| Item ID |
Description |
Implementation |
| Patient selection |
|
NOTE: All criteria were scored yes (+), no (‐) or don't know (?). |
| b1 |
Was an adequate method of randomisation applied? |
A random (unpredictable) allocation sequence must have been applied. Methods of allocation using date of birth, date of admission, hospital numbers, or alternation are not considered to be appropriate. |
| b2 |
Was the treatment allocation concealed? |
Allocation should have been performed by an independent person who is not responsible for determining eligibility for inclusion. This person has no information about the patients included in the trial and has no influence on the allocation sequence or the decision about eligibility for inclusion. |
| c |
Were the groups similar at baseline with regard to the most important prognostic indicators? |
Groups must be similar at baseline with regard to at least three of the four prognostic indicators of age, sex, duration of symptoms and value of main outcome measure(s). |
| Interventions |
|
|
| e |
Were co‐interventions avoided or similar for all groups? |
Co‐interventions should either have been avoided in the trial design or be similar in the groups. |
| f |
Were the patients blinded for the intervention? |
Adequate information about blinding must have been provided. |
| Outcome measurement |
|
|
| g |
Was the outcome assessor blinded to the intervention? |
Adequate information about blinding must have been provided. |
| j |
Was the drop‐out/loss to follow‐up rate described and acceptable? |
Included patients who did not complete the follow‐up period or were not included in the analysis, must have been described. If the percentage of drop‐outs and loss to follow‐up is < 20% for short‐term follow‐up and < 30% for long‐term follow‐up, and loss to follow‐up does not lead to substantial bias, a '+' is scored. (N.B. these percentages are arbitrary and not supported by empirical evidence). |
| l |
Was the timing of the outcome assessment similar for all groups? |
Timing of outcome assessment should have been started from the moment of treatment allocation and be identical for all intervention groups and for all important outcome assessments. |
| Statistics |
|
|
| n |
Did the analysis include an intention‐to‐treat analysis? |
For all randomised patients, the most important moments of effect measurement should have been reported/analysed (minus missing values), irrespective of non‐compliance and co‐interventions. |
