DA006 - Collection of Follow-up Data Guidelines

DA006	Guidelines for Collection of Follow-Up Data
Review Committee: Data	Start Date: 4/01/2008
Attachments: None	Last Revised Date: 8/22/2024
Forms: None	Last Reviewed Date: 8/27/2020

Introduction:

The TBIMS uses an established set of rules including procedural steps for follow-up data collection (FORM 2) for the TBIMS National Database (NDB).

Purpose:

To institute a standard procedure for collection of follow-up data for the NDB.

Scope:

TBIMS and TBIMS longitudinal follow-up centers that collect follow-up data for the TBIMS NDB.

Responsibilities:

TBIMS staff responsible for Form 2 data collection for the TBIMS NDB (e.g., TBI researchers or clinicians, research assistants, study coordinators).

Procedural steps:

For the first year of follow-up, data collection should occur within 2 months before to 2 months after the anniversary date of the injury. For follow-up year 2, data collection should occur within 3 months before to 3 months after the anniversary date of the injury. For follow-up years 5 and thereafter, data collection should occur within 6 months before to 6 months after the anniversary date of the injury.
Centers should run the Inter-Form Values by Subject ID report prior to completing a Form 2 for a participant.
If possible, the participant should be asked to stay on the phone after collection of Form 2 data, so that the error checks can be run and any questions clarified.
If a participant expires during initial inpatient rehabilitation, no Form 2 is to be completed. If, however, the participant expires after rehabilitation discharge but before the next Form 2 window, the Form 2 should be completed and coded as expired.
If a participant is still in their first inpatient rehabilitation stay at the time that their first anniversary of injury follow-up window is about to close, collect the Form 2 Year 1 follow-up information within the follow-up window. The rehabilitation hospital would be the residence, living with other patients; FIM/DRS should be obtained at that time.
Follow-up should be attempted according to the TBIMS schedule for every participant (person with TBI) for whom a Form 1 was submitted, unless the participant was reported as expired or withdrew authorization to collect data in a prior follow-up year.
If a participant withdraws authorization, that means that they do not wish to participate in any data collection from the time of withdrawal forward and will not be contacted again. It does not mean that all of their previously collected data is deleted from the database. Participants wishing to withdraw from the study should not be asked if they want all their previous data deleted from the database; however, if they state they want all their previous data deleted then it should be deleted.
A participant may refuse to be interviewed because they are too busy or do not wish to be bothered, etc. This would be considered a refusal and not a withdrawal. If this is the case, the interviewer should ask if he/she can contact the participant again. The interviewer should also gently suggest rescheduling the interview to a later time in the Form 2 window, or offer the mail-out version of Form 2.
If a proxy refuses for the participant and the participant has full capacity for decision making, the proxy should be informed that the refusal needs to come from the participant. If confirmation of refusal from the participant cannot be obtained, it is recommended to code as lost. If a proxy wants to withdraw the participant (or states that the participant wants to withdraw) and the participant has full capacity for decision making, the proxy should be informed that the withdrawal request needs to come from the participant. If this cannot be confirmed, either by phone or in writing, do not withdraw the participant, code current follow-up as lost, and attempt to contact at next follow-up.
The primary source of information for the annual follow-up should be the participant. If the participant does not or cannot respond to certain questions or to all questions, then the significant other who knows the participant best becomes the participant’s proxy and may answer for the participant.
A "significant other" is someone who knows the participant well and is available, able, and willing to answer questions reliably about that individual's daily life. This person is typically a family member but is not required to be related to the participant or to live with that person. A significant other may be a non-traditional person such as a nurse at the facility where the person resides, a legal/public guardian, a roommate, a close friend, etc. The significant other must know the participant sufficiently well to answer questions accurately. The significant other may qualify to answer some questions but not others.
Questions that the proxy cannot answer reliably are coded as "unknown". The proxy must not answer [SWLS], [GNHLTH], [BTACT], [PHQ9], and [GAD7].

