Table A3.
Quality of RCTs.
| Internal validity | Overall assessment | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ID | Author | Year | 1.1 | 1.2 | 1.3 | 1.4 | 1.5 | 1.6 | 1.7 | 1.8 | 1.9 | 1.10 | 2.1 | 2.2 | 2.3 |
| 1.1- | LESS Trial | 2014- | Y | Y | Y | Y | Y | Y | Y | 3.5% | Y | CS | ++ | Y | Y |
| 1.3 | (Lumbar Epidural injections for Spinal Stenosis trial) | 2018 | |||||||||||||
| 2.1- | SPORT (Spine Patient Outcomes Research Trial) | 2011- | Y | Y | CS | DA | Y | Y | Y | DA | Y | CS | ++ | Y | Y |
| 2.5 | randomized arm | 2016 | |||||||||||||
Abbreviations: ID, identification number; Y, yes; N, no; CS, can't say; DA, does not apply; ++, high quality; +, acceptable; 0, low quality.
1.1 The study addresses an appropriate and clearly focused question.
1.2 The assignment of subjects to treatment groups is randomized.
1.3 An adequate concealment method is used.
1.4 The design keeps subjects and investigators "blind" about treatment allocation.
1.5 The treatment and control groups are similar at the start of the trial.
1.6 The only difference between groups is the treatment under investigation.
1.7 All relevant outcomes are measured in a standard, valid and reliable way.
1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?.
1.9 All the subjects are analyzed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).
1.10 Where the study is carried out at more than one site, results are comparable for all sites.
2.1 How well was the study done to minimize bias?.
2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?.
2.3 Are the results of this study directly applicable to the patient group targeted in this guideline?.