What can cross-form do for you? (Part 3 of 3)

In the examples given here and here, our cross-form logic depended on data with a known location. In the first case, we knew exactly which event, form, and item to turn to in order to retrieve participate sex and date of birth. In the second case, each of our event dates marked the start of a unique, one-time event, so “finding their address” within the database was a straightforward process.

Now where did I leave that item value?

But what happens when we need to reference data with an indeterminate location, supposing that it even exists? In these cases, we may need to walk around a remote neighborhood, comparing building shapes and sizes, before we find what we’re looking for.

Consider a study that requires drug cessation if a certain adverse event recurs within 90 days. For an Alzheimer’s study, that adverse event may be detection of ARIA (amyloid-related imaging abnormalities) on an MRI scan. Suppose that a second presentation of ARIA within 90 days of the first means that the participant must discontinue study drug. What better occasion could there be for “checking the records” than while reporting a new ARIA? Checking the records here means:

  • retrieving the start dates of any previous AE whose report indicated ARIA
  • calculating the days’ difference between the most recent of the dates above with the new ARIA presentation date
  • showing an alert if that difference is less than 91 days

It’s hardly complex, but a busy CRC working with dozens of participants in multiple trials may forget to follow the process. Cross-form logic, on the other hand, never forgets. The screenshots below depict the result of a third AE report for a single participant. Of the two previous reports, the first indicated detection of ARIA on 1-Nov-2018.  Because the newest ARIA, on 24-Jan-2019, falls within 90 days of the prior one, the form displays instructions to discontinue study drug. 

 

The AE log for this participant shows two reports. The first, documenting an AE on 1-Nov-2018, indicates ARIA.
Here the CRC is reporting a new presentation of ARIA, on 24-Jan-2019. That date is fewer than 91 days after the previous ARIA of 1-Nov-2018. As a result, the form displays the relevant instructions from the protocol.

Few questions are too complex for cross-form logic to answer and act upon. If you can state a rule in logical or mathematical terms, you can most likely implement it using a straightforward expression, no matter how many other forms you need to reference. The OpenDataKit library of XPath functions offers a wealth of tools you can combine to create smart, versatile forms that collaborate with researchers.  So don’t let your innovation stop with drug development or study design: carry it through to your forms!

What can cross-form do for you? (Part 2 of 3)

In the previous post, we presented a cross-form example of clinical data collected in one event factoring into the normal lab range for a subsequent event. But clinical data aren’t the only factors that drive decisions. When an event occurred may determine when it should happen next. Dosing visits provide a common example. Depending on the protocol, dosing might occur at precise intervals (e.g. exactly 21 days between doses) or within windows (e.g. at least 7 days and no more than 10 days from the previous dose). Your EDC system should be able to enforce either type of scheduling, by reading not only the dates entered into forms, but dates found in form and event metadata.

In the example illustrated below, the form makes calculations between the start of a current event (“Dosing Visit 2”) and the start of the previous visit (“Dosing Visit 1”). According to this imaginary protocol, no fewer than 7 and no more than 10 days may elapse between these two visits.

  • If dosing visit 2 occurs within this range, the form guides the site-based user on how to prepare the dose.
  • If dosing visit 2 has a start date fewer than 7 days after dosing visit 1, the form displays instructions not to proceed, and provides the earliest and latest start dates for the visit.
  • Finally, if dosing visit 2 has a start date greater than 10 days after dosing visit 1, the form displays instructions to submit a protocol deviation note.

All of these calculations and feedback take place instantaneously.

For this participant, Dosing Visit 2 is within window.
For this participant, Dosing Visit 2 has been scheduled for too early a date.
For this participant, Dosing Visit 2, were it to occur, would happen beyond the 10 day maximum from Dosing Visit 1.

Up next: check for recurring Adverse Events

What can cross-form do for you? (Part 1 of 3)

Your study database has just locked. To celebrate, you decide to treat your two in-house monitors to dinner in the city. You’d like to offer your colleagues a choice of three restaurants. Take a moment and imagine which three restaurants you’d choose. Got it? Now suppose you recall that one of your monitors follows a gluten-free diet. Does that change your selection? If all of your initial picks specialized in wheat pasta, it ought to.

What’s good for dinner plans is essential for study conduct, when data quality and safety are on the line. An unremarkable value for height in one participant ought to trigger a query for another; for example, for a teen and a six-year-old enrolled in a pediatric trial. To evaluate the input in one field based on data in another, data managers rely on cross-field edit checks. If the fields are part of distinct forms, that evaluation is known as a cross-form edit check.

At OpenClinica, we extend this capability. We give data managers a tool to make their forms responsive to any element they choose from their database, from the participant’s most recently recorded blood pressure to the start date of the last dosing visit. Using easy-to-understand syntax in the form definition, data managers may reference any item in the database to trigger dynamic edit checks, make calculations, show/hide relevant information, and even change the content and logic of the active form. Your forms can now “know it all” to present a fully contextualized data capture experience.

We developed this feature to help our users:

  • capture more consistent, higher quality data,
  • drive protocol compliance,
  • highlight potential safety issues, and
  • mitigate the risk of unnecessary study procedures.

The capability goes far beyond cross-form edit checks. This is total study intelligence. Below is the first of three case studies we’ll present this month that illustrate the difference. If your study has requirements that resemble these, don’t hesitate to contact us for a more in-depth guided tour.

Case #1: Age- and Sex-Dependent Normal Lab Range

One person’s high blood pressure is another person’s normal. Why? The primary reasons are differences in age and sex. When it comes to lab results, “normal” may also be a function of the specific lab conducting the analysis. But not all studies rely on lab-specific ranges. For clarity’s sake, let’s imagine a study that will evaluate lab values against standards that are lab-independent. Known as “textbook ranges”, these ranges define the upper and lower bound of normal based solely on patient-specific factors. Below is a table indicating the lower and upper limits of normal for DHEA-S in adult males and females:

Chances are that a form associated with a screening event has already captured a participant’s sex and date of birth. A subsequent event may include a lab form. It’s inefficient to ask for the participant’s sex and age on this lab form. Sex has already been documented, after all, and age requires a calculation that compares the specimen collection date with the participant’s date of birth. Asking a CRC to make that calculation opens the door to error, especially if collection occurred close to the participant’s birthday. But age and sex information is required to determine whether an entered value is above or below the limits of normal.

Enter cross-form logic, which handily “pulls in” the required data from an external form. In the current case, an expression within the form compares the specimen collection date with the externally-supplied date of birth, to calculate participant age. That age, together with the externally-supplied sex and lower and upper limits indicated within the lab form, are all it takes to instantly evaluate the lab value against the appropriate range for the participant. Results of that evaluation may trigger or hide additional fields, get piped into question or response text for a separate item, or simply provide instructions, as shown in this video.


 

Up next: comparing event dates to ensure that dosing occurs within window.