When a person *cannot be interviewed¹, has expired, withdrawn authorization, refused to be interviewed, or is incarcerated, a limited amount of information – shown in the table below – is to be entered onto the Form 2.

group /v ariable	lost	expired	w ithdrew	inca rcerated	re fused
	Attempt follow-up at next follow-up window opening.	No further f ollow-up.	No further f ollow-up.	Attempt follow-up at next follow-up window opening to determine if still inc arcerated.	Attempt fo llow-up at next fo llow-up window o pening.
KEYS	Center ID Subject ID Follow-up year	Center ID Subject ID Follow-up year	Center ID Subject ID Follow-up year	Center ID Subject ID Follow-up year	Center ID Subject ID Fo llow-up year
If lost, why?	Code reason lost	82-NA, Expired	81-NA	81-NA	81-NA
FU /FollowUp	0 7/07/7777	0 4/04/4444	0 5/05/5555	07/07/7777	07/ 07/7777
CSEDTH/ DeathF	0 9/09/9999 (0 8/08/8888 if known to be alive)	[e xpiration date]	0 8/08/8888	08/08/8888	08/ 08/8888
CSEDTH/ Dea thCause1F Dea thCause2F	99999 (88888 if known to be alive)	[ICD-9 Codes] To be completed by the NDSC	88888	88888	88888
CSEDTH/ De athECodeF	99999 (88888 if known to be alive)	[External ICDCode] To be completed by the NDSC	88888	88888	88888
RES/ResF	blank	blank	blank	04	blank
all other variables	blank	blank	blank	blank	blank

EXPIRED or WITHDREW AUTHORIZATION. For participants who have expired or who withdrew authorization to continue with the study, enter the information shown in the table above. If the data collector learns prior to window opening that the person expired or withdraws authorization, the above information may be entered at any time up to and including the quarter in which the follow-up would have been due. Regardless of the quarter in which this information is entered, the “Follow-Up Period” is coded as the year of the follow-up that would have been due (e.g., year 01, year 02, year 05, et cetera). For expired participants and those who withdraw authorization, no additional Form 2’s are ever entered.
INCARCERATED. Data should not be collected from the participant or from a proxy while the participant is incarcerated. Find out if the incarcerated person will be released prior to the closing of the data collection window (only if obtaining such information is acceptable to your IRB and Investigator). If the person will be released before the window closes, then complete Form 2 data should be collected between the time of release and window closing. Do not collect follow-up information about participants who are incarcerated throughout the follow-up window. For these participants--and for participants who were released prior to window closing but about whom data was not able to be collected--enter the data shown in the table above. If unable to reach a participant to complete a follow-up, and the participant was incarcerated for half or more of the follow-up window, the participant can be coded as incarcerated. Persons who are on house arrest should be treated as incarcerated, however a person on parole or probation can be followed, as long as they are free to come and go as they please. If there is any question about the definition of prisoner, centers should check with their individual IRB and review OHRP guidelines (US Dept of Health & Human Services Office for Human Research Protections.)
Follow-up evaluations that have been started or completed prior to the window start date should have a call back during the window to clarify that nothing has changed. The date of the call back occurring within the follow-up window should be used as the interview date. If a call back cannot be completed, the original interview date outside the follow-up window should be used.
To classify an interview as “followed” an interview or mail-out must be started. There is no minimum number of data elements that need to be answered, but you must have more than the participant’s living status.
Follow-up evaluations that have been started but cannot be completed by the time the data collection window closes can be completed within two weeks after the window closes. The interview date should be the date the interview was started.
Follow-up evaluations that have been started but not completed during the first contact should be completed within 4 weeks. The follow-up date should be the date of initial data collection. If it takes longer than 4 weeks to complete the follow-up, data collected during the initial data collection period should be verified, and the follow-up date should be the second date that data was collected. Mail-outs will be exempt from the 4-week rule. In the unusual case where the 2-week extension window is used to complete the follow-up beyond the 4-week time frame, (e.g., interview started January 1st, follow-up window closes January 30th, interview completed February 5th), the follow-up date should be the date of data collection that was in the follow-up window (January 1st in this example).
Missing data may not be filled in using data obtained outside the follow-up window. Data collected outside the follow-up window may not be added to Form 2’s that were originally entered without data. Data may be obtained outside the follow-up window from sources that had collected the data within the follow-up window--for example, data collected by clinicians during a clinical follow-up which occurred during the follow-up window.
If phone contact with the participant is not possible, all information except: [SWLS], [GNHLTH], [BTACT], [PHQ9], and [GAD7] should be collected from a significant other by phone. The participant should be sent the [SWLS], [GNHLTH], [BTACT], [PHQ9], and [GAD7] items by mail, along with a self-addressed return envelope if these questionnaires can be completed.
If telephone contact with the participant and significant others is not successful, the participant should be sent the mail-out version of the Form 2 after personalized information (name, enrollment date, name and contact information of Form 2 data collector) has been added to the form, along with a self-addressed return envelope. If a completed mailout is returned but not dated, the date of follow-up should be coded as the date the mailout was postmarked.
If adequate data are not obtained from the participant by telephone or by mail-out, the mail-out Form 2 should be sent to the significant other after personalized information (name, enrollment date, name and contact information of Form 2 data collector) has been added to the form, along with a self-addressed return envelope.
Centers are not required to keep a paper printout of Form 2 but are strongly encouraged to back up their quarterly data in some form: paper, excel download, PDF.

