diff --git a/exercises/02-python.py b/exercises/02-python.py index c54eaec..0defefe 100644 --- a/exercises/02-python.py +++ b/exercises/02-python.py @@ -1,2 +1,54 @@ +# R/Pharma 2025 Workshop: dsjconvert in Python +# Exercises for hands-on practice with the dsjconvert Python package + +# EXERCISE INSTRUCTIONS: +# 1. Load the required packages need to complete the exercises +# 2. Find the main() function and work through each exercise in order +# 3. Replace TODO comments with actual Python code +# 4. Use the examples is the slides to help you, or +# 5. Check the examples in the dsjconvert README.md (https://github.com/swhume/dataset-json) +# 6. Run your code to make sure it works +# 7. Check your answers against exercises/answers/02-python-answer.py +# 8. Ask for help if you get stuck! + +from pathlib import Path +from dsjconvert import XPTConverter, MetadataExtractor +from dsjconvert import DatasetJSONToXPTConverter + + +def check_data_dir_exists() -> None: + directory_path = Path("data") + if not directory_path.is_dir(): + raise FileNotFoundError(f"The directory '{directory_path}' does not exist or is not a directory.") + + +def main(): + check_data_dir_exists() + + # ============================================================================= + # SOLUTION to Dataset-JSON conversion exercises using Python and dsjconvert + # ============================================================================= + + # Exercise 1: convert cm.xpt to CM.ndjson using the define.xml metadata + data_path = Path(__file__).parent.joinpath("data") + xpt_file = Path(data_path).joinpath("cm.xpt") + define_file = Path(data_path).joinpath("define.xml") + # TODO use a function to convert cm.xpt to CM.ndjson using the define.xml metadata + + # Exercise 2: convert vs.xpt to VS.ndjson without using the define.xml metadata + xpt_file = Path(data_path).joinpath("vs.xpt") + # TODO use a function to convert vs.xpt to VS.ndjson without using the define.xml metadata + + # Exercise 3: convert dm.xpt to dm.json using the define.xml metadata + xpt_file = Path(data_path).joinpath("dm.xpt") + # TODO use a function to convert dm.xpt to dm.json using the define.xml metadata + + # Exercise 4: convert MH.ndjson to mh.xpt using the define.xml metadata + dsj_file = Path(data_path).joinpath("MH.ndjson") + # TODO use a function to convert MH.ndjson to mh.xpt + + +if __name__ == '__main__': + main() # Placeholder for python diff --git a/exercises/answers/02-python-answer.py b/exercises/answers/02-python-answer.py index 7cdf609..0c0894a 100644 --- a/exercises/answers/02-python-answer.py +++ b/exercises/answers/02-python-answer.py @@ -1 +1,80 @@ +# R/Pharma 2025 Workshop: dsjconvert in Python +# Solution to the exercises for hands-on practice with the dsjconvert Python package +# ============================================================================= +# This is the solution to the Python dsjconvert exercises. +# ============================================================================= +# EXERCISE INSTRUCTIONS: +# 1. Load the required packages need to complete the exercises +# 2. Find the main() function and work through each exercise in order +# 3. Replace TODO comments with actual Python code +# 4. Use the examples is the slides to help you, or +# 5. Check the examples in the dsjconvert README.md (https://github.com/swhume/dataset-json) +# 6. Run your code to make sure it works +# 7. Check your answers against exercises/answers/02-python-answer.py +# 8. Ask for help if you get stuck! + +from pathlib import Path +from dsjconvert import XPTConverter, MetadataExtractor +from dsjconvert import DatasetJSONToXPTConverter + + +def convert_xpt_dataset(dsj_format: str, data_path: Path, xpt_file: Path, define_file: Path = None): + if define_file: + extractor = MetadataExtractor(define_file) + converter = XPTConverter( + metadata_extractor=extractor, + output_format=dsj_format, + skip_validation=True + ) + else: + converter = XPTConverter( + output_format=dsj_format, + skip_validation=True + ) + converter.convert_dataset(xpt_file, data_path) + + +def convert_dsj_dataset(dsj_format: str, data_path: Path, dsj_file: Path): + converter = DatasetJSONToXPTConverter(input_format=dsj_format, skip_validation=True) + converter.convert_dataset(dsj_file, data_path) + + +def check_data_dir_exists() -> None: + directory_path = Path("data") + if not directory_path.is_dir(): + raise FileNotFoundError(f"The directory '{directory_path}' does not exist or is not a directory.") + + +def main(): + check_data_dir_exists() + + # ============================================================================= + # SOLUTION to Dataset-JSON conversion exercises using Python and dsjconvert + # ============================================================================= + + # Exercise 1: convert cm.xpt to CM.ndjson using the define.xml metadata + data_path = Path(__file__).parent.joinpath("data") + xpt_file = Path(data_path).joinpath("cm.xpt") + define_file = Path(data_path).joinpath("define.xml") + # TODO use a function to convert cm.xpt to CM.ndjson using the define.xml metadata + convert_xpt_dataset('ndjson', data_path, xpt_file, define_file) + + # Exercise 2: convert vs.xpt to VS.ndjson without using the define.xml metadata + xpt_file = Path(data_path).joinpath("vs.xpt") + # TODO use a function to convert vs.xpt to VS.ndjson without using the define.xml metadata + convert_xpt_dataset('ndjson', data_path, xpt_file) + + # Exercise 3: convert dm.xpt to dm.json using the define.xml metadata + xpt_file = Path(data_path).joinpath("dm.xpt") + # TODO use a function to convert dm.xpt to dm.json using the define.xml metadata + convert_xpt_dataset('json', data_path, xpt_file, define_file) + + # Exercise 4: convert MH.ndjson to mh.xpt using the define.xml metadata + dsj_file = Path(data_path).joinpath("MH.ndjson") + # TODO use a function to convert MH.ndjson to mh.xpt + convert_dsj_dataset("ndjson", data_path, dsj_file) + + +if __name__ == '__main__': + main() # Placeholder for answers diff --git a/exercises/data/MH.ndjson b/exercises/data/MH.ndjson new file mode 100644 index 0000000..d71b9d5 --- /dev/null +++ b/exercises/data/MH.ndjson @@ -0,0 +1,1818 @@ +{"datasetJSONCreationDateTime": "2025-10-27T11:01:56", "datasetJSONVersion": "1.1.0", "itemGroupOID": "IG.MH", "records": 1817, "name": "MH", "label": "MH", "columns": [{"itemOID": "IT.MH.STUDYID", "name": "STUDYID", "label": "Study Identifier", "dataType": "string"}, {"itemOID": "IT.MH.DOMAIN", "name": "DOMAIN", "label": "Domain Abbreviation", "dataType": "string"}, {"itemOID": "IT.MH.USUBJID", "name": "USUBJID", "label": "Unique Subject Identifier", "dataType": "string"}, {"itemOID": "IT.MH.MHSEQ", "name": "MHSEQ", "label": "Sequence Number", "dataType": "double"}, {"itemOID": "IT.MH.MHSPID", "name": "MHSPID", "label": "Sponsor-Defined Identifier", "dataType": "string"}, {"itemOID": "IT.MH.MHTERM", "name": "MHTERM", "label": "Reported Term for the Medical History", "dataType": "string"}, {"itemOID": "IT.MH.MHLLT", "name": "MHLLT", "label": "Lowest Level Term", "dataType": "string"}, {"itemOID": "IT.MH.MHDECOD", "name": "MHDECOD", "label": "Dictionary-Derived Term", "dataType": "string"}, {"itemOID": "IT.MH.MHHLT", "name": "MHHLT", "label": "High Level Term", "dataType": "string"}, {"itemOID": "IT.MH.MHHLGT", "name": "MHHLGT", "label": "High Level Group Term", "dataType": "string"}, {"itemOID": "IT.MH.MHCAT", "name": "MHCAT", "label": "Category for Medical History", "dataType": "string"}, {"itemOID": "IT.MH.MHBODSYS", "name": "MHBODSYS", "label": "Body System or Organ Class", "dataType": "string"}, {"itemOID": "IT.MH.MHSEV", "name": "MHSEV", "label": "Severity/Intensity", "dataType": "string"}, {"itemOID": "IT.MH.VISITNUM", "name": "VISITNUM", "label": "Visit Number", "dataType": "double"}, {"itemOID": "IT.MH.VISIT", "name": "VISIT", "label": "Visit Name", "dataType": "string"}, {"itemOID": "IT.MH.VISITDY", "name": "VISITDY", "label": "Planned Study Day of Visit", "dataType": "double"}, {"itemOID": "IT.MH.MHDTC", "name": "MHDTC", "label": "Date/Time of History Collection", "dataType": "string"}, {"itemOID": "IT.MH.MHSTDTC", "name": "MHSTDTC", "label": "Start Date/Time of Medical History Event", "dataType": "string"}, {"itemOID": "IT.MH.MHDY", "name": "MHDY", "label": "Study Day of History Collection", "dataType": "double"}]} +["CDISCPILOT01", "MH", "01-701-1015", 9.0, "", "ALZHEIMER'S DISEASE", "", "", "", "", "PRIMARY DIAGNOSIS", "", "", 1.0, "SCREENING 1", -7.0, "2013-12-26", "2010-04-30", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 10.0, "", "VERBATIM_0539", "GALLBLADDER STONES", "CHOLELITHIASIS", "HLT_0084", "HLGT_0177", "HISTORICAL DIAGNOSIS", "HEPATOBILIARY DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2013-12-26", "2012", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 4.0, "E02", "VERBATIM_0841", "HEARTBURN", "DYSPEPSIA", "HLT_0244", "HLGT_0716", "SIGNIFICANT PRE-EXISTING CONDITION", "GASTROINTESTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-12-26", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 2.0, "E03", "VERBATIM_0301", "HEADACHE", "HEADACHE", "HLT_0064", "HLGT_0344", "SIGNIFICANT PRE-EXISTING CONDITION", "NERVOUS SYSTEM DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-12-26", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 5.0, "E04", "VERBATIM_1779", "NUMBNESS IN LEG", "HYPOAESTHESIA", "HLT_0014", "HLGT_0528", "SIGNIFICANT PRE-EXISTING CONDITION", "NERVOUS SYSTEM DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-12-26", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 8.0, "", "VERBATIM_0140", "SUBTOTAL HYSTERECTOMY", "HYSTERECTOMY", "HLT_0675", "HLGT_0657", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2013-12-26", "1986", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 1.0, "E01", "VERBATIM_0135", "PALPITATIONS", "PALPITATIONS", "HLT_0493", "HLGT_0593", "SIGNIFICANT PRE-EXISTING CONDITION", "CARDIAC DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-12-26", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 11.0, "", "VERBATIM_1230", "SORE THROAT", "PHARYNGOLARYNGEAL PAIN", "HLT_0130", "HLGT_0402", "HISTORICAL DIAGNOSIS", "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2013-12-26", "2013-12", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 6.0, "", "VERBATIM_1004", "THYROIDECTOMY PARTIAL", "THYROIDECTOMY