MONICA Manual, Part IV, Section 1

	Event Registration Data CORE DATA TRANSFER FORMAT - ACUTE CORONARY CARE Form: 02 Version: 6          30.11.89

Instructions

The purpose of this record format is to provide an exact and common format for MONICA Collaborating Centres (MCCs) to transfer the Core Data on acute coronary care to the MONICA Data Centre (MDC). The data should be sent on magnetic tapes, not on paper forms. This format therefore corresponds with the layout of the information on magnetic tape and need not correspond with the format of locally used paper forms, although the information available on the latter has to be convertible to the former. Instructions for data transfer on magnetic tapes are given in Part V, Section 1: Data Transfer to the MONICA Data Centre. To avoid errors, special attention should be paid in extracting these data items from the local data set.

General instructions

The ITEM NAME on the document is a computer variable name used for the item by the MDC.

The COLUMNS indicate the columns in which the code for the item is to appear in the record on the magnetic tape. Data for different events must be written on different records. It is recommended that the MONICA Collaborating Centres (MCCs) use records long enough to include all the acute coronary care data for an event.

Blank fields are not allowed in the magnetic tape record.

Instructions for making corrections to data that have already been sent to the MDC are given in Part V, Section 1: Data Transfer to the MONICA Data Centre.

Please contact the MDC for instructions if you cannot provide information as specified in this document, and contact the MONICA Quality Control Centre for Event Registration in Dundee if you are experiencing any problems with interpreting the coding of specific items.

Specific instructions for each item

Follow these instructions carefully when creating a computer file for transfer from the MONICA Collaborating Centre (MCC) to the MONICA Data Centre. Please ensure that the instructions are for the version of the Core Data Transfer Format that is being used. Specific instructions are listed by item below.

Item 1

Enter 02 to indicate CORE DATA TRANSFER FORMAT, ACUTE CORONARY CARE

Item 2

Enter the version number that is being used by your MONICA Collaborating Centre. If the number is not 6, these instructions do not correspond to the format you are using. Check that you are using the valid version.

Item 3

Enter the official MONICA Collaborating Centre code number as it appears in Part I, Appendix 2: MONICA Collaborating Centres and Reporting Units. If your centre is not listed, or is erroneously listed in this appendix, contact the MDC for instructions.

Item 4

Enter the official MONICA Reporting Unit Code Number as it appears in Part I, Appendix 2. Even if your centre has only one population, enter the appropriate code number here.

Item 5

Enter the 7-digit serial number of the event for which the record had been completed. Each serial number issued must be unique within each MONICA Reporting Unit and within each register (stroke register or coronary event register). Different MONICA Reporting Units and different registers may use the same serial numbers. However, the serial numbers within a Reporting Unit and register must be different for each calendar year of event registration. Check that the serial number being entered is correct.

Note especially that the serial number allocated for an acute coronary care transfer record must be the same serial number as that allocated for a coronary event transfer record, and the two records must refer to the same event in the same individual. It is therefore ESSENTIAL that MONICA Collaborating Centres have systems for checking that the serial numbers are correct.

Item 6

Enter the exact date of birth. If the day and or the month are not known, enter 99s. If the year of birth is not known, use an estimate of the age to derive a year of birth and code that. Records with the year of birth entered as 99 (not known) are not acceptable as they cannot be allocated to an age group for analysis.

Item 7

Onset is the onset of the acute symptoms of the coronary event (or, in their absence, the fatal collapse of the person). Where the patient has vague or intermittent symptoms followed by prolonged more severe symptoms, followed by a call for medical help, the time of onset will be the time of onset of the prolonged symptoms. Where several attacks of symptoms occur and each of these attacks could qualify as a possible onset, the onset should be timed from the onset of the first typical event of chest pain lasting more than 20 minutes. Where the patient has vague or intermittent or otherwise atypical symptoms before calling medical help, and then has typical symptoms after being seen, then the time of the onset should be that of the symptoms that led to a medical consultation. Where there is a vague onset and a slow increase in severity of symptoms over several days, that is a crescendo onset, then it will not be possible to time the onset accurately.

