Seems Like An Old Story Now

By now I have had arthritis for more than half of my life, so it's hard to even remember feeling normal and healthy.

I have rheumatoid arthritis (RA). It’s an autoimmune disease that does not affect any of my relatives, including my 50 first cousins.

50

When my kids were pre-teens I started to have pain and swelling in my wrists, fingers and feet. I was suddenly so tired after work that I would just lie down and feel unable to get up again, even for dinner. 

I was losing weight too but I thought that was because I switched from Pepsi to Diet Coke. 

My GP doctor seemed to think the symptoms were all in my head. When I said I was extremely tired he said "You're a busy active Mom."  When I told him about my foot pain he said it was because I was on my feet a lot. And when I had an oval cyst on the back of my hand he said they used to call them Bible Thumpers, because if you whacked them with the Family Bible they would go away.

My doctor made me feel that I was exaggerating and incompetent and I felt powerless to change the situation. When I left his office I would feel I should try harder but that brief dismissal did not help me at all. I knew there was a problem - sometimes I actually could not stand up first thing in the morning and had to crawl into the bathroom. 

The last time I saw him he told me to take 12 aspirin a day and come back in 3 months. That did not work at all and I still have ringing in my ears caused by all those aspirin.

Walking Gallery Jacket by Regina Holliday reflects this era

The only way I could think of to deal with the problem was to change doctors. Sadly the 2nd Dr. was no help either. The 3^rd was actually a foot surgeon who got the right answer less than 5 minutes after I saw him in his clinic.

During that 2 years it took to be diagnosed I developed permanent joint damage in my hands and feet (also jaw and neck as I found out many years later). One seemingly trivial result was that to this day I wear ugly shoes because it’s better than limping. I have had 10 surgeries to maintain my functional abilities but have a weak grip, can’t garden or vacuum and hate to stand a lot even at parties.

I have taken immune suppressant drugs and NSAIDS for the past 30 years and managed to work up until I retired, though I did need to change my job for one that had less physical stress.

That happened in the 80’s so even when I had a name for my health problem all I knew was what I learned from my doctor. This was before home computers were common and with a job and 2 kids I did not have the time or energy to do all I needed to do, let alone go to the library to learn more.

Things are different now. Last week googled my original symptoms “pain in hands and feet, fatigue, swollen joints" and found a million results in total with 7 out of the top 10 links mentioning RA.

Imagine if I had access to that in the 1980s – I might have known very quickly what was wrong and insisted on seeing a specialist. With knowledge we have power, and it is great to see more and more patients becoming very knowledgeable about their own health.

... to be continued in the next post... Active vs Reactive Patients

This post is part of RA Blog Week at the end of Arthritis Awareness Month. To see more blogs on this topic click here

Using Orthotics in Rheumatoid Arthritis

In case you wonder what orthotics or orthoses are, here's a picture of the side view of one of my insoles beside a foot (not mine). With the side view you can see the layers that provide the support and cushioning.

Using insoles that are custom made for my feet has meant less pain, and keeps me from limping most of the time.

This week I read an abstract about a clinical trial done in the UK. It was called "Clinical effectiveness and cost-effectiveness of foot orthoses for people with established rheumatoid arthritis: an exploratory clinical trial". Though I looked for the full paper I could not gain access to it prior to writing this. I have since read the full paper. It makes my conclusions less clear cut.

The conclusion of this trial is that even though "semi-rigid customized foot orthoses can improve pain and disability scores in comparison to simple insoles" that providing them is not worth the money on a Quality Adjusted Life Year (QALY) basis. 

Fake money for false savings (IMO)

They conclude this despite the fact that people with rheumatoid arthritis (RA) have "greater difficulty with activities of daily living, increased fear of falling and greater self-reported foot impairment." 1

The pain and disability experienced by people with rheumatoid arthritis who have involvement of their weight bearing joints will frequently lead to damage to the ankles, knees or hips due to poor gait mechanics. 

It is estimated that one in three adults with RA will fall once or more times per year (Stanmore et al, 2013) with younger adults falling as often as older adults. Additionally 68% of people in the UK who have RA are reported to be physically inactive. In fact I have wondered for years why anyone thinks that a "Walk" is a good way to raise funds for RA.

People who have pain and disability when they walk are less able to remain in the workforce, accomplish normal chores and errands and often experience social isolation.

As a person who has been using customized orthotic insoles for over 32 years I would like to say that my experience of these insoles includes 1,664 weeks of use which is 350% more hours than the whole clinical trial in total which included 41 (only 29 completed the study) people for a term of 16 weeks. (464 actual person weeks of usage). 

I realize that the experience of one person is not research - it is qualitative and experiential, and yet the sheer length of time people with RA must live with this pain and disability should not be so easily disregarded. My 1664 weeks provides a perspective on the length of the trial.

Through the use of custom made orthotic insoles I have been able to delay most of the surgeries I have needed for up to twenty years. I would maintain that a 16 week trial is far too short to come  to conclusions about long term efficacy, and that this trial has limited exposure to experiential evidence, based on the short duration and small sample size.

