Determine Who Should Join
Set Language Requirements
Decide what language(s) you will use for your registry. The simplest option is to use one language, but given that you’ll want to recruit as many people living with the rare disease as you to your registry, consider translating your questions into multiple languages.
- What languages are spoken by patients and their caregivers?
- How often is English used as either as a first or second language in the countries in which you are recruiting for your registry?
- What language(s) will you use to contact registry participants?
- Are you able to afford professional translators or find qualified volunteers?
- PROs: No translation is needed. Using a professional to translate your registry questions into another language can be costly. Using a native speaker as an informal translator can introduce errors or inconsistencies. Cultural or linguistic differences can also impact the way people interpret the registry questions. Work out all the “bugs” in your questions in one language before you translate them into other languages (otherwise, you’ll spend time and money using the translation services each time a change is needed as you work out the kinks). If you work out all the “bugs” first before translating the questions, you may be able to work with international rare disease patient advocacy groups to help fund translation into their language.
- CONs: Some patients may not be able to participate. Multiple languages are used for registries involving participants all over the world. Especially when the patient population is very small, it can be important to include as many people as possible in the registry. If a participant does not speak the language, he or she will not be able to participate unless a friend or relative can complete the registry questions.
- PROs: More patients will be able to participate. Multiple languages are used for registries involving patients all over the world. Especially when the patient population is very small, it can be important to include as many people as possible in the registry.
- CONs: Translation increases the cost and complexity of your registry. It may be difficult to identify translators for each language and assess their ability to be medically and technically proficient. It is important to ensure that the registry questions are translated consistently across the different languages. A translator will also need to convert all the answers back into one language.
Set Language Requirements
Chapter 3: Registry Design in Registries for Evaluating Patient Outcomes: A User’s Guide, [internet]. 4th Edition Agency for Healthcare Research Quality (AHRQ) (link)
Establish Diagnostic Criteria
HIPAA Privacy Rule: Information for Patients U.S. Department of Health and Human Services: Health Information Privacy (link)