Medical presence is the time at which skilled medical care for the patient first becomes available, either in the form of a medical practitioner, or a specially trained and equipped team of paramedics, police, firemen, etc. able to treat cardiac arrest.

In the absence of medical or paramedic presence outside hospital, arrival at hospital counts as the time of medical presence. Estimate the time delay using circumstantial evidence if necessary. An estimate should be preferred to coding 9 (insufficient data).

Time delay until a doctor or resuscitation team is present should be recorded even if, when they arrive, they decide that the subject is dead and no medical intervention should be made. (Such cases would be coded as medically unattended under item 10, MANAGE, of the coronary event record). However, if the call for medical help is not for possible treatment or resuscitation, but simply to certify death, and the event is therefore not treated as a medical emergency, then the time interval should be coded as 8 - not relevant. If in doubt as to whether to code the time interval or not, code it.

Note that medical presence is not identical to item 9 INITC (initial care) as external cardiac massage given by a trained layperson or ambulanceperson would qualify for item 9 but not for item 7.

Item 8

Accurate time delay between onset of symptoms and medical presence, if known. This is expressed in hours and minutes. A coronary event must be detected within 28 days of the onset of symptoms and the time delay therefore must be less than 672 hours! If there was a crescendo or indeterminate onset, or if the data are otherwise insufficient, code 999 99. Code 888 88 if the code item TIME was 8.

Item 9

Code 1 for bystanders who have been trained in resuscitation techniques and who have carried out cardiopulmonary resuscitation on the victim. Bystander would include nurses etc. who happened to be present. Do not code 1 for untrained bystanders, such as relatives or friends who offer advice or treatment.

Code 2 for a doctor practising in the community who is called to the patient for that reason, whether or not the patient was previously registered as a patient with that doctor.

Code 3 for specially trained paramedics or a medical team, in either case specially trained and deployed to give cardiopulmonary resuscitation if needed. Routine ambulances do not qualify unless attendants have been specially trained for this task, including the use of defibrillators.

Code 4 for any sort of hospital.

Code 5 for bystander, and/or medical practitioner followed by medical team.

Code 6 for routine ambulance with no special facilities for cardiac resuscitation such as a defibrillator.

Code 8 for not relevant. This option should be used only where emergency or medical services were not involved at all. (For example if a body is found and death is confirmed later by medico-legal mechanisms without any "care" of the victim.) Such a case would have to be medically unattended (code 4 in item 10 MANAGE in the coronary event record).

Code 9 for insufficient data.

Item 10

Code 1 (yes) if the patient collapsed apparently lifeless, or is found dead outside hospital, or if the first medical record on arrival at hospital shows that the patient was in cardiac arrest on arrival. Cardiac arrest does not have to be witnessed or confirmed by electrocardiographic evidence.

Code 2 (no) if the heart did not stop before reaching hospital.

Code 8 (not relevant) if the onset occurred in hospital.

Code 9 (insufficient data) if evidence is insufficient to answer otherwise.

Item 11

Code 1 (yes) for any known attempt that includes external cardiac massage and artificial respiration by any person or persons. It does not need to be successful. Use code 1 only if the code for item 10 was 1.

Code 2 (no) for cases in which cardiac arrest occurred outside hospital but no attempt was made at resuscitation.

Code 8 (not relevant) for cases in which no cardiac arrest occurred outside hospital or the onset of the attack occurred in hospital.

Code 9 for insufficient data.

Item 12

Code 1 (yes) for cases in which resuscitation was initiated before transport to hospital and continued after arrival, and for those in which it was started on arrival, the patient having been brought in in a state of cardiac arrest.

Code 2 (no) if resuscitation was stopped immediately on arrival at hospital or never started despite patient being in cardiac arrest on arrival.

Code 8 (not relevant) if there was no cardiac arrest outside hospital, or if the patient was never brought to hospital, or if the onset of the attack occurred when the patient was already in hospital.

Code 9 for insufficient data.

