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Past Opportunities to Provide Input
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Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
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- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
- Executive Team
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- Staff Conflict of Interest Disclosures
Multiple sclerosis is an often disabling neurological condition that affects about 400,000 people in the United States. People with MS can develop a wide variety of symptoms, including vision problems, fatigue, pain, and loss of coordination. The disease is diagnosed by a thorough examination that may use magnetic resonance imaging (MRI) to detect damage, or lesions, in the brain and spinal cord.
The majority of people newly diagnosed with MS go through periods of relative health followed by episodes of new or worsening symptoms, referred to as relapses. Since 1993, disease-modifying therapies have been available that can lessen the frequency and severity of relapses and prevent new MRI lesions. The Food and Drug Administration has approved 14 drugs to treat the symptoms and slow the course of this relapsing-remitting form of MS.
A PCORI-funded study is now testing whether some patients, after years of successful treatment, could safely stop taking those drugs.
Why is this an important issue? The average annual wholesale cost of the drugs is $90,000. Some of the treatments are taken orally, but others require injections. Most have side effects, some of which can be serious. “I give myself a shot three times a week. I don’t want to do that for the rest of my life,” says Robin Beland, MBA, a vice president of sales at a technology company, who was diagnosed with MS around 20 years ago.
So, he and a team of both researchers and other members of the healthcare community have launched a project to begin to answer that question. The study will recruit 300 patients with MS at 15 centers across the country. The patients in the study have been continuously taking MS medications for at least five years with no relapses or new lesions. Half of the participants will be randomly assigned to stop taking their medicines, and the other half will continue.
I give myself a shot three times a week. I don’t want to do that for the rest of my life.Robin Beland, MBA
The research team will closely monitor the patients for two years, performing MRI scans and tracking symptoms, to see how the patients who continue taking the disease-modifying therapies compare to those who halt their medicines.
Although it is important for patients to continue in their assigned group at least until they have a new relapse or MRI lesion, all participants will retain the right to stop, restart, or change their medicine should they feel that is appropriate for them.
The study is enrolling people age 55 and older. “As patients age, relapses generally happen less often, and there’s a reduction in new lesions,” Corboy says. “And most importantly, studies have shown that as people age, the medicines tend to be less effective.”
It’s possible, Corboy says, that Beland, who is 55, and others are getting little or no benefit from their medications, while still experiencing side effects.
Weighing the Risks of Stopping Medication
Beland plans to sign up for the study. “I do MRIs yearly, and I don’t have any new lesions. I don’t know if that’s because of the drug or not,” she says.
PCORI's Multiple Sclerosis Focus
As of March 2017, PCORI has funded seven patient-centered comparative clinical effectiveness research studies, totaling $26 million, about multiple sclerosis (MS).
Two of those studies compare the pros and cons of drugs to reduce MS attacks or slow the disease’s progression. Another assesses whether patients with MS in rural and low-income areas benefit as much from rehabilitation therapies provided via telehealth as they do from clinic-delivered treatments.
For more information, see our topic page, fact sheet, and a listing of current funded projects related to MS. You can also learn more about other PCORI-funded projects on MS in these blog posts: When a Clinician Becomes a Patient and A Multifaceted Disease Requires a Patient-Centered Response. Learn more about the former post’s guest author, Stephanie Buxhoeveden, here.
She’s willing to risk having a relapse if the study randomly assigns her to the group of the patients who stop taking medicines. “If I go off the medicine and something happens, then I’ll go back on,” she says.
Corboy’s team is getting ready to enroll patients at 15 study sites, three of which are supported by funding from the National Multiple Sclerosis Society. To gauge the likelihood of success in recruiting participants, the team did a preliminary survey asking patients whether they’d consider joining such a study.
“Some people are scared about going off medication,” Corboy says. “They say, ‘If it ain’t broke, don’t fix it.’ They won’t want to join our study, and we understand their concerns. But everybody is interested in the study’s results.”
If the research finds no downside to stopping medication, Corboy thinks a larger study should take place, perhaps homing in on the best age to stop taking the medications. If, however, going off disease-modifying drugs carries significant risks, Corboy says, “that would reassure physicians and patients that it’s worthwhile to continue to use these medications in spite of the costs and hassle and side effects.”
There could, of course, be a gray area in the results, where patients face a slight risk of relapse or lesion if they stop treatments. Each patient and doctor would then need to weigh the options together.
Patients and other stakeholders have been involved from the beginning of the study through two stakeholder advisory committees based at the University of Colorado and the Cleveland Clinic, one of the study sites. The advisory committees worked intensively on the language in questionnaires to ask patients about how satisfied they are with their treatment or lack thereof.
