From 9766a5f1db4e57e233aa46d0819d8971353dafe8 Mon Sep 17 00:00:00 2001 From: Meng-Chau Date: Thu, 11 Aug 2022 14:37:01 -0400 Subject: [PATCH 1/8] bug fix push --- .../IPledge/R4/files/IPledgeRule-0.1.0.cql | 36 +++++++++++ ...estionnaire-R4-CanGetPregnant-IPledge.json | 62 +++++++++++++++++++ ...ionnaire-R4-CannotGetPregnant-IPledge.json | 62 +++++++++++++++++++ ...naire-R4-PrescriberEnrollment-IPledge.json | 30 +++++++++ CRD-DTR/IPledge/TopicMetadata.json | 17 +++++ 5 files changed, 207 insertions(+) create mode 100644 CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql create mode 100644 CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json create mode 100644 CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json create mode 100644 CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json create mode 100644 CRD-DTR/IPledge/TopicMetadata.json diff --git a/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql new file mode 100644 index 0000000..7780fca --- /dev/null +++ b/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql @@ -0,0 +1,36 @@ +library IPledgeRule version '0.1.0' +using FHIR version '4.0.0' +include FHIRHelpers version '4.0.0' called FHIRHelpers + + +parameter Patient Patient +parameter medication_request MedicationRequest +parameter medication_dispense MedicationDispense +parameter medication_statement MedicationStatement + +define RULE_APPLIES: + true + +define PRIORAUTH_REQUIRED: + false + +define DOCUMENTATION_REQUIRED: + true + +define RESULT_InfoLink: + 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/IPledge_2020_08_04_REMS_Full.pdf' + +define RESULT_QuestionnaireOrderUri: + 'Questionnaire/IPledgeRemsPatientEnrollmentCanGetPregnant' + +define RESULT_QuestionnairePrescriberKnowledgeAssessmentUri: + 'Questionnaire/IPledgeRemsPatientEnrollmentCannotGetPregnant' + +define RESULT_QuestionnairePrescriberEnrollmentUri: + 'Questionnaire/IPledgeRemsPrescriberEnrollmentForm' + +define RESULT_requestId: + medication_request + +define RESULT_dispense: + medication_dispense \ No newline at end of file diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json new file mode 100644 index 0000000..2dae65e --- /dev/null +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json @@ -0,0 +1,62 @@ +{ + "resourceType": "Questionnaire", + "id": "IPledgeRemsPatientEnrollmentCanGetPregnant", + "name": "IPledgeRemsPatientEnrollmentCanGetPregnant", + "title": "IPledge Rems Patient Enrollment (Can Get Pregnant)", + "status": "draft", + "subjectType": [ + "Patient" + ], + "date": "2020-05-20", + "publisher": "Da Vinci DTR", + "item": [ + { + "linkId": "1", + "type": "group", + "text": "Determine Patient Category", + "item": [ + + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Pregnancy Test Results", + "item": [ + + ] + }, + { + "linkId": "3", + "type": "group", + "text": "Enter Patient Information", + "item": [ + + ] + }, + { + "linkId": "4", + "type": "group", + "text": "Informed Consent (For All Patients)", + "item": [ + + ] + }, + { + "linkId": "5", + "type": "group", + "text": "Informed Consent About Birth Defects (For Patients Who Can Get Pregnant)", + "item": [ + + ] + }, + { + "linkId": "6", + "type": "group", + "text": "Patient Counseling", + "item": [ + + ] + } + ] +} \ No newline at end of file diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json new file mode 100644 index 0000000..386864a --- /dev/null +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json @@ -0,0 +1,62 @@ +{ + "resourceType": "Questionnaire", + "id": "IPledgeRemsPatientEnrollmentCannotGetPregnant", + "name": "IPledgeRemsPatientEnrollmentCannotGetPregnant", + "title": "IPledge Rems Patient Enrollment (Cannot Get Pregnant)", + "status": "draft", + "subjectType": [ + "Patient" + ], + "date": "2020-05-20", + "publisher": "Da Vinci DTR", + "item": [ + { + "linkId": "1", + "type": "group", + "text": "Determine Patient Category", + "item": [ + + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Determine Risk Category", + "item": [ + + ] + }, + { + "linkId": "3", + "type": "group", + "text": "Confirm Risk Category", + "item": [ + + ] + }, + { + "linkId": "4", + "type": "group", + "text": "Enter Patient Information", + "item": [ + + ] + }, + { + "linkId": "5", + "type": "group", + "text": "Informed Consent (For All Patients)", + "item": [ + + ] + }, + { + "linkId": "6", + "type": "group", + "text": "Patient Counseling", + "item": [ + + ] + } + ] +} \ No newline at end of file diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json new file mode 100644 index 0000000..250bea8 --- /dev/null +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json @@ -0,0 +1,30 @@ +{ + "resourceType": "Questionnaire", + "id": "IPledgeRemsPrescriberEnrollmentForm", + "name": "IPledgeRemsPrescriberEnrollmentForm", + "title": "IPledge Rems Prescriber Enrollment Form", + "status": "draft", + "subjectType": [ + "Practitioner" + ], + "date": "2022-05-28", + "publisher": "FDA-REMS", + "item": [ + { + "linkId": "1", + "type": "group", + "text": "Prescriber Information", + "item": [ + + ] + }, + { + "linkId": "2", + "type": "group", + "text": "Prescriber Attestation", + "item": [ + + ] + } + ] +} \ No newline at end of file diff --git a/CRD-DTR/IPledge/TopicMetadata.json b/CRD-DTR/IPledge/TopicMetadata.json new file mode 100644 index 0000000..a6d33c1 --- /dev/null +++ b/CRD-DTR/IPledge/TopicMetadata.json @@ -0,0 +1,17 @@ +{ + "topic": "IPledge", + "payers": [ + "cms" + ], + "mappings": [ + { + "codeSystem": "rxnorm", + "codes":[ + "6064" + ] + } + ], + "fhirVersions": [ + "R4" + ] +} From 0a06a162b8e3217bad2396082c824a4606f514a4 Mon Sep 17 00:00:00 2001 From: Meng-Chau Date: Mon, 15 Aug 2022 08:44:07 -0400 Subject: [PATCH 2/8] Completed forms --- ...estionnaire-R4-CanGetPregnant-IPledge.json | 418 +++++++++++++++++- ...ionnaire-R4-CannotGetPregnant-IPledge.json | 317 ++++++++++++- ...naire-R4-PrescriberEnrollment-IPledge.json | 213 ++++++++- 3 files changed, 934 insertions(+), 14 deletions(-) diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json index 2dae65e..b57a447 100644 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json @@ -15,7 +15,25 @@ "type": "group", "text": "Determine Patient Category", "item": [ - + { + "linkId": "1.1", + "text": "Before enrolling your patient in the iPLEDGE REMS, you must determine if this is a patient who can become pregnant. In the iPLEDGE REMS, the definition of a patient who can become pregnant is: • A patient who has not had a hysterectomy and/or bilateral oophorectomy • The patient is not post-menopausal • A patient who has not yet started menstruating • A patient who has had a tubal sterilization • A transgender male with viable female reproductive organs", + "type": "display" + }, + { + "linkId": "1.2", + "text": "Determine patient category", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueString": "Patient who can become pregnant" + }, + { + "valueString": "Patient who cannot become pregnant" + } + ] + } ] }, { @@ -23,7 +41,39 @@ "type": "group", "text": "Pregnancy Test Results", "item": [ - + { + "linkId": "2.1", + "text": "Enter in-office test results", + "type": "display" + }, + { + "linkId": "2.2", + "text": "In office pregnancy test result", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "77386006", + "system": "http://snomed.info/sct", + "display": "In-office pregnancy test is positive" + } + }, + { + "valueCoding": { + "code": "60001007", + "system": "http://snomed.info/sct", + "display": "In-office pregnancy test is negative" + } + } + ] + }, + { + "linkId": "2.3", + "text": "Date of in-office positive or negative pregnancy test (MM/DD/YYYY)", + "type": "string", + "required": true + } ] }, { @@ -31,7 +81,94 @@ "type": "group", "text": "Enter Patient Information", "item": [ - + { + "linkId": "3.1", + "text": "First Name", + "type": "string", + "required": true + }, + { + "linkId": "3.2", + "text": "Middle Initial", + "type": "string", + "required": false + }, + { + "linkId": "3.3", + "text": "Last Name", + "type": "string", + "required": true + }, + { + "linkId": "3.4", + "text": "Address Line 1", + "type": "string", + "required": true + }, + { + "linkId": "3.5", + "text": "Address Line 2", + "type": "string", + "required": false + }, + { + "linkId": "3.6", + "text": "City", + "type": "string", + "required": true + }, + { + "linkId": "3.7", + "text": "State", + "type": "string", + "required": true + }, + { + "linkId": "3.8", + "text": "Zip", + "type": "string", + "required": true + }, + { + "linkId": "3.9", + "text": "Mobile Phone Number", + "type": "string", + "required": true + }, + { + "linkId": "3.10", + "text": "E-mail", + "type": "string", + "required": true + }, + { + "linkId": "3.11", + "text": "Date of Birth", + "type": "string", + "required": true + }, + { + "linkId": "3.12", + "text": "Preferred Method of Communication", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "email", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Email" + } + }, + { + "valueCoding": { + "code": "sms", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Text Message" + } + } + ] + } ] }, { @@ -39,7 +176,83 @@ "type": "group", "text": "Informed Consent (For All Patients)", "item": [ - + { + "linkId": "4.1", + "text": "To be completed by the patient (and parent or guardian if the patient is under age 18) and signed by the doctor. Read each item below and check the box provided if you understand each item and agree to follow your doctor's instructions. A parent or guardian of a patient under age 18 must also read and understand each item before signing the agreement. Do not sign this agreement, and do not take isotretinoin if there is anything that you do not understand about all the information you have received about using isotretinoin.", + "type": "display" + }, + { + "linkId": "4.2", + "text": "1. I understand that isotretinoin is a medicine used in patients 12 years of age and older, who are not pregnant for the treatment of severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. If untreated, severe nodular acne can lead to permanent scars.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.3", + "text": "2. My doctor has told me about my choices for treating my acne", + "type": "boolean", + "required": true + }, + { + "linkId": "4.4", + "text": "3. I understand that there are serious side effects that may happen while I am taking isotretinoin. These have been explained to me. These side effects include serious birth defects in babies of pregnant patients. [Note: There is a second informed consent about birth defects (for patients who can get pregnant)].", + "type": "boolean", + "required": true + }, + { + "linkId": "4.5", + "text": "4. I understand that some patients while taking isotretinoin or soon after stopping isotetrinoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, anxious or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sport activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives, and some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent. Some people have had other signs of depression while taking isotretinoin (see #7).", + "type": "boolean", + "required": true + }, + { + "linkId": "4.6", + "text": "5. Before I start taking isotretinoin, I agree to tell my doctor if I have ever had symptoms of depression (see #7), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.7", + "text": "6. Before I start taking isotretinoin, I agree to tell my doctor if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any other serious mental problems.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.8", + "text": "7. Once I start taking isotretinoin, I agree to stop using isotretinoin and tell my doctor right away if any of the following signs and symptoms of depression or psychosis happen. • Start to feel sad or have crying spells • Lose interest in activities I once enjoyed • Sleep too much or have trouble sleeping • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence) • Have a change in my appetite or body weight • Have trouble concentrating • Withdraw from my friends or family • Feel like I have no energy • Have feelings of worthlessness or guilt • Start having thoughts about hurting myself or taking my own life (suicidal thoughts) • Start acting on dangerous impulses • Start seeing or hearing things that are not real", + "type": "boolean", + "required": true + }, + { + "linkId": "4.9", + "text": "8. I agree to return to see my doctor every month I take isotretinoin to get a new prescription for isotretinoin, to check my progress, and to check for signs of side effects.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.10", + "text": "9. Isotretinoin wil be prescribed just for me - I will not share isotretinoin with other people because it may cause serious side effects, including birth defects.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.11", + "text": "10. I will not give blood while taking isotretinoin or for 1 moth after I stop taking isotretinoin. I understand that if someone who is pregnant gets my donated blood, their baby may be exposed to isotretinoin and may be born with serious birth defects.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.12", + "text": "11. I have read the iPLEDGE REMS Fact Sheet and other materials my provider provided me containing important safety information about isotretinoin. I understand all the information I received.