PARTIAL", "HLT_0243", "HLGT_0016", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2013-12-26", "1973", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 3.0, "E05", "VERBATIM_0825", "TINNITUS", "TINNITUS", "HLT_0570", "HLGT_0180", "SIGNIFICANT PRE-EXISTING CONDITION", "EAR AND LABYRINTH DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-12-26", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1015", 7.0, "", "VERBATIM_1716", "TONSILLECTOMY", "TONSILLECTOMY", "HLT_0202", "HLGT_0199", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2013-12-26", "1973", -7.0] +["CDISCPILOT01", "MH", "01-701-1023", 16.0, "", "ALZHEIMER'S DISEASE", "", "", "", "", "PRIMARY DIAGNOSIS", "", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2006-03-11", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 9.0, "", "VERBATIM_1775", "APPENDECTOMY", "APPENDICECTOMY", "HLT_0707", "HLGT_0363", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "1956", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 8.0, "", "VERBATIM_0788", "APPENDICITIS", "APPENDICITIS", "HLT_0703", "HLGT_0283", "HISTORICAL DIAGNOSIS", "INFECTIONS AND INFESTATIONS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "1956", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 19.0, "", "VERBATIM_0291", "LOW BACK PAIN", "BACK PAIN", "HLT_0115", "HLGT_0508", "HISTORICAL DIAGNOSIS", "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2007", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 21.0, "", "VERBATIM_0073", "CELLULITIS OF FOOT", "CELLULITIS", "HLT_0613", "HLGT_0066", "HISTORICAL DIAGNOSIS", "INFECTIONS AND INFESTATIONS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2009", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 4.0, "E04", "VERBATIM_0800", "INDIGESTION", "DYSPEPSIA", "HLT_0244", "HLGT_0716", "SIGNIFICANT PRE-EXISTING CONDITION", "GASTROINTESTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-22", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 6.0, "E01", "VERBATIM_1042", "DYSPNEA EXERTIONAL", "DYSPNOEA EXERTIONAL", "HLT_0465", "HLGT_0475", "SIGNIFICANT PRE-EXISTING CONDITION", "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-22", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 20.0, "", "VERBATIM_1154", "ECZEMA", "ECZEMA", "HLT_0747", "HLGT_0748", "HISTORICAL DIAGNOSIS", "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2007", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 1.0, "E02", "VERBATIM_0249", "GASTROESOPHAGEAL REFLUX", "GASTROOESOPHAGEAL REFLUX DISEASE", "HLT_0407", "HLGT_0304", "SIGNIFICANT PRE-EXISTING CONDITION", "GASTROINTESTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-22", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 5.0, "E05", "VERBATIM_0929", "HEADACHE", "HEADACHE", "HLT_0064", "HLGT_0344", "SIGNIFICANT PRE-EXISTING CONDITION", "NERVOUS SYSTEM DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-22", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 3.0, "E03", "VERBATIM_0699", "HIATAL HERNIA", "HIATUS HERNIA", "HLT_0159", "HLGT_0109", "SIGNIFICANT PRE-EXISTING CONDITION", "GASTROINTESTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-22", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 15.0, "", "VERBATIM_0342", "HYPERTENSION", "HYPERTENSION", "HLT_0228", "HLGT_0476", "HISTORICAL DIAGNOSIS", "VASCULAR DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2005-10", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 12.0, "", "VERBATIM_0596", "NUMBNESS OF UPPER ARM", "HYPOAESTHESIA", "HLT_0014", "HLGT_0528", "HISTORICAL DIAGNOSIS", "NERVOUS SYSTEM DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "1982", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 13.0, "", "VERBATIM_1554", "INGUINAL HERNIA REPAIR", "INGUINAL HERNIA REPAIR", "HLT_0320", "HLGT_0772", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "1999", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 2.0, "E06", "VERBATIM_0461", "MUSCULAR PAIN", "MYALGIA", "HLT_0700", "HLGT_0121", "SIGNIFICANT PRE-EXISTING CONDITION", "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-22", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 7.0, "E07", "VERBATIM_1532", "MYOPIA", "MYOPIA", "HLT_0282", "HLGT_0271", "SIGNIFICANT PRE-EXISTING CONDITION", "EYE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-22", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 18.0, "", "VERBATIM_1617", "PAIN TRAUMA ACTIVATED", "PAIN TRAUMA ACTIVATED", "HLT_0579", "HLGT_0732", "HISTORICAL DIAGNOSIS", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2006-04", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 17.0, "", "VERBATIM_0388", "PENILE PROSTHESIS INSERTION", "PENILE PROSTHESIS INSERTION", "HLT_0448", "HLGT_0303", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2006-04", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 22.0, "", "VERBATIM_1364", "ITCHY SKIN", "PRURITUS", "HLT_0778", "HLGT_0695", "HISTORICAL DIAGNOSIS", "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2009", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 14.0, "", "VERBATIM_1200", "SCIATICA", "SCIATICA", "HLT_0242", "HLGT_0293", "HISTORICAL DIAGNOSIS", "NERVOUS SYSTEM DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "2005", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 11.0, "", "VERBATIM_1769", "SINUSITIS", "SINUSITIS", "HLT_0262", "HLGT_0249", "HISTORICAL DIAGNOSIS", "INFECTIONS AND INFESTATIONS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "1978", -14.0] +["CDISCPILOT01", "MH", "01-701-1023", 10.0, "", "VERBATIM_1002", "ELBOW FRACTURE", "UPPER LIMB FRACTURE", "HLT_0472", "HLGT_0247", "HISTORICAL DIAGNOSIS", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "", 1.0, "SCREENING 1", -7.0, "2012-07-22", "1963", -14.0] +["CDISCPILOT01", "MH", "01-701-1028", 6.0, "", "ALZHEIMER'S DISEASE", "", "", "", "", "PRIMARY DIAGNOSIS", "", "", 1.0, "SCREENING 1", -7.0, "2013-07-11", "2009-12-16", -8.0] +["CDISCPILOT01", "MH", "01-701-1028", 4.0, "", "VERBATIM_1775", "APPENDECTOMY", "APPENDICECTOMY", "HLT_0707", "HLGT_0363", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2013-07-11", "1968", -8.0] +["CDISCPILOT01", "MH", "01-701-1028", 3.0, "E02", "VERBATIM_1686", "ARTHRITIS", "ARTHRITIS", "HLT_0019", "HLGT_0587", "SIGNIFICANT PRE-EXISTING CONDITION", "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "MODERATE", 1.0, "SCREENING 1", -7.0, "2013-07-11", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1028", 5.0, "", "VERBATIM_1006", "LIPECTOMY", "LIPECTOMY", "HLT_0233", "HLGT_0786", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2013-07-11", "1981", -8.0] +["CDISCPILOT01", "MH", "01-701-1028", 1.0, "E01", "VERBATIM_0428", "LIPOMA", "LIPOMA", "HLT_0487", "HLGT_0591", "SIGNIFICANT PRE-EXISTING CONDITION", "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "MODERATE", 1.0, "SCREENING 1", -7.0, "2013-07-11", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1028", 2.0, "E03", "VERBATIM_0507", "PRESBYOPIA", "PRESBYOPIA", "HLT_0230", "HLGT_0759", "SIGNIFICANT PRE-EXISTING CONDITION", "EYE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-07-11", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 26.0, "", "ALZHEIMER'S DISEASE", "", "", "", "", "PRIMARY DIAGNOSIS", "", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "2009-08-02", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 4.0, "E09", "VERBATIM_0746", "ANGINA PECTORIS", "ANGINA PECTORIS", "HLT_0033", "HLGT_0063", "SIGNIFICANT PRE-EXISTING CONDITION", "CARDIAC DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 3.0, "E05", "VERBATIM_0672", "KNEE PAIN", "ARTHRALGIA", "HLT_0375", "HLGT_0610", "SIGNIFICANT PRE-EXISTING CONDITION", "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 2.0, "E03", "VERBATIM_0165", "BALANCE DIFFICULTY", "BALANCE DISORDER", "HLT_0541", "HLGT_0101", "SIGNIFICANT PRE-EXISTING CONDITION", "NERVOUS SYSTEM DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 1.0, "E02", "VERBATIM_0138", "BENIGN PROSTATIC HYPERTROPHY", "BENIGN PROSTATIC HYPERPLASIA", "HLT_0215", "HLGT_0568", "SIGNIFICANT PRE-EXISTING CONDITION", "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 6.0, "E08", "VERBATIM_1421", "COUGH", "COUGH", "HLT_0701", "HLGT_0280", "SIGNIFICANT PRE-EXISTING CONDITION", "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 24.0, "", "VERBATIM_0816", "EOSINOPHILIC PNEUMONIA", "EOSINOPHILIC PNEUMONIA", "HLT_0207", "HLGT_0529", "HISTORICAL DIAGNOSIS", "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "2008", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 18.0, "", "VERBATIM_0991", "HAND REPAIR OPERATION", "HAND REPAIR OPERATION", "HLT_0581", "HLGT_0276", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1982", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 14.0, "", "VERBATIM_0201", "IRON DEFICIENCY ANEMIA", "IRON DEFICIENCY ANAEMIA", "HLT_0331", "HLGT_0739", "HISTORICAL DIAGNOSIS", "BLOOD AND LYMPHATIC SYSTEM DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1972", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 23.0, "", "VERBATIM_1457", "FRACTURED JAW", "JAW FRACTURE", "HLT_0488", "HLGT_0420", "HISTORICAL DIAGNOSIS", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "2007", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 25.0, "", "VERBATIM_1209", "JOINT PROSTHESIS INSERTION", "JOINT ARTHROPLASTY", "HLT_0416", "HLGT_0120", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "2008", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 15.0, "", "VERBATIM_0429", "LACERATION", "LACERATION", "HLT_0668", "HLGT_0567", "HISTORICAL DIAGNOSIS", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1982", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 13.0, "", "VERBATIM_1425", "LOCALIZED EDEMA", "LOCALISED OEDEMA", "HLT_0410", "HLGT_0372", "HISTORICAL DIAGNOSIS", "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1964", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 5.0, "E04", "VERBATIM_0858", "GONARTHRITIS", "MONARTHRITIS", "HLT_0592", "HLGT_0196", "SIGNIFICANT PRE-EXISTING CONDITION", "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 7.0, "E06", "VERBATIM_1532", "MYOPIA", "MYOPIA", "HLT_0282", "HLGT_0271", "SIGNIFICANT PRE-EXISTING CONDITION", "EYE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 8.0, "E07", "VERBATIM_1612", "NASAL CONGESTION", "NASAL CONGESTION", "HLT_0118", "HLGT_0549", "SIGNIFICANT PRE-EXISTING CONDITION", "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 11.0, "", "VERBATIM_0868", "NERVE COMPRESSION", "NERVE COMPRESSION", "HLT_0463", "HLGT_0502", "HISTORICAL DIAGNOSIS", "NERVOUS SYSTEM DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1955", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 9.0, "E01", "VERBATIM_1653", "ANKLE EDEMA", "OEDEMA PERIPHERAL", "HLT_0661", "HLGT_0137", "SIGNIFICANT PRE-EXISTING CONDITION", "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-03-10", "", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 12.0, "", "VERBATIM_1594", "PLEURISY", "PLEURISY", "HLT_0268", "HLGT_0356", "HISTORICAL DIAGNOSIS", "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1955", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 21.0, "", "VERBATIM_0870", "FRACTURED RIBS", "RIB FRACTURE", "HLT_0292", "HLGT_0583", "HISTORICAL DIAGNOSIS", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "2007", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 17.0, "", "VERBATIM_0752", "LOSS OF SENSATION", "SENSORY LOSS", "HLT_0164", "HLGT_0718", "HISTORICAL DIAGNOSIS", "NERVOUS SYSTEM DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1982", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 16.0, "", "VERBATIM_0581", "FAINTING", "SYNCOPE", "HLT_0440", "HLGT_0310", "HISTORICAL DIAGNOSIS", "NERVOUS SYSTEM DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1982", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 10.0, "", "VERBATIM_1716", "TONSILLECTOMY", "TONSILLECTOMY", "HLT_0202", "HLGT_0199", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1951", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 20.0, "", "VERBATIM_1756", "UMBILICAL HERNIA", "UMBILICAL HERNIA", "HLT_0067", "HLGT_0187", "HISTORICAL DIAGNOSIS", "GASTROINTESTINAL DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1993", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 19.0, "", "VERBATIM_0116", "UMBILICAL HERNIA REPAIR", "UMBILICAL HERNIA REPAIR", "HLT_0278", "HLGT_0377", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "1993", -8.0] +["CDISCPILOT01", "MH", "01-701-1033", 22.0, "", "VERBATIM_1156", "ELBOW FRACTURE", "UPPER LIMB FRACTURE", "HLT_0472", "HLGT_0247", "HISTORICAL DIAGNOSIS", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "", 1.0, "SCREENING 1", -7.0, "2014-03-10", "2007", -8.0] +["CDISCPILOT01", "MH", "01-701-1034", 13.0, "", "ALZHEIMER'S DISEASE", "", "", "", "", "PRIMARY DIAGNOSIS", "", "", 1.0, "SCREENING 1", -7.0, "2014-06-24", "2011-09-29", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 5.0, "E01", "VERBATIM_1385", "ABDOMINAL PAIN", "ABDOMINAL PAIN", "HLT_0217", "HLGT_0419", "SIGNIFICANT PRE-EXISTING CONDITION", "GASTROINTESTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-06-24", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 10.0, "", "VERBATIM_1133", "RECTAL FISTULA", "ANAL FISTULA", "HLT_0653", "HLGT_0268", "HISTORICAL DIAGNOSIS", "GASTROINTESTINAL DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-06-24", "1962", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 8.0, "", "VERBATIM_1775", "APPENDECTOMY", "APPENDICECTOMY", "HLT_0707", "HLGT_0363", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-06-24", "1949", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 3.0, "E06", "VERBATIM_0753", "ARTHRITIS", "ARTHRITIS", "HLT_0019", "HLGT_0587", "SIGNIFICANT PRE-EXISTING CONDITION", "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-06-24", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 4.0, "E04", "VERBATIM_0763", "ARTHRITIS", "ARTHRITIS", "HLT_0019", "HLGT_0587", "SIGNIFICANT PRE-EXISTING CONDITION", "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-06-24", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 16.0, "", "VERBATIM_1680", "BLOOD PRESSURE INCREASED", "BLOOD PRESSURE INCREASED", "HLT_0399", "HLGT_0647", "HISTORICAL DIAGNOSIS", "INVESTIGATIONS", "", 1.0, "SCREENING 1", -7.0, "2014-06-24", "2014-06-11", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 1.0, "E02", "VERBATIM_0443", "CONSTIPATION", "CONSTIPATION", "HLT_0402", "HLGT_0635", "SIGNIFICANT PRE-EXISTING CONDITION", "GASTROINTESTINAL 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1.0, "SCREENING 1", -7.0, "2014-06-24", "", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 9.0, "", "VERBATIM_0936", "HYSTERECTOMY", "HYSTERECTOMY", "HLT_0675", "HLGT_0657", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-06-24", "1960", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 14.0, "", "VERBATIM_0122", "LEG FRACTURE", "LOWER LIMB FRACTURE", "HLT_0348", "HLGT_0435", "HISTORICAL DIAGNOSIS", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "", 1.0, "SCREENING 1", -7.0, "2014-06-24", "2012", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 15.0, "", "VERBATIM_0973", "MUSCLE SPASMS", "MUSCLE SPASMS", "HLT_0078", "HLGT_0750", "HISTORICAL DIAGNOSIS", "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2014-06-24", "2013-12-21", -7.0] +["CDISCPILOT01", "MH", "01-701-1034", 7.0, "", "VERBATIM_1716", "TONSILLECTOMY", "TONSILLECTOMY", "HLT_0202", "HLGT_0199", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", 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"2012", -21.0] +["CDISCPILOT01", "MH", "01-701-1047", 11.0, "", "VERBATIM_1324", "CHOLECYSTECTOMY", "CHOLECYSTECTOMY", "HLT_0149", "HLGT_0074", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2013-01-22", "1987", -21.0] +["CDISCPILOT01", "MH", "01-701-1047", 15.0, "", "VERBATIM_0361", "BLADDER INFECTION", "CYSTITIS", "HLT_0739", "HLGT_0129", "HISTORICAL DIAGNOSIS", "INFECTIONS AND INFESTATIONS", "", 1.0, "SCREENING 1", -7.0, "2013-01-22", "2012", -21.0] +["CDISCPILOT01", "MH", "01-701-1047", 13.0, "", "VERBATIM_1684", "HEMORRHOIDS", "HAEMORRHOIDS", "HLT_0681", "HLGT_0485", "HISTORICAL DIAGNOSIS", "GASTROINTESTINAL DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2013-01-22", "2009", -21.0] +["CDISCPILOT01", "MH", "01-701-1047", 3.0, "E01", "VERBATIM_0699", "HIATAL HERNIA", "HIATUS HERNIA", "HLT_0159", "HLGT_0109", "SIGNIFICANT PRE-EXISTING CONDITION", "GASTROINTESTINAL DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-01-22", "", -21.0] 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"SCREENING 1", -7.0, "2012-07-08", "2009-04", -14.0] +["CDISCPILOT01", "MH", "01-701-1192", 2.0, "E15", "VERBATIM_0908", "INFERIOR MYOCARDIAL INFARCTION", "MYOCARDIAL INFARCTION", "HLT_0649", "HLGT_0688", "SIGNIFICANT PRE-EXISTING CONDITION", "CARDIAC DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-08", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1192", 19.0, "", "VERBATIM_1391", "NASAL CYST REMOVAL", "NASAL CYST REMOVAL", "HLT_0086", "HLGT_0082", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2012-07-08", "2010-04-22", -14.0] +["CDISCPILOT01", "MH", "01-701-1192", 1.0, "E05", "VERBATIM_0507", "PRESBYOPIA", "PRESBYOPIA", "HLT_0230", "HLGT_0759", "SIGNIFICANT PRE-EXISTING CONDITION", "EYE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2012-07-08", "", -14.0] +["CDISCPILOT01", "MH", "01-701-1192", 8.0, "", "VERBATIM_1716", "TONSILLECTOMY", "TONSILLECTOMY", "HLT_0202", "HLGT_0199", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", 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"MILD", 1.0, "SCREENING 1", -7.0, "2013-08-20", "", -7.0] +["CDISCPILOT01", "MH", "01-704-1009", 1.0, "E06", "VERBATIM_0292", "INTERMITTENT HEADACHE", "HEADACHE", "HLT_0064", "HLGT_0344", "SIGNIFICANT PRE-EXISTING CONDITION", "NERVOUS SYSTEM DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-08-20", "", -7.0] +["CDISCPILOT01", "MH", "01-704-1009", 4.0, "E11", "VERBATIM_1635", "MYOCARDIAL INFARCTION", "MYOCARDIAL INFARCTION", "HLT_0649", "HLGT_0688", "SIGNIFICANT PRE-EXISTING CONDITION", "CARDIAC DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-08-20", "", -7.0] +["CDISCPILOT01", "MH", "01-704-1009", 2.0, "E05", "VERBATIM_1029", "SEASONAL ALLERGY", "SEASONAL ALLERGY", "HLT_0714", "HLGT_0782", "SIGNIFICANT PRE-EXISTING CONDITION", "IMMUNE SYSTEM DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-08-20", "", -7.0] +["CDISCPILOT01", "MH", "01-704-1010", 9.0, "", "ALZHEIMER'S DISEASE", "", "", "", "", "PRIMARY DIAGNOSIS", "", "", 1.0, "SCREENING 1", -7.0, "2014-02-08", "2006-01-02", 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1.0, "", "VERBATIM_1464", "CORONARY ARTERY BYPASS", "CORONARY ARTERY SURGERY", "HLT_0457", "HLGT_0045", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-05-08", "1997-06", -6.0] +["CDISCPILOT01", "MH", "01-716-1311", 3.0, "", "VERBATIM_1436", "HIP REPLACEMENT", "HIP ARTHROPLASTY", "HLT_0709", "HLGT_0449", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-05-08", "2005-06", -6.0] +["CDISCPILOT01", "MH", "01-716-1311", 5.0, "", "VERBATIM_1062", "HIP REPLACEMENT", "HIP ARTHROPLASTY", "HLT_0709", "HLGT_0449", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-05-08", "2008-06", -6.0] +["CDISCPILOT01", "MH", "01-716-1364", 10.0, "", "ALZHEIMER'S DISEASE", "", "", "", "", "PRIMARY DIAGNOSIS", "", "", 1.0, "SCREENING 1", -7.0, "2013-06-27", "2010-08-10", -7.0] +["CDISCPILOT01", "MH", "01-716-1364", 2.0, "E02", "VERBATIM_1309", "ARTHRITIS", "ARTHRITIS", 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"HLT_0201", "HLGT_0554", "HISTORICAL DIAGNOSIS", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "", 1.0, "SCREENING 1", -7.0, "2013-04-27", "2010", -8.0] +["CDISCPILOT01", "MH", "01-716-1418", 1.0, "E04", "VERBATIM_1305", "INTENTION TREMOR", "INTENTION TREMOR", "HLT_0413", "HLGT_0453", "SIGNIFICANT PRE-EXISTING CONDITION", "NERVOUS SYSTEM DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-04-27", "", -8.0] +["CDISCPILOT01", "MH", "01-716-1418", 2.0, "E01", "VERBATIM_1676", "INJURY TO FINGER NOS", "LIMB INJURY", "HLT_0476", "HLGT_0667", "SIGNIFICANT PRE-EXISTING CONDITION", "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "MILD", 1.0, "SCREENING 1", -7.0, "2013-04-27", "", -8.0] +["CDISCPILOT01", "MH", "01-716-1418", 3.0, "", "VERBATIM_1560", "KIDNEY STONE", "NEPHROLITHIASIS", "HLT_0439", "HLGT_0546", "HISTORICAL DIAGNOSIS", "RENAL AND URINARY DISORDERS", "", 1.0, "SCREENING 1", -7.0, "2013-04-27", "2007", -8.0] +["CDISCPILOT01", "MH", "01-716-1441", 8.0, "", "ALZHEIMER'S DISEASE", "", "", "", "", "PRIMARY DIAGNOSIS", "", "", 1.0, "SCREENING 1", -7.0, "2014-01-13", "2010-05-25", -9.0] +["CDISCPILOT01", "MH", "01-716-1441", 5.0, "E02", "VERBATIM_0999", "ACTINIC KERATOSIS", "ACTINIC