“Ultimately, patient satisfaction is the bottom line,” Corboy says.
Editor's note: At the time that this blog post was published, Diane E. Bild, MD, MPH served as associate director in the Clinical Effectiveness and Decision Science program.
September 23, 2021, 3:45 PM
Comment by lewis,
I was diagnosed with MS in August of this year--the icing on the cake of what has been 2020. I viewed this a set back and we would work through this together. My husband was very supportive, but has taken on the role of 'caregiver' more than spouse. In my case, this has not been necessary but has erected an immovable barrier between us as he turns more and more to coworkers for emotional support. If I try to show him emotional support for what he has lost in my diagnosis, he pushes me away and denies there is a problem. In the meantime, he talks to his coworkers about his feelings. I am on LTD now, I driving again and can look after myself. I am not in need of a nurse or caregiver. I can walk without aid, I am diligent about exercising, diet, and meditation, and brain building games to keep myself as sharp as I can be after the relapse. But I am feeling lost and alone as my husband turns away from me and all support I offer to engage instead on a deeper level with people at work.
May 4, 2021, 12:48 AM
Comment by Cindi,
I’ve had MS for 29 years... i am now 50. I was scared being finally informed at 22 of this diagnosis so at first i was on medications... participated in an oral myelin sheath study that failed in the end, then took copaxone, rebif, Avonex... i was in and out of the hospital needing the 5 days of IV steroids during for about a 9 year period of time and then i had enough and went off meds...i was done!!
In about the last 20 years I’ve had 2 bouts of optic neuritis last being 12 years ago and have been symptom free while being off medication... I’ve had only 1 new lesion seen 3 years ago that we can tell which hadn’t caused any symptoms. I’m only 1 of many MS patients at my neurologist office on no medications and continuing to do as well as i do.
Unfortunately my sister 2 years older than i, having been diagnosed 4-5 years after i was, is not as fortunate. She has been through the gambit of meds/treatment now on Ocrevus for past 2 years but no new lessons and without exacerbation in past 5 years. Unfortunately her symptoms have now caused her to go on disability being unable to walk safely, being wheelchair bound. She relies on the medication as well as every 3 week steroid infusion to keep going as well as she can. I find it amazing that 2 people, within the same family have very individualized disease processes and how the medication effect each one differently!
March 12, 2021, 8:04 AM
Comment by mary,
I couldn’t & didn’t tolerate Copaxone. I’m 61 and also wondering if I can stop Rebif. I’ve been on all the injections over the course of my diagnosis of 24 years.
February 21, 2021, 10:45 PM
Comment by Lori A Belmont,
Diagnosed in 2013, no changes on scan at all 2021 pretty much, avonex, want to go off....62 y/o, i personally think ive had it forever im so clumsy.
December 4, 2020, 4:11 AM
Comment by Pauline,
I am 61 years old. Diagnosed at age 40. On Avonex for the first 7 years. Had a really bad exacerbation. Switched to copaxone. Fairly stable now and have reduced injections to 3 times per week from daily. I’m thinking about stopping.
I’m curious as to what this study has found.
October 23, 2020, 5:45 PM
Comment by Susan R Stolt,
I am very interested in this study. Diagnosed in 2000 with MS, I endured 4-5 years of frequent relapses. My medications were Copaxone (2 months), Rebif (5 years), and Plegridy (6 years). I am 55 and have had no relapses (or maybe mild ones that I didn't notice?) for the last 16 years. Just this month, my insurance informed that it will no longer pay for Plegridy and wants me to try out an additional DMT. I'm unsure if I should do this, or just discontinue medication entirely. Please someone help me to make the decision.
October 1, 2020, 11:13 AM
Comment by Dosula,
According to the NMSS, some people stop taking disease-modifying medication for reasons including side effects, perceptions they’re not feeling better or because they still experience exacerbations, or insurance purposes.
August 12, 2020, 12:26 PM
Comment by PCORI Blog,
Hi, Sebastian. Thanks for reading our blog. This study is ongoing through 2021. You can sign up for updates by visiting the project page and clicking the Sign Up for Updates box near the top of the page.
August 4, 2020, 7:26 AM
Comment by Sebastian,
Was diagnosed in 2007 at age 18.
I’m 31 now and have been on Avonex for 13 years with no symptoms / attacks during that time. Last MRI a few years ago was clean with no new lesions.
I’m still young but would love to know what happens with this study. My doctor says if I make it to 40 with no attacks, he’ll pull me off the meds.
