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Decisional Dilemmas in Discontinuing Prolonged Disease-Modifying Treatment for Multiple Sclerosis
Comparative Effectiveness Reviews, No. 150
Investigators: Mary Butler, PhD, MBA, Mary L Forte, PhD, DC, Natalie Schwehr, MAc, LAc, Adam Carpenter, MD, and Robert L Kane, MD.
Author Information and AffiliationsStructured Abstract
Objective:
We conducted a systematic review to examine the long-term consequences of discontinuing disease-modifying treatment (DMT) for multiple sclerosis (MS) by examining the long-term benefits and harms, and the reasons for discontinuing treatment. We also examined the evidence for people's values, beliefs, and preferences regarding discontinuing DMT.
Data sources:
We searched Medline®, PsycInfo®, Scopus, and the Cochrane Clinical Trials Registry through August 2014 plus reference lists of included studies and recent systematic reviews.
Methods:
Two investigators screened abstracts and full texts of identified references for eligibility. Eligible studies included studies of over 3 years that examined Food and Drug Administration–approved DMTs compared with placebo, other active DMT, or no DMT for adults with clinically isolated syndrome or MS in outpatient settings for patient-centered outcomes. We excluded studies of mitoxantrone, since it has a maximum lifetime dosage. Timing was relaxed for women who were considering pregnancy or already pregnant or patients discontinuing natalizumab due to risk factor changes. We extracted data, assessed risk of bias of individual studies, and evaluated strength of the body of evidence for each comparison and outcome. We also evaluated, using Technical Brief methods, studies of any design that examined individuals' attitudes, values, and preferences for discontinuing treatments and health states, or factors and processes patients with MS and clinicians use in shared decisionmaking.
Results:
We identified 27 unique studies with discontinuation information: 16 of these contained complete information to allow full analysis of long-term benefits and harms. Evidence was insufficient for long-term benefits of DMTs for secondary progressive MS patients and most outcomes for relapsing-remitting MS (RRMS) patients. Low-strength evidence suggests higher long-term all-cause survival for treatment-naïve RRMS patients who did not delay starting interferon beta-1b by 2 years and used DMTs for a longer duration than for those who started later. Low-strength evidence suggests that interferon did not change RRMS patients' disability progression. Limited low-strength evidence suggests that long-term harms do not differ from short-term harms. The majority of discontinuation tends to occur within 2 to 3 years. Another 25 unique studies provided intrapersonal, interpersonal, and shared decisionmaking information. No study directly asked why people may be reluctant to discontinue when treatment no longer seems effective; taken as a whole, the literature set provides some insight. The preferences literature underscores the complexity of the topic and the processes underlying decisionmaking.
Conclusions:
MS patients and providers have little information to guide decisions to discontinue DMT.
Contents
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2012-00016-I. Prepared by: Minnesota Evidence-based Practice Center, Minneapolis, MN
Suggested citation:
Butler M, Forte ML, Schwehr N, Carpenter A, Kane RL. Decisional Dilemmas in Discontinuing Prolonged Disease-Modifying Treatment for Multiple Sclerosis. Comparative Effectiveness Review No. 150. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2012-00016-I.) AHRQ Publication No. 15-EHC012-EF. Rockville, MD: Agency for Healthcare Research and Quality; April 2015. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00016-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
AHRQ or U.S. Department of Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
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.ahrq.gov
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