Home Medizin Die Macht der von Patienten berichteten Ergebnisse, die durch Barrieren gehemmt werden

Die Macht der von Patienten berichteten Ergebnisse, die durch Barrieren gehemmt werden

von NFI Redaktion

WEST PALM BEACH, Florida – Patient-Reported Outcomes (PROs) define the issues that are important to the patient, but their potential in Multiple Sclerosis (MS) is likely to remain untapped until obstacles, including lack of incentives, are systematically addressed. This was discussed by experts participating in a symposium at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024.

These obstacles include a lack of consensus on how and which PROs should be collected, the absence of a systematic method for interpreting the significance of PRO changes, and the lack of reimbursement for the time spent capturing PRO data and entering it into medical records, said Robert McBurney, PhD, President of the nonprofit Accelerated Cure Project for Multiple Sclerosis, Washington, DC.

Useful Clinical Information

PROs can identify hidden symptoms of MS and provide information on the relative importance of standard disease progression measures, such as disability, but currently „these are rarely captured or used as a guide for treatment decisions,“ said McBurney.

According to McBurney, a meaningful analogy can be drawn between MS and musculoskeletal disorders such as arthritis. In both cases, not all patients experience the burden of the disease in the same way, whether through conventional laboratory or imaging evidence of disease activity, or through PROs capturing anxiety, depression, and specific impairments that impact daily activities.

However, the Centers for Medicare and Medicaid Services (CMS) now mandate the input of PRO data for reimbursement of certain forms of orthopedic surgery, while MS, according to McBurney, lags behind.

The difference between orthopedics and MS lies in the evidence presented to CMS showing that improvement in PROs is important for patient outcomes and well-being. McBurney argued that the same type of data is lacking for MS.

There is a need for better-designed clinical studies to confirm that positive impacts on PROs can improve treatment outcomes for patients, but McBurney suggested that PRO data from the many MS patient registries could be a simpler first step. He reported that 24 out of 43 MS registries worldwide now capture PRO data.

Unfortunately, the AXON registry managed by the American Academy of Neurology is not among them, McBurney said. This is not an oversight. McBurney explained that the first attempt to add PROs to the data collected by AXON began more than five years ago, but several complications thwarted the process. A new effort is currently planned.

By developing data showing the importance of PROs, AAN could „take the lead“ in establishing the collection of PRO data as a standard for care and obtaining third-party reimbursement, McBurney said.

However, he warned that a validated methodology for capturing PRO data and identifying clinically significant changes in scores will be crucial for the benefit of PROs.

A Way Forward

Ideally, PRO data collected during a patient visit would resemble a lab test. Just as blood tests generate data in the context of normative ranges for a dozen or more parameters, PRO data could be displayed with the same context type, allowing doctors and patients to see a specific PRO measurement compared to a normative range, making the results easily interpretable, McBurney said.

But there are obstacles here too. There are numerous validated PRO sets available without a consensus on which could serve as a standard. While Dr. McBurney highlighted the SymptoMScreen tool as one that is already recommended by the MS Data Alliance, a nonprofit organization supported by the European Charcot Foundation to turn real MS data into evidence suitable for MS care, he acknowledged that this is just one of many options.

„The SymptoMScreen has been used in several clinical studies and is relatively easy to use,“ said McBurney. While there is no single „best“ instrument for measuring PROs, a standard could drive the process forward.

Giancarlo Comi, MD, President of the European Charcot Foundation, agreed that PROs are likely to be integrated into routine MS treatment as all the current obstacles described by McBurney are being addressed.

Comi said PROs are particularly important in treating progressive MS, as he believes traditional biomarkers such as brain images may poorly capture disease burden.

„The EMA [European Medicines Agency] and FDA [Food and Drug Administration] are both very interested in using PROs to evaluate treatments for MS,“ he said.

PROs could be integrated into routine care by doctors who believe they help in treatment decision-making, but McBurney and Comi agree that a certain approach, including financial incentives, is likely needed to encourage doctors to capture and record PROs before they are routinely used.

Dr. McBurney reports no relevant financial disclosures. Dr. Comi reports financial relationships with Almirall, Celgene, Genzyme, Hoffman-LaRoche, Janssen, Merck, Novartis, and Sanofi.

Related Posts

Adblock Detected

Please support us by disabling your AdBlocker extension from your browsers for our website.