MORGAM Manual

Data Transfer Format: Coronary Events Inventory Form: 27 Version: 4 Date: 14.06.2005

© National Institute for Health and Welfare and the MORGAM Project investigators Last updated: 31 October 2007 For more information, please contact Kari Kuulasmaa (firstname.lastname@thl.fi)

The purpose of this transfer format is to provide an exact and common format for the MORGAM Participating Centres (MPCs) to transfer data on the exit from the follow-up for non-fatal coronary events and the number of fatal and non-fatal coronary events in the MORGAM cohorts to the MORGAM Data Centre (MDC). Data in the format specified here should be submitted to the MDC for every member of each MORGAM cohort. The members of the cohort are defined in section Definition and selection of cohorts. The data should be sent through e-mail, not on paper forms.

Contents

• Format specification
• General instructions
• Specific instructions for each item
• Updates

Format specification

General Instructions

The record format is ASCII fixed length and record size is 35 characters. The position of each data item in the record is given in column "COLUMNS" of this data transfer format. There should be one record of data for every member of each MORGAM cohort.

For each member of the cohort, the number of coronary events given in this format should be the same as the number of coronary event records in the Data transfer format: coronary events (Form 22) submitted by the MPC.

This format corresponds with the layout of the information on the electronic data file which is transferred, and need not correspond with the format of locally used paper forms or electronic files. Instructions for transferring the data are given in section Data communication between the Participating Centres and the MDC. To avoid errors, special attention should be paid in extracting these data items from the local data set.

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

Blank fields are not allowed in the record.

Instructions for making corrections to data that have already been sent to the MDC are given in Section Data communication between the Participating Centres and the MDC.

Please contact the MDC for instructions if you cannot provide information as specified in this document or if you have any problems with the interpretation of the coding for any specific items.

Specific instructions for each item

Follow these instructions carefully when creating a computer file for the data transfer from the MPC to the MDC.

Number 27 indicates the "Data transfer format: coronary events inventory".

Enter the version number from the heading of the "Data transfer format: coronary events inventory" which you are using. If the version number of the data transfer format which you are using is not "4", these instructions do not correspond to the format you are using. Check that you are using the valid version of the format.

Items CENTRE...SERIAL

These are key items used for merging the different records of the same individual. Please make sure that the codes are identical with those used for the same person in the "Data transfer format: MONICA survey data".

Code 88 (irrelevant). The purpose of this item is to reserve fixed columns for the key items in all data transfer formats. This is a key item in the event data formats, but irrelevant for the other data transfer formats.

The first two columns are for the month; code 01 - 12, or code 99 if the month is not known. Enter the year of birth, in full four characters, in the last four columns. If the year of birth is not known, which should be very rare, derive the year of birth from an estimate of the age.

This item is the same as item MBIRTH of the "Data transfer format: MONICA survey data", and it will be used for double checking the key items. If you compile the data for this record from various sources, please extract the data for this item from a different source than for the MONICA survey record.

This item is the same as item SEX of the "Data transfer format: MONICA survey data", and it will be used for double checking the key items. If you compile the data for this record from various sources, please extract the data for this item from a different source than for the MONICA survey record.

Items EXDATEC...EXREASC: Data on exit from the follow-up for non-fatal coronary events

The date and reason of exit from the mortality follow-up was given in items EXDATE and EXREAS of the Data transfer format: follow-up data.

The purpose of items EXDATEC and EXREASC is to provide the person's exit date from the follow-up of non-fatal coronary events and the reason for the exit in the case where the date is earlier than from the mortality follow-up. Examples of such a situation are:

• If the person has moved out from the study area, it may not be possible for him or her to come to the follow-up examinations, but if he or she dies, the MPC will receive the death certificate.
• When the follow-up for non-fatal events is based on specific event registration (such as MONICA registration), which ended earlier than the follow-up for fatal events, then EXDATEC should give the exit date from the follow-up of non-fatal events.

Note, however, that the date of a non-fatal event should not be coded for EXDATEC even if recurrent non-fatal events were not followed up. In such situations the end of follow-up for the data analysis will depend on the exact definition used for the end-point event, and will be taken from the date of the event.

Enter the exact date of exit from the follow-up for non-fatal events. The first two columns are for the day; code 01 -31 for specific dates. The next two columns are for the month; code 01 - 12. The last four columns are for the year.

