|
| Item* | Item no. (label)** |
|
| (A) Selection of participants | Participants |
| (1) Were the criteria for in-/exclusion defined sufficiently and clearly? | A1 (in-/exclusion) |
| (2) Were the criteria for in-/exclusion defined before intervention? | A2 (predefined) |
| (3) Was the health status recorded in a valid and reliable way? | A3 (health status) |
| (4) Were the diagnostic criteria of the disease described? | A4 (diagnostic criteria) |
| (5) Were the studied/exposed patients representative for the majority of the exposed population or the “standard users” of the intervention? | A5 (representativity) |
|
| (B) Allocation and study participation | Allocation |
| (1) Were the exposed/cases and nonexposed/controls from the same base population? | B1 (basic population) |
| (2) Were intervention/exposed and control/nonexposed groups comparable at baseline? | B2 (comparable) |
| (3) Was allocation randomized, with a standardized procedure? | B3 (randomization) |
| (4) Was randomization blinded? | B4 (blinded randomization) |
| (5) Were known/possible confounders considered at baseline? | B5 (confounders) |
|
| (C) Intervention/exposition | Intervention |
| (1) Were intervention or exposition recorded in a valid, reliable, and similar way? | C1 (recording) |
| (2) Apart from intervention, were intervention and control groups treated similarly? | C2 (similar treatment) |
| (3) In case of other treatments, were they recorded in a valid and reliable way? | C3 (other treatments) |
| (4) For RCTs: were placebos used for the control group? | C4 (placebo use) |
| (5) For RCTs: was the way of placebo administration documented? | C5 (placebo documented) |
|
| (D) Study administration | Administration |
| (1) Are there indications for “overmatching”? | D1 (overmatching) |
| (2) In multicentre studies: were the diagnostic and therapeutic methods and the outcome recording in the centres identical? | D2 (multicentre) |
| (3) Was if assured that participants did not crossover between intervention and control group? | D3 (no crossover) |
|
| (E) Outcome recording | Outcome |
| (1) Were patient-centred outcome parameters used? | E1 (patient-centred) |
| (2) Were the outcomes recorded in a valid and reliable way? | E2 (recording) |
| (3) Was outcome recording blinded? | E3 (blinded outcomes) |
| (4) For case series: was the distribution of prognostic factors recorded sufficiently? | E4 (prognostic factors) |
|
| (F) Drop-outs | Drop-outs |
| (1) Was the response rate in intervention/control group sufficient, or, for cohort studies, could a sufficient part of the cohort be tracked for the full study duration? | F1 (evaluable number) |
| (2) Were the reasons for the dropouts of participants stated? | F2 (reasons) |
| (3) Were the outcomes of dropouts described and included in the analysis? | F3 (outcomes) |
| (4) If differences were found: were they significant? | F4 (significance) |
| (5) If differences were found: were they relevant? | F5 (relevance) |
|
| (G) Statistical analysis | Statistics |
| (1) Were the described analytic methods correct and the information sufficient for a flawless analysis? | G1 (correct) |
| (2) Were confidence intervals given for means and for significance tests? | G2 (CIs given) |
| (3) Were the results presented in graphical form, and were the underlying values stated? | G3 (graphics) |
|
