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Follow-up process and end-points |
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© National Institute for Health and Welfare
and the MORGAM Project investigators Last updated: 28 September 2006 For more information, please contact Kari.Kuulasmaa (firstname.lastname@thl.fi) |
Each member of the cohort should be followed up for death, and optionally for non-fatal coronary, stroke and thrombo-embolic events. The follow-up of a person continues until the earliest one of the following events occurs:
If an MPC wants to apply any other exit criteria, such as an upper age limit for the follow-up, these should first be agreed with the MDC.
Loss to follow-up should be kept as rare as possible. The date as well as the reason for the exit from the study must be recorded by the MPC for every member of the cohorts.
A non-fatal event is never a reason for exit from the study. However, in some MPCs it may happen that the follow-up for non-fatal events will have to be stopped earlier than the follow-up for fatal events. In such cases, also the earlier date and reason for the exit from the follow-up for non-fatal events must be recorded.
Every MPC must follow-up the cohorts for death. Whenever possible, the final official underlying cause of death should be provided. If this is not available the cause of death should be derived from the latest available source, such as the death certificate. If the death was possibly caused by a coronary event or stroke, it should be validated using the MONICA or other standardized procedure. (However, it is recognized that some centres will not be able to do such validation).
The follow-up for non-fatal coronary events is optional, but recommended. Details of the data requirements on these are described in item COREV of the Data transfer format: coronary events inventory and in the Data transfer format: coronary events. Here is a summary.
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:
In addition to these, the MPCs may wish to provide data on:
Follow-up for these end-points will provide useful information both for the general cohort study in MORGAM and for the genetic substudy.
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.
The follow-up for non-fatal stroke events is optional, but recommended. Details of the data requirements on these are described in item STROKES of the Data transfer format: stroke events inventory and in the Data transfer format: stroke events. If the MPC decides to send data on non-fatal stroke events to the MDC, both first and recurrect events should be included.
The follow-up for non-fatal venous throbmoembolic events is optional for the cohorts which take part in the genetic substudy, and should be done only if the coverage of non-fatal hospitalized events is good. Data on thromboembolic events will not be collected for the cohorts which do not take part in the genetic substudy. Details of the data requirements on the throbmoembolic events are described in item VTEV of the Data transfer format: venous thromboembolic events inventory and in the Data transfer format: venous thromboembolic events.
For every member of the cohort (i.e. for all for whom the baseline data were provided - see Form 20), the MPC should transfer the data specified in
to the MDC. The same concerns the Data transfer format: venous thromboembolic events inventory (Form 29) if the optional thromboembolic events were followed up.
In addition, for every fatal or non-fatal coronary event, stroke, or thromboembolic event, data specified in the respective data transfer format:
should be transferred to the MDC.
Instructions for the transfer of the data are given in section Data communication between the Participating Centres and the MDC.
MPCs, which have already transferred their follow-up data to the MDC, may later be able to extend the follow-up period. They are encouraged to extend the follow-up period and to transfer the additional follow-up data to the MDC. The data requirements are the same as above.
| Date | Update |
|---|---|
| 2006-09-28 | Section "Data requirements" was added. |