Participant diversity in clinical trials of rehabilitation interventions for people with multiple sclerosis: A scoping review.

BACKGROUND

The selection and description of participants in clinical trials enables health care providers to determine generalizability of findings to the populations they serve. Limited diversity of participants in trials restricts evidence-based decision-making.

OBJECTIVES

To determine the extent to which diverse participants are being included in clinical trials of rehabilitation interventions for people with multiple sclerosis (MS).

METHODS

We conducted a scoping review of MS rehabilitation trials published since January 2002 using MEDLINE, CINAHL, and Web of Science. Covidence was used to facilitate the review. Article selection required randomized control design, a rehabilitation intervention, and a functional status outcome. Data extracted included details of intervention(s), outcomes, and participant selection and description using a social determinants of health framework.

RESULT: A total of 243 studies were included. Exercise interventions and impairment-focused outcomes were most common. Most studies used only a MS Clinic for recruitment. Common exclusion criteria were physical or mental comorbidities, disability, age, and cognitive impairment. Participant age and sex were reported for almost all trials; reporting of other social determinants of health was atypical.

CONCLUSION

MS rehabilitation trials have used limited recruitment methods, restricted samples, and reported few participant descriptors. Changes are required to enhance participant diversity and the descriptions of participant characteristics.