A prospective cohort study investigating contributors to mild cognitive impairment in adults with spinal cord injury: study protocol

Table 1 Predictors, primary and secondary outcome measures, and assessment timepoints

Assessment time-points	Visit-type
Study phase	Acute monitoring	At rehab		At discharge	In community
Visit number		(V0)	(V1)	(V2)	(V3)
Eligibility pre-screening (by treating Clinician)		✓
Informed Consent			✓
Primary outcome
Measure	Measurement tool
Cognitive functioning	NUCOG		✓	✓	✓
Predictors* and secondary outcomes**
Measure	Measurement tool
Autonomic assessment*	HRV		✓	✓	✓
Current medications*	Medical records	✓	✓	✓	✓
Diagnostic evidence of TBI*	Cerebral CT/MRI scan	✓
	GCS	✓
	PTA	✓
Demographics*	Medical records	✓
Environmental factors*	Carer/family status		✓	✓	✓
Environmental factors*	Compensation status		✓	✓	✓
Injury characteristics*	Medical records	✓
Medical History*	Medical records	✓
Other co-morbidities	Medical records*	✓
Other co-morbidities	SCI SCS**		✓	✓	✓
Participation measure**	WHODAS domain				✓
Personal factors**	ADAPSS		✓	✓	✓
	Brief COPE		✓	✓	✓
	CD-RISC Short Form		✓	✓	✓
	MSES		✓	✓	✓
	WHO ASSIST		✓	✓	✓
Psychological measures**	GAD-7		✓	✓	✓
	PCL-5		✓	✓	✓
	PHQ-9		✓	✓	✓
Psychosocial measures**	Berlin Questionnaire		✓	✓	✓
	FSS		✓	✓	✓
	ISCoS pain dataset		✓	✓	✓
	PCS		✓	✓	✓
	PSQA		✓	✓	✓
	SSQ		✓	✓	✓
QoL measure**	EQ-5D-5L		✓	✓	✓
Return to work**	Questionnaire				✓
Severity of injury*	SCI: AIS and FIM	✓
Severity of injury*	TBI: WPTAS	✓
Transition ED*	ED record	✓
Vital signs*	BP, HR, RR, and Temp	✓	✓	✓	✓

Abbreviations: ADAPSS Appraisal of DisAbility Primary and Secondary Scale, AIS American Spinal Injury Association Impairment Scale, BP blood pressure, Brief COPE Coping Orientation to Problems Experienced, CD-RISC Connor-Davidson Resilience Scale, ED Emergency Department, EQ-5D-5L Euro Quality of Life 5-Dimensional 5-level, FIM Functional Impairment Scale, FSS Fatigue Severity Scale, GAD-7 Generalized Anxiety Disorder 7-Item Scale, GCS Glasgow Coma Scale, HR heart rate, HRV heart rate variability, ISCoS International Spinal Cord Society, MH Mental health, MSES Moorong Self-efficacy Scale, NUCOG Neuropsychiatry Unit Cognitive Assessment Tool, PCS Pain Catastrophizing Scale, PHQ-9 Patient Health Questionnaire-9, PSQA Pittsburgh Sleep Quality Assessment, PTA post-traumatic amnesia, PCL-5 Post-traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders Firth Version, RR respiratory rate, SCI spinal cord injury, SCI SCS Spinal Cord Injury Secondary Condition Scale, SSQ Social Support Questionnaire, TBI traumatic brain injury, Temp temperature, WHO ASSIST World Health Organisation Alcohol Smoking and Substance Involvement Screening Test, WHODAS World Health Organisation Disability Assessment Scale, WPTAS Westmead Post Traumatic Amnesia Scale
*Predictor measure
**Outcome measure

ISSN: 1471-2377