Summary of the method for grading data and recommendation on the basis of both efficacy and safety/tolerability
| Grading on basis of efficacy . | . |
|---|---|
| Level 1 | Good research-based evidence, supported by at least 2 placebo controlled studies of sufficient magnitude and good quality. In case of the presence of negative RCTs, positive RCTs should outnumber negative ones |
| Level 2 | Fair research-based evidence, from 1 randomized, double-blind placebo controlled trial Also in case 1 or more trials exist, however, they fail to fulfil all the criteria above (e.g., very small sample size or no placebo control) as well as in case of positive meta-analysis alone |
| Level 3 | Some evidence from comparative studies without placebo arm or from post-hoc analyses |
| Level 4 | Inconclusive data or poor-quality RCTs |
| Level 5 | Negative data |
| Grading on the basis of safety and tolerability | |
| Level 1 | Very good tolerability, few side effects that are not enduring, do not cause significant distress, and are not life-threatening and do not compromise the overall somatic health of patient |
| Level 2 | Moderate tolerability, many side effects that could be enduring, and cause significant distress but are not life-threatening, although they could compromise the overall somatic health of the patient Agents with very good overall tolerability but with rare life-threatening adverse events, could be classified here only if the lethality risk can be essentially considered to be negligible with application of procedures and protocols (e.g., laboratory testing, titration schedules, etc.) |
| Level 3 | Poor tolerability, many side effects that are enduring, cause significant distress, compromise the overall somatic health of patient, or are life-threatening Agents with moderate overall tolerability and rare, life-threatening adverse events should be classified here even in case the lethality risk can be essentially considered to be negligible with the application of procedures and protocols (e.g., laboratory testing, titration schedules, etc.) |
| Recommendations for treatment (combination of efficacy and safety/tolerability) | |
| Level 1 | Level 1 or 2 for efficacy and 1 for safety/tolerability |
| Level 2 | Level 1 or 2 for efficacy and 2 for safety/tolerability |
| Level 3 | Level 3 for efficacy and 1 or 2 for safety/tolerability |
| Level 4 | Level 4 for efficacy or 3 for safety/tolerability |
| Level 5 | Level 5 for efficacy (not recommended) |
| Grading on basis of efficacy . | . |
|---|---|
| Level 1 | Good research-based evidence, supported by at least 2 placebo controlled studies of sufficient magnitude and good quality. In case of the presence of negative RCTs, positive RCTs should outnumber negative ones |
| Level 2 | Fair research-based evidence, from 1 randomized, double-blind placebo controlled trial Also in case 1 or more trials exist, however, they fail to fulfil all the criteria above (e.g., very small sample size or no placebo control) as well as in case of positive meta-analysis alone |
| Level 3 | Some evidence from comparative studies without placebo arm or from post-hoc analyses |
| Level 4 | Inconclusive data or poor-quality RCTs |
| Level 5 | Negative data |
| Grading on the basis of safety and tolerability | |
| Level 1 | Very good tolerability, few side effects that are not enduring, do not cause significant distress, and are not life-threatening and do not compromise the overall somatic health of patient |
| Level 2 | Moderate tolerability, many side effects that could be enduring, and cause significant distress but are not life-threatening, although they could compromise the overall somatic health of the patient Agents with very good overall tolerability but with rare life-threatening adverse events, could be classified here only if the lethality risk can be essentially considered to be negligible with application of procedures and protocols (e.g., laboratory testing, titration schedules, etc.) |
| Level 3 | Poor tolerability, many side effects that are enduring, cause significant distress, compromise the overall somatic health of patient, or are life-threatening Agents with moderate overall tolerability and rare, life-threatening adverse events should be classified here even in case the lethality risk can be essentially considered to be negligible with the application of procedures and protocols (e.g., laboratory testing, titration schedules, etc.) |
| Recommendations for treatment (combination of efficacy and safety/tolerability) | |
| Level 1 | Level 1 or 2 for efficacy and 1 for safety/tolerability |
| Level 2 | Level 1 or 2 for efficacy and 2 for safety/tolerability |
| Level 3 | Level 3 for efficacy and 1 or 2 for safety/tolerability |
| Level 4 | Level 4 for efficacy or 3 for safety/tolerability |
| Level 5 | Level 5 for efficacy (not recommended) |
Abbreviation: RCT, randomized controlled trial.
