Table 1.
Method | Assessment | Score* |
---|---|---|
Randomization | A method to generate the sequence of randomization will be regarded as appropriate if it allowed each study participant to have the same chance of receiving each intervention and the investigators could not predict which treatment was next. | 1 point |
If the method to generate the sequence of randomization was described and it was appropriate (table of random numbers, computer generated, etc) | Add 1 point | |
If the method to generate the sequence of randomization was described and it was inappropriate (patients were allocated alternately, or according to date of birth, date of admission, or hospital number, etc) | Deduct 1 point | |
Double blinding | A study must be regarded as double blind if the word “double blind” is used. The method will be regarded as appropriate if it is stated that neither the person doing the assessments nor the study participant could identify the intervention being assessed, or if in the absence of such a statement the use of active placebos, identical placebos, or dummies is mentioned | 1 point |
If the method of double blinding was described and it was appropriate (identical placebo, active placebo, dummy, etc) | Add 1 point | |
If the study was described as double blind, but the method of blinding was inappropriate (eg, comparison of tablet versus injection with no double dummy) | Deduct 1 point | |
Withdrawals and dropouts | Participants who were included in the study but did not complete the observation period or who were not included in the analysis must be described. The number and the reasons for withdrawal in each group must be stated. If there were no withdrawals, it should be stated in the article. If there is no statement on withdrawals, this item must be given no points | 1 point |
Total score | 0–5 points |
* The minimum score is 0 (poor quality, significant flaws in design or conduct of trial); the maximum score is 5. (Reprinted from Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1–12, copyright © 1996, with permission from Elsevier.)