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dig_documentation.pdf
Digitalis Investigation Group (DIG)
Data Documentation
The DIG Trial w as a ra nd om ized , do ub le-b lind, multicen ter tria l with more tha n 3 00 ce nte rs in
the Un ited Sta tes an d C an ad a p artic ipa ting . Th e p urp os e o f the trial w as to e xamine the sa fety
an d e ffica cy of D igo xin in trea ting pa tien ts w ith con ge stive he art fa ilure in sinu s rh ythm . Dig italis
wa s introd uc ed clinica lly mo re th an 20 0 ye ars ag o a nd ha s s inc e b ec om e a co mmon ly
pre sc ribe d m ed ica tion for th e tre atm en t of h ea rt failu re; h ow ever, th ere wa s c on sid era ble
uncertainty surrounding its safety and efficacy. Small trials indicated that Digoxin alleviated
some of the symptoms of heart failure, prolonged exercise tolerance, and generally improved
the quality of patients' lives. Unfortunately, these trials were generally small and although they
did focus on the effect of treatment on patients’ relief from heart failure symptoms and quality of
life, they failed to address the effect of treatment on cardiovascular outcomes. Questions about
the sa fety o f D igo xin w ere also a co nc ern . Dig oxin to xicity is un co mmon in small trials w ith
careful surveillance, however, the long-term effects of therapeutic levels of Digoxin were less
clea r.
The DIG da tas et c on sists o f ba se line an d o utc om e d ata from the main DIG trial. In the main
trial, heart failure patients meeting the eligibility criterion and whose ejection fraction was 45%
or less were randomized to receive either a placebo or digoxin. Outcomes assessed in the trial
included: cardiovascular mortality, hospitalization or death from worsening heart failure,
hospitalization due to other cardiovascular causes and hospitalization due to non-cardiovascular
ca us es .
The dataset was prepared to enable students to reproduce the analysis leading to the results of
the paper published in the New England Journal of Medicine in 1997 (The effect of digoxin on
mo rtality an d m orb idity in p atien ts with he art failure . Th e D igitalis Investigatio n G rou p. N En gl J
Med. 1997 Feb 20;336(8):525-33) by the Digitalis Investigation Group. Some data not
discussed in the NEJM article are included in the teaching data set (body mass index, serum
creatinine, serum potassium, systolic and diastolic blood pressure, etc.). In order to create an
anonymous dataset that protects patient confidentiality, most variables have been permuted
over th e s et o f pa tien ts w ithin trea tmen t gro up . Th ere fore , this dataset can reproduce the
results of the NEJM paper; however, it would be inappropriate to use this dataset for
other research or publication purposes. Multidimensional relationships, not included in the
NE JM , may n ot h ave b ee n p res erved du ring the pe rm uta tion pro ce ss .
The rem ain de r of th e d oc um en tatio n in clu de s b as eline a nd even t form s, a nn ota ted with variab le
na mes , ou tpu t from SA S c on ten ts p roc ed ure an d s ele cte d m ea ns an d p rop ortio ns from the DIG
da tas et.
Randomization Number
__ __ __ / __ __ __ __
NHLBI-VA Study #995
D IG IT A LIS IN V E S TIG A T IO N G R O U P Revised FEB 1992
BASELINE FORM
Local Center Name
PRINT Patient Name ID
Last First M.I.
Date of Randomization Mo __ __ Day __ __ Yr __ __
Items 1 through 9 must be transmitted over the telephone at the time of randomization.
1. SOCIAL SECURITY NUMBER ......................................................................................... __ __ __ - __ __ - __ __ __ __
2. DATE OF BIRTH ........................................................................................................................................ Mo Day Yr
3. EJECTION FRACTION (percent) .................................................................................................................... EJF_PER
A. METHOD (1=Radionuclide, 2=Angiography, 3=2-D Echo) ................................................................ EJFMETH
4. SEX (1=Male, 2=Female) ........................................................................................................................................... SEX
5. RACE (1=White, 2=Nonwhite) ................................................................................................................................ RACE
6. CHEST X-RAY (CT-ratio) .................................................................................................................................. CHESTX
7. WEIGHT .................................................................................................................................................... Kg OR lbs.