June 17, 2020, 6:50 PM
Comment by Deborah Cayson,
I am 59, diagnosed in 1992 and have been taking Betaseron with very little lesions accept in the beginning, no new ones as of most recent mri last year. Doctor now only sees me yearly. I too am interested in learning the result of this study.
June 3, 2020, 6:52 PM
Comment by lilly,
I’ve been on meds since 2002. Just stopped Tecfidera in 2020. All has been pretty good for a long, long time. Will have an MRI in a year to see how it looks
I am 62
April 22, 2020, 8:47 PM
Comment by Ann Brueser,
I have taken Copaxone since it came out in 1997. I switched the 40 mg when it came out which was a welcome relief after all those years taking it daily. I have had no relapses for years and my MRI's pretty much doesn't change. My doctor talked about going off it since they don't really know yet the long term for the drug in older patients. I turn 65 soon and the cost will be so much more on Medicare than it was on my regular insurance with the Shared Solutions copay help. Never had to pay a cent. On Medicare it will cost into the thousands out of pocket. So wondering about not taking it anymore.
March 31, 2020, 1:18 AM
Comment by Kathleen Orr,
I was diagnosed with MS at 50 and was on Betaseron for 18 years. I had only minimal symptoms during that time and no big changes in lesions. My neurologist took me off Betaseron even though I would have preferred to continue. About 6 months later I had symptoms similar to my first diagnosis, like facial numbness, eye and ear pain. I was hospitalized and given steroids but told it was not MS related-probably trigeminal neuralgia. Now I have had a hip replacement and a revision of that replacement and 9
months later I still cannot walk with a normal gate. I am wondering if the issue is MS related.
November 19, 2019, 10:03 PM
Comment by Debbie Baker,
Was diagnosed in 1988 at the age of 27. I have been on avonex for 10 years and rebif for 12 years, and am now 59.. My MRIs have been stable on meds for 12 years. My neurologist wants me to come off rebif, and as others are am apprehensive. He agreed to do an MRI in 6 months of I stop my rebif. Would certainly be interested in the study.
November 11, 2019, 12:17 AM
Comment by Joyce,
I was diagnosed in 1978/79 at 27 and now am 70 with having given myself injections of Copaxone for the past 20 years. I would love to quit the drugs as it is expensive at Social Security age and the new insurances out there along with just tired of the shots. I have been free of any attacks for probably 30 years.
October 15, 2019, 12:59 PM
Comment by Rose Levine,
I was diagnosed with MS since 1998 and have been on Avonex since then.
I will be 66 next week and find that the side effects are getting more pronounced. To say I would love to be off this medication is an understatement. I have been well with no relapses and no visible sign off the disease in 20 years. Please put me on your monthly updates.
Thank you Rose
September 13, 2019, 12:59 AM
Comment by Ken Underwood,
Interested in study? I will be 64 shortly and have been on seven different DMT’s over twenty five years. Currently on Aubagio. Neurologist mentioned going off before much longer, six months. Going in for MRI and decide then.
January 11, 2019, 2:54 PM
Comment by PCORI Blog,
Hi, Beth, thanks for reading. We encourage you to find out more about this study by visiting the project page and clicking Sign Up for Updates box near the top of the page to receive email updates.
January 11, 2019, 2:55 PM
Comment by PCORI Blog,
Hi Charlotte. We don’t have a related funded project in your area at this time, but we encourage you to stay up to date on this study by visiting the project page and clicking the Sign Up for Updates box near the top of the page. Our topic page can provide you more information on PCORI’s multiple sclerosis research portfolio.
January 11, 2019, 2:53 PM
Comment by PCORI Blog,
Hi, Aron, thanks for your comment. We encourage you to stay up to date on this study by visiting the project page and clicking the Sign Up for Updates box in near the top of the page.
January 11, 2019, 2:56 PM
Comment by PCORI Blog,
Hi, Beth, thanks for reading. We encourage you to find out more about this study by visiting the project page and clicking the Sign Up for Updates box near the top of the page to receive email updates.
March 27, 2019, 9:29 PM
Comment by PCORI Blog,
Hi, Nancy, thanks for your comment. This project is ongoing, so there aren't results yet, but we suggest clicking on the Sign Up for Updates box near the top of the project page to stay informed on this work.
March 27, 2019, 9:32 PM
Comment by PCORI Blog,
Thanks, everyone, for your comments. We suggest signing up for email updates for news on this project by clicking the Sign Up for Updates box near the top of the project page.
