Obstetrics and Periodontal Therapy (opt) Study Manual of Operations Version 1 March 3, 2003 Brief Table of Contents



Download 1.22 Mb.
Page6/18
Date04.12.2016
Size1.22 Mb.
1   2   3   4   5   6   7   8   9   ...   18

II.5.2. Procedures



II.5.2.1. Test Group Subjects. The Periodontal Hygienist collects data on new medications since the last visit (Form 12; see Section II.5.5, below) and provides care as specified below.
At Study Visits 2, 4, and 6, test subjects receive a new soft Oral B 35-indicator straight toothbrush and a package of waxed dental floss.
At Study Visits 3 and 5, the subject first undergoes the full-mouth periodontal examination and measurement (see Sections II.4.1 "Specification of the Study Intervention" and III.1 "Periodontal Measurements"). After the exam and measurement, the subject undergoes maintenance procedures, described in the next paragraph.
Test subjects receive a full-mouth supragingival polishing using prophy paste containing fluoride (Nupro Medium), a rubber prophy cup and slow-speed handpiece. All teeth receive interdental flossing by the Periodontal Hygienist. The Periodontal Hygienist inspects tooth sites that bleed during polishing or that bleed during the course of daily oral hygiene per subject report. If the bleeding is due to recurrent or residual calculus, the site(s) are rescaled/root planed at that visit. Sites that bleed on probing at Visits 3 and 5 are not automatically rescaled because the blinded examiner determines whether to rescale and which sites are rescaled.
At each visit, oral hygiene instructions (specified in Section II.4.1, "Specification of the Study Intervention") are reviewed and reinforced.
II.5.2.2. Control Group Subjects. The Periodontal Hygienist collects data on new medications since the last visit (Form 12; see Section II.5.5, below) and provides care as specified below.
At each visit, control subjects receive an extra-oral and visual intra-oral examination. Control subjects do not have their teeth polished or flossed at these visits. Control subjects do not receive a toothbrush or floss until the end of the deferred therapy appointment.
At Study Visits 3 and 5, the subject also undergoes the full-mouth periodontal examination and measurement (see Sections II.4.1 "Specification of the Study Intervention" and III.1 "Periodontal Measurements").
Any essential dental care that has not been completed may be discussed with the subject, but the subjects will not receive any instructions in oral hygiene.
II.5.3. Timing, Location, Reminders, Late/Missed Visits
II.5.3.1. Timing. Whenever possible, the monthly follow-up visits for all subjects will coincide with their monthly prenatal obstetrical visits.
The windows for each visit are:
• Visit 2: 17-20 weeks of pregnancy

