11 - Health benefits, side effects and risks
The health benefits, side effects, and risks have been considered in formulating the recommendations.
User’s Manual Description:
The guideline should consider health benefits, side effects, and risks when formulating the recommendations. For example, a guideline on the management of breast cancer may include a discussion on the overall effects on various final outcomes. These may include: survival, quality of life, adverse effects, and symptom management or a discussion comparing one treatment option to another. There should be evidence that these issues have been addressed.
Where to Look:
Examine the paragraphs/chapters describing the guideline development process for a description of the body of evidence, its interpretation, and the translation to practice recommendations. Examples of commonly labeled sections or chapters in a guideline where this information can be found include: methods, interpretation, discussion, and recommendations.
How to Rate:
Item content includes the following CRITERIA:
- supporting data and report of benefits
- supporting data and report of harms/side effects/risks
- reporting of the balance/trade-off between benefits and harms/side effects/risks
- recommendations reflect considerations of both benefits and harms/side effects/risks
Additional CONSIDERATIONS:
- Is the item well written? Are the descriptions clear and concise?
- Is the item content easy to find in the guideline?
- Is the discussion an integral part of the guideline development process? (i.e., taking place during recommendation formulation rather than post-formulation as an afterthought)
- Has the guideline development group considered the benefits and harms equally?