KERATOSIS", "HLT_0609", "HLGT_0490", "SIGNIFICANT PRE-EXISTING CONDITION", "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-01-13", "", -9.0] +["CDISCPILOT01", "MH", "01-716-1441", 2.0, "E01", "VERBATIM_0376", "LEFT CATARACT", "CATARACT", "HLT_0090", "HLGT_0498", "SIGNIFICANT PRE-EXISTING CONDITION", "EYE DISORDERS", "MILD", 1.0, "SCREENING 1", -7.0, "2014-01-13", "", -9.0] +["CDISCPILOT01", "MH", "01-716-1441", 9.0, "", "VERBATIM_0977", "CATARACT OPERATION", "CATARACT OPERATION", "HLT_0432", "HLGT_0058", "HISTORICAL DIAGNOSIS", "SURGICAL AND MEDICAL PROCEDURES", "", 1.0, "SCREENING 1", -7.0, "2014-01-13", "2010-11", -9.0] +["CDISCPILOT01", "MH", "01-716-1441", 7.0, "", "VERBATIM_1436", "HIP REPLACEMENT", "HIP ARTHROPLASTY", "HLT_0709", "HLGT_0449", 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High_End + + + + + Follow_up + + + + + + + Screening + + + + + Treatment + + + + + Follow-Up + + + + + + + Screen + + + + + Placebo + + + + + Low + + + + + High_Start + + + + + High_Middle + + + + + High_End + + + + + Follow_up + + + + + Unplanned + + + + + + + NOT HISPANIC OR LATINO + + + + + + HISPANIC OR LATINO + + + + + + + + + mg + + + + + + + + + PATCH + + + + + + + + + QD + + + + + + + + + TRANSDERMAL + + + + + + + + + PLACEBO + + + + + XANOMELINE + + + + + + + 1 + + + + + 2 + + + + + 3 + + + + + 4 + + + + + + + INCLUSION + + + + + + EXCLUSION + + + + + + + + + Males and postmenopausal females at least 50 years of age. + + + + + Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines (Protocol Attachment LZZT.7). + + + + + MMSE score of 10 to 23. + + + + + Modified Hachinski Ischemic Scale score of <= 4. (Protocol Attachment LZZT.8). + + + + + CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. + + + + + Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver. + + + + + Geographic proximity to investigator's site that allows adequate follow-up. + + + + + Caregiverwill monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home. + + + + + Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of xanomeline. + + + + + Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study. + + + + + Serious illness which required hospitalization within 3 months of screening. + + + + + Diagnosis of serious neurological conditions. + + + + + Episode of depression meeting DSM-IV criteria within 3 months of screening. + + + + + A history of mental illness within the last 5 years. + + + + + A history of syncope within the last 5 years. + + + + + Evidence from ECG recording at screening of any listed condition. + + + + + A history within the last 5 years of a serious cardiovascular disorder. + + + + + A history within the last 5 years of a serious gastrointestinal disorder. + + + + + A history within the last 5 years of a serious endocrine disorder. + + + + + A history within the last 5 years of a serious respiratory disorder (see list). + + + + + A history within the last 5 years of a serious genitourinary disorder. + + + + + A history within the last 5 years of a serious rheumatologic disorder. + + + + + A known history of human immunodeficiency virus (HIV) within the last 5 years. + + + + + A history within the last 5 years of a serious infectious disease (see list in protocol). + + + + + A history within the last 5 years of a primary or recurrent malignant disease (with exceptions, see list in protocol). + + + + + Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy). + + + + + Laboratory test values exceeding the Lilly Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, etc. + + + + + Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests. + + + + + Positive syphilis screening with confirmatory testing. + + + + + Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only). + + + + + Treatment with medications within 1 month prior to enrollment (see list). + + + + + + + Males and postmenopausal females at least 50 years of age. + + + + + Diagnosis of probable AD as defined by NINCDS and the ADRDA guidelines (Protocol Attachment LZZT.7). + + + + + MMSE score of 10 to 23. + + + + + Modified Hachinski Ischemic Scale score of <= 4. (Protocol Attachment LZZT.8). + + + + + CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year. + + + + + Investigator has obtained informed consent signed by the patient (and/or legal representative) and by the caregiver. + + + + + Geographic proximity to investigator's site that allows adequate follow-up. + + + + + Caregiverwill monitor administration of prescribed medications, and will be responsible for the overall care of the patient at home. + + + + + Persons who have previously completed or withdrawn from this study or any other investigating xanomeline TTS or the oral formulation of xanomeline. + + + + + Use of any investigational agent or approved Alzheimer's therapeutic medication within 30 days prior to enrollment into the study. + + + + + Serious illness which required hospitalization within 3 months of screening. + + + + + Diagnosis of serious neurological conditions. + + + + + Episode of depression meeting DSM-IV criteria within 3 months of screening. + + + + + A history of mental illness within the last 5 years. + + + + + A history of syncope within the last 5 years. + + + + + Evidence from ECG recording at screening of any listed condition. + + + + + A history within the last 5 years of a serious cardiovascular disorder. + + + + + A history within the last 5 years of a serious gastrointestinal disorder. + + + + + A history within the last 5 years of a serious endocrine disorder. + + + + + A history within the last 5 years of a serious respiratory disorder (see list). + + + + + A history within the last 5 years of a serious genitourinary disorder. + + + + + A history within the last 5 years of a serious rheumatologic disorder. + + + + + A known history of human immunodeficiency virus (HIV) within the last 5 years. + + + + + A history within the last 5 years of a serious infectious disease (see list in protocol). + + + + + A history within the last 5 years of a primary or recurrent malignant disease (with exceptions, see list in protocol). + + + + + Visual, hearing, or communication disabilities impairing the ability to participate in the study; (for example, inability to speak or understand English, illiteracy). + + + + + Laboratory test values exceeding the Lilly Reference Range III for the patient's age in any of the following analytes: creatinine, total bilirubin, SGOT, SGPT, etc. + + + + + Central laboratory test values below reference range for folate, and vitamin B12, and outside reference range for thyroid function tests. + + + + + Positive syphilis screening with confirmatory testing. + + + + + Central laboratory test value above reference range for glycosylated hemoglobin (A1C) (insulin dependent diabetes mellitus patients only). + + + + + Treatment with medications within 1 month prior to enrollment (see list). + + + + + + + CHEMISTRY + + + + + HEMATOLOGY + + + + + OTHER + + + + + URINALYSIS + + + + + + + LOW + + + + + NORMAL + + + + + HIGH + + + + + ABNORMAL + + + + + + + 10^9/L + + + + + 10^12/L + + + + + U/L + + + + + + fL + + + + + + fmol + + + + + g/L + + + + + + mU/L + + + + + + mmol/L + + + + + + pmol/L + + + + + + umol/L + + + + + + + + + HISTORICAL DIAGNOSIS + + + + + PRIMARY DIAGNOSIS + + + + + SIGNIFICANT PRE-EXISTING CONDITION + + + + + + + NOT DONE + + + + + + + + + NO + + + + + YES + + + + + NOT APPLICABLE + + + + + + + RECOVERED/RESOLVED + + + + + + NOT RECOVERED/NOT RESOLVED + + + + + + FATAL + + + + + + + + + ABSENT + + + + + PRESENT + + + + + + + ABSENT + + + + + PRESENT + + + + + + + ABSENT + + + + + NOT APPLICABLE + + + + + + + CLINICAL STUDY SPONSOR + + + + + + + WORD RECALL TASK + + + + + NAMING OBJECTS AND FINGERS (REFER TO 5 C + + + + + DELAYED WORD RECALL + + + + + COMMANDS + + + + + CONSTRUCTIONAL PRAXIS + + + + + IDEATIONAL PRAXIS + + + + + ORIENTATION + + + + + WORD RECOGNITION + + + + + ATTENTION/VISUAL SEARCH TASK + + + + + MAZE SOLUTION + + + + + SPOKEN LANGUAGE ABILITY + + + + + COMPREHENSION OF SPOKEN LANGUAGE + + + + + WORD FINDING DIFFICULTY IN SPONTANEOUS S + + + + + RECALL OF TEST INSTRUCTIONS + + + + + ADAS-COG(11) Subscore + + + + + EXTENT OF CHANGE, IF ANY, SINCE BASELINE + + + + + UNDERTAKE TO WASH HIMSELF/HERSELF + + + + + UNDERTAKE TO BRUSH HIS/HER TEETH + + + + + DECIDE TO CARE FOR HIS/HER HAIR + + + + + PREPARE FOR WASHING, TAKING A BATH + + + + + WASH AND DRY COMPLETELY SAFELY + + + + + BRUSH HIS/HER TEETH + + + + + CARE FOR HIS/HER HAIR + + + + + UNDERTAKE TO DRESS HIMSELF/HERSELF + + + + + CHOOSE APPROPRIATE CLOTHING + + + + + DRESS HIMSELF/HERSELF + + + + + DRESS HIMSELF/HERSELF COMPLETELY + + + + + UNDRESS HIMSELF/HERSELF COMPLETELY + + + + + DECIDE TO USE THE TOILET AT APPROPRIATE + + + + + USE THE TOILET WITHOUT "ACCIDENTS" + + + + + DECIDE THAT HE/SHE NEEDS TO EAT + + + + + CHOOSE APPROPRIATE UTENSILS + + + + + EAT HIS/HER MEALS AT A NORMAL PACE + + + + + UNDERTAKE TO PREPARE A LIGHT MEAL + + + + + ADEQUATELY PLAN A LIGHT MEAL OR SNACK + + + + + PREPARE OR COOK A LIGHT MEAL OR A SNACK + + + + + ATTEMPT TO TELEPHONE SOMEONE + + + + + FIND AND DIAL A TELEPHONE NUMBER CORRECT + + + + + CARRY OUT A TELEPHONE CONVERSATION + + + + + WRITE AND CONVEY A TELEPHONE MESSAGE + + + + + UNDERTAKE TO GO OUT + + + + + ADEQUATELY ORGANIZE AN OUTING + + + + + GO OUT AND REACH A FAMILIAR DESTINATION + + + + + SAFELY TAKE CAR, BUS, TAXI + + + + + RETURN FROM THE STORE + + + + + INTEREST IN HIS/HER PERSONAL AFFAIRS + + + + + PAY HIS/HER BILLS + + + + + ORGANIZE HIS/HER CORRESPONDENCE + + + + + HANDLE ADEQUATELY HIS/HER MONEY + + + + + DECIDE TO TAKE HIS/HER MEDICATIONS + + + + + TAKE HIS/HER MEDICATIONS AS PRESCRIBED + + + + + SHOW AN INTEREST IN LEISURE ACTIVITY + + + + + TAKE AN INTEREST IN HOUSEHOLD CHORES + + + + + PLAN AND ORGANIZE HOUSEHOLD CHORES + + + + + COMPLETE HOUSEHOLD CHORES + + + + + STAY SAFELY AT HOME BY HIMSELF/HERSELF + + + + + ABRUPT ONSET + + + + + STEPWISE DETERIORATION + + + + + FLUCTUATING COURSE + + + + + NOCTURNAL CONFUSION + + + + + RELATIVE PRESERVATION OF PERSONALITY + + + + + DEPRESSION + + + + + SOMATIC COMPLAINTS + + + + + EMOTIONAL INCONTINENCE + + + + + HISTORY OF HYPERTENSION + + + + + HISTORY OF STROKES + + + + + EVIDENCE OF ASSOCIATED ATHEROSCLEROSIS + + + + + FOCAL NEUROLOGICAL SYMPTOMS + + + + + FOCAL NEUROLOGICAL SIGNS + + + + + WHAT IS THE (YEAR) (SEASON) (DATE) ? + + + + + WHERE