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. 2014 Oct 14;2014:0812.

Table.

GRADE Evaluation of interventions for Breast pain.

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.