Clinical Protocol Criteria

SDTM based SPARQL Expression

HL7 based SPARQL Expression

Start of the SPARQL query - setting up the appropriate patient variables

SELECT ?patient
WHERE {
?patient rdf:type sdtm:Patient .
?x sdtm:subject ?patient .

SELECT ?patient
WHERE {
?patient rdf:type hl7:Person .
?patient hl7:player hl7:Patient .

monotherapy with metformin, insulin secretagogue, or alpha-glucosidase inhibitors, or a low-dose combination of these at ≤ 50% maximal dose
Dosing is stable for 8 weeks

?x1 sdtm:subject ?patient .
?x1 rdf:type sdtm:Metformin .
?x1 sdtm:dosePerAdministration ?doseX1 .
?x1 sdtm:maxDosage ?maxDose .
?x1 sdtm:endDateTime ?dateTimeX1 .
OPTIONAL {
?x2 sdtm:subject ?patient .
?x2 rdf:type sdtm:Metformin .
?x2 sdtm:dosePerAdministration ?doseX2 .
?x2 sdtm:startDateTime ?dateTimeX2 .
FILTER ((?doseX1 <> ?doseX2 && ?dateTimeX2-?dateTimex1 < 8 weeks)
| | ?doseX1/?maxDose > 0.5)
}
FILTER (?doseX1/?maxDose < 0.5 && !BOUND(?x2))
UNION
/* similar expression for InsulinSecretagogue */
UNION
/* Similar expression for AlphaGlucosidaseInhibitors */

?x1 hl7:subject ?patient .
?x1 rdf:type hl7:SubstanceAdministration .
?x1 hl7:consumable ?consumable1 .
?consumable1 rdf:type hl7:Medication .
?consumable1 hl7:hasName "Coded Entry for Metformin" .
?x1 hl7:doseQuantity ?doseX1 .
?x1 hl7:maxDoseQuantity ?maxDose .
?x1 hl7:effectiveTime ?timeInterval1 .
?timeInterval1 hl7:end ?dateTimeX1 .
OPTIONAL {
?x2 hl7:subject ?patient .
?x1 hl7:consumable ?consumable2 .
?consumable2 rdf:type hl7:Medication .
?consumable2 hl7:hasName "Coded Entry for Metformin" .
?x2 hl7:doseQuantity ?doseX2 .
?x1 hl7:effectiveTime ?timeInterval2
?timeInterval2 hl7:end ?dateTimeX2 .
FILTER ((?doseX1 <> ?doseX2 && ?dateTimeX2-?dateTimex1 < 8 weeks)
| | ?doseX2/?maxDose > 0.5)
}
FILTER (?doseX1/?maxDose < 0.5 && !BOUND(?x2))
UNION
/* similar expression for InsulinSecretagogue */
UNION
/* Similar expression for AlphaGlucosidaseInhibitors */

FPG ≤ 225 mg/dL and HbA1c > 7% and ≤ 9.5%

?result1 rdf:type sdtm:FPG .
?result1 sdtm:hasValue ?value1 .
?result1 sdtm:hasUnit sdtm:mgdL .
?result2 rdf:type sdtm:HbA1c .
?result2 sdtm:hasValue ?value2 .
?result2 sdtm:hasUnit sdtm:percentage
FILTER ( ?value1 <= 225 && ?value2 > 7 && ?value2 <= 9.5 )

?result1 rdf:type hl7:FPG .
?result1 hl7:hasData ?value1 .
?result2 rdf:type hl7:Hemoglobin .
?result2 hl7:hasData ?value2 .
FILTER ( ?value1 <= 225 && ?value2 > 7 && ?value2 <= 9.5 )

Age ≥ 18 and < 75

?patient sdtm:hasAge ?age .
FILTER ( ?age >= 18 && ?age < 75 )

?patient hl7:birthTime ?birthTime .
FILTER ( today - ?birthTime >= 18 && today - ?birthTime < 75)

History of long-term therapy with insulin (> 30 days) within the last year

?x rdf:type sdtm:Insulin .
?x sdtm:startDate ?date1 .
?x sdtm:endDate ?date2 .
FILTER
(
( ?date1 >= (today-1year) && ?date2 <= today && ?date2-?date1 > 30 days )
| | (?date1 < (today-1year) && ?date2 > today && (today-1year-?date1 > 30 days | | ?date2-today+1year > 30 days))
| | ?date1 < today-1year
)

Therapy with rosiglitazone (Avandia) or pioglitazone (Actos), or extendin-4 (Byetta), alone or in combination in the previous 6 months

?x rdf:type ?y .
{
?y owl:equivalentClass sdtm:Rosiglitazone .
UNION
?y owl:equivalentClass sdtm:Pioglitazone .
UNION
?y owl:equivalentClass sdtm:ExtendIn-4 .
}
?x sdtm:startDateTime ?date1 .
?x sdtm:endDateTime ?date2 .
FILTER (?date1 > today-6months | | ?date2 > today-6months)

Patients requiring corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)

{
{?x rdf:type sdtm:Corticosteriod .
?x sdtm:startDateTime ?date .
FILTER (today - ?date < 3months) }
UNION
{ _:x1 rdf:type sdtm:Corticosteriod .
...
_:x14 rdf:type sdtm:Corticosteriod .
_:x1 sdtm:administrationRoute sdtm:Oral .
...
_:x14 sdtm:administrationRoute sdtm:Oral .
_:x1 sdtm:startDateTime ?date1 .
_:x2 sdtm:startDateTime ?date2 .
...
_:x14 sdtm:startDateTime ?date14 .
FILTER (?date2 = ?date1+1day && ... ?date14 = ?date1+14days) }
}