Increased surgery and the future need for custom-made footwear might quickly erode the short term savings that would seem to benefit the healthcare system, while leaving patients with more pain and increased disability.

There is no sign that patients were involved in this trial in any way beyond being subjects. I would like to see some patient involvement in the outcomes that are to be measured in future research.

Help With RA Treatment Decisions: ANSWER-2 or a Decision Aid

My friend commented last week that in 30 years with RA she had never seen the new and far more helpful type of pamphlet or booklet called a Decision Aid. My experience was the same as hers - the only time I ever saw a decision aid was during training to be a Peer Mentor, so that I could be an advisor to people who were newly diagnosed. Decision Aids are are much more useful than an informational pamphlet.

Now imagine how useful it would be to have an interactive decision aid. That's ANSWER-2, a new tool to help patients make decisions about starting a new drug or staying on their current treatment if their doctor has recommended a biologic drug. Right now it is at the prototype stage and it is being tested against a decision aid. The researchers and patients who created it are conducting a randomized controlled trial. If you join you will be testing either ANSWER-2 or the paper based decision aid.

Background
When I was finally diagnosed with RA it was almost two years after I first developed symptoms. At that time I assumed that getting good treatment from a specialist would make me better. I was wrong then, though the treatment did help. The good news is that better results are more likely to happen now than in the 1980's
I was so sick at that time that I believe I would have taken any medical treatment suggested by a doctor to get my life back to what it had been like. I knew next to nothing about rheumatoid arthritis itself, let alone the possibilities for treatment so I did exactly what my rheumatologist suggested.

Things are different now

Before the internet was available to us all, information was scattered and hard to put together. The facts I knew did not form part of a big picture. My doctor would talk about possible new treatments but my part in the decision always slowed down the process by months because I had to find and learn what I needed to know.

It was a puzzle, not a big picture.

When I heard of a way that would help me to make important decisions I was really excited by the idea. Now that a Decision Aid can be an online interactive tool it can be a whole new ball game!

Here's what happened: 
I had reached the point where my doctor suggested it was time to think about a change in the drug I was taking for rheumatoid arthritis. After 30+ years with RA and 8 years on my previous drug, it no longer seemed to be working. 

That made me a candidate to try ANSWER-2 so I volunteered. It was developed by Arthritis Research Canada (ARC) as a research project funded by the Canadian Institute for Health Research (CIHR), and is based on scientific evidence, not information from manufacturers.

That background helped because with government funding I knew that the intention of the tool was not to promote a particular drug. It was also reassuring to me that patients were involved in the development of ANSWER-2 and participated on the research team. 

The program started by asking me about my priorities and what I thought was most important. It helped me to balance the convenience vs my anxiety about a change vs worries over starting a new drug. This was exactly what I remembered going through the first time in other decisions about new drugs.

So with those personal preferences entered, the next area dealt with the potential treatments - On to the decision area! When I saw the possible choices I found that they were ranked in a way that made perfect sense to me.

This is what the first page of ANSWER-2 looks like. Sorry it's little small.

Another benefit in using it was a description of the drugs and the comparison of the risks and benefits of each one laid out right in front of me in columns. That really helped me with my choice.

As I went through the screens I could also watch stories from real patients as a part of the program (I even knew one of them).

Since this is a prototype more people are needed to test it. At this moment the trial is only available in Canada and the US. Participating in the trial will help the investigators learn whether ANSWER-2 or a standard decision aid is more empowering to patients.

To try this out it you must have rheumatoid arthritis and be considering a decision about biologic therapy - whether to start t or to change to another drug. If you are eligible you will randomly be assigned to either the online ANSWER-2 or else a Medication Guide in a pdf version. If you test the pdf you will have access to the online version at the end of the trial.

Click this link to apply if you are in Canada. The heading on the page is "SuPER: Supporting Patient care with Electronic Resource"

OR

For US users please contact Sharan Rai at SRAI1@mgh.harvard.edu to enroll in the trial.

For US and Canada: 


To learn more, please contact Jasmina Geldman at jgeldman@arthritisresearch.ca or 1-877-871-4575. She can answer all of your questions.

Focus Group Ground Rules:Should They Apply When You Consult Patients?

When you are asked questions before you start a survey, or before you are invited to a focus group for market research you might notice that you are almost always asked a few questions before you can start the survey or be invited to a focus group.

Imagine the topic is banking. You'd be asked:

Do you or does anyone in your family work now or in the past in market research, advertising or media?
Do you now or did you ever work for a financial services provider?

If you said yes to either you would not be invited.

These are the basic questions and they're designed for two things. Sometime to keep the client's competition from learning about the client's plans or to ensure that the other focus group participants are comfortable voicing their opinions.

Focus Group

In the 20 years I spent organizing focus groups this never changed. We often asked our clients for clarification, or a bit of stretching the boundaries to make our job easier but this was never an area where there was flexibility.

When we asked for exceptions the answer we got was this:
As we go around the table and give each person a chance to speak and give their opinion, the dynamics of the discussion change dramatically after someone who is considered an expert gives an opinion on the topic of the group

No one wants to be at odds with the person who is seen to know more than the others because of experience. The person who 'knows the topic' has an overweight influence on the discussion whether they mean to or not.

