# | Step name | Activities |
1 | Literature review to identify existing items | This is a search of the literature surrounding established PROMs within the target health condition, and relevant self-reported measures within the target technology category. This considers the socio-technical context of the target domains, and serves as the foundation for building proposed outcome measure items. Items that represent the range of domain-relevant experiences are identified. |
2 | Binning and winnowing | Binning involves categorising the selected items according to the effects of PGHD utilisation that they could measure. Winnowing excludes items that would not be able to measure effects of using PGHD. It also excludes items based on QIR criteria: items that are too narrow, disease-specific, redundant or confusing.26 |
3 | Item revision process | In this step, retained items are revised according to QIR criteria to ensure: consistency of item response options; similarity in wording contexts; concise and simple items; item independence from other questions and that items encourage use of available response options to reduce cognitive burden on respondents.26 Additionally for PROM-PGHD, some item terminologies may be revised to better match the target health condition and technology category, to make them more specific to the target domains. |
4 | Focus groups and interviews with target patient cohort | This step ensures that patient input is elicited in the development of item banks. It enables the developers to understand the vocabulary and thinking processes of the target group, and to gather feedback on individual items. It is aimed to bridge relevant gaps between the current items and the target domain or concepts to be measured. This may also highlight other measurement areas expressed by patients that are not covered in the preliminary item bank. |
5 | Final item revisions | Based on patient input gathered from the previous step, the items are revised once more. They are tested with the Lexile Analyser (MetaMetrics, Durham, North Carolina) to assess their readability; to catch items that may still be difficult to read. After the revisions are completed, field testing on the items may begin, in order to understand their quantitative characteristics. |
PGHD, person-generated health data; PROMs, patient-reported outcome measures; QIR, Qualitative Item Review.