Table.
Important outcomes | Breast pain, Quality of life | ||||||||
Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
What are the effects of treatments for breast pain? | |||||||||
1 (60) | Breast pain | Topical NSAIDs versus placebo | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and sub-group analysis |
1 (100) | Breast pain | Topical NSAIDs versus oral NSAIDs | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
1 (40) | Breast pain | Oral NSAIDs versus placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, no significance assessment of between-group difference, and unclear method of randomisation |
1 (61) | Breast pain | Danazol versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data; directness point deducted for restricted population |
1 (147) | Breast pain | Gonadorelin analogues (goserelin; luteinising hormone-releasing hormone analogues) versus placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
3 (241) | Breast pain | Tamoxifen versus placebo | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results; directness point deducted for uncertainty about definition of outcomes |
2 (361) | Breast pain | Different doses of tamoxifen versus each other | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
2 (58) | Breast pain | Progestogens versus placebo | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, poor follow-up, and incomplete reporting of results |
1 (64) | Breast pain | Danazol versus tamoxifen | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data; directness point deducted for restricted population |
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.