Download How do I complete the DAILY RECORD FORM for SARI?

Guidance for completing the DAILY RECORD FORM for Severe Acute Respiratory Infection
(SARI)
Organisation of CRFs:
The clinical information at admission and during hospitalisation should be recorded in the
Core CRF and the Daily Record Forms. The Data recorded in the Daily Record Forms
supplements the data recorded in the Core CRF and provides greater detail on a day-byday basis. The Supplementary Data Form can be used to record additional information, or
when additional space is required for certain sections of the CRF or Daily Record Form.
How do I complete the DAILY RECORD FORM for SARI?
Unless otherwise instructed, for each day of the patient’s admission to a clinical centre (hospital)
with a suspected/confirmed SARI-causing infection, you should complete an individual Daily Record
Form. Where a patient has a long stay, selected days may be recorded instead, according to a locally
agreed protocol. For example, daily record forms may be completed only for days where biological
samples for research were obtained, if this is agreed by investigators beforehand. Whereas the Core
CRF provides an overview/summary of key findings and events for the entire episode, the Daily
Record Form is designed to provide much greater detail, on a day-by-day basis.
GENERAL GUIDANCE
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One form should be completed for each day that the patient is staying in the clinical centre
(hospital)
Please complete every line of every section
For the purposes of data analysis, it is also important to know when the answer to a
particular question is not known. Therefore, please mark the ‘unknown’ box for a particular
question/section if this is the case. If an ‘unknown’ box is not shown, please see the step-bystep guidance below for further guidance
Some sections have open areas where you can write in additional information. To permit
standardised data entry, please avoid writing additional information outside of these areas
We recommend writing clearly in black or blue ink, using BLOCK-CAPITAL LETTERS
Place a (X) when you choose the corresponding answer and strike through (/////) if you want
to delete this choice. If we want to re-check this answer, make the newly (X) beside and add
your initials to confirm
Please enter the patient identification code (if available) and the date of birth at the bottom
of each and every sheet
Please keep all of the sheets for a single patient together e.g. with a staple or treasury tags,
or in folder that is unique to the patient
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Page 3 (section 5 – pharmacokinetics of antimicrobials/immunomodulatory drugs) need only
be printed off and completed if a relevant pharmacokinetic (PK) study is being undertaken
and samples are being obtained with the intention of contributing to a PK study
DETAILED GUIDANCE ON COMPLETING THE DAILY RECORD FORM
Section 1: Date and Demographics
1.1 Date
Enter the date in the DD/MM/YYYY format i.e. day/month/year for the day of hospital stay for
which this form is being completed. For example, if you are recording data collected on the 1st
June 2013, enter 01/06/2013.
1.2 Study Day
If the patient has been enrolled in a study and this Daily Record Form is being used to collect
data for that study, enter the study day correlating to the date of form completion for this
patient. Alternatively, if this form is being used for a one-off assessment at 3 months from
enrolment, then place a cross (X) in the box marked ‘3 months’, or if is it being used for a one-off
assessment at 6 months, then place a cross in the box marked ‘6 months’.
1.3 Patient identification code
Assign a unique, anonymizing patient identification code to each patient consisting of a 2-didgit
site number (contact the Coordinating Centre to get this number if it is not issues upon
registration with the data management system) and a 3 digit patient number sequentially
assigned at each site starting with 001.
It should look like this: XX-YYY, where XX is the site number and YYY is the patient number.
1.4 Date of Birth
Enter the patient’s date of birth in the DD/MM/YYYY format i.e. day/month/year. For example,
the date of birth of 16th May 1976 should be entered as 16/05/1976. If the complete date of
birth is not known, please enter any information that is available i.e. year only and insert NK/NK
for the day and month components. For example, if it is only known that the patient was born in
1981, enter NK/NK/1981.
1.5 Estimated age
If date of birth is not known, enter the estimated age of the patient in years at the time of
admission to the clinical centre (hospital).
Section 2: Daily Treatment
This section refers to specific levels of care or specific interventions that the patient received on the
day for which data are being collected.
Please provide a response to every question.
2.1
Care on ICU/ITU/IMC/HDU
Please place a cross (X) in the box marked ‘yes’ if the patient received care in an intensive
care unit (ICU), intensive therapy/treatment unit (ITU), intermediate care (IMC) unit or high
dependency unit (HDU) on this particular day. If the patient didn’t receive care in any of
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these units, place a cross in the box marked ‘no’. If is not known whether the patient
received care in one of these units, place a cross in the box marked ‘unknown’.
2.2
Supplemental oxygen?
If supplemental oxygen (at any concentration >21%) was given by any means of delivery on
this particular day, place a cross in the box marked ‘yes’. If supplemental oxygen was not
given, place a cross in the box marked ‘no’. If the answer is not known, place a cross (X) in
the box marked ‘unknown’.