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.13", + "text": "12. My doctor and I have decided I should take isotretinoin. I understand that I must be qualified in the iPLEDGE REMS to have my prescription filled each month. I understand that I can stop taking isotretinoin at any time. I agree to tell my doctor if I stop taking isotretinoin.", + "type": "boolean", + "required": true + } ] }, { @@ -47,15 +260,208 @@ "type": "group", "text": "Informed Consent About Birth Defects (For Patients Who Can Get Pregnant)", "item": [ - + { + "linkId": "5.1", + "text": "About Birth Defects (for patients who can get pregnant): To be completed by the patient (and their parent or guardian if the patient is under age 18) and signed by their doctor. Read each item below and check in the box provided to show that you understand each item and agree to follow your doctor's instructions. Do not sign this consent, and do not take isotretinoin if there is anything that you do not understand. A parent or guardian of a minor patient (under 18) must also read and check each item before signing the consent.", + "type": "display" + }, + { + "linkId": "5.2", + "text": "1. I understand that there is a very high chance that my unborn baby could have life-threatening birth defects if I am pregnant or become pregnant while taking isotretinoin. This can happen with any amount and even if take for short periods of time. This is why I must not be pregnant while taking isotretinoin.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.3", + "text": "2. I understand that I must not get pregnant one month before, during the entire time of my treatment, and for one month after the end of my treatment with isotretinoin.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.4", + "text": "3. I understand that I must completely avoid having any sexual contact (penis-vaginal) with a partner who coud get me pregnant, or I must use two separate effective forms of birth control (contraception) at the same time. The only exceptions are if I have had any surgery to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am post-menopausal.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.5", + "text": "4. I understand that hormonal birth control products are among the most effective forms of birth control. Combination birth control pills and other hormonal products include skin patches, shots, under-the-skin implants, vaginal rings, and intrauterine devices (IUDs). Any method of birth control can fail. That is why I must use two different birth control forms at the same time, starting one month before, during, and for one month after stopping therapy every time I have sexual contact (penis-vaginal) with a partner who could get me pregnant, even if one of the forms I choose is hormonal birth control.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.6", + "text": "5. I understand that the following are effective forms of birth control:", + "type": "boolean", + "required": true, + "item": [ + { + "linkId": "5.6.1", + "text": "Primary forms: • tying my tubes (tubal sterilization) • male vasectomy • intrauterine device • hormonal (combination birth control pills, skin patches, shots, under-the-skin implants, or vaginal rings)", + "type": "display" + }, + { + "linkId": "5.6.2", + "text": "Secondary forms, barrier: • male latex condom with or without spermicide • diaphragm with spermicide • cervical cap with spermicide", + "type": "display" + }, + { + "linkId": "5.6.3", + "text": "Other: • vaginal sponge (contains spermicide)", + "type": "display" + }, + { + "linkId": "5.6.4", + "text": "A diaphragm and cervical cap must each be used with spermicide, a special cream that kills sperm. I understand that at least one of my two forms of birth control must be a primary method.", + "type": "display" + } + ] + }, + { + "linkId": "5.7", + "text": "6. I will talk to my doctor about any medicines, including herbal products I plan to take during my isotretinoin treatment, because hormonal birth control forms may not work if I am taking certain medicines or herbal products.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.8", + "text": "7. I may receive a free birth control counseling session from a doctor or other family planning expert. My isotretinoin doctor can give me an iPLEDGE REMS Contraception Counseling Guide for this free consultation.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.9", + "text": "8. I must begin using the birth control forms I have chosen as described above at least one month before I start taking isotretinoin.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.10", + "text": "9. I cannot get my first prescription for isotretinoin unless my doctor has told me that I have two negative pregnancy test results. The first pregnancy test should be done when my doctor decides to prescribe isotretinoin. The second pregnancy test must be done in a lab during the first 5 days of my menstural period right before starting isotretinoin therapy treatment, or as instructed by my doctor. I will then have one pregnancy test; in a lab: • every month during treatment • at the end of treatment • and 1 month after stopping treatment. I must not start taking isotretinoin until I am sure that I am not pregnant, have negative results from two pregnancy tests, and the second test has been done in a lab.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.11", + "text": "10. I have read and understand the materials my doctor has provided to me, including the iPLEDGE REMS Guide for Patients who Can Get Pregnant and iPLEDGE REMS Fact Sheet. I have recieved information on emergency birth control.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.12", + "text": "11. I must stop taking isotretinoin right away and call my doctor if I get pregnant, miss my expected menstrual period, stop using birth control, or have sexual contact (penis-vaginal) with a partner who could get me pregnant, without using my two birth control forms at any time.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.13", + "text": "12. My doctor provided me with information about the purpose and importance of providing information to the iPLEDGE REMS should I become pregnant while taking isotretinoin or within one month of the last dose. I understand that if I become pregnant, information about my pregnancy, my health, and my baby's health may be shared with the makers of isotretinoin, authorized parties who maintain the iPLEDGE REMS for the makers of isotretinoin, and government health regulatory authorities.", + "type": "boolean", + "required": true + }, + { + "linkId": "5.14", + "text": "13. I understand that being qualified to receive isotretinoin in the iPLEDGE REMS means that I: • have had two negative urine or blood pregnancy tests before receiving the first isotretinoin prescription. The second test must be done in a lab. I must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before I recieve another isotretinoin prescription • have chosen and agreed to use two forms of effective birth control at the same time. At least one method must be a primary method of birth control unless I have chosen never to have sexual contact (penis-vaginal) with a partner who could get me pregnant (abstinence), or I have undergone a hysterectomy or bilateral oophorectomy, or I have been medically confirmed to be post-menopausal. I must use two forms of birth control for at least one month before I start isotretinoin therapy. I must receieve counseling, repeated on a monthly basis, about birth control and behaviors associated with an increased risk of pregnancy • have signed an Informed Consent For Patients Who Can Get Pregnant (for patients who can get pregnant) that contains warmings about the chance of possible birth defects if I am pregnant or becoming pregnant and my unborn baby is exposed to isotretinoin • have been informed of and understand the purpose and importance of providing information to the iPLEDGE REMS should I become pregnant while taking isotretinoin or within 1 month of the last dose • have interacted with the iPLEDGE REMS before starting isotretinoin and on a monthly basis to answer questions on the program requirements and to enter my two chosen forms of birth control", + "type": "boolean", + "required": true + }, + { + "linkId": "5.15", + "text": "14. My doctor has answered all my questions about isotretinoin, and I understand that it is my responsibility not to get pregnant one month before, during isotretinoin treatment, or for one month after I stop taking isotretinoin.", + "type": "boolean", + "required": true + } + ] }, { "linkId": "6", "type": "group", + "text": "Patient Attestation", + "item": [ + { + "linkId": "6.1", + "text": "Patient Attestation", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueString": "Patient Attestation" + }, + { + "valueString": "Parent or Guardian Attestation" + } + ] + }, + { + "linkId": "6.2", + "text": "I now allow my doctor to begin my treatment with isotretinoin.", + "type": "display" + }, + { + "linkId": "6.3", + "text": "Patient Initials", + "type": "string", + "required": true + }, + { + "linkId": "6.4", + "text": "Patient Name", + "type": "string", + "required": true + }, + { + "linkId": "6.5", + "text": "Patient Signature", + "type": "string", + "required": true + }, + { + "linkId": "6.6", + "text": "I authorize the above signature to be the legally binding equivalent of my handwritten signature.", + "type": "display" + } + ] + }, + { + "linkId": "7", + "type": "group", "text": "Patient Counseling", "item": [ - + { + "linkId": "7.1", + "text": "I have counseled this patient on the following: • Requirement to use 2 effective forms of birth control together correctly all the time • Drug should not be shared with anyone, even any drug remaining after treatment • Blood should not be donated while taking isotretinoin • Patient REMS requirements", + "type": "boolean", + "required": true + }, + { + "linkId": "7.2", + "text": "In my opinion, this patient understands and is capable of complying with the requirements of the iPLEDGE REMS", + "type": "boolean", + "required": true + }, + { + "linkId": "7.3", + "text": "I have: • fully explained to the patient, the nature and purpose of isotretinoin treatment, including its benefits and risks to patients who can get pregnant • provided the patient with the appropriate educational materials, such as the iPLEDGE REMS Fact Sheet and asked the patient if there are any questions regarding treatment with isotretinoin • answered those questions to the best of my ability", + "type": "display" + }, + { + "linkId": "7.4", + "text": "Doctor Name", + "type": "string", + "required": true + }, + { + "linkId": "7.5", + "text": "Doctor Signature", + "type": "string", + "required": true + }, + { + "linkId": "7.6", + "text": "I authorize the above signature to be the legally binding equivalent to my handwritten signature.", + "type": "display" + } ] } ] diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json index 386864a..301b678 100644 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json @@ -15,7 +15,25 @@ "type": "group", "text": "Determine Patient Category", "item": [ - + { + "linkId": "1.1", + "text": "Before enrolling your patient in the iPLEDGE REMS, you must determine if this is a patient who can become pregnant. In the iPLEDGE REMS, the definition of a patient who can become pregnant is: • A patient who has not had a hysterectomy and/or bilateral oophorectomy • The patient is not post-menopausal • A patient who has not yet started menstruating • A patient who has had a tubal sterilization • A transgender male with viable female reproductive organs", + "type": "display" + }, + { + "linkId": "1.2", + "text": "Determine patient category", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueString": "Patient who can become pregnant" + }, + { + "valueString": "Patient who cannot become pregnant" + } + ] + } ] }, { @@ -23,7 +41,21 @@ "type": "group", "text": "Determine Risk Category", "item": [ - + { + "linkId": "2.1", + "text": "You have indicated that this patient is a patient who cannot become pregnant. The questions that follow will assign a risk category for this patient, based on the reproductive potential according to the requirements of the iPLEDGE REMS. All patients who cannot get pregnant are considered patients who can get pregnant unless one or more of the following applies: 1. Patient is cicgender male (borm a male, aka cis-male) 2. Patient has had a hysterectomy 3. Patient has had a bilateral oophorectomy 4. Patient is post-menopausal", + "type": "display" + }, + { + "linkId": "2.2", + "text": "Please note that the following conditions DO NOT qualify a patient to be moved from the patient who can become pregnant risk category • Tubal sterilization • Male vasectomy • Abstinence • Patient has not had a first menstrual period (pre-menarche) • Patient is currently in menopause (but not yet post-menupausal)", + "type": "display" + }, + { + "linkId": "2.2", + "text": "Please acknowledge your understanding of the qualification criteria as presented in order to proceed with assigning a risk category for this patient.", + "type": "boolean" + } ] }, { @@ -31,7 +63,35 @@ "type": "group", "text": "Confirm Risk Category", "item": [ - + { + "linkId": "3.1", + "text": "Is the patient cisgender male (born a male, aka cis-male)", + "type": "boolean", + "required": true + }, + { + "linkId": "3.2", + "text": "Has the patient had a hysterectomy?", + "type": "boolean", + "required": true + }, + { + "linkId": "3.3", + "text": "Has the patient had a bilateral oophorectomy?", + "type": "boolean", + "required": true + }, + { + "linkId": "3.4", + "text": "For the iPLEDGE REMS, a patient is considered post-menopausal upon cessation of previously occurring menses as a reuslt of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., spontaneous menopause). Hormonal deficiency should be properly documented in the case of spontaneuous menopause as follows: 1. If age > 54 years and with absence of normal menses: serum FSH (Follicle Stimulating