• Visit 3: 21-24 weeks of pregnancy

• Visit 4: 25-28 weeks of pregnancy

• Visit 5: 29-32 weeks of pregnancy



• Visit 6: 33-36 weeks of pregnancy
Ideally, a subject's Visit 2 should occur four weeks after her Baseline/Randomization Visit (Visit 1). Thus, if she was randomized during week 14 of her pregnancy, Visit 2 should occur during week 18, Visit 3 during week 22, and so on. However, this ideal timing will not always be possible, and the visit windows indicate appropriate other dates.
If a subject's Visit 2 does not occur between 17 and 20 weeks of pregnancy inclusive, then she has missed Visit 2, and analogously for Visits 3 through 6. Procedures in case of missed visits are discussed below in Section II.5.3.4 "Late and Missed Visits".
II.5.3.2. Location. The procedures are performed either in a dental clinic adjacent to the Enrollment Site or in the Site's obstetrics clinic using the portable dental chair, light, and handpiece. In this manner, subjects do not have to schedule separate appointments for their follow-up study visits.
II.5.3.3. Reminders. The Enrollment Site Study Coordinator will work with the obstetrics clinic appointment clerk to ensure that subjects receive a reminder of their combined monthly prenatal visit and dental follow-up visit. Reminders may be made by phone call or postcard. If using a postcard, be sure the postcard is folded in such a manner as to ensure study confidentiality.
II.5.3.4. Late and Missed Visits. If a subject's Visit 2 does not occur between 17 and 20 weeks of pregnancy inclusive, then she has missed Visit 2 and Visit 2 is not "made up" later. (And analogously for Visits 3 through 6.) Form 23 (described below in Section II.5.5) should be completed to report the missed visit.
Although missed visits per se are not made up, if a subject misses Visit 3 or Visit 5, when study data are scheduled for collection, these data items must be collected at the next visit the subject attends. This includes collecting plaque and serum samples. The Subject Event Checklist (Form 05) reminds the Study Coordinator to collect data from missed visits at the next visit.
Finally, if a subject delivers her baby before Visit 5, then she should have her Visit 5 data (periodontal measurements, plaque sample, and serum sample) collected as soon as possible after delivery.
II.5.4. Data Collection Visits (Scheduled at Visits 3 and 5)
Clinical periodontal measures are obtained on all subjects at Study Visit 3 (21-24 weeks of pregnancy) and Visit 5 (29-32 weeks). At Visit 5, post-baseline plaque and serum samples are also taken.
Before probing, the Periodontal Hygienist reviews the subject’s medical history and determine if she requires antibiotic premedication for periodontal procedures or if she is now at medical risk if she undergoes the examination. If the subject’s medical history or medical risk has changed since the previous examination visit, the hygienist should complete the adverse event form or serious adverse event form as appropriate. If antibiotic premedication is now required, the subject should be given a regimen approved for the particular indication and examined no sooner than 60 minutes afterwards. Alternatively, the subject can be given a prescription for an antibiotic, and reappointed as soon as possible.
The Periodontal Examiner obtains periodontal measures in the same order used during the baseline examination (see Section II.2.4 and Section III.1). The order is as follows:
1. Plaque Index from 6 surfaces of the 6 Ramfjord Index teeth

2. Gingival Index from 6 surfaces of all teeth

3. Pocket depth from 6 surfaces of all teeth

4. CEJ·GM from 6 surfaces of all teeth

5. Bleeding on probing from 6 surfaces of all teeth

6. Calculus Index from 6 surfaces of the 6 Ramfjord Index teeth


Details of these procedures and the criteria for scoring the indices are provided in Section III.1.2 "Equipment, Standards, and Special Situations".
Having taken the clinical periodontal measurements, the Periodontal Hygienist then determines whether any tooth sites have progressive attachment loss by comparing the new CAL measurements, site-by-site, to the baseline CAL measurements. This may be done in any manner the Hygienist finds quick and accurate; here is one possible method. The baseline Form 11 has, for each quadrant, a line of boxes containing CAL measurements. If a quadrant's line of baseline CALs is placed next to the line of follow-up CALs, the two visits are easily compared. One way to do this is to photocopy each page of the baseline Form 11 onto a transparency, using a blank sheet of paper to block out everything on the page except the two lines of CAL measurements. The resulting transparency is blank except for the lines of baseline CAL measurements. To compare measurements for (say) Quadrant 1, put a blank piece of paper under the transparency so it just covers the line of baseline CALs for Quadrant 1, and place the transparency and blank paper on top of the new Form 11 so that the baseline Quadrant 1 CALs line up under the current Quadrant 1 CALs. If any sites have progressed, the subject has a periodontal adverse event and a Form 40 must be completed (see Section III.9 "Reporting Adverse Events").
Having assessed periodontal disease progression, the examiner then (at Visit 5) procures the plaque sample. The baseline periodontal data form (Form 11, Periodontal Measurements) records the four tooth sites that were selected at baseline for plaque sampling, and which should also be sampled at follow-up. As at baseline, the examiner uses a sterile curette and removes all subgingival plaque from the designated pocket; the examiner uses the same curette for each site to obtain a subgingival plaque sample from each of the four sites. The samples are pooled in a labeled microcentrifuge tube containing phosphate-buffered saline (PBS). Details of the plaque sampling protocol are provided in Section III.2 "Collecting, Storing, and Shipping Dental Plaque Samples (Enrollment Site Procedures)".
The Study Coordinator then sends the subject to have a venous blood sample taken to obtain serum (see Section III.4 "Collecting, Processing, Storing, and Shipping Serum Samples (Enrollment Site Procedures)").
If a subject misses Visit 3 or Visit 5, periodontal measurements and plaque and serum samples must be collected at the next visit the subject attends. If the subject misses Visit 3, try to get the data at Visit 4; if the subject misses Visit 5, try to get the data at Visit 6.
Finally, if a subject delivers her baby before Visit 5, then she should have her Visit 5 data (periodontal measurements, plaque sample, and serum sample) collected as soon as possible after delivery.
II.5.5. Documenting Maintenance Visits (Form 23; also Forms 12, 40, and 41)
The only forms completed at all maintenance visits (Visits 2 through 6) are Form 12 "Medications" and Form 23 "Confirmation of Study Visit/Report of Missed Visit". Form 12 is described in Section II.2.4.5. "Obtain Baseline Medications (Form 12, Medications)". Completion of Form 23 is described immediately below.
Other forms that may be used during Visits 2 through 6 are Form 40 "Periodontal Adverse Experiences" and Form 41 "Serious Adverse Experiences", which are described in detail in Section III.9 "Reporting Adverse Events".