2.5
Non-invasive mechanical ventilation?
If the patient received non-invasive mechanical ventilation (NIV), defined as the provision of
mechanical ventilatory support through the patient's upper airway using a mask or similar
device, on this particular day, place a cross (X) in the box marked ‘yes’. If they did not, place
a cross in the box marked ‘no’. If the answer is not known, place a cross in the box marked
‘unknown’.
Please note that BiPAP and CPAP ventilation modes are not unique to NIV; they can also be
given via invasive mechanical ventilation, so please check.
2.6
Invasive mechanical ventilation?
Invasive ventilation refers to a patient that has undergone tracheal intubation
(entubation) for the purpose of invasive mechanical ventilation. The mode of intubation may
be orotracheal, nasotracheal, or via a cricothyrotomy or tracheotomy. Place a cross (X) in the
relevant box (‘yes’, ‘no’ or ‘unknown’).
2.7
Oscillatory Ventilation?
Oscillatory ventilation refers to high frequency oscillatory ventilation (HFOV). If the patient
received HFOV on this particular day, place a cross (X) in the box marked ‘yes’. If they did
not, place a cross in the box marked ‘no’. If the answer is not known, place a cross in the box
marked ‘unknown’.
2.8
Extracorporeal membrane oxygenation (ECMO) or interventional lung-assist therapy (iLA)?
Extracorporeal membrane oxygenation (ECMO) is an extracorporeal technique of providing
cardiac and respiratory support to a patient, with the ability to oxygenate and remove
carbon dioxide from blood. Interventional lung-assist (iLA) therapy is typically a pump-less
method capable of improving extracorporeal gas exchange with a membrane that is
integrated in a passive arteriovenous shunt. An example device is the Novalung® iLA
membrane ventilator.
If the patient received ECMO on this particular day, place a cross (X) in the box marked
‘ECMO’. If the patient received iLA therapy on this particular day, place a cross in the box
marked ‘iLA’. If the patient did not receive either of these therapies, place a cross in the box
marked ‘none’. If it is not known whether the patient received either of these therapies,
place a cross in the box marked ‘unknown’.
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2.9
Renal replacement therapy (RRT) or dialysis?
Renal replacement therapy includes haemodialysis, peritoneal dialysis, intermittent
haemodialysis (IHD), on-line intermittent haemofiltration (IHF), on-line haemodilfiltration
(IHDF), continuous haemofiltration (CHF) and continuous haemodiafiltration (CHDF),
continuous venovenous haemofiltration (CVVH), continuous venovenous haemodialysis
(CVVHD), continuous venovenous haemodiafiltration (CVVHDF), slow continuous
ultrafiltration (SCUF), continuous arteriovenous haemofiltration (CAVHD) and sustained lowefficiency dialysis (SLED).
If the patient received RRT or dialysis on this particular day, place a cross (X) in the box
marked ‘yes’. If the patient did not receive any RRT or dialysis, place a cross in the box
marked ‘no’. If it is not known whether they received RRT or dialysis, place a cross in the
box marked ‘unknown’.
2.10
Plasmapheresis?
Plasmapheresis (plasma exchange) refers to the extracorporeal separation of blood
components, resulting in a filtered product. Methods include discontinuous flow
centrifugation, continuous flow centrifugation and plasma filtration. If the patient received
plasmapheresis on this particular day, place a cross (X) in the box marked ‘yes’. If they did
not, enter a cross in the box marked ‘no’. If the answer is not known, place a cross in the box
marked ‘unknown’.
2.11
Inotropes/vasopressors?
An inotrope is a pharmaceutical agent that alters the force myocardial contractility.
Commonly used ‘positive’ inotropes include dobutamine, dopamine, adrenaline
(epinephrine) and noradrenaline (norepinephrine).
A vasopressor is a pharmaceutical agent that causes vasoconstriction, thereby increasing
blood pressure. Agents include vasopressin, terlipressin and phenylephrine. Some inotropes
also demonstrate vasopressor activity.
If the patient received an inotrope or vasopressor on this particular day, place a cross (X) in
the box marked ‘yes’. If they did not, place a cross in the box marked ‘no’. If the answer is
not known, place a cross in the box marked ‘unknown’.
2.12
Oral rehydration only?
If the patient did not receive supplemental fluids (colloid solutions and crystalloid solutions)
via intravenous or intraosseous routes on this particular day, place a cross (X) in the box
marked ‘yes’. If they did receive fluid intravenous or intraosseous fluid replacement,
place a cross in the box marked ‘no’. If the answer is not known, place a cross in the box
marked ‘unknown’.
2.13
Intravenous immunoglobulin?
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If the patient received intravenous immunoglobulin (IVIG, human normal immunoglobulin
for intravenous administration) on this particular day, place a cross (X) in the box marked
‘yes’.
