HCLS/ClinicalObservationsInteroperability/SPARQL8.html
Clinical Protocol Criteria | SDTM 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 . |
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 |
| ?doseX1/?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 ) |
Age ≥ 18 and < 75 | ?patient sdtm:hasAge ?age . FILTER ( ?age >= 18 && ?age < 75 ) |
History of long-term therapy with insulin (> 30 days) within the last year | | (?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) ) |
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 | | ?value < 10 && ?gender = "female" ) |