To complete Form 23, begin by attaching a Patient ID (PID) label to the indicated place in the upper right-hand corner of the form and by filling in the other identification information in the upper right-hand corner.


• Item 1 records the Visit number. If Form 23 is being used to report a missed visit, fill in the number of the missed visit. Otherwise, fill in the number of the completed visit.
• Item 2 records whether the subject attended the visit. If she attended the visit, check "Yes" and stop, the form is complete. If she missed the visit, check "No" and continue to Item 3.
• Item 3 records the reason for missing the visit. If the subject's whereabouts are unknown, if she has moved to a different location and cannot attend visits, or if she has withdrawn consent for study participation, complete Form 50 "Change in Follow-up Status or Withdrawal of Consent" to record her change of status.
II.5.6. Monitoring Subjects' Periodontal Status: Procedures in Case of Progressive Disease
Full-mouth periodontal data are recorded at Visit 3 (21-24 weeks of gestation) and Visit 5 (29 -32 weeks) to monitor subjects for evidence of progressive periodontal disease. Also, subjects receive brief monthly oral examinations at other visits. (Test subjects also receive tooth polishings and oral hygiene instructions at these visits). At Study Visits 2, 4, and 6, the examiner surveys the periodontal tissues for obvious signs of progressive disease or periodontal pathoses that require immediate attention, e.g., periodontal abscess, recently loosened teeth, severe or diffuse inflammation, or pregnancy tumor. Subjects receive localized or generalized assessments and urgent care at these interim visits if warranted. Adverse periodontal events are recorded on Form 40 "Periodontal Adverse Events"; serious adverse events are recorded on Form 41 "Serious Adverse Events".
II.5.6.1. Progressive attachment loss (5 or fewer sites cumulatively). At the completion of the periodontal examinations (scheduled during study visits 3 and 5), the treatment hygienist or chair side assistant compares the current CAL recordings to the baseline values. Sites exhibiting more than 2 mm of attachment loss -- that is, 3 mm or more of attachment loss -- since baseline (Baseline/Randomization Visit [Visit #1]) meet the OPT Study's definition of progressive attachment loss.
If a subject is found to have 5 or fewer cumulative sites with more than 2 mm attachment loss since baseline, the examiner tells the Study Coordinator, who arranges to have the treatment hygienist provide rescue treatment as soon as possible. The treatment hygienist scales and root planes the teeth showing disease progression using procedures specified in Section II.4.1 "Specification of Study Intervention". The same localized treatment is delivered whether the subject is in the test or control group, so the examiner remains blinded to the subject’s group assignment. The affected teeth are now "exited from the study" in the narrow sense that study analyses will not use future measurements from those sites; instead, the clinical data will be carried forward from the time of treatment and analyzed on an intent-to-treat basis.
II.5.6.2. Generalized progressive attachment loss (6 or more sites cumulatively). If a subject is found to have 6 or more cumulative tooth sites with more than 2 mm of attachment loss since baseline, the examiner tells the Study Coordinator, who then determines the subject’s group assignment (Test or Control). The examiner remains blinded to the subject’s group assignment.
If the subject is in the CONTROL group (deferred periodontal therapy), the Study Coordinator arranges to have the subject receive full-mouth scaling and root planing from the Periodontal Hygienist. The subject is now "exited from the study" in the narrow sense that study analyses will not use her future clinical periodontal measurements; instead, her clinical data will be carried forward from the time of treatment and analyzed on an intent-to-treat basis. The subject will still be followed until she delivers her baby.
If the subject is in the TEST group (immediate periodontal therapy), the Study Coordinator arranges to have the Consulting Periodontist review the study record as soon as possible. If the Consulting Periodontist confirms the diagnosis of generalized progressive periodontitis, s/he may select sites for plaque sampling and microbial sensitivity testing and prescribes a treatment plan.
If prescribed by the Consulting Periodontist, the Study Coordinator arranges for the Periodontal Hygienist to obtain plaque samples for microbial analysis. Each Enrollment Site uses one lab for all of its microbial sensitivity testing arising from breakthrough periodontal disease. (The different Sites, however, need not use the same lab.) Laboratory results are returned to the Consulting Periodontist.
The Consulting Periodontist plans treatment at his/her discretion. S/he can personally treat the subject or refer her to a resident at the Enrollment Site for therapy. Rescue treatment will generally consist of full mouth debridement, using procedures specified in Section II.4.1, and may involve use of systemic antibiotics, as indicated based on the subject’s medical status and the results of the bacterial assays and antibiotic sensitivity tests. However, rescue therapy need not involve systemic antibiotics or antibiotic sensitivity tests; these are used at the discretion of the treating periodontist.
Only FDA category B antibiotics should be prescribed for test subjects who experience generalized progressive periodontitis. Penicillins, erythromycin, cephalosporins, metronidazole and clindamycin are all category B drugs. Examples of antibacterial regimens that have been shown to be effective in the treatment of refractory periodontitis include:
• Augmentin 250 mg tid for 7 days

