Table 4, Levels of Evidence and Grading of Recommendationsa - Short- and Long-Term Use of Benzodiazepines in Patients with Generalized Anxiety Disorder: A Review of Guidelines

Guideline/Author, Year, Country	Quality or Level of Evidence	Grading/Strength of Recommendation
BAP,⁵ 2014, UK	Categories of evidence relevant to treatment: I [M] - Evidence from meta-analysis of randomized double-blind placebo-controlled trials. I [PCT] - Evidence from at least one randomized double-blind placebo-controlled trial. II - Evidence from at least one randomized double-blind comparator-controlled trial (without placebo). III - Evidence from non-experimental descriptive studies. IV - Evidence from expert committee reports or opinions and/or clinical experience of respected authorities. Categories of evidence relevant to observational findings and associations: I - Evidence from large representative population samples. II - Evidence from small, well designed but not necessarily representative samples. III - Evidence from non-representative surveys, case reports. IV - Evidence from expert committee reports or opinions and/or clinical experience of respected authorities.	A - Directly based on category I evidence (either I [M] or I [PCT]). B - Directly based on category II evidence or an extrapolated recommendation from category I evidence. C - Directly based on category III evidence or an extrapolated recommendation from category I or II evidence. D - Directly based on category IV evidence or an extrapolated recommendation from other categories. S - Standard of clinical care.
Bandelow et al.,¹⁰ 2013, Germany^b	Assessment of levels based on SIGN protocol: 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias. 1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias. 1 - Meta-analyses, systematic reviews, or RCTs with a high risk of bias. 2++ High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal. 2+ Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal. 2 - Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal. 3 Non-analytic studies, eg case reports, case series. 4 Expert opinion.	NR
NICE,¹² 2011, UK	Quality of evidence:¹¹ High - Further research is very unlikely to change our confidence in the estimate of the effect. Moderate - Further research is likely to have an important impact on our confidence in the estimate of the effect and may change the estimate. Low - Further research is very likely to have an important impact on our confidence in the estimate of the effect and is likely to change the estimate. Very low - Any estimate of effect is very uncertain. Overall assessment of the paper: ++ - All or most of the criteria have been fulfilled. Where they have not been fulfilled, the conclusions of the study or review are thought very unlikely to alter the conclusions. + - Some of the criteria have been fulfilled. Those criteria that have not been fulfilled or not adequately described are thought unlikely to alter the conclusions. - - Few or no criteria fulfilled. The conclusions of the study are thought likely or very likely to alter the conclusions.	The strength of each recommendation was reflected in the wording of the recommendation, rather than by using labels or symbols.
CPA,⁶ 2006, Canada	1 – Meta-analysis or replicated RCT that includes a placebo condition. 2 – At least one RCT with placebo or active comparison condition. 3 – Uncontrolled trial with at least 10 or more subjects. 4 – Anecdotal reports or expert opinion.	First-line – Level 1 or Level 2 evidence plus clinical support for efficacy and safety. Second-line – Level 3 evidence or higher plus clinical support for efficacy and safety. Third-line – Level 4 evidence or higher plus clinical support for efficacy and safety. Not recommended – Level 1 or Level 2 evidence for lack of efficacy.

Guideline/Author,
Year,
Country

Quality or Level of Evidence

Grading/Strength of Recommendation

BAP,⁵
2014,
UK

Categories of evidence relevant to treatment:

I [M] - Evidence from meta-analysis of randomized double-blind placebo-controlled trials.
I [PCT] - Evidence from at least one randomized double-blind placebo-controlled trial.
II - Evidence from at least one randomized double-blind comparator-controlled trial (without placebo).
III - Evidence from non-experimental descriptive studies.
IV - Evidence from expert committee reports or opinions and/or clinical experience of respected authorities.

Categories of evidence relevant to observational findings and associations:

I - Evidence from large representative population samples.
II - Evidence from small, well designed but not necessarily representative samples.
III - Evidence from non-representative surveys, case reports.
IV - Evidence from expert committee reports or opinions and/or clinical experience of respected authorities.

A - Directly based on category I evidence (either I [M] or I [PCT]).

B - Directly based on category II evidence or an extrapolated recommendation from category I evidence.

C - Directly based on category III evidence or an extrapolated recommendation from category I or II evidence.

D - Directly based on category IV evidence or an extrapolated recommendation from other categories.

S - Standard of clinical care.

Bandelow et al.,¹⁰
2013,
Germany^b

Assessment of levels based on SIGN protocol:

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias.

1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias.

1 - Meta-analyses, systematic reviews, or RCTs with a high risk of bias.

2++ High quality systematic reviews of case control or cohort studies.

High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal.

2+ Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal.

2 - Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal.

3 Non-analytic studies, eg case reports, case series.

4 Expert opinion.

NICE,¹²
2011,
UK

Quality of evidence:¹¹

High - Further research is very unlikely to change our confidence in the estimate of the effect.

Moderate - Further research is likely to have an important impact on our confidence in the estimate of the effect and may change the estimate.

Low - Further research is very likely to have an important impact on our confidence in the estimate of the effect and is likely to change the estimate.

Very low - Any estimate of effect is very uncertain.

Overall assessment of the paper:

++ - All or most of the criteria have been fulfilled. Where they have not been fulfilled, the conclusions of the study or review are thought very unlikely to alter the conclusions.

+ - Some of the criteria have been fulfilled.
Those criteria that have not been fulfilled or not adequately described are thought unlikely to alter the conclusions.

- - Few or no criteria fulfilled. The conclusions of the study are thought likely or very likely to alter the conclusions.

The strength of each recommendation was reflected in the wording of the recommendation, rather than by using labels or symbols.

CPA,⁶
2006,
Canada

1 – Meta-analysis or replicated RCT that includes a placebo condition.

2 – At least one RCT with placebo or active comparison condition.

3 – Uncontrolled trial with at least 10 or more subjects.

4 – Anecdotal reports or expert opinion.

First-line – Level 1 or Level 2 evidence plus clinical support for efficacy and safety.

Second-line – Level 3 evidence or higher plus clinical support for efficacy and safety.

Third-line – Level 4 evidence or higher plus clinical support for efficacy and safety.

Not recommended – Level 1 or Level 2 evidence for lack of efficacy.

From: APPENDIX 5, Summary of Guideline Evidence Levels and Strength of Recommendations

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Table 4Levels of Evidence and Grading of Recommendations^a

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