Examples of commercial IVIG preparations include Octagam®, Intragam P®, KIOVIG®,
Flebogamma 5% DIF®, Carimune NF®, Gamunex®, Gammagard S/D®, Gammagard Liquid®,
Gammaked® and Privigen®.
2.14
Blood transfusion or products?
If the patient received a transfusion of blood (whole blood or packed red blood cells) or
other blood products excluding human normal immunoglublin (e.g. albumin, granulocytes,
platelets, fresh-frozen plasma (FFP), FP24, PF-24, cryoprecipitate, protein C concentrate,
cryosupernatant, or a specific non-recombinant clotting factor) on this particular day, place a
cross in the box marked ‘yes’. If they did not, place a cross in the box marked ‘no’. If the
answer is not known, place a cross in the box marked ‘unknown’.
2.15
OTHER intervention
Please mention here any other specific therapeutic intervention that the patient received on
this particular day and that you believe may be relevant. Please provide as much detail as
possible, including duration of therapy, where appropriate.
Section 3: Daily Laboratory Results
This section refers only to those laboratory tests on appropriate samples that were obtained on the
day for which data are being recorded. It is expected, but not essential, that most laboratory tests
will have been performed on the same day as the samples were obtained.
Where different units of measurements are provided, please circle the unit of measurement stated
with the patient’s result.
For any individual laboratory test, if the test was not performed then please enter ‘NM’.
If laboratory tests were not performed on this particular day, or if results are not available, please
place a cross (X) in the box marked ‘no laboratory results available’ and move on to section 5.
3.1
Biochemistry & Haematology
Enter the results of biochemistry and haematology laboratory investigations here,
remembering to circle the appropriate unit of measurement after entering the value, where
appropriate. If any individual test was not performed or the result is unavailable, please
enter ‘NM’.
3.2
Haemoglobin (Hb or Hgb) refers to haemoglobin concentration measurement in blood.
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3.3
Platelets refers to the platelet count in blood.
3.4
ALT is alanine transaminase (also called serum glutamic pyruvate transaminase, SGPT).
3.5
AST is aspartate transaminase (also called serum glutamic oxaloacetic transaminase, SGOT).
3.6
Blood urea nitrogen (BUN) is also known as ‘urea’, measured in a blood sample.
3.7
Creatinine refers to serum creatinine.
3.8
Haematocrit (Ht or HCT), also known as packed cell volume (PCV) or erythrocyte volume
fraction (EVF), is the volume percentage (%) of red blood cells in blood.
3.9
APTT is activated partial thromboplastin time, measure in seconds). APTR is the activated
partial thromboplastin ratio. Please enter the value and circle the test used (‘APTT’ or
‘APTR’).
3.10
PT is the prothrombin time. INR is the international normalised ratio. Enter the value and
circle to indicate which test was used (‘PT’ or INR’). If both PT and INR were reported, please
provide the PT result.
3.11
Bilirubin refers to total bilirubin measured in the blood.
3.12
Glucose refers to blood glucose.
3.13
LDH is lactate dehydrogenase, measured in a sample of arterial or venous blood.
3.14
Lactate refers to blood lactate.
3.15
WBC count is the total white blood cell count in blood.
3.16
C-reactive protein (CRP) refers to the blood (serum or plasma) CRP level.
3.17
Erythrocyte Sed Rate is the erythrocyte sedimentation rate (ESR; Biernacki's Reaction). It is
the rate at which red blood cells sediment in a period of one hour, measured in millimetres
per hour and performed under standardised laboratory conditions (e.g. anticoagulated
blood placed in an upright Westergren tube).
3.18
Creatine kinase (CK, or creatine phosphokinase, CPK) refers to total creatine kinase
measured in the blood.
3.19
Blood Gas
This refers to the blood gas analysis that was performed at the time when the patient was
admitted to the clinical centre (hospital). Please remember to circle the appropriate unit of
measurement after entering the value, where appropriate. If any individual test was not
performed or the result is unavailable, please enter ‘NM’.
3.20
Date blood gas performed
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Enter the date when blood gas analysis was performed, in day/month/year format
(DD/MM/YYYY). If blood gas analysis was not performed, place a cross (X) in the box marked
‘blood gas not performed’.
3.21
Sample taken on [room air or supplemental oxygen]
Indicate whether the blood gas sample was performed whilst the patient was receiving
supplemental oxygen, or alternatively, room air, by placing a cross (X) in the appropriate box
(‘room air’ or ‘supplemental O2’). If not known, place a cross in the box marked ‘unknown’.
3.22
If supplemental oxygen was given via an oxygen regulating device (e.g. Venturi mask) at
the time the blood gas was performed, enter the percentage (FiO2) of supplemental oxygen
in the space provided. If a percentage is not known or provided, enter the oxygen flow rate
in litres per minute in the space provided.
