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. 2021 Nov 27;21:264. doi: 10.1186/s12874-021-01464-x

Table 1.

Host trial eligibility criteria

Criterion % Rationale
Aged 18 years or over; 0% The content is not suitable to people under 18; for example, given the program’s focus on daily functioning associated with work, university, parenting, etc. Coupled with consideration of MS demographics, inclusion of persons 17 or under is not warranted.
Fluent in written and spoken English; 1.6% Given the program’s focus on group interaction, fluency in the majority language (i.e. English) is vital for being able to fully participate and engage in the program, as well as avoiding confound.
Have a diagnosis of multiple sclerosis; 0% COB-MS is a Cognitive Occupation-Based program for people with MS and cognitive difficulties; thus, a diagnosis of MS is fundamental.
Have cognitive difficulties; 72% COB-MS is a Cognitive Occupation-Based program for people with MS and cognitive difficulties; thus, having cognitive difficulties is fundamental.
No neurologic history other than MS (e.g. dementia); 8.1% Presence of another neurologic condition could potentially confound the research.
No history of major depressive disorder, schizophrenia, or bipolar disorder I or II; 4.8% Presence of such conditions could potentially confound the research.
No history of diagnosed substance use or dependence disorder; 1.6% Presence of such histories could potentially confound the research.
Not currently undergoing any other form of cognitive rehabilitation; 3.2% An alternative form of cognitive rehabilitation could confound the research.
Not currently experiencing an active relapse; 3.2% Ethically, it would not be appropriate to ask individuals to participate in the program if they were experiencing an active relapse. Moreover, an active relapse could confound the research.
Are a resident of the Republic of Ireland; 1.6% Residency in Ireland is a practical requirement in relation to the feasibility and acceptability of the trial in the context of a country whose healthcare is provided by the Health Service Executive and more specifically, COB-MS delivered through CORU-registered occupational therapists.
Not living with cognitive impairment that would affect reliable participation or capacity to give informed consent; 0% Cognitive impairment to such extent would impede participants’ ability to reliably participate in, engage with and feasibly implement the program, which is fundamental to its design. Moreover, impairment to such extent could confound the research.
Not incarcerated or institutionalized; and 3.2% Incarceration or institutionalisation could prohibit an individual’s ability to participate in and engage with the program.
Not living with organic brain damage (unrelated to MS). 1.6% Presence of such conditions or damage could potentially confound the research.