8. HEIGHT ................................................................................................................................................... cms OR inches
9. SERUM CREATININE LEVEL .......................................................................................... CREAT mg/dl OR mol/l
9A. SERUM POTASSIUM LEVEL .............................................................................. KLEVEL mEq/l OR __.__ mmol/l
10. PLEASE RECORD RECOMMENDED DIGOXIN DOSE .......................................................................... DIGDOSER
11. PLEASE RECORD RANDOMIZATION NUMBER ........................................................................................................
Complete the following information - not to be transmitted by telephone.
12. APPROXIMATE DURATION OF CHF (months) ............................................................................................. CHFDUR
SIGNS OR SYMPTOMS: 0=None or Unknown, 1=Present, 2=Past, 3=Present and Past
(Present is defined as < 1 month. Past is > 1 month prior to randomization.)
13. RALES ................................................................................................................................................................... RALES
14. ELEVATED JUGULAR VENOUS PRESSURE ............................................................................................. ELEVJVP
15. PERIPHERAL EDEMA ...................................................................................................................................... PEDEMA
16. DYSPNEA AT REST OR ORTHOPNEA ........................................................................................................ RESTDYS
17. DYSPNEA ON EXERTION ......................................................................................................................... EXERTDYS
18. LIMITATION OF ACTIVITY ...................................................................................................................... ACTLIMIT
19. S3 .............................................................................................................................................................................. S3
20. RADIOLOGIC EVIDENCE OF PULMONARY CONGESTION ................................................................... PULCONG
21. HEART RATE (beats/minute) ....................................................................................................................... HEARTRTE
22. BLOOD PRESSURE (mm Hg) ............................................................................................................. SYSBP / DIABP
23. CURRENT NYHA FUNCTIONAL CLASS (use codes below) ................................................................... FUNCTCLS 1 = Class I (Patients w ith cardiac d isease but w ithout resulting limitation of physica l activity. Ordinary p hysical ac tivity
doe s not ca use und ue fatigue or d yspne a). 2 = Class II (Patients w ith cardiac d isease resulting in slight limitation of phys ical activity. They a re com fortable at re st.
Ord inary phys ical activity cause s fatigue or d yspne a). 3 = Class III (Patients w ith cardiac d isease resulting in marke d limitation of physica l activity. They are com fortable at re st.
Less than ord inary activity caus es fatigue o r dysp nea). 4 = Class IV ((P atients w ith cardiac d isease resulting in inability to carry on a ny phys ical activity without d iscomfo rt.
Symp toms o f cardiac insu fficiency are pre sent ev en at res t. If any physica l activity is undertak en, sym ptom s are increase d.)
VA Form 10 -20914 a(NR) JAN 1991
Revised FEB 1992
STUDY #995 - BASELINE FORM (PAGE 2 OF 2) RANDOMIZATION NO. __ __ __ / __ __ __ __
24. ETIOLOGY OF CHF ................................................................................................................. PRIMARY CHFETIOL 1=Ischemic 4=Idiopathic 2=Hypertensive 5=Alcohol related 3=Valvular 6=Other
Specify ________________________________
C O D E : Y E S = 1 N O O R U N K N O W N = 0
25. PREVIOUS MYOCARDIAL INFARCTION ..................................................................................................... PREVMI
26. CURRENT ANGINA .......................................................................................................................................... ANGINA
27. HISTORY OF DIABETES ............................................................................................................................ DIABETES
28. HISTORY OF HYPERTENSION ................................................................................................................. HYPERTEN
CURRENT DRUG USE:
29. USE OF DIGOXIN WITHIN ONE WEEK PRIOR TO RANDOMIZATION ................................................... DIGUSE
30. POTASSIUM-SPARING DIURETICS ............................................................................................................ DIURETK
31. OTHER DIURETICS .......................................................................................................................................... DIURET
31A. POTASSIUM SUPPLEMENT ................................................................................................................................. KSUPP
32. ACE INHIBITOR ........................................................................................................................................... ACEINHIB
33. NITRATES (ORAL OR PASTE) ................................................................................................................... NITRATES
34. HYDRALAZINE ................................................................................................................................................. HYDRAL
35. OTHER VASODILATORS, SPECIFY ................................................................................................................... VASOD
36. DOSE OF DIGOXIN/PLACEBO (D-995) PRESCRIBED (mg/day) .............................................................. DIGDOSE
(For all doses, give the patient one bottle of study drug.)