Hormone) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed 2. If age < 54 years and with the absence of normal menses: negative serum or urine -hCG with concurrently elevated serum FSH (Follicle Stiumulating Hormone) level in the post-menopausal, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assay is performed.", + "type": "display" + }, + { + "linkId": "3.5", + "text": "Using the definition above, is the patient post-menopausal?", + "type": "boolean", + "required": true + } ] }, { @@ -39,7 +99,94 @@ "type": "group", "text": "Enter Patient Information", "item": [ - + { + "linkId": "3.1", + "text": "First Name", + "type": "string", + "required": true + }, + { + "linkId": "3.2", + "text": "Middle Initial", + "type": "string", + "required": false + }, + { + "linkId": "3.3", + "text": "Last Name", + "type": "string", + "required": true + }, + { + "linkId": "3.4", + "text": "Address Line 1", + "type": "string", + "required": true + }, + { + "linkId": "3.5", + "text": "Address Line 2", + "type": "string", + "required": false + }, + { + "linkId": "3.6", + "text": "City", + "type": "string", + "required": true + }, + { + "linkId": "3.7", + "text": "State", + "type": "string", + "required": true + }, + { + "linkId": "3.8", + "text": "Zip", + "type": "string", + "required": true + }, + { + "linkId": "3.9", + "text": "Mobile Phone Number", + "type": "string", + "required": true + }, + { + "linkId": "3.10", + "text": "E-mail", + "type": "string", + "required": true + }, + { + "linkId": "3.11", + "text": "Date of Birth", + "type": "string", + "required": true + }, + { + "linkId": "3.12", + "text": "Preferred Method of Communication", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "email", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Email" + } + }, + { + "valueCoding": { + "code": "sms", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Text Message" + } + } + ] + } ] }, { @@ -47,15 +194,173 @@ "type": "group", "text": "Informed Consent (For All Patients)", "item": [ - + { + "linkId": "4.1", + "text": "To be completed by the patient (and parent or guardian if the patient is under age 18) and signed by the doctor. Read each item below and check the box provided if you understand each item and agree to follow your doctor's instructions. A parent or guardian of a patient under age 18 must also read and understand each item before signing the agreement. Do not sign this agreement, and do not take isotretinoin if there is anything that you do not understand about all the information you have received about using isotretinoin.", + "type": "display" + }, + { + "linkId": "4.2", + "text": "1. I understand that isotretinoin is a medicine used in patients 12 years of age and older, who are not pregnant for the treatment of severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. If untreated, severe nodular acne can lead to permanent scars.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.3", + "text": "2. My doctor has told me about my choices for treating my acne", + "type": "boolean", + "required": true + }, + { + "linkId": "4.4", + "text": "3. I understand that there are serious side effects that may happen while I am taking isotretinoin. These have been explained to me. These side effects include serious birth defects in babies of pregnant patients. [Note: There is a second informed consent about birth defects (for patients who can get pregnant)].", + "type": "boolean", + "required": true + }, + { + "linkId": "4.5", + "text": "4. I understand that some patients while taking isotretinoin or soon after stopping isotetrinoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, anxious or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sport activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives, and some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent. Some people have had other signs of depression while taking isotretinoin (see #7).", + "type": "boolean", + "required": true + }, + { + "linkId": "4.6", + "text": "5. Before I start taking isotretinoin, I agree to tell my doctor if I have ever had symptoms of depression (see #7), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.7", + "text": "6. Before I start taking isotretinoin, I agree to tell my doctor if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any other serious mental problems.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.8", + "text": "7. Once I start taking isotretinoin, I agree to stop using isotretinoin and tell my doctor right away if any of the following signs and symptoms of depression or psychosis happen. • Start to feel sad or have crying spells • Lose interest in activities I once enjoyed • Sleep too much or have trouble sleeping • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence) • Have a change in my appetite or body weight • Have trouble concentrating • Withdraw from my friends or family • Feel like I have no energy • Have feelings of worthlessness or guilt • Start having thoughts about hurting myself or taking my own life (suicidal thoughts) • Start acting on dangerous impulses • Start seeing or hearing things that are not real", + "type": "boolean", + "required": true + }, + { + "linkId": "4.9", + "text": "8. I agree to return to see my doctor every month I take isotretinoin to get a new prescription for isotretinoin, to check my progress, and to check for signs of side effects.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.10", + "text": "9. Isotretinoin wil be prescribed just for me - I will not share isotretinoin with other people because it may cause serious side effects, including birth defects.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.11", + "text": "10. I will not give blood while taking isotretinoin or for 1 moth after I stop taking isotretinoin. I understand that if someone who is pregnant gets my donated blood, their baby may be exposed to isotretinoin and may be born with serious birth defects.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.12", + "text": "11. I have read the iPLEDGE REMS Fact Sheet and other materials my provider provided me containing important safety information about isotretinoin. I understand all the information I received.", + "type": "boolean", + "required": true + }, + { + "linkId": "4.13", + "text": "12. My doctor and I have decided I should take isotretinoin. I understand that I must be qualified in the iPLEDGE REMS to have my prescription filled each month. I understand that I can stop taking isotretinoin at any time. I agree to tell my doctor if I stop taking isotretinoin.", + "type": "boolean", + "required": true + } ] }, { "linkId": "6", "type": "group", + "text": "Patient Attestation", + "item": [ + { + "linkId": "6.1", + "text": "Patient Attestation", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueString": "Patient Attestation" + }, + { + "valueString": "Parent or Guardian Attestation" + } + ] + }, + { + "linkId": "6.2", + "text": "I now allow my doctor to begin my treatment with isotretinoin.", + "type": "display" + }, + { + "linkId": "6.3", + "text": "Patient Initials", + "type": "string", + "required": true + }, + { + "linkId": "6.4", + "text": "Patient Name", + "type": "string", + "required": true + }, + { + "linkId": "6.5", + "text": "Patient Signature", + "type": "string", + "required": true + }, + { + "linkId": "6.6", + "text": "I authorize the above signature to be the legally binding equivalent of my handwritten signature.", + "type": "display" + } + ] + }, + { + "linkId": "7", + "type": "group", "text": "Patient Counseling", "item": [ - + { + "linkId": "7.1", + "text": "I have counseled this patient on the following: • Requirement to use 2 effective forms of birth control together correctly all the time • Drug should not be shared with anyone, even any drug remaining after treatment • Blood should not be donated while taking isotretinoin • Patient REMS requirements", + "type": "boolean", + "required": true + }, + { + "linkId": "7.2", + "text": "In my opinion, this patient understands and is capable of complying with the requirements of the iPLEDGE REMS", + "type": "boolean", + "required": true + }, + { + "linkId": "7.3", + "text": "I have: • fully explained to the patient, the nature and purpose of isotretinoin treatment, including its benefits and risks to patients who can get pregnant • provided the patient with the appropriate educational materials, such as the iPLEDGE REMS Fact Sheet and asked the patient if there are any questions regarding treatment with isotretinoin • answered those questions to the best of my ability", + "type": "display" + }, + { + "linkId": "7.4", + "text": "Doctor Name", + "type": "string", + "required": true + }, + { + "linkId": "7.5", + "text": "Doctor Signature", + "type": "string", + "required": true + }, + { + "linkId": "7.6", + "text": "I authorize the above signature to be the legally binding equivalent to my handwritten signature.", + "type": "display" + } ] } ] diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json index 250bea8..83abbc5 100644 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json @@ -15,7 +15,165 @@ "type": "group", "text": "Prescriber Information", "item": [ - + { + "linkId": "1.1", + "text": "Attention: This enrollment page is for licensed prescribers only. If you are a patient, you must be enrolled in iPLEDGE REMS by your prescriber. The iPLEDGE REMS will require prescribers to provide a National Provider Identifier (NPI). If your NPI is not on file with the iPLEDGE REMS, you will be prompted to enter your NPI upon first log-in to the iPLEDGE REMS. Failure to supply this identifier may result in your patients' prescriptions not being authorized for dispensing.", + "type": "display" + }, + { + "linkId": "1.2", + "text": "NPI Number", + "type": "string", + "required": true + }, + { + "linkId": "1.3", + "text": "First Name", + "type": "string", + "required": true + }, + { + "linkId": "1.4", + "text": "MI", + "type": "string", + "required": false + }, + { + "linkId": "1.5", + "text": "Last Name", + "type": "string", + "required": true + }, + { + "linkId": "1.6", + "text": "Suffix", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "MD", + "system": "http://terminology.hl7.org/CodeSystem/v2-0360|2.7", + "display": "MD" + } + }, + { + "valueCoding": { + "code": "DO", + "system": "http://terminology.hl7.org/CodeSystem/v2-0360|2.7", + "display": "DO" + } + }, + { + "valueCoding": { + "code": "NP", + "system": "http://terminology.hl7.org/CodeSystem/v2-0360|2.7", + "display": "NP" + } + }, + { + "valueCoding": { + "code": "PA", + "system": "http://terminology.hl7.org/CodeSystem/v2-0360|2.7", + "display": "PA" + } + }, + { + "valueCoding": { + "code": "Other", + "display": "Other" + } + } + ] + }, + { + "linkId": "1.7", + "text": "Specialty", + "type": "string", + "required": true + }, + { + "linkId": "1.8", + "text": "Practice Name", + "type": "string", + "required": false + }, + { + "linkId": "1.9", + "text": "Address Line 1", + "type": "string", + "required": true + }, + { + "linkId": "1.10", + "text": "Address Line 2", + "type": "string", + "required": false + }, + { + "linkId": "1.11", + "text": "City", + "type": "string", + "required": true + }, + { + "linkId": "1.12", + "text": "State", + "type": "string", + "required": true + }, + { + "linkId": "1.13", + "text": "Zip", + "type": "string", + "required": true + }, + { + "linkId": "1.14", + "text": "Phone Number", + "type": "string", + "required": true + }, + { + "linkId": "1.15", + "text": "Ext", + "type": "string", + "required": false + }, + { + "linkId": "1.16", + "text": "Fax Number", + "type": "string", + "required": true + }, + { + "linkId": "1.17", + "text": "Email", + "type": "string", + "required": true + }, + { + "linkId": "1.18", + "text": "Preferred Method of Communication", + "type": "choice", + "required": true, + "answerOption": [ + { + "valueCoding": { + "code": "email", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Email" + } + }, + { + "valueCoding": { + "code": "phone", + "system": "http://hl7.org/fhir/contact-point-system", + "display": "Phone" + } + } + ] + } ] }, { @@ -23,7 +181,58 @@ "type": "group", "text": "Prescriber Attestation", "item": [ - + { + "linkId": "2.1", + "text": "Prescribers can only activate their enrollment by affirming that they meet requirements and will comply with all iPLEDGE REMS requirements by attesting to the following points:", + "type": "display" + }, + { + "linkId": "2.2", + "text": "I know the risk and severity of fetal injury/birth defects from isotretinoin.", + "type": "display" + }, + { + "linkId": "2.3", + "text": "I know the risk factors for unplanned pregnancy and the effective measures for avoidance of unplaned pregnancy.", + "type": "display" + }, + { + "linkId": "2.4", + "text": "I have the expertise to provide the patient with detailed pregnancy prevention counseling, or I will refer the patient to an expert for such counseling, reimbursed by the manufacturer.", + "type": "display" + }, + { + "linkId": "2.5", + "text": "I will comply with the iPLEDGE REMS requirements described in the booklet, iPLEDGE REMS Prescriber Guide.", + "type": "display" + }, + { + "linkId": "2.6", + "text": "Before beginning treatment of patients who can become pregnant with isotretinoin, and on a monthly basis, the patient will be counseled to avoid pregnancy by using two forms of contraception simultaneously and continously for at least one month prior to initiation of isotretinoin treatment, during isotretinoin treatment and for one month after discontinuing isotretinoin treatment, unless the patient commits to continous abstinence, not having any sexual contact with a partner that could result in pregnancy.", + "type": "display" + }, + { + "linkId": "2.7", + "text": "I