Patient Reported Outcome Measure Translations and Cross-Cultural Validations

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• Making cancer clinical trials more inclusive

  Indigenous and culturally and linguistically diverse (CALD) Australians face barriers to participation in cancer clinical trials, and national efforts are underway to ensure trials become more inclusive (1, 2).

  While the most pressing imperative is to improve access to trials, it is also important that trial methods are inclusive once patients become enrolled.

• The role of PROMs

  PROMs give a ‘voice’ to trial participants regarding how disease and treatments impact their everyday functioning and health-related quality of life (HRQL).

  PROMs can capture differences in how impacts are culturally appraised that have important implications for the generalisability and translation of trial findings into clinical practice with the aim of improving outcomes.

• Cross-cultural validation versus translation

  Translation alone offers no guarantee that PROM items will be interpreted in the same way by different cultural groups, or that items cover aspects of HRQL that are important cross-culturally. 

  Cross-cultural validation is defined as “the degree to which the performance of the items on a translated or culturally adapted PROM are an adequate reflection of the performance of the items of the original version” (3). 

  This form of validation involves re-testing of psychometric properties such as content and structural validity in the new population group, and may sometimes require revisions to the original items to improve comparability.

  Like validation more generally, cross-cultural validation is best seen as an ongoing process rather than a definitive property for any given patient group. It’s up to the reader to make up her/his mind about whether the evidence is sufficient for the purpose required.

  While cross-cultural validation usually focuses on translated versions of PROMs, sometimes the same language version will need revalidating in population sub-groups that differ by culture but not language.

  Whenever PROMs are used in multiple translations that have not been culturally validated, it is important to record which version was used for each participant so analyses can look for consistent patterns which might suggest items are being interpreted in disparate ways between versions (4).

  What PROM translations/cultural validations are available?

• EORTC and FACIT translations

  The European Organisation for the Research and Treatment of Cancer (EORTC) and Functional Assessment of Chronic Illness Therapy (FACIT) produce the two most widely-used suites of cancer-specific PROMs.

  Click on the below links to access the EORTC and FACIT online search engines to search for translations. 

  https://qol.eortc.org/form/#1 [opens external site]

  https://wizard.facit.org/ [opens external site]

  • On the FACIT search engine
    • Select an age - select 'all', 'adult' or 'paediatric'
    • What are you searching for? - select 'existing measure' or 'individual items'
    • Search by - select 'language'
    • Language - select default as 'all' or choose specific language
    • Click on 'search'

• CQUEST list of translations/cross-cultural validations

  We have developed a list of translations/cross-cultural validations for PROMs that are widely used in cancer clinical trials but not produced by the EORTC or FACIT. To find a PROM relevant to your research, search by PROM name, type, issue or language.

  download the list (xls, 110kb)

  Classifications for PROM types and issues in the list use the same taxonomy as the PoCoG Psycho-oncology Outcomes Database (PoD), a database of PROMs commonly used in cancer studies that is available for free to PoCoG members.

  PoCoG Psycho-oncology Outcomes Database (PoD) [opens external site]

• PROMs for Aboriginal and/or Torres Strait Islander people

  Unfortunately, we could identify no PROMs commonly used in cancer clinical trials that have been developed, translated or culturally validated for any of Australia’s Aboriginal or Torres Strait Islander peoples.

  CQUEST members are involved in developing a new wellbeing measure called WM2 (What Matters 2) Adults for Aboriginal and Torres Strait Islander adults, underpinned by values and preferences (5). However, this is a general measure not specifically designed for cancer or clinical trials.

  For clinical use, a measure called the Supportive Care Needs Assessment Tool for Indigenous People (SCNAT-IP) has been developed for assessing cancer care needs and is supported by online training.

  supportive care needs assessment tool for indigenous people (scnat-ip) [opens external site]

  A further patient-reported experience measure (PREM) called the Indigenous People’s Experiences of Cancer Care Survey (IPECCS) is also currently under development (6).

• Help us improve our list of translations/cross-cultural validations

  Our list was last updated on 29 April 2022, and will be subject to further updates and inclusion of further PROMs on an ongoing basis.

  If you know of translated and/or cross-culturally validated versions of PROMs that are commonly used in cancer clinical trials and have not yet been included in the list, please let CQUEST know via cquest@uts.edu.au so we can include them.

• References

  1. Australian Clinical Trials Alliance (ACTA). Clinical trial awareness and access amongst culturally and linguistically diverse (CALD) populations: environmental scan 2020 [Available from: https://clinicaltrialsalliance.org.au/wp-content/uploads/2020/06/ACTA-Clinical-trials-and-CALD-population_Environmental-Scan-V3_final.pdf]. [opens external site]
  2. Cunningham J, Garvey G. Are there systematic barriers to participation in cancer treatment trials by Aboriginal and Torres Strait Islander cancer patients in Australia? Australian and New Zealand Journal of Public Health. 2021;45(1):39-45.
  3. Consensus-based Standards for the selection of health Measurement Instruments (COSMIN). COSMIN Taxonomy of Measurement Properties 2020 [Available from: https://www.cosmin.nl/tools/cosmin-taxonomy-measurement-properties/]. [opens external site]
  4. Slade A, Retzer A, Ahmed K, Kyte D, Keeley T, Armes J, et al. Systematic review of the use of translated patient-reported outcome measures in cancer trials. Trials. 2021;22(1):1-16.
  5. Howard K, Anderson K, Cunningham J, Cass A, Ratcliffe J, Whop LJ, et al. What Matters 2 Adults: a study protocol to develop a new preference-based wellbeing measure with Aboriginal and Torres Strait Islander adults (WM2Adults). BMC Public Health. 2020;20(1):1739.
  6. Green M, Cunningham J, Anderson K, Griffiths K, Garvey G. Measuring cancer care experiences of Aboriginal and Torres Strait Islander people in Australia: Trial of a new approach that privileges patient voices. Patient Experience Journal. 2021;8:43-57.