Evidence of problem

English language skill has been shown to be a valid indicator of health status in the UK.15 The UK 2011 census revealed that only 65% of people who were not proficient in the English language were in good health, compared with nearly 88% with English as their main language.16 17 The areas in the UK where the disease burden is the greatest also have the lowest participation rates in research, with language barriers being cited as one of the three primary reasons for the under-representation observed.18

Most research investigating language-based exclusion in clinical research is based in the USA, and in the adult population. Reviews of articles in major US journals and study protocols from the last four decades show that language ability was a common reason for exclusion and that there is a potential rise in the trend of exclusionary practice based on language.2–4 One review that included UK studies found that 84% of articles did not discuss language issues at all.5

UK data are limited, and no studies or reviews have been found that explore language-based exclusion in PEM research. A review from the USA of >5000 paediatric research articles published between 2012 and 2021 found that only 9% of studies included people who required translation services.19

Language-based exclusion contributes to the lack of diversity in participant population and for PEM, this risks an evidence base which does not account for the disease burden according to background and heritage, as well as potentially fails to include an at-risk and vulnerable group of children.1 16 17

What are the barriers

Paediatric emergency departments have unique challenges surrounding seeking consent for clinical research in situations that can be sensitive and time limited.20 Even when it is possible to be language inclusive, it may be difficult to accommodate all languages due to the unpredictable nature of emergency departments. Moreover, there is evidence to suggest that in PEM, interpreters for clinical purposes are used less as the department becomes busier, this may also impact clinical research.21

Ensuring quality of translation could be another barrier as interpretation and translation are not statutorily regulated and there are no universal standards that have to be followed, meaning that quality control across services may vary and translation agencies do not have to provide someone qualified.22 This contrasts with the clear standards that exist within research for data collection, analysis and interpretation.22–24 It is the responsibility of individual researchers to assess the quality of the service they intend to use.25 This could potentially be a time consuming and daunting task and may be difficult to complete depending on the resources available.

Even where resources are available and rigorous processes have been followed, studies have shown that the way in which a word or phrase is translated according to a regional and cultural variations can significantly alter the study’s findings.22 26 Translators need to consider the participants’ country of origin and the context of the phrase within regional variations.

The potential increase in cost that interpretation and translation may add to a research study could be prohibitive.27 The cost of obtaining culturally and linguistically accurate translations, in time, money and resources, may not be justifiable depending on factors such as how often the service is likely to be used.

Potential solutions

To facilitate further exploration and learning around language inclusion, researchers should be encouraged to discuss linguistic diversity of the research population, how translation occurred and any barriers to inclusion. This would highlight any potential biases in the interpretation of the research findings, as well as helping to identify barriers and facilitators to being language inclusive on a larger scale.

To ensure that time, money and resources are allocated appropriately, language needs in clinical research should be considered during the planning stage by both investigators and funding agencies.25 This includes a language and literacy assessment of the study population, enabling researchers to determine demand, which would then inform a more precise cost-benefit valuation for the use of translation services within the study.25 28 The National Institute for Health and Care Research (NIHR) advises that the percentage of the target population that relies on interpreters should be reflected in the proportion of people who do not speak English included in the study.25

National funding bodies in the UK have developed guidelines and frameworks aimed at improving inclusion in clinical research.1 29 Frameworks such as INCLUDE and HIAT provide tools to guide improved inclusion of underserved communities and reduce health inequalities in research.1 30 The NIHR has also produced a two-part guide on how to conduct research involving interpreters and translators, and how to calculate the associated cost.25 31

For ethical approval, the Health Research Authority (HRA) offers guidance on their integrated Research Application System for approvals and permissions. This outlines requirements for applications where translation services are to be used in a study.32 Proposals for translation will be considered by the Ethics Committee as part of the application process.32 Email correspondence with the HRA confirmed that translated versions of documents do not need to be submitted with the applications, and for ongoing studies, amendments can be submitted detailing what provisions are in place for the use of translation services.

Where written translation is required, methods such as Brislin’s back translation model are advised to ensure equivalency between the original and translated text (table 1).18 28 33 34 Where possible, interpreters should have awareness of regional and cultural differences.18 26 35 Having an accepted standard or qualification for research translators would hold translation agencies accountable to a minimal standard and reduce the workload for researchers. Table 2 (table 2)summarises the core problems and potential solutions in language inclusivity research.

When researchers do not have access to translation services, more readily available and free services such as Google Translate are advised against due to the high risk of errors and lack of confidentiality regulations.36 37 The Department of Health and Social Care advises against the use of family members for translation for clinical care.37 38 Given the unpredictable nature of emergency departments, family members are often more immediately available and may be helpful in providing cultural context for translation for research participation in an emergency setting. However, a balanced consideration is vital, and the NIHR cautions that if family members are used, then the integrity of the translated response need to be considered, as well as ensuring that private and confidential information is protected.18 Bilingual healthcare providers can be useful in translating for patients in emergency clinical situations.39 While professional standards of clinical care may make this more acceptable than using family members, they would still need appropriate training in research consent.