Table 2. A4R Condition 2: Publicity .
Feature | What Could Be Recommended for This Feature in General? | What Could Be Recommended for This Feature With Regard to RDs and RTs Specifically? |
Transparency of criteria and evidence considered and approaches used to consider them |
Should the evidence that was considered and the methods to select and synthesize the evidence be made public?
• Yes, always and unconditionally • Yes, should be described adequately and justified meticulously (including all value judgments used in the process of generating and selecting evidence), then made public • Should the criteria and the deliberative approach to consider them be made public? • Yes, deliberations and advice published on the website of the HTA agency Protect individuals according to Chatham House Rule |
• Additional attention to justifying the selected endpoints |
Understandability of reasoning behind decision |
What could be recommended to facilitate making reasons leading to the decision explicit and understandable to stakeholders, including the public?
• Keep it simple and understandable. The art of good documentation and communication needs to be more valued and further developed • Communicate honestly about uncertainties and imperfection of decisions • Include a natural language account of the process, the key evidence used and the facts |
• Knowledge brokers and health anthropologists can play an important role. Avoid emotion-laden communications, which are counterproductive for legitimizing decisions |
Clarity of values underlying the decision |
Should values underlying decisions be stated? Should there be a reference to the broader objectives and underlying mandate of the agency/institution/healthcare system?
• Yes, generally. Also, the extent to which the intervention contributes to or infringes upon the mandate of the healthcare system and broader societal objectives must become explicit • Clarify the weights of the different criteria in the final decision |
• Public health impact is generally low in RDs, we have to address the fact that incidence and prevalence are low |
Abbreviations: A4R, accountability for reasonableness; RD, rare disease; RT, regenerative therapy; HTA, health technology assessment.