• Metronidazole 500 mg bid for 7 days

• Augmentin 250 mg. tid + Metronidazole 250 mg. tid administered concomitantly for 7 days

II.5.7. Incentive for Attending Visits: A Gift Certificate for Each Visit

Subjects are given a gift certificate after each study visit as an incentive to attend the visit. In addition, subjects are given a small infant toy at each study visit, not to include the essential dental care visits. The DCC study manager will ship the toys to each site on a quarterly basis.


The Study Coordinator is responsible for the gift certificates and their distribution to subjects. Procedures for managing and accounting for the gift certificates are described in Section III.12. "Incentive Payments (Gift Certificates)".

II.6. After The Birth (Form 60, Delivery Data & Pregnancy Adverse Events and Form 61, Neonatal Outcome Data)
Because babies do not schedule their arrivals for our convenience, delivery data are collected by chart review after the delivery.
II.6.1. Objectives
The purposes of the post-natal data collection are:
• to record information about the baby, and

• to record adverse experiences occurring during the pregnancy.


II.6.2. Who Records Birth Data?
Birth data are recorded by the Treatment-Blinded Obstetrical Nurse Data Recorder. After the data have been recorded on Form 60 (Delivery Data & Pregnancy Adverse Events) and Form 61 (Neonatal Outcome Data), the Obstetrical Nurse gives the completed forms to the Study Coordinator, who makes copies of the originals and then sends the originals to the Data Coordinating Center (DCC).
II.6.3. Data Collection for Deliveries at the Enrollment Site (Forms 60, 61)
Twice each week, the Obstetrical Nurse checks the Site's delivery log book to see if any subjects have delivered their babies.
To simplify this task, each week the DCC sends to the Site's Study Coordinator a sorted list of Patient IDs (PIDs) for subjects that have reached or passed 20 weeks gestational age but for whom no Form 60 (Delivery Data & Pregnancy Adverse Events) has been recorded at the DCC. The list of PIDs is sorted with the highest gestational ages at the top of the list and the lowest gestational ages at the bottom of the list. The Study Coordinator links the PIDs on the list to the subjects' names and gives the subject names, in sorted order, to the Obstetrical Nurse.
Once the Obstetrical Nurse has identified subjects who have delivered their babies, s/he abstracts the necessary data from that subject's chart.
Data are recorded on Form 60 (Delivery Data & Pregnancy Adverse Events) and Form 61 (Neonatal Outcome Data), depicted below.
B
egin a subject's Form 60 by attaching a PID label to the upper right-hand corner of the form, filling in the Enrollment Site's identifier (NY for New York, MN for Minneapolis, KY for Lexington, MS for Jackson), the date on which the form is completed, and the Obstetrical Nurse's initials.

• Part A of the form records standard data describing the baby.

