Protocol Overview

January 21, 2010

The Expert Review Panel has not reviewed this measure yet.

This protocol is divided into two parts. Part I consists of the Study of Osteoporotic Fractures (SOF) Fractures and Falls History: History of Fractures Questionnaire, which is a self-administered questionnaire to assess the location of the respondent’s broken bone(s) and the age(s) at which the break(s) occurred. Part II contains the Framingham Osteoporosis Study Fracture Assessment form to confirm the respondent’s self-reported fracture history.

Although the Fractures and Falls History: History of Fractures Questionnaire was originally developed for women ages 65 and older, the PhenX Skin, Bone, Muscle and Joint Working Group recommends that it could be used on adults of all ages.

Self-report questionnaires have been found to have variable rates of false positives. These rates are decreased when self-reports are coupled with confirmation/adjudication. Therefore, the Working Group recommends that the Fractures and Falls History: History of Fractures Questionnaire be corroborated with a medical record confirmation and adjudication from the Framingham Osteoporosis Study. This study also includes a fracture index to classify fracture locations.

Part I: Study of Osteoporotic Fractures (SOF) Fractures and Falls History: History of Fractures Questionnaire

FAMILY HISTORY OF BROKEN BONES AND FRACTURES

Clinic use only

ID

Date

1. Has a doctor ever said that you had a broken or fractured bone? (MARK ONE BOX.)

         [ ] Yes

         [ ] No PLEASE GO TO QUESTION 2

         [ ] Don’t Know PLEASE GO TO QUESTION 2

IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone.

HAS A DOCTOR EVER TOLD YOU THAT YOU HAD:

2. Osteoporosis, sometimes called thin or brittle bones?

         [ ] Yes

         [ ] No PLEASE GO TO QUESTION 3

         [ ] Don’t Know PLEASE GO TO QUESTION 3

IF YES, how old were you when a doctor first told you this? I was___years old.

3. Fracture of the spine or fracture of the vertebrae?

         [ ] Yes

         [ ] No

         [ ] Don’t Know

IF YES, how old were you when a doctor first told you this? I was____years old.

© 2010 SOF Online, produced by the Coordinating Center, University of California San Francisco

Part II: Framingham Osteoporosis Study Fracture Assessment Form

Note: The PhenX Skin, Bone, Muscle and Joint Working Group recommends that this form be completed by personnel trained in performing medical records review.

HIP FRACTURE FORM

DATE HIP FRACTURE OCCURRED: ____/____/____ (Month/Day/Year)

1. SOURCE(S) OF HIP FRACTURE CONFIRMATION:

1.1. Orthopedic notes

1.2. X-ray report

1.3. Discharge summary

1.4. OR report

1.5. ER notes

1.6. Other ________________________

2. HIP FACTURE SIDE:

3. HIP FRACTURE LOCATION:

4. HIP FRACTURE TREATMENT:

5. OTHER FRACTURE(S) OCCURED AT SAME TIME:

6. CIRCUMSTANCES OF HIP FRACTURE:

7. LOCATION OF FALL OR TRAUMA:

8. TIME OF DAY FRACTURE OCCURRED:

9. DEATH OCCURED DURING HIP FRACTURE HOSPITALIZATION:

10. DETAILED CIRCUMSTANCES OF HIP FRACTURE:

11. DATE DATA RETRIEVAL COMPLETED: ____/____/____ (Month/Day/Year)

12. DATE OF ADJUDICATION BY MD FRACTURE COORDINATOR: ____/____/____ (Month/Day/Year)

13. FINAL ADJUDICATION BY ENDPOINTS COMMITTEE REQUIRED:

14. DATE OF ADJUDICATION BY ENDPOINTS COMMITTEE: ____/____/____ (Month/Day/Year)

15. Comments (not for data entry):

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

NON-HIP FRACTURE FORM

DATE FRACTURE OCCURRED: ____/____/____ (Month/Day/Year)

