Table of Contents for Manual of Operations - Biostatistics

I.1. Introduction and Overview of the Study I-1. I.2. Organization and ..... All
participants will be referred to a general dentist for treatment of carious, fractured,
... Animal and bacteriologic studies support this association [8-10]. ...... The final
sample size was set at 816 subjects to allow equal numbers to be enrolled at
each site.

Part of the document


Obstetrics and Periodontal Therapy (OPT) Study Manual of Operations Version 1
March 3, 2003
Brief Table of Contents I. Overview
I.1. Introduction and Overview of the Study I-1
I.2. Organization and Administration (Including Study Roster) I-
I.3. Schedule of Visits and Evaluations I- II. A Subject's Path Through the Study II.1. Recruitment, Consent, and Entry into the Study II-
II.2. The Baseline/Randomization Visit (Visit 1) II-
II.3. Essential Dental Care II-
II.4. Study Intervention: Immediate Periodontal Therapy (Test Group) II-
II.5. Maintenance Visits (Visits 2 to 6) II-
II.6. After The Birth (Form 60, Delivery Data & Pregnancy Adverse
Events) II-
II.7. Deferred Periodontal Therapy (Control Group) II-
II.8. Subjects Who Withdraw Consent or Are Lost to Follow-up II- III. Details on Procedures III.1. Periodontal Measurements III-
III.2. Collecting and Storing Dental Plaque Samples (Enrollment Site
Procedures) III-
III.3. Overview of Plaque Assays (Microbiology Lab Procedures) III-
III.4. Collecting, Processing, and Storing Serum Samples (Enrollment
Site Procedures) III-
III.5. Overview of Serum Assays (Host Response Lab Procedures) III-
III.6. Informed Consent (Including Consent Forms) III-
III.7. Maintaining Confidentiality III-
III.8. Blinding and Unblinding III-
III.9. Reporting Adverse Events III-
III.10. Data and Safety Monitoring Activities III-
III.11. Study Compliance III-
III.12. Incentive Payments (Gift Certificates) III-
III.13. Randomization III-
III.14. Data Collection Procedures III-
III.15. Data Management and Error Correction III-
III.16. Data Requests by Enrollment Sites III- IV. Policies and Reporting IV.1. Good Clinical Practice IV-
IV.2. Reports IV-
IV.3. MOP Maintenance IV-
IV.4. Miscellaneous Policies IV- V. Case Report Forms VI. Questions and Answers, References VI.1. Questions and Answers VI-
VI.2. References VI- Detailed Table of Contents I. Overview I.1. Introduction and Overview of the Study I-
I.1.1. Synopsis I-
I.1.2. Background and Rationale I-
I.1.2.1. Association of Preterm Delivery and Low Birth Weight and
Periodontal Disease I-
I.1.2.2. Animal studies I-
I.1.2.3. Immunological responses I-
I.1.2.4. Periodontal infection and bacteremias I-
I.1.2.5. Biologic Rationale and Working Hypothesis I-
I.1.3. Study Design I-
I.1.3.1. Overview I-
I.1.3.2. Subject population, study intervention, outcome measures
I-
I.1.3.3. Procedures I-
I.1.3.4. Safety monitoring I-
I.1.3.5. Statistical considerations I-
I.1.3.6. Training I-
I.1.4. References for Introduction and Overview I-
I.2. Organization and Administration I-
I.2.1. Participating Units I-
I.2.2. Study Organization and Administration I-
I.2.2.1. The Steering Committee I-
I.2.2.2. Enrollment site personnel I-
I.2.2.3. Data Coordinating Center (DCC) I-
I.2.3. Study Roster I-
I.3. Schedule of Visits and Evaluations I- II. A Subject's Path Through the Study II.1. Recruitment, Consent, and Entry into the Study II-
II.1.1. Initial Contact and Recruitment II-
II.1.1.1. Procedures II-
II.1.1.2. Recruitment Log (Form 00) II-
II.1.2. Informed consent II-
II.1.3. Procedures for Enrollment into the Study: Enrollment form
(Form 01),
Patient Locator Information (Form 02), Patient Log (Form
03), Baseline
Obstetric Data (Form 10), Payment, and Transmittal to the
Data
Coordinating Center II-
II.1.3.1. Patient ID (PID), Enrollment Code, and Labels II-
II.1.3.2. Enrollment Form (Form 01) II-
II.1.3.3. Patient Locator Information (Form 02) II-
II.1.3.4. Patient Log (Form 03) II-
II.1.3.5 Patient Tracking (Form 06) II-
II.1.3.6. Baseline Obstetric Data (Form 10) II-
II.1.3.7. Dispense Gift Certificate II-
II.1.3.8. Transmit documents to the Data Coordinating Center (DCC)
II-
II.2. The Baseline/Randomization Visit (Visit 1) II-
II.2.1. Purpose II-
