Table 3.

Adequacy of the randomisation process

1) Adequate

i) a central allocation process by an office or third party unaware of subject characteristics

ii) pre-numbered packages of support administered to carers sequentially

iii) use of an on-site or coded computer system with a locked, unreadable file with allocation occurring only after carers or patient details are inputted

iv) assignment via scaled, numbered and opaque envelopes

v) other combinations which provide evidence of adequacy in concealment

2) Unclear

i) study used list or tables to allocate assignments

ii) use of "envelopes" or" sealed envelopes

iii) simply stating that the study was randomised with no further details

3) Inadequate

i) by using case numbers, dates of birth, age group, alternation or date of referral and other similar methods

ii) use of any other system in which allocation can be known in advance such as pre-printed lists of random numbers or open computer allocation lists.