16. SOURCE(S) OF FRACTURE CONFIRMATION:

16.1. Orthopedic notes

16.2. X-ray report

16.3. Discharge summary

16.4. OR report

16.5. ER notes

16.6. Other ________________________

17. FRACTURE SIDE:

18. FRACTURE LOCATION:

(see fracture location codes, write in) ________________________________

19. FRACTURE TREATMENT:

20. OTHER FRACTURE(S) OCCURED AT SAME TIME:

21. CIRCUMSTANCES OF FRACTURE:

22. LOCATION OF FALL OR TRAUMA:

23. TIME OF DAY FRACTURE OCCURRED:

24. DEATH OCCURRED DURING FRACTURE HOSPITALIZATION:

25. DETAILED CIRCUMSTANCES OF FRACTURE:

26. DATE DATA RETRIEVAL COMPLETED: ____/____/____ (Month/Day/Year)

27. DATE OF ADJUDICATION BY MD FRACTURE COORDINATOR: ____/____/____ (Month/Day/Year)

28. FINAL ADJUDICATION BY ENDPOINTS COMMITTEE REQUIRED:

29. DATE OF ADJUDICATION BY ENDPOINTS COMMITTEE: ____/____/____ (Month/Day/Year)

30. Comments (not for data entry):

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

FRACTURE LOCATION CODES

• 1.0 - Hip (USE HIP FRACTURE FORM)
• 1.1 - femoral neck
• 1.2 - intertrochanteric
• 1.3 – other

• 2.0 - Wrist (unspecified)
• 2.1 - distal radius (Colles’; Smith)
• 2.2 - distal ulna
• 2.3 - both distal radius and ulna

• 3.0 – Skull

• 4.0 - Facial bones (includes jaw, nose, cheek)

• 5.0 - Neck
• 5.1 - first cervical vertebra
• 5.2 - second cervical vertebra
• 5.3 - thrid cervical vertebra
• 5.4 - fourth cervical vertebra
• 5.5 - fifth cervical vertebra
• 5.6 - sixth cervical vertebra
• 5.7 - seventh cervical vertebra
• 5.8 - multiple cervical vertebrae

• 6.0 - Shoulder
• 6.1 - clavicle or collar bone
• 6.2 - scapula (shoulder blade)

• 7.0 - Arm (unspecified)
• 7.1 - humerus (upper arm)
• 7.2 - elbow
• 7.3 - radius a/o ulna, proximal or mid shaft

• 8.0 – Hand

• 9.0 – Fingers

• 10.0 - Other small bones in wrist

• 11.0 – Ribs

• 12.0 - Chest/Sternum

• 13.0 - Thoracic Spine (unspecified)
• 13.1 - first thoracic vertebra
• 13.2 - second thoracic vertebra
• 13.3 - third thoracic vertebra
• 13.4 - fourth thoracic vertebra
• 13.5 - fifth thoracic vertebra
• 13.6 - sixth thoracic vertebra
• 13.7 - seventh thoracic vertebra
• 13.8 - eighth thoracic vertebra
• 13.9 - ninth thoracic vertebra
• 13.10 - tenth thoracic vertebra
• 13.11 - eleventh thoracic vertebra
• 13.12 - twelfth thoracic vertebra
• 13.13 - multiple thoracic vertebrae

• 14.0 - Lumbar Spine (unspecified)
• 14.1 - first lumbar vertebra
• 14.2 - second lumbar vertebra
• 14.3 - third lumbar vertebra
• 14.4 - fourth lumbar vertebra
• 14.5 - fifth lumbar vertebra
• 14.6 - multiple lumbar vertebrae

• 15.0 – Pelvis

• 16.0 - Tailbone/Coccyx/Sacrum

• 17.0 - Leg (unspecified)
• 17.1 - femur (not hip)
• 17.2 - patella
• 17.3 - tibia
• 17.4 - fibula
• 17.5 - both tibia/fibula

• 18.0 - Ankle (includes distal tibia and fibula)

• 19.0 - Foot/Metatarsal

• 20.0 – Toes

• 21.0 - Heel/Os Calcis

Fracture Adjudication

When data retrieval for a reported fracture has been completed, the individual investigating the reported fracture will attach all relevant materials to the fracture form and complete the form. The packet will then be passed on to Dr. (FILL IN NAME) for review and fracture adjudication. Dr. (FILL IN NAME) will decide if the reported fracture should be coded as a "fracture" or a "non-fracture". Dr. (FILL IN NAME) may determine there is not sufficient evidence to determine fracture status. In this case, the packet will be returned to the field coordinator for further investigation.