ARE WE: (STATE) (COUNTRY) (TOWN) ? + + + + + NAME 3 OBJECTS: 1 SECOND TO SAY EACH. + + + + + SERIAL 7'S. 1 POINT FOR EACH CORRECT. + + + + + ASK FOR THE 3 OBJECTS REPEATED ABOVE. + + + + + NAME A PENCIL, AND WATCH (2 POINTS) + + + + + DELUSIONS PRESENT + + + + + DELUSIONS DISTRESS + + + + + DELUSIONS FREQUENCY + + + + + DELUSIONS Score + + + + + DELUSIONS SEVERITY + + + + + HALLUCINATIONS PRESENT + + + + + HALLUCINATIONS DISTRESS + + + + + HALLUCINATIONS FREQUENCY + + + + + HALLUCINATIONS Score + + + + + HALLUCINATIONS SEVERITY + + + + + AGITATION/AGRESSION PRESENT + + + + + AGITATION/AGRESSION DISTRESS + + + + + AGITATION/AGRESSION FREQUENCY + + + + + AGITATION/AGRESSION Score + + + + + AGITATION/AGRESSION SEVERITY + + + + + DEPRESSION/DYSPHORIA PRESENT + + + + + DEPRESSION/DYSPHORIA DISTRESS + + + + + DEPRESSION/DYSPHORIA FREQUENCY + + + + + DEPRESSION/DYSPHORIA Score + + + + + DEPRESSION/DYSPHORIA SEVERITY + + + + + ANXIETY PRESENT + + + + + ANXIETY DISTRESS + + + + + ANXIETY FREQUENCY + + + + + ANXIETY Score + + + + + ANXIETY SEVERITY + + + + + EUPHORIA/ELATION PRESENT + + + + + EUPHORIA/ELATION DISTRESS + + + + + EUPHORIA/ELATION FREQUENCY + + + + + EUPHORIA/ELATION Score + + + + + EUPHORIA/ELATION SEVERITY + + + + + APATHY/INDIFFERENCE PRESENT + + + + + APATHY/INDIFFERENCE DISTRESS + + + + + APATHY/INDIFFERENCE FREQUENCY + + + + + APATHY/INDIFFERENCE Score + + + + + APATHY/INDIFFERENCE SEVERITY + + + + + DISINHIBITION PRESENT + + + + + DISINHIBITION DISTRESS + + + + + DISINHIBITION FREQUENCY + + + + + DISINHIBITION Score + + + + + DISINHIBITION SEVERITY + + + + + IRRITABILITY/LABILITY PRESENT + + + + + IRRITABILITY/LABILITY DISTRESS + + + + + IRRITABILITY/LABILITY FREQUENCY + + + + + IRRITABILITY/LABILITY Score + + + + + IRRITABILITY/LABILITY SEVERITY + + + + + ABERRANT MOTOR BEHAVIOR PRESENT + + + + + ABERRANT MOTOR BEHAVIOR DISTRESS + + + + + ABERRANT MOTOR BEHAVIOR FREQUENCY + + + + + ABERRANT MOTOR BEHAVIOR Score + + + + + ABERRANT MOTOR BEHAVIOR SEVERITY + + + + + NIGHT-TIME BEHAVIOR PRESENT + + + + + NIGHT-TIME BEHAVIOR DISTRESS + + + + + NIGHT-TIME BEHAVIOR FREQUENCY + + + + + NIGHT-TIME BEHAVIOR Score + + + + + NIGHT-TIME BEHAVIOR SEVERITY + + + + + APPETITE/EATING CHANGE PRESENT + + + + + APPETITE/EATING CHANGE DISTRESS + + + + + APPETITE/EATING CHANGE FREQUENCY + + + + + APPETITE/EATING CHANGE Score + + + + + APPETITE/EATING CHANGE SEVERITY + + + + + NPI-X (9) Total Score + + + + + + + ALZHEIMER'S DISEASE ASSESSMENT SCALE + + + + + CLINICIAN'S INTERVIEW-BASED IMPRESSION OF CHANGE (CIBIC+) + + + + + DISABILITY ASSESSMENT FOR DEMENTIA (DAD) + + + + + MINI-MENTAL STATE + + + + + MODIFIED HACHINSKI ISCHEMIC SCORE + + + + + NEUROPSYCHIATRIC INVENTORY - REVISED (NPI-X) + + + + + + + sec + + + + + + + + + WHITE + + + + + + BLACK OR AFRICAN AMERICAN + + + + + + AMERICAN INDIAN OR ALASKA NATIVE + + + + + + ASIAN + + + + + + + + + GROUPING QUALIFIER + + + + + IDENTIFIER + + + + + QUALIFIER + + + + + RECORD QUALIFIER + + + + + RESULT + + + + + RESULT QUALIFIER + + + + + RULE + + + + + SYNONYM QUALIFIER + + + + + TIMING + + + + + TOPIC + + + + + VARIABLE QUALIFIER + + + + + + + Level of Education Attained + + + + + + + EDUCATION + + + + + + + 1 + + + + + 2 + + + + + 3 + + + + + + + 1 + + + + + 2 + + + + + 3 + + + + + 4 + + + + + 5 + + + + + + + 1 + + + + + 2 + + + + + 3 + + + + + 4 + + + + + 5 + + + + + 6 + + + + + 7 + + + + + 8 + + + + + 9 + + + + + + + YEARS + + + + + + + + + MILD + + + + + + MODERATE + + + + + + SEVERE + + + + + + + + + 1 + + + + + 2 + + + + + 3 + + + + + + + Female + + + + + + Male + + + + + + Unknown + + + + + + + + + Both + + + + + Female + + + + + Male + + + + + + + TREAMENT EMERGENT FLAG + + + + + + + Completers of Week 16 Population Flag + + + + + Completers of Week 24 Population Flag + + + + + Completers of Week 8 Population Flag + + + + + Efficacy Population Flag + + + + + Intent to Treat Population Flag + + + + + Safety Population Flag + + + + + + + PROTOCOL ENTRY CRITERIA NOT MET + + + + + + + ENDPOINT VALUE FLAG + + + + + LAB RESULT/UPPER LIMIT OF NORMAL + + + + + + + Double Blind Study + + + + + Open Label Study + + + + + Single Blind Study + + + + + + + ACTIVE + + + + + NONE + + + + + PLACEBO + + + + + + + Cure Study + + + + + Diagnosis Study + + + + + Adverse Effect Mitigation Study + + + + + Prevention Study + + + + + Treatment Study + + + + + + + Phase I Trial + + + + + Phase I/II Trial + + + + + Phase II Trial + + + + + Phase II/III Trial + + + + + Phase IIa Trial + + + + + Phase IIb Trial + + + + + Phase III Trial + + + + + Phase IIIa Trial + + + + + Phase IIIb Trial + + + + + Phase IV Trial + + + + + Phase V Trial + + + + + NA + + + + + + + Bioavailability Study + + + + + Therapeutic Equivalency Study + + + + + Efficacy Study + + + + + Pharmacodynamic Study + + + + + Pharmacoeconomic Study + + + + + Pharmacogenomic Study + + + + + Pharmacokinetic Study + + + + + Safety Study + + + + + + + SCREENING 1 + + + + + UNSCHEDULED 1.1 + + + + + UNSCHEDULED 1.2 + + + + + UNSCHEDULED 1.3 + + + + + SCREENING 2 + + + + + BASELINE + + + + + UNSCHEDULED 3.1 + + + + + AMBUL ECG PLACEMENT + + + + + WEEK 2 + + + + + UNSCHEDULED 4.1 + + + + + UNSCHEDULED 4.2 + + + + + WEEK 4 + + + + + UNSCHEDULED 5.1 + + + + + AMBUL ECG REMOVAL + + + + + UNSCHEDULED 6.1 + + + + + WEEK 6 + + + + + UNSCHEDULED 7.1 + + + + + WEEK 8 + + + + + WEEK 10 (T) + + + + + UNSCHEDULED 8.2 + + + + + WEEK 12 + + + + + WEEK 14 (T) + + + + + UNSCHEDULED 9.2 + + + + + UNSCHEDULED 9.3 + + + + + WEEK 16 + + + + + WEEK 18 (T) + + + + + UNSCHEDULED 10.2 + + + + + WEEK 20 + + + + + WEEK 22 (T) + + + + + UNSCHEDULED 11.2 + + + + + WEEK 24 + + + + + UNSCHEDULED 12.1 + + + + + WEEK 26 + + + + + UNSCHEDULED 13.1 + + + + + AE FOLLOW-UP + + + + + RETRIEVAL + + + + + Rash followup + + + + + + + SCREENING 1 + + + + + UNSCHEDULED 1.1 + + + + + UNSCHEDULED 1.2 + + + + + UNSCHEDULED 1.3 + + + + + SCREENING 2 + + + + + BASELINE + + + + + UNSCHEDULED 3.1 + + + + + AMBUL ECG PLACEMENT + + + + + WEEK 2 + + + + + UNSCHEDULED 4.1 + + + + + UNSCHEDULED 4.2 + + + + + WEEK 4 + + + + + UNSCHEDULED 5.1 + + + + + AMBUL ECG REMOVAL + + + + + UNSCHEDULED 6.1 + + + + + WEEK 6 + + + + + UNSCHEDULED 7.1 + + + + + WEEK 8 + + + + + WEEK 10 (T) + + + + + UNSCHEDULED 8.2 + + + + + WEEK 12 + + + + + WEEK 14 (T) + + + + + UNSCHEDULED 9.2 + + + + + UNSCHEDULED 9.3 + + + + + WEEK 16 + + + + + WEEK 18 (T) + + + + + UNSCHEDULED 10.2 + + + + + WEEK 20 + + + + + WEEK 22 (T) + + + + + UNSCHEDULED 11.2 + + + + + WEEK 24 + + + + + UNSCHEDULED 12.1 + + + + + WEEK 26 + + + + + UNSCHEDULED 13.1 + + + + + AE FOLLOW-UP + + + + + RETRIEVAL + + + + + Rash followup + + + + + + + Diastolic Blood Pressure + + + + + + Height + + + + + + Pulse Rate + + + + + + Systolic Blood Pressure + + + + + + Temperature + + + + + + Weight + + + + + + + + + ORAL CAVITY + + + + + + EAR + + + + + + + + + STANDING + + + + + + SUPINE + + + + + + + + + AFTER LYING DOWN FOR 5 MINUTES + + + + + AFTER STANDING FOR 1 MINUTE + + + + + AFTER STANDING FOR 3 MINUTES + + + + + + + AFTER LYING DOWN FOR 5 MINUTES + + + + + AFTER STANDING FOR 1 MINUTE + + + + + AFTER STANDING FOR 3 MINUTES + + + + + + + PATIENT STANDING + + + + + PATIENT SUPINE + + + + + + + C + + + + + + F + + + + + + beats/min + + + + + + cm + + + + + + in + + + + + + LB + + + + + + kg + + + + + + mmHg + + + + + + + + + No + + + + + + Yes + + + + + + + + + Yes + + + + + + + + + + + + + + + + + AEACN=Null (data on action taken concerning study treatment was not collected) + + + + + Date of final visit (SV) + + + + + Sequential number identifying records within each USUBJID + + + + + Use AESTDTC to determine from the SDTM SE what EPOCH this record falls under. +If SE.SESTDTC <= AESTDTC < SE.SEENDTC, then use that EPOCH. + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Sequential number identifying records within each USUBJID + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + TV.VISITDY + + + + + Use CMSTDTC to determine from the SDTM SE what EPOCH this record falls under. +If SE.SESTDTC <= CMSTDTC < SE.SEENDTC, then use that EPOCH. + + + + + Total scores of "ALZHEIMER'S DISEASE ASSESSMENT SCALE" and "NEUROPSYCHIATRIC INVENTORY - REVISED (NPI-X)" were derived as described in the SAP. For all other Test codes: LBSTRESN= LBSTRESC converted to numeric + + + + + (date portion of --DTC) minus (date portion of RFSTDTC) , add 1 if -- DTC >= RFSTDC + + + + + Derived from EX + + + + + Derived from EX + + + + + Subject's Age at start of study drug (RFSTDTC). + + + + + Derived from site information + + + + + If DS record exists with DSDECOD="DEATH" then DTHDTC=AEENDTC. + + + + + If DS record exists with DSDECOD="DEATH" then DEATHFL=Y. + + + + + Derived from Origin entered on CRF: ETHINC="HISPANIC OR LATINO" if Origin="Hispanic". Otherwise ETHNIC="NOT HISPANIC OR LATINO" + + + + + Date/time of last study drug treatment derived from EX + + + + + Date of informed consent was not entered in database (see annotated CRF) + + + + + DSSTDTC of last disposition event + + + + + Date/time of first study drug treatment derived from EX + + + + + RFXENDTC=RFENDTC + + + + + RFXSTDTC=RFSTDTC + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Sequential number identifying records within each USUBJID + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Use DSSTDTC to determine from the SDTM SE what EPOCH this record falls under. +If SE.SESTDTC <= DSSTDTC < SE.SEENDTC, then use that EPOCH. + + + + + Sequential number identifying records within each USUBJID + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + TV.VISITDY + + + + + Use EXDTC to determine from the SDTM SE what EPOCH this record falls under. +If SE.SESTDTC <= EXDTC < SE.SEENDTC, then use that EPOCH. + + + + + If VISIT="SCREENING" then LBBLFL=Y + + + + + If LBSTRESN > LBSTNRHI then LBNRIND="HIGH". If LBSTRESN < LBSTNRLO then LBNRIND="LOW". If LBSTRESN between LBSTNRLO and LBSTNRHI then LBNRIND="NORMAL". Selected urinalysis parameters (e.g. Ketones) are classified as NORMAL or ABNORMAL only. + + + + + Sequential number identifying records within each USUBJID + + + + + LBORNRHI converted to standard unit (LBSTRESU) + + + + + LBORNRLO converted to standard unit (LBSTRESU) + + + + + LBORRES converted to standard unit (LBSTRESU) + + + + + LBSTRESC converted to numeric + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + TV.VISITDY + + + + + Use LBDTC to determine from the SDTM SE what EPOCH