The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials

Table 1 Baseline data collected prior to randomisation in the three trials

Data item	FOCUS	AFFINITY	EFFECTS
Eligibility confirmed	+	+	+
Consent confirmed	+	+	+ Patient only
Participant’s names	+	+	+
Date of birth	+	+	+
Gender	+	+	+
Ethnicity	+	+	+
Living arrangements	+	+	+
Employment	+	+	+
Co-morbidities (existing)
• Previous ischaemic stroke/TIA	+	+	+
• Previous intracranial bleeding	+	+	+
• Coronary heart disease	+	+	+
• Current or past depression	+	+	+
• Diabetes	+	+	+
• Gastrointestinal bleeding	+	+	+
• Hyponatraemia	+	+	+
• Fractures	+	+	+
Current medication	+	+	+
NIHSS including subsections [28]	+	+	+
Prior independence	1 Question	mRS	1 Question
Ability to walk alone	+	+	+
Ability to lift both arms	+	+	+
Post-stroke disability (smRSq) [31–33]		+
Patient health questionnaire (PHQ) [43, 56]	2-Question version	9-Question version	2-Question version
Haemorrhage on brain imaging?	+	+	+
OCSP classification for ischaemic stroke [57]	+	+	+
Modified TOAST classification [58]	+	+	+
Renal and liver function test results		+
Contact details to facilitate central follow-up	+		+
Unique identifier to facilitate central follow-up	+

ISSN: 1745-6215