ALLC 1992 - childhood acute lymphoblastic
leukaemia - data structure and protocols
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ALLC
1992 data preparation: brief written protocol
Strict confidentiality of trial results is
observed. Information is held in the Clinical Trial Service Unit computers
in a form which can be accessed only by known individuals.
All patient records are converted into
'pink form' (1992) format (described below) if not already supplied in
it. Results received as tables are converted into sets of synthetic 'pink
form' records. The following routine checks (where appropriate) are performed
on every 'pink form' compilation:
-
Duplicate patient entries
-
Patient identifier missing
-
Gender missing
-
Birth date missing
-
Initial w.b.c. missing
-
Diagnosis date missing
-
Randomisation date missing
-
Treatment allocation missing
-
First complete remission date missing
-
First event type missing
-
First event date missing
-
Survival status missing
-
Death date missing
-
Birth date wrong or out of range
-
Diagnosis date wrong or out of range
-
either Diagnosis date after, or more
than 1y before randomisation date
-
or Diagnosis date before, or more than
1y after randomisation date
-
Randomisation date wrong, before 1945 or out
of range
-
First complete remission date wrong or out
of range
-
First complete remission date more than 1y
after diagnosis date
-
First event date wrong or out of range
-
Last follow-up or death date wrong or out
of range
-
Gender code unknown
-
Randomisation age over 25
-
Initial w.b.c. out of range
-
Treatment allocation code unknown
-
First event type code unknown
-
Testicular relapse reported in female patient
-
Survival status code unknown
-
Cause of death given when alive
-
'Remission death' specified with non-'dead'
status
-
Two different death dates given
The total numbers of patients and the distributions
of randomisation age, gender, initial leukocyte count (w.b.c.) and first
event types are checked for any significant imbalance between treatment
groups. These four distributions are compared as follows. Patients are
grouped into five categories according to randomisation age (0 - 2 years;
3 - 14 years; 15 - 19 years; 20 - 99 years; unknown) and a chi-squared
test is applied to the population of the four categories found in each
treatment group. Similarly, three categories are formed for gender (male;
female; unknown), five for w.b.c. (0·0 - 0·9; 1·0
- 9·9; 10·0 - 99·9; 100·0 + x 109
per litre; unknown) and seven for first event types (death in remission;
haematological relapse; central nervous system relapse; testicular relapse;
other relapse, multiple relapse; unknown) and these are tested in the same
way as the categories formed for randomisation ages.
If an event such as relapse 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, time elapsed since last follow-up
and log w.b.c. 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 subsequent recorded event. Finally, the distribution of time
elapsed since randomisation is checked in the same two ways for any significant
imbalance between patients in the two categories of known gender, the four
categories of age and the four categories of known w.b.c.
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 patients 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.
Contact
Please address inquiries concerning data preparation
and checking to:
Vaughan Evans
Childhood A.L.L. Workshop Secretariat
C.T.S.U.
Radcliffe Infirmary
Oxford OX2 6HE
England
Tel. U.K.(44)-Oxford(1865)-557241; FAX: U.K.(44)-Oxford(1865)-558817
Specification
of ALLC 1992 'pink form' format
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 |
2 |
Gender |
I1 |
21 |
Value |
Description |
Abbreviation |
1 |
Male |
M |
2 |
Female |
F |
|
Sex |
3 |
Date of birth |
I6 |
23 - 28 |
DDMMYY |
Birth Date |
4 |
Initial w.b.c. |
I5 |
30 - 34 |
Value |
Description |
Abbreviation |
x 108 / litre |
|
|
-1 |
Unknown |
|
|
Init. w.b.c. |
5 |
Diagnosis date |
I6 |
36 - 41 |
DDMMYY |
1-Trt. Date |
6 |
Date of first remission |
I6 |
43 - 48 |
Value |
Description |
Abbreviation |
DDMMYY |
|
|
-1 |
Definitely no CR |
|
-2 |
CR on unknown date |
|
|
1st CR Date |
7 |
Randomisation date |
I6 |
50 - 55 |
DDMMYY |
Randn. Date |
8 |
Treatment group allocated (as on master
list) |
I1 |
57 |
|
Trt. Grp |
9 |
Type of first event |
A3 |
59 - 61 |
Value |
Description |
Abbreviation |
D |
Death in remission |
D |
H |
Haematological relapse |
H |
C |
