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Table 6 Exclusion decisions rendered during case review for Trial 2

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

Exclusion criterion Exclusion reasons for participants (n =22) who met a single exclusion criterion Exclusion reasons for participants (n =11) who met multiple exclusion criteria Number of participants meeting each exclusion criterion alone or combined with another
Evaluation or referral required* 7 9 16
Compliance^ 7 5 12
Aortic aneurysm 2 1 3
Alcohol or drug use 2 1 3
Treatment safety 2 1 3
Concurrent clinical management% 1 2 3
Memory impairment 1 1 2
Quebec Task Force for Spinal Disorders classification# 0 1 1
Cancer, active treatment 0 1 1
  1. *Evaluation or referral reasons such as recent medication changes with new onset of side effects, cardiovascular symptoms (e.g., unstable angina, new onset cardiac symptoms), progressive neurological signs/symptoms, depression or other mental health concern, etc.
  2. ^Compliance concerns such as transportation issues, family or work responsibilities, or reluctance for randomization to medical care group.
  3. %Concurrent clinical management such as advanced renal disease or cardiovascular disease.
  4. #Quebec Task Force for Spinal Disorders classifications 10 to 11 were exclusionary in this trial.