Item 13

Code 1 (yes) if the patient collapsed apparently lifeless, or is found dead in hospital, but the collapse must have occurred after arrival in hospital. It is not possible to distinguish cardiac arrest from death, nor does the cardiac arrest have to be witnessed, and electrocardiographic confirmation is not necessary. If bystanders thought that cardiac arrest had occurred and the medical attendants subsequently doubted it, the judgement of the witnesses at the time of the episode should take precedence, unless there is clear evidence to the contrary (such as patient conscious and ECG monitor lead detached). In hospital means after being admitted to hospital or taken into the emergency room. Cardiac arrest occurring on the way to hospital, in the ambulance or in the street would not qualify even if the patient was still in cardiac arrest on arrival at hospital.

Code 2 (no) if the heart did not stop in hospital.

Code 8 (not relevant) for cases not taken to hospital, or for those already in cardiac arrest or dead on arrival at hospital.

Code 9 (insufficient data) if there is not enough data to code 1,2 or 8.

Item 14

Code 1 (yes) for external cardiac massage and/or electrical defibrillation carried out by nurses or doctors in hospital. It does not need to be successful.

Code 2 (no) if cardiac arrest or death occurred without any attempted resuscitation.

Code 8 (not relevant) if no cardiac arrest occurred in hospital or the patient was never in hospital during the event.

Code 9 (insufficient data) if there is insufficient information to code 1,2 or 8.

Item 15

This is the first RECORDED blood pressure in the available records and so blood pressure MEASURED but not recorded is not coded here.

Code 000 if the subject was in cardiac arrest, dead, or pulseless when first seen by someone who could have recorded the blood pressure.

Code systolic blood pressure recordings between 30 and 270mm Hg as recorded.

Code 888 if the records have been obtained and no blood pressure was recorded.

Code 999 if it has not been possible to obtain the records to see what was recorded.

Item 16

Code 000 if the subject is first seen in cardiac arrest or dead and never recovers.

Code the maximum pulse rate per minute of 30 - 300 as recorded during the first 24 hours of medical care. If only one rate is recorded, use that. If there are no pulse readings available, heart rate can be obtained from the electrocardiograms.

Code 888 if records have been obtained and there is no record of a pulse rate on them nor an electrocardiogram.

Code 999 if it has not been possible to obtain the records.

Item 17

Code 1 if 9-2 is present in any one graph in any one lead group.

Code 2 if graphs are available and codable and there are no 9-2 codes.

Code 8 if no ECGs were recorded during the attack, or they were all uncodable.

Code 9 if graphs were recorded but are not available.

See Paragraph 2.4 of this Section (Manual IV:1:2.4) for Electrocardiographic criteria.

Item 18

Code 1 if Minnesota codes 4-1 or 4-2 are present in any one graph in any one lead group.

Code 2 if graphs are available and codable and there are no 4-1 or 4-2 codes.

Code 8 if no ECGs were recorded in the attack, or they were all uncodable for this item.

Code 9 if graphs were recorded but are not available.

Item 19

Code 1 if criteria for "development of Q-waves" are satisfied according to protocol criteria (see Section 2.4).

Code 2 if graphs are available and codable and these criteria are not satisfied.

Code 8 if no ECGs were recorded in the attack or they were all uncodable.

Code 9 if graphs were recorded but not available.

Item 20

Code 1 if the ECG changes that led to the coding of the episode were in the anterior lead group (leads V1-V5).

This means that static evidence of old anterior infarction does not qualify. There has to be evidence of electrocardiograpic progression within the anterior lead group, and this must be as severe or more severe than any electrocardiographic progression in other lead groups.

These criteria are met by any of the following: (see Manual IV:1:2.4)

1. if the answer to 19, ECGEVO is yes, and the criteria were met within the anterior lead group. This means that there is either a progression from no Q to an unequivocal Q within the anterior lead group, or a lesser Q progression (no Q to equivocal Q or equivocal Q to unequivocal Q), plus any necessary 4,5 or 9 code progression to satisfy MONICA criteria; both progressions occurring within the anterior lead group.
2. if the criteria for evolution of an injury current are met within this lead group, so that both the sustained 9-2 codes and the T-wave progression occur within the anterior lead group (MONICA ECG code 1.8 - see Manual IV:1:2.4).
3. if the criteria for probable ECG progression are met within the leads V1-V5, (MONICA ECG code 2.1-2.3) in the absence of criteria for definite electrocardiographic progression in either the anterior or other lead groups.

