Table.
Important outcomes | Daily activities and work, Pain | ||||||||
Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
What are the effects of pharmacological treatments for primary dysmenorrhoea? | |||||||||
at least 34 (at least 1319) | Pain | NSAIDs versus placebo | 4 | –2 | –1 | 0 | +1 | Low | Quality points deducted for incomplete reporting of results and weak methods; consistency point deducted for statistical heterogeneity; effect size point added for OR >2 and <0.5 |
at least 5 (at least 306) | Daily activities and work | NSAIDs versus placebo | 4 | –2 | 0 | –1 | +1 | Low | Quality points deducted for incomplete reporting of results and weak methods; effect size point added for OR <0.5; directness point deducted for inclusion of data on aspirin |
unclear (unclear) | Pain | Different NSAIDs versus each other | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, comparing single agent versus rest of group, and weak methods |
at least 3 (unclear) | Daily activities and work | Different NSAIDs versus each other | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, comparing single agent versus rest of group, and weak methods |
6 (unclear) | Pain | Aspirin versus placebo | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for weak methods and incomplete reporting of results; directness point deducted for different conclusions depending on the analysis performed |
at least 3 (at least 203) | Daily activities and work | Aspirin versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for weak methods and incomplete reporting of results |
1 (30) | Pain | Paracetamol versus placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting, and reporting of results post-crossover |
1 (30) | Pain | Paracetamol versus aspirin | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting, and reporting of results post-crossover |
3 (less than 175) | Pain | Aspirin versus NSAIDs | 4 | –3 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and weak methods; directness point deducted for outcome data per cycle |
1 (fewer than 96) | Daily activities and work | Aspirin versus NSAIDs | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and weak methods |
3 (fewer than 196) | Pain | Paracetamol versus NSAIDs | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and weak methods |
7 (604) | Pain | Combined oral contraceptives versus placebo/no treatment | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for weak methods; consistency point deducted for statistical heterogeneity |
1 (107) | Daily activities and work | Combined oral contraceptives versus placebo/no treatment | 4 | –1 | 0 | –2 | 0 | Very low | Quality point deducted for sparse data; directness points deducted for use of composite measure (including function and pain), no ITT analysis, and small number of comparators |
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.