OMERACT RA Remission: Patient Perspective Lay Summary

Background
At OMERACT 2010 the draft ACR-EULAR remission criteria were criticized during a workshop because
participants felt patient-important information might be missing. The ACR-EULAR rheumatoid
arthritis (RA) remission criteria include three items that are scored by patients themselves (patient
reported outcomes). These are patient global assessment (‘considering all the ways your arthritis
affects you how would you say your health is’), pain, and physical function. It was unknown whether
this captures everything that matters to patients. A working group was formed to tackle this
problem.
First, we ran nine focus groups (group discussions) across 3 countries to see what people with RA
said was important for them to consider themselves in remission (their ‘disease activity as good as
gone’). Then we took all the things people told us were important from these groups (‘domains’),
and put them into a survey using the same wording patients had used in the focus groups. We sent
the survey to people with RA (274 responses from 6 countries) and asked them to rate how
important each of these domains are to them, and to pick their top three. We found that pain,
fatigue and independence were the most important for patients to consider their disease activity as
good as gone.
For the three top priorities for patients, these quotes provide an example of how they were
discussed in the focus groups:
Pain: “No pain is remission”; “When the disease was as good as gone I had absolutely no symptoms; I
was strong, had absolutely no pain”
Fatigue: “For me the stiffness and fatigue. That I would just have the energy, then I would even be
prepared to put up with the pain
Independence: “Independence of personal care and independence of the jobs in the house”; “I’m
happy if I can open a jar of cucumbers without going to somebody else and asking for help”

The next step involved studying patients over time to see whether these prioritized domains make
any difference to assessing patients as in remission or not, and to look at which instruments work
best to measure these, and then decide whether this information points towards the need to change
the current ACR-EULAR definition.
We looked at whether patients were in remission according to the ACR-EULAR definition (‘Boolean
remission’), whether they would consider themselves in remission (‘patient-perceived remission’),
we tried different instruments for measuring pain, fatigue and independence. For independence a
numerical rating scale (participants select a number from 0 to 10) asking “Over the last week, have
you been able to do things as and when you want, without needing any kind of assistance?”, scoring
0 for no assistance to 10 for a lot of assistance.
246 patients selected for having low disease activity were included at the start of the study, and 200+
were followed up at 3 and 6 months to see whether changes in patient responses to the instruments
track with changes in their disease activity status. Treatment was not controlled.

Problems: much fewer patients than anticipated, 3 and 6 month data only from two centers, no
radiograph data, limited data (especially over time) on independence

Results
Pain and fatigue numerical rating scales (NRS) work well in the low disease activity setting.
For the new instrument ‘independence NRS’ results are mixed, but interesting. The value of adding
items to the current criteria appears limited, but replacement of Patient Global Assessment (PtGA)
for either fatigue or independence could be further explored, as these domains appear to be a strong
predictor of good Health Assessment Questionnaire (HAQ) outcome.
A comparison of the difference between patient-perceived and Boolean (ACR-EULAR) remission
reveals that Boolean criteria are stricter than patient-perceived remission. Most discrepant patients
(those who were not in remission according to both Boolean and self-perceived remission) are in
self-perceived remission but not Boolean remission; patients meeting Boolean but not self-perceived
remission are very rare. In patients not meeting Boolean remission it is often PtGA that fails. The
mean (average) of PtGA in such patients is about 2 (out of 10).

Conclusions
1. The current data is limited, but given our experience to date, this is all we are likely to get for
the coming 5-10 years.
2. With this data we can conclude that pain and fatigue (in the current core set), but also
independence, are important domains in the patient perception of (near) remission. Our
PRPs note that for independence it will be important to distinguish between disease activity
and existing damage.
3. A proposal to change the current definition needs very strong arguments for several reasons.
The data presented here are in themselves insufficient for such a proposal. However, a
discussion can be started about the cutoff point for PtGA and the need to collect further data
to support substitution of PtGA for either fatigue or independence.