Download Chapter 6: Baseline Examination Visit

XACT Manual of Procedures
Chapter 6: Baseline Examination Visit
Summary of edits between Version 4.0 and 5.0

Section D. Updated to include option of not mailing Baseline Questionnaire in advance of BV
visit.

Section E.1. Updated to incorporate changes in amount of days participants take run-in mints to
18-days.

Section E.4. Updated minimum number of mints that participant should consume in order to be
randomized.

Section E.4. Updated procedures for recording reasons for non-randomization.

Section E.6. Updated procedures for completing randomization process to include completion
and entry of CRF.

Section E.7. Updated to include option of not mailing Baseline Questionnaire in advance of BV
visit.

Summary of edits between Version 3.1 and Version 3.2. Changed Section E12 to F.
Summary of edits between Version 3.2 and 4.0

Section A. Reordered visit steps

Section C. Minor wording changes

Section D. Minor wording changes

Section E.1. Added instructions for gathering adherence data at Baseline

Renumbered Sections

Section E.2. Added new section “E.2 Assess possible side effects related to mint use

Section E.3. Added new content to section about review of Enrollment Medical History form
Section E.4. Added threshold for the number of mints a participant should have consumed during
Run-in to be eligible for randomization

Section E.4. Added completion of the Early Termination form as necessary.

Section F. Added Eligibility Confirmation Form completed, Side Effects Form completed,
Review Enrollment Medical History and Baseline Visit Checklist Completed were added.
Summary of edits between Version 3.1 and Version 3.2

Section D. added “Baseline” to Medical History form

Section E.2. Deleted “If an SAE has occurred, a Concomitant Medications form must also be
completed at the visit”.

Section E.3. Changed “57+” lozenges to “71 +” and “56 lozenges” to “69 lozenges”. Deleted “a
new Eligibility Questionnaire is completed and these new values are recorded (this form becomes
a new record in the database)” and added “and the participant is no longer eligible to participate,
complete the study termination form and indicate the reason the participant is no longer eligible”.

Section E.5. Added “baseline” to Medical History
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
Section E.9. Deleted 122 lozenges per bottle to 90 and deleted “3’ bottles for initial dispensing to
“5” bottles.

Section E.9. Changed Study Day “7+” to “7-9” # of lozenges/day “4”. Added “Study Day 10+ #
number of lozenges/day 5”.

Section F. Deleted “Side effects forms” from the Previously completed (and entered) section.

Changed all references from lozenge(s) to mint(s).
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Chapter 6: Baseline Examination Visit
The baseline examination visit is the second face-to-face meeting with a study participant. At this visit the
experiences of the run-in period are reviewed and discussed. A final decision is made by both the
participant and the Study Coordinator regarding participation for the duration of the study. If the decision
is to participate, the baseline clinical examination is performed, the participant is randomized, and the
intervention is initiated.
A. Purpose
The purposes of the baseline examination visit are to:
1. Assess run-in period adherence and experiences
2. Assess participant side effects related to mint use
3. Review Enrollment Medical History information
4. Evaluate presence or absence of Serious Adverse Events
5. Confirm Eligibility and enter into DEMS
6. Perform the baseline oral examination
7. Perform randomization
8. Obtain Baseline Questionnaire information
9. Schedule Intervention Follow-up Call
10. Review Participant Contact Form
11. Dispense initial supply of intervention mints and review Intervention Information Sheet
12. Reimburse participant
13. Enter remainder of data into the DEMS
14. Place examination findings in institutional record, if applicable
B. Personnel
Study Coordinator (SC)
Dental Examiner
Recorder
C. Setting
The baseline enrollment visit occurs in the clinical center. It is a visit led by the Study Coordinator and
scheduled for a period when the Examiner and Recorder will be available (see MOP Chapter 4,
Enrollment Visit, E.8). The visit is scheduled to last approximately one hour. A private office and/or
clinical operatory is used.
D. Preparation for the Baseline Examination Visit
The SC or other study personnel reminds the enrollee of the baseline examination appointment during the
reminder call (see Chapter 5, Run-In Period, Section E).
The SC (or other study personnel) mails the Baseline Questionnaire a week before the scheduled visit (see
Chapter 5, Run-In Period, Section F) if the Questionnaire is being mailed. Sites also have the option of
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set aside time at the Baseline Visit to allow the participant to complete the questionnaire instead of
mailing it in advance.
The following materials are needed at the time of the baseline examination visit:

