PhenX Working Group Guidance April 3rd, 2014

Criteria for Selecting Measures The measures should be: Clearly defined Well established Broadly applicable and generally accepted Low burden to participants and investigators Broadly validated and demonstrated utility Reproducible Specific Reliable Standard measurement protocols exist Additional criteria include: Crosscutting relevance for population groups Relevance to mental health research Use in major reference study (e.g., NHANES) Open-source software and nonproprietary instruments preferred Brevity Expectation of acceptance by the research community Set down by PhenX Steering Committee

Considerations for Deliberating Measures Existing, well-established, and freely available Requirements on both study participants and investigators (i.e., burden) Acceptance for the foreseeable future Primary focus on domestic research with consideration for international standards Number of protocols for the same measure (i.e., age-specific or gender-specific protocols) Multiple protocols should be comparable Comparability of equipment models/types Multi-part questionnaires or repeated measures acceptable as a single measure

Consensus Decision-making WG member presentations at the in-person meeting WG members prioritize 12 measures to go to outreach Seek guidance from the SC/MHRP Liaisons

Special Requirements and Burden Requirement Category Required (Yes/No) Major equipment Specialized training Specialized requirements for biospecimen collection Average time of greater than 15 minutes in an unaffected individual Yes in any category means measure is high burden

Communications/Reporting Work with WG manager In-person meeting Conference calls before & after outreach period PhenX portal

Outreach Preparation Outreach helps the WG refine measures for the Toolkit and build consensus Purpose is to obtain opinions regarding prioritizing the measures. Includes: Definition & purpose of the measure Measure protocol