will not prescribe isotretinoin to any patient who can become pregnant until verifying the patient has a negative screening pregnancy test and monthly CLIA-certified (Clinical Laboratory Improvement Amendment) pregnancy tests. Patients should have a pregnancy test at the completion of the entire course of isotretinoin and another pregnancy test one month laer.", + "type": "display" + }, + { + "linkId": "2.8", + "text": "I will report any pregnancy case that I become aware of while the patient who can become pregnant is on isotretinoin or one month after the last dose to the pregnancy registry.", + "type": "display" + }, + { + "linkId": "2.9", + "type": "choice", + "answerOption": [ + { + "valueString": "I attest to the statements above" + }, + { + "valueString": "I do not attest to the statements above" + } + ] + } ] } ] From cd32f7409f9518c361e85c8a8ef162ace3e4fb6c Mon Sep 17 00:00:00 2001 From: Meng-Chau Date: Mon, 15 Aug 2022 15:56:53 -0400 Subject: [PATCH 3/8] combine patient forms --- ...estionnaire-R4-CanGetPregnant-IPledge.json | 279 +++++++++---- ...ionnaire-R4-CannotGetPregnant-IPledge.json | 367 ------------------ 2 files changed, 208 insertions(+), 438 deletions(-) delete mode 100644 CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json index b57a447..5bf9991 100644 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json @@ -23,14 +23,13 @@ { "linkId": "1.2", "text": "Determine patient category", - "type": "choice", - "required": true, - "answerOption": [ - { - "valueString": "Patient who can become pregnant" - }, + "type": "group", + "item": [ { - "valueString": "Patient who cannot become pregnant" + "linkId": "1.2.1", + "text": "Patient who can get pregnant", + "type": "boolean", + "required": true } ] } @@ -71,84 +70,163 @@ { "linkId": "2.3", "text": "Date of in-office positive or negative pregnancy test (MM/DD/YYYY)", - "type": "string", + "type": "date", "required": true } + ], + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": true + } ] }, { "linkId": "3", "type": "group", - "text": "Enter Patient Information", + "text": "Determine Risk Category", "item": [ { "linkId": "3.1", + "text": "You have indicated that this patient is a patient who cannot become pregnant. The questions that follow will assign a risk category for this patient, based on the reproductive potential according to the requirements of the iPLEDGE REMS. All patients who cannot get pregnant are considered patients who can get pregnant unless one or more of the following applies: 1. Patient is cicgender male (borm a male, aka cis-male) 2. Patient has had a hysterectomy 3. Patient has had a bilateral oophorectomy 4. Patient is post-menopausal", + "type": "display" + }, + { + "linkId": "3.2", + "text": "Please note that the following conditions DO NOT qualify a patient to be moved from the patient who can become pregnant risk category • Tubal sterilization • Male vasectomy • Abstinence • Patient has not had a first menstrual period (pre-menarche) • Patient is currently in menopause (but not yet post-menupausal)", + "type": "display" + }, + { + "linkId": "3.3", + "text": "Please acknowledge your understanding of the qualification criteria as presented in order to proceed with assigning a risk category for this patient.", + "type": "boolean" + } + ], + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": false + } + ] + }, + { + "linkId": "4", + "type": "group", + "text": "Confirm Risk Category", + "item": [ + { + "linkId": "4.1", + "text": "Is the patient cisgender male (born a male, aka cis-male)", + "type": "boolean", + "required": true + }, + { + "linkId": "4.2", + "text": "Has the patient had a hysterectomy?", + "type": "boolean", + "required": true + }, + { + "linkId": "4.3", + "text": "Has the patient had a bilateral oophorectomy?", + "type": "boolean", + "required": true + }, + { + "linkId": "4.4", + "text": "For the iPLEDGE REMS, a patient is considered post-menopausal upon cessation of previously occurring menses as a reuslt of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., spontaneous menopause). Hormonal deficiency should be properly documented in the case of spontaneuous menopause as follows: 1. If age > 54 years and with absence of normal menses: serum FSH (Follicle Stimulating Hormone) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed 2. If age < 54 years and with the absence of normal menses: negative serum or urine -hCG with concurrently elevated serum FSH (Follicle Stiumulating Hormone) level in the post-menopausal, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assay is performed.", + "type": "display" + }, + { + "linkId": "4.5", + "text": "Using the definition above, is the patient post-menopausal?", + "type": "boolean", + "required": true + } + ], + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": false + } + ] + }, + { + "linkId": "5", + "type": "group", + "text": "Enter Patient Information", + "item": [ + { + "linkId": "5.1", "text": "First Name", "type": "string", "required": true }, { - "linkId": "3.2", + "linkId": "5.2", "text": "Middle Initial", "type": "string", "required": false }, { - "linkId": "3.3", + "linkId": "5.3", "text": "Last Name", "type": "string", "required": true }, { - "linkId": "3.4", + "linkId": "5.4", "text": "Address Line 1", "type": "string", "required": true }, { - "linkId": "3.5", + "linkId": "5.5", "text": "Address Line 2", "type": "string", "required": false }, { - "linkId": "3.6", + "linkId": "5.6", "text": "City", "type": "string", "required": true }, { - "linkId": "3.7", + "linkId": "5.7", "text": "State", "type": "string", "required": true }, { - "linkId": "3.8", + "linkId": "5.8", "text": "Zip", "type": "string", "required": true }, { - "linkId": "3.9", + "linkId": "5.9", "text": "Mobile Phone Number", "type": "string", "required": true }, { - "linkId": "3.10", + "linkId": "5.10", "text": "E-mail", "type": "string", "required": true }, { - "linkId": "3.11", + "linkId": "5.11", "text": "Date of Birth", - "type": "string", + "type": "date", "required": true }, { - "linkId": "3.12", + "linkId": "5.12", "text": "Preferred Method of Communication", "type": "choice", "required": true, @@ -172,83 +250,83 @@ ] }, { - "linkId": "4", + "linkId": "6", "type": "group", "text": "Informed Consent (For All Patients)", "item": [ { - "linkId": "4.1", + "linkId": "6.1", "text": "To be completed by the patient (and parent or guardian if the patient is under age 18) and signed by the doctor. Read each item below and check the box provided if you understand each item and agree to follow your doctor's instructions. A parent or guardian of a patient under age 18 must also read and understand each item before signing the agreement. Do not sign this agreement, and do not take isotretinoin if there is anything that you do not understand about all the information you have received about using isotretinoin.", "type": "display" }, { - "linkId": "4.2", + "linkId": "6.2", "text": "1. I understand that isotretinoin is a medicine used in patients 12 years of age and older, who are not pregnant for the treatment of severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. If untreated, severe nodular acne can lead to permanent scars.", "type": "boolean", "required": true }, { - "linkId": "4.3", + "linkId": "6.3", "text": "2. My doctor has told me about my choices for treating my acne", "type": "boolean", "required": true }, { - "linkId": "4.4", + "linkId": "6.4", "text": "3. I understand that there are serious side effects that may happen while I am taking isotretinoin. These have been explained to me. These side effects include serious birth defects in babies of pregnant patients. [Note: There is a second informed consent about birth defects (for patients who can get pregnant)].", "type": "boolean", "required": true }, { - "linkId": "4.5", + "linkId": "6.5", "text": "4. I understand that some patients while taking isotretinoin or soon after stopping isotetrinoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, anxious or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sport activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives, and some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent. Some people have had other signs of depression while taking isotretinoin (see #7).", "type": "boolean", "required": true }, { - "linkId": "4.6", + "linkId": "6.6", "text": "5. Before I start taking isotretinoin, I agree to tell my doctor if I have ever had symptoms of depression (see #7), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there.", "type": "boolean", "required": true }, { - "linkId": "4.7", + "linkId": "6.7", "text": "6. Before I start taking isotretinoin, I agree to tell my doctor if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any other serious mental problems.", "type": "boolean", "required": true }, { - "linkId": "4.8", + "linkId": "6.8", "text": "7. Once I start taking isotretinoin, I agree to stop using isotretinoin and tell my doctor right away if any of the following signs and symptoms of depression or psychosis happen. • Start to feel sad or have crying spells • Lose interest in activities I once enjoyed • Sleep too much or have trouble sleeping • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence) • Have a change in my appetite or body weight • Have trouble concentrating • Withdraw from my friends or family • Feel like I have no energy • Have feelings of worthlessness or guilt • Start having thoughts about hurting myself or taking my own life (suicidal thoughts) • Start acting on dangerous impulses • Start seeing or hearing things that are not real", "type": "boolean", "required": true }, { - "linkId": "4.9", + "linkId": "6.9", "text": "8. I agree to return to see my doctor every month I take isotretinoin to get a new prescription for isotretinoin, to check my progress, and to check for signs of side effects.", "type": "boolean", "required": true }, { - "linkId": "4.10", + "linkId": "6.10", "text": "9. Isotretinoin wil be prescribed just for me - I will not share isotretinoin with other people because it may cause serious side effects, including birth defects.", "type": "boolean", "required": true }, { - "linkId": "4.11", + "linkId": "6.11", "text": "10. I will not give blood while taking isotretinoin or for 1 moth after I stop taking isotretinoin. I understand that if someone who is pregnant gets my donated blood, their baby may be exposed to isotretinoin and may be born with serious birth defects.", "type": "boolean", "required": true }, { - "linkId": "4.12", + "linkId": "6.12", "text": "11. I have read the iPLEDGE REMS Fact Sheet and other materials my provider provided me containing important safety information about isotretinoin. I understand all the information I received.", "type": "boolean", "required": true }, { - "linkId": "4.13", + "linkId": "6.13", "text": "12. My doctor and I have decided I should take isotretinoin. I understand that I must be qualified in the iPLEDGE REMS to have my prescription filled each month. I understand that I can stop taking isotretinoin at any time. I agree to tell my doctor if I stop taking isotretinoin.", "type": "boolean", "required": true @@ -256,131 +334,138 @@ ] }, { - "linkId": "5", + "linkId": "7", "type": "group", "text": "Informed Consent About Birth Defects (For Patients Who Can Get Pregnant)", "item": [ { - "linkId": "5.1", + "linkId": "7.1", "text": "About Birth Defects (for patients who can get pregnant): To be completed by the patient (and their parent or guardian if the patient is under age 18) and signed by their doctor. Read each item below and check in the box provided to show that you understand each item and agree to follow your doctor's instructions. Do not sign this consent, and do not take isotretinoin if there is anything that you do not understand. A parent or guardian of a minor patient (under 18) must also read and check each item before signing the consent.", "type": "display" }, { - "linkId": "5.2", + "linkId": "7.2", "text": "1. I understand that there is a very high chance that my unborn baby could have life-threatening birth defects if I am pregnant or become pregnant while taking isotretinoin. This can happen with any amount and even if take for short periods of time. This is why I must not be pregnant while taking isotretinoin.", "type": "boolean", "required": true }, { - "linkId": "5.3", + "linkId": "7.3", "text": "2. I understand that I must not get pregnant one month before, during the entire time of my treatment, and for one month after the end of my treatment with isotretinoin.", "type": "boolean", "required": true }, { - "linkId": "5.4", + "linkId": "7.4", "text": "3. I understand that I must completely avoid having any sexual contact (penis-vaginal) with a partner who coud get me pregnant, or I must use two separate effective forms of birth control (contraception) at the same time. The only exceptions are if I have had any surgery to remove the uterus (a hysterectomy) or both of my ovaries (bilateral oophorectomy), or my doctor has medically confirmed that I am post-menopausal.", "type": "boolean", "required": true }, { - "linkId": "5.5", + "linkId": "7.5", "text": "4. I understand that hormonal birth control products are among the most effective forms of birth control. Combination birth control pills and other hormonal products include skin patches, shots, under-the-skin implants, vaginal rings, and intrauterine devices (IUDs). Any method of birth control can fail. That is why I must use two different birth control forms at the same time, starting one month before, during, and for one month after stopping therapy every time I have sexual contact (penis-vaginal) with a partner who could get me pregnant, even if one of the forms I choose is hormonal