1. Study Enrollment, Retention, and 2-year data
Molly McGuire
October 19th, 2018

2. Objectives Overview of Prospective Study
Requirements for and Logistics of Enrollment
Target Enrollment by cohort
Actual Enrollment by cohort
1-Year Follow Up
2-Year Follow Up
Introduction to the study data
Frequently Asked Questions

3. Prospective Study Overview

4. Multicenter Perthes Study Objectives
Evaluate the impact of surgical containment in children between the ages of 6- 8 years with LCPD on the shape of the femoral head compared with non- osteotomy management without prolonged containment.
Compare 6 weeks versus 6 months of postoperative NWB in patients treated with surgical containment and onset of LCPD between 8-11 years of age.
Describe demographic characteristics, treatment effects, potential of perfusion MRI, and patient-reported outcomes for children with onset of LCPD before age 6 and after age 11.
Evaluate the impact of containment treatment (surgical or bracing) in children with LCPD in the Late Stages of disease on the shape of the femoral head compared with no containment.

5. Requirements for Enrollment
AP/Frog X-ray
Informed Consent
Between ages 1 and 18
Waldenstrom staging information
Date of Diagnostic X-Ray and Date of Birth
Date of Presentation to IPSG member or group
Affected Hip
Primary treatment
Treating provider’s assessment of hypoperfusion on perfusion MRI (if early stage and >6 years old)
Maximum abduction x-ray (if late stage)

6. Exclusion Criteria Previous surgery on the affected hip
Underlying cause of AVN (for <11 groups only)
Hemoglobinopathy
Endocrine dysfunction
Treated with oral or IV steroid or chemotherapy for >30 consecutive days
History of congenital or acquired hip disease (i.e. – DDH, dislocation, fracture)
Any form of skeletal dysplasia
Down Syndrome
Coagulopathy
Hemophilia
Leukemia
Sickle Cell disease

7. Patient Enrollment Criteria & Cohort Groups

8. How are patients enrolled?

9. Issues surrounding enrollment
Missing data in screening form, for example:
Missing Yes/No response for exclusion criteria
No assessment of hypoperfusion
No date of consent
Requirements not met, for example:
No frog x-ray was done
No perfusion MRI was done
No data use agreement in place

10. Questions?

11. Current Prospective Study Enrollment and Retention

12. Enrollment Data Participants who were consented
Screening Committee approval
Screening Form data is complete
N=306 hips (299 participants)
By cohort
By site
Are we meeting enrollment goals?

13. Target Enrollment vs Actual Enrollment
Does not include 8-11 Non-surgical and MRI follow-up groups
Reassess target sample size, per age group and 5=year vs 2-year.

14. Early Stage Enrollment, 6-8
From 20 unique institutions
83% were over 50 percent hypoperfused at time of enrollment
106 were Stage I
32 were Stage II

15. Early Stage Enrollment, 8-11
From 29 unique institutions
86% were over 50 percent hypoperfused at time of enrollment
82 were Stage I
16 were Stage II

16. Target Enrollment vs Actual Enrollment-

17. Late Stage Enrollment, 6-11
From 5 unique institutions
11 were Stage IIb
3 were Stage IIIa

18. Registry Enrollment, <6
From 9 unique institutions
0.03% surgical
22 were Early Stage
18 were Late Stage

19. Registry Enrollment, >11
From 7 unique institutions
86% surgical
12 were Early Stage
1 was Late Stage

20. Total enrollment by site, October 2018 (n=306)
Institution
#Hips Enrolled
TSRH 72
KMCH 50
CHOP 36
GCSH 22
CCOM 17
CNMC 12
TXCH 10
TJPO 9
SNCH 8
OCRI
CHLA 7
HAMB
LCCH
CHOA 6
Institution
#Hips Enrolled
BCCH 6
NWCH 5
ACHC 4
JHMD
SHNC 3
CHHB 2
KPLA
MFNY
SPSM 1
OAPH
CHAB
SSLC
BOCH
DPHC
OHSU
64% are from top five centers

21. Number of Hips Eligible
Total Retention Rate
Visit Type
Number of Hips Eligible
Initial Visit
292
12 Month Visit
237
24 Month Visit
175
60 Month Visit 26
Total Visits
730
Only enrolled hips

22. Total 2-Year Follow Up Eligibility (n=185)
Early Stage 6-8 Non-Surgical (n=7)
Early Stage 6-8 Surgical (n=81)
Early Stage 6-8 MRI Observation (n=14)
Early Stage 8-11 Non-Surgical (n=2)
Early Stage Weeks NWB (n=24)
Early Stage Months NWB (n=25)
Early Stage 8-11 MRI Observation (n=7)
Late Stage (n=1)
>11 Registry (n=9)
<6 Registry (n=5)

23. Total 2-Year Follow up Eligibility
Institution
#Hips Eligible for 2-Year Follow Up
%Total Hips Eligible for 2-Year Follow Up
KMCH 35
20%
TSRH 34
19%
GCSH 16 9%
CHOP 15 8%
TXCH 10 6%
CNMC 9 5%
CCOM 8
SNCH
HAMB 7
NWCH 5 3%
ACHC 4 2%
JHMD
OCRI 3
CHLA
CHOA
SHNC
LCCH 2 1%
BCCH
CHHB
KPLA 1
SPSM
TOTAL
175
100%
- Analyzed a sub-set of hips with forms marked “complete”. 109 for clinic visit data and 126 for radiographic data
- 28/126 hips with correctly entered radiographic data do NOT have 2-year x-rays available.