July 31, 2019, 7:26 PM
Comment by PCORI Blog,
Hi, Julie, thanks for reading. This study is ongoing through 2021. You can sign up for updates by visiting the project page and clicking the Sign Up for Updates box near the top of the page.
August 19, 2019, 10:37 AM
Comment by Karen,
I am following this closely. I was dx'd 3 weeks shy of 52 and will be 57 in a few months, so I will hit that 5 year no-relapse-NEDA-on-the-annual-MRI mark very soon. I really did want to participate in this study, but alas, I washed out on the exclusion criteria (I've had cancer in the last 5 years). I am on Tec with only minor side-effects, but I would prefer to not be on a medication that no one really knows for sure is working at my age. I'm sticking it out for now, but the results of this study are of great interest to many of us of a certain age and at a certain point in the MS festivities.
August 9, 2019, 6:37 PM
Comment by ivy,
I haven’t had a new lesion in 10 years! I’ve been on betaseron , avonex and now Tecfidera. I’m 61 and my lymphocytes systematically dropping . My doc seems concerned about taking me off the meds. At this age, I’m afraid of the meds Messing with my white blood cells
August 8, 2019, 7:13 PM
Comment by Gloria,
Was your grandmother getting the infusion for the all of the 30 years she was diagnosed?
July 28, 2019, 2:00 AM
Comment by Julie Chham,
July 7, 2019, 12:45 PM
Comment by janice kaiser,
Diagnosed in 2000 am now turning 73. No relapses and on Avonex. Been wanting to stop for couple of years now. Have no neurologist presently. Will be consulting primary care to see about stopping meds.
June 19, 2019, 11:59 PM
Comment by jill,
I was dx in 1998 and was on copaxon until last year, I was switched over To Aubagio and have been on it for almost a year. I stopp d taking it this week and have made an appointment with my neurologist. I am having peripheral neuropathy. At this point, the other medications carry too much risk of cancer, breast, thyroid, skin so I am planning on going back to Copaxon. I’m 57, I work out 4 times a week, 3 at Pure Barre and one yoga, I ride my horses at least three times a week and work. I would honestly love to get off all these medications. This study is fascinating to me, I will be following your data.
June 13, 2019, 5:17 PM
Comment by Janice Songer,
I too am 59 and suspected by neurologist to have MS in late 80s, but since he said he couldn’t do anything I didn’t have spinal tap to confirm. Symptoms went away and I forgot about it till it was found in 2005. Started with Copaxone but had problems. Told I was benign ms and I stopped treatment. Started on Avonex a few years later. Got worse and had to retire. Couldn’t afford the medication so got off it 2012. Got better for a few years. DNA test shows I don’t metabolism neuro meds right. Now balance worse, but DR can’t address DNA results, just try and see. Still not on anything and trying to judge what gives me the best quality of life.
June 11, 2019, 4:33 PM
Comment by Quynh-Loan Luong,
I was diagnosed in with MS, at 51, in 2012 and have been treated with Copaxone, Tysarbri, back to Copaxone, Ocreveus and now waiting for Siponimod. I had relapses while on Copaxone. Ocreveus did not help me and I experienced many side effects. My MS was downgraded to either primary/secondary PP. After going through all the screening tests for Siponimod/Mayzent, I am seriously considering going off medication.
May 19, 2019, 2:49 AM
Comment by liliana,
DONT! A doctor recommended that my grandmother (who had been treated for MS 30 + years via infusions) stop taking getting her infusions and she died a month later. This is a women who was still shooting hoops in the backyard with Her grandchildren days before she died. There is no evidence that suggests it’s safer to stop being treated. This “theory” lead to fatal advice.
May 10, 2019, 1:28 AM
Comment by Susan,
Very interesting article. This is the first I've learned that the MS drugs lose there effectiveness as you age. I will be 70 next year and had been on Copaxone for 16 years. Little change in my MRI's, but they do show a lot of lesions, but no new physical issues except for balance and fatigue. I wonder why my Dr insists on staying on a DMD forever? I have decided to go off of it for a while to see if I notice a difference, but my Dr is really unhappy. Is he getting a kik back or something?? I didn't know about a study, I'm on the East coast, but really want to know about this. Thank you for the article!