If the exact date is not known, use the best available circumstantial evidence to estimate the exact date. If the person was lost to follow-up, and there is no other evidence, use the mid point between the day when the person was last known to be under follow-up for non-fatal events and the date when the loss to follow-up was observed.

If the exit date for non-fatal events was the same as for fatal events, code the same date for EXDATE and EXDATEC. This also applies to the situations where a non-fatal event occurs during follow-up and recurrent non-fatal events are not followed up, but the person would be under follow-up if the event had not occurred (see above).

If there is an upper age limit for the follow-up of non-fatal coronary events, and the person's age was above the limit already at the baseline examination, then code 77777777. This code applies to some of the MORGAM cohorts only.

If non-fatal coronary events are not followed at all in the cohort, then code 88888888. Note however, that if 88888888 is used for some member of the cohort, it should be used for all members of the cohort. If the subjects are generally followed up for non-fatal coronary events, but some individuals were not (e.g. because of refusal), then code the same date for EXDATEC and item DEXAM of the MONICA Survey Data.

If the date of exit for non-fatal events is different from the date of exit for fatal events, code here the reason for the earlier exit. Remember, however, that all reasonable effort should be made to keep the number of subjects lost to follow-up as small as possible.

Code 1 if the MPC ended the follow-up of the cohort for non-fatal events earlier than for deaths, and the person reached the end of the period. In such a case no EXDATEC in the cohort should be later than the end of the follow-up period for non-fatal events.
Code 2 if the subject is known to have moved to such a place that he or she cannot be followed up for non-fatal events.
Code 3 if the the person has refused to participate in the follow-up for non-fatal events.
Code 4 if the reason is different from those described using codes 1, 2 and 3. For example, if the follow-up carried out up to specific age only and the person reaches that age, then use code 4.
Code 8 if EXDATEC = EXDATE or 77777777 or 88888888.

Items COREV: Number of coronary events recorded

Enter the total number of fatal and non-fatal coronary events as specified below. The number should be the same as the number of coronary event records (Form 22) submitted for the person.

Code 00 if there are no events during the follow-up period.

A separate record in the "Data transfer format - coronary events" should be sent to the MDC for:

• Acute coronary events:
  • a death during the follow-up period which either
    • has a CHD code in the death certificate or final death diagnoses. This includes ICD-8 and 9 codes 410-414 and ICD-10 codes I20-I25, or
    • has a code of sudden or unattended death or cardiac arrest as an underlying cause of death in the death certificate or final death diagnoses. This includes ICD-8 code 795, ICD-9 code 798 and ICD-10 codes I46, R96, R98 and R99.
    • would lead to MORGAM diagnostic category of AMI or coronary death (i.e. DGNCAT = 1, 2, 3 or 5 in Form 22).
  • non-fatal coronary events. The recording of non-fatal coronary events is optional, but recommended. If the MPC decides to send to the MDC data on non-fatal coronary events, the extent to which it is being done will have to be agreed with the MDC before or at the time of the data transfer. Alternative schemes providing data on non-fatal events include:
    • person's first non-fatal definite AMIs (i.e. DGNCAT=1 in Form 22) during the follow-up period.
    • person's first and recurrent non-fatal definite AMIs.
    • person's first non-fatal definite and possible AMIs (i.e. DGNCAT=1, 2 or 3 in Form 22).
    • person's first and recurrent non-fatal definite and possible AMIs.

    In addition to these, the MPC may wish to provide data on:

    • person's first diagnosis of unstable angina pectoris (i.e. DGNCAT=4 in Form 22), provided that it was not preceded by a definite or possible AMI.
    • person's first unclassifiable coronary event (i.e. DGNCAT=5 in Form 22), provided that it was not preceded by a definite or possible AMI.
    • person's first silent myocardial infarction (i.e. DGNCAT=6 in Form 22), provided that it was not preceded by a definite or possible AMI.
    • first cardiac revascularization (or, alternatively, on first and recurrent cardiac revascularizations)

    In addition, the cohorts which take part in the genetic substudy, also have the option to provide data on

    • person's first recorded angina pectoris, provided that it was not preceded by an acute coronary event or a cardiac revascularization. It is hoped that the follow-up for this end-point also covers angina pectoris which was diagnosed outside hospital, but if the MPC can follow-up only for hospitalized cases, also such data will be useful.

All acute coronary events following an acute coronary event within 28 days should be considered as the same event, and therefore only one event record should be submitted for them.

Updates