• Item A. 2: For babies delivered at locations other than the Enrollment Site, see Section II.6.4, "Obtaining Data for Deliveries the Enrollment Site" (below).
• Item A. 3: If the delivery was a stillbirth or spontaneous abortion, this is a serious adverse event that must be reported immediately. Upon completing the Form 60, the Obstetrical Nurse should check with the Study Coordinator whether this serious adverse event has indeed been reported. If it has not yet been reported, it must be reported immediately on Form 41 (Serious Adverse Event), obtainable from the Study Coordinator. Further information about completing Form 41 (Serious Adverse Event) and submitting it are in Section III.9. "Reporting Serious Adverse Events".
• Item A. 5: Gestational age should be reported in weeks and days if possible; if the chart records only weeks, mark an “x” in the box for days.



• Part B of the form records adverse events occurring during the pregnancy or detected at delivery. It is intended that Part B be completed based solely on information in the subject's chart. Thus, for example, the Obstetrical Nurse should not seek information outside the chart regarding fetal congenital abnormalities. The presumption is that all of these adverse events are of sufficient severity that if they occurred, they will be recorded in the subject's chart.


• Item B. 2: Note that this item asks only for abnormalities diagnosed by ultrasound or at delivery, which should be recorded in the subject's chart. If any such abnormalities are found, this is a serious adverse event that must be reported immediately. Upon completing the Form 60, the Obstetrical Nurse should check with the Study Coordinator whether this serious adverse event has indeed been reported. If it has not yet been reported, it must be reported immediately on Form 41 (Serious Adverse Event), obtainable from the Study Coordinator. Further information about completing Form 41 (Serious Adverse Event) and submitting it are in Section III.9. "Reporting Serious Adverse Events".
Once the Obstetrical Nurse has identified subjects who have delivered their babies, s/he must also abstract the necessary data from that newborn chart.
Newborn data are recorded on Form 61 (Neonatal Outcome Data), depicted below. These data will usually be found in the newborn medical chart.
Begin a subject's Form 61 by attaching a PID label to the upper right-hand corner of the form, filling in the Enrollment Site's identifier (NY for New York, MN for Minneapolis, KY for Lexington, MS for Jackson), the date on which the form is completed, and the Obstetrical Nurse's initials.



Item 5: If the infant died following delivery, this event must be reported as a serious adverse event. Upon completing Form 61, the Obstetrical Nurse should check with the Study Coordinator whether this serious adverse event has indeed been reported. If it has not yet been reported, it must be reported immediately on Form 41 (Serious Adverse Event), obtainable from the Study Coordinator. Further information about completing Form 41 (Serious Adverse Event) and submitting it are in Section III.9. "Reporting Serious Adverse Events".



II.6.4. Obtaining Data for Deliveries Outside the Enrollment Site
Some subjects who are not lost to follow-up and have not withdrawn their consent will nonetheless be unable deliver to their babies at the Enrollment Site. This can happen because:
• The subject has moved to a different geographical location.

• For some other reason, the subject cannot deliver her baby at the Enrollment Site.

• The subject could have delivered her baby at the Enrollment Site but she could not

reach the Enrollment Site because she was temporarily out of town, had rapid



labor, or experienced some other emergency.
In any of these cases, it will usually be possible to gather the most important data about the birth, if not all of the birth data. The single most important data item is the date of birth, from which gestational age at birth can be determined. If the subject is not lost to follow-up and has not withdrawn her consent for follow-up, it should always be possible to obtain the birth date.
If the subject has moved to a different geographical location, her new location should be recorded on Form 50 (Change in Follow-up Status or Withdrawal of Consent), Item 5. This should allow the Study Coordinator to obtain the birth date directly from the subject. If the subject has selected a place to deliver her baby, Item 4b of her Form 50 should have contact information at the new hospital or other facility. Other delivery data should be obtainable from the new hospital or other facility, although this may be quite involved as different institutions will have different procedures for releasing the subject's chart to the Study Coordinator.
If the subject cannot deliver her baby at the Enrollment Site for some other reason, but the Study Coordinator can still contact her, then the birth date can still be obtained. Obtaining other data will depend on the reason that the subject cannot deliver her baby at the Enrollment Site. No doubt it will require considerable ingenuity to obtain data beyond the birth date for some subjects.
If the subject could have delivered her baby at the Enrollment Site but exigency prevented it, it may nonetheless be possible to collect all of the delivery data. Again, this will depend on circumstances, though as long as the Study Coordinator can still contact the subject, the date of birth should still be available.