37. PATIENT ADDRESS: ______________________________________________________________
TELEPHONE: AREA CODE: ___________ NUMBER: ________________________
38. NAME, ADDRESS AND TELEPHONE NO. OF FAMILY OR PRIVATE PHYSICIAN:
NAME: ______________________________________________________________
ADDRESS: ______________________________________________________________
TELEPHONE: AREA CODE: ___________ NUMBER: ________________________
39. NAME, ADDRESS AND TELEPHONE NO. OF CLOSE FRIEND OR RELATIVE NOT LIVING WITH PATIENT:
NAME: ______________________________________________________________
ADDRESS: ______________________________________________________________
TELEPHONE: AREA CODE: ___________ NUMBER: ________________________
40. DATE OF NEXT VISIT ................................................................................................... Mo __ __ Day __ __ Yr __ __
41. LAST NAME AND FIRST INITIAL OF INDIVIDUAL RANDOMIZING PATIENT (IN CAPITALS) ................................... ________________________________________
L a s t F ir s t In i ti a l
Signature ________________________________________
PLEASE RETURN FORM TO DATA COORDINATING CENTER AT PERRY POINT. VA Form 10 -20914 a(NR) JAN 1991
Calculated variables:
AGE (in years): INT(Date of Randomization-Date of Birth)/365.25
BM I (Body M ass Index): Weight in kg/Height in meters2
NSYM (Number of symptoms of CHF): Sum of Questions 13 through 20. If sign or symptom of CHF was
either currently or previously present, then symptom was considered ‘present’. The sum of all present
symptoms was assigned to NSYM. If the sum was four or more, then it was assigned the value 4.
TRT MT (Placebo or active treatment assignment): 0=Assigned to placebo group, 1=Assigned to treatment
group
Randomization Number
__ __ __ / __ __ __ __
NHLBI-VA Study #995 DIGITALIS INVESTIGATION GROUP Revised FEB 1992
EVENT FORM
Local Center Name ____________________________________________
PRINT Patient Name __________________________________________ Last First M.I.
Date of Event Mo __ __ Day __ __ Yr __ __
PLEASE COMPLETE A SEPARATE EVENT FORM FOR EACH HOSPITALIZATION OR EPISODE OF SUSPECTED DIGOXIN TOXICITY. CODE DISCHARGE DIAGNOSES FOR EACH HOSPITALIZATION.
A. HOSPITALIZATION (Defined as admission to hospital for at least 24 hours.) CODE: 1=YES Days Rand 0=NO To Event (1)
01. WAS PATIENT HOSPITALIZED? (If No, Go to Section B) ........................................................................................................................................................................................
IF YES , COMP LETE QUESTIONS 02 THROUGH 17 AND QUESTIONS 27a AN D 27b.
02. WORSENING HEART FAILURE ..................................................................................................................................................................................... WHF WHFDAYS
03. DIGOXIN TOXICITY (If YES, complete Section B below) ................................................................................................................................................ DIG DIGDAYS
04. MYOCARDIAL INFARCTION .............................................................................................................................................................................................. MI MIDAYS
05. UNSTABLE ANGI NA ................................................................................................................................................................................................... UANG UANGDAYS
06. STROKE .......................................................................................................................................................................................................................... STRK STRKDAYS
07. ARRHYTHMIA - SUPRAVENTRICULAR ........................................................................................................................................................................ SVA SVADAYS
08. ARRHYTHMIA - VENTRICULAR ................................................................................................................................................................................ VENA VENADAYS
09*. CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) .................................................................................................................................. CREV CREVDAYS
10*. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) .......................................................................................................... CREV CREVDAYS 11. CARDIAC TRANSPLANTATION ...............................................................................................................................................................................................................................
12. VALVE OPERATION ..................................................................................................................................................................................................................................................
&13. OTHER CARDIAC SURGERY, SPECIFY ___________________________________________________________ .................................................. OCVD OCVDDAYS
&14. OTHER CARDIOVASCULAR REASON, SPECIFY ________________________________________________ ........................................................ OCVD OCVDDAYS
15. RESPIRATORY INFECTION ........................................................................................................................................................................................... RINF RINFDAYS
16. OTHER NONCARDIAC, NONVASCULAR REASON, SPECIFY ____________________________________ ............................................................... OTH OTHDAYS 17. ENTER NUMBER OF PRIMARY REASON FOR HOSPITALIZATION (USE QUESTIONS 02-16 TO CODE) .......................................................................................................
