JACC: Heart Failure
State-of-the-Art Review
Design of a “Lean” Case Report Form for Heart Failure Therapeutic Development
Mitchell A. Psotka, Mona Fiuzat, Peter E. Carson, David P. Kao, Jeffrey Cerkvenik, Daniel E. Schaber, Patrick Verta, Robert T. Kazmierski, Meir Shinnar, Norman Stockbridge, Ellis F. Unger, Bram Zuckerman, Javed Butler, G. Michael Felker, Marvin A. Konstam, JoAnn Lindenfeld, Scott D. Solomon, John R. Teerlink, Christopher M. O'Connor and William T. Abraham
Table 1
Table 1
Data Items Included in Representative CRFs
| CRF 1 | CRF 2 | CRF 3 | CRF 4 | CRF 5 | CRF 6 | Consensus | |
|---|---|---|---|---|---|---|---|
| Demographics | 4 | 5 | 3 | 6 | 4 | 3 | 4 |
| Vital signs | 5 | 6 | 5 | 3 | 9 | 4 | 7 |
| Physical examination | 2 | 20 | 1 | 1 | 10 | 0 | 4 |
| Medical history | 23 | 34 | 18 | 57 | 41 | 32 | 20 |
| Laboratory tests | 0 | 32 | 11 | 1 | 15 | 6 | 7 |
| Imaging tests | 2 | 12 | 2 | 0 | 1 | 1 | 1 |
| Electrocardiogram | 2 | 11 | 1 | 0 | 0 | 0 | 3 |
| Concomitant medications | All† | 13 | 8 | HF‡ | 14 | 4 | 29 |
| Quality of life assessment | Yes (EQ-5D) | Yes (MLHFQ) | Yes (MLHFQ) | Yes (MLHFQ, EQ-5D) | Yes (IPQ, KCCQ-12) | No | Yes§ |
| 6-min walk test | Yes | Yes | Yes | Yes | No | No | No |
| Events∗ | 16 | 10 | 34 | 16 | 6 | 8 | 6 |
| Total items | 51† | 143 | 83 | 84 | 100 | 58 | 81 |
CRF = case report form; EQ-5D = EuroQol 5D; FDA = Food and Drug Administration; IPQ = Brief Illness Perception Questionnaire; KCCQ = Kansas City Cardiomyopathy Questionnaire; MLHFQ = Minnesota Living with Heart Failure Questionnaire.
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