1. Susan Novotny & Rebecca Dieckmann
Database Updates
Susan Novotny & Rebecca Dieckmann

2. Disclaimer:
Becca and Susan fully acknowledge that the database and data collection sheets contain errors despite 100s of hours using them, looking at them, and combing them for errors.
These are considered version 1.0, and will require modification.
Errors should be reported to:

3. Thank you to the
Gillette Children’s
Hospital Foundation

4. IPSG Database: Former 6 databases merged into ONE
6-8 enrolled patient database
8-11 patient screening database
8-11 enrolled patient database
>11 patient screening database
>11 enrolled patient database
6-8 patient screening database 1

5. IPSG Database: Former 6 databases merged into ONE: Current Cohorts
6-8 study
(n=122)
8-11 study
(n=76)
>11 study
(n=11)
Late Stage
< 6 study
(n=4)
**Studies minimally tested
In the database and data sheets

6. Old Database
New
Database

7. Data Collection
Sheets for Each
Instrument
Initial Data
Audit

8. Data Collection Sheets – Data Migration
All old data was extracted
by hand, using new data
collection sheets
Repeating forms
for each follow-up
visit

9. Data Collection Sheets
We now use 7 data collection sheets for the IPSG to collect patient data.
Data collection sheets downloaded directly from REDCap are no longer appropriate.
Data collection sheets are either completed by the patient or provider
Provider :
Screening Form
Clinic Visit – clinical evaluation data
Clinic Visit – radiographic data
OR Data
MRI Data
Patient:
Demographics Form
Clinic Visit

10. Data Collection Sheets
New database contains innumerable changes, minor and major.
Examples:
New Questions never before asked
Specificity of previously asked questions
Timeline given to previously asked questions
Due to time constraints, we cannot review all of these today
Please thoroughly review the data collection sheets to
understand what changes were made
Report any errors

11. New or Changed Items on Data Collection Sheets
The Highlights

12. New Questions Date written, informed consent
(Q1) List of potential exclusionary criteria
(Q3) LCPD bilaterally – no longer exclusionary
Date of presentation to an IPSG member or their group
**Assumed people knew this was first H&P visit. We now know there is a misunderstanding regarding this and an SOP will follow as well as modification to DCF.

13. (Q7) Late Stage Study: (IIb- IIIa) Maximum hip abduction x-ray uploaded and measurements are required for enrollment.

14. Changed Questions
(Q5) “Date of Diagnosis” changed to “Date of first diagnostic X-Ray”
(Q8) Primary treatment options listed as Surgical vs Non-Surgical
Non-Surgical treatments:
Bracing
Casting
Soft Tissue Release
(Q11) When reporting perfusion MRI data, we ask for epiphyseal avascularity (in %), NOT perfusion.
*note detailed questions for these procedures lives in the OR Data Collection sheet

15. Patient-Reported Physical Activity
(Q11-14) Clarified the timeframe the patient should consider when answering the question
1-3 months (demographics)
Last 30 days (clinic visits)
Defined each answer in amount of times per week (e.g., almost every day, less than once per week)

16. (Q5) Measure of passive abduction with leg in extension
Changed:
(Q5) Measure of passive abduction with leg in extension
Visual estimation
Goniometer
Inclinometer
(Q7) Abduction Brace
New questions about whether or not a patient is treated with an abduction brace.
New:

17. (Q5) Type of Gadolinium used: we expanded our options
Changed Questions
New Questions
(Q5) Type of Gadolinium used: we expanded our options
(Q1) Type of MRI: perfusion vs non-perfusion
Reason for perfusion MRI
initial vs repeat assessment
Reason for non-perfusion MRI
assess perfusion for repeat drilling vs assess pain

18. Please take note
When you enter the data into the REDCap database, there is a ton of branching logic.
Examples:
Length of post-procedural weight-bearing restriction only appear if a patient is grouped to the 8-11 cohort in the screening form
When Femoral Varus Osteotomy is chosen, degree of varus and type of implant used questions appear

19. Relative Femoral Neck Lengthening
Added Procedures:
Osteochondroplasty
Physeal arrest for LLD
Relative Femoral Neck Lengthening
*Note the non-surgical procedures are also located in this form * *
For example:
Added an option for Contoured DCP
Error in answer
choices reported

20. (Q3) What post-operative casting/orthosis prescribed?
Changed Questions
(Q3) What post-operative casting/orthosis prescribed?
Abduction pillow
Wide abduction brace
(Q5) Weight-bearing Status
**answer choices match the Clinic Visit – Physician form

21. Coordinator Conference Calls – August 2017
Outline and clearly communicate specific changes within the IPSG so that all satellite sites are on the same page as the lead site
Answer any questions and address concerns.
IPSG Recent Changes
Stress the importance of:
Completing the short-term data audit
Internally auditing all local data over time
Labeling and Uploading all patient x-rays
IPSG Data – Audit and X-Rays
Establish open lines of communication to increase the quality of the study
Communication

22. Data Auditing – Initial Data Audit for Manuscript
Purpose of this audit is to gather as much of the IPSG patient data as possible in the first three instruments to run analysis for the Demographics Paper
We recognize that gathering new question data may not be possible.
Need sites to locally review their own data
The Demographics manuscript describes from a global standpoint how children with early stage Perthes have initially presented.
We need data updated to:
Document Inclusion/Exclusion Criteria
Confirm patients are in the correct cohort for data analysis
Deadline: September 1, 2017

23. Early Stage Studies - for those reaching: Skeletal Maturity or their 5 year visit
Skeletal Maturity: defined as any of the following:
Radiographically apparent
Girls > 14 years
Boys > 16 years
Standing of bilateral X-ray of the lower extremity
Stulberg Classification
Leg Length discrepancy
Mechanical Axis Deviation (valgus/varus and amount)
Modified Hip Harris Score
Iowa Hip Score
IPSG measurements (at 2 and 5 years)
Deformity index, Stulberg Classification, Hip morphology, Sphericity Deviation Score

24. IPSG Resources
REDCap Website:
IPSG Website:
New patient screening form:
Data Collection Sheets and other Resources:
Database or Datasheet errors should be reported to: