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Aggregate grades of evidence by question type |
| Table 2. | ||||
|---|---|---|---|---|
Aggregate grades of evidence by question type | ||||
| Grade | OCEBM Level | Treatment | Harm | |
| A | 1 | Systematic review of randomized trials | Systematic review of randomized trials, nested case-control studies, or observational studies with dramatic effect | |
| B | 2 | Randomized trials or observational studies with dramatic effects or highly consistent evidence | Randomized trials or observational studies with dramatic effects or highly consistent evidence | |
| C | 3–4 | Nonrandomized or historically controlled studies, including case-control and observational studies | Nonrandomized controlled cohort or follow-up study (post-marketing surveillance) with sufficient numbers to rule out a common harm, case-series, case-control, or historically controlled studies | |
| D | 5 | Case reports, mechanism-based reasoning, or reasoning from first principles | ||
| X | NA | Exceptional situations where validating studies cannot be performed and there is a clear preponderance of benefit over harm | ||
OCEBM, Oxford Centre for Evidence-Based Medicine; NA, not applicable. | ||||
| Table 2. | ||||
Aggregate grades of evidence by question type | ||||
| Grade | OCEBM Level | Treatment | Harm | |
| A | 1 | Systematic review of randomized trials | Systematic review of randomized trials, nested case-control studies, or observational studies with dramatic effect | |
| B | 2 | Randomized trials or observational studies with dramatic effects or highly consistent evidence | Randomized trials or observational studies with dramatic effects or highly consistent evidence | |
| C | 3–4 | Nonrandomized or historically controlled studies, including case-control and observational studies | Nonrandomized controlled cohort or follow-up study (post-marketing surveillance) with sufficient numbers to rule out a common harm, case-series, case-control, or historically controlled studies | |
| D | 5 | Case reports, mechanism-based reasoning, or reasoning from first principles | ||
| X | NA | Exceptional situations where validating studies cannot be performed and there is a clear preponderance of benefit over harm | ||
OCEBM, Oxford Centre for Evidence-Based Medicine; NA, not applicable. |
Classification of evidence-based statements
Clinical practice guidelines are intended to reduce inappropriate variations in clinical care, minimize harm, promote cost-effective practice, and produce optimal health outcomes for patients. Thus, an evidence-based approach to guideline development requires that the evidence supporting a policy be identified, appraised, and summarized and that an explicit link between the evidence and statements be defined. The recommended actions are stated along with the specific circumstances under which to perform them, linked to the supporting evidence. The potential benefits and risks associated with the recommendations are also described. Therefore, evidence-based statements should reflect both the quality of evidence and the expected balance between the benefits and harm for patients. Similar to previous guidelines, the GDG evaluated the evidence levels of the literature as highquality, medium-quality, or low-quality evidence (Table 1). In this framework, RCTs are designated as high-quality evidence and case series or expert opinions as low-quality evidence based on the probability of bias. The GDG developed evidence-based statements that reflected both the quality of evidence and the balance between potential harm and benefits. The definitions of evidence-based statements are listed in Tables 2 and 3 [44]. Table 2 was adapted to include only treatment recommendations from the Oxford Centre for Evidence-Based Medicine. This clinical practice guideline is based on the best available scientific evidence for the key questions as determined by the GDG. This means that our clinical practice guideline is not intended to replace the professional judgment of clinicians, but should help to inform clinical decision-making in particular clinical circumstances. The GDG proposed that action statements would be strongly recommended when less frequent variation in clinical practice may be expected (Table 3). By contrast, those deemed to be an “option” could be selected depending on the clinical situation. Therefore, clinicians should always act and decide in a way that they believe will best serve their patients’ interests and needs, regardless of our recommendations in this guideline. The primary goal of the GDG was to establish a clinical practice guideline through a transparent process and to document this process.