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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.
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ISSN: 1745-6215