* CABG and PTCA surgeries combined to create the composite variable Coronary Revascularization (CREV)
&Other cardiac surgery and Other cardiovascular reason combined to form composite variable Other CVD (OCVD).
(1) If no event occurred, number of days is from randomization until l date of last contact or date of death
Derived Variables or events not included on the Event Form:
C V D (CV D H osp italization ): First H osp italization for CVD cause (Worsening heart failure, Arrythmia,
Digo xin Toxicity, MI, Unstable angina, Stroke, Coronary revascularization, Cardiac transplantation, other
cardiovascular)
C V D D A Y S (Days randomization to first CVD Hosp.): Number of days from ran dom ization to the first
hospitalization for a CVD cause.
HO SP (First Hospitalization for any reason): First Hospitalization for patient
H O S P D A Y S (Days randomization to first Hospitalization): Nu mber o f days from rand omization to the first
hospitalization.
NHOSP (Nu mbe r of H osp italizations): Number of times a patient was hospitalized over the course of the
study
NOTE: Th e Atrio ventric ular B lock, B radya rrythmia event in dicate d in the NE JM article wa s not inc luded with
this version of the D IG da taset due to the small number of events. The event ‘Unspecified Hospitalization’ was
com bined with Other Non-Cardiac, Non-Vascular Hospitalization and the event ‘Cardiac Transplantation’ was
comb ined with ‘Other C ardiovasc ular’ also due to sm all counts.
Randomization Number
__ __ __ / __ __ __ __
NHLBI-VA Study #995 DIGITALIS INVESTIGATION GROUP Revised FEB 1992
FOLLOW-UP FORM
Local Center Name ______________________________________________
PRINT Patient Name __________________________________________
Last First M.I.
Date of Follow-Up Visit Mo __ __ Day __ __ Yr __ __
CIRCLE CLOSEST VISIT (MONTH) 01* 04 08 12* 16 20 24 28 32 36 40 44 48 52 56 60 NUMBER:
(*Please draw Digoxin blood level at this visit if instructed by the Data Coordinating Center.)
1. DID PATIENT DIE ?(0=No, 1=Yes): .................................................................................................................. DEATH
A. DATE OF DEATH ............................................................................................................................ Mo Day Yr
B. PRIMARY CAUSE OF DEATH ............................................................................................................... REASON 1=Worsening Heart Failure 2=Other Cardiac 3=Other Vascular 4=Unknown 5=Non cardiac, nonvascular cause
Derived Variab les:
DEA TH DAY : Number of days from Rando mization till date of death or last contact date if alive
DW HF : Prim ary stud y endp oint: D eath o r Ho spitaliza tion from worse ning he art failure.
DW HFD AYS : Days from randomization to the primary endpoint of death or hospitalization from worsening
heart failure.