If Dr. (FILL IN NAME) decides an additional opinion on fracture status is warranted, he/she may send the fracture in question to the Endpoints Committee for final adjudication. The Committee, comprised of Drs. (FILL IN NAME OF PHYSICIAN, FILL IN NAME OF SECOND PHYSICIAN) and a consulting orthopedic surgeon, will review the fracture information and come to a final decision on the status of the reported fracture.

If a reported fracture is deemed a true "fracture" by Dr. (FILL IN NAME) or the Endpoints Committee, the fracture form will be sent to be entered into the official fracture database. Those coded as a "non-fracture" will be stored in the field coordinator’s office.

Export Variables

Variable Name	Variable ID	Variable Description	Version	Mapping
PX170901_Doctor_Diagnosed_Fractured_Bone	PX170901010000	Has a doctor ever said that you had a broken or fractured bone? (MARK ONE BOX.)	4	N/A
PX170901_Broken_Bone_1	PX170901010101	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Broken Bone	4	N/A
PX170901_Age_When_Broken_1	PX170901010102	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Age When Broken	4	N/A
PX170901_Broken_Bone_2	PX170901010201	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Broken Bone	4	N/A
PX170901_Age_When_Broken_2	PX170901010202	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Age When Broken	4	N/A
PX170901_Broken_Bone_3	PX170901010301	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Broken Bone	4	N/A
PX170901_Age_When_Broken_3	PX170901010302	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Age When Broken	4	N/A
PX170901_Broken_Bone_4	PX170901010401	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Broken Bone	4	N/A
PX170901_Age_When_Broken_4	PX170901010402	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Age When Broken	4	N/A
PX170901_Broken_Bone_5	PX170901010501	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Broken Bone	4	N/A
PX170901_Age_When_Broken_5	PX170901010502	IF YES, please write down the names of all the bones you have broken (for example, "wrist" or "spine") and your age when you broke that bone. Age When Broken	4	N/A
PX170901_Osteoporosis	PX170901020000	HAS A DOCTOR EVER TOLD YOU THAT YOU HAD: Osteoporosis, sometimes called thin or brittle bones?	4	N/A
PX170901_Osteoporosis_Age	PX170901020100	IF YES, how old were you when a doctor first told you this? I was___years old.	4	N/A
PX170901_Fractured_Spine_Or_Vertebrae	PX170901030000	HAS A DOCTOR EVER TOLD YOU THAT YOU HAD: Fracture of the spine or fracture of the vertebrae?	4	N/A
PX170901_Fractured_Spine_Or_Vertebrae_Age	PX170901030100	IF YES, how old were you when a doctor first told you this? I was____years old.	4	N/A
PX170901_Date_Hip_Fracture_Occurred_Month	PX170901040100	DATE HIP FRACTURE OCCURRED - Month	4	N/A
PX170901_Date_Hip_Fracture_Occurred_Day	PX170901040200	DATE HIP FRACTURE OCCURRED - Day	4	N/A
PX170901_Date_Hip_Fracture_Occurred_Year	PX170901040300	DATE HIP FRACTURE OCCURRED - Year	4	N/A
PX170901_Hip_Fracture_Confirmation_Orthopedic_Notes	PX170901050100	SOURCE(S) OF HIP FRACTURE CONFIRMATION: Orthopedic notes	4	N/A
PX170901_Hip_Fracture_Confirmation_Xray_Report	PX170901050200	SOURCE(S) OF HIP FRACTURE CONFIRMATION: X-ray report	4	N/A