this record falls under. +If SE.SESTDTC <= LBDTC < SE.SEENDTC, then use that EPOCH. + + + + + Sequential number identifying records within each USUBJID + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + TV.VISITDY + + + + + If VISIT="BASELINE" then QSBLFL="Y" + + + + + QSDTC=SV.SVSTDTC of the respective VISIT + + + + + Sequential number identifying records within each USUBJID + + + + + Derived standardized value for collect result (QSORRES) + + + + + QSSTRESU=QSORRESU + + + + + see SAP + + + + + see SAP + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + TV.VISITDY + + + + + Use QSDTC to determine from the SDTM SE what EPOCH this record falls under. If SE.SESTDTC <= QSDTC < SE.SEENDTC, then use that EPOCH. + + + + + Derived from parent record + + + + + Derived from parent record + + + + + Domain abbreviations for domains which are related to at least one other domain. Derived from parent record + + + + + Records with the same RELID value can be considered as related records + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Sequential number identifying records within each USUBJID + + + + + SCORRES converted to standard unit + + + + + SCSTRESC converted to numeric + + + + + SCSTRESU=SCORRESU + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Last date/time when data pertaining to that element were collected + + + + + Sequential number identifying records within each USUBJID + + + + + Earliest date/time when data pertaining to that element were collected + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Use SE.ETCD to determine from the SDTM TA what should be the EPOCH value. + + + + + Value of AESEQ of corresponding parent record + + + + + see SAP + + + + + see value level metadata + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + see SAP + + + + + see SAP + + + + + see SAP + + + + + see SAP + + + + + see SAP + + + + + see SAP + + + + + see value level metadata + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Value of DSSEQ of corresponding parent record + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Value of LBSEQ of corresponding parent record + + + + + see SAP + + + + + LBSTRESN / LBSTNRHI + + + + + see value level metadata + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + Lastt date when data were collected for the corresponding visit. + + + + + Earliest date when data were collected for the corresponding visit. + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + TV.VISITDY + + + + + Use SVSTDTC to determine from the SDTM SE what EPOCH this record falls under. If SE.SESTDTC <= SVSTDTC < SE.SEENDTC, then use that EPOCH. + + + + + Sequential number identifying records within each TSPARMCD + + + + + Concatenation of STUDYID, DM.SITEID and DM.SUBJID + + + + + TV.VISITDY + + + + + If VISIT="BASELINE" then VSBLFL="Y" + + + + + VSTPT expressed in the ISO 8601 format for durations + + + + + Sequential number identifying records within each USUBJID + + + + + VSORRES converted to standard unit + + + + + VSSTRESC converted to numeric + + + + + Use VSDTC to determine from the SDTM SE what EPOCH this record falls under. If SE.SESTDTC <= VSDTC < SE.SEENDTC, then use that EPOCH. + + + + + ATC Level 1 + + + + + AGEU="YEARS" + + + + + According to randomization list + + + + + According to randomization list + + + + + Standard unit per parameter assigned for summarizing analyses + + + + + Category values are assigned according to the CRF Section label wich was used to collect that type of medical history information. + + + + + Individual test results which were not collected on CRF but derived are flagged with QSDRVFL="Y" + + + + + Corresponds to the CRF Section label where the data were obtained from. + + + + + IDVAR="AESEQ" + + + + + RDOMAIN="AE" + + + + + IDVAR=" " + + + + + IDVARVAL= " " + + + + + RDOMAIN="AE" + + + + + IDVAR="DSSEQ" + + + + + see value level metadata + + + + + RDOMAIN="DS" + + + + + IDVAR="LBSEQ" + + + + + RDOMAIN="LB" + + + + + Standard unit defined per parameter for summarizing analysis + + + + Annotated Case Report Form + + + + \ No newline at end of file diff --git a/exercises/data/dm.xpt b/exercises/data/dm.xpt new file mode 100644 index 0000000..3602fbb Binary files /dev/null and b/exercises/data/dm.xpt differ diff --git a/exercises/data/vs.xpt b/exercises/data/vs.xpt new file mode 100644 index 0000000..ca0cb49 Binary files /dev/null and b/exercises/data/vs.xpt differ diff --git a/slides/02-why/index.qmd b/slides/02-why/index.qmd index 7a17397..5322c92 100644 --- a/slides/02-why/index.qmd +++ b/slides/02-why/index.qmd @@ -19,4 +19,127 @@ execute: cache: false --- -## Placeholder \ No newline at end of file +# Why Change? + +## Why Change from SAS V5 XPORT (XPT)? +::: {.incremental} +- Game Boy. Sega Genesis. The Casio F-91W. And SAS XPT. +- All were introduced in 1989. +- In 1999, the FDA standardized the submission of clinical data using SAS XPT. +- In 2012, FDA organized a Public Meeting on Study Data Exchange and later conducted the Dataset-XML pilot. +- From a programming perspective, we now work in a multilingual world. +- And now it may be time for SAS XPT to meet its end. +::: + +## SAS XPT Limitations (Part 1 of 2) +::: {.incremental} +1. **Data File Format** + - Limited variable types + - Limited to US ASCII encoding + - 8-character variable names + - 40-character labels + - 200-character field widths +2. **Storage** + - Inefficient use of storage space + - The inability to compress datasets leads to file logistical issues (e.g., splitting datasets) +::: + +## SAS XPT Limitations (Part 1 of 2) +::: {.incremental} +3. **Content** + - Lacks a robust metadata layer + - Only works for 2-dimensional data structures +4. **Extensibility** + - Not extensible +::: + +## What is Dataset-JSON? +::: {.incremental} +- A CDISC data exchange format for tabular datasets +- Designed to support a broad range of data exchange scenarios +- Supports API and file-based data exchange +- JSON/NDJSON is simple to implement, very stable, and widely supported +- Extensible to support new metadata and new use cases +::: + +# Why Dataset-JSON? + +## Why JSON? +::: {.incremental} +- JSON is the most widely used data interchange standard globally +- JSON is a lightweight text-based interchange format +- JSON is very simple and widely supported +- JSON is easy to read and write +- JSON targets data exchange +- JSON is a language independent standard +::: + +## Dataset-JSON as an Alternative Transport Format for Regulatory Submissions Pilot +::: {.incremental} +- The pilot was a collaboration between CDISC, PHUSE, and the FDA +- The pilot final readout occurred in June 2024 +- The pilot demonstrated that Dataset-JSON can transport data without disruption to business +- Pilot findings resulted in: (1) standards updates, (2) User’s Guide content, and (3) tool updates and enhancements +- FDA testing included internal testing and external testing including submissions using the test ESG +::: + +# Why not Parquet? + +## JSON Definition +**From the JSON website:** JSON is a lightweight data-interchange format. It is easy for humans to read and write. It is easy for machines to +parse and generate. JSON is a text format that is completely language independent but uses conventions that are +familiar to programmers. These properties make JSON an ideal data-interchange language. + +## Parquet Definition +**From the Parquet website:** Apache Parquet is an open source, column-oriented data file format designed for efficient data storage and retrieval. +It provides efficient data compression and encoding schemes with enhanced performance to handle complex data in bulk. +We created Parquet to make the advantages of compressed, efficient columnar data representation available to any +project in the Hadoop ecosystem. + +## What is the Purpose of Dataset-JSON? +::: {.incremental} +1. Addresses the data exchange use case +2. API and File-based data exchange +3. Optimized for breadth of support and ease of implementation for a broad range of data exchange scenarios +4. Aligned with other data exchange standards, HL7 FHIR and ODM v2.0 +::: + +## What is the Purpose of Parquet? +::: {.incremental} +1. Addresses the storage and analytical processing use case +2. File-based data exchange +3. Optimized for storage and analytical data processing performance +4. Aligned with sponsor statistical computing environment use +::: + +## Dataset-JSON Assumptions (Part 1 of 2) +::: {.incremental} +1. Data exchange scenarios include datasets generated by applications such as EDC, ePRO, labs, and other data sources +2. APIs will provide the most common means to exchange data +3. Aligns with: + - ODM v2.0, define.json, and works with Define-XML + - DDF USDM, ARS, CORE, CDISC Library, OAK, and other CDISC projects + - Healthcare data exchange standards like HL7 FHIR +::: + +## Dataset-JSON Assumptions (Part 2 of 2) +::: {.incremental} +4. Systems will not make frequent reads/writes to Dataset-JSON files +5. Extensible. Most vendors extend ODM-based standards +6. Many vendors already import/export JSON +7. Addresses SAS XPT limitations +8. Commit to creating Dataset-JSON Parquet conversion software +::: + +## References (Part 1 of 2) +- [CDISC Dataset-JSON v1.1 Standard](https://github.com/cdisc-org/DataExchange-DatasetJson) +- [No More XPT? Piloting New Dataset-JSON For FDA Submissions](https://www.clinicalleader.com/doc/no-more-xpt-piloting-new-dataset-json-for-fda-submissions-0001) +- [Why JSON for Datasets?](https://www.linkedin.com/pulse/why-json-datasets-sam-hume-iw6ee) +- [JSON Standard](https://www.json.org/json-en.html) + +## References (Part 2 of 2) +- [NDJSON Standard](https://github.com/ndjson/ndjson-spec) +- [Parquet Standard](https://parquet.apache.org/) +- [PHUSE White Paper: Transport for the Next Generation](https://www.cdisc.org/sites/default/files/2023-05/Transport-for-the-Next-Generation-Version-1.0.pdf) +- [FDA: Test Report for DS-XML Pilot](https://web.archive.org/web/20160208090353/http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM443327.pdf) +- [Dataset-JSON as an Alternative Transport Format for Regulatory Submissions: Final Pilot Report](https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/WP-88+Dataset-JSON+Report.pdf) diff --git a/slides/03-what/index.qmd b/slides/03-what/index.qmd index d949271..a4eb266 100644 --- a/slides/03-what/index.qmd +++ b/slides/03-what/index.qmd @@ -19,4 +19,306 @@ execute: cache: false --- -## Placeholder \ No newline at end of file +## Introduction to Dataset-JSON +::: {.incremental} +- Dataset-JSON is a data exchange standard for sharing tabular data using JSON. +- It is designed to meet a wide range of data exchange scenarios, including regulatory submissions and API-based data exchange. +- Each Dataset-JSON dataset can optionally reference a Define-XML file. +- Dataset-JSON uses lowerCamelCase notation for attribute names. +- Dataset-JSON must contain only one dataset per file. +::: + +## Example Dataset-JSON Top-level Metadata +```json +{ + "datasetJSONCreationDateTime": "2024-07-30T09:38:42", + "datasetJSONVersion": "1.1.0", + "fileOID": "www.cdisc.org/StudyMSGv2/1/2024-07-30/dd", + "dbLastModifiedDateTime": "2020-08-21T09:14:25", + "originator": "CDISC SDTM MSG Team", + "sourceSystem": {"name": "Sponsor System", "version": "1.0"}, + "studyOID": "cdisc.com.CDISCPILOT01", + "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3", + "metaDataRef": "define.xml", + "itemGroupOID": "IG.DD", + "records": 3, + "name": "DD", + "label": "Death Details", + "columns": [ ], + "rows": [ ] +} +``` + +## Top-level Metadata Attributes (Part 1 of 4) + +| Attribute | Description | +|----------|------------------------| +| datasetJSONCreationDateTime | The date/time the Dataset-JSON file was created. | +| datasetJSONVersion | The version of the Dataset-JSON standard used to create the dataset.