Table 1.

Clinical trials that reported patient and public involvement in their design and conduct.

Author (years)	Name	Description	Funder/country	People affected by MS/members of public	Other stakeholders	Nature of stakeholder involvement a
Ehde et al. 10	MS-care trial	Test of a collaborative care intervention vs usual care in an outpatient specialty clinic for participants with chronic pain and/or major depressive disorder	PCORI/United States	Individuals with MS, partners/family members of individuals with MS	MS clinic providers/staff, representatives of community advocacy groups	Shaping study design and intervention, identifying outcomes of interest to stakeholders, troubleshooting problems during study implementation, monitoring study progress, participating in dissemination of study results
Kratz et al. 12	COMBO-MS trial	Test of cognitive behavioral therapy (CBT), modafinil, or both for fatigue in MS	PCORI/United States	Individuals with MS, family members and partners of people with MS	MS neurologists and clinical staff, payer representatives from Blue Care Network, individuals from community advocacy groups	Research questions developed from clinician stakeholders’ experiences, and input from patient and payer stakeholders. Protocol developed with stakeholder input and consensus stakeholder approval before finalization. Quarterly team meetings involve all stakeholders and address study operations including regulatory issues, recruitment and retention strategies, adverse events, treatment adherence. In the first year of study, stakeholders chose layout and photos for recruitment materials, made eligibility criteria broader and more inclusive, added outcome measures, provided guidance as to how to return information to study participants
Kever et al. 10	ASPIRE trial	Test of aspirin as a means of preventing overheating and improving exercise performance in MS as compared to acetaminophen and placebo	NIH/United States	Individuals with MS involved throughout development and conduct of the study		Input regarding outcome variables and study design. Incorporated participant feedback from a prior pilot trial
Motl et al. 13	STEP for MS	To compare a supervised, facility-based setting vs a remotely coached/guided, home-based setting using telerehabilitation for walking dysfunction and mobility disability	PCORI/United States	People with MS, caregivers	Clinicians (physicians and rehabilitation providers with experience in MS), community exercise specialists, representatives from MS advocacy groups including the National MS Society and iConquerMS, a policymaker, insurance representative	Person with MS included as co-investigator, member of study steering committee, chair of the advisory board. The advisory board provided input regarding delivery and evaluation methods of the intervention, including selection of screening tools, primary and secondary outcome measures, testing the web portal, decisions regarding frequency and length of assessment visits, strategies for recruitment and revisions of the training manual and other study materials. The board met monthly during the planning phase of the study and will meet every 2 months during the intervention phase. During the final phase, the board will engage in data interpretation and dissemination of findings
Plow et al. 18	REFRESH	To compare three formats of delivering the Managing Fatigue intervention: teleconference, Internet, and in person	PCORI/United States	Individuals with MS	Policy advocates, insurance representatives, clinicians, researchers	Inform all aspects of the study including drafting and reviewing recruitment and intervention material, study branding, selecting the delivery formats to test, assessing acceptability of online questionnaires, and review of the informed consent process. Stakeholders will continue to meet throughout the study to guide recruitment, disseminate findings and create an infrastructure for implementation
Ontaneda et al. 15	DELIVER-MS	To compare the effectiveness of early intensive vs escalation approaches for the treatment of relapsing remitting MS	PCORI/United States and United Kingdom	People with MS, caregivers of people with MS	Insurance industry representatives, healthcare agency regulators, advocacy group representatives, investigators constitute advisory committee	Advisory committee informs, guides planning, conduct, dissemination of the clinical trial. Works with the steering committee.
Nourbakhsh et al.16,17	TRIUMPHANT-MS	To test modafinil, amantadine, methylphenidate for MS fatigue	PCORI/United States	Patients with MS	Advisory committee including academic and community neurologists, experts in MS fatigue, representative from National MS Society	Provided guidance and feedback during design, execution and reporting of trial results
Nordfalk et al. 14		To evaluate the effect of specific communication training for neurologists on how to provide complex information about treatment options to patients with MS	Stiftelsen Dam/Norway	Patient with MS	Professor of medical ethics	Served as advisory group

MS: multiple sclerosis; NIH: National Institutes of Health; PCORI: Patient-Centered Outcomes Research Institute.

^aNo distinctions were described in the nature of the involvement of people affected by multiple sclerosis (MS) versus other stakeholders.