The CONTENTS Procedure
Data Set Name: DIG Observations: 6800
Member Type: DATA Variables: 72
Engine: V612 Indexes: 0
Created: Observation Length: 576
Last Modified: Deleted Observations: 0
Protection: Compressed: NO
Data Set Type: Sorted: NO
Label:
-----Engine/Host Dependent Information-----
Data Set Page Size: 16384
Number of Data Set Pages: 244
First Data Page: 1
Max Obs per Page: 28
Obs in First Data Page: 12
Number of Data Set Repairs: 0
File Name: dig.sd2
Release Created: 6.08.00
Host Created: WIN
The CONTENTS Procedure
-----Variables Ordered by Position-----
# Variable Type Len Label
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1 ID Num 8 Patient ID
2 TRTMT Num 8 0=Placebo, 1=Treatment
3 AGE Num 8 Calculated: age at randomization
4 RACE Num 8 Q5: Race, 1=White 2=Nonwhite
5 SEX Num 8 Q4: Sex, 1=Male 2=Female
6 EJF_PER Num 8 Q3: Ejection fraction (percent)
7 EJFMETH Num 8 Q3A: Ejection Fraction method
8 CHESTX Num 8 Q6: Chest X-ray (CT-Ratio)
9 BMI Num 8 Calculated: Body Mass Index (kg/M*M)
10 KLEVEL Num 8 Q9A: Serum Potassium level
11 CREAT Num 8 Q9: Serum Creatinine (mg/dL)
12 DIGDOSER Num 8 Q10: Recommended Digoxin dose
13 CHFDUR Num 8 Q12: Duration of CHF (months)
14 RALES Num 8 Q13: Rales
15 ELEVJVP Num 8 Q14: Elevated jugular venous pressure
16 PEDEMA Num 8 Q15: Peripheral Edema
17 RESTDYS Num 8 Q16: Dyspnea at Rest
18 EXERTDYS Num 8 Q17: Dyspnea on Exertion
19 ACTLIMIT Num 8 Q18: Limitation of activity
20 S3 Num 8 Q19: S3 Gallop
21 PULCONG Num 8 Q20: Pulmonary congestion
22 NSYM Num 8 Calculated: Sum of Q13-Q20, Y/N status
23 HEARTRTE Num 8 Q21: Heart Rate (beats/min)
24 DIABP Num 8 Q22: Diastolic BP (mmHg)
25 SYSBP Num 8 Q22: Sysolic BP (mmHg)
26 FUNCTCLS Num 8 Q23: NYHA Functional Class
27 CHFETIOL Num 8 Q24: CHF Etiology
28 PREVMI Num 8 Q25: Previous Myocardial Infarction
29 ANGINA Num 8 Q26: Current Angina
30 DIABETES Num 8 Q27: History of Diabetes
31 HYPERTEN Num 8 Q28: History of Hypertension
32 DIGUSE Num 8 Q29: Digoxin within past week
33 DIURETK Num 8 Q30: Potassium sparing Diuretics
34 DIURET Num 8 Q31: Other Diuretics
35 KSUPP Num 8 Q31A: Potassium supplements
36 ACEINHIB Num 8 Q32: Ace inhibitors
37 NITRATES Num 8 Q33: Nitrates
38 HYDRAL Num 8 Q34: Hydralazine
39 VASOD Num 8 Q35: Other Vasodilators
40 DIGDOSE Num 8 Q36: Dose of Digoxin/Placebo prescribed
41 CVD Num 8 Hosp: Cardiovascular Disease
42 CVDDAYS Num 8 Days randomization to First CVD Hosp
43 WHF Num 8 Hosp: Worsening Heart Failure
44 WHFDAYS Num 8 Days randomization to First WHF Hosp
45 DIG Num 8 Hosp: Digoxin Toxicity
46 DIGDAYS Num 8 Days rand. to First Digoxin Tox Hosp
47 MI Num 8 Hosp: Myocardial Infarction
48 MIDAYS Num 8 Days randomization to First MI Hosp
49 UANG Num 8 Hosp: Unstable Angina
50 UANGDAYS Num 8 Days rand. to First Unstable Angina Hosp
51 STRK Num 8 Hosp: Stroke
52 STRKDAYS Num 8 Days randomization to First Stroke Hosp
53 SVA Num 8 Hosp: Supraventricular Arrhythmia
54 SVADAYS Num 8 Days rand. to First SupraVent Arr. Hosp
55 VENA Num 8 Hosp: Ventricular Arrhythmia
The CONTENTS Procedure
-----Variables Ordered by Position-----
# Variable Type Len Label
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56 VENADAYS Num 8 Days rand. to First Vent. Arr. Hosp