May 10, 2019, 1:18 AM
Comment by Susan,
Hello Judith, I was glad to see someone who is in my age bracket that was on Copaxone for many years. I was DX with Gillian Barre syndrome in 2002, then DX with MS in 2003 after sixth nerve palsy in my eye causing severe double vision (which went away in about 8 weeks). After going in Copaxone that year, there were no more exacerbations -- they just stopped. I deal mostly with fatigue and poor balance. Yearly MRI's had only occasional new lesions with no symptoms. I keep asking my Dr if i can stop the injections, I will be 70 next year. I took myself off and my Dr is not happy. I wonder if I did the right thing? But you know the hassle of injections -- and I do not want a drug that makes me feel bad. So I just stopped.
April 19, 2019, 10:37 PM
Comment by cindy m wiegand,
hi beth I am 57yrs and recently diagnose w/ MS 2018 was a very stressful yr DR wants me start Ocrevus I am scared to star Ocrevus trade off does not look good as women ended up with breast cancer; respiratory infections migraines etc.. with Ocrevus Did it help?
April 15, 2019, 5:00 PM
Comment by Stephen,
This is a good idea. Perhaps a long trial of treatment followed by observation would be best. Especially since the prices of the medicines are so high these days. Perhaps insurance companies would support doing the research.
March 27, 2019, 9:30 PM
Comment by PCORI Blog,
Thanks for reading, Maureen.
March 25, 2019, 10:02 PM
Comment by malissa thompson,
I am 59 and have had MS for 31 years-now in Secondary progressive- I would love to discontinue Avonex as I’m losing a day a week from side effects- have discussed this with my neuro and she was okay with it for a year with a before and after MRI
March 20, 2019, 10:54 PM
Comment by Louanne Nourse,
Your study is of critical importance to so many of we Baby Boomers who may have been diagnosed early but are aging without a roadmap on our MS. I was diagnosed with RRMS in 2002 and have remained on Copaxone/Glatopa ever since. My neurologist recommends that I end injections at age 65, in just a few months as studies were showing medication might not be effective. A recent brain MRI showed no new activity. I would like to stop but relapse or a shift to Progressive is frightening. Some studies seem to indicate the odds of this shift are relatively high. Thank you for this study. Are you still accepting participant applications?
March 18, 2019, 6:17 PM
Comment by maureen ruffino,
I was diagnosed with RRMS in 1996. I started on Copaxone injections on April 15, 1997 and have been on it ever since. I will be 65 next month. I would love to stop the injections and have some fear of stopping since I have been very very stable for nearly 15 years. But to not have the cost and the trouble is very appealing.
March 14, 2019, 11:13 PM
Comment by nancy,
What was the outcome of the study about those who stopped taking their MS drug? Thank you!
February 27, 2019, 7:29 PM
Comment by PCORI Blog,
Hello, Judith. Thank you so much for your comment.
February 16, 2019, 6:59 PM
Comment by judith brooks,
I was diagnosed with MS in 2001 by Dr, Barbara Guisser in Tucson AZ. I started on Copaxone right away and took it faithfully until last September. when I switched to Aubagio. I have NEVER had a relapse nor a change in my MRI’s.
I will be 75 yo this year and have decided to stop taking all medications for MS.
December 20, 2018, 5:38 PM
Comment by Nakiesha Salter,
how are you now? I started taking Copaxone but I feel like crap and have been thinking of getting off.
November 28, 2018, 10:40 PM
Comment by PCORI,
Hi, Gloria. Thanks for your comment. We recommend talking to your physician about what treatment option might be right for you.
November 28, 2018, 10:39 PM
Comment by PCORI,
Hello, Kaye. Thank you for your comment. If you'd like to find out more on this study, you may do so here.
November 25, 2018, 2:28 AM
Comment by andrea,
I would love to know more about this study. I was told I had ms in 2007 but had Lyme in 2004. I chose not to take meds but in 2017 started having more trouble and after meeting a new neurologist, I chose ocrevus infusion. I don’t do meds well and having side effects. But going to try for awhile. I’m really not wanting to take this long periods of time. I’m 51 now and in good health otherwise. I’ve alwsys taken vitaminD and believe other herbs have helped me a long the way. I would love more information.
November 5, 2018, 11:30 PM
Comment by Celia,
I was dx 11/2013 with RRMS and was on Copaxone since. I stopped taken the medication about one year ago and have no new lessions signs or symptoms.
October 23, 2018, 4:55 PM
Comment by Charlotte Hanson,
Do you know of any similar studies being conducted in other areas of the country? I live in Nashville, TN and we have an MS clinic here through Vanderbilt Neurology. I only had one episode which led to diagnosis. After 5 years with no episodes and no new activity shown on MRIs for that period, I came off of Avonex. I would like to know more about long-term risks for being off meds. I would participate in a study, if it were in Nashville, TN.
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