All patient records are converted into 'pink form' (2000) format (described below) if not already supplied in it. Results received as tables are converted into sets of synthetic records. The following routine checks (where appropriate) are performed on every compilation:
If an event such as the recurrence of disease is reported at a date later than the quoted last follow-up date, the last follow-up date is automatically changed to the later date. The completeness of follow-up is then calculated for the end of each calendar year. The distributions of randomisation dates, randomisation ages and time elapsed since last follow-up are checked for any significant imbalance between treatment groups in two ways as follows. Firstly, a t-test is applied to the difference between the mean value of each distribution for patients in each group with the corresponding mean for patients in the remainder. Secondly, an F-ratio is calculated for each distribution by comparing the variance between the groups with the variance within the groups. The distribution of time elapsed since last follow-up is also checked in these two ways for any significant imbalance between those patients with and those patients without a recorded recurrence of disease. Finally, the distribution of time elapsed since last follow-up is checked in the same two ways for any significant imbalance between patients in two categories of menopausal status (pre- or perimenopausal; postmenopausal), two categories of axillary nodal status (negative; positive), two categories of oestrogen receptor status (poor; positive) and two categories of progesterone receptor status (poor; positive).
Where patient serial numbers form an obvious sequence it is checked for missing numbers.
A tabulated breakdown of variables is produced for each trial, together (where relevant) with lists of patents in 'problematical' categories such as those with lapsed follow-up, uncertain death cause or second malignancy site. Graphs of accrual date and the proportion of living patients still on follow-up as a function of time from randomisation by treatment allocation are also produced, together with Kaplan-Meier life-table curves. Before trial data are finally incorporated into the overview, the analyses described above are sent to the participating trialist(s) for checking and approval.
Item | Description | FORTRAN | Columns | Details | Abbreviation | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
0 | Trial/stratum identifying code | I6 | 1 - 6 | Trial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1 | Patient identifier (or sequence number) | A12 | 8 - 19 | Patient Identifier | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2 | Randomisation date | I8 | 21 - 28 | DDMMYYYY | Random. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3 | Treatment group allocated (as on master list) | I1 | 30 | Group | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
4 | Randomisation age | I3 | 32 - 34 | years | Age | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
5 | Menopausal status at randomisation | I1 | 36 |
|
Meno | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6 | Surgery: first mastectomy | I2 | 38 - 39 |
|
Surg. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
7 | Axillary status at randomisation | I2 | 41 - 42 |
|
Axilla | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
8 | Oestrogen receptor (ER) coding | I1 | 44 |
|
Units | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
9 | Oestrogen receptor measurement (> 0: as (8)) | I4 | 46 - 49 |
|
ER | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
10 | Progesterone receptor (PR) coding | I1 | 51 |
|
Units | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
11 | Progesterone receptor measurement (> 0: as (10)) | I4 | 53 - 56 |
|
PR | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
12 | Laterality of primary tumour(s) | I1 | 58 |
|
Side | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
13 | Size of primary tumour (> 0: mm) | I3 | 60 - 62 |
|
Size | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
14 | Histological grade of primary tumour | I2 | 63 - 64 |
|
Grade | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
15 | Contralateral | I1 | 66 |
|
Contra. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
16 | Date of contralateral breast cancer | I8 | 68 - 75 | DDMMYYYY | Contra. Date | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
17 | Second malignancy (ICD) | A5 | 77 - 81 | 2Ca. ICD | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
18 | ICD revision for second malignancy | I1 | 82 - 83 | 7-10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
19 | Date of second malignancy | I8 | 85 - 92 | DDMMYYYY | 2Ca. Date | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
20 | No. of additional malignancies | I1 | 94 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
21 | Distant/unknown-site recurrence | I1 | 96 |
|
Distant | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
22 | Date of first distant/unknown-site recurrence | I8 | 98 - 105 | DDMMYYYY | Distant Date | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
23 | Prior local recurrence | I1 | 107 |
|
Local | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
24 | Date of prior local recurrence | I8 | 109 - 116 | DDMMYYYY | Local Date | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
25 | State when last traced | I2 | 118 - 119 |
|
Status | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
26 | Date died or last traced | I8 | 121 - 128 | DDMMYYYY | Status Date | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