II.2.2. Timing of the Baseline/Randomization Visit (Visit 1) II-
II.2.3. Scheduling and Preparing for the Baseline Visit II-
II.2.4. Sequence of Procedures and Forms, including the Randomization
II-
II.2.4.1. Baseline Oral Exam II-
II.2.4.2. Periodontal Exam, Form 11 (Periodontal Measurements) II-
II.2.4.3. Plaque Sampling, Form 11 (Periodontal Measurements) II-
II.2.4.4. Establish Eligibility, Form 04 (Randomization/Exclusion)
II-
II.2.4.5. Randomize the Subject, Form 04
(Randomization/Exclusion),
Continued II-
II.2.4.6. Obtain Baseline Medications (Form 12, Medications) II-
II.2.4.7. Blood Draw for the Serum Sample II-
II.2.4.8. Schedule appointments for Essential Dental Care and, if
appropriate, for study periodontal therapy II-
II.2.4.9. Dispense the Gift Certificate II-
II.2.4.10. Begin the Event Checklist (Form 05) II-
II.3. Essential Dental Care II-
II.3.1. Timing of Essential Dental Care II-
II.3.2. Definition of Essential Dental Care II-
II.3.3. Documenting Essential Dental Care: Form 20 (Confirmation of
Essential Dental Care) II-
II.3.4. Incentive for Completing Essential Dental Care: A Gift
Certificate
for Each Visit II-
II.4. Study Intervention: Immediate Periodontal Therapy (Test Group) II-
II.4.1. Specification of Study Intervention II-
II.4.2. Timing of the Intervention II-
II.4.3. Who Provides the Study Intervention? II-
II.4.4. Documenting the Intervention (Form 21) II-
II.4.5. Incentive for Completing Study Therapy: A Gift for Each
Visit II-
II.5. Maintenance Visits (Visits 2 to 6) II-
II.5.1. Objectives and Procedures II-
II.5.2. Procedures II-
II.5.2.1. Test Group Subjects II-
II.5.2.2. Control Group Subjects II-
II.5.3. Location, Visit Windows, Reminders, Late/Missed Visits II-
II.5.3.1. Timing II-
II.5.3.2. Location II-
II.5.3.3. Reminders II-
II.5.3.4. Late and Missed Visits II-
II.5.4. Data Collection Visits (Scheduled at Visits 3 and 5) II-
II.5.5. Documenting Maintenance Visits (Form 23; also Forms 12, 40,
41) II-
II.5.6. Monitoring Subjects' Periodontal Status: Procedures in Case
of
Progressive Disease II-
II.5.6.1. Progressive attachment loss (5 or fewer sites
cumulatively) II-
II.5.6.2. Generalized progressive attachment loss (6 or more sites
cumulatively) II-
II.5.7. Incentive for Attending Visits: A Gift Certificate for Each
Visit II-
II.6. After The Birth (Form 60, Delivery Data & Pregnancy Adverse
Events) II-
II.6.1. Objectives II-
II.6.2. Who Records Birth Data? II-
II.6.3. Data Collection for Deliveries at the Enrollment Site (Form
60) II-
II.6.4. Obtaining Data for Deliveries Outside the Enrollment Site II-
II.7. Study Treatment: The Control Group II-
II.7.1. Specification of the Control Group Treatment II-
II.7.2. Timing of the Control Treatment II-
II.7.3. Who Provides the Control Treatment? II-
II.7.4. Documenting the Control Treatment (Form 22) II-
II.7.5. Incentive for Completing Control Therapy: A Gift Certificate
for
Each Visit II- II.8. Subjects Who Withdraw Consent or Are Lost to Follow-up II- II.8.1. Definitions of "Withdraw Consent" and "Lost to Follow-up" II-
II.8.2. When to Complete Form 50 (Change in Follow-up Status or
Withdrawal of Consent) II-
II.8.3. Steps to Take Before Concluding that a Subject's Whereabouts
Are
Unknown II-
II.8.4. Documenting Withdrawal of Consent II-
II.8.5. How to Complete Form 50 (Change in Follow-up Status or
Withdrawal of Consent) II- III. Details on Procedures III.1. Periodontal Measurements III-
III.1.1. Who Obtains the Periodontal Measurements? III-
III.1.2. Equipment, Standards and Special Situations III-
III.1.2.2. Substitutions for Missing Teeth III-
III.1.2.3. Tooth Locations for Scoring or Measuring III-
III.1.2.4. Order of Measurement III-
III.1.2.5. Criteria for the Plaque Index (Löe 1967) III-
III.1.2.6. Criteria for the Gingival Index (Löe, 1967) III-
III.1.2.7. Pocket depth III-
III.1.2.8. Clinical Attachment Loss III-
III.1.2.9. Criteria for Bleeding on Probing III-
III.1.2.10. Criteria for the Calculus Index (from OHI-S; Greene,
1967) III-
III.1.3. Training and Calibration Protocols III-
III.2. Collecting, Storing, and Shipping Dental Plaque Samples
(Enrollment
Site Procedures) III-
III.2.1. Equipment and Standards III-
III.2.1.1. Equipment Provided by the Enrollment