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Study Enrollment, Retention, and 2-year data

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Presentation on theme: "Study Enrollment, Retention, and 2-year data"— Presentation transcript:

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

30

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!


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