Table 1.

Amendments required to improve the documentation of weights and values.

Modifications required

Clarification on how to assign weights

Provide more instructions on how to complete these sections on weighting and valuing

Recommend a consistent approach for weighting through a drop-down list of either numerical ranking or qualitative descriptors

Recommend a free text box for cases whereby the weightings are not clear-cut

Clarify if the weightings are to add up to 100% for both the benefits and risks, or are they to be considered separately for each component

Provide some examples to illustrate the intention of the sections

Reasons not being fit for purpose

Not sure how to complete these sections