This study is the first of its kind to highlight the challenges associated with using PROMs with populations who may require specific assistance, such as those with low literacy and/or learning disabilities. According to our findings the EQ-5D and the SGRQ, in their current form, may have limited accessibility for these groups. Participants advocated for changes in the format (e.g. larger font sizes) and mode of administration (e.g. assistance with completion) of PROMs. The findings are also pertinent to others who find it difficult to engage with written material due to impairments of memory, attention, or comprehension (e.g. some people with dementia, acquired brain injuries). The actions taken to support people with low literacy skills or learning disabilities may have wider benefits beyond these groups.
Leverage-saliency theory of survey participation helps to frame the discussion about how the attributes of a questionnaire impact people’s ability and desire to respond in various ways.[23
] ‘Salient attributes’ are the features of the survey that a person considers important in their decision on whether to complete the questionnaire. ‘Leverage’ is the weight the person gives to a salient feature. For example, someone may consider font size salient, and it may carry high positive leverage, while s/he does not like the topic of the questionnaire so it carries negative leverage. If the font size is big enough to make the tool easy to use, it can overcome a person’s negative feelings about the survey topic, and s/he will be more likely to complete the questionnaire.
PROM formatting and their administration were salient attributes for participants and could be addressed to improve participants’ ability to complete PROMs. The format of current paper-based questionnaires was considered feasible with modifications that are typical of information given to people with learning disabilities (such as large font size and consistency) [24
]. In contrast to other studies and initiatives [11
] our participants did not suggest technology-supported solutions to PROMs administration but this might be because it was not explicitly offered as an option. While formatting modifications were important, the way PROMs were administered was seen as even more significant and thus also carry more leverage. Completing PROMs at home was seen to make PROM completion easier because in this setting people could access their preferred source of support. Guidance in the past has focused on waiting rooms [8
], which may not work for all participants. Patient participants, regardless of reading ability, gave this issue considerably higher salience than health professional participants. While one of our professional participants suggested sending PROMs home would result in over-thought answers, it was exactly this opportunity to have the time to think and concentrate on a PROM that patient participants felt was necessary to complete the PROM accurately. Without the time to focus, which often is not provided in clinical settings, they may feel frustrated or intimidated to complete it without assistance.
The perception of form-filling based on past experience was also salient but carried negative leverage that could potentially be overcome through a clear understanding of the purpose of PROMs. Our findings suggest that previous negative experiences with form filling lowered some participants’ confidence to complete forms, and that participants were concerned that PROMs were ‘just another form’ for which they would never see feedback. These perceptions carried negative leverage as they made participants less likely to want to complete PROMs. But participants spoke positively when they understood PROMs as beneficial to help express their perceived health and wellbeing to professionals and help others with this information. This perception suggests that the purpose and use of PROMs is also salient to users. In addition to matching the formatting and administration of PROMs with the respondents’ assistance requirements, clearly conveying the benefits of the tools to participants may foster their ability to complete them, and overcome the negative leverage carried by the negative perception of form-filling in general. Health professionals have also repeatedly highlighted the need to see a purpose and benefit to clinical practice before they consider PROMs worth administering [1
], and it is equally important to feedback the results directly to patients.
Tailoring PROMs administration, as our findings suggest may be helpful, is potentially controversial because the purist view of PROMs is that they should be delivered in exactly the same format that they were developed to ensure validity and comparability. For example, the authors of the SGRQ state that the questionnaire should be completed without any assistance because of the potential bias introduced to the patients’ responses [19
]. However, Harniss et al. [25
] point out that accommodations, such as the formatting and administration methods our participants suggested, can also reduce the bias associated with excluding a large number of people from using PROMs. Pragmatically, practitioners may need to balance the requirement to use PROMs exactly how they were developed with the need to ensure accessibility and full use in practice by making some amendments to formatting and administration. In some cases researchers have validated alternative methods for PROMs (e.g. phone administration of the SGRQ [20
]) or guidelines have suggested that a clinician should be on hand while a patient is completing a PROM to answer questions [19
]. Even under these circumstances, the degree and type of assistance and tailoring that is required will vary and typically go beyond solely having a clinician on hand to answer questions. We cannot propose a definite solution to the sometimes contradictory theoretical and practical nature of PROMs. However, considering this issue using leverage-saliency theory suggests that easy read modifications and assistance to complete PROMs could increase the likelihood that people with low literacy skills or learning disabilities will be able to use PROMs as they are both highly salient.
There were some limitations that may affect the applicability of our findings beyond our study. Our sample was small and there is limited work on this issue in the PROMs literature to ground our findings. However, we did reach topical saturation as similar themes emerged from various participants after the preliminary analysis. Our findings regarding formatting are also consistent with existing guidance for creating accessible information for people with learning disabilities [24
]. As we recruited professionals through contacts and involved people who were already accessing support from the third sector or from community health services, the participants may have already had an interest in research and PROMs. Finally, sometimes it was difficult to decide whether a participant was influenced by her/his support worker, or was responding to please without full comprehension of the question.