PX170901_Hip_Fracture_Confirmation_Discharge_Summary	PX170901050300	SOURCE(S) OF HIP FRACTURE CONFIRMATION: Discharge summary	4	N/A
PX170901_Hip_Fracture_Confirmation_OR_Report	PX170901050400	SOURCE(S) OF HIP FRACTURE CONFIRMATION: OR report	4	N/A
PX170901_Hip_Fracture_Confirmation_ER_Notes	PX170901050500	SOURCE(S) OF HIP FRACTURE CONFIRMATION: ER notes	4	N/A
PX170901_Hip_Fracture_Confirmation_Other	PX170901050600	SOURCE(S) OF HIP FRACTURE CONFIRMATION: Other	4	N/A
PX170901_Hip_Fracture_Confirmation_Other_Specify	PX170901050601	SOURCE(S) OF HIP FRACTURE CONFIRMATION: Other, specify	4	N/A
PX170901_Hip_Facture_Side	PX170901060000	HIP FACTURE SIDE:	4	N/A
PX170901_Hip_Fracture_Location	PX170901070000	HIP FRACTURE LOCATION:	4	N/A
PX170901_Hip_Fracture_Location_Other_Specify	PX170901070100	HIP FRACTURE LOCATION: Other, specify	4	N/A
PX170901_Hip_Fracture_Treatment	PX170901080000	HIP FRACTURE TREATMENT:	4	N/A
PX170901_Hip_Fracture_Treatment_Other_Specify	PX170901080100	HIP FRACTURE TREATMENT: Other, specify	4	N/A
PX170901_Circumstances_Of_Hip_Fracture	PX170901100000	CIRCUMSTANCES OF HIP FRACTURE:	4	N/A
PX170901_Hip_Fracture_Location_Fall_Trauma	PX170901110000	LOCATION OF FALL OR TRAUMA:	4	N/A
PX170901_Hip_Location_Fall_Trauma_Specify	PX170901110100	LOCATION OF FALL OR TRAUMA: Other, specify	4	N/A
PX170901_Time_Hip_Fracture_Occurred	PX170901120000	TIME OF DAY FRACTURE OCCURRED:	4	N/A
PX170901_Time_Hip_Fracture_Occurred_Specify	PX170901120100	TIME OF DAY FRACTURE OCCURRED: Other, specify	4	N/A
PX170901_Hip_Fracture_Death_During_Hospitalization	PX170901130000	DEATH OCCURED DURING HIP FRACTURE HOSPITALIZATION:	4	N/A
PX170901_Detailed_Circumstances_Of_Hip_Fracture	PX170901140000	DETAILED CIRCUMSTANCES OF HIP FRACTURE:	4	N/A
PX170901_Hip_Fracture_Retrieval_Completed_Month	PX170901150100	DATE DATA RETRIEVAL COMPLETED: Month	4	N/A
PX170901_Hip_Fracture_Retrieval_Completed_Day	PX170901150200	DATE DATA RETRIEVAL COMPLETED: Day	4	N/A
PX170901_Hip_Fracture_Retrieval_Completed_Year	PX170901150300	DATE DATA RETRIEVAL COMPLETED: Year	4	N/A
PX170901_Hip_Fracture_Date_Adjudication_Month	PX170901160100	DATE OF ADJUDICATION BY MD FRACTURE COORDINATOR: Month	4	N/A
PX170901_Hip_Fracture_Date_Adjudication_Day	PX170901160200	DATE OF ADJUDICATION BY MD FRACTURE COORDINATOR: Day	4	N/A
PX170901_Hip_Fracture_Date_Adjudication_Year	PX170901160300	DATE OF ADJUDICATION BY MD FRACTURE COORDINATOR: Year	4	N/A
PX170901_Hip_Fracture_Final_Adjudication_Required	PX170901170000	FINAL ADJUDICATION BY ENDPOINTS COMMITTEE REQUIRED:	4	N/A
PX170901_Hip_Fracture_Committee_Ajudication_Month	PX170901180100	DATE OF ADJUDICATION BY ENDPOINTS COMMITTEE: Month	4	N/A
PX170901_Hip_Fracture_Committee_Ajudication_Day	PX170901180200	DATE OF ADJUDICATION BY ENDPOINTS COMMITTEE: Day	4	N/A
PX170901_Hip_Fracture_Committee_Ajudication_Year	PX170901180300	DATE OF ADJUDICATION BY ENDPOINTS COMMITTEE: Year	4	N/A
PX170901_Hip_Fracture_Comments	PX170901190000	Comments (not for data entry):	4	N/A
PX170901_Date_Fracture_Occurred_Month	PX170901200100	DATE FRACTURE OCCURRED - Month	4	N/A
PX170901_Date_Fracture_Occurred_Day	PX170901200200	DATE FRACTURE OCCURRED - Day	4	N/A
