Table 2.

Methodological elements to describe informed consent

Study	Element
	Did investigators describe how eligible people were identified?	Were eligible people equally likely to be approached to participate?	If eligible people were not equally likely to be approached to participate, how were people chosen for participation?	Did investigators report consent related outcomes for all eligible people?
Al-Shahi 2005w2	Yes	No	Approval by general practitioner or hospital consultant	Yes
Bryant 2006w4	Yes	Yes	NA	Yes
Buckleyw5	Yes	No	Contact by general practitioner	Yes
Dunn 2004w7	Yes	Yes	NA	Yes
Edlund 1985w8	Yes	Yes	NA	Yes
Harris 2004w10	Yes	No	Approval by general practitioner or district nurses, no dementia, alive and living in practice area; on the electoral register and had contact with the practice within the last 5 years*	Yes
Huang 2007w11	Yes	Yes	NA	Yes
Jacobsen 1999w12	Yes	Yes	Random selection	Yes
Klassen 2005; healthy childrenw13	Yes	No	Ability to contact, English language, vital status of mother or baby	Yes
Klassen 2005; NICUw13	Yes	No	Ability to contact, English language, vital status of mother or baby	Yes
Matsui; genetic 2005w15	Yes	No	Not stated	No
Matsui; non-genetic 2005w15	Yes	No	Not stated	No
McKinney 2005w16	Yes	No	Not stated	Yes
Schwartz 2005w19	Yes	No	Not stated	No
Tate 2006w20	Yes	Yes	NA	Yes
Tu 2004; phase Iw1	Yes	No	Doctor approval, patient availability	Yes
Tu 2004; phase IIw1	Yes	No	Doctor approval, patient availability	Yes
Woolf 2000w21	Yes	Yes	Random selection	Yes
Yawn 1998w23	Yes	No	Not stated	Yes
Young 2001w24	Yes	Yes	NA	Yes

NICU=neonatal intensive care unit; NA=not available. Criteria informed by Guyatt and Rennie.⁸

*Reasons for exclusion reported in Harris et al.¹³