birth control.", "type": "boolean", "required": true }, { - "linkId": "5.6", + "linkId": "7.6", "text": "5. I understand that the following are effective forms of birth control:", "type": "boolean", "required": true, "item": [ { - "linkId": "5.6.1", + "linkId": "7.6.1", "text": "Primary forms: • tying my tubes (tubal sterilization) • male vasectomy • intrauterine device • hormonal (combination birth control pills, skin patches, shots, under-the-skin implants, or vaginal rings)", "type": "display" }, { - "linkId": "5.6.2", + "linkId": "7.6.2", "text": "Secondary forms, barrier: • male latex condom with or without spermicide • diaphragm with spermicide • cervical cap with spermicide", "type": "display" }, { - "linkId": "5.6.3", + "linkId": "7.6.3", "text": "Other: • vaginal sponge (contains spermicide)", "type": "display" }, { - "linkId": "5.6.4", + "linkId": "7.6.4", "text": "A diaphragm and cervical cap must each be used with spermicide, a special cream that kills sperm. I understand that at least one of my two forms of birth control must be a primary method.", "type": "display" } ] }, { - "linkId": "5.7", + "linkId": "7.7", "text": "6. I will talk to my doctor about any medicines, including herbal products I plan to take during my isotretinoin treatment, because hormonal birth control forms may not work if I am taking certain medicines or herbal products.", "type": "boolean", "required": true }, { - "linkId": "5.8", + "linkId": "7.8", "text": "7. I may receive a free birth control counseling session from a doctor or other family planning expert. My isotretinoin doctor can give me an iPLEDGE REMS Contraception Counseling Guide for this free consultation.", "type": "boolean", "required": true }, { - "linkId": "5.9", + "linkId": "7.9", "text": "8. I must begin using the birth control forms I have chosen as described above at least one month before I start taking isotretinoin.", "type": "boolean", "required": true }, { - "linkId": "5.10", + "linkId": "7.10", "text": "9. I cannot get my first prescription for isotretinoin unless my doctor has told me that I have two negative pregnancy test results. The first pregnancy test should be done when my doctor decides to prescribe isotretinoin. The second pregnancy test must be done in a lab during the first 5 days of my menstural period right before starting isotretinoin therapy treatment, or as instructed by my doctor. I will then have one pregnancy test; in a lab: • every month during treatment • at the end of treatment • and 1 month after stopping treatment. I must not start taking isotretinoin until I am sure that I am not pregnant, have negative results from two pregnancy tests, and the second test has been done in a lab.", "type": "boolean", "required": true }, { - "linkId": "5.11", + "linkId": "7.11", "text": "10. I have read and understand the materials my doctor has provided to me, including the iPLEDGE REMS Guide for Patients who Can Get Pregnant and iPLEDGE REMS Fact Sheet. I have recieved information on emergency birth control.", "type": "boolean", "required": true }, { - "linkId": "5.12", + "linkId": "7.12", "text": "11. I must stop taking isotretinoin right away and call my doctor if I get pregnant, miss my expected menstrual period, stop using birth control, or have sexual contact (penis-vaginal) with a partner who could get me pregnant, without using my two birth control forms at any time.", "type": "boolean", "required": true }, { - "linkId": "5.13", + "linkId": "7.13", "text": "12. My doctor provided me with information about the purpose and importance of providing information to the iPLEDGE REMS should I become pregnant while taking isotretinoin or within one month of the last dose. I understand that if I become pregnant, information about my pregnancy, my health, and my baby's health may be shared with the makers of isotretinoin, authorized parties who maintain the iPLEDGE REMS for the makers of isotretinoin, and government health regulatory authorities.", "type": "boolean", "required": true }, { - "linkId": "5.14", + "linkId": "7.14", "text": "13. I understand that being qualified to receive isotretinoin in the iPLEDGE REMS means that I: • have had two negative urine or blood pregnancy tests before receiving the first isotretinoin prescription. The second test must be done in a lab. I must have a negative result from a urine or blood pregnancy test done in a lab repeated each month before I recieve another isotretinoin prescription • have chosen and agreed to use two forms of effective birth control at the same time. At least one method must be a primary method of birth control unless I have chosen never to have sexual contact (penis-vaginal) with a partner who could get me pregnant (abstinence), or I have undergone a hysterectomy or bilateral oophorectomy, or I have been medically confirmed to be post-menopausal. I must use two forms of birth control for at least one month before I start isotretinoin therapy. I must receieve counseling, repeated on a monthly basis, about birth control and behaviors associated with an increased risk of pregnancy • have signed an Informed Consent For Patients Who Can Get Pregnant (for patients who can get pregnant) that contains warmings about the chance of possible birth defects if I am pregnant or becoming pregnant and my unborn baby is exposed to isotretinoin • have been informed of and understand the purpose and importance of providing information to the iPLEDGE REMS should I become pregnant while taking isotretinoin or within 1 month of the last dose • have interacted with the iPLEDGE REMS before starting isotretinoin and on a monthly basis to answer questions on the program requirements and to enter my two chosen forms of birth control", "type": "boolean", "required": true }, { - "linkId": "5.15", + "linkId": "7.15", "text": "14. My doctor has answered all my questions about isotretinoin, and I understand that it is my responsibility not to get pregnant one month before, during isotretinoin treatment, or for one month after I stop taking isotretinoin.", "type": "boolean", "required": true } + ], + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": true + } ] }, { - "linkId": "6", + "linkId": "8", "type": "group", "text": "Patient Attestation", "item": [ { - "linkId": "6.1", + "linkId": "8.1", "text": "Patient Attestation", "type": "choice", "required": true, @@ -394,71 +479,123 @@ ] }, { - "linkId": "6.2", + "linkId": "8.2", "text": "I now allow my doctor to begin my treatment with isotretinoin.", "type": "display" }, { - "linkId": "6.3", + "linkId": "8.3", "text": "Patient Initials", "type": "string", "required": true }, { - "linkId": "6.4", + "linkId": "8.4", "text": "Patient Name", "type": "string", "required": true }, { - "linkId": "6.5", + "linkId": "8.5", "text": "Patient Signature", "type": "string", "required": true }, { - "linkId": "6.6", + "linkId": "8.6", "text": "I authorize the above signature to be the legally binding equivalent of my handwritten signature.", "type": "display" } ] }, { - "linkId": "7", + "linkId": "9", "type": "group", "text": "Patient Counseling", "item": [ { - "linkId": "7.1", + "linkId": "9.1", "text": "I have counseled this patient on the following: • Requirement to use 2 effective forms of birth control together correctly all the time • Drug should not be shared with anyone, even any drug remaining after treatment • Blood should not be donated while taking isotretinoin • Patient REMS requirements", "type": "boolean", - "required": true + "required": true, + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": true + } + ] }, { - "linkId": "7.2", + "linkId": "9.2", + "text": "I have counseled this patient on the following: • Drug should not be shared with anyone, even any drug remaining after treatment • Blood should not be donated while taking isotretinoin • Patient REMS requirements", + "type": "boolean", + "required": true, + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": false + } + ] + }, + { + "linkId": "9.3", + "text": "I have prescribed (maximum) 30-day supply of isotretinoin", + "type": "boolean", + "required": true, + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": false + } + ] + }, + { + "linkId": "9.4", "text": "In my opinion, this patient understands and is capable of complying with the requirements of the iPLEDGE REMS", "type": "boolean", "required": true }, { - "linkId": "7.3", + "linkId": "9.5", "text": "I have: • fully explained to the patient, the nature and purpose of isotretinoin treatment, including its benefits and risks to patients who can get pregnant • provided the patient with the appropriate educational materials, such as the iPLEDGE REMS Fact Sheet and asked the patient if there are any questions regarding treatment with isotretinoin • answered those questions to the best of my ability", - "type": "display" + "type": "display", + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": true + } + ] }, { - "linkId": "7.4", + "linkId": "9.6", + "text": "I have: • fully explained to the patient, the nature and purpose of isotretinoin treatment, including its benefits and risks • provided the patient with the appropriate educational materials, such as the iPLEDGE REMS Fact Sheet and asked the patient if there are any questions regarding treatment with isotretinoin • answered those questions to the best of my ability", + "type": "display", + "enableWhen": [ + { + "question": "1.2.1", + "operator": "=", + "answerBoolean": false + } + ] + }, + { + "linkId": "9.7", "text": "Doctor Name", "type": "string", "required": true }, { - "linkId": "7.5", + "linkId": "9.8", "text": "Doctor Signature", "type": "string", "required": true }, { - "linkId": "7.6", + "linkId": "9.9", "text": "I authorize the above signature to be the legally binding equivalent to my handwritten signature.", "type": "display" } diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json deleted file mode 100644 index 301b678..0000000 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CannotGetPregnant-IPledge.json +++ /dev/null @@ -1,367 +0,0 @@ -{ - "resourceType": "Questionnaire", - "id": "IPledgeRemsPatientEnrollmentCannotGetPregnant", - "name": "IPledgeRemsPatientEnrollmentCannotGetPregnant", - "title": "IPledge Rems Patient Enrollment (Cannot Get Pregnant)", - "status": "draft", - "subjectType": [ - "Patient" - ], - "date": "2020-05-20", - "publisher": "Da Vinci DTR", - "item": [ - { - "linkId": "1", - "type": "group", - "text": "Determine Patient Category", - "item": [ - { - "linkId": "1.1", - "text": "Before enrolling your patient in the iPLEDGE REMS, you must determine if this is a patient who can become pregnant. In the iPLEDGE REMS, the definition of a patient who can become pregnant is: • A patient who has not had a hysterectomy and/or bilateral oophorectomy • The patient is not post-menopausal • A patient who has not yet started menstruating • A patient who has had a tubal sterilization • A transgender male with viable female reproductive organs", - "type": "display" - }, - { - "linkId": "1.2", - "text": "Determine patient category", - "type": "choice", - "required": true, - "answerOption": [ - { - "valueString": "Patient who can become pregnant" - }, - { - "valueString": "Patient who cannot become pregnant" - } - ] - } - ] - }, - { - "linkId": "2", - "type": "group", - "text": "Determine Risk Category", - "item": [ - { - "linkId": "2.1", - "text": "You have indicated that this patient is a patient who cannot become pregnant. The questions that follow will assign a risk category for this patient, based on the reproductive potential according to the requirements of the iPLEDGE REMS. All patients who cannot get pregnant are considered patients who can get pregnant unless one or more of the following applies: 1. Patient is cicgender male (borm a male, aka cis-male) 2. Patient has had a hysterectomy 3. Patient has had a bilateral oophorectomy 4. Patient is post-menopausal", - "type": "display" - }, - { - "linkId": "2.2", - "text": "Please note that the following conditions DO NOT qualify a patient to be moved from the patient who can become pregnant risk category • Tubal sterilization • Male vasectomy • Abstinence • Patient has not had a first menstrual period (pre-menarche) • Patient is currently in menopause (but not yet post-menupausal)", - "type": "display" - }, - { - "linkId": "2.2", - "text": "Please acknowledge your understanding of the qualification criteria as presented in order to proceed with assigning a risk category for this patient.", - "type": "boolean" - } - ] - }, - { - "linkId": "3", - "type": "group", - "text": "Confirm Risk Category", - "item": [ - { - "linkId": "3.1", - "text": "Is the patient cisgender male (born a male, aka cis-male)", - "type": "boolean", - "required": true - }, - { - "linkId": "3.2", - "text": "Has the patient had a hysterectomy?", - "type": "boolean", - "required": true - }, - { - "linkId": "3.3", - "text": "Has the patient had a bilateral oophorectomy?", - "type": "boolean", - "required": true - }, - { - "linkId": "3.4", - "text": "For the iPLEDGE REMS, a patient is considered post-menopausal upon cessation of previously occurring menses as a reuslt of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., spontaneous menopause). Hormonal deficiency should be properly documented in the case of spontaneuous menopause as follows: 1. If age > 54 years and with absence of normal menses: serum FSH (Follicle Stimulating Hormone) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed 2. If age < 54 years and with the absence of normal menses: negative serum or urine -hCG with concurrently elevated serum FSH (Follicle Stiumulating Hormone) level in the post-menopausal, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assay