PX170901_Date_Fracture_Occurred_Year	PX170901200300	DATE FRACTURE OCCURRED - Year	4	N/A
PX170901_Fracture_Confirmation_Orthopedic_Notes	PX170901200400	SOURCE(S) OF FRACTURE CONFIRMATION: Orthopedic notes	4	N/A
PX170901_Fracture_Confirmation_Xray_Report	PX170901200500	SOURCE(S) OF FRACTURE CONFIRMATION: X-ray report	4	N/A
PX170901_Fracture_Confirmation_Discharge_Summary	PX170901200600	SOURCE(S) OF FRACTURE CONFIRMATION: Discharge summary	4	N/A
PX170901_Fracture_Confirmation_OR_Report	PX170901200700	SOURCE(S) OF FRACTURE CONFIRMATION: OR report	4	N/A
PX170901_Fracture_Confirmation_ER_Notes	PX170901200800	SOURCE(S) OF FRACTURE CONFIRMATION: ER notes	4	N/A
PX170901_Fracture_Confirmation_Other	PX170901200900	SOURCE(S) OF FRACTURE CONFIRMATION: Other	4	N/A
PX170901_Fracture_Confirmation_Other_Specify	PX170901200901	Other, specify	4	N/A
PX170901_Fracture_Side	PX170901210000	FRACTURE SIDE	4	N/A
PX170901_Fracture_Location	PX170901220000	FRACTURE LOCATION:	4	N/A
PX170901_Fracture_Treatment	PX170901230000	FRACTURE TREATMENT:	4	N/A
PX170901_Hip_Fracture_Other_Fracture	PX170901090000	OTHER FRACTURE(S) OCCURED AT SAME TIME:	4	N/A
PX170901_Fracture_Treatment_Other_Specify	PX170901230100	FRACTURE TREATMENT: Other, specify	4	N/A
PX170901_Other_Fracture_Occured_At_Same_Time	PX170901240000	OTHER FRACTURE(S) OCCURED AT SAME TIME:	4	N/A
PX170901_Circumstances_Of_Fracture	PX170901250000	CIRCUMSTANCES OF FRACTURE:	4	N/A
PX170901_FractureLocation_Fall_Trauma	PX170901260000	LOCATION OF FALL OR TRAUMA:	4	N/A
PX170901_Fracture_Location_Fall_Trauma_Specify	PX170901260100	LOCATION OF FALL OR TRAUMA: Other, specify	4	N/A
PX170901_Time_Fracture_Occurred	PX170901270000	TIME OF DAY FRACTURE OCCURRED:	4	N/A
PX170901_Time_Fracture_Occurred_Other_Specify	PX170901270100	TIME OF DAY FRACTURE OCCURRED: Other, specify	4	N/A
PX170901_Fracture_Death_During_Hospitalization	PX170901280000	DEATH OCCURRED DURING FRACTURE HOSPITALIZATION:	4	N/A
PX170901_Detailed_Circumstances_Of_Fracture	PX170901290000	DETAILED CIRCUMSTANCES OF FRACTURE:	4	N/A
PX170901_Fracture_Data_Retrieval_Completed_Month	PX170901300100	DATE DATA RETRIEVAL COMPLETED: Month	4	N/A
PX170901_Fracture_Data_Retrieval_Completed_Day	PX170901300200	DATE DATA RETRIEVAL COMPLETED: Day	4	N/A
PX170901_Fracture_Data_Retrieval_Completed_Year	PX170901300300	DATE DATA RETRIEVAL COMPLETED: Year	4	N/A
PX170901_Fracture_Date_Of_Adjudication_Month	PX170901310100	DATE OF ADJUDICATION BY MD FRACTURE COORDINATOR: Month	4	N/A
PX170901_Fracture_Date_Of_Adjudication_Day	PX170901310200	DATE OF ADJUDICATION BY MD FRACTURE COORDINATOR: Day	4	N/A
PX170901_Fracture_Date_Of_Adjudication_Year	PX170901310300	DATE OF ADJUDICATION BY MD FRACTURE COORDINATOR: Year	4	N/A
PX170901_Fracture_Final_Adjudication_Required	PX170901320000	FINAL ADJUDICATION BY ENDPOINTS COMMITTEE REQUIRED:	4	N/A
PX170901_Fracture_Date_Committee_Month	PX170901330100	DATE OF ADJUDICATION BY ENDPOINTS COMMITTEE: Month	4	N/A
PX170901_Fracture_Date_Committee_Day	PX170901330200	DATE OF ADJUDICATION BY ENDPOINTS COMMITTEE: Day	4	N/A
PX170901_Fracture_Date_Committee_Year	PX170901330300	DATE OF ADJUDICATION BY ENDPOINTS COMMITTEE: Year	4	N/A
PX170901_Fracture_Comments	PX170901340000	Comments (not for data entry):	4	N/A