Training requirements:

Staff persons who are responsible for the Form 2 data collection for TBIMS should be familiar with these criteria. On-going training will be conducted by quarterly data collector teleconferences and in-person data collectors’ meetings.

Compliance:

All follow-up data collectors are required to comply with these guidelines, and attend the quarterly data collector teleconferences and in-person data collectors’ meetings.

References:

None

History:

Date	Action
4/1/2008	Version used to create this SOP.
9/16/2008	Transferred to SOP template and approved by SOP Review Committee.
12/12/2008	Revised to clarify difference between refused and withdrawn, and added PHQ-9 as variable not collected from proxy. Approved by Data Committee, SOP Committee, Planning Committee and Project Directors.
	Added clarification about not interviewing persons that are on house arrest. A person on parole or probation should be followed.
	Added rule about interviewing subject prior to the window open date.
10/1/2010	Added GAD-7 to list of items that cannot be completed by a proxy.
11/17/2011	Clarified the Interview date to be entered if partial information was achieved outside of the follow-up window.
1/1/2013	Updated variable #’s to new variable group names. Table updated to new order. Added new variable group GNHLTH to list of items that cannot be completed by a proxy.
4/1/2013	Added bullet regarding centers not being required to keep printout of Form 2.
10/1/2013	Updated SOP to reference newly added QOL variable, and to expand on contacting prisoners.
9/8/2014	Removed the referenced form, as it is now part of online data entry (Guidelines and Strategies for Maximizing Follow-Up form). Within Procedural Steps: (1) bullet added that centers should run the “Inter-Form Values by Subject ID” report prior to completing a Form 2; (2) bullet added that the participant should remain on the phone (if possible) while error checks are run, so that any questions can be clarified; and (3) bullet added regarding classifying a case as “followed.”
12/01/2015	Added clarifications regarding proxy refusals.
12/01/2015	Added a follow-up window of 4 weeks for cases started but not completed on first contact.
1/15/2017	Deleted completion instructions for INTMTHD variable group. (This variable group was deleted from the Form 2 data collection form.)
9/30/2018	Added note to “Incarcerated” bullet – “If unable to reach a participant to complete a follow-up, and the participant was incarcerated for half or more of the follow-up window, the participant can be coded as incarcerated.”
8/27/2020	BTACT, PHQ9, GAD7 added to list of items not to be collected from an SO. QOL removed from list. Further explanation added regarding when a participant expires between rehabilitation discharge and Form 2 data collection. Further guidance added regarding handling refusals (versus withdrawals).
7/6/2021	Changed “refusal” to “lost” in bullet regarding how to code when a proxy refuses for participant.
12/3/2021	Updated proxy refusal bullet to include note that the proxy should be informed that the refusal/withdrawal needs to come from the participant.
10/01/2022	Completion table updated to reflect updated standardized coding.
8/22/2024	Added note to bullet about mailout - “If a completed mailout is returned but not dated, the date of follow-up should be coded as the date the mailout was postmarked.”

Review schedule:

At least every 5 years.

As specified in the Guidelines and Strategies for Maximizing Follow-up SOP.↩︎