Table of Contents for Manual of Operations - Biostatistics

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