.7	151	57.2
	Objective	2 + primary outcomes	3	18.8	6	10.9	13	19.7	6	4.7	28	10.6
	Both	1 primary outcome	0	0.0	0	0.0	0	0.0	3	2.4	3^g	1.1
	Both	2 + primary outcomes	1	6.3	2	3.6	1	1.5	14	11.0	18	6.8
	Not clear	1 primary outcome	2	12.5	1	1.8	3	4.5	6	4.7	12	4.5
	Not clear	2 + primary outcomes	0	0.0	0	0.0	1	1.5	2	1.6	3	1.1
Allocation ratio	Equal e.g. 1:1		13	81.3	46	83.6	55	83.3	115	90.6	229	86.7
	Not equal e.g. 2:1		2	12.5	8	14.5	10	15.2	12	9.4	32	12.1
	Not clear		1	6.3	1	1.8	1	1.5	0	0.0	3	1.1
Unit of randomisation	Individual		12	75.0	52	94.5	62	93.9	113	89.0	239	90.5
	GP practice		0	0.0	0	0.0	1	1.5	9	7.1	10	3.8
	Dyad (e.g. mother-child)		1	6.3	1	1.8	1	1.5	2	1.6	5	1.9
	Other		3	18.8	2	3.6	2	3.0	3	2.4	10^h	3.8
Blinding	Yes, blinding		11	68.8	37	67.3	45	68.2	69	54.3	162	61.4
	No, not blinded	Justification provided	2	12.5	3	5.5	5	7.6	33	26.0	43ⁱ	16.3
	No, not blinded	Justification not provided	1	6.3	9	16.4	15	22.7	10	7.9	35	13.3
	Not clear		2	12.5	6	10.9	1	1.5	15	11.8	24	9.1

BMJ British Medical Journal, HTA Health Technology Assessment Monograph series, NEJM New England Journal of Medicine
^aAdvertisements in newsletters (n = 1); Child and Adolescent Mental Health Services (n = 1); Community mental health teams (n = 1); Community nurse services (n = 1); Community nursing services and community leg ulcers clinics (n = 1); Community old age psychiatry services (n = 1); Community sources (n = 1); Department of Veterans Affairs (n = 3); National population registrar (n = 1); Community paediatricians (n = 1); Registrar (n = 3); Schools (n = 1); Secondary schools (n = 1); University podiatry schools and podiatry clinics (n = 1); Vaccination centres in schools (n = 1); Villages (n = 1); Not specified (n = 8)
^bOther setting: Veterans Affairs Medical Centre (n = 1); From other trials (n = 1)
^cNot clear: Adult mental health setting (n = 1); Antenatal clinic (n = 1); Centres (n = 29); Child and Adolescent Mental Health Services (n = 1); Child Development Centre (n = 1); Clinic site (n = 1); Clinical centres (n = 1); Clinical sites (n = 1), Clinics (n = 2); Countries (n = 2); European medical centres (n = 1); Institutes (n = 1); Institutions (n = 1); Sites (n = 13); Not described (n = 7)
^dTotal arms equal to: six (n = 2); eight (n = 1); nine (n = 1); twelve (n = 1)
^eDefined by UK Clinical Research Collaboration Health Research Classification System
^fCategories not mutually exclusive
^gBoth: Composite (n = 3) (Disease improvement calculated from CHAQ, physician’ global assessment of disease activity, parents’ global assessment of overall well-being, number of joints with limited range of movement (ROM), number of active joints and erythrocyte sedimentation rate (n = 1)); Foot and Ankle Outcome Score (n = 1); Post-operative nausea and vomiting (n = 1)
^hOther units of randomisation: Clinic (n = 1); Family (n = 2); Hospital (n = 1); Household (n = 1); Partner (n = 1); School (n = 1); Village (n = 1); Year group (n = 1); Paediatric diabetes services (n = 1)
ⁱJustification for no blinding: Not possible or practical due to nature of intervention or trial design (n = 30); Not possible/practical as in practice caused difficulties for patients (n = 1); Not possible/practical as shown by other similar trials (n = 2); Not possible/practical so cluster randomisation approach used (n = 1); Not possible – no additional justification given (n = 4); Attempted to blind although were not successful (n = 1); Large sample size means that results are not compromise (n = 1); Not blinding reflects real practice (n = 2); Test for impact of not blinding post trial (n = 1)

Back to article page

ISSN: 1745-6215

Contact us

Submission enquiries: Access here and click Contact Us
General enquiries: info@biomedcentral.com