Summary of the method for grading data and recommendation on the basis of both efficacy and safety/tolerability
| Grading on basis of efficacy . | . |
|---|---|
| Level 1 | Good research-based evidence, supported by at least 2 placebo controlled studies of sufficient magnitude and good quality. In case of the presence of negative RCTs, positive RCTs should outnumber negative ones |
| Level 2 | Fair research-based evidence, from 1 randomized, double-blind placebo controlled trial Also in case 1 or more trials exist, however, they fail to fulfil all the criteria above (e.g., very small sample size or no placebo control) as well as in case of positive meta-analysis alone |
| Level 3 | Some evidence from comparative studies without placebo arm or from post-hoc analyses |
| Level 4 | Inconclusive data or poor-quality RCTs |
| Level 5 | Negative data |
| Grading on the basis of safety and tolerability | |
| Level 1 | Very good tolerability, few side effects that are not enduring, do not cause significant distress, and are not life-threatening and do not compromise the overall somatic health of patient |
| Level 2 | Moderate tolerability, many side effects that could be enduring, and cause significant distress but are not life-threatening, although they could compromise the overall somatic health of the patient Agents with very good overall tolerability but with rare life-threatening adverse events, could be classified here only if the lethality risk can be essentially considered to be negligible with application of procedures and protocols (e.g., laboratory testing, titration schedules, etc.) |
| Level 3 | Poor tolerability, many side effects that are enduring, cause significant distress, compromise the overall somatic health of patient, or are life-threatening Agents with moderate overall tolerability and rare, life-threatening adverse events should be classified here even in case the lethality risk can be essentially considered to be negligible with the application of procedures and protocols (e.g., laboratory testing, titration schedules, etc.) |
| Recommendations for treatment (combination of efficacy and safety/tolerability) | |
| Level 1 | Level 1 or 2 for efficacy and 1 for safety/tolerability |
| Level 2 | Level 1 or 2 for efficacy and 2 for safety/tolerability |
| Level 3 | Level 3 for efficacy and 1 or 2 for safety/tolerability |
| Level 4 | Level 4 for efficacy or 3 for safety/tolerability |
| Level 5 | Level 5 for efficacy (not recommended) |
| Grading on basis of efficacy . | . |
|---|---|
| Level 1 | Good research-based evidence, supported by at least 2 placebo controlled studies of sufficient magnitude and good quality. In case of the presence of negative RCTs, positive RCTs should outnumber negative ones |
| Level 2 | Fair research-based evidence, from 1 randomized, double-blind placebo controlled trial Also in case 1 or more trials exist, however, they fail to fulfil all the criteria above (e.g., very small sample size or no placebo control) as well as in case of positive meta-analysis alone |
| Level 3 | Some evidence from comparative studies without placebo arm or from post-hoc analyses |
| Level 4 | Inconclusive data or poor-quality RCTs |
| Level 5 | Negative data |
| Grading on the basis of safety and tolerability | |
| Level 1 | Very good tolerability, few side effects that are not enduring, do not cause significant distress, and are not life-threatening and do not compromise the overall somatic health of patient |
| Level 2 | Moderate tolerability, many side effects that could be enduring, and cause significant distress but are not life-threatening, although they could compromise the overall somatic health of the patient Agents with very good overall tolerability but with rare life-threatening adverse events, could be classified here only if the lethality risk can be essentially considered to be negligible with application of procedures and protocols (e.g., laboratory testing, titration schedules, etc.) |
| Level 3 | Poor tolerability, many side effects that are enduring, cause significant distress, compromise the overall somatic health of patient, or are life-threatening Agents with moderate overall tolerability and rare, life-threatening adverse events should be classified here even in case the lethality risk can be essentially considered to be negligible with the application of procedures and protocols (e.g., laboratory testing, titration schedules, etc.) |
| Recommendations for treatment (combination of efficacy and safety/tolerability) | |
| Level 1 | Level 1 or 2 for efficacy and 1 for safety/tolerability |
| Level 2 | Level 1 or 2 for efficacy and 2 for safety/tolerability |
| Level 3 | Level 3 for efficacy and 1 or 2 for safety/tolerability |
| Level 4 | Level 4 for efficacy or 3 for safety/tolerability |
| Level 5 | Level 5 for efficacy (not recommended) |
Abbreviation: RCT, randomized controlled trial.
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