DR-1: Requirements for the design of registries
Registries established for conducting PCOR must have the following characteristics.
- Registry Purpose and Protocol
The purpose of the registry should be clearly defined to guide the design of key registry features including, but not limited to: the target population, the research question/s to be addressed, the data source utilized, the data elements collected, data sharing policies, and the stakeholders involved in the development and use of the registry. Participants and other key stakeholders should be engaged in registry and protocol development. Registries should aim to be user-oriented in design and function.
- Data Safety and Security
Registry custodians should comply with IRB requirements, local and national laws, and where applicable, HIPAA. Registries should provide information describing type of data collection (primary or secondary source data), data use agreements, informed consent documents, data security protections, plans for maintaining data protection if the registry ends, and approaches to protecting security including risk and/or process for re-identification of participants, especially for medical or claims records.
- Data Elements and Quality
Standardized data element definitions and/or data dictionaries should be used whenever possible. When creating a new registry, published literature should be reviewed to identify existing, widely used definitions of outcomes, exposure, and confounders before drafting new definitions.
When collecting primary data, conduct multi-stakeholder engagement with potential participants and data users to prioritize data collection needs. When participants support their face validity, utilize validated instruments or patient-reported outcome measures when available. If secondary data sources (e.g., electronic medical records, claims data) are utilized, describe the original purpose of the secondary data and verify the accuracy and completeness of the data, as well as the approach to and validity of the linkages performed between the primary and secondary sources.
The specifics of the quality assurance plan will depend on the type of data (primary or secondary) collected by the registry. In general, the plan should address: 1) structured training tools for data abstractors/curators; 2) use of data quality checks for ranges and logical consistency for key exposure and outcome variables and covariates; and 3) data review and verification procedures, including source data verification plans (where feasible and appropriate), and validation statistics focused on data quality for the key exposure and outcome variables and key covariates. A risk-based approach to quality assurance is advisable, focused on variables of greatest importance.
- Confounding
Registries should identify important potential confounders pertinent to the purpose and scope of the research during the planning phase and collect reasonably sufficient data on these potential confounders to facilitate the use of appropriate statistical techniques during the analysis phase. When conducting analysis, refer to the PCORI Methodology Standards for Data Integrity and Rigorous Analyses and the Standards for Causal Inference Methods.
- Systematic Participant Recruitment and Enrollment
Develop a sampling plan (population-based or otherwise) of the target population and identify recruitment strategies for participants that minimize the impact of selection bias. Participants should be enrolled systematically, with similar procedures implemented at all participating sites and for each intervention of interest. Confirm adherence to agreed-upon enrollment practices.
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Participant Follow-Up
The objective(s) of the registry should determine the type, extent, and length of participant follow-up.
Describe the frequency with which follow-up measures will be ascertained, consider linkage with other data sources such as the National Death Index to enhance long-term follow-up, and identify the date of last contact with the participant in existing registries, where appropriate. Ensure that the participants are followed in as unbiased a manner as possible, using similar procedures at all participating sites.
Monitor loss to follow-up to ensure best efforts are used to achieve follow-up time that is adequate to address the main objective. At the outset of the registry, develop a retention plan that documents when a participant will be considered lost to follow-up and what actions will be taken to minimize loss of pertinent data. Retention efforts should be developed with stakeholders to ensure the efforts are suitable for the target population and anticipated challenges are addressed appropriately.
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Public Comments - Methodology Standards
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6: Standards for Data Registries
DR-1: Requirements for the design of registries
Registries established for conducting PCOR must have the following characteristics.
The purpose of the registry should be clearly defined to guide the design of key registry features including, but not limited to: the target population, the research question/s to be addressed, the data source utilized, the data elements collected, data sharing policies, and the stakeholders involved in the development and use of the registry. Participants and other key stakeholders should be engaged in registry and protocol development. Registries should aim to be user-oriented in design and function.
Registry custodians should comply with IRB requirements, local and national laws, and where applicable, HIPAA. Registries should provide information describing type of data collection (primary or secondary source data), data use agreements, informed consent documents, data security protections, plans for maintaining data protection if the registry ends, and approaches to protecting security including risk and/or process for re-identification of participants, especially for medical or claims records.
Standardized data element definitions and/or data dictionaries should be used whenever possible. When creating a new registry, published literature should be reviewed to identify existing, widely used definitions of outcomes, exposure, and confounders before drafting new definitions.
When collecting primary data, conduct multi-stakeholder engagement with potential participants and data users to prioritize data collection needs. When participants support their face validity, utilize validated instruments or patient-reported outcome measures when available. If secondary data sources (e.g., electronic medical records, claims data) are utilized, describe the original purpose of the secondary data and verify the accuracy and completeness of the data, as well as the approach to and validity of the linkages performed between the primary and secondary sources.
The specifics of the quality assurance plan will depend on the type of data (primary or secondary) collected by the registry. In general, the plan should address: 1) structured training tools for data abstractors/curators; 2) use of data quality checks for ranges and logical consistency for key exposure and outcome variables and covariates; and 3) data review and verification procedures, including source data verification plans (where feasible and appropriate), and validation statistics focused on data quality for the key exposure and outcome variables and key covariates. A risk-based approach to quality assurance is advisable, focused on variables of greatest importance.
Registries should identify important potential confounders pertinent to the purpose and scope of the research during the planning phase and collect reasonably sufficient data on these potential confounders to facilitate the use of appropriate statistical techniques during the analysis phase. When conducting analysis, refer to the PCORI Methodology Standards for Data Integrity and Rigorous Analyses and the Standards for Causal Inference Methods.
Develop a sampling plan (population-based or otherwise) of the target population and identify recruitment strategies for participants that minimize the impact of selection bias. Participants should be enrolled systematically, with similar procedures implemented at all participating sites and for each intervention of interest. Confirm adherence to agreed-upon enrollment practices.
The objective(s) of the registry should determine the type, extent, and length of participant follow-up.
Describe the frequency with which follow-up measures will be ascertained, consider linkage with other data sources such as the National Death Index to enhance long-term follow-up, and identify the date of last contact with the participant in existing registries, where appropriate. Ensure that the participants are followed in as unbiased a manner as possible, using similar procedures at all participating sites.
Monitor loss to follow-up to ensure best efforts are used to achieve follow-up time that is adequate to address the main objective. At the outset of the registry, develop a retention plan that documents when a participant will be considered lost to follow-up and what actions will be taken to minimize loss of pertinent data. Retention efforts should be developed with stakeholders to ensure the efforts are suitable for the target population and anticipated challenges are addressed appropriately.
Public comments