When preparing PRO measures for use with populations who are culturally and linguistically diverse, it is critically important that the intended audience understands both the measure and what is being asked of them. Researchers should recognize that cultural adaptation of a PRO measure is typically more involved that simple linguistic translation. The following working definitions are useful in considering their distinction:

• Cultural adaptation: Adapting an existing instrument to measure a phenomenon in a different culture
• Linguistic adaptation: Translating an existing instrument to measure a phenomenon in people who speak another languag

Key Point: Cultural and linguistic adaptation of PRO measures can enable inclusion of a broader study population and enhanced generalizability of results. However, if a measure has not been adapted or translated appropriately, then the population may not understand what is being asked of them. Therefore, the data collected from the measure may not accurately reflect the underlying construct(s) of interest (Gjersing et al. 2010).

We surveyed study investigators from the first round of PRISM NIH Collaboratory Trials to understand and describe efforts for cultural adaptation and linguistic translation for PROs.  We received survey responses from 6 NIH Collaboratory Trial investigators. Of these, the BackInAction and BeatPain Utah studies were the only studies that performed PRO adaptations. Below, we describe the strategies used by the study investigators to ensure PRO cultural and linguistic appropriateness.

BackInAction (Nielsen et al. 2021)

The BackInAction study is comparing a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for chronic low back pain in older adults. The study sample will be recruited from 4 diverse health plans to represent the ethnic and racial composition of Medicare enrollees. Whenever possible, as per FDA guidelines (FDA Guidance for Industry 2009), the study used the published Spanish versions for the selected PRO instruments. When translations were not readily available, they performed linguistic adaptation using standard translation and back-translation techniques for adapting instruments. The investigators created a Spanish version of all instruments used in the baseline and follow-up interviews. One of the healthcare systems had experience translating for clinical research, so a translator within the health system conducted the translation for the trial. Although cognitive testing was not performed with a sample of native speakers, the study team felt they gathered all the evidence needed to support use of the adapted instruments.

BeatPain Utah

BeatPain Utah compares the effectiveness of nonpharmacologic intervention strategies for patients with back pain seeking care in Federally Qualified Health Centers throughout the state of Utah. Because a large proportion of the population is expected to be culturally Latinx and Spanish-speaking, the study team made cultural and linguistic adaptations to the PROs and other materials used for the project. Spanish translation proceeded through the following steps:

• Informal review of instrument content by native speakers or other stakeholder(s) (aka face validity assessment)
• Pilot testing in sample of native speakers to evaluate content (aka cognitive testing of adapted measure)
• Role playing intervention sessions with members of the research team who share the cultural background of many of our anticipated participants

The study team also provided training in cultural considerations for all members of the study intervention delivery team.

For translation of some study-related materials, such as the consent cover letter and IRB-approved materials, a certified translator was used. For other aspects of the study, such as screening scripts, intervention materials and exercise videos, etc., translation was performed by members of the study team who were both culturally Latinx and Spanish-speaking.

Spanish versions of the PROs used as primary and secondary endpoints were all previously validated in other studies.

FM TIPS, OPTIMUM, GRACE, and NOHARM did not make cultural or linguistic adaptations, with all 4 noting that it was not feasible in the timeframe. OPTIMUM also noted that they are not enrolling participants who speak other languages. Only NOHARM has future plans to perform cultural and linguistic translations for Hispanic/Latino participants. See Section 2 for a list of PROs collected by all the trials.

In this initial assessment, consideration of cultural and linguistic adaptation of PRO instruments were found to be relevant to half of PRISM NIH Collaboratory Trials. For the two projects that did not previously perform or plan to perform adaptations, feasibility within the timeframe was a major barrier. When planning pragmatic trials, choosing PRO instruments with readily available versions for relevant target populations should be a priority. Having to perform individual linguistic and cultural adaptations for specific tools could be time consuming and costly, as it typically requires cognitive testing to ensure the translation is interpreted in the intended way.

The Report of the ISPOR Task Force for Translation and Cultural Adaptation suggests involving relevant stakeholders for both forward and backward translation and cognitive debriefing, which is intended to ensure that that target audience understands the materials (Wild et al. 2005).