ECFSPR ENCOUNTER VARIABLES (vs 1.1)
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1 European Cystic Fibrosis Society Patient Registry ECFSPR Encounter variables vs 1 ECFSPR ENCOUNTER VARIABLES (vs 1.1) Field Name Chapter title Sub chapter title Name Clinic (for visit) Date Coding Date of Encounter Date Calendar to select date: dd/mm/yyyy Doctor Date open field Weight (kg) Respir/Nutrit Numeric value in kg, to 1 decimal place (with point, not comma) Height (cm) Respir/Nutrit Numeric value in cm, without decimals Age as decimal (computed) Age in months (computed) automatic calculation automatic calculation Weight z-score Respir/Nutrit automatic calculation Weight age percentile Respir/Nutrit automatic calculation Height z-score Respir/Nutrit automatic calculation Height age percentile Respir/Nutrit automatic calculation BMI Respir/Nutrit automatic calculation BMI z-score Respir/Nutrit automatic calculation BMI percentile Respir/Nutrit automatic calculation FEV1 (litres) Respir/Nutrit record value in litres (two decimals, use '.' for decimals) of FEV1% predicted according to local reference values; (1) If unknown or not collected. FVC (litres) Respir/Nutrit record value in litres (two decimals, use '.' for decimals) of the FVC according to local reference values; (-1) Unkown Date of FEV1 measurement Respir/Nutrit dd/mm/yyyy FEF (litres) Respir/Nutrit open field Value in L/sec (-1) Unkown FEV1% of predicted Respir/Nutrit automatic calculation FVC% of predicted Respir/Nutrit automatic calculation FEV1 / FVC Respir/Nutrit automatic calculation FEF 25-75% of predicted Respir/Nutrit automatic calculation 1
2 Result of LCI 2.5% Respir/Nutrit Value recorded at time of visit (-1) Unkown Month of LCI 2.5% measurement Respir/Nutrit mm Day of LCI 2.5% measurement Respir/Nutrit dd Device used for LCI measurement Respir/Nutrit t done (1) Ecomedics Exhalyzer D N2- Washout (2) Ecomedics Exhalyzer SF6 (Tracergas 4 %) (3) Innovision Innocor (4) NDD Easyone Pro Seen by Physiotherapist Respir/Nutrit Seen by Dietician Respir/Nutrit Seen by Psychotherapist Respir/Nutrit Maintenance Therapy Maintenance Nebulised Tobramycin Therapy Maintenance Nebulised Colomycin Therapy Maintenance Nebulised Aztreonam Therapy Maintenance Nebulised Levofloxacin (1) Continuously (2) Alternating monthly (1) Continuously (2) Alternating monthly (1) Continuously (2) Alternating monthly (1) Continuously (2) Alternating monthly
3 Tobramycin dry powder inhaler Therapy Maintenance Colomycin dry powder inhaler Therapy Maintenance (1) Continuously (2) Alternating monthly (1) Continuously (2) Alternating monthly Nebulised / dry powder antibiotics - Other Therapy Maintenance (1) Continuously (2) Alternating monthly Name of nebulised / dry powder antibiotics - Other Therapy Maintenance open field. Azithromycin / MacrolideMaintenance Therapy Therapy Maintenance (1) Azithromycine (2) Erythromycine (3) Clarithromycin] Chronic oral antibiotics Therapy Maintenance (1) Quinolone (Ciprofloxacin, Moxifloxacin, Levofloxacin, etc.) (2 Sulphonamide (trimethoprim/ sulfamethoxazole) (3) Cephalosporin (cephalexin, cefuroxime, cefaclor, etc.) (4) Penicillin (amoxicillin (including amoxicillin combination with clavulanic acid) (5) Flucloxacillin etc. (6) Tetracycline (doxycycline, minocycline etc) (7) Metronidazole (8) Clindamycin (9) Rifampicin (10) Sodium fusiadate (11) Chloramphenicol (12) Other + open field
4 Chronic antifungal therapy Therapy Maintenance (1) Itraconazole (2 Voriconazole (3) Posaconazole (4) Other + open field Use of rhdnase Therapy Respiratory Hypertonic saline Therapy Respiratory (1) 3% (2) 7% Use of Mannitol Therapy Respiratory Inhaled short acting bronchodilators Therapy Respiratory (1) Salbuterol (2) Terbutaline (3) Other Inhaled long acting bronchodilators Therapy Respiratory (1) Salbuterol (2) Other Inhaled steroid alone Therapy Respiratory (1) Fluticasone (2) Budesonide (3) Beclomethasone (4) Other Inhaled steroid with LABA Therapy Respiratory (1) Fluticasone - Salmeterol (2) Budesonide - Formoterol (3) Other Inhaled LAMA Therapy Respiratory (1) Tiotropium (2) Other
