Use Cases

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)