Code 2 if the graphs are available and codable and these criteria are not met.

Code 8 if no ECGs were recorded in the attack, or they were all uncodable.

Code 9 if graphs were recorded but are not available.

Items 21-23

What was the maximum enzyme level as a percentage of the high normal value?

Code the maximum value of each cardiac enzyme as a percentage of the upper limit of normal for that enzyme for that particular laboratory. Code percentages for all events, also for those with non-specific elevation in enzymes.

Code 8888 if such tests were not done.

Code 9999 if tests were done but results are not available.

Item 21

Code the percentage value, as recorded.

Code 8888 if creatinine phosphokinase test not done.

Code 9999 if there is insufficient data to know if tests done or results not available.

Different isoenzymes of this enzyme may all be used. Use the most abnormal.

Item 22

Code the percentage value, as recorded.

Code 8888 if aspartate transaminase test not done.

Code 9999 if there is insufficient data to know if tests done or results not available

Item 23

Code the percentage value, as recorded

Code 8888 if hydroxybutyric dehydrogenase test not done

Code 9999 if there is insufficient data to know if tests done or results not available

Different isoenzymes of this enzyme may all be used, such as lactate dehydrogenase.

Item 24

Code 1 for any sort of tobacco smoking on a regular basis within 3 months of the onset of the attack.

Item 25

Coronary (cardiac) care and intensive care areas should be defined locally in terms reflecting the concept of a ward or part of a ward specially designated for the purpose of acute cardiac or cardiorespiratory care, including the provision of ECG monitors with oscilloscopes and alarms, and the constant presence of staff trained in the detection and treatment of arrhythmias.

Code 8 for a medically unattended death.

Item 26

The duration of stay in a special treatment area should be recorded in calendar days, obtained most easily by subtracting the date of admission from the date of transfer. Patients who die in the unit or are transferred out on the date of admission therefore have the length of stay in the unit recorded as 00 days. They are distinguished from patients who were not admitted at all (coded 2 item 25) as these are coded as 88 not relevant. Code 99 is reserved for patients who were admitted but the duration is not known, and for those in which item 25 was coded as not known. Code the total length of stay for patients admitted, transferred out and then readmitted to the CCU.

Items 27 to 78 (excluding 43, 44 and 77)

DRUGS AND PROCEDURES

FOR ITEMS 27-78 (excluding 43, 44 and 77)

1 = yes

2 = no

8 = not relevant (cannot be used in items 27-42)

9 = insufficient data

N.B. Note special coding rules for 52, 53, 61, 62 and 76.

The following items concern drug therapy and procedures: before the onset of the event that is being coded; during the event (that is from the time of onset until discharge from hospital, or 28 days); and post-event, that is at discharge or on mobilization of the patient after the period of acute therapy of the attack.

Each centre should prepare a list of drugs used locally which fall into each of the following drug categories. If a drug potentially falls into two different classes it should be coded into only one category so that it does not appear twice. However, a compound formulation that contains two drugs may be entered into two drug classes. The list annexed to this Section gives the official names of drugs in different MONICA classes. Local coders should be provided with a similar list giving local names. In this list drugs have been allocated to their most specific category. For example, drugs are coded as calcium blockers, beta blockers, or inotropic drugs rather than antiarrhythmic drugs, and as diuretics rather than other antihypertensive drugs.

Items previously left as 8s and named FINT*1-4 in previous versions of this transfer format are now being used. Only FINTD3, FINTD4 and FINTP3 remain unchanged.

The drug categories and procedures are given a suffix, explained here:

..B before the onset of the event.

Code 1 (yes) for medication and pacing before onset. This means that the patient was believed to be on this treatment at the time of the onset of the coronary event or within 28 days beforehand. Information on medication more than 28 days before the event which has been discontinued is not of interest. For procedures such as coronary artery angiography, angioplasty and bypass surgery, any time previous to the onset will qualify and this information should be available from the medical history.

Code 2 (no) if the patient was not on this treatment within 28 days before onset of the event, or there is no record of this procedure in the medical history. Absence of a history of medication or of the interventions in a written medical history should be taken as evidence that the answer is no.