is performed.", - "type": "display" - }, - { - "linkId": "3.5", - "text": "Using the definition above, is the patient post-menopausal?", - "type": "boolean", - "required": true - } - ] - }, - { - "linkId": "4", - "type": "group", - "text": "Enter Patient Information", - "item": [ - { - "linkId": "3.1", - "text": "First Name", - "type": "string", - "required": true - }, - { - "linkId": "3.2", - "text": "Middle Initial", - "type": "string", - "required": false - }, - { - "linkId": "3.3", - "text": "Last Name", - "type": "string", - "required": true - }, - { - "linkId": "3.4", - "text": "Address Line 1", - "type": "string", - "required": true - }, - { - "linkId": "3.5", - "text": "Address Line 2", - "type": "string", - "required": false - }, - { - "linkId": "3.6", - "text": "City", - "type": "string", - "required": true - }, - { - "linkId": "3.7", - "text": "State", - "type": "string", - "required": true - }, - { - "linkId": "3.8", - "text": "Zip", - "type": "string", - "required": true - }, - { - "linkId": "3.9", - "text": "Mobile Phone Number", - "type": "string", - "required": true - }, - { - "linkId": "3.10", - "text": "E-mail", - "type": "string", - "required": true - }, - { - "linkId": "3.11", - "text": "Date of Birth", - "type": "string", - "required": true - }, - { - "linkId": "3.12", - "text": "Preferred Method of Communication", - "type": "choice", - "required": true, - "answerOption": [ - { - "valueCoding": { - "code": "email", - "system": "http://hl7.org/fhir/contact-point-system", - "display": "Email" - } - }, - { - "valueCoding": { - "code": "sms", - "system": "http://hl7.org/fhir/contact-point-system", - "display": "Text Message" - } - } - ] - } - ] - }, - { - "linkId": "5", - "type": "group", - "text": "Informed Consent (For All Patients)", - "item": [ - { - "linkId": "4.1", - "text": "To be completed by the patient (and parent or guardian if the patient is under age 18) and signed by the doctor. Read each item below and check the box provided if you understand each item and agree to follow your doctor's instructions. A parent or guardian of a patient under age 18 must also read and understand each item before signing the agreement. Do not sign this agreement, and do not take isotretinoin if there is anything that you do not understand about all the information you have received about using isotretinoin.", - "type": "display" - }, - { - "linkId": "4.2", - "text": "1. I understand that isotretinoin is a medicine used in patients 12 years of age and older, who are not pregnant for the treatment of severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics. In severe nodular acne, many red, swollen, tender lumps form in the skin. If untreated, severe nodular acne can lead to permanent scars.", - "type": "boolean", - "required": true - }, - { - "linkId": "4.3", - "text": "2. My doctor has told me about my choices for treating my acne", - "type": "boolean", - "required": true - }, - { - "linkId": "4.4", - "text": "3. I understand that there are serious side effects that may happen while I am taking isotretinoin. These have been explained to me. These side effects include serious birth defects in babies of pregnant patients. [Note: There is a second informed consent about birth defects (for patients who can get pregnant)].", - "type": "boolean", - "required": true - }, - { - "linkId": "4.5", - "text": "4. I understand that some patients while taking isotretinoin or soon after stopping isotetrinoin, have become depressed or developed other serious mental problems. Symptoms of depression include sad, anxious or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sport activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives, and some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on isotretinoin becoming aggressive or violent. Some people have had other signs of depression while taking isotretinoin (see #7).", - "type": "boolean", - "required": true - }, - { - "linkId": "4.6", - "text": "5. Before I start taking isotretinoin, I agree to tell my doctor if I have ever had symptoms of depression (see #7), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there.", - "type": "boolean", - "required": true - }, - { - "linkId": "4.7", - "text": "6. Before I start taking isotretinoin, I agree to tell my doctor if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any other serious mental problems.", - "type": "boolean", - "required": true - }, - { - "linkId": "4.8", - "text": "7. Once I start taking isotretinoin, I agree to stop using isotretinoin and tell my doctor right away if any of the following signs and symptoms of depression or psychosis happen. • Start to feel sad or have crying spells • Lose interest in activities I once enjoyed • Sleep too much or have trouble sleeping • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence) • Have a change in my appetite or body weight • Have trouble concentrating • Withdraw from my friends or family • Feel like I have no energy • Have feelings of worthlessness or guilt • Start having thoughts about hurting myself or taking my own life (suicidal thoughts) • Start acting on dangerous impulses • Start seeing or hearing things that are not real", - "type": "boolean", - "required": true - }, - { - "linkId": "4.9", - "text": "8. I agree to return to see my doctor every month I take isotretinoin to get a new prescription for isotretinoin, to check my progress, and to check for signs of side effects.", - "type": "boolean", - "required": true - }, - { - "linkId": "4.10", - "text": "9. Isotretinoin wil be prescribed just for me - I will not share isotretinoin with other people because it may cause serious side effects, including birth defects.", - "type": "boolean", - "required": true - }, - { - "linkId": "4.11", - "text": "10. I will not give blood while taking isotretinoin or for 1 moth after I stop taking isotretinoin. I understand that if someone who is pregnant gets my donated blood, their baby may be exposed to isotretinoin and may be born with serious birth defects.", - "type": "boolean", - "required": true - }, - { - "linkId": "4.12", - "text": "11. I have read the iPLEDGE REMS Fact Sheet and other materials my provider provided me containing important safety information about isotretinoin. I understand all the information I received.", - "type": "boolean", - "required": true - }, - { - "linkId": "4.13", - "text": "12. My doctor and I have decided I should take isotretinoin. I understand that I must be qualified in the iPLEDGE REMS to have my prescription filled each month. I understand that I can stop taking isotretinoin at any time. I agree to tell my doctor if I stop taking isotretinoin.", - "type": "boolean", - "required": true - } - ] - }, - { - "linkId": "6", - "type": "group", - "text": "Patient Attestation", - "item": [ - { - "linkId": "6.1", - "text": "Patient Attestation", - "type": "choice", - "required": true, - "answerOption": [ - { - "valueString": "Patient Attestation" - }, - { - "valueString": "Parent or Guardian Attestation" - } - ] - }, - { - "linkId": "6.2", - "text": "I now allow my doctor to begin my treatment with isotretinoin.", - "type": "display" - }, - { - "linkId": "6.3", - "text": "Patient Initials", - "type": "string", - "required": true - }, - { - "linkId": "6.4", - "text": "Patient Name", - "type": "string", - "required": true - }, - { - "linkId": "6.5", - "text": "Patient Signature", - "type": "string", - "required": true - }, - { - "linkId": "6.6", - "text": "I authorize the above signature to be the legally binding equivalent of my handwritten signature.", - "type": "display" - } - ] - }, - { - "linkId": "7", - "type": "group", - "text": "Patient Counseling", - "item": [ - { - "linkId": "7.1", - "text": "I have counseled this patient on the following: • Requirement to use 2 effective forms of birth control together correctly all the time • Drug should not be shared with anyone, even any drug remaining after treatment • Blood should not be donated while taking isotretinoin • Patient REMS requirements", - "type": "boolean", - "required": true - }, - { - "linkId": "7.2", - "text": "In my opinion, this patient understands and is capable of complying with the requirements of the iPLEDGE REMS", - "type": "boolean", - "required": true - }, - { - "linkId": "7.3", - "text": "I have: • fully explained to the patient, the nature and purpose of isotretinoin treatment, including its benefits and risks to patients who can get pregnant • provided the patient with the appropriate educational materials, such as the iPLEDGE REMS Fact Sheet and asked the patient if there are any questions regarding treatment with isotretinoin • answered those questions to the best of my ability", - "type": "display" - }, - { - "linkId": "7.4", - "text": "Doctor Name", - "type": "string", - "required": true - }, - { - "linkId": "7.5", - "text": "Doctor Signature", - "type": "string", - "required": true - }, - { - "linkId": "7.6", - "text": "I authorize the above signature to be the legally binding equivalent to my handwritten signature.", - "type": "display" - } - ] - } - ] -} \ No newline at end of file From d6fce16f478efdd034a33489aae922ae9fa31585 Mon Sep 17 00:00:00 2001 From: Meng-Chau Date: Tue, 16 Aug 2022 08:26:52 -0400 Subject: [PATCH 4/8] final changes --- CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql | 5 +---- ...tPregnant-IPledge.json => Questionnaire-R4-IPledge.json} | 6 +++--- 2 files changed, 4 insertions(+), 7 deletions(-) rename CRD-DTR/IPledge/R4/resources/{Questionnaire-R4-CanGetPregnant-IPledge.json => Questionnaire-R4-IPledge.json} (99%) diff --git a/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql index 7780fca..fa8856a 100644 --- a/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql +++ b/CRD-DTR/IPledge/R4/files/IPledgeRule-0.1.0.cql @@ -21,10 +21,7 @@ define RESULT_InfoLink: 'https://www.accessdata.fda.gov/drugsatfda_docs/rems/IPledge_2020_08_04_REMS_Full.pdf' define RESULT_QuestionnaireOrderUri: - 'Questionnaire/IPledgeRemsPatientEnrollmentCanGetPregnant' - -define RESULT_QuestionnairePrescriberKnowledgeAssessmentUri: - 'Questionnaire/IPledgeRemsPatientEnrollmentCannotGetPregnant' + 'Questionnaire/IPledgeRemsPatientEnrollment' define RESULT_QuestionnairePrescriberEnrollmentUri: 'Questionnaire/IPledgeRemsPrescriberEnrollmentForm' diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-IPledge.json similarity index 99% rename from CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json rename to CRD-DTR/IPledge/R4/resources/Questionnaire-R4-IPledge.json index 5bf9991..b6290e7 100644 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-CanGetPregnant-IPledge.json +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-IPledge.json @@ -1,8 +1,8 @@ { "resourceType": "Questionnaire", - "id": "IPledgeRemsPatientEnrollmentCanGetPregnant", - "name": "IPledgeRemsPatientEnrollmentCanGetPregnant", - "title": "IPledge Rems Patient Enrollment (Can Get Pregnant)", + "id": "IPledgeRemsPatientEnrollment", + "name": "IPledgeRemsPatientEnrollment", + "title": "IPledge Rems Patient Enrollment", "status": "draft", "subjectType": [ "Patient" From c22662694da9b88c2a7cd881e1804572483dd1de Mon Sep 17 00:00:00 2001 From: Meng-Chau Date: Tue, 16 Aug 2022 13:24:38 -0400 Subject: [PATCH 5/8] extension issue push --- .../R4/files/IPledgePrepopulation-0.1.0.cql | 0 ...rescriberEnrollmentPrepopulation-0.1.0.cql | 48 ++++++++ .../Library-IPledge-prepopulation.json | 0 ...dgePrescriberEnrollment-prepopulation.json | 109 ++++++++++++++++++ ...naire-R4-PrescriberEnrollment-IPledge.json | 6 + 5 files changed, 163 insertions(+) create mode 100644 CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql create mode 100644 CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql create mode 100644 CRD-DTR/IPledge/R4/resources/Library-IPledge-prepopulation.json create mode 100644 CRD-DTR/IPledge/R4/resources/Library-R4-IPledgePrescriberEnrollment-prepopulation.json diff --git a/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql new file mode 100644 index 0000000..e69de29 diff --git a/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql new file mode 100644 index 0000000..f87f017 --- /dev/null +++ b/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql @@ -0,0 +1,48 @@ +library IPledgePrescriberEnrollmentPrepopulation version '0.1.0' +using FHIR version '4.0.0' +include FHIRHelpers version '4.0.0' called FHIRHelpers + + +codesystem "ICD-10-CM": 'http://hl7.org/fhir/sid/icd-10-cm' +codesystem "LOINC": 'http://loinc.org' +codesystem "SNOMED-CT": 'http://snomed.info/sct' +codesystem "RXNORM": 'http://www.nlm.nih.gov/research/umls/rxnorm' + +valueset "TuralioValueSet": 'http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.197' + + +code "Oncologist":'394592004' from "SNOMED-CT" + +parameter device_request DeviceRequest +parameter service_request ServiceRequest +parameter medication_request MedicationRequest + +context Patient + +define Today: Today() + +define "SigningProviderReference": Coalesce(device_request.performer.reference.value, service_request.performer.reference.value, medication_request.requester.reference.value) +// Get Practitioner +define OrderingProvider: singleton from ( + [Practitioner] practitioner + where ('Practitioner/' + practitioner.id) = SigningProviderReference) + +define Qualifications: singleton from ( + "OrderingProvider".qualification[0].code.coding[0].code.value) + +define Credentials: {Qualifications} + +define PractitionerRole: singleton from ( + [PractitionerRole] prole + where (prole.practitioner.reference.value) = SigningProviderReference) + +define Specialty: FHIRHelpers.ToConcept("PractitionerRole".specialty[0] as FHIR.CodeableConcept).codes + +define PreferredCommunication: {(singleton from ( + "OrderingProvider".telecom telecom where telecom.rank.value = 1)).system.value} + +define OrgName: ([Organization] org).name.value + +define MD: (singleton from ( + "OrderingProvider".identifier identifier + where identifier.type.coding[0].code = 'MD')).value.value \ No newline at end of file diff --git a/CRD-DTR/IPledge/R4/resources/Library-IPledge-prepopulation.json b/CRD-DTR/IPledge/R4/resources/Library-IPledge-prepopulation.json new file mode 100644 index 0000000..e69de29 diff --git a/CRD-DTR/IPledge/R4/resources/Library-R4-IPledgePrescriberEnrollment-prepopulation.json b/CRD-DTR/IPledge/R4/resources/Library-R4-IPledgePrescriberEnrollment-prepopulation.json new file mode 100644 index 0000000..718b122 --- /dev/null +++ b/CRD-DTR/IPledge/R4/resources/Library-R4-IPledgePrescriberEnrollment-prepopulation.json @@ -0,0 +1,109 @@ +{ + "resourceType": "Library", + "id": "IPledgePrescriberEnrollment-prepopulation", + "url": "http://hl7.org/fhir/us/davinci-dtr/Library/IPledgePrescriberEnrollment-prepopulation", + "name": "IPledgePrescriberEnrollment-prepopulation", + "version": "0.1.0", + "title": "IPledgePrescriberEnrollment Prepopulation", + "status": "draft", + "type": { + "coding": [ + { + "code": "logic-library" + } + ] + }, + "relatedArtifact": [ + { + "type": "depends-on", + "resource": "Library/FHIRHelpers-4.0.0" + }, + { + "type": "depends-on", + "resource": "Library/CDS_Connect_Commons_for_FHIRv400" + }, + { + "type": "depends-on", + "resource": "Library/DTRHelpers" + } + ], + "dataRequirement": [ + { + "type": "Condition", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.81" + } + ] + }, + { + "type": "Condition", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.198" + } + ] + }, + { + "type": "Procedure", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.90" + } + ] + }, + { + "type": "MedicationRequest", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.192" + } + ] + }, + { + "type": "MedicationRequest", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.193" + } + ] + }, + { + "type": "Observation" + }, + { + "type": "MedicationStatement", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.197" + } + ] + }, + { + "type": "Practitioner" + }, + { + "type": "PractitionerRole", + "subjectCodeableConcept": { + "coding": [ + { + "system": "http://hl7.org/fhir/ValueSet/subject-type", + "code": "Practitioner" + } + ] + } + } + ], + "content": [ + { + "contentType": "application/elm+json", + "url": "files/IPledge/r4/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql" + } + ] + } \ No newline at end of file diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json index 83abbc5..d875217 100644 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json @@ -9,6 +9,12 @@ ], "date": "2022-05-28", "publisher": "FDA-REMS", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", + "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/IPledgePrescriberEnrollment-prepopulation" + } + ], "item": [ { "linkId": "1", From e9087391cf455ad1300aedca7648bb6597f8d654 Mon Sep 17 00:00:00 2001 From: Meng-Chau Date: Tue, 16 Aug 2022 15:18:14 -0400 Subject: [PATCH 6/8] fixes cont --- .../R4/files/IPledgePrepopulation-0.1.0.cql | 130 ++++++++++++++++++ .../Library-IPledge-prepopulation.json | 0 .../Library-R4-IPledge-prepopulation.json | 95 +++++++++++++ 3 files changed, 225 insertions(+) delete mode 100644 CRD-DTR/IPledge/R4/resources/Library-IPledge-prepopulation.json create mode 100644 CRD-DTR/IPledge/R4/resources/Library-R4-IPledge-prepopulation.json diff --git a/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql index e69de29..6e9b807 100644 --- a/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql +++ b/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql @@ -0,0 +1,130 @@ +library DrugHasREMSPrepopulation version '0.1.0' +using FHIR version '4.0.0' +include FHIRHelpers version '4.0.0' called FHIRHelpers +include CDS_Connect_Commons_for_FHIRv400 version '1.0.2' called CDS +include DTRHelpers version '0.1.0' called DTR + +codesystem "ICD-10-CM": 'http://hl7.org/fhir/sid/icd-10-cm' +codesystem "LOINC": 'http://loinc.org' +codesystem "SNOMED-CT": 'http://snomed.info/sct' +codesystem "RXNORM": 'http://www.nlm.nih.gov/research/umls/rxnorm' + + +valueset "HepaticMedicalHistory": 'http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.198' +valueset "TuralioValueSet": 'http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.197' + +code "29463-7": '29463-7' from "LOINC" +code "2183102": '2183102' from "RXNORM" +code "AST": '1920-8' from "LOINC" +code "ALT": '1742-6' from "LOINC" +code "GGT": '2324-2' from "LOINC" +code "TotalBilirubin": '1975-2' from "LOINC" +code "DirectBilirubin": '1968-7' from "LOINC" +code "ALP": '13874-3' from "LOINC" +code "Albumin": '1751-7' from "LOINC" +code "PT": '5902-2' from "LOINC" + +parameter medication_request MedicationRequest +parameter medication_dispense MedicationDispense + +context Patient + +// get observations +define "WeightList": [Observation: "29463-7"] +define "LatestWeight": CDS.MostRecent(CDS.WithUnit(CDS.Verified("WeightList"),'mg')) +define "LatestWeightResult": DTR.GetObservationValue("LatestWeight") + +define "Turalio": [MedicationStatement: "TuralioValueSet"] +define "TakingTuralio": exists("Turalio") +define "TuralioDate": + if "TakingTuralio" + then First("Turalio").effective.value + else + null + +define "LatestAST": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "AST"]), 'U/L')) +define "ASTResult": (convert DTR.GetObservationValue("LatestAST") to String) + ' U/L' +define "ASTDate": + if exists("LatestAST") + then "LatestAST".issued.value + else + null + +define "LatestALT": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "ALT"]), 'U/L')) +define "ALTResult": (convert DTR.GetObservationValue("LatestALT") to String) + ' U/L' +define "ALTDate": + if exists("LatestALT") + then "LatestALT".issued.value + else + null + +define "LatestGGT": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "GGT"]), 'U/L')) +define "GGTResult": (convert DTR.GetObservationValue("LatestGGT") to String) + ' U/L' +define "GGTDate": + if exists("LatestGGT") + then "LatestGGT".issued.value + else + null + +define "LatestTotalBilirubin": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "TotalBilirubin"]), 'mg/dL')) +define "TotalBilirubinResult": (convert DTR.GetObservationValue("LatestTotalBilirubin") to String) + ' mg/dL' +define "TotalBilirubinDate": + if exists("LatestTotalBilirubin") + then "LatestTotalBilirubin".issued.value + else + null + +define "LatestDirectBilirubin": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "DirectBilirubin"]), 'mg/dL')) +define "DirectBilirubinResult": (convert DTR.GetObservationValue("LatestDirectBilirubin") to String) + ' mg/dL' +define "DirectBilirubinDate": + if exists("LatestDirectBilirubin") + then "LatestDirectBilirubin".issued.value + else + null + +define "LatestALP": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "ALP"]), 'U/L')) +define "ALPResult": (convert DTR.GetObservationValue("LatestALP") to String) + ' U/L' +define "ALPDate": + if exists("LatestALP") + then "LatestALP".issued.value + else + null + +define "LatestAlbumin": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "Albumin"]), 'g/dL')) +define "AlbuminResult": (convert DTR.GetObservationValue("LatestAlbumin") to String) + ' g/dL' +define "AlbuminDate": + if exists("LatestAlbumin") + then "LatestAlbumin".issued.value + else + null + +define "LatestPT": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "PT"]), 's')) +define "PTResult": (convert DTR.GetObservationValue("LatestPT") to String) + ' s' +define "PTDate": + if exists("LatestPT") + then "LatestPT".issued.value + else + null + +define "MedList": [MedicationStatement] M + where M.status.value = 'active' + +define "TakingMeds": not exists("MedList") +define function GetMedicationsTupleList(MedStatementList List): + distinct( + flatten( + MedStatementList MedStatement + let MedicationList: + (MedStatement.medication.coding) CODING + return (FHIRHelpers.ToCode(CODING).display + ' - ' + FHIRHelpers.ToCode(CODING).code) + + return MedicationList + ) + ) +define "Meds": GetMedicationsTupleList(MedList) +define "MedsString": + Meds M + aggregate Result starting '': Result + ', ' + M + +define "MedicalHistoryList": [Condition: "HepaticMedicalHistory"] +define "MedicalHistory": DTR.CodesFromConditions(CDS.Confirmed("MedicalHistoryList")) \ No newline at end of file diff --git a/CRD-DTR/IPledge/R4/resources/Library-IPledge-prepopulation.json b/CRD-DTR/IPledge/R4/resources/Library-IPledge-prepopulation.json deleted file mode 100644 index e69de29..0000000 diff --git a/CRD-DTR/IPledge/R4/resources/Library-R4-IPledge-prepopulation.json b/CRD-DTR/IPledge/R4/resources/Library-R4-IPledge-prepopulation.json new file mode 100644 index 0000000..4a36c29 --- /dev/null +++ b/CRD-DTR/IPledge/R4/resources/Library-R4-IPledge-prepopulation.json @@ -0,0 +1,95 @@ +{ + "resourceType": "Library", + "id": "IPledge-prepopulation", + "url": "http://hl7.org/fhir/us/davinci-dtr/Library/IPledge-prepopulation", + "name": "IPledge-prepopulation", + "version": "0.1.0", + "title": "IPledge Prepopulation", + "status": "draft", + "type": { + "coding": [ + { + "code": "logic-library" + } + ] + }, + "relatedArtifact": [ + { + "type": "depends-on", + "resource": "Library/FHIRHelpers-4.0.0" + }, + { + "type": "depends-on", + "resource": "Library/CDS_Connect_Commons_for_FHIRv400" + }, + { + "type": "depends-on", + "resource": "Library/DTRHelpers" + } + ], + "dataRequirement": [ + { + "type": "Condition", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.81" + } + ] + }, + { + "type": "Condition", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.198" + } + ] + }, + { + "type": "Procedure", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.90" + } + ] + }, + { + "type": "MedicationRequest", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.192" + } + ] + }, + { + "type": "MedicationRequest", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.193" + } + ] + }, + { + "type": "Observation" + }, + { + "type": "MedicationStatement", + "codeFilter": [ + { + "path": "code", + "valueSet": "http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.197" + } + ] + } + ], + "content": [ + { + "contentType": "application/elm+json", + "url": "files/IPledge/r4/IPledgePrepopulation-0.1.0.cql" + } + ] +} \ No newline at end of file From 49fa5ccda99e5a9449f2edd445834fec25b2d2eb Mon Sep 17 00:00:00 2001 From: Meng-Chau Date: Thu, 18 Aug 2022 14:48:05 -0400 Subject: [PATCH 7/8] prepopulation --- .../R4/files/IPledgePrepopulation-0.1.0.cql | 122 +--------- ...rescriberEnrollmentPrepopulation-0.1.0.cql | 13 +- .../resources/Questionnaire-R4-IPledge.json | 135 ++++++++++- ...naire-R4-PrescriberEnrollment-IPledge.json | 228 ++++++++++++++++-- 4 files changed, 335 insertions(+), 163 deletions(-) diff --git a/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql index 6e9b807..4960e2f 100644 --- a/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql +++ b/CRD-DTR/IPledge/R4/files/IPledgePrepopulation-0.1.0.cql @@ -1,4 +1,4 @@ -library DrugHasREMSPrepopulation version '0.1.0' +library IPledgePrepopulation version '0.1.0' using FHIR version '4.0.0' include FHIRHelpers version '4.0.0' called FHIRHelpers include CDS_Connect_Commons_for_FHIRv400 version '1.0.2' called CDS @@ -8,123 +8,3 @@ codesystem "ICD-10-CM": 'http://hl7.org/fhir/sid/icd-10-cm' codesystem "LOINC": 'http://loinc.org' codesystem "SNOMED-CT": 'http://snomed.info/sct' codesystem "RXNORM": 'http://www.nlm.nih.gov/research/umls/rxnorm' - - -valueset "HepaticMedicalHistory": 'http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.198' -valueset "TuralioValueSet": 'http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.197' - -code "29463-7": '29463-7' from "LOINC" -code "2183102": '2183102' from "RXNORM" -code "AST": '1920-8' from "LOINC" -code "ALT": '1742-6' from "LOINC" -code "GGT": '2324-2' from "LOINC" -code "TotalBilirubin": '1975-2' from "LOINC" -code "DirectBilirubin": '1968-7' from "LOINC" -code "ALP": '13874-3' from "LOINC" -code "Albumin": '1751-7' from "LOINC" -code "PT": '5902-2' from "LOINC" - -parameter medication_request MedicationRequest -parameter medication_dispense MedicationDispense - -context Patient - -// get observations -define "WeightList": [Observation: "29463-7"] -define "LatestWeight": CDS.MostRecent(CDS.WithUnit(CDS.Verified("WeightList"),'mg')) -define "LatestWeightResult": DTR.GetObservationValue("LatestWeight") - -define "Turalio": [MedicationStatement: "TuralioValueSet"] -define "TakingTuralio": exists("Turalio") -define "TuralioDate": - if "TakingTuralio" - then First("Turalio").effective.value - else - null - -define "LatestAST": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "AST"]), 'U/L')) -define "ASTResult": (convert DTR.GetObservationValue("LatestAST") to String) + ' U/L' -define "ASTDate": - if exists("LatestAST") - then "LatestAST".issued.value - else - null - -define "LatestALT": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "ALT"]), 'U/L')) -define "ALTResult": (convert DTR.GetObservationValue("LatestALT") to String) + ' U/L' -define "ALTDate": - if exists("LatestALT") - then "LatestALT".issued.value - else - null - -define "LatestGGT": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "GGT"]), 'U/L')) -define "GGTResult": (convert DTR.GetObservationValue("LatestGGT") to String) + ' U/L' -define "GGTDate": - if exists("LatestGGT") - then "LatestGGT".issued.value - else - null - -define "LatestTotalBilirubin": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "TotalBilirubin"]), 'mg/dL')) -define "TotalBilirubinResult": (convert DTR.GetObservationValue("LatestTotalBilirubin") to String) + ' mg/dL' -define "TotalBilirubinDate": - if