| +| fileOID | A unique identifier for this dataset.| +| dbLastModifiedDateTime | The date/time the source database was last modified. | +| originator | The organization that generated the dataset. | + +## Top-level Metadata Attributes (Part 2 of 4) + +| Attribute | Description | +|-----------|-----------------------| +| sourceSystem | The information system from which the dataset content was sourced. | +| sourceSystem.name | The name of the sourceSystem above. | +| sourceSystem.version | The version of the sourceSystem above. | +| studyOID | Unique identifier for the study that may function as a foreign key to a Study/@OID in a Define-XML file. | + +## Top-level Metadata Attributes (Part 3 of 4) + +| Attribute | Description | +|-----------|-----------------------| +| metaDataVersionOID | Unique identifier for the metadata version that may also function as a foreign key to a MetaDataVersion/@OID in an associated Define-XML.| +| metaDataRef | URI for a metadata file describing the dataset, such as a Define-XML file. | +| itemGroupOID | Unique identifier for the dataset that may function as a foreign key to an ItemGroupDef/@OID in a Define-XML file. | +| records | The total number of records in a dataset. | + +## Top-level Metadata Attributes (Part 4 of 4) + +| Attribute | Description | +|-----------|-----------------------| +| name | The human readable name for the dataset. | +| label | A short description of the dataset. | +| columns | An array of metadata objects that describe the dataset variables. | +| rows | An array of data record arrays that represent the dataset rows. | + +## Column Metadata +::: {.incremental} +- **columns** is an array of basic information about dataset variables. +- The **order of elements** in the array must be the same as **the order of variables** in the described dataset. +::: + +## Example Dataset-JSON Column Metadata +```json + "columns": [ + { + "itemOID": "IT.DD.STUDYID", + "name": "STUDYID", + "label": "Study Identifier", + "dataType": "string", + "length": 12, + "keySequence": 1 + }, + { + "itemOID": "IT.DD.DOMAIN", + "name": "DOMAIN", + "label": "Domain Abbreviation", + "dataType": "string", + "length": 2 + } +] +``` + +## Column Metadata Attributes (Part 1 of 2) + +| Attribute | Description | +|-----------|-----------------------| +| itemOID | Unique identifier for the variable that may function as a foreign key to an ItemDef/@OID in a Define-XML file. | +| name | Variable name | +| label | Variable description | +| dataType | Logical data type of the variable. | + +## Column Metadata Attributes (Part 2 of 2) +| Attribute | Description | +|-----------|-----------------------| +| targetDataType | The variable with a specified dataType must be converted into the targetDataType when transforming the Dataset-JSON dataset into an operational format. | +| length | Specifies the number of characters allowed for the variable value when it is represented as a text. The variable lengths are planned lengths. | +| displayFormat | A SAS display format value used for data visualization of numeric float and date values. | +| keySequence | Indicates that this item is a key variable and the order of the keys in the dataset structure. | + +## Row Data +- **rows** is an array of records with variable values. +- Each record is represented as an array of variable values. +```json +"rows": [ + [1, "MyStudy", "001", "DM", 56], + [2, "MyStudy", "002", "DM", 26], +] +``` +- Missing values are represented by null. +```json +[1, "MyStudy", null, "DM", null], +``` +- Empty strings are represented by "". +```json +[1, "MyStudy", "", "DM", null], +``` + +## Date/Time Variables +::: {.incremental} +- Timing variables (datetime, date, time) are stored as ISO 8601 strings in the JSON format. +- The targetDataType attribute needs to be specified when different from dataType attribute or the JSON data type. +- The targetDataType for the date and datetime variables need not mentioned for SDTM datasets as the logical type is same as JSON. +- For ADaM datasets, the targetDataType must be set to integer. +::: + +## Example Dates for the TRTSDT, TRTEDT, and ASTDT Variables (ADaM, numeric) +```{.json code-line-numbers="4-6,15"} +"columns": [ + {"itemOID": "IT.AE.STUDYID", "name": "STUDYID", "label": "Study Identifier", + "dataType": "string", "length": 12}, + {"itemOID": "IT.ADAE.TRTSDT", "name": "TRTSDT", + "label": "Date of First Exposure to Treatment", "dataType": "date", + "targetDataType": "integer", "displayFormat": "E8601DA."}, + {"itemOID": "IT.ADAE.TRTEDT", "name": "TRTEDT", + "label": "Date of Last Exposure to Treatment", "dataType": "date", + "targetDataType": "integer", "displayFormat": "E8601DA."}, + {"itemOID": "IT.ADAE.ASTDT", "name": "ASTDT", + "label": "Analysis Start Date", "dataType": "date", + "targetDataType": "integer", "displayFormat": "E8601DA.", "keySequence": 3} +] +"rows": [ + ["CDISCPILOT01", "..." , "2014-01-02", "2014-07-02", "2014-01-03", "..."] +] +``` + +## Define-XML and Dataset-JSON +::: {.incremental} +- Define-XML is an XML standard, while Dataset-JSON uses JSON +- Dataset-JSON includes the basic metadata needed to process a dataset +- Common metadata in Dataset-JSON and Define-XML should be the same +- Dataset-JSON includes an optional reference to a Define-XML +- Define-XML remains a requirement for submissions +::: + +## Referencing Define-XML (Example 1 of 2) +```{.json code-line-numbers="10"} +{ + "datasetJSONCreationDateTime": "2024-07-30T09:38:42", + "datasetJSONVersion": "1.1.0", + "fileOID": "www.cdisc.org/StudyMSGv2/1/2024-07-30/dd", + "dbLastModifiedDateTime": "2020-08-21T09:14:25", + "originator": "CDISC SDTM MSG Team", + "sourceSystem": {"name": "Sponsor System", "version": "1.0"}, + "studyOID": "cdisc.com/CDISCPILOT01", + "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3", + "metaDataRef": "define.xml", + "itemGroupOID": "IG.DD", + "records": 3, + "name": "DD", + "label": "Death Details", + "columns": [ ], + "rows": [ ] +``` + +## Referencing Define-XML (Example 2 of 2) +```{.json code-line-numbers="10"} +{ + "datasetJSONCreationDateTime": "2024-07-30T09:38:42", + "datasetJSONVersion": "1.1.0", + "fileOID": "www.cdisc.org/StudyMSGv2/1/2024-07-30/dd", + "dbLastModifiedDateTime": "2020-08-21T09:14:25", + "originator": "CDISC SDTM MSG Team", + "sourceSystem": {"name": "Sponsor System", "version": "1.0"}, + "studyOID": "cdisc.com/CDISCPILOT01", + "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3", + "metaDataRef": "https://metadata.location.org/CDISCPILOT01/define.xml", + "itemGroupOID": "IG.DD", + "records": 3, + "name": "DD", + "label": "Death Details", + "columns": [ ], + "rows": [ ] +``` + +# The NDJSON Format + +## What is NDJSON? +::: {.incremental} +- NDJSON = Newline Delimited JSON - each line is valid JSON +- NDJSON is a standard for delimiting JSON in stream protocols +- NDJSON is a variation of JSON that's designed for bulk data transfer +- Dataset-JSON NDJSON and JSON formatted datasets have the same content +- NDJSON content is written or read as 1 line of valid JSON at a time +::: + +## Why NDJSON for Dataset-JSON? +::: {.incremental} +- The NDJSON representation simplifies streaming large datasets +- Datasets can easily be read or written one row at a time without loading the entire dataset into memory +- Most programming languages have libraries that read a large JSON dataset as a stream. +- NDJSON makes it easy for the program to read and write a row at a time. +::: + +## When to use NDJSON? +::: {.incremental} +- In a data exchange scenario, the sender and receiver determine whether to use the JSON or NDJSON representation of Dataset-JSON +- No official guidelines on when to use 1 format over the other +- NDJSON targets large dataset processing but can be used anytime the sender and receiver agree to use the format +- Converting between JSON and NDJSON is straightforward +- Standard Dataset-JSON API specification supports streaming NDJSON +::: + +## How to create NDJSON from Dataset-JSON +- Row 1: all the Dataset-JSON metadata is represented as a JSON object in one row + - Includes dataset metadata and column definitions +- Row 2-n: each data row is written as an array in a single line of JSON +- NDJSON files use `.ndjson` as the extension + - JSON files use `.json` as the extension + +## NDJSON Example +```json +{"datasetJSONCreationDateTime": "2023-06-28T15:38:43", "datasetJSONVersion": "1.1.0", "fileOID": "..." } +[1, "CDISCPILOT01", "DM", "CDISC001", 84], +[2, "CDISCPILOT01", "DM", "CDISC002", 76], +[3, "CDISCPILOT01", "DM", "CDISC003", 61] +``` +# Processing Dataset-JSON + +## Dataset-JSON Open-Source Tools +::: {.incremental} +- R conversion package by Atorus Research and Johnson & Johnson +- Python conversion package by Sam Hume +- SAS conversion tool by Lex Jansen +- Dataset-JSON Viewer software +- Numerous others +::: + +## Dataset-JSON File Size Influencers +::: {.incremental} +- Dataset-JSON