24. Total 2-Year Follow Up Data Available
Retention of Clinic Visit Data
Retention of Radiographic Data
175 Eligible
175 Eligible
66 forms missing data
49 forms missing data
109 have clinic visit forms marked “complete”
126 have x-ray forms marked “complete”
24 patients not seen
30 patients did not get x-rays
85 clinic visits completed
96 sets two-year x-rays completed

25. Total 2-Year Clinic Visit Data
- 78% completed their visit for the 2-year clinical visit, 22% were missed/dropped out

26. 6-8 Prospective Study, 2 year data

27. Total 2-Year Follow Up Eligibility (n=185)
Early Stage 6-8 Non-Surgical (n=7)
Early Stage 6-8 Surgical (n=81)
Early Stage 6-8 MRI Observation (n=14)
Early Stage 8-11 Non-Surgical (n=2)
Early Stage Weeks NWB (n=24)
Early Stage Months NWB (n=25)
Early Stage 8-11 MRI Observation (n=7)
Late Stage (n=1)
>11 Registry (n=9)
<6 Registry (n=5)

28. 8-11 Prospective Study, 2 year data

29. How to improve follow-up?
Call patients
Standard of Care
Generate data reports
Training Opportunities

31. Overview of Study Data

32. Types of Study Data Screening Form Demographics Form
Clinical Visit Data
Radiographic Data
Modified Harris Hip
MRI Data
OR Data*
-1,916 clinic visits with status completed!

33. OR Data 291 Procedures on 200 unique hips
Max of 4 procedures on a single hip
3 repeat drilling procedures
1 I&D for infection
2 Hip distractor applications
- Includes only OR forms marked “complete”

34. Adductor Tenotomy Row Labels Count of Complete? CHOP 22 TSRH 6 CHOA 5
CHLA 3
SHNC
SNCH
ACHC 2
LCCH
TXCH
GCSH 1
MFNY
NWCH
OHSU
Grand Total 52

35. Epiphyseal Drilling or Tunneling
Average number of drills is 5.3 (range: 1-9)
Average size of K-wire used is mm (range: 0.064mm- 6mm)
Row Labels
Count of Complete?
TSRH 4
CCOM 1
NWCH
OCRI
Grand Total 7

36. Femoral Varus Osteotomy
Row Labels
Count of Complete?
KMCH 48
TSRH 24
CHOP 17
GCSH 14
TXCH 9
CNMC 8
HAMB 7
CHOA 6
SNCH
CCOM 4
NWCH
CHLA 3
LCCH
SHNC
ACHC 2
BCCH
CHHB
JHMD
MFNY
BOCH 1
KPLA
OAPH
OCRI
OHSU
SSLC
Grand Total
172
Femoral Varus Osteotomy

37. Greater Trochanteric Apophysiodesis
Row Labels
Count of Complete?
KMCH 44
TSRH 18
SNCH 5
NWCH 4
CHHB 2
CHLA
GCSH
BCCH 1
CHOA
CHOP
HAMB
JHMD
SHNC
SSLC
Grand Total 84

38. Pelvic Osteotomy (Salter, Shelf, Other)
Row Labels
Count of Complete?
HAMB 6
TJPO 1
Grand Total 7

39. Petrie Cast
Row Labels
Count of Complete?
CHOP 11
TSRH 8
CHOA 3
GCSH
SHNC 2
CHLA 1
MFNY
NWCH
SNCH
Grand Total 31
Intended duration of petrie casting averages 5.35 weeks (range: 4-6 weeks)

40. “Other” Procedures Row Labels Count of Complete? CNMC 1 HAMB KMCH 36
LCCH
TSRH 5
Grand Total 44

41. Missing OR Data Complications during/after surgery
Postoperative Casting/Orthosis

42. IPSG Frequently Asked Questions

43. IPSG Frequently Asked Questions
Guide for coordinators and investigators
Execution of study
Questions from IPSG s and training sessions
Made for coordinators, but helpful for everyone
Assembled by Molly, Susan, and Harry
More standardized, stock responses

44. DATA COLLECTION & PATIENT ENROLLMENT
What is considered the final follow-up visit, after the 5-year visit?
Are we collecting data retrospectively?
Do participants need to fill out separate Patient Questionnaire for each hip when they have bilateral Perthes?
How do I know whether my new patient screening form was approved?

45. MRI & RADIOGRAPHIC DATA
Our patient had an MRI and clinic visit before informed consent was obtained. How do we enter this data?
Is a standing AP x-ray the same as a supine AP x-ray for this study? Can I submit an AIR view?
My patient was consented the same day as his initial visit, but no x- rays were collected that day since x-rays from two weeks earlier at an outside facility were reviewed. What should I put for initial x- rays?