C.N.S. relapse |
C |
T |
Testicular relapse |
T |
O |
Other relapse |
O |
|
Multiple |
|
|
1st Event |
10 |
Date of first event |
I6 |
63 - 68 |
DDMMYY |
Event Date |
11 |
State when last traced |
I1 |
70 |
Value |
Description |
Abbreviation |
1 |
Alive |
Alive |
2 |
Dead |
Dead |
3 |
Lost |
Lost |
|
State |
12 |
Date died or last traced |
I6 |
72 - 77 |
DDMMYY |
L.F.U. |
13 |
Cause of death (extra category) |
I2 |
78 - 79 |
Value |
Description |
Abbreviation |
1 |
Iatrogenic |
Iatro |
2 |
Infective |
Infec |
3 |
Non-A.L. leukaemia |
OLeuk |
4 |
Second neoplasm |
Neop2 |
5 |
Heart |
Heart |
6 |
Thrombotic or embolic |
ThEmb |
7 |
Other vascular |
OVasc |
8 |
Extraneous cause |
Extra |
9 |
Not 1 - 8 and not A.L.L. |
NotAL |
10 |
Not A.L.L. |
NotAL |
11 |
A.L.L. |
ALL |
12 |
Unascertainable cause |
Unkn. |
13 |
Haemorrhage |
Haem |
14 |
Hypoplasia |
Hypo |
15 |
Pneumonitis |
Pnmit |
16 |
Effusion |
Effu |
17 |
Pneumonia |
Pneum |
18 |
Cytomegalovirus infection |
CMV |
19 |
Adenoviral sepsis |
ADVs |
20 |
Kidney failure |
KidnF |
21 |
Pancreatitis |
Pancr |
22 |
Meningitis |
Menin |
23 |
Acute myeloid leukaemia |
AML |
24 |
Sepsis |
Sepsi |
25 |
Encephalitis |
Encts |
26 |
Hepatitis |
Hepat |
27 |
Enterocolitis |
Entco |
28 |
VAHS |
VAHS |
29 |
Liver failure |
LivFa |
30 |
Encephalopathy |
Encpy |
31 |
Ataxia telangiectasia |
AtaxT |
32 |
Ascites |
Ascite |
33 |
Perforation of colon |
PerfC |
|
Death |
14 |
Name (if given), cause of death and comments |
A |
81 - end |
|
Name |
Missing or unknown items are left blank or
set to zero.
ALLC
1992 data form rubric
GUARANTEE OF CONFIDENTIALITY OF DATA
ANY INFORMATION PROVIDED TO THE CHILDHOOD
A.L.L. WORKSHOP SECRETARIAT WILL BE HELD SECURELY AND IN STRICT CONFIDENCE.
NOTES ON FORMAT OF DATA REQUESTED OVERLEAF
Special coding conventions
Please accompany these forms by an explanatory
letter about any special coding conventions (e.g. on site of first
recurrence, cause of death) you have used, plus notes on any special features
of the study(s) to which you wish to draw particular attention.
Dates that are not (or not yet) known exactly
either leave DAY blank, and give
(approximate or provisional) month and year;
or leave DAY and MONTH blank, and
just give approximate year.
BASELINE DATA
Patient identifier
Any convenient convention you wish, in
case any correspondence becomes necessary. (If reporting several trials,
please try to use a system that implicitly specifies both the trial and
the patient.)
Date of birth
See note above on approximate dates.
Gender
Initial w.b.c:
Initial leucocyte count (units: 109
per litre).
Date of diagnosis
See note above on approximate dates.
Date of 1st randomisation
Date on which the primary treatment was
randomised. Please include ALL patients EVER randomised. Ignore all non-randomised
patients. See note above on approximate dates.
Trt. gp. allocated
Treatment group number at first randomisation:
1 or 2 only, for 2-group trials, or a wider range for trials with more
arms, as defined by you at the top of the form. N.B: even if, in
reality, some quite different (or even opposite!) treatment was inadvertently
given, what is wanted is the originally-allocated treatment. (For
patients erroneously entered more than once, give only the initial allocation.)
FOLLOW-UP DATA
Date of 1st complete remission
Use your own definition of complete remission,
but please give this date even if complete remission was achieved on second-line
or non-protocol treatments. Please leave blank if complete remission was
not achieved. See note above on approximate dates.
Date of 1st recurrence
See note above on approximate dates.
Site of 1st recurrence
Please use your own coding convention
and send it to us; or use D = death in remission; H = haematological relapse;
C = C.N.S. relapse; T = testicular relapse; O = other relapse; HT = combined
haematological and testicular relapse; HTC = combined haematological, testicular
and C.N.S. relapse; etc.
Date died/last traced
Date of death, or date last known to be
alive, as accurately as possible: see note above on approximate dates.
Dead/other
1 = alive when last traced; 2 = known
to be dead.
Death cause (if died in remission)
Please use your own coding convention
and send it to us. Alternatively, please send a separate list giving causes
of death for patients dying in remission, in whatever format is most convenient
for you.
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[End of document, updated to 1 September
2000]