Adherence coaching is not shared-decision making!

The paper by Col et al. (
Col et al., 2023
) reports on an RCT studying the impact of a web-based MS support tool on DMT utilization in n = 507 patients with RRMS against usual care as the control group. We highly appreciate the authors’ efforts to develop a digital intervention aiming to empower patients, but we strongly reject the work to be titled as “implementing shared decision-making” (SDM).

Besides age > 18 and a planned appointment, no further inclusion criterion was applied. 265 and 242 pwMS were randomized to two groups. However, about one-third of both groups did not provide FU data until the study ended after 12 months. At baseline, about 80 % in both groups were on DMTs, more than 50 % received infusion therapies, only 25 % were on tablets, and less than 20 % had either stopped DMT or never had a DMT in the past. Based on a trend of more DMT usage in previously untreated groups in the MS-SUPPORT tool group and a shorter time to start treatment, the authors conclude the tool's efficacy. In addition, authors report higher rates of “perfect adherence” in daily dosed DMTs in the MS-SUPPORT group with impressive 81 % versus 56 %, however as well not significant. A number of other outcome results, most of them non-significant trends, are reported based on PROMS. The authors conclude improved SDM, together with more DMT utilization and adherence.

This study leaves more questions than it answers. First, the goal of the intervention is not clear. SDM does not primarily aim at increasing DMT utilization and adherence rates. Based on the development studies, there is no evidence that MS-SUPPORT is really a tool to facilitate SDM. (
Stacey et al., 2024
) SDM is a communication model or process in which people who are personally affected or potentially affected by a health problem work with healthcare professionals to make informed health decisions based on the available evidence and their values. Patient decision aids are tools to facilitate SDM by helping “patients to make specific and deliberate choices from among healthcare options“. (
Col et al., 2019
) Based on the inclusion criteria, the characteristics of the participants and the information on the MS-SUPPORT tool in the supplement, it seems like a decision to be made was not necessary to be included in the study (e.g. to start an immunotherapy or different interventions to be physically active).

While measuring SDM is far from straightforward, no outcomes aiming to document the most important element of “sharing” in the SDM process are provided. No information about increased knowledge is communicated, which often is a primary goal of patient decision aids to facilitate the communication between the patient and the physician. Without providing evidence-based patient information, SDM resulting in informed patient choice is impossible, which seems not to be given as documented in the developmental work of MS-SUPPORT (
Col et al., 2019
). Here, treatment effects on relapses, disability, and MRI are not adequately presented, e.g., as absolute risk reductions, but just summarized with an indication of beneficial effects for all listed DMTs for all outcomes. Also the many inherent uncertainties (nicely described in the updated Cochrane review on MS immunotherapies by (
Gonzalez-Lorenzo et al., 2024
)) seem not to be communicated when going though the developmental paper. It seems like the MS-SUPPORT is rather designed to support PwMS when ambivalences occur, affecting, for example, medication adherence, or to support also lifestyle changes or indicate that starting a decision-making process might be appropriate (e.g. due to side effects). Therefore, the adequate framing of the intervention rather would have been “a DMT utilization and adherence promoting intervention”. A substantial number of patients was lost in the FU, making any conclusion for the primary endpoint, which was only met by trend, difficult.

Taken together, it is a pity that the enormous effort and burden on patients and physicians does not help to increase our understanding of DMT management in MS based on SDM. Furthermore, the concept of SDM seems to be misunderstood as here a rather paternalistic approach was followed by focussing on the importance of patients following clinicians’ advice and adhering to DMTs.