The digitization of Clinical Outcomes Assessments or COAs into electronic format has become mainstream for data collection in many clinical trials. As it becomes more routine to migrate traditional paper questionnaires into eCOAs or Electronic Clinical Outcomes Assessments, there is growing need for COA developers to contribute to the design of their measures from an on-screen perspective. The importance of correctly migrating a COA is essential, and developers need to be a part of the process.
Why digitize COAs?
There is a growing preference for clinical trials to use eCOA or electronic Clinical Outcomes Assessments. eCOAs have a high level of accessibility and usability that is convenient for both clinicians and research participants. eCOAs provide numerous advantages in that they improve patient compliance, provide high-quality data collection, and are more cost effective than traditional paper data collection.
With this transition from traditional paper questionnaires to electronic versions, it is imperative that eCOAs are designed to meet the same requirements and have the same level of validity. Incorrectly migrated COAs may unintentionally change a questionnaire, thereby influencing the validity of the COA. During the COA digitization process, no assumptions should be made as the COA developer’s intentions may not be fully understood without their consultation.
Developer involvement in the migration of their COA into an electronic format is essential to produce a valid, consistent version of the COA that can be standardized by eCOA providers.
Essential considerations for successful eCOA migration
Paper versions of questionnaires do not always seamlessly transfer well into electronic versions. When evaluating a COA for migration, there are multiple factors to consider that may not be apparent just by looking at the original questionnaire. COAs may contain elements or enforce requirements that must be applied but are not seen at face-value. Rather than within the COA itself, considerations like these may be provided in instructional guides or the COA’s accompanying manual. There are several common situations where developer feedback on eCOA migration is necessary.
Some COA migration requirements are clear such as keeping the original text and formatting as closely as possible to the paper COA. However, migration into electronic format many times involves specific requirements for digitization. For example, questionnaire instructions or examples on how to complete questionnaire items may need to be modified to make sense on tablet or smartphone, e.g., updating “circle your response” to “select your response”. Other examples include adding recall periods to the instruction text that are not reflective of the original paper version. Some COAs provide a recall period in their instructions ,e.g. “in the past week,” but when using a screen-by-screen approach in an eCOA, the recall period needs to display on each screen to remind the respondent to focus on a particular time period. Questionnaire redundancies such as instructional text stating to “select one response” when only one answer can be selected or numbering that does not make sense once branching logic is applied are eliminated in many cases. On paper versions, respondents can forget the recall period or select more than one answer for a questionnaire item. Updated formatting due to lack of screen space or platform capability can also be reflected in electronic versions, changing the original appearance of the paper version that may not look at all like the COA it is based on
Considerations around skipping questionnaire items may need to be determined as this could affect the layout and scoring of an eCOA. There are scenarios where all items are skippable, specific questions or sections are skippable, or no items in the questionnaire are skippable. If specific questions do not necessitate an answer, mechanisms such as skipping notifications and confirmations are required. It is essential for eCOA solution implementers to proactively plan for scenarios where formatting or UX and UI options may be limited.
Sometimes, those who implement eCOA solutions cannot apply a widget (e.g., controls to select responses in the software), follow rules or apply certain formatting. Sometimes, eCOA implementation solutions lack certain formatting or UX or UI options needed to fully comply with the paper version. For example, horizontal Numeric Rating Scales (NRS) and or Visual Analogue Scales (VAS) are applied to a smartphone screen where NRS or VAS can only be displayed vertically, deviating from its original orientation. In another instance, two controls or data entry points need to appear on one screen, but the software platform only allows for one question or one data point per screen. Additionally, COAs that contain free text elements may need modification or cannot be implemented in the software solution. In cases like the above, it is essential to get the COA developer’s feedback on which alternatives are acceptable. Scientific validity of a scale must be ensured when components of the questionnaire are migrated into an electronic format.
Which COAs are most apt for digitization?
Clinician-Reported Outcomes (ClinRO) can be challenging to migrate into electronic versions, as complex clinical information may be captured. Patient-Reported Outcome measures or PROs tend to be more straightforward in their application to electronic format as they are completed by study participants and have fewer complex requirements. However, Clinician-Reported Outcome measures or ClinROs can include lengthy directions, clinical testing result values (e.g., FEV1 or laboratory results) and may prompt the entry of data from clinical tests that may not be available at the time of ClinRO completion. This can lead to issues with scoring or special training for site staff. Sometimes, custom formatting needs to be implemented for ease of completion by assessors. In some cases, clinical data points that are part of the original questionnaire are removed from electronic migrated versions as they would rather be captured in a Case Report Form or CRF. These are only a few examples of scenarios that are encountered during the migration process which require developer feedback from a scientific perspective.
In comparison, Patient-Reported Outcome measures or PROs tend to be more straightforward in their application to electronic format as they are completed by study participants and have fewer complex requirements.
To ensure scientific validity is kept to the same standard as what is collected on a paper version, developers should always be asked for validation, and hard rules for COA compliance should be enforced.
eBooklets: guidelines for specific COA digitization
Guides for electronic versions of COAs are incredibly valuable to eCOA providers and other stakeholders in eCOA migration. When the requirements for digitization are clearly defined, guess work is removed from the design process and replaced by solutions tailored to the specific COA digitization process.
At Mapi Research Trust, our goal is to assist COA developers in the creation of guides for electronic versions of their COAs. Our eBooklet team, comprised of eCOA experts, guides developers though a process to migrate their COA into an eCOA. Although COAs can still be used in paper format, we recommend the creation of digital versions as electronic formats have become commonplace.
The eBooklets are guides made in collaboration with COA developers and are provided to eCOA providers, academic institutions or others responsible for COA migration. They contain information on appropriate COA controls (NRS, VRS, Radio button etc.) and behaviors (branching, logic, scale types, skipping, scrolling, etc.). They also provide design recommendations and considerations, including work arounds for eCOA platform limitations. Technical drawings to illustrate branching/other special functions and screen by screen examples are documented in eBooklets.
With all of the questions surrounding the application of COAs into electronic format, COA developers are essential to these conversations. COA developers design questionnaires as scientific instruments, using specific measurement techniques in a particular format. They go through rigorous processes to make sure that they are validated, meet regulatory and or ethics committee standards, and, where needed, government or organizational approval from academic institutions. Responsibility for clear design requirements is a duty for those that develop and implement eCOA solutions.