I heard this point of view from another perspective at the HCSMCA Unconference in Vancouver. In a conversation with Dr. Paul Dempsey he talked about setting up a Moms group on his website so parents could support one another. He found that a lot of the wisdom of  'Dr. Mom' flowed among the participants - until he stepped in. The conversation stopped when he (the expert) started to take part.

This can make a difference when organizations, government or organized groups try to hear from patients. 

Everyone's opinions are valid, but I would suggest that when there is a broad range of experience among patients, especially when some of the patients are or were health care professionals or health care workers, that holding separate focus groups would produce a better range of opinions and include more voices.

Patient Groups - Hard Work and Lots of Questions

Last week I attended the CADTH symposium in Ottawa as a member of the Sjogren's Society of Canada.

You might wonder exactly what CADTH is and why I would want to attend. The Canadian Agency for Drugs and Technologies in Health (CADTH) is an independent, not-for-profit organization that provides public healthcare decision-makers with evidence about the appropriate use of drugs and medical devices. Patient input is used in deliberations and decisions.

It is becoming much more important in health care to have the patient, caregiver and public point of view and we see organizations making changes because of this.  Sarah Berglas of CADTH pointed out that 5 yrs ago they asked clinical experts what was important to patients. Now they are asking patients for this information.

To make it easier for patient groups to take part CADTH provides templates and sample submissions on their website to help them.

One of CADTH's aims is meaningful involvement of patients and patient groups in the drug review process.

I heard two important comments about patient submissions:

"Patient experience brings the disease to life" -- Fiona Miller

“The review team has often never met a patient with the disease” -- Frank Gavin

At one of the panels at CADTH, Zal Press of Patient Commando suggested that out of 1682 patient groups, only about 18 have the capacity to make submissions to CADTH to be considered by the Common Drug Review.

Questions that came up: 

How much thought is being given to the cost in terms of time and energy that it takes the patient group to do this?

How can patient groups running on a shoestring with few resources do a drug submission effectively?

Is this small number of groups who make submissions a good representation of the voice of patients and the public generally?

What about the idea of independent financial support for patient groups?
Are we asking too much of patient groups? We invest in clinical evidence, why not patient evidence?

Just the facts? 

Dr Ahmed Bayoumi, who is a member of the Common Drug Expert Committee, asked in the panel whether patient groups have the agency to speak for their patients. 

Dr Bayoumi said with patient submissions the decisions made are better decisions - that statement left patients in the room with questions. How do we know that our submissions really have an impact and can possibly change a decision?

Barry Stein of the Colorectal Cancer Association of Canada said he is disappointed that patient experience is most often used to enrich, rather than change, reimbursement and coverage decisions.

Are patient groups working so hard on submissions for drug after drug, just so that the decisions made in meeting can be “better”?

What about the reality that qualitative research and experiential results are heavily discounted in favour of ‘real' evidence from trials and quantitative research?

How often do we call patient experience evidence? Why do we not call it patient evidence? -- Frank Gavin

What terms do we use to describe patient input? Information is a neutral term, but patient information is not seen as data -- Frank Gavin

The panel talked about evidence vs advocacy. We are dichotomizing this form of evidence. How do we incorporate it?

Gail Attara said that understanding the patient perspective is important. "Is a fifth medication for a condition needed?" She answered Yes, if you are a patient for whom the first four didn't work. Also that the patient's individual goals and decisions may not always follow evidence.

Sarah Berglas: Need to work with patients to capture big ideas on acceptability of treatment, "how life is lived, not just survival"

Those of us attending the panel discussion got concrete advice on making our submissions  to the Common Drug Review have more impact and be more useful.

1.     Discussing unmet needs and quality of life is very relevant

2.      Be very specific about therapy, side effects and challenges e.g. efficacy decreases over time.

3.      Include numbers if we have them

4.      Include strong quotes that "hook into people's brains" and illustrate the authentic voice of the patient.

Advice to patient groups on submissions: Be specific in what you include and pick powerful direct quotes. Sarah Berglas, Patient Engagement Officer, CADTH

Ducks in a row

Advice for patient groups from Gail Attara from badgut.org

If patient groups could make submissions in person it would be more satisfying. Why can't patients comment on draft reports like other experts?

Patient group submissions are heavy on quotes, testimony and voice. Patients have the feeling that lived experience can’t compete with clinical data when the end result is up to the funders. Some patient groups wonder how much of  a difference their input makes.

There is a need to develop patient capacity.

I'm always conscious that patients have no strong networks to enable us to stay in touch and connect in between events like CADTH.

HTA provides the facts: ethics judges the facts. All who are affected need to be heard. Are patient values represented in HTA?

There is limited operational (action-oriented) guidance to assist HTA with the evaluation of ethical issues.

Even at the Plenary we heard this question: How do patient groups organize so they can feed into changes within the health care system?

A slide from Dr Ahmed Bayoumi's presentation