46. PATIENT-REPORTED OUTCOME DATA COLLECTION
Are the Patient-Reported Outcomes (PROs) available in Spanish?
Can I collect the PROs by mail or ?
What Patient-Reported Outcomes are we collecting, and when?

47. ETHICS AND REGULATORY
Where can I upload my Continuing Review approval letter for IPSG?
The HIPPA language is contained within our consent form, so there is not a separate HIPPA document. How do I notify IPSG of this in the Regulatory Binder?

48. MEMBERSHIP AND RESPONSIBILITIES
My PI’s membership status is “Inactive”. What can we do to make them an “Active” IPSG member?
I need an invoice from TSRH in order for my institution to cover my membership fee. What should I do? .

49. DATA QUALITY AND COMPLETENESS
How do I know if I have any missing data?
My site PI schedules visits every 4 months instead of everything 3 months. Do I mark my patients’ as “visit not completed”?
I didn’t collect the Demographics form data at the initial visit. Should I report it as missing? .

50. DATABASE
What do the old study ID numbers and letters stand for? Do I need to re-label old x-rays?
My patient had 2 post-op clinic visits prior to the 3-month visit. Which visit should be collected? If both, is there a way to add an additional time point in REDCap?
I consented a patient that has an AP but no frog x-ray from the initial visit. Can I still submit them for enrollment?

51. Next Steps Review with IPSG Coordinators Post on the website
Provide to new coordinators for training

52. Thank You!

53. Molly McGuire October 19th, 2018
REDCap Updates
Molly McGuire
October 19th, 2018

54. Objectives
Database updates & Demo
Data monitoring initiatives

55. Database PSAs Old databases will be archived
REDCap Upgrade in August 2018
Changes coming with PROMIS

56. Dashboard Viewer

57. File Repository

58. Project Bookmarks
Link to project materials from the members-only website
Link to New Patient Enrollment form

59. Reports

60. Additional Clinic Visit Data

61. Demo

62. Data Monitoring

63. Audit Process is Ongoing and Dynamic
1:1 review for missing variables, discordant data using Data Resolution Workflow
Calculation of visit dates and comparison of radiograph vs clinic visit dates to check for outliers
Check for duplicate records and consistency of bilateral participant data
Ensure cross-over patients are correctly documented
Ensure baseline date is correct
Data Completion Rate algorithm
Cross-Over examples:
6 months NWB vs 6 weeks NWB
Non-surgical vs Surgical
Baseline dates
Date of surgery for surgical patients
Date of Presentation for non-surgical patients
Date of Petrie/Bracing initiation for bracing patients

64. Data Completion Rates
Data Completion Rates can help sites determine where opportunities for improvement are.
If your site’s overall data is >80% complete at any given time, your Membership point toward Data Completion is awarded.
One quick way to get a sense of your Data Completion Rate is to review your REDCap Dashboard regularly.
You can visually estimate the percentage complete and how many need your attention.

65. What are Data Completion Rates?
Algorithm built in REDCap to ensure data is entered by the study site and correct to the best of our abilities.
What contributes to data forms being considered “complete”?
Which participants are reviewed?
What types of data are considered in the algorithm?
Screening Form
Demographics Form
Clinical Visit Data
Radiographic Data
Modified Harris Hip
MRI Data
OR Data
What contributes to data being “complete”?
Site has entered data with NO missing fields and has marked the form for review.
Central Coordinator has reviewed the data and marks the form “complete”.
Which participants are reviewed?
- Both submitted AND enrolled records are included in the algorithm.

66. Data Resolution Workflow
Data Quality function in REDCap
Allows us to communicate about missing or discordant data via queries
A query is opened when data appears to be incomplete; it is then assigned to the appropriate study team
Study team must provide a response by reviewing the data, confirming with provider, or pulling the medical records.

67. Examples of Data Queries

68. List of Queries is stored in the Data Resolution Dashboard

69. Data Resolution Workflow
Open queries typically mean your form is counted as “incomplete” (red)
Queries waiting for review are marked “unverified” (yellow)
As soon as they are resolved, your form is marked “complete” (green)

70. As of October 11, 2018 at 12:06pm

71. Data Completion by Site
Data Completion Rate (%)
ACHC
99.06
BCCH
46.29
BOCH
65.14
CCHM
21.90
CCMC
14.29
CCOM
78.24
CHAB
94.29
CHCO
46.33
CHHB
77.36
CHLA
84.60
CHOA
83.33
CHOP
76.17
CNMC
80.23
DPHC
28.57
GCHS
69.47
HAMB
80.41
JHMD
57.50
KMCH
87.34
KPLA
82.14
LCCH
47.19
MFNY
87.01
NWCH
76.47
NYUL
57.14
OAPH
87.74
OCRI
68.67
OHSU
85.71
SNCH
73.66
SPSM
72.73
SSLC
TJPO
40.30
TSRH
79.54
TXCH
47.53

72. Questions?

73. Thank You!