Completed Adherence Assessment form from the Run-in Follow-up Call

Patient clinical chart

Baseline Questionnaire completed by participant or blank copy for participant to complete

Completed Enrollment Medical History form

Side Effects form

Eligibility Confirmation form

Serious Adverse Events form (if relevant)

Baseline Oral Examination Recording form

Baseline Visit Checklist

Randomization form

Early Termination form (if relevant)

Stamped, addressed mailing pouch for return of unused mints from run-in period (if not returned
during visit)

Intervention Information Sheet

Mint Dispensing Log

Reimbursement Log
In addition, the person conducting the Baseline Visit needs to have convenient access to a computer that
can access the DEMS and access to the locked storage area for the mints. After the randomization ID
number is obtained through the DEMS randomization process, s/he retrieves and dispenses the
intervention mints with the corresponding randomization number.
E. Conducting the Baseline Examination Visit
Summary: Visit activities occur in the order listed in the “Purpose” section above. After reviewing the
participant’s experiences and compliance during the run-in period, a joint participation decision is reached
between the Study Coordinator and the potential participant. If the decision is made to have the
participant continue, an oral examination is performed, followed by review of the completed Baseline
Questionnaire. If the participant failed to bring in a completed Baseline Questionnaire, s/he is asked to
complete it before the oral examination, so that all participants have these two experiences in the same
order. The SC randomizes the participant using the DEMS immediately after the baseline examination.
This requires entry of the Eligibility Confirmation form. Before departing, the participant is given an
initial supply of intervention mints, instructions for their use, and an appointment for the Intervention
Follow-up Call is made.
E.1 Review Adherence
The Study Coordinator and the participant discuss the run-in period experience. This conversation is
guided by the Adherence Assessment form completed during the Run-in Call. The discussion focuses on
the participant’s adherence and attitude toward the daily use requirement after 18-days of experience with
it, and the participant’s commitment to attempting to maintain the regimen for the next three years. The
enrollee is also instructed not to consume any additional mints from the run-in supply.
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If a participant cannot come in for their Baseline Visit within a week of the end of the Run-in period then
the Adherence Assessment form for the Baseline Visit can be completed through a telephone call with the
participant. This call must be conducted within the acceptable window for the Baseline Visit.
E.2 Assess possible side effects related to mint use
Complete the Side Effects form with the participant. During this process, the Study Coordinator may
become aware of side effects that may be classified as Serious Adverse Events. If this occurs, further
discussions about the side effect are warranted to determine if the event meets Serious Adverse Event
criteria. If the event is serious, see section E.3 for information on how to proceed.
E.3 Review completed Enrollment Medical History Form and Evaluate any possible SAEs
The Study Coordinator reviews the completed Enrollment Medical History form with the participant. If
anything has changed, record description and information about change in the participant’s progress
notes. Once the review is complete, have the participant initial and date in the indicated fields at the end
of the form.
During the Enrollment Medical History review process, the Study Coordinator may learn about any
possible events that may be considered Serious Adverse Events. If any incidents meet the criteria for a
Serious Adverse Event, the SC completes the Serious Adverse Events form, and all notification
procedures are followed (see MOP Chapter 15, Data and Safety Monitoring
Follow-up may be required for ongoing SAEs, especially to assess relatedness, action, outcome, and
resolution. Review the subject’s previous unresolved SAEs from previous contacts at this visit if relevant.
E.4 Make the final enrollment decision
Following the run-in adherence discussion, the Study Coordinator decides whether to offer the enrollee
the opportunity to continue participation in the study. This decision is based on the SC’s assessment of
the likelihood that the enrollee:

