Step 3.
Develop the Right Questions to Ask

3.0 Overview

Decide which questions to include in your registry and how the answers will be formatted. Data are most useful if they have been collected in a standardized way (that is, everyone is asked the same questions and answers are provided in the same format). Choose an established data standard for collecting patient information for your registry.

3.1 Collect Patient Information

The first required questions to include in your registry are the patient’s name and age. Collect the patient’s date of birth to know his or her exact age, to be able to track it over time, and for researchers who recruit patients from specific age groups. 

If you allow a caregiver to register on behalf of a patient, include a question to clarify that the patient is not filling out the registry form, and capture the caregiver’s name.

The next set of questions address participant contact information. Depending on how you intend to contact them, typical information to gather includes participants’ e-mail address, mailing address, and phone number. To reduce errors, confirm data entry, such as having participants enter their e-mail address twice or using postal address verification.

The Clinical Data Interchange Standards Consortium (CDISC) develops data standards that are used worldwide to streamline medical research. Examples of other data standards include Systematized Nomenclature of Medicine (SNOMED) and Unified Medical Language System (UMLS). There are also other data standards.  Which one you choose is less important than selecting one data standard and using it consistently.

3.2 Decide on Demographic Questions

Including demographic (e.g., age, sex, race/ethnicity) questions can help you learn more about the participants in your registry. The goals of your registry will determine whether these questions are optional. A best practice is to follow demographic standards, because this will allow you to compare your results with other data sources. Refer to RaDaR Tool: Standard Contact & Demographic Questions to view sample questions selected using data standards established by The Clinical Data Interchange Standards Consortium (CDISC).

3.3 Create Questions About Diagnosis

Consider what questions on diagnosis you need to include to verify that a participant meets requirements to join your registry. To avoid, “survey fatigue” and overwhelming the person answering the questions, it is important to be mindful about the number of questions included in this section. Be selective in the questions you include.

For example:

  1.  How was the patient diagnosed? (Consider providing answer options (e.g., clinical evaluation, laboratory tests, imaging tests, or diagnostic procedures))
  2.  At what age was the patient diagnosed? 
  3. What is the name of the clinician who diagnosed the patient?
  4. What is the medical specialty of the clinician who made the diagnosis?
  5. What was the diagnosis?
  6. Name of medical center, practice, or hospital where patient was diagnosed.

3.4 Document Permissions to Use Data

Include questions that clarify how you intend to use the information you collect for your registry, who will have access to the data, how the data will be shared and with whom, and decide if any uses will be optional. This will give participants the ability to opt out if they choose. Being clear and transparent will help build trust in your registry and data collection methods, and underscore your role as a data steward. To learn more about obtaining informed consent, you may want to read Global Gene’s Rare Toolkit: Informed Consent – Important for Treatment Decisions and Advancing Research.

If you’ve decided to recruit patients from other countries, it’s important to familiarize yourself with that country’s laws regarding data privacy and security (e.g., European Union (EU) General Data Protection Regulation (GDPR) for European countries).

Decide which questions to include in your registry and how the answers will be formatted. Data are most useful if they have been collected in a standardized way (that is, everyone is asked the same questions and answers are provided in the same format). Choose an established data standard for collecting patient information for your registry.

The first required questions to include in your registry are the patient’s name and age. Collect the patient’s date of birth to know his or her exact age, to be able to track it over time, and for researchers who recruit patients from specific age groups. 

If you allow a caregiver to register on behalf of a patient, include a question to clarify that the patient is not filling out the registry form, and capture the caregiver’s name.

The next set of questions address participant contact information. Depending on how you intend to contact them, typical information to gather includes participants’ e-mail address, mailing address, and phone number. To reduce errors, confirm data entry, such as having participants enter their e-mail address twice or using postal address verification.

The Clinical Data Interchange Standards Consortium (CDISC) develops data standards that are used worldwide to streamline medical research. Examples of other data standards include Systematized Nomenclature of Medicine (SNOMED) and Unified Medical Language System (UMLS). There are also other data standards.  Which one you choose is less important than selecting one data standard and using it consistently.

Including demographic (e.g., age, sex, race/ethnicity) questions can help you learn more about the participants in your registry. The goals of your registry will determine whether these questions are optional. A best practice is to follow demographic standards, because this will allow you to compare your results with other data sources. Refer to RaDaR Tool: Standard Contact & Demographic Questions to view sample questions selected using data standards established by The Clinical Data Interchange Standards Consortium (CDISC).

Consider what questions on diagnosis you need to include to verify that a participant meets requirements to join your registry. To avoid, “survey fatigue” and overwhelming the person answering the questions, it is important to be mindful about the number of questions included in this section. Be selective in the questions you include.

For example:

  1.  How was the patient diagnosed? (Consider providing answer options (e.g., clinical evaluation, laboratory tests, imaging tests, or diagnostic procedures))
  2.  At what age was the patient diagnosed? 
  3. What is the name of the clinician who diagnosed the patient?
  4. What is the medical specialty of the clinician who made the diagnosis?
  5. What was the diagnosis?
  6. Name of medical center, practice, or hospital where patient was diagnosed.

Include questions that clarify how you intend to use the information you collect for your registry, who will have access to the data, how the data will be shared and with whom, and decide if any uses will be optional. This will give participants the ability to opt out if they choose. Being clear and transparent will help build trust in your registry and data collection methods, and underscore your role as a data steward. To learn more about obtaining informed consent, you may want to read Global Gene’s Rare Toolkit: Informed Consent – Important for Treatment Decisions and Advancing Research.

If you’ve decided to recruit patients from other countries, it’s important to familiarize yourself with that country’s laws regarding data privacy and security (e.g., European Union (EU) General Data Protection Regulation (GDPR) for European countries).

Continue to Step 4. Decide How to Collect & Store Your Data after you finish Step 3