FHS SCAN Forms QxQs MOP Alterations Date Requestor JC by wantyou


                             Forms/QxQs/MOP Alterations

Date      Requestor   Form/MOP          Sect/Ques     Change Made
1/3/02    JC          MOP1,                           Corrected redundancy in 4 & 5 [Both listed as
                      Recruitment                     priority for recruitment, clarified those section
                                                      headers]. Renumbered subheads, inserted #6
                                                      Recruitment Flow. Added Appendix III,
                                                      Recruitment Roster, as indicated in Section 5,
                                                      Page 5
3/18/02   GH/LW       MOP2           Abdominal (Waist) Girth. Took out ‘two
                      Anthropometry                   measurements needed; one measurement
3/18/02   Heiss/LW    MOP2           Hip Girth. Took out ‘two measurements
                      Anthropometry                   needed; one measurement needed.
3/18/02   GH/LW       Anthro Form                     Question on hip girth measurement/WH ratio.
                                                      No change made.
3/18/02   LW          MOP2              2.6.2         The pregnancy test should read QuickVue
                      Preg Determ                     (Quidel).
3/18/02   GH/LW       MOP2           Cuff Size Selection. Changed to “Record arm
                      Sitting BP                      circumference to nearest cm” [not 1/10 of cm].
3/18/02   GH/LW       Sitting BP QxQs   2             Changed to “Record arm circumference to
                                                      nearest cm” [not 1/10 of cm].
3/18/02   AH/LW       Report/Refer      2             Total Cholesterol added to Referral Chart
          JC          MOP2                            Added form name and page number when
                                                      reader was referred to Appendix for particular
          JC          MOP2/Itinerary    2.2.3         This is in Appendix 2, not Appendix 1, as it is
                                                      an internal form.
          JC          MOP2/Contact      2.5
                      MOP2/Anthropom                  The form, question by question instructions are
                      etry                            in Appendix 1; quality control checklists,
                                                      centimeter to inches conversion table are
                                                      located in Appendix 2.
3/21/02   JC          MOP2              Append 2      Added all components of Appendix 2
3/21/02   JC          MOP1                            Took out references to Med Hx, Family Hx, and
                                                      Address forms [not used in this study as Phase 1
                                                      forms]. Altered telephone script accordingly.
4/05/02   JC          MOP2/CT Scan      2.21.2        Took out referral letters in body; put in
4/05/02    JC            Added Appendix 2                   Internal Forms and Checklists
                                                            2.1 Checklist of Completing Paper Forms and
                                                                 Interviewing Techniques
                                                            2.2 Checklists for performing Anthropometric
                                                            2.3 Checklist for Standing Height Measurement
                                                            2.4 Checklist for Weight Measurement
                                                            2.5 Checklist for Hip Measurement
                                                            2.6 Checklist for Waist Measurement
                                                            2.7 Checklist for Arm Circumference
                                                            2.8 Conversion Chart
                                                            2.9 Anthropometry Equipment Calibration Log
                                                            2.10 Anthropometry Equipment Calibration Log
                                                            2.11 Report on Use of Observation and
                                                                 Equipment Checklist

4/05/02    JC            Added Appendix 3                   Results and Reporting
                                                            3.1 Summary of FHS-SCAN Results for
                                                                Participants and Their Physicians
                                                            3.2 Participant Alert Letter
                                                            3.3 Physician Alert Letter
                                                            3.4 Letter to Enclose in “Summary of FHS
                                                            Results” to Physicians Only
6/07/02                  Forms              Venipuncture    Added #14 Person Completing This Form
                                            Form/ QXQ
6/10/02                  Forms              Medication Hx   Added question for OTC as first question in
                                            Form/QxQ        both form and QxQs.
6/20/02                  Forms              Pregnancy       For women > 55, added ‘tubal ligation’ to
                                            Determination   question 3 and in QxQs.
7/9/02                   MOP 4              Venipuncture    Replaced Venipuncture form with updated form
                                            Form            from Forms & QXQs
7/15/02                  Forms/QxQs         Medical          In QxQs, statement added to include parents
                                            History          that died before the age of 50. Now reads:
                                            Update          12.e, f, g, h Natural mother (father) refers to
                                                            birth mother (father). If the mother or father
                                                            died before the age of 50, the box “MOTHER
                                                            [FATHER] LESS THAN AGE 50”
                                                             should be checked.