II.7. Study Treatment: The Control Group
II.7.1. Specification of the Control Group Treatment
Overview: No periodontal treatment or oral hygiene instruction will be given to control subjects until after delivery, unless of course they exhibit evidence of progressive periodontal disease (See Section II.5.5 for details on the rescue treatment).
Specific Methods: The periodontal treatment and oral hygiene instructions provided to control subjects following delivery will be identical to that provided to test subjects (described in Section II.4.1.)
Control subjects will receive between 1.5 - 6.0 hours of supra- and subgingival scaling and root planing. Treatment will be administered over one to four 1.5-hour appointments. If needed, the additional appointments will be completed within 14 days of the first appointment, whenever possible. All deferred periodontal therapy must be completed 3 months following the date of delivery.
II.7.2. Timing of the Control Treatment
All periodontal treatment will be completed as soon as possible following delivery.
II.7.3. Who Provides the Control Treatment?
The Periodontal Hygienist, under the supervision of the Enrollment Site's Principal Investigator (PI), will provide periodontal treatment to control subjects.
The Enrollment Site PI will monitor the Periodontal Hygienist to ensure that all treatments are performed according to the study protocol, as specified in this document.
II.7.4. Documenting the Control Treatment (Form 22)
Control-group periodontal treatment is documented on Form 22 "Confirmation of Deferred Periodontal Therapy". Because control-group treatment occurs after delivery, it cannot affect the pregnancy in the same way as test-group treatment, so less information is recorded for control subjects. Accordingly, Form 22 is very simple.



• If the whole treatment plan was completed, check box 3, "Treatment was completed" and in the space provided, enter the date on which treatment was completed.


• If the subject accepted some treatment but only part of the treatment plan was completed, check box 2, "Subject accepted only partial treatment" and in the space provided, enter the date on which the subject refused further treatment.

• If the subject refused any treatment, check box 1, "Subject refused all treatment" and in the space provided, enter the date on which the subject refused any treatment.


II.7.5. Incentive for Completing Control Therapy: A Gift Certificate for Each Visit
Subjects are given a gift certificate after each control-group therapy visit as an incentive to attend the visit and receive the care. In addition, each subject is given a small infant toy, developmentally appropriate for a neonate.
The Study Coordinator is responsible for the gift certificates and their distribution to subjects. Procedures for managing and accounting for the gift certificates are described in Section III.12. "Incentive Payments (Gift Certificates)".


II.8. Subjects Who Withdraw Consent or Are Lost to Follow-up
II.8.1. Definitions of "Withdraw Consent" and "Lost to Follow-up"
A subject can partially or totally withdraw consent. If she totally withdraws consent, then OPT Study personnel may not attempt to collect any further data or samples from her. But a subject may withdraw consent only for collection of specific data items, for example, regarding drug or alcohol addiction. Similarly, a subject may withdraw consent for collection of any data except the birth date and the baby's weight.
Likewise, a subject can be partially or totally lost to follow-up. A subject is partially lost to follow-up if she is unable to attend further visits but is still willing to provide, for example, birth data. This can happen if the subject moves away from the Enrollment Site's city, or has a condition that requires bed rest. If the subject is willing, however, it is still possible to collect birth date and weight, and it may be possible to review the subject's and infant’s chart at the location where she delivered her baby.
A subject is totally lost to follow-up if she dies or her whereabouts are unknown, that is, she has disappeared according to all available contacts. In this case, generally no further data can be collected.
II.8.2. When to Complete Form 50 (Change in Follow-up Status or Withdrawal of Consent)
Form 50's purpose is to record when, for any reason, a subject is no longer willing or able to provide complete data to the OPT Study. It should be filled out each time the subject wholly or partially withdraws consent, or is wholly or partially lost to follow-up.
A given subject may have more than one Form 50. For example, if a subject moves to a different city after Visit #2 but is willing to have birth date and weight collected, a Form 50 would be completed documenting this change of follow-up status. If the subject then dies before delivering her baby, a second Form 50 would be completed documenting this calamity.
II.8.3. Steps to Take Before Concluding that a Subject's Whereabouts Are Unknown.
Every effort should be made to maintain contact with each subject randomized in the OPT Study. At enrollment, the subject should have provided names and contact information for two people who can be contacted in case of emergency or if the subject appears to be lost to follow-up (see Section II.1.3.3 "Patient Locator Information (Form 02)"). Each contact person's address, telephone number, and relationship to the subject should be obtained with the clear understanding that strict subject confidentiality will always be maintained.
When a subject cannot be located or contacted directly – for example, scheduled visits have been missed and Site staff cannot reach the subject by phone after several attempts – the Study Coordinator should try to locate the subject through the people named as contacts, without indicating that the subject is in a research study. If the persons are located but are unwilling to provide the subject's location, ask them to ask the subject to contact the Site.
Other methods may be used to determine a subject's whereabouts, depending on the Site's subject population. Some potential methods are:
• Mailing a registered letter to the subject's last known address, requesting that she contact the Study Coordinator by telephone, calling collect if the call is long-distance.