files tend to be smaller than XPT , with a ratio of ~0.7 +- Pretty printing Dataset-JSON adds newline, tab characters or spaces that inflate the size +- Compression significantly reduces Dataset-JSON file sizes +- In XPT, space is allocated for missing values. Dataset-JSON uses empty string quotes or null to represent the missing values. +- Note: in XPT a missing variable with length=XX occupies XX bytes +::: + +## Dataset-JSON Encoding +- JSON uses UTF-8 encoding by default +- UTF-8 encoding: + - Supports Unicode and represents any language and alphabet + - Is the most widely supported encoding scheme used on the Internet + - JSON standard requires UTF-8 support +- SAS V5 XPORT uses an older encoding scheme + +# Validating Dataset-JSON + +## Dataset-JSON Validation +::: {.incremental} +- **Option 1:** schema validate JSON files using dataset.schema.json +- **Option 2:** use the LinkML YAML model to validate the dataset +- **Option 3:** validate NDJSON one line at a time +- **Note:** schema validation does not replace the need for conformance rule checks +::: + +## References +- [Camel Case](https://en.wikipedia.org/wiki/Camel_case) +- [User Guide article on representing numeric dates](https://wiki.cdisc.org/display/PUB/Representing+Numeric+Dates) +- [Alignment of Dataset-JSON with Define-XML](https://wiki.cdisc.org/display/PUB/Alignment+of+Dataset-JSON+with+Define-XML) + +## References: Conversion Software +- [R conversion package by Atorus Research and Johnson & Johnson](https://github.com/atorus-research/datasetjson) +- [Python conversion package by Sam Hume](https://github.com/swhume/dataset-json) +- [SAS conversion tool by Lex Jansen](https://github.com/lexjansen/dataset-json-sas) + +## References: Viewer Software +- [Dataset-JSON Viewer Hackathon Winner](https://github.com/defineEditor/vde-dataset-viewer) +- [Dataset-JSON Viewer Hackathon Runner-up](https://github.com/1mgroot/Open-Dataset-JSON) +- [Dataset-JSON Viewer: JSON Visualizer](https://github.com/pfizer-opensource/JSON_Visualizer) +- [Dataset-JSON Viewer: Smart Submission Dataset Viewer](https://sourceforge.net/projects/smart-submission-dataset-viewe/) +- [Dataset-JSON Viewer: R-Shiny](https://github.com/sbarcelo777/Dataset-JSON-hackathon) +- [Dataset-JSON Viewer: EDA Viewer](https://github.com/explore-eda/dataset-json-viewer) diff --git a/slides/05-how-py/index.qmd b/slides/05-how-py/index.qmd index ab4e8f1..34ab388 100644 --- a/slides/05-how-py/index.qmd +++ b/slides/05-how-py/index.qmd @@ -19,4 +19,106 @@ execute: cache: false --- -## Placeholder \ No newline at end of file +# How to Read/Write Dataset-JSON using Python + +## Getting to Know dsjconvert for Dataset-JSON +::: {.incremental} +1. Introduction to the dsjconvert package +2. Using dsjconvert: as a command-line tool +3. Using dsjconvert: as a Python package +4. Exercises: getting your hands dirty +::: + +## Introduction to dsjconvert +::: {.incremental} +- Converts SAS XPT and SAS7BDAT files to Dataset-JSON v1.1 in JSON or NDJSON +- Converts Dataset-JSON in JSON or NDJSON to SAS XPT +- Validates Dataset-JSON datasets +- Functions as a CLI application or a Python library +::: + +## dsjconvert Features +::: {.incremental} +- **Multiple Input Formats**: Converts XPT, SAS7BDAT, and Dataset-JSON datasets +- **Dual Output Formats**: Dataset-JSON and SAS XPT +- **Dual Dataset-JSON Formats**: Supports JSON and NDJSON Dataset-JSON formats +- **Flexible Metadata**: Use Define-XML metadata or auto-infer from source data +- **Validation**: Built-in validation against Dataset-JSON schemas +- **Logging**: Configurable logging levels for debugging +::: + +## Usage: as a CLI Tool +Convert XPT files using defaults (NDJSON format): +```bash +dsjconvert -v -x +``` +Convert SAS7BDAT files to JSON format: +```bash +dsjconvert -v -b --format json +``` +Convert Dataset-JSON to XPT +```bash +dsjconvert -v --to-xpt --input-format ndjson +``` + +## Usage: as a Python Library +```python +from dsjconvert import XPTConverter, MetadataExtractor + +# With Define-XML metadata +extractor = MetadataExtractor('path/to/define.xml') +converter = XPTConverter( + metadata_extractor=extractor, + output_format='ndjson', + skip_validation=True +) +converter.convert_dataset('input.xpt', 'output_dir') + +# Without Define-XML (auto-infer metadata) +converter = XPTConverter(output_format='ndjson') +converter.convert_dataset('input.xpt', 'output_dir') +``` + +## Usage: as a Python Library +Convert multiple SAS7BDAT files to JSON format: +```python +import os +from dsjconvert import SAS7BDATConverter + +converter = SAS7BDATConverter(output_format='json') + +# Get all SAS files +sas_dir = 'data' +sas_files = [f for f in os.listdir(sas_dir) if f.endswith('.sas7bdat')] + +# Convert each file +for sas_file in sas_files: + input_path = os.path.join(sas_dir, sas_file) + output_path = converter.convert_dataset(input_path, 'output') + print(f"Converted: {output_path}") +``` + +## Usage: as a Python Library +Convert Dataset-JSON to SAS XPT +```python +from dsjconvert import DatasetJSONToXPTConverter + +converter = DatasetJSONToXPTConverter(input_format='ndjson') +xpt_path = converter.convert_dataset('input.ndjson', 'output_dir') +``` + +## Questions? +::: {.incremental} +- Questions? +- Let's get into the exercises! +- The exercises focus on converting to and from Dataset-JSON +- Open `exercises/02-python.py` and work through the exercises +::: + +## dsjconvert Exercises +::: {.incremental} +1. Convert cm.xpt to CM.ndjson using the define.xml metadata +2. Convert vs.xpt to VS.ndjson without using the define.xml metadata +3. Convert dm.xpt to DM.json using the define.xml metadata +4. Convert MH.ndjson to mh.xpt using the define.xml metadata +::: diff --git a/slides/05-how-py/requirements.txt b/slides/05-how-py/requirements.txt new file mode 100644 index 0000000..b92c8d9 --- /dev/null +++ b/slides/05-how-py/requirements.txt @@ -0,0 +1,4 @@ +dsjconvert>=0.9.1 +linkml>=1.7.0 +pandas==2.3.3 +pyreadstat==1.3.1 \ No newline at end of file diff --git a/slides/06-future/index.qmd b/slides/06-future/index.qmd index ccfc4ed..7c53ac8 100644 --- a/slides/06-future/index.qmd +++ b/slides/06-future/index.qmd @@ -19,4 +19,73 @@ execute: cache: false --- -## Placeholder \ No newline at end of file +# Submission Pilot + +# FDA Request For Comments (RFC) + +## FDA FR Notice for Dataset-JSON Comments (Part 1 of 2) +::: {.incremental} +- In 2022, the FDA evaluated alternatives to serve as possible replacements to SAS V5 XPT +- The FDA determined that JSON was the optimal modern format to serve as a replacement to SAS V5 XPT +- JSON is the most commonly used format to represent HL7 FHIR-based EHR data +- HL7 FHIR has been endorsed for EHR data by the Assistant Secretary for Technology Policy and ONC HIT +- The CDISC-PHUSE pilot results demonstrated that Dataset-JSON could serve as a transport file for study data +::: + +## FDA FR Notice for Dataset-JSON Comments (Part 2 of 2) +::: {.incremental} +- The vast majority of industry comments to the FDA were positive +- Of the few negative comments, many were dated or inaccurate assessments +- Several comments requested adequate testing and transition time to accommodate a change +- Next step may be an FR Notice outlining an official FDA submissions pilot +::: + +# Dataset-JSON API and Compressed Dataset-JSON + +## Dataset-JSON API Standard (Part 1 of 2) +::: {.incremental} +- A REST-based standard API specification (OAS 3.1) for the exchange of Dataset-JSON datasets +- The API supports full CRUD operations, but a read-only implementation is valid +- Primarily implements JSON, but also supports streaming NDJSON +- Many API clients and servers may never work with Dataset-JSON as a file format +::: + +## Dataset-JSON API Standard (Part 2 of 2) +::: {.incremental} +- A User Guide is available to support implementing the API +- The OAS 3.1 formatted specification can be used to generate code for clients and servers +- Successfully completed Public Review and the final standard should be published in December 2025 +- A POC API implementation will be available in December 2025 +::: + +## Compressed Dataset-JSON (Part 1 of 2) +:::{.incremental} +- Based on NDJSON format, which makes it easy to process large datasets. +- Contents is compressed using a standard DEFLATE algorithm, widely supported by programming languages, including SAS, R, Python. +- Compression algorithm is widely used and supported: PNG, DOCX, web traffic, etc. +- Compression is also supported by the API +::: + +## Compressed Dataset-JSON (Part 2 of 2) +:::{.incremental} +- SDTM package is 15 times smaller and ADaM package is 18 times smaller (larger datasets see greater compression) +- All formats (JSON, NDJSON, and Compressed Dataset-JSON) represent the same underlying information +- Uses the .dsjc file extension +- Successfully completed Public Review and the final standard should be published in December 2025 +::: + +# References + +## References (Part 1 of 2) +- [FDA FR Notice for Dataset-JSON Comments](https://www.federalregister.gov/documents/2025/04/09/2025-06051/electronic-study-data-submission-data-standards-clinical-data-interchange-standards-consortium) +- [Dataset-JSON API Specification in HTML](https://cdisc-org.github.io/DataExchange-DatasetJson-API/) +- [Dataset-JSON API Specification User Guide](https://github.com/cdisc-org/DataExchange-DatasetJson-API/blob/main/docs/dataset-json-api-1-0-ug.md) +- [Dataset-JSON API Specification in OpenAPI Specification](https://github.com/cdisc-org/DataExchange-DatasetJson-API/blob/main/openapi/dataset-json-api-1-0.json) +- [Compressed Dataset-JSON Specification](https://github.com/cdisc-org/DataExchange-DatasetJson/blob/master/doc/compressed-dataset-json1-1.md) + +## References (Part 2 of 2) +- [NDJSON Standard](https://github.com/ndjson/ndjson-spec) +- [Parquet Standard](https://parquet.apache.org/) +- [PHUSE White Paper: Transport for the Next Generation](https://www.cdisc.org/sites/default/files/2023-05/Transport-for-the-Next-Generation-Version-1.0.pdf) +- [FDA: Test Report for DS-XML Pilot](https://web.archive.org/web/20160208090353/http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM443327.pdf) +- [Dataset-JSON as an Alternative Transport Format for Regulatory Submissions: Final Pilot Report](https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/WP-88+Dataset-JSON+Report.pdf)