Guidance for Migration of FACIT Measures from Paper to Electronic Platforms
This guidance provides instruction and information related to the migration of FACIT measures to any electronic clinical outcome assessment (eCOA) platform. This guidance will be subject to continual review and revision as electronic assessment methods evolve.
Font/Layout
FACIT items are presented on paper using Times New Roman 12-point font. We suggest that electronic administration aim to be as close to this standard as possible. If a 12-point font is not possible given screen size, the largest reasonable size is recommended. Use of bolded or underlined text from the paper version should be replicated in the e-version. For multiple-item layouts, it is recommended to retain as much of the formatting of the horizontal alignment of items and response options (0-4) in the paper version as possible. A vertical presentation of the response options is acceptable for single-item layouts.
Title screen/copyright
FACIT.org requires that the title of the measure, version number, and copyright information be listed at least once for each administered assessment. At minimum, an introductory screen should be presented prior to the measure or items with this information; where feasible, please ensure the FACIT copyright is listed on each screen. All copyright information can be found in the header and footer of the paper version of each measure.
Instructions/placement
FACIT paper-and-pencil measures typically contain two sentences of instructions: “Below is a list of statements that other people with your illness have said are important” and “Please select one number per line to indicate your response as it applies to the past 7 days.” Web-based implementation and/or implementation on larger devices with more than one item per screen must model the placement and wording of the instructions as they appear in the paper-and-pencil version to the extent possible. The first screen should have both instruction sentences and subsequent screens should have only the second sentence of instructions. For implementation on handheld devices, FACIT instructions should appear on a screen preceding the items.
While our research suggests that the wording of the instructions is acceptable for electronic administration, we have developed alternative wording for electronic administration in which "circle or mark" has been revised to "select" which can be utilized upon request. Further revisions to the instructions to accommodate eCOA vendor device limitations are acceptable; however, FACIT.org assumes no liability for managing eCOA vendor-specific instructions nor for errors in additionally revised instructions or errors in data collection caused by revisions of instructions by eCOA vendors and their subcontractors.
Items per screen
For handheld devices, we recommend the display of 1 item per screen, including response options (0-4) and descriptors (not at all, a little bit, somewhat, quite a bit, very much). It is permitted to exclude response options provided the descriptors are included if the developer’s format restricts the use of numbers, but diligence must be paid in assuring proper scoring of the measure. The display of multiple items per screen is recommended with larger device screen formats. For web-based implementation and larger devices such as tablets, developers are encouraged to retain as much of the original paper format as possible. For all devices, scroll bars are not allowed.
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No FACIT item, including translations, should be revised without permission from FACIT.org.
Response option format
For web-based implementation and/or implementation on larger devices with more than one item per screen, it is encouraged to replicate the format of the paper-and-pencil version as much as possible. As noted previously, for multiple-item formats, a horizontal alignment of items and response options (0-4) is recommended with the descriptors (not at all, a little bit, somewhat, quite a bit, very much) listed above the response options (0-4). For handheld device implementation with item responses placed in a vertical format, it is recommended to display the response options next to each item, from 0 (not at all) to 4 (very much). Under no circumstances may the order of the response options be changed.
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No FACIT response option, including translations, should be revised without permission from FACIT.org.
Subscale headers
We recommend including subscale headers when a full scale/subscale is administered, but it is not required, particularly if it inhibits display of the items themselves.
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No FACIT subscale header, including translations, should be revised without permission from FACIT.org.
Q1/GS7/Skip patterns
The skip pattern with an introductory question, such as that with item GS7, should remain consistent with the paper-and-pencil version of the measure. If this is not possible due to eCOA vendor platform limitations, revisions of skip patterns are acceptable; however, FACIT.org assumes no liability for errors in additionally revised skip patterns or errors in data collection caused by revisions of skip patterns by eCOA vendors and their subcontractors.
Item skipping
Users should be allowed to skip items, though not invited to skip items. Users should be able to revisit items or change responses as desired prior to submitting the completed measure.
Item codes, found in the shaded box that runs along the left margin of the FACIT paper forms, should ideally be presented with the item. If they are not, a minimum requirement is that they “travel” with their respective item in the software and into the database. This is essential for proper scoring and communication.
Translations
All FACIT measures are developed with a universal approach: for languages spoken in more than one country, there is one, universal version of a measure’s translation, rather than country-specific versions.
Any changes to a translated FACIT item without written permission from FACIT.org is in violation of Intellectual Property protections and it is possible that the data analysis could be adversely affected.
Screen Reviews and Certifications
FACIT does not require screen review and approval of its measures. No additional certifications for electronic versions are needed.
Updated Recommendations on Evidence Needed to Support Measurement Comparability Among Modes of Data Collection for Patient-Reported Outcome Measures: A Good Practices Report of an ISPOR Task Force (O’Donohoe, et. al. DOI:https://doi.org/10.1016/j.jval.2023.01.001)
Version 2 | 14 May 2021