Use of weightloss drugs e.g., Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanol-amine), or similar medications within 3 months of screening

?x rdf:type sdtm:Medication .
?x sdtm:hasCategory sdtm:WeightLossMedication .
?x sdtm:startDateTime ?startDate .
?x sdtm:endDateTime ?endDate .
FILTER (?startDate > today-3months | | ?endDate > today - 3months)

Serum creatinine > 1.4 for women and > 1.5 for men or eGFR < 60 calculated using the Modification of Diet in Renal Disease (MDRD) equation

{ ?result rdf:type sdtm:SerumCreatinine .
?result sdtm:hasValue ?value .
?patient sdtm:gender ?gender .
FILTER ( ?value > 1.5 && ?gender = "male" | | ?value > 1.4 && ?gender = "female" ) }
UNION { ?result rdf:type sdtm:eGFR .
?result sdtm:hasValue ?value .
?result sdtm:hasMethod sdtm:MDRDEquation .
FILTER ( ?value < 60 ) }

Uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg on three or more assessments on more than one day)

?bp1 sdtm:subject ?patient .
?bp1 sdtm:hasValue ?value1 .
?bp1 rdf:type ?y .
?bp1 sdtm:hasUnit sdtm:mmHg .
?bp1 sdtm:dateTimeOfMeasurement ?date1
...
?bp3 sdtm:subject ?patient .
?bp3 rdf:type ?y .
?bp3 sdtm:hasValue ?value3 .
?bp3 sdtm:hasUnit sdtm:mmHg .
?bp3 sdtm:dateTimeOfMeasurement ?date3
{ ?y owl:equivalentClass sdtm:SystolicBloodPressure .
FILTER (?value1 > 150 && ?value2 > 150 && ?value3 > 150 && (?date1 <> ?date2 | | ?date2 <> ?date3 | | ?date3 <> ?date1) }
UNION
{ ?y owl:equivalentClass sdtm:DiastolicBloodPressure .
FILTER (?value1 > 95 && ?value2 > 95 && ?value3 > 95 && (?date1 <> ?date2 | | ?date2 <> ?date3 | | ?date3 <> ?date1) )

?bp1 hl7:subject ?patient .
?bp1 hl7:hasData ?value1 .
?bp1 rdf:type ?y .
?bp1 hl7:datatype ??? .
?bp1 hl7:effectiveTime ?timeInterval1 .
?timeInterval1 hl7:start ?date1 .
...
?bp3 hl7:subject ?patient .
?bp3 hl7:hasData ?value3 .
?bp3 rdf:type ?y .
?bp3 hl7:datatype ??? .
?bp3 hl7:effectiveTime ?timeInterval3 .
?timeInterval3 hl7:start ?date3 .
{ ?y owl:equivalentClass hl7:SystolicBloodPressureObservation .
FILTER (?value1 > 150 && ?value2 > 150 && ?value3 > 150 && (?date1 <> ?date2 | | ?date2 <> ?date3 | | ?date3 <> ?date1) }
UNION
{ ?y owl:equivalentClass hl7:DiastolicBloodPressureObservation .
FILTER (?value1 > 95 && ?value2 > 95 && ?value3 > 95 && (?date1 <> ?date2 | | ?date2 <> ?date3 | | ?date3 <> ?date1) )

Platelets < 100000 cu mm at screening

?x rdf:type sdtm:Platelets .
?x sdtm:hasValue ?value .
?x sdtm:hasUnit sdtm:cu_mm .
FILTER ( ?value < 100000 )

AST (SGOT) > 2.50 x ULN or ALT (SGPT) > 2.50 x ULN at screening

{ ?x rdf:type sdtm:AST_SGOT .
?x sdtm:hasValue ?value.
?x sdtm:upperLimitReferenceRange ?uln .
FILTER ( ?value > 2.5 * ?uln ) }
UNION
{ ?x rdf:type sdtm:ALT_SGPT .
?x sdtm:hasValue ?value.
?x sdtm:upperLimitReferenceRange .
FILTER ( ?value > 2.5 * ?uln ) }

Total Bilirubin > 1.50 x ULN at screening

?x rdf:type sdtm:TotalBilirubin .
?x sdtm:hasValue ?value .
?x sdtm:upperLimitReferenceRange ?uln .
FILTER ( ?value > 1.5 * ?uln )

Triglycerides (TG) > 500 mg/dL at screening

?x rdf:type sdtm:Triglycerides .
?x sdtm:hasValue ?value .
?x sdtm:hasUnit sdtm:mgdL .
FILTER ( ?value > 500 )

Chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months

_:x1 rdf:type sdtm:NSAID .
_:x1 sdtm:startDateTime ?date1 .
...
_:x8 rdf:type sdtm:NSAID .
_:x8 sdtm:startDateTime ?date8 .
FILTER (?date1 > today-2months && ?date8 < today && ?date2 = date1+1day && ... && ?date8 = ?date1+7days)

Use of warfarin (Coumadin), clopidogrel (Plavix) or other anticoagulants

?x rdf:type sdtm:AntiCoagulant .

Use of probenecid (Benemid, Probalan), sulfinpyrazone (Anturane) or other uricosuric agents

?x rdf:type sdtm:UricosuricAgent .

Hemoglobin < 12 g/dL (males), < 10 g/dL (females) at screening

?x rdf:type sdtm:Hemoglobin .
?x sdtm:hasValue ?value .
?x sdtm:hasUnit sdtm:gdL .
?patient sdtm:gender ?gender .
FILTER ( ?value < 12 && ?gender = "male" | | ?value < 10 && ?gender = "female" )