STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

ter Meulen, Bastiaan C.; van Dongen, Johanna M.; van der Vegt, Marinus; Weinstein, Henry C.; Ostelo, Raymond W. J. G.

doi:10.1186/s13063-020-05018-2

Trials

Table 3 Primary outcomes according to treatment and timing

From: STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

		Intervention group 1, mean (SD)	Intervention group 2, mean (SD)	Control group, mean (SD)	Comparison 1, treatment effect, mean difference (95% CI)	Comparison 2, treatment effect, mean difference (95% CI)	Comparison 3, treatment effect, mean difference (95% CI)
Outcome
Back pain	Overall effect				X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	Baseline	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	3 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	6 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	12 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	26 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
Leg pain	Overall effect				X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	Baseline	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	3 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	6 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	12 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	26 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
Physical functioning	Overall effect				X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	Baseline	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	3 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	6 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	12 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	26 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
		Intervention group, N (%)		Control group (%), N (%)	Treatment effect, odds ratio (95% CI)	Treatment effect, odds ratio (95% CI)	Treatment effect, odds ratio (95%CI)
Global Perceived Effect	Overall effect				X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	3 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	6 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	12 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_
	26 weeks	X (XX)	X (XX)	X (XX)	X (XX–XX)_	X (XX–XX)_	X (XX–XX)_

Note: Comparison 1: intervention group 1 versus control; comparison 2: intervention group 2 versus control; comparison 3: intervention group 1 versus Intervention group 2

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ISSN: 1745-6215

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