5 Inhaled nasal steroid Therapy Respiratory Oral steroid Therapy Respiratory High dose ibuprofen Therapy Respiratory Leukotrien receptor antagonist Therapy Respiratory Oxygen therapy Therapy Respiratory (1) During excercise (2) At night time (3) Continuous (4) Other Non-invasive positive pressure ventilation (NIPPV) Therapy Respiratory (1) CPAP (contin. positive airway pressure) (2) BPAP (bi-level positive airway pressure) Pancreatic enzyme replacement Therapy Nutrition / GI Ursodeoxycholic acid Therapy Nutrition / GI Proton pump inhibitors (PPI) Therapy Nutrition / GI H2 Blocker Therapy Nutrition / GI Appetite Stimulating Medication Therapy Nutrition / GI Enteral feeding Therapy Nutrition / GI (1) PEG (2) NG
6 Vitamin A supplements Therapy Nutrition / GI Vitamin D supplements Therapy Nutrition / GI Vitamin E supplements Therapy Nutrition / GI Vitamin K supplements Therapy Nutrition / GI Hormonal contraception Therapy Endocrine Calcium supplementation Therapy Endocrine Antidepressants Therapy Endocrine Bisphosphonate Therapy Endocrine Insulin Therapy Endocrine (1) Intermittant (2) Daily Oral Hypoglycemic Therapy Endocrine CFTR modifier therapy Therapy Other therapy (1) Ivacaftor (2) Orkambi (3) Symkevi (4) Other (specify) + text field If scrollbox Date of diagnosis of pulmonary exacerbation Stop date of pulmonary exacerbation Was patient treated with IV antibiotics for this Pulmonary Exacerbation? Exacerbation history Exacerbation history Exacerbation history Date field DD/MM/YYYY (calendar) Date field DD/MM/YYYY (calendar)
7 Was patient treated with Inhaled antibiotics for this Pulmonary Exacerbation? Exacerbation history Was patient hospitalized for this Pulmonary Exacerbation? Exacerbation history Oral antibiotic Exacerbation history Stop (selection of date) Continuing name (drop-down list) (1) Flucloxacillin (2) Other (please specify)] + open field Inhaled antibiotic Exacerbation history Start (selection of date) Stop (selection of date) Continuing name (drop-down list) (1) Amikacin (2) Aztreonam (3) Colistin (4) Flucloxacillin (5) Tobramycin (6) Gentamicin (7) Vancomycin (8) Other (please specify)] + open field Intravenous Exacerbation history Start (selection of date) Stop (selection of date) Continuing Drop-down list: (1) Amikacin (2) Aztreonam (3) Cefoxitin (4) Ceftazidime (5) Colistin (6) Flucloxacillin (7) Fosfamycin (8) Tobramycin (9) Gentamicin (10) Meropenem (11) Teicoplanin (12) Vancomycin (13) Cephradine; (14) Other (please specify) + open field Dropdownlist: Flucloxacillin Other (please specify)] + open field Unknown If YES drop-down list Drop-down list if YES
8 Hospitalisation Exacerbation history Admission (date) Discharge (date) Continuing Reason: (1) CF Pulmonary exacerbation (2) Other - CF related (3) Other-non CF related (4) CF related-hemoptysis (5) CF related-distal Intestinal Obstruction (6) Elective Surgery (7) CF related-pneumothorax (8) CF related-end Stage Lung Disease Hospitalisation planned Exacerbation history Hospitalisation admittance Exacerbation history (1 Clinic (2) Emergency Room If YES, dropdown list: Clinic Emergency Room Hospitalisation in ICU Exacerbation history Sample type Microbiology (1) OP swab (2) Spontaneous sputum (3) Bronchoscopy (4) Induced sputum (5) Pharyngeal aspiration (6) Other Start & End date If YES Drop down list: OP swab Spontaneous sputum Bronchoscopy Induced sputum Pharyngeal aspiration Other Sample date Microbiology Calendar to select date Has the subject tested positive for any of the following: Mucoid Pseudomonas aeruginosa Microbiology Non-mucoid Pseudomonas aeruginosa Microbiology
9 Staphylococcus aureus Microbiology MRSA Microbiology Burkholderia cepacia complex Microbiology Non-tuberculous mycobacteria Microbiology (1) MAC (2) Abscessus (3) Other Was Non-tuberculous mycobacteria cultured? Stenotrophomonas maltophilia Microbiology Achromobacter species xylosoxidans Microbiology Haemophilus influenzae (any species) Microbiology Other bacteria or fungus Microbiology (please specify) + open field ABPA Complications of CF (1) ABPA (2) ABPA requiring treatment If yes: dropdownlist: ABPA; ABPA requiring treatment Default: Unknown