• Contacting the Enrollment Site's social workers.

• Contacting social service agencies such as Medicaid or food stamps.

• Contacting neighbors at the subject's last known address. A reverse telephone directory is helpful for this purpose.

• Contacting the Department of Motor Vehicles.

• Contacting the subject's employer.


These are only to be treated as sources of information about the subject's whereabouts. Study personnel must protect the subject's confidentiality and should never provide information about subjects to these or other sources.
The Study Coordinator should record each step taken to locate a subject, to avoid duplicating effort and annoying contacts who might otherwise be willing to help.
If all efforts to locate the subject fail, a Form 50 should be completed. At the close of the study, Site personnel will be asked to try again to locate subjects whose whereabouts are unknown.
If the subject is contacted but refuses further participation in the OPT Study, a Form 50 should be completed to document her withdrawal of consent.
II.8.4. Documenting Withdrawal of Consent
If a subject indicates that she wishes to withdraw consent, her wish must be honored. Just as it is a severe ethical breach to enroll a subject without her consent, so it is a severe ethical breach not to honor her withdrawal of consent.
If a subject indicates her wish to withdraw consent to someone other than the Study Coordinator, she should be referred to the Study Coordinator. The Study Coordinator should solicit the subject's cooperation for partial data collection, even just the birth date and weight, if the subject seems like she might be receptive. The Study Coordinator should make every effort to obtain from the subject a written, signed document stating
• that she is withdrawing consent,

• the extent to which she is withdrawing consent, if less than totally, and



• the date as of which consent is withdrawn.
If the subject needs help writing this document, the Study Coordinator should provide it. If the subject cannot write, the Study Coordinator may record the subject's words on paper but should avoid putting words in the subject's mouth.
If the subject refuses to provide a written statement withdrawing consent, the Study Coordinator should document the subject's withdrawal in a memo for the record, including the extent to which she is withdrawing consent, if less than totally, and the date as of which consent is withdrawn. A copy of this memo should be filed with the copies of the subject's forms.
At all times during this process, the subject should be treated with the utmost respect and courtesy. This is her due, of course, but also, subjects sometimes change their minds and there is no reason to foreclose that possibility.
II.8.5. How to Complete Form 50 (Change in Follow-up Status or Withdrawal of Consent)
Begin by attaching a Patient ID (PID) label to the indicated place in the upper right-hand corner of the form and filling in the other identifying information in the upper right-hand corner.
• Item 2: The purpose of these dates is to allow us to analyze the subject's data up to the point at which her whereabouts became unknown. If she "disappeared" before delivering her baby, it is still useful to know when her whereabouts were last known. If her date of delivery is known, this is extremely valuable as it allows us to compute the OPT Study's main outcome measure, the gestational age at delivery.
• Item 4b: The subject may be willing to have her chart reviewed by OPT Study personnel. If so, this is extremely valuable and should be pursued. Use this spot on the form to record contact information for the subject's anticipated location of delivery.

Item 5: Use this item to record anything that doesn't fit into Items 1-4, for example, if the subject withdraws consent for specific data items. If in doubt, contact the Statistical Study Manager at the Data Coordinating Center (DCC).



Share with your friends:
1   2   3   4   5   6   7   8   9   ...   18


The database is protected by copyright ©dentisty.org 2019
send message

    Main page