Below are four example use cases utilizing the ACT Network.
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Use Case 1: Rheumatoid Arthritis

Clinical trial to evaluate safety and efficacy of a novel biologic in early rheumatoid arthritis inadequate responders to methotrexate.

Inclusion Criteria:

Diagnosis

  • Rheumatoid arthritis (ICD-9 714.0)
  • Duration of disease: <2 years
  • Active disease: CRP >1.2x ULN or ESR >30 mm/hr (note: clinical findings generally required for enrollment, but would not be in structured data)

Demographics

  • Age: Between 18 and 75 years
  • Sex: No criteria

Medications

  • Methotrexate >3 months at >7.5 mg/week
  • Currently on Prednisone <10 mg/day or not on prednisone
  • No current biologic (etanercept, golimumab, adalimiumab, infliximab, certulizumab, anakinra, rituximab) or JAK inhibitor (tofacitinib)

Laboratory

  • Hgb >10 g/dl, ALT and AST <ULN
  • and T bili <ULN, Creatinine <ULN

Exclusion Criteria

  • Active tuberculosis
  • Hepatitis B
  • Hepatitis C
  • HIV
  • Pregnancy
  • Enrolled in another clinical trial

Pseudocode

Age between 18 and 75 years
AND Rheumatoid arthritis diagnosis
AND NOT [Tuberculosis, Hepatitis B, Hepatitis C, or HIV diagnosis]

AND methotrexate order
AND NOT [prednisone >10 mg/day orders, tanercept, golimumab, adalimumab, infliximab, 
certolizumab, anakinra, rituximab, or tofacitinib orders] since 1 January 2014

AND NOT [Hemoglobin ≤10 g/dL, ALT ≥55 U/L, AST ≥48 U/L, Total bilirubin ≥1.0 mg/dL, 
or Creatinine ≥1.3 mg/dL] since 1 January 2014

Use Case 2: Hepatitis C

Identification of subjects with early stage fibrosis secondary to Hepatitis C infection.

Inclusion Criteria

Diagnosis

  • Hepatitis C ICD9 code 070.54
  • HCV RNA positive

Demographics

  • Age: 18 to 64
  • Sex: No criteria

Laboratory

  • AST available
  • ALT available
  • Platelet count available

Exclusion Criteria

  • Prior treatment with interferon

Pseudocode

Age between 18 and 64 years
AND Hepatitis C (ICD9 070.54) diagnosis 

AND positive Hepatitis C RNA test or Hepatitis C virus Ab or Hepatitis C virus IgG Ab
AND has Platelet measurement
AND has ALT measurement
AND has AST measurement

AND NOT [interferon order]

Use Case 3: Multiple Sclerosis

Inclusion Criteria:

Diagnosis

  • Diagnosed with or suspected relapsing remitting multiple sclerosis optic neuritis ,transverse myelitis, cerebral or brainstem demyelinating event, neuromyelitis optica, migraine with abnormal MRI, CNS demyelinating event
  • Duration of disease: no restriction
  • Active disease: evidence by brain or spinal cord MRI, oligoclonal banding

Demographics

  • Age: Between 18 and 65 years inclusive
  • Sex: No criteria

Medications

  • Steroids currently or anytime in the last 6 months
  • Anti-coagulation or anti-platelet therapy (e.g. Coumadin, Pradaxa, Plavix, heparin)
  • Use of interferon beta 1a, interferon beta 1b, glatiramer acetate, natalizumab, teroflunomide, dimethyl fumarate, fingolimod, mitoxantrone, rituximab, cyclophosphamide, IVIG) in past 6 months

Laboratory

  • IgG Index any level
  • White blood cell count
  • Negative VDRL
  • Myelin basic protein

Exclusion Criteria

  • History of Hepatitis B or C
  • HIV
  • History of lymphoma
  • History of bone marrow transplant

Use Case 4: Biliary atresia

Rare pediatric disease use case (contributed by Ronald J. Sokol, Colorado Clinical and Translational Sciences Institute)

Proposed Clinical Trial: Clinical trial of new anti-fibrosis medication for children with biliary atresia who have undergone hepatic portoenterostomy and have evidence of portal hypertension but have not yet had liver transplant.

Inclusion criteria

Diagnosis

  • Diagnosis of biliary atresia (ICD-9-CM 751.61)
  • Status post Kasai hepatic portoenterostomy (ICD-9-CM 51.37 or CPT code 47701, 47765, or 47785)
  • Presence of portal hypertension (572.3), or as defined by either platelet count < 100,000 or WBC < 4,000 or presence of esophageal varices (ICD-9 CM 456.0, 456.1, 456.20, 456.21)

Demographics

  • Age: 2 years through 18 years
  • Gender: No critera
  • Race/Ethnicity: Any race or ethnic group

Exclusion criteria

  • Having undergone a liver transplantation (CPT – 47135, 47136)
  • Serum creatinine > 1.5 mg/dl
  • Asthma (ICD-9-CM 493.0, 493.1, 493.2, 493.8, 493.9)