27 | ICD revision for death cause | I2 | 130 - 131 | 7-10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
28 | Cause of death (ICD) | A5 | 133 - 137 | ICD | D. ICD | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
29 | Cause of death | I2 | 138 - 139 |
|
"Cause" | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
30 | Name (if given) and comments | A | 141 - end | Extra information |
Value | Description | ICD-7 | ICD-8 | ICD-9 | ICD-10 |
2 | Pneumonia | 490-493 | 480-486 | 480-486 | J12-J18 |
3 | Lymphatic and haematopoietic, non-AML | 200-203
204.0-204.1 205 |
200-204
205.1 206.1 207.1 275.5 |
200-204
205.1 206.1 207.1 208.1 273.3 |
C81-C91
C92.1 C93.1 C94.1 C95.1 C96 |
4 | Other second malignancy, site specified | 140-197
Excluding: 151 153-156 162 (except 162.2) 170 172 174-175 |
140-194
Excluding: 151 153-155 162 174 182-183 |
140-194
Excluding: 151 153-155 162 174 179 182-183 |
C00-C75
C97 Excluding: C16 C18-C22 C33-C34 C50 C54-C57 |
5 | Ischaemic heart disease | 420
422.1 |
410-414 | 410-414 | I20-I25 |
6 | DVT and pulmonary embolism | 463-466
684 |
450-451
453 673 |
415
451 453 673 |
I26
I80 I82 O88.2 |
7 | Cerebrovascular | 330-334 | 430-438 | 430-438 | I60-I69 |
8 | External cause | E800-E999
N800-N999 |
E800-E999
N800-N999 |
800-999
E800-E999 |
S00-Y98 |
9 | Other specified disease | All other ICD codes | All other ICD codes | All other ICD codes | All other ICD codes |
10 | Unknown, but not breast cancer (Note 6) | - | - | - | - |
11 | Breast cancer or its metastases | 170 | 174 | 174 | C50 |
12 | Unascertainable cause | - | - | - | - |
13 | Non-pneumonia respiratory | 470-527
783 Excluding: 490-493 502 527 |
460-519
783 Excluding: 480-486 491-492 |
460-519
786 Excluding: 480-486 491-492 496 |
J00-J99
R04-R09 Excluding: J12-J18 J41-J44 |
14 | Hepatic disease | 092
580-583 |
070
570-573 |
070
570-573 |
B15-B19
K70-K77 |
15 | Infectious/parasitic (excluding viral hepatitis) | 001-138
Excluding: 092 |
000-136
Excluding: 070 |
001-139
279.1 Excluding: 070 |
A00-A99
B00-B99 Excluding: B15-B19 |
16 | Other circulatory | 400-468
782 795.2 Excluding: 420 422.1 434.1-434.2 463-466 |
390-458
782 795 Excluding: 410-414 427.0-427.1 430-438 450-451 453 |
390-459
785 798 Excluding: 410-415 428 430-438 451 453 |
I00-I99
R00-R02 R57 R96 Excluding: I20-I26 I50 I60-I69 I80 I82 |
17 | AML (definite / probable / possible) | 204.2-204.4 | 205-207
Excluding: 205.1 206.1 207.1 |
205-208
Excluding: 205.1 206.1 207.1 208.1 |
C92-C95
Excluding: C92.1 C93.1 C94.1 C95.1 |
18 | Other second malignancy, site unspecified | 156
198-199 |
195-199
Excluding: 197.8 |
195-199 | C76-C80 |
19 | Endometrial cancer | 172 | 182
Excluding: 182.9 |
182 | C54 |
20 | Colorectal cancer | 153-154 | 153-154 | 153-154 | C18-C21 |
21 | Primary liver cancer | 155 | 155 | 155.0-155.1 | C22
Excluding: C22.9 |
22 | Gastric cancer | 151 | 151 | 151 | C16 |
23 | Ovarian cancer | 175 | 183 | 183 | C56-C57 |
24 | Unknown second malignancy, non-breast (Note 6) | - | - | - | - |
25 | Lung cancer | 162
Excluding: 162.2 |
162 | 162 | C33-C34 |
26 | Uterine cancer, part unspecified | 174 | 182.9 | 179 | C55 |
27 | Liver cancer, unspecified | - | 197.8 | 155.2 | C22.9 |
28 | Heart failure | 434.1-434.2 | 427.0-427.1 | 428 | I50 |
29 | Chronic obstructive lung disease | 502
527 |
491-492 | 491-492
496 |
J41-J44 |
1. If a textual description of the cause of death is given, this should be put in the comments field using the (d. ....) convention. If the description includes labels (1a, 1b etc), these should also be entered as they help to determine the underlying cause of death.2. If a patient does not have a 'recurrence' recorded before her death (i.e. she has had neither an isolated local recurrence, nor a distant recurrence or recurrence of unknown site, nor a contralateral breast cancer), the "cause" (item 29) needs to be put into the record. This code should be set to the underlying cause of death using the standard ICD rules for selecting the underlying cause, except that pulmonary embolism should take precedence over the cause of the pulmonary embolism. For deaths after a 'recurrence', the item-29 "cause" does not need to be put into the record.
3. If the trialist supplies a single ICD code for the underlying cause of death, that and the ICD revision should be put into the record (items 28 and 27 respectively). ICD codes are ranged left and omit the point character '.', where relevant. If the trialist has supplied more than one ICD code for a patient's death, and the underlying cause of death is not clear, all the ICD codes should be put into the comments field using the ICDx[xxx,xxx,...] convention.
4. ICD7[199.9], ICD8[199.9], ICD9[199.9] and ICD10[C80.9] are special flags to indicate that the trialist has tried and failed to obtain information on the site of a malignancy.
5. External causes of death should be coded according to the cause rather than the nature of the injury (i.e. E codes in ICD revisions 7-9 and V-Y codes in revision 10), where possible.
6. "Cause" codes 10 and 24 are used to indicate that the trialist has tried and failed to obtain more specific information.
7. "Cause" code 1 (iatrogenic) is no longer used. Such deaths are now coded to their appropriate place according to ICD rules (e.g. in ICD-9, death due to toxicity from antineoplastic drugs is E933.1, death due to acute myeloid leukaemia probably caused by antineoplastic drugs is 205.0 and death due to pulmonary fibrosis that is possible radiation-induced is 515).
[End of document, updated to 1 March 2002]