SCTC Arthritis Sub-Committee Summary
Working Group Leaders: Jessica Gordon, MD, MSc, Sindhu Johnson, MD, PhD, and Phil Clements, MD
- Develop arthritis specific outcome measures for use in clinical trials in SSc
- Delphi Goal – make recommendations for future study of outcome measures
Activities 2014-5: Delphi exercise – 2 rounds of voting.
Question posed to participants:
- Vote on various outcomes with respect to its use in a clinical trial focused on arthritis in SSc.
- For use in a clinical trial each measure should be feasible, reliable, valid, and able to show change.
- Items were ranked 1-9. Plan was to disregard any items with a mean score <3, keep items with a mean score >7 and reconsider items rated >3 and <7.
- Complete Delphi Exercise
- Make recommendations for outcome measures to be used as secondary v primary outcomes in SSc clinical trials.
Table shows outcome measure and mean score for Delphi Round 1/Delphi Round 2
|Disregard (mean score <3)||Reconsider (mean score 3-7)||Keep (mean score >7)|
|Joint Tenderness Count 44 5.96/5.02||Joint Tenderness Count 28 7.51/7.20|
|Joint Tenderness Count 66 5.9/4.06||Joint Swelling Count 287.38/7.0|
|Joint Swelling Count 44 5.87/5.06||TFR 8.27/8.15|
|Joint Swelling Count 665.02/3.89||Contractures- small joints 7.27/7.27|
|Synovitis 28 6.52/6.10||Contractures- large joints 7.15/7.06|
|Synovitis 44 5.26/4.71||CRP7.30/7.10|
|Synovitis 4.98/3.75||sHAQ – DI7.44/7.63|
|Finger to palm (mm) 6.23/5.65||Pt. Global VAS/Likert 7.19/7.25|
|FTP-Delta (n=8) 5.96/5.52|
|Michigan Hand Disability Index (added)5.47|
|MD Global VAS/Likert6.92/6.9|
|ROM large joints 5.55/5.73|
Participants Comments listed below:
Unclear how to differentiate “arthritis” from sclerodermatous skin disease-related symptoms and dysfunction.
It was difficult for me to cross compare the various patient-reported outcome measures because some of them are newer and there is less literature on their utility in systemic sclerosis.
Measures need to be practical.
Patient burden is main consideration as volume of forms being filled out is becoming excessive for severely affected patients.
The choice of PRO is difficult. The problem is we don’t know which will be most sensitive to change. A comparison in an interventional study would be useful even if the drug does not work to try to assess which of the hand PROs moves the best with physical exam or other measures.
RE: tendon rubs and ultrasound. I believe that we should employ develop simple means of identifying rubs more sensitive than palpation. Ultrasound on static subject won’t do it. I would suggest this be further pursued and I think is very much needed.
This is excellent exercise covers a lot of area
I think that we should only use instruments that have been validated in SSc. I could not find any references pertaining to SSc for the Michigan Hand Disability Instrument. As a group, perhaps we should validate the instruments we plan to use if validation has not already been done?
I did not score synovitis highly as I don’t know what it means beyond a TJC and SJC. Counting more joints increases error. CKs have nothing to do with inflammatory arthritis, so I likely over scored it. The standardization and sensitivity to change of US in a multi-site trial of SSc IA would be a nightmare and MRIs of joints are not really feasible, so they were scored low. Michigan Hand scale is not sensitive to change in SSc
I voted no for PROMIS because I think that the questions included in this instrument would be altered in patients with joint disease but also in patients with myositis, severe anemia, lung disease, heart disease, etc, so it would be confusing. I think that we should include CK and Hb in the evaluation not as outcomes but to rule out that the symptoms are due to myopahty or anemia.
My answers reflect the specificity of the question – “arthritis”. Many low rated measures belong in overall assessment of disease, e.g. PT and MD globals
1. ROM is not only related to “arthritis” but to soft tissue contractures. so if treating arthritis that may not change. 2. u/s may be the best objective way to track synovitis and now available in many places. have to see if we could standardize results across sites. 3.clinical “synovitis” itself may be good if we could agree on a definition and demonstrate some intra- and inter-observer reliability. sort of a combo of tenderness and swelling that in mind of observer represents synovial inflammation. also needs reliabilty testing
1) Could not access the info on some of the hand scales (ie pdf not available without pay). 2) Ultrasound seems rather underscored considering its current value. Particularly for detecting possible changes
SCTC Arthritis Working Group – Minutes 11.7.15
- Delphi Findings Review
- Items scored >7 will be kept
- Is it an issue that ultrasound is not used/ranked highly?
- There’s no standardization for analysis
- Could make strong recommendation in paper’s body text
- Standardization should be coming…
- Can be reimbursed for doing US, not so much for MRI. Potential impact?
- Arthritis vs. Tendinopathy
- Can you observe a contracted tendon on ultrasound?
- What about tendinosis?
- Perhaps an important thing to observe in patients who now have looser skin, but still have ongoing contractions
- Synovitis is difficult to palpate in SSc…
- Reason why US is so important
- Table to include in paper/prior to administering Delphi III
- What are PRO’s?
- What PRO’s have been used in SSc? Which have been validated?
- Information to include: Ease of use, additional personnel/equipment
- Next steps
- Send out progress report from this meeting to SCTC
- Update respondents on the missing PRO’s
- Report not only mean score, but perhaps the proportion of people receiving 7 or higher.
- Tips for next round
- Include ESR in addition to CRP, as CRP is not always as readily accessible outside of the US.
- Provide a write-up/background on Assessments/PRO’s for investigators to read prior to completing next round. Investigators may not currently be familiar with them (ex: Cochin).
- Have Delphi respondents identify themselves (years assessing SSc, etc.) prior to next round.
- Remove all “Keeps” and only show “Reconsiders”
- A few Q’s
- “Is it ok to delete Joint Tenderness Count 44/66 & Joint Swelling Count 44/66?” – Perhaps ask in the next round Delphi
- “Is it an issue that we don’t use these in practice?”