The Fractures and Falls History: History of Fractures Questionnaire was selected because it was used in a large prospective multisite study focusing on osteoporosis.

The Framingham Osteoporosis Study Fracture Assessment Questionnaire was vetted against other protocols and selected because it was used in a large longitudinal study involving hip and non-hip fractures of men and women.

The Study of Osteoporotic Fractures (SOF) Fractures and Falls History: History of Fractures Questionnaire:

Question numbers 18, 38, and 39.

San Francisco Coordinating Center
185 Berry St.
Lobby 4, Suite 5700
San Francisco, CA 94107
(415) 514-8000

© 2010 SOF Online, produced by the Coordinating Center, University of California San Francisco

Framingham Osteoporosis Study Fracture Assessment Form:

The Framingham Osteoporosis Study Fracture Assessment Questionnaire was developed as part of the Framingham Osteoporosis Study. Questions Offspring Hip Fracture Form Q1A-E (1.1-1.5), Q1I (1.6), Q2-Q9 (2-9), and Q12-Q17 (10-15). Questions Offspring Non-Hip Fracture Form Q1A-E (16.1-16.5), Q1I (16.6), Q2-Q9, (17-24), and Q12-Q17 (25-30).

Adult

English

The Study of Osteoporotic Fractures (SOF) Fractures and Falls History: History of Fractures Questionnaire: Adult females, aged 65 or older

Framingham Osteoporosis Study Fracture Assessment Form: Adults, aged 18 or older

The Study of Osteoporotic Fractures (SOF) Fractures and Falls History: History of Fractures Questionnaire: None

Framingham Osteoporosis Study Fracture Ascertainment Form: Personnel should be trained in performing medical records review

The Study of Osteoporotic Fractures (SOF) Fractures and Falls History: History of Fractures Questionnaire: None

Framingham Osteoporosis Study Fracture Ascertainment Form:None

Standard	Name	ID	Source
Common Data Elements (CDE)	Bone Fracture History Assessment Description Text	3158250	CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)	Fracture hx proto	64390-8	LOINC

None

Self-administered questionnaire and medical record abstraction

None

Requirement Category	Required
Average time of greater than 15 minutes in an unaffected individual	No
Major equipment	No
Specialized requirements for biospecimen collection	No
Specialized training	Yes

The Expert Review Panel has not reviewed this measure yet.