7/15/02                  Forms/QxQs         Informed        Informed Consent Change form added to
                                            Consent         accommodate those that may choose to alter
                                            Change Form     their level of consent during the course of this
7/17/02                  MOP2               Venipuncture;   Added, “Incident Forms should be sent to the
                                            2.11.2          Data Coordinating Center.”
7/17/02                  Forms/QxQs         Venipuncture    Added clarification that Incident Reports only
                                            Form/Incident   were sent to the DCC; Venipuncture forms were
                                            Report          not needed.
12/18/02   Heiss,        Forms/QxQs         Medical Hx      Remove Question 11e [currently not in DES] in
           Wagenknecht                                      form and QxQ; renumbered Question 11
2/12/03   Lange/Study    Forms/QxQs   Pregnancy       3.a Expanded wording to now read: Have you
          Coordinators                Determination   had a hysterectomy… [removal of uterus] or a
                                      Form            tubal ligation [tubes tied]?
                                      Inflammation    Added :
                                      QxQ             3.b &3.c Episode is defined as a period of time
                                                      when the participant suffered from continual
                                                      pain, with no significant relief. If a participant
                                                      answers “I have arthritis
                                                      all the time,” answer “Y” to 3.b and 3.c.

                                      Anthropometr    2. Expanded wording to now read: Weight is
                                      y QxQ           taken with minimal clothing, with watch and
                                                      heavy jewelry removed. Record results to the
                                                      nearest pound, rounding down after participant
                                                      has stepped off the scale.
                                      Venipuncture    2. Added to the end: Participants may be
                                      QxQ             rescheduled for a blood draw up to one month
                                                      following the clinic visit.
                                      Sitting BP       3. Added: Before the BP measurement
                                      QxQ              procedure, explain to the participant what to
                                                       expect and how long the procedure will take.
                                                       The following script is used:
                                                               “This part of the exam involves taking
                                                       your resting blood pressure. It will take about
                                                       10 minutes. We would like you to sit
                                                       comfortably with both feet on the floor and
                                                       your arm supported on the table. I will ask
                                                       you to sit quietly for five minutes. Then we will
                                                       take your blood pressure three times, one
                                                       minute apart, using an automated device. We
                                                       will give you your blood pressure results and
                                                       discuss them with you at the end of your visit.”
                  Components Missing From MOP2 and Appendices
Missing         Location   What is Needed                      Update 3/20/02
Anthropometry   2.8        Need conversion table centimeter    I have found a conversion chart,
                           to inches for conversion table as   but in hard copy only. Would
                           referred to in 2.8 and of   someone have an electronic
                           MOP2. I have monthly and daily      version?
                           calibration logs, and arm
MOP2/Anthro     2.8.2      Checklists added: participant
                           preparation, and height, weight,
                           waist, and hip measurements
MOP2/Anthro    Added a checklist for weight
                           measurement (Appendix 2).
MOP2/Anthro    Added checklist for waist
                           measurement (Appendix 2).
MOP2/Anthro    Added a checklist for hip
                           measurement (Appendix 2).
MOP/            2.10.2     Refer to the Bioimpedance           Are we going to use?
Bioimpedence               Manual of Procedures (Weight
                           Manager Version 2.05a,
                           Instruction Manual, in the
                           Appendix to this manual of
MOP/Quality     2.8.6      Added a Report on Use of
Control                    Observation and Equipment
                           Checklist (Appendix 2).
MOP2/Overview   2.1        Added General Instructions for      Do we need a “Guide to
                           Completing Paper Forms and          Reception” script?
                           Interviewing Techniques for
                           Appendix 2.

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