A2. Methodological Quality Questionnaire

Internal validity

1. Was the assigned treatment adequately concealed prior to allocation?

X1

2. Were the outcomes of patients who withdrew or were excluded after allocation described and included in an intention to treat analysis?

X2

3. Were the outcome assessors blind to assignment status?

X3

4. Were the participants blind to assignment status following allocation?

X4

5. Were the treatment providers blind to assignment status?

X5

6. Were the care programs, other than the trial options, identical?

X6

7. Were the withdrawals <10% of the trial population?

X7

External validity

1. Were the inclusion and exclusion criteria for entry clearly defined?

X8

2. Were the outcome measures used clearly defined?

X9

3. Were accuracy, precision, observer variation of measures adequate?

X10

4. Was the timing of the outcome measures appropriate?

X11

5. The quality of allocation concealment was graded?

X12

Statistical validity

1. Was the main endpoint mentioned?

X13

2. Was the power analysis described?

X14

3. Baseline comparison reported?

X15

4. Statistical technique appropriate?

X16

5. Table and graphical results clear?

X17