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Developing the key questions is an important first phase in HTA's assessment process. It determines the scope of the evidence report the clinical committee will use to reach their coverage decision.
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An assessment begins by defining key questions. This is an important stage of the study because it determines the scope the report. Key questions direct the evidence researcher by providing details on the technology and the setting in which it will be reviewed. They also identify:
- Special populations to be included.
- Interventions to be studied.
- Comparators to be included
- Outcomes of interest.
- Policy considerations.
- Study design.
Key questions are designed to address the:
- Criteria in HTA's law: efficacy, safety, cost-effectiveness, effect on special populations; and
- Purpose of the report: to form the primary basis of a coverage decision by the clinical committee.
Key questions are developed by HTA, with assistance from participating state agency medical directors, clinical consultants and the technology assessment center. Input is also solicited from the public, stakeholders and clinical experts in the health technology field. Public comments are reviewed and responses are published with the final key questions.
Draft key questions are posted online to gather public input and any additional evidence to be considered in the evidence review. Since key questions guide the evidence report, HTA seeks input on whether the questions have included the appropriate topics to address HTA's mandate to gather evidence on safety, efficacy, and cost effectiveness relevant to coverage determinations. Input on the following questions is especially helpful:
- Have appropriate populations or indications been identified?
- Are appropriate comparators identified?
- Have appropriate patient-oriented outcome measures been included?
- What special policy or clinical considerations could affect the review?