57 CREV Num 8 Hosp: Coronary Revascularization
58 CREVDAYS Num 8 Days rand. to First Cor. Revasc.
59 OCVD Num 8 Hosp: Other Cardiovascular Event
60 OCVDDAYS Num 8 Days rand. to First Other CVD Hosp
61 RINF Num 8 Hosp: Respiratory Infection
62 RINFDAYS Num 8 Days rand. to First Resp. Infection Hosp
63 OTH Num 8 Hosp: Other noncardiac, nonvascular
64 OTHDAYS Num 8 Days rand. to 1st Other Non CVD Hosp
65 HOSP Num 8 Hosp: Any Hospitalization
66 HOSPDAYS Num 8 Days randomization to First Any Hosp
67 NHOSP Num 8 Number of Hospitalizations
68 DEATH Num 8 Vital Status of Patient 1=Death 0=Alive
69 DEATHDAY Num 8 Days till last followup or death
70 REASON Num 8 Cause of Death
71 DWHF Num 8 Primary Endpt: Death or Hosp from HF
72 DWHFDAYS Num 8 Days rand. to death or Hosp from WHF
DIG Trial: Selected Means by Treatment Group
Placebo Digoxin
N Mean Median Std N Mean Median Std
Calculated: age at
randomization 3403 63.55 65.0 10.81 3397 63.42 64.0 11.02
Q22: Sysolic BP (mmHg) 3401 126.02 124.0 19.94 3396 125.57 122.0 19.94
Q22: Diastolic BP (mmHg) 3400 74.91 75.0 11.06 3395 74.89 75.0 11.47
Q9: Serum Creatinine (mg/dL) 3403 1.29 1.2 0.37 3397 1.28 1.2 0.37
Q9A: Serum Potassium level 2993 4.46 4.3 7.87 3006 4.33 4.3 0.51
Q6: Chest X-ray (CT-Ratio) 3402 0.53 0.5 0.07 3396 0.53 0.5 0.07
Q12: Duration of CHF (months) 3397 29.80 16.0 36.55 3389 30.52 17.0 37.21
Q3: Ejection fraction (%) 3403 28.45 29.0 8.85 3397 28.63 29.0 8.85
DIG Trial: Selected Proportions by Treatment Group
Placebo Digoxin
N ColPctN N ColPctN
Q4: Sex, 1=Male 2=Female
Men 2634 77.6 2631 77.8
Women 760 22.4 752 22.2
Q5: Race, 1=White 2=Nonwhite
White 2891 85.2 2899 85.7
Non-white 503 14.8 484 14.3
Q23: NYHA Functional Class
Class I 440 13.0 464 13.7
Class II 1851 54.5 1805 53.4
Class III 1037 30.6 1039 30.7
Class IV 66 1.9 75 2.2
Q25: Previous Myocardial Infarction
No 1177 34.7 1192 35.2
Yes 2217 65.3 2191 64.8
Q26: Current Angina
No 2497 73.6 2462 72.8
Yes 897 26.4 921 27.2
Q27: History of Diabetes
No 2423 71.4 2426 71.7
Yes 971 28.6 957 28.3
Q28: History of Hypertension
No 1843 54.3 1859 55.0
Yes 1551 45.7 1524 45.0
Q29: Digoxin within past week
No 1880 55.4 1891 55.9
Yes 1514 44.6 1492 44.1
Q30: Potassium sparing Diuretics
No 3117 91.8 3145 93.0
Yes 277 8.2 238 7.0
Q31: Other Diuretics
No 729 21.5 737 21.8
Yes 2665 78.5 2646 78.2
Q32: Ace inhibitors
No 178 5.2 200 5.9
Yes 3216 94.8 3183 94.1
Q33: Nitrates
No 1932 56.9 1958 57.9
Yes 1462 43.1 1425 42.1
Q35: Other Vasodilators
No 3345 98.6 3351 99.1
Yes 49 1.4 32 0.9
DIG Trial: Selected Outcomes by Treatment Group
Placebo Digoxin
N ColPctN N ColPctN
Vital Status of Patient 1=Death 0=Alive
Alive 2209 64.9 2216 65.2
Died 1194 35.1 1181 34.8
Hosp: Cardiovascular Disease
No Event 1553 45.6 1703 50.1
First Event 1850 54.4 1694 49.9
Hosp: Worsening Heart Failure
No Event 2223 65.3 2487 73.2
First Event 1180 34.7 910 26.8
Hosp: Supraventricular Arrhythmia
No Event 3251 95.5 3264 96.1
First Event 152 4.5 133 3.9
Hosp: Myocardial Infarction
No Event 3202 94.1 3202 94.3
First Event 201 5.9 195 5.7
Hosp: Unstable Angina
No Event 3005 88.3 2998 88.3
First Event 398 11.7 399 11.7
Hosp: Stroke
No Event 3239 95.2 3240 95.4
First Event 164 4.8 157 4.6
Hosp: Coronary Revascularization
No Event 3332 97.9 3314 97.6
First Event 71 2.1 83 2.4
