NeuroBITE includes studies with all levels of evidence described by the National Health and Medical Research Council.
| Level of Evidence | Study Design | Maximum Ratings on the PEDro-P Scale |
|---|---|---|
| I | Evidence obtained from a systematic review of all relevant randomised controlled trials. | not rated on NeuroBITE |
| II | Evidence obtained from at least one properly designed randomised controlled trial. | 10 |
| III-1 | Evidence obtained from well-designed pseudo-randomised controlled trials (alternate allocation or some other method). | 8 |
| III-2 | Evidence obtained from comparative studies (including systematic reviews of such studies) with concurrent controls and allocation not randomised, cohort studies, case-control studies, or interrupted time series with a control group. | 8 |
| III-3 | Evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel control group. | 8 |
| IV | Evidence obtained from case series, either post-test or pretest/post-test. | not rated on NeuroBITE |
| Source: NHMRC 1999 | ||
It is noted that "a methodologically poor randomised trial (level II) may, however, provide a weaker basis for a recommendation than a high-quality observational study without randomisation, which can provide level III-2 evidence" (NHMRC, 1999, p.15). This means that an RCT (level II) with a score of 3 may be less methodologically sound than a non-RCT with a score of 6. For further information on Levels of Evidence see the NHMRC website.
Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence
| Question | Step 1 (Level 1*) | Step 2 (Level 2*) | Step 3 (Level 3*) | Step 4 (Level 4*) | Step 5 (Level 5) |
|---|---|---|---|---|---|
| How common is the problem? | Local and current random sample surveys (or censuses) | Systematic review of surveys that allow matching to local circumstances** | Local non-random sample** | Case-series** | n/a |
| Is this diagnostic or monitoring test accurate? (Diagnosis) | Systematic review of cross sectional studies with consistently applied reference standard and blinding | Individual cross sectional studies with consistently applied reference standard and blinding | Non-consecutive studies, or studies without consistently applied reference standards** | Case-control studies, or “poor or non-independent reference standard** | Mechanism-based reasoning |
| What will happen if we do not add a therapy? (Prognosis) | Systematic review of inception cohort studies | Inception cohort studies | Cohort study or control arm of randomized trial* | Case-series or case- control studies, or poor quality prognostic cohort study** | n/a |
| Does this intervention help? (Treatment Benefits) | Systematic review of randomized trials or n-of-1 trials | Randomized trial or observational study with dramatic effect | Non-randomized controlled cohort/follow-up study** | Case-series, case-control studies, or historically controlled studies** | Mechanism-based reasoning |
| What are the COMMON harms? (Treatment Harms) | Systematic review of randomized trials, systematic review of nested case-control studies, n- of-1 trial with the patient you are raising the question about, or observational study with dramatic effect | Individual randomized trial or (exceptionally) observational study with dramatic effect | Non-randomized controlled cohort/follow-up study (post-marketing surveillance) provided there are sufficient numbers to rule out a common harm. (For long-term harms the duration of follow-up must be sufficient.)** | Case-series, case-control, or historically controlled studies** | Mechanism-based reasoning |
| What are the RARE harms? (Treatment Harms) | Systematic review of randomized trials or n-of-1 trial | Randomized trial or (exceptionally) observational study with dramatic effect | |||
| Is this (early detection) test worthwhile? (Screening) | Systematic review of randomized trials | Randomized trial | Non -randomized controlled cohort/follow-up study** | Case-series, case-control, or historically controlled studies** | Mechanism-based reasoning |
* Level may be graded down on the basis of study quality, imprecision, indirectness (study PICO does not match questions PICO), because of inconsistency between studies, or because the absolute effect size is very small; Level may be graded up if there is a large or very large effect size.
** As always, a systematic review is generally better than an individual study.
OCEBM Levels of Evidence Working Group*. 'The Oxford 2011 Levels of Evidence'. Oxford Centre for Evidence-Based Medicine.
http://www.cebm.net/index.aspx?o=5653* OCEBM Table of Evidence Working Group = Jeremy Howick, Iain Chalmers (James Lind Library), Paul Glasziou, Trish Greenhalgh, Carl Heneghan, Alessandro Liberati, Ivan Moschetti, Bob Phillips, Hazel Thornton, Olive Goddard and Mary Hodgkinson