Will continue to participate for the duration of the study

Is entering the study with the intent to adhere to the regimen to the extent possible
The participant must have consumed at least 38 or more mints in the Run-in period to be eligible for
randomization. A participant who doesn’t meet the minimum threshold should not be randomized because
they have not demonstrated adequate adherence to the mint schedule.
The benefit of any doubt should be given to the enrollee. Perfect adherence is not a criterion for selection
to participate. Rather, we wish to include participants with the intent to maintain good adherence.
Imperfect adherence by some participants is expected and is part of the trial. Minimum adherence criteria
for continuation are use of more than one-half of mints overall (38+ mints) during the 18-day run-in
period, determined by self-report and confirmed by return of fewer than 38 mints.
An enrollee who is offered the opportunity to participate is asked directly if he or she wants to continue in
the study. With a negative response, probe gently and in a non-threatening manner for the reason for
refusal. Best efforts should be made to illicit a very specific reason for early termination. The enrollee is
thanked and excused. The reason for the enrollee’s response is then recorded on the Early Termination
Form and an Randomization form is completed indicating that the participant was not randomized.
For an enrollee who is not offered the opportunity to continue, the reason for not extending the offer is
recorded on the Early Termination Form along with the indication that the participant was not randomized
on the Randomization Form. The reason(s) for not extending an offer to continue in the study are
explained in a neutral, non-punishing way to the enrollee.
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For a continuing participant, the Eligibility Confirmation form is completed to confirm eligibility status.
If the SC concludes that the participant no longer meets eligibility requirements, the participant will be
dismissed. The reason for non-randomization is recorded on the Early Termination form as ‘Participant
Ineligible’ and a Randomization Form is completing indicating that the participant was not randomized.
E.5 Perform the baseline oral examination
The baseline oral examination is a detailed caries examination of the coronal and root surfaces of all teeth
present. The Examiner does not have access to radiographs, treatment notes, treatment plans, or screening
notes from the participant’s institutional chart.
The details of the examination procedure and recording are presented in Chapter 13, Training and
Monitoring. In brief, each coronal surface (occlusal, buccal, lingual, mesial and distal) and each exposed
root surface (facial, lingual, mesial and distal) is examined for the presence of a caries lesion. The
examination begins in the participant’s upper right quadrant with tooth #1, if present, and continues in
numerical order through tooth #32. For each tooth space, the status of the tooth is recorded as present or
missing. If present, each surface is scored for filling status, caries status and severity, and caries activity.
The soft tissue examination consists of visual inspection of lips, buccal mucosa, gingiva, palate,
oropharynx, tongue, and sublingual tissues.
Surface status scores are called by the Examiner and recorded on the Oral Examination form by the
Recorder. Both the Examiner and Recorder are appropriately trained before initiation of the project (see
Chapter 13, Training and Monitoring). The Recorder prompts for all uncalled surfaces and requests
clarification for all illogical calls. Once the examination is complete, both the Examiner and Recorder
scan the examination form to verify that it is complete and that the required examiner, recorder, and
participant ID numbers and the date are recorded on the form. The Recorder is responsible for returning
the completed examination form to the Study Coordinator.
E.6 Perform randomization
The Study Coordinator randomizes the participant after the decision to continue participation has been
made jointly by the Study Coordinator and the participant, and the baseline eligibility criteria have been
reviewed with a favorable outcome.
The SC performs randomization by entering the required information into the DEMS (MOP Chapter 19,
Randomization). The DEMS will return the randomization assignment. The randomization report
indicates date and time of the randomization and identifies the randomization ID number assigned to the
participant. The randomization ID number is used to identify the mints to be dispensed to that participant.
This randomization report is printed, initialed, and dated by the staff member completing the
randomization and placed in the participant’s research chart. The SC must also complete and enter the
randomization form after the actual randomization has been completed in the DEMS.
E.7 Review/Complete Baseline Questionnaire
If the participant is continuing in the study, the participant is asked to review the completed Baseline
Questionnaire with the Study Coordinator. If the participant has not brought the completed form of if the
site has opted not to mail the Questionnaire to the participant in advance of the visit, s/he is given a copy
to complete at this time. The Study Coordinator then reviews the form, checking for non-responses,
illogical responses, and any areas of uncertainty indicated by the participant. Each question is briefly
inspected and the respondent queried about any inconsistent or incomplete responses (see Chapter 12,
Data Management, for additional details on reviewing completed forms). If the participant left a copy at
home, ask the participant to discard it rather than sending it in later.
E.8 Schedule phone contact for the initial intervention period
Review the Intervention Information Sheet, reminding the participant that he or she will be contacted by
telephone two weeks into the intervention.
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Explain that the purposes of this call are to:

