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"Patient Characteristic, Clinical Trial Participant"

Performance/Reporting Period
2021
QDM Datatype (QDM Version 5.5 Guidance Update):

Data elements that meet criteria using this datatype should document that the patient is a clinical trial participant for the clinical trial indicated by the QDM category and its corresponding value set.

Timing:

The relevantPeriod addresses:

  • startTime - The time the clinical trial began.
  • stopTime - The time the clinical trial ended.
QDM Datatype and Definition

Individual Characteristic

Individual Characteristic represents specific factors about a patient, clinician, provider, or facility. Included are demographics, behavioral factors, social or cultural factors, available resources, and preferences. Behaviors reference responses or actions that affect (either positively or negatively) health or healthcare. Included in this category are mental health issues, adherence issues unrelated to other factors or resources, coping ability, grief issues, and substance use/abuse. Social/cultural factors are characteristics of an individual related to family/caregiver support, education, and literacy (including health literacy), primary language, cultural beliefs (including health beliefs), persistent life stressors, spiritual and religious beliefs, immigration status, and history of abuse or neglect. Resources are means available to a patient to meet health and healthcare needs, which might include caregiver support, insurance coverage, financial resources, and community resources to which the patient is already connected and from which the patient is receiving benefit. Preferences are choices made by patients and their caregivers relative to options for care or treatment (including scheduling, care experience, and meeting of personal health goals) and the sharing and disclosure of their health information.
QDM Attributes

reason

The thought process or justification for the datatype. In some measures, specific treatments are acceptable inclusion criteria only if a justified reason is present. Each of these measures uses a value set (often, but not exclusively, using SNOMED CT) to express acceptable justification reasons. Other measures specify reasons as justification for exclusions. Examples include patient, system, or medical-related reasons for declining to perform specific actions. Each of these measures also uses a value set to express acceptable justification reasons for declining to perform expected actions.

relevantPeriod

Relevant Period addresses the time between the start of an action to the end of an action. Each datatype using relevant period defines specific definitions for the start and stop time for the action listed.

Note: negation rationale indicates a one-time documentation of a reason an activity is not performed. Negation of QDM datatyperelated actions for a reason always use the author dateTime attribute to reference timing and must not use relevantPeriod