CORE CLINICAL DATASET

Transcription

1 The following pages are the CORE CLINICAL DATASET for Ebolavirus disease. The forms are featured in order of priority. Therefore, when resources are limited, data collection can be reduced as required while maintaining the most critical information to inform patient care decisions. Definitions and explanations are featured in footnotes where appropriate. Medication form can be prefilled with prescriptive drug names, doses, times and circles to indicate when treatment should be given according to standard care at the site. Laboratory reference ranges can be adjusted according to the local laboratory. For more information please contact These forms have been annotated with CDASH variable names to facilitate harmonisation of data collection formats and structures so that data can be more easily aggregated and compared across sources. These names are compliant with CDISC standards. For information, a copy of the CDASH variable names or more tools, please contact data@iddo.org. For complete Ebola data standards, see the CDISC Ebola Therapeutic Area Users Guide.

2 ADMISSION Date of admission to this facility: [ D ][ D ]/[ M ][ ]/[ 2 ][ 0 ][ ][ ] Facility name: Facility country: Patient Surname: Other names: Date of birth (DD/MM/YYYY): [ ][ ]/[ ][ ]/[ ][ ][ ][ ] OR Estimated age [ ][ ][ ] years OR (if <2 years) [ ][ ] months Sex: Male Female Weight: [ ][ ][ ] kg Measured Estimated If FEMALE: Is the patient pregnant? Yes No If PREGNANT: Gestation age of fetus (nearest week): [ ][ ] Date of onset of first/earliest symptom (DD/MM/YYYY): [ ][ ]/[ ][ ]/[ 2 ][ 0 ][ 1 ][ 7 ] Ebolavirus PCR Complete with all results Sample Collection Date (DD/MM/YYYY) Time of collection Sample type Lab identifier Test kit Result CT value OUTCOME - Complete at discharge, transfer or death Final EVD diagnosis: Laboratory-confirmed Probable Suspect Non-case What was the patient s outcome? Achieved discharge criteria Deceased Fled Transferred to another facility Date of outcome: (DD/MM/YYYY) [ ][ ]/[ ][ ]/[ 2 ][ 0 ][ 1 ][ 7 ] If FEMALE: Did the patient give birth within the previous 6 weeks? YES NO If YES: What was the outcome of the pregnancy? Live birth Still birth Termination Spontaneous abortion/miscarriage If YES: Date of pregnancy outcome (DD/MM/YYYY): [ ][ ]/[ ][ ]/[ 2 ][ 0 ][ 1 ][ ] EVD CORE CLINICAL DATASET Version 10DEC14 2

3 OBSERVATIONS AND HYDRATION - Complete with events that have occurred since the previous assessment. YEAR 2017 Admission / / / / / / / Time (HH:MM, 24-hour clock) : : : : : : : Temperature C Respiratory Rate breaths/minute Heart Rate / Pulse beats/minute Systolic Blood Pressure mmhg Diastolic Blood Pressure mmhg LOWEST Consciousness Alert, Verbal stimuli, Painful stimuli, Unresponsive A V P U A V P U A V P U A V P U A V P U A V P U A V P U Weakness/asthenia? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Pain? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Nausea? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Vomiting? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Diarrhoea? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Unusual Bleeding/bruising? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Anorexia/dysphagia/ poor intake? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Signs of dehydration 1? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Signs of shock 2? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Anuria 3? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Disorientation? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Agitation? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Seizure? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Patient status/group A B C A B C A B C A B C A B C A B C (A, B, C, D, E - see below) 4 D E D E D E D E D E D E D E HYDRATION: Since the previous assessment, has the patient received: Enteral fluids 5? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Parenteral fluids? Yes No Yes No Yes No Yes No Yes No Yes No Yes No Method of parenteral fluid administration 6 Parenteral fluid given Total litres/24 hours 1 Finger Tip Capillary Refill Time of >2 seconds with decreased urine output, absent tears, dry mucous membranes = moderate dehydration 2 Cold hands with finger tip capillary refill > 3 seconds, and weak & fast pulse 3 Anuria: <100ml urine in previous 24 hours 4 Patient Status/groups: A - Ambulatory patients without significant gastrointestinal symptoms B - Weakness interfering with capacity for self-care and/or vomiting interfering with oral intake C - Signs of shock D - Physician decision to shift emphasis from resuscitative to palliative care due to poor prognostic indicators and/or failure to respond to therapy E - Convalescent 5 Enteral fluids include oral and/or nasogastric 6 Method of parenteral fluid administration: IV:Infusion, IV:Bolus, Subcutaneous, Intraosseous EVD CORE CLINICAL DATASET Version 10DEC14 3

4 DAILY MEDICATIONS & BLOOD PRODUCTS: Complete time of administration for all from admission to outcome. YEAR 2017 / / / / / / / 7 Drug 8 /Blood Product: 7 Complete with each of the times (space provided for up to 5 daily) when the named product is given 8 Generic name preferred. EVD CORE CLINICAL DATASET Version 10DEC14 4

5 LABORATORY RESULTS 9 - Complete with all available results ß MOST CRITICAL à YEAR 20 / / / / / / / Sodium/Na meq/l Potassium/K meq/l Blood Urea Nitrogen 3-7mmol/L or 7-21mg/d Creatinine μmol/L or mg/dL Chloride/Cl meq/l Bicarbonate/HCO meq/l Calcium (total)/ca meq/l Glucose 4-6 mmol/l or mg/dl Lactate mmol/l or mg/dl Amylase U/L Bilirubin (total) µmol/L or mg/dL AST/SGOT 8-40 U/L ALT/SGPT 5-21 U/L Albumin g/l Haemoglobin g/L or 12-17g/dL Haematocrit % WBC count x10 9 /L or x10 3 /µl Platelets x10 9 /L or x10 3 /μl D-dimer ng/ml or mcg/ml APTT seconds PT seconds INR Creatine kinase U/L 9 Sample reference ranges are listed. These should be updated according to the available laboratory. EVD CORE CLINICAL DATASET Version 10DEC14 5