Eligibility determination for clinical trials: development of a case review process at a chiropractic research center

Table 5 Exclusion decisions rendered during case review for Trial 1

Exclusion criterion	Exclusion reasons for participants (n =122) who met a single exclusion criterion	Exclusion reasons for participants (n =63) who met multiple exclusion criteria	Number of participants meeting each exclusion criterion alone or combined with another
Other exclusions*	81	27	108
Safety risk^	17	14	26
Quebec Task Force for Spinal Disorders classification^#	13	9	22
General poor health	4	10	14
Alcohol or drug use	3	3	6
Osteoporosis	1	2	3
Uncontrolled hypertension	2	0	2
Vascular claudication	1	1	2
Bleeding disorder	0	1	1
Prior spinal surgery	0	1	1

*Other exclusions included compliance concerns, referral needed, peripheral neuropathy, neuromuscular disease, or participant unable to tolerate study procedures.
^Safety risks related to treatment or testing procedures such as inflammatory spondyloarthropathy.
^#Quebec Task Force for Spinal Disorders classifications 4 to 6 and 8 to 11 were exclusionary in this trial.

ISSN: 1745-6215