FHS-SCAN 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 220.127.116.11 Abdominal (Waist) Girth. Took out ‘two Anthropometry measurements needed; one measurement needed. 3/18/02 Heiss/LW MOP2 18.104.22.168 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 22.214.171.124 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 information. 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 Form 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 appendices 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 Measurements 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 Measurement 2.8 Conversion Chart 2.9 Anthropometry Equipment Calibration Log /Weekly 2.10 Anthropometry Equipment Calibration Log /Monthly 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. Form/QxQ 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 study. 7/17/02 MOP2 Venipuncture; Added, “Incident Forms should be sent to the 2.11.2 Data Coordinating Center.” Procedures 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 accordingly. 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.” FHS-SCAN 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 126.96.36.199 of someone have an electronic MOP2. I have monthly and daily version? calibration logs, and arm circumference MOP2/Anthro 2.8.2 Checklists added: participant preparation, and height, weight, waist, and hip measurements MOP2/Anthro 188.8.131.52 Added a checklist for weight measurement (Appendix 2). MOP2/Anthro 184.108.40.206 Added checklist for waist measurement (Appendix 2). MOP2/Anthro 220.127.116.11 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 procedures). 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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