exists("LatestTotalBilirubin") - then "LatestTotalBilirubin".issued.value - else - null - -define "LatestDirectBilirubin": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "DirectBilirubin"]), 'mg/dL')) -define "DirectBilirubinResult": (convert DTR.GetObservationValue("LatestDirectBilirubin") to String) + ' mg/dL' -define "DirectBilirubinDate": - if exists("LatestDirectBilirubin") - then "LatestDirectBilirubin".issued.value - else - null - -define "LatestALP": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "ALP"]), 'U/L')) -define "ALPResult": (convert DTR.GetObservationValue("LatestALP") to String) + ' U/L' -define "ALPDate": - if exists("LatestALP") - then "LatestALP".issued.value - else - null - -define "LatestAlbumin": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "Albumin"]), 'g/dL')) -define "AlbuminResult": (convert DTR.GetObservationValue("LatestAlbumin") to String) + ' g/dL' -define "AlbuminDate": - if exists("LatestAlbumin") - then "LatestAlbumin".issued.value - else - null - -define "LatestPT": CDS.MostRecent(CDS.WithUnit(CDS.Verified([Observation: "PT"]), 's')) -define "PTResult": (convert DTR.GetObservationValue("LatestPT") to String) + ' s' -define "PTDate": - if exists("LatestPT") - then "LatestPT".issued.value - else - null - -define "MedList": [MedicationStatement] M - where M.status.value = 'active' - -define "TakingMeds": not exists("MedList") -define function GetMedicationsTupleList(MedStatementList List): - distinct( - flatten( - MedStatementList MedStatement - let MedicationList: - (MedStatement.medication.coding) CODING - return (FHIRHelpers.ToCode(CODING).display + ' - ' + FHIRHelpers.ToCode(CODING).code) - - return MedicationList - ) - ) -define "Meds": GetMedicationsTupleList(MedList) -define "MedsString": - Meds M - aggregate Result starting '': Result + ', ' + M - -define "MedicalHistoryList": [Condition: "HepaticMedicalHistory"] -define "MedicalHistory": DTR.CodesFromConditions(CDS.Confirmed("MedicalHistoryList")) \ No newline at end of file diff --git a/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql index f87f017..09bf21f 100644 --- a/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql +++ b/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql @@ -2,15 +2,11 @@ library IPledgePrescriberEnrollmentPrepopulation version '0.1.0' using FHIR version '4.0.0' include FHIRHelpers version '4.0.0' called FHIRHelpers - codesystem "ICD-10-CM": 'http://hl7.org/fhir/sid/icd-10-cm' codesystem "LOINC": 'http://loinc.org' codesystem "SNOMED-CT": 'http://snomed.info/sct' codesystem "RXNORM": 'http://www.nlm.nih.gov/research/umls/rxnorm' -valueset "TuralioValueSet": 'http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113762.1.4.1219.197' - - code "Oncologist":'394592004' from "SNOMED-CT" parameter device_request DeviceRequest @@ -45,4 +41,11 @@ define OrgName: ([Organization] org).name.value define MD: (singleton from ( "OrderingProvider".identifier identifier - where identifier.type.coding[0].code = 'MD')).value.value \ No newline at end of file + where identifier.type.coding[0].code = 'MD')).value.value + +define ValidTIRFCredentials: + from "OrderingProvider".qualification qualification + where qualification.identifier.system.value = 'http://www.nlm.nih.gov/research/umls/rxnorm' and qualification.identifier.value.value = '6064' + +define ThirdPartyCredentials: ValidTIRFCredentials[0].code.text.value +define ThirdPartyIssuer: ValidTIRFCredentials[0].issuer.display.value \ No newline at end of file diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-IPledge.json index b6290e7..4e309a7 100644 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-IPledge.json +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-IPledge.json @@ -9,6 +9,20 @@ ], "date": "2020-05-20", "publisher": "Da Vinci DTR", + "extension": [ + { + "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", + "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/IPledge-prepopulation" + }, + { + "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", + "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/BasicPatientInfo-prepopulation" + }, + { + "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", + "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/BasicPractitionerInfo-prepopulation" + } + ], "item": [ { "linkId": "1", @@ -163,25 +177,61 @@ "linkId": "5.1", "text": "First Name", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".FirstName" + } + } + ] }, { "linkId": "5.2", "text": "Middle Initial", "type": "string", - "required": false + "required": false, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".MiddleInitial" + } + } + ] }, { "linkId": "5.3", "text": "Last Name", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".LastName" + } + } + ] }, { "linkId": "5.4", "text": "Address Line 1", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".Line" + } + } + ] }, { "linkId": "5.5", @@ -193,25 +243,61 @@ "linkId": "5.6", "text": "City", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".City" + } + } + ] }, { "linkId": "5.7", "text": "State", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".State" + } + } + ] }, { "linkId": "5.8", "text": "Zip", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".Zip" + } + } + ] }, { "linkId": "5.9", "text": "Mobile Phone Number", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".Phone" + } + } + ] }, { "linkId": "5.10", @@ -223,7 +309,16 @@ "linkId": "5.11", "text": "Date of Birth", "type": "date", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".DateOfBirth" + } + } + ] }, { "linkId": "5.12", @@ -493,7 +588,16 @@ "linkId": "8.4", "text": "Patient Name", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPatientInfoPrepopulation\".FullName" + } + } + ] }, { "linkId": "8.5", @@ -586,7 +690,16 @@ "linkId": "9.7", "text": "Doctor Name", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".FullName" + } + } + ] }, { "linkId": "9.8", diff --git a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json index d875217..cad37a0 100644 --- a/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json +++ b/CRD-DTR/IPledge/R4/resources/Questionnaire-R4-PrescriberEnrollment-IPledge.json @@ -11,8 +11,12 @@ "publisher": "FDA-REMS", "extension": [ { - "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", - "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/IPledgePrescriberEnrollment-prepopulation" + "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", + "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/IPledgePrescriberEnrollment-prepopulation" + }, + { + "url": "http://hl7.org/fhir/StructureDefinition/cqf-library", + "valueCanonical": "http://hl7.org/fhir/us/davinci-dtr/Library/BasicPractitionerInfo-prepopulation" } ], "item": [ @@ -30,31 +34,76 @@ "linkId": "1.2", "text": "NPI Number", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".NPI" + } + } + ] }, { "linkId": "1.3", "text": "First Name", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".FirstName" + } + } + ] }, { "linkId": "1.4", "text": "MI", "type": "string", - "required": false + "required": false, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".MiddleInitial" + } + } + ] }, { "linkId": "1.5", "text": "Last Name", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".LastName" + } + } + ] }, { "linkId": "1.6", "text": "Suffix", - "type": "choice", + "type": "open-choice", "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"IPledgePrescriberEnrollmentPrepopulation\".Credentials" + } + } + ], "answerOption": [ { "valueCoding": { @@ -95,20 +144,47 @@ { "linkId": "1.7", "text": "Specialty", - "type": "string", - "required": true + "type": "open-choice", + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"IPledgePrescriberEnrollmentPrepopulation\".Specialty" + } + } + ] }, { "linkId": "1.8", "text": "Practice Name", "type": "string", - "required": false + "required": false, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"IPledgePrescriberEnrollmentPrepopulation\".OrgName" + } + } + ] }, { "linkId": "1.9", "text": "Address Line 1", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".Line" + } + } + ] }, { "linkId": "1.10", @@ -120,25 +196,61 @@ "linkId": "1.11", "text": "City", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".City" + } + } + ] }, { "linkId": "1.12", "text": "State", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".State" + } + } + ] }, { "linkId": "1.13", "text": "Zip", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".Zip" + } + } + ] }, { "linkId": "1.14", "text": "Phone Number", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".Phone" + } + } + ] }, { "linkId": "1.15", @@ -150,19 +262,46 @@ "linkId": "1.16", "text": "Fax Number", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".Fax" + } + } + ] }, { "linkId": "1.17", "text": "Email", "type": "string", - "required": true + "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"BasicPractitionerInfoPrepopulation\".Email" + } + } + ] }, { "linkId": "1.18", "text": "Preferred Method of Communication", "type": "choice", "required": true, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"IPledgePrescriberEnrollmentPrepopulation\".PreferredCommunication" + } + } + ], "answerOption": [ { "valueCoding": { @@ -185,50 +324,87 @@ { "linkId": "2", "type": "group", - "text": "Prescriber Attestation", + "text": "Prescriber Certification (if applicable)", "item": [ { "linkId": "2.1", + "text": "Prescriber Certification Type", + "type": "string", + "required": false, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"IPledgePrescriberEnrollmentPrepopulation\".ThirdPartyCredentials" + } + } + ] + }, + { + "linkId": "2.2", + "text": "Prescriber Certification Issuer", + "type": "string", + "required": false, + "extension": [ + { + "url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression", + "valueExpression": { + "language": "text/cql", + "expression": "\"IPledgePrescriberEnrollmentPrepopulation\".ThirdPartyIssuer" + } + } + ] + } + ] + }, + { + "linkId": "3", + "type": "group", + "text": "Prescriber Attestation", + "item": [ + { + "linkId": "3.1", "text": "Prescribers can only activate their enrollment by affirming that they meet requirements and will comply with all iPLEDGE REMS requirements by attesting to the following points:", "type": "display" }, { - "linkId": "2.2", + "linkId": "3.2", "text": "I know the risk and severity of fetal injury/birth defects from isotretinoin.", "type": "display" }, { - "linkId": "2.3", + "linkId": "3.3", "text": "I know the risk factors for unplanned pregnancy and the effective measures for avoidance of unplaned pregnancy.", "type": "display" }, { - "linkId": "2.4", + "linkId": "3.4", "text": "I have the expertise to provide the patient with detailed pregnancy prevention counseling, or I will refer the patient to an expert for such counseling, reimbursed by the manufacturer.", "type": "display" }, { - "linkId": "2.5", + "linkId": "3.5", "text": "I will comply with the iPLEDGE REMS requirements described in the booklet, iPLEDGE REMS Prescriber Guide.", "type": "display" }, { - "linkId": "2.6", + "linkId": "3.6", "text": "Before beginning treatment of patients who can become pregnant with isotretinoin, and on a monthly basis, the patient will be counseled to avoid pregnancy by using two forms of contraception simultaneously and continously for at least one month prior to initiation of isotretinoin treatment, during isotretinoin treatment and for one month after discontinuing isotretinoin treatment, unless the patient commits to continous abstinence, not having any sexual contact with a partner that could result in pregnancy.", "type": "display" }, { - "linkId": "2.7", + "linkId": "3.7", "text": "I will not prescribe isotretinoin to any patient who can become pregnant until verifying the patient has a negative screening pregnancy test and monthly CLIA-certified (Clinical Laboratory Improvement Amendment) pregnancy tests. Patients should have a pregnancy test at the completion of the entire course of isotretinoin and another pregnancy test one month laer.", "type": "display" }, { - "linkId": "2.8", + "linkId": "3.8", "text": "I will report any pregnancy case that I become aware of while the patient who can become pregnant is on isotretinoin or one month after the last dose to the pregnancy registry.", "type": "display" }, { - "linkId": "2.9", + "linkId": "3.9", "type": "choice", "answerOption": [ { From bcbd8f5865e87997fd9844224ff14da72bc6625b Mon Sep 17 00:00:00 2001 From: Meng-Chau Date: Thu, 18 Aug 2022 14:58:07 -0400 Subject: [PATCH 8/8] Spelling error --- .../IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql | 6 +++--- 1 file changed, 3 insertions(+), 3 deletions(-) diff --git a/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql b/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql index 09bf21f..6e6b1af 100644 --- a/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql +++ b/CRD-DTR/IPledge/R4/files/IPledgePrescriberEnrollmentPrepopulation-0.1.0.cql @@ -43,9 +43,9 @@ define MD: (singleton from ( "OrderingProvider".identifier identifier where identifier.type.coding[0].code = 'MD')).value.value -define ValidTIRFCredentials: +define ValidIPledgeCredentials: from "OrderingProvider".qualification qualification where qualification.identifier.system.value = 'http://www.nlm.nih.gov/research/umls/rxnorm' and qualification.identifier.value.value = '6064' -define ThirdPartyCredentials: ValidTIRFCredentials[0].code.text.value -define ThirdPartyIssuer: ValidTIRFCredentials[0].issuer.display.value \ No newline at end of file +define ThirdPartyCredentials: ValidIPledgeCredentials[0].code.text.value +define ThirdPartyIssuer: ValidIPledgeCredentials[0].issuer.display.value \ No newline at end of file