Box 117 Example coding instructions for an IPD metaanalysis

M eta-Ana lysis of Chemotherapy in Locally Advanced Bladder Cancer

1 male

2 female

9 unknown CLINICAL STAGE T Category

1 T1

2 T2

3 T3

4 T4a

5 T4b 7 other

9 unknown N Category

0 NO

1 N1

2 N2

9 unknown M Category

0 MO

1 M1

9 unknown PATHOLOGICAL STAGE pT Category

Please code as suggested for Clinial Stage

PN Category

Please code as suggested for Clinial Stage pM Category

Please code as suggested for Clinial Stage

Allocated Treatment

1 chemotherapy

2 control

Local Treatment — Surgery

0 no surgery

1 radical cystectomy

2 partial cystectomy 7 other surgery

9 unknown

Suggested Coding

Local Treatment-Radiotherapy

0 no radiotherapy

1 radical radiotherapy

2 pre-operative radiotherapy

3 post-operative radiotherapy

4 pre- and post-operative radiotherapy

7 other radiotherapy 9 unknown

Grade

Code as convenient, but please give details of the system used (e.g. UICC etc)

Performance Status

Code as convenient, but please give details of the system used (e.g.

WHO etc)

Tumour Diameter

Please supply as the largest single dimension of the tumour in mm unknown = 999

Renal Function

Code as convenient, but please give details of the measurement used (e.g. creatinine clearance, glomerular filtration rate etc.)

Pre-treatment Haemoglobin

Please supply giving details of the measurement used (e.g. g/dl, mmol/l etc.)

Local Recurrence/Progression

0 no evidence of recurrence / progression

1 local recurrence

2 local progression

Distant Metastases

0 no distant metastases

1 distant metastases 9 unknown

Treatment on Recurrence/Progression 1st digit - Surgery

0 no surgery

1 surgery

8 not applicable

9 unknown

2nd digit - radiotherapy

0 no radiotherapy

1 radiotherapy

8 not applicable

9 unknown

3rd digit - chemotherapy

0 no chemotherapy

1 chemotherapy

8 not applicable

9 unknown

Survival status

0 alive

1 dead

Bladder cancer present at death

0 no

1 yes

8 not applicable

9 unknown

Cause of death

1 bladder cancer

2 chemotherapy-related toxicity

3 radiotherapy-related toxicity

4 surgical complications

5 secondary tumour

6 other chronic disease

7 other

8 not applicable

9 unknown

Excluded from most recent Analysis

0 no

1 yes

Example of Data Form

Patient 10

Centre 10

Date of Birth (dd/mm/yyyy or dd/mm/yy)

Age

Sex

category

category

category

pT category

pN category

pM category

Grade

Performance Status

Tumour Diametei

Renal Function

Pretreatment Haemoglobin

Allocated Treatmen

1234

i

01/05/1943

49

1

3

0

3

9

0

2

2

SO

55

10.5

1

1235

2

12/09/32

54

2

2

-

<

2

1

i

-

«

«7

96.0

2

Local Treatment (surgery)

Local Treatment (radiotherapy)

Local Recurrence Status

0ate of local Recurrence 1 Progression (dd/mm/yyyy or ddfmm/yy)

Distant Metastases

Date of Distant Metastases

Treatment on Recurrence / Progression (3 digits)

Survival Status

Date of Death/ Last follow up (dd/mm/yyyy or dd/mm/yy)

Bladder Cancer Present at Oeath

Cause of Death

Excluded from most recent Analysis

Reason for Exclusion

1

0

1

JO/OC/1995

0

i

24/03/1997

<

-

2

2

0

11

11/10/99

011

0

12/04/2000

*

i

didn't compete ti««tment

The meta-analysis coordinators should provide details of the desired coding of variables (Box 11.7) but will generally accept data in whichever form it is most convenient for trialists to supply it. Provision of data may entail considerable work for the trialist and so good communication is essential, both to convince them of the value of the project, and to explain what is required of them.

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