Table.
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.