- Items 1–12 represent: 1, a clearly stated aim; 2, inclusion of consecutive patients; 3, prospective collection of data; 4, endpoints appropriate to the aim of the study; 5, unbiased assessment of the study endpoint; 6, follow-up period appropriate to the aim of the study; and 7, loss to follow-up less than 5%; 8, prospective calculation of the study size. An item scored 0 means not mentioned, 1 means reported but inadequate, and 2 means reported and adequate. The total score was 16 for self-controlled studies. Use red for 0, yellow for 1 yellow and green for 2