Code 9 if there is insufficient data to know whether these treatments or procedures had been used on this patient prior to the event.

..D during the event, that is, after the onset and before discharge from hospital. To prevent difficulties in follow up of subjects beyond the 28-day obligatory period, if this precedes discharge from hospital, the 28-day point can be used as the period of assessment of these treatments and procedures rather than the time of discharge from hospital, provided that the rules are kept consistent over time, and agree with those for coding drugs and procedures at mobilization and discharge (see later). Each MCC will need to decide whether to use 28 days or discharge from hospital as the division between these two groups of drugs and treatments. (Survival however must be assessed at 28 days, that is item 11 of the coronary event record).

Code 1 (yes) for any drug or procedure used between the onset of acute symptoms and the time at which convalescent or discharge therapy was started. Use emergency medical service or general practitioner records for the period outside hospital and the hospital drug records for the period of hospitalization. Code a drug even if it was used only once, and whether it was given by mouth or by injection. (MCCs will need to establish local coding rules as to whether the basis for coding during the event should be doctors prescriptions of what was ordered, or nursing records of what was given, as occasionally drugs will be written up but not administered.)

Code 2 (no) if there was no evidence that this drug or procedure was used.

Code 8 (not relevant) for the unallocated columns 61-62 and also for any patients who were found dead at the onset of the event, and who had no treatment or intervention in the event for that reason.

Code 9 (insufficient data) for patients for whom there are no records available from which therapy or interventions can be discovered, and there may have been drugs and interventions administered. If a patient was found in circumstances in which medication and procedures could not have been used, then it is reasonable to code 2 (no) rather than 9 (insufficient data).

..P post-episode (on discharge from hospital, at mobilization or at 28 days depending on local rules). Drugs and procedures prescribed for the post-acute, convalescent phase of management of the episode. If records are being examined after discharge from hospital, the medication and treatment prescribed for the patient to take away with him (home or to convalescence) should be coded. MCCs that normally register patients while they are still in hospital should formulate rules for following convalescent treatment.

Special rules will be needed also for a patient still in hospital at 28 days, as this is the limit of the obligatory period of follow-up.

Code 1 (yes) for drugs and treatments prescribed on discharge or mobilization.

Code 2 (no) if there is no evidence that the drug or treatment was prescribed.

Code 8 (not relevant) for unallocated columns and for patients who died during the acute phase of treatment (that is before discharge or mobilization or 28 days).

Code 9 (insufficient data) for patients for whom no record of treatment on discharge is available and there is reason to believe that such treatment may have been prescribed.

Item 27

Item 28

Item 29

Item 30

Item 31

Item 32

Item 33

Item 34

Item 35

Item 36

Item 37

Item 38

Item 39

Item 40

Item 41

Item 42

Item 43-44

(This is a new item for version 4 of this format)

The duration of stay in hospital should be recorded in calendar days, obtained most easily by subtracting the date of admission from the date of discharge. Length of stay refers to the acute hospital only and not to transfer to a convalescent home or spa, but local rules should be laid down for ambiguous situations. Patients who die on the day of admission should have length of stay recorded as 00 days. Those who are not admitted to hospital at all are coded as 88 (not relevant). Code 99 is reserved for those patients who were admitted but the duration is not known, and for those whose admission status was not known. Note the length of hospital stay included admission to the coronary care unit and should therefore exceed or equal the total entered under CSTAY - it cannot be less.

For onset in hospital, use the date of onset - not the date of admission.

Item 45

Item 46

Item 47

Item 48

Item 49

Item 50

Item 51

Item 52

Item 53

Item 54

Item 55

Item 56

Item 57

Item 58

Item 59

Item 60

Item 61

Code = 8

Item 62

Code = 8

Item 63

Item 64

Item 65

Item 66

Item 67

Item 68

Item 69

Item 70

Item 71

Item 72

Item 73

Item 74

Item 75

Item 76

Code = 8

Item 77

Do not use code 1 if the patient died in ambulance.

Item 78

Item 78 must be defined locally but it implies a structured programme of graded exercises coupled with attention to coronary risk factors such as obesity, smoking, diet, etc.