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A key component of an interim or final Research Performance Progress Report (RPPR) is the Project Outcomes summary (Section I). Project Outcomes provide information regarding the cumulative outcomes or findings of the project and are made public through NIH RePORTER.
As noted in the RPPR Instruction Guide, Project Outcome summaries should not exceed half a page and must be written according to the following guidelines:
- Is written for the general public in clear, concise, and comprehensible language
- Is suitable for dissemination to the general public, as the information may be available electronically
- Does not include proprietary, confidential information or trade secrets
Recipients conducting NIH-defined Phase III Clinical Trials must also include results of valid analyses by sex/gender, race, and ethnicity in the Project Outcome Summary (see Example 1 below). For more information on valid analysis, see the Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical Trials (Valid Analysis) page.
Project: “The VITamin D and OmegA-3 TriaL (VITAL)
Contact PI: JoAnn E. Manson
Organization: Brigham and Women’s Hospital, Harvard Medical School
The VITAL trial investigated whether taking high-dose vitamin D and/or omega-3 fatty acid supplements daily impacts the risk of cancer or cardiovascular disease among generally healthy midlife and older adults. Study participants were followed for an average of five years.
We found that overall, neither vitamin D supplementation (2000 IU daily) nor omega-3 fatty acid supplementation (1 g daily) reduced the risk of total invasive cancer. However, vitamin D supplementation did result in a 17% overall reduction in cancer death, although this was not statistically significant. With vitamin D supplementation, there were no differences between men and women in the cancer risk findings. However, a small and borderline significant 23% decrease in total cancer incidence was observed among African-American participants. In the overall cohort, advanced cancers (metastatic plus fatal cancers) were significantly decreased. With omega-3 fatty acid supplementation, women had a small nonsignificant reduction in risk of total invasive cancer, while men had no risk reduction.
Taking daily moderate-to-high dose vitamin D supplements did not reduce the risk of major cardiovascular events such as stroke, heart attack, or cardiovascular death. These results were not significantly different when comparing men and women or when comparing participants from different racial or ethnic groups.
Similarly, omega-3 fatty acid supplementation did not result in reduced risk of major cardiovascular events for the overall study population. However, there were some differences by subgroup and the type of cardiovascular event. Among those with lower-than-average fish intake at baseline, omega-3 fatty acid supplementation reduced the risk of major cardiovascular events by 19%. When heart attack was analyzed separately, omega-3 fatty acid supplementation resulted in a 28% reduction in the risk of heart attack (similar reduction in men and women), with the greatest benefit (77% reduction) observed among African-Americans. A significant reduction in heart attack was also observed among those with lower-than-average dietary fish intake and those with two or more risk factors for heart attack.
Project: “Heart Rate Recovery and Mortality”
Contact PI: Michael S Lauer, MD
Organization: Cleveland Clinic
During exercise, heart rate increases to meet increasing muscle demands for blood. Immediately after exercise, heart rate decreases. We call the decrease in heart rate after exercise “heart rate recovery.” Scientists believe that heart rate recovery reflects the the “autonomic nervous system,” the part of the nervous system that we are not aware of. It regulates “automatic” functions like heart rate, blood pressure, and breathing. It turns out that heart rate falls faster in people who are in good physical shape. In work we did before getting this grant, we found that slower falls in heart rate predicted a higher risk of early death.
In this project, we analyzed data from tens of thousands of Cleveland Clinic patients who had exercise tests as part of their routine care. Our technicians recorded heart rate every few minutes during exercise and one minute after exercise.
These were some of our main findings:
- We confirmed that heart rate recovery predicts death.
- Heart rate recovery is lower in people with diabetes and in people who have more severe heart disease; even so, low heart rate recovery predicts death in people with diabetes and in people with severe heart disease.
- Heart rate recovery is lower in older adults, and predicts death in older adults.
- Heart rate recovery is lower in people who are poor (in terms of money). We thought this might be true because some scientists think that people who are poor may suffer from problems with their nervous systems. Our finding may help us understand why poor people have higher risks of early death.
- We found that extra heart beats after exercise also predicts death. This finding may shed light on why people with low heart rate recovery have a higher risk of death: their nervous system problems may increase the risk of electrical problems with their hearts.