Comparison of statistical methods for the analysis of patient-reported outcomes (PROs), particularly the Short-Form 36 (SF-36), in randomised controlled trials (RCTs) using standardised effect size (SES): an empirical analysis

Table 3 Characteristics of the three RCTs that used SF-36 domain scores as clinical outcomes

Trial name	Trial population	Primary outcome	Follow-up timepoints (months)	Sample size at baseline			Max sample size analysed (PRO)			Ref
Trial name	Trial population	Primary outcome	Follow-up timepoints (months)	Total	Control	Treat	Total	Control	Treat	Ref
COPD	Patients with chronic obstructive pulmonary disease	Difference in improvement in endurance shuttle walking test (ESWT) during 18 months follow-up	2, 6, 12, 18	239	129	110	174	93	81	[38]
LM^a	Independently living older people (aged 65 or more)	SF-36v2 MH at 6 months follow-up	6, 24	288	143	145	262	126	136	[39]
PLINY^a	Independently living older people (aged 75 or more)	SF-36v2 MH at 6 months follow-up	6	157	79	78	56	30	26	[40]
*Total*				684	351	333	492	249	243

^aTrials using SF-36 domains as primary outcomes. PLINY and LM used SF-36v2 MH at 6 months as primary clinical outcomes
MH mental health, PRO patient-reported outcome, SF-36v2 Short-Form 36 version 2

ISSN: 1477-7525