3.23
Sample type
Place a cross (X) in the box corresponding to the blood source for the blood gas: ‘arterial’,
‘venous’ or ‘capillary’. If the source of blood is unknown, place a cross in the box marked
‘unknown’.
3.24
PO2 is the partial pressure of oxygen measured in the sample.
3.25
PCO2 is the partial pressure of carbon dioxide measured in the sample.
3.26
pH is the measure of the activity of the (solvated) hydrogen ion (H+) measured in the
sample.
3.27
Base excess refers to standardised base excess (SBE). If standardised base excess is not
reported, enter the base excess value presented.
3.28
HCO3- refers to the bicarbonate measured in the blood gas sample.
3.29
Lactate refers to lactate measured in the blood gas sample.
3.30
Any other significant laboratory results
Enter any other laboratory results from the time of admission that are thought to be
relevant or significant. For each result, state the sample type, date of testing, the name of
test/laboratory parameter, the result and units of measurement (if appropriate). Please use
the Supplementary Data Form if more space is required.
Section 4: Pathogen testing
4.1
Was pathogen testing performed on the date above?
This refers to laboratory assays used to detect all pathogens, where the sample was
collected on the same day for which data are being collected. Detection by polymerase chain
reaction (PCR) testing is a commonly used method. Rapid antigen and serological testing (to detect
antibodies against the pathogen) may also be employed.
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If samples for testing were collected on this particular day, place a cross (X) in the box
marked ‘yes’. If not, place a cross marked ‘no’. If it is not known whether samples were
collected for pathogen testing on this day, place a cross in the box marked ‘unknown’.
4.2
Details of pathogen testing per sample type
If the patient did undergo pathogen detection testing, please complete every row of the
table. Each row corresponds to a different sample type, as indicated in the first column,
‘sample type’. If ‘other’ sample type is selected, please indicate the type of sample. In the
second column (‘pathogen’), please state the name of the pathogen that the test was trying
to detect. In the third column (‘result’), please state whether the named pathogen was
detected (positive) in that sample type or was not detected (negative), by placing a cross (X)
in the appropriate box (‘positive’ or ‘negative’). For each sample type, if testing was not
performed, place a cross in the box marked ‘not done’. In the final column (‘method’), place
a cross in the box marked ‘PCR’ if polymerase chain reaction was used; otherwise, place a
cross in the box marked ‘other’ and write in the method of testing. If the method is not
known, write in ‘unknown’.
Section 5: Pharmacokinetics of antimicrobials/immunomodulatory drugs
This page only needs to be completed if a relevant pharmacokinetic (PK) study is being
undertaken and samples are being obtained on this particular day with the intention that
they will be used in a PK study.
5.1
Drug under study
Enter the name of the drug being studied.
5.2
Start date
Enter the date that the drug being studied was commenced, in DD/MM/YYYY format.
5.3
Precise time of 1st pharmacokinetic blood draw
Enter the precise time (using24-hour clock notation, HH:MM) that the first PK sample was
obtained on this particular day. If not known, enter ‘NK’. If no sample was collected, enter
‘NS’.
5.4
Precise time of 2nd pharmacokinetic blood draw
Enter the precise time (using24-hour clock notation, HH:MM) that the second PK sample was
obtained on this particular day. If not known, enter ‘NK’. If no sample was collected, enter
‘NS’.
5.5
Precise time of 3rd pharmacokinetic blood draw
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Enter the precise time (using24-hour clock notation, HH:MM) that the third PK sample was
obtained on this particular day. If not known, enter ‘NK’. If no sample was collected, enter
‘NS’.
5.6
Prescribed times of administration
Specify the dose regimen for each drug, e.g. once daily, twice daily, hourly, etc.
5.7
Please record all doses of the drug given in the last 24 hours
For the drug (medication) being studied, record the details for each and every
administration within the last 24 hours (00:00h – 23:59h on the day being recorded).
Complete a separate row for each administration within the 24h period.
In the first column (‘dose’), enter the amount as a number and then the units of
measurement for the dose. For example, if the dose is 75 milligrams, enter ‘75’ next to
‘amount’ and ‘MG’ next to ‘units’. In the second column (‘route of administration’), place a
cross (X) in the appropriate box (‘IV’; ‘oral’; ‘inhlaed’; ‘other’). If ‘other’ is selected, state the
route in the space provided. In the third column, enter the precise time the drug was given,
using 24h-clock notation (HH:MM). This is not the time the drug was prescribed or
dispensed; it is the time that the drug actually entered the patient’s body via the
documented route of administration. If the drug was given as an infusion, enter the precise
time the infusion was commenced. If given as an infusion, in the final column enter the
precise time infusion finished, again using 24h-clock notation (HH:MM).
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