10 Asthma Complications of CF DIOS Complications of CF (1) hospitalisation unknown (2) hospitalisation required (2) hospitalisation not required Glucose tolerance test done Complications of CF (1) Normal 2) Impaired glucose tolerance (3) Diabetic (4) Fasting hyperglycaemia (5) Yes, Other Pneumothorax requiring chest drain since last encounter Complications of CF Liver GI disease Complications of CF (1) Cirrhosis with portal hypertension 2) Cirrhosis without portal hypertension / hypersplenism (3) Cirrhosis portal hypertension unknown (4) Liver disease without cirrhosis (5) Variacel bleeding Hemoptysis more than 250ml since last encounter Complications of CF Pancreatitis Complications of CF Malignancy diagnosed since last encounter Complications of CF (99) Missing (1) Colorectal cancer (2) Small bowel cancer (3) Lymphoid leukemia (4) Testicular cancer (5) Breast cancer (6) Cancer of the Thyroid (7) Type unknown (8) Other (+ free text field ) If YES drop-down list:
11 Sinusitis Complications of CF Osteoporosis Complications of CF Osteopenia Complications of CF Gastroesophageal reflux Complications of CF Arthritis Complications of CF Anxiety Complications of CF Depression Complications of CF Salt loss syndrome Complications of CF
12 Comorbidities Complications of CF If YES drop-down list Date of lab sample: Liver Chemistries (LC) (1) Cardiac Arrhythmias (2 Cardiovascular Disease (including Heart failure) (3) Cholesterolemia (4) Chronic Pain (5) Constipation (6) Eye Disease (7) Cataract (8) Gall stone (9) Hearing Los (10) Hypertension with cholesterolemia (11) Hypertension without cholesterolemia (12) Pulmonary Arteria (13) Hypertension (14) Infertility (15) Micro gall bladder (16) Nasal polyp (17) Rectal prolapse (18) Renal disease (19) Nephrolithiasis (20) Renal disease Proteinuria (21) Renal disease Proteinuria requiring dialysis (22) Renal disease GFR <50% (23) Renal disease microalbuminuria dd/mm/yyyy ALT - Result: Liver Chemistries (LC) Unit: Liver Chemistries (LC) U/L; μmol/l AST Result: Liver Chemistries (LC) Unit: Liver Chemistries (LC) U/L; μmol/l GGT Result: Liver Chemistries (LC) Unit: Liver Chemistries (LC) U/L; μmol/l Alkaline Phosphatase Result: Liver Chemistries (LC) Unit: Liver Chemistries (LC) U/L; μmol/l BILIRUBIN Result: Liver Chemistries (LC) Unit: Liver Chemistries (LC) U/L; μmol/l Has the patient died since last encounter Vital status / Date of death Vital status / Vital Status (0) He/she died (1) He/she is alive Calendar to select date
13 Cause of death Vital status / (1) Respiratory (2) ation (3) Non-CF related (4) Liver GI (5) Trauma (6) Suicide (6) Non-CF related (7) Other (+ open text field) (cause of death not collected) Has the patient been assessed for, or had an active transplant since the last encounter Vital status / Reffered, awaiting assesment Vital status / Assessed, awaiting decision Vital status / Lung / Liver / Kidney / Other Lung / Liver / Kidney Decision made: unsuitable for listing Vital status / Lung / Liver / Kidney Decision made: on active list Vital status / ed Vital status / Lung / Liver / Kidney Lung / Liver / Kidney (date of transplant + tickbox Re-transplant not visible) (date of transplant + tickbox Retransplant not visible) (date of transplant + tickbox Re-transplant will become visible) Date of transplant Vital status / Lung / Liver / Kidney Calendar. Variable becomes visible when yes transplanted. Re-transplant Vital status / Lung / Liver / Kidney Tick box type Other transplant Drop down list Reffered, awaiting assesment Vital status / Other transplant Assessed, awaiting decision Vital status / Decision made: unsuitable for listing Vital status / Other transplant Other transplant
14 Decision made: on active list Vital status / ed Vital status / Other transplant Other transplant (date of transplant + tickbox Re-transplant not visible) (date of transplant + tickbox Retransplant not visible) (date of transplant + tickbox Re-transplant will become visible) Date of transplant Vital status / Re-transplant Vital status / Other transplant Other transplant Calendar Field becomes visible when yes transplanted. Did patient or caregiver reconsent/re-assent at any time? Re-consent / -Assent Date of written informed consent Re-consent / -Assent dd/mm/yyyy Informed CONSENT provided by: Re-consent / -Assent (0) Patient (1) Caregiver Did patient provide informed Assent? Re-consent / -Assent Date of informed Assent: Re-consent / -Assent dd/mm/yyyy Calendar Protocol version to which this consent/assent corresponds (please enter the version, e,g, 1.0, 2.0, etc.): Re-consent / -Assent text field
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