Assess how closely the participant has been able to follow the dosage schedule

Capture any side effects or other reactions to the mints that might be experienced
Agree on a time when the participant is likely to be available and record the date and time for the call on
the participant’s copy of the Intervention Information Sheet. Record the information on a second copy of
the Intervention Information Sheet for placement in the participant’s consent folder. In a process similar
to that used during the enrollment visit for the run-in period, schedule the call in the presence of the
participant to reinforce the idea that this is an agreed-upon “appointment” for checking on the
participant’s progress. Confirm that the participant will be expecting this contact, so that it is not
perceived as intrusive. Enter the scheduled call date and time into the contact reminder screen in the
DEMS.
Inform the participant that there will be routine re-supply telephone checks scheduled at quarterly
intervals and an annual visit around their first year anniversary.
E.9 Update Contact Information Form
Review with the participant. If any information has changed, update the form following proper data
correction procedures.
E.10 Dispense initial supply of mints
The SC will dispense an initial supply of the intervention mints labeled with the randomization ID
number that corresponds to the randomization ID number assigned to the participant by the DEMS. The
mints are dispensed to the participant in bottles of 75 mints per bottle. The participant is given a total of 7
bottles for the initial dispensing. The participant is also given a carrying tin that will hold a few days’
worth of mints and written instructions for their use. The participant is informed that re-supply during the
first year is accomplished by mail and will be accompanied by telephonic adherence assessment and
encouragement. The Study Coordinator reviews the daily usage requirements with the participant,
including the number of mints to be consumed during the current day:
Visit time
Up to 12 noon After 12 noon
# of mints on Day 1
2
1
The SC also reviews the mint schedule for the start-up period:
Study day
# of mints/day
2-3
4-6
7-9
10+
2
3
4
5
The SC also confirms the desired telephone number and time of day for follow-up contacts. The address
for re-supply mailings is also confirmed at this time. An address usable by the USPS or other traceable
mail shipper is necessary. All of this information is found on the Contact Information form, which was
completed at the enrollment visit and updated as necessary. The dispensing is recorded on the Mint
Dispensing Log.
E.11 Provide participation payment
The participant is given a participation payment for the Baseline examination. The participant signs a
receipt for the check or other form of payment. The Study Coordinator records the participant’s payment
in the Reimbursement Log, which is stored in the Subject Consent Chart together with the signed receipt.
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E.12 Dismiss participant
After confirmation of the initial intervention contacts, the SC asks the participant if there are any other
questions. Any such questions are addressed immediately, and any uncertainty that the participant
expresses about intervention responsibility is discussed and clarified until uncertainty is dispelled. This is
the final face-to-face contact with the participant for one year, so care should be taken to ensure that the
participant is knowledgeable and confident about his or her role in the study.
Following this final discussion, the SC reviews the Baseline Visit Checklist, and each completed item is
ticked off. Any omitted steps are completed at this time.
Confirm that parking cost has been taken care of, and offer parking tokens if needed. Ensure that the
participant knows the way out to parking or other transportation, and escort if desired.
E.13 Place examination results in participant’s institutional chart
The results of the oral examination, i.e., the surfaces where caries were recorded, should be placed in the
participant’s institution dental chart, if the participant is a patient of record in the institution.
F. Records Management for the Baseline Examination Visit
This visit is “data intense” and “activity rich” in that a good deal of recorded data is generated from a
variety of activities. For that reason, a Baseline Visit Checklist form is used to assure that all needed
activities and data collection are successfully completed during the course of the visit. The checklist
includes the following activities:

Eligibility Confirmation form completed

Adherence Assessment form completed

Side Effects Form Completed

Enrollment Medical History Questionnaire reviewed

Serious Adverse Event form completed (if relevant)

Baseline Questionnaire completed

Oral Examination form completed

Randomization completed and report signed and dated

Randomization form completed, even if participant is not randomized into the study

Intervention Information Sheet provided and copy produced

Initial supply of mints dispensed and dispensing logged

Contact arrangements reviewed

Baseline Visit Checklist completed
The Participant Research Chart contains the following items:
Newly completed or newly updated

Baseline Questionnaire

Adherence Assessment form

Eligibility Confirmation form
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
Side Effects Form

Serious Adverse Event form (if relevant)

Oral Examination form

Randomization form

Randomization assignment report printed

Intervention Information Sheet (with call schedule)

Baseline Visit Checklist

Mint Dispensing Log

Reimbursement Log

Baseline Visit Checklist

Baseline Visit Progress Notes Checklist
Previously completed (and entered)

Run-in Call Notes form

Eligibility Questionnaire

Demographic form

Enrollment Visit Checklist

Serious Adverse Event form (if relevant)

Enrollment Medical History Questionnaire now initialed and dated by participant
The Participant Consent Folder contains the following items:
Newly completed or newly updated

Intervention Information Sheet with call schedule

Contact Information Form
Previously completed

Original signed/co-signed and dated screening and study consent forms

Run-in Information Sheet with baseline visit date and run-in call schedule
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