Semantic Infrastructure Services |
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Semantic Infrastructure Forms User Story 2:
Support of form annotations to enable form behavior
Domain Description
A forms curator is sitting down to create the case report forms for a new trial titled "Study of Ad.p53 DC Vaccine and 1-MTin Metastatic Invasive Breast Cancer." Her goal it to make the forms intuitive, reduce human error when collecting data, and as precise as possible. When building the demographics form, she decides to make the age data element derived from the date of birth data element. Entering data that can simply be calculated from other data can only introduce errors, especially since date of birth is also captured in the hospital system so can easily be validated. When building the medical history CRF, she realizes that fifteen of the questions only relate to women that have previously been pregnant. She promptly enters a skip pattern based on the gender question, as well as the pregnancy question. That should significantly save time. Now that all the questions are entered, she goes back to edit them so have minimum lengths for required text questions, maximum lengths for numeric questions, pick-lists for those questions with a particular set of possible answers, and a data mask for the social security number question. Now, the clinical data management system can render the forms via PDF using all of this handy information.
Technical Description
Forms provide a convenient paper-like electronic mechanism to capture data in a structured way. For example, when a patient is placed on a clinical trial, data about the patient's demographics and eligibility for the trial need to be captured. However, forms can also exhibit specific behavior that may or may not be reusable. These include skip patterns (if the answer to question 10 is "Yes" then skip to question 15), derived values ("what is your age" and "is your age less than, greater than, or equal to 65), and composite answers ("check all" or "more than one of the above"). Furthermore, specific requirements about how a form is rendered can exist. For example, the question description, help text, valid values, maximum and minimum answer length, the format of a data mask (such as SSN), etc. It is important to be able to allow for forms to be annotated with this behavior such that tools can appropriately render and act upon them. Furthermore, if appropriate, web- and paper-based collection instruments can be automatically generated from this metadata.
