Table 2.
Select examples of generic and disease-specific PROs from patients with CHD and HF
| Author, date | Trial name | Comparators | Outcome Measures | Health Status Domain | Assessment Timepoints | Summary of Results |
|---|---|---|---|---|---|---|
| CABG | ||||||
| Abdallah, 2013 Magnuson, 2013 |
FREEDOM | CABG vs. PCI | EQ-5D | Generic | B, 1, 6, 12 months | CABG and PCI improved health status/QOL. PCI produced faster improvement, but health status improved with CABG at 6 months-2 year. Beyond 2 years, no consistent differences. |
| SAQ | Disease-specific | |||||
| Bishawi, 2013 | ROOBY | On-pump vs. Off-pump CABG | SF-36 | Generic | B, 3, 12 months | Both arms improved general and disease--specific QOL by 3 months through 1-year post-bypass. There were no differences in QOL between the two groups. |
| SAQ | Disease-specific | |||||
| Abdallah, 2017 | SYNTAX | CABG v. PCI | SF-36 | Generic | B, 1, 6, 12, 36, and 60 months | Greater improvement was reported in angina frequency and physical function (SAQ), and the role physical and emotional scales (SF-36) compared to PCI. |
| SAQ | Disease-specific | |||||
| Baron, 2017 | EXCEL | CABG vs. PCI | SF-12, EQ-5D, PHQ-8 | Generic | B, 1, 12, and 36 months | Both PCI and CABG patients showed significant improvements in disease- specific and generic health status through 36 months. |
| SAQ | Disease-specific | |||||
| Gaudino/Masterson Creber (ongoing trial) | ROMA: QOL | CABG (MAG vs. SAG) | PROMIS-29, SF-12, EQ-5D, PROMIS- PQ Neuro | Generic | B, first post-op visit, 6, 12, 24, 36, 48, 60 months | Trial recruitment is ongoing across the ROMA sites. PRO measures are assessed preoperatively, first-operative visit, 6 and 12 months, and 2, 3, and 4 years after CABG surgery. |
| SAQ | Disease-specific | |||||
| Heart Failure | ||||||
| Calvert, 2005 | CARE-HF | Usual care vs. device therapy | EQ-5D | Generic | B | Mean EQ-5D score was significantly lower in the CARE-HF population than in the general population. Increasing MLWHF score was associated with a decrease in EQ-5D score. |
| MLWHF | Disease-specific | |||||
| Xiong, 2012 | SADHART-CHF | Sertraline vs. placebo | SF-36 | Generic | B, 12 weeks | Depression remission in HF patients led to significantly higher improvements in SF-36 and KCCQ scores. |
| KCCQ | Disease-specific | |||||
| Bekelman, 2015 | PCDM | Usual care vs. PCDM | KCCQ | Disease-specific | B, 3, 6, 12 months | Significant improvement in the KCCQ overall summary scores in both groups after 1 year, but no significant difference between groups. |
| Solomon, 2019 | PARAGON-HF | Sacubitril-valsartan vs. valsartan for HF | KCCQ | Disease-specific | B, 8 months | More patients in sacubitril-valsartan group had improvements of 5+ points in the KCCQ compared to valsartan group. |
Abbreviations: B: baseline, EQ-5D: Euro-Qol-5D, GADS: Generalized Anxiety Disorder Assessment, HADS: Hospital Anxiety and Depression Scale, HF: heart failure, HFpEF: Heart failure with preserved ejection fraction, KCCQ: Kansas City Cardiomyopathy Questionnaire, MLWHF: Minnesota Living with Heart Failure questionnaire, MoCA: Montreal Cognitive Assessment, PCDM: Patient Centered Disease Management, PCI: Percutaneous Coronary Intervention, PHQ-9: Patient Health Questionnaire-9, POAF: postoperative atrial fibrillation, PROMIS: Patient Reported Outcomes Measurement Information System, PROMIS-PQ Neuro: Neuropathic Pain, PRO: patient-reported outcome, QOL: quality of life, SAQ: Seattle Angina Questionnaire, SF-12, SF-36: Short Form Health Survey 12-item, 36-item