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. 2011 Oct 11;2011:2302.

Table.

GRADE Evaluation of interventions for Insomnia (primary) in older people.

Important outcomes Symptom improvement
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of non-drug treatments for primary insomnia in older people (aged 60 years and older)?
at least 9 (at least 82) Symptom improvement CBT versus no treatment 4 0 0 –1 0 Moderate Directness point deducted for mixed population (unclear in 1 study; comorbid insomnia in another) and range of variants of CBT assessed (unclear if all variants equally effective)
2 (95) Symptom improvement Exercise versus no treatment 4 –2 0 0 0 Low Quality points deducted for sparse data and for subgroup analysis
1 (61) Symptom improvement Timed exposure to bright light versus no treatment 4 –3 0 0 0 Very low Quality points deducted for sparse data, poor follow-up, and incomplete reporting of results
What are the effects of drug treatments for primary insomnia in older people (aged 60 years and older)?
1 (25) Symptom improvement Diphenhydramine versus placebo 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and weak methods
at least 9 (at least 627) Symptom improvement Benzodiazepines versus placebo 4 0 0 0 0 High
3 (1019) Symptom improvement Zaleplon versus placebo 4 –1 0 –1 0 Low Quality point deducted for incomplete reporting of results. Directness point deducted for inconsistent results depending on outcome measured and dose used
3 (970) Symptom improvement Zolpidem versus placebo 4 –1 0 –1 0 Low Quality point deducted for incomplete reporting of results. Directness point deducted for short follow-up in 1 RCT (1 day)
3 (339) Symptom improvement Zolpidem versus benzodiazepines 4 –1 0 –1 0 Low Quality point deducted for incomplete reporting of results. Directness point deducted for subjective outcome
2 (144) Symptom improvement Different doses of zolpidem versus each other 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
2 (619) Symptom improvement Zopiclone versus placebo 4 –1 0 –1 0 Low Quality point deducted for incomplete reporting of results. Directness point deducted for low follow-up (74% in 1 RCT)

We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.