Results Summary and Professional Abstract
Results of This Project
Early-Stage and Localized Prostate Cancer
Early-stage prostate cancer can be treated in different ways. Two recent PCORI-funded research studies provide new information on the effects of treatments and can help patients navigate their treatment decisions.
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked about the influence of direct-to-consumer advertising on treatment choice for prostate cancer, noting that this could be an important avenue of investigation. The researchers stated that information on the influence of direct-to-consumer advertising is largely anecdotal, but there has been concern that advertisements for some newer therapies may be misleading regarding the advantages of these treatments. The researchers stated that they did not take such advertising into account in this study because understanding the factors associated with treatment selection was not a goal of this study.
- The reviewers asked about inclusion of hormone therapy, specifically, androgen deprivation therapy (ADT) as a covariate for analyses rather than as one of the compared treatments. The researchers explained that ADT-alone treatment is not guideline recommended, although ADT is acceptable as an adjunct treatment. Therefore, it would not be helpful to measure ADT as an individual treatment.
- The reviewers asked why the researchers included a small cohort of patients receiving stereotactic body radiation therapy (SBRT) because it is not clear that these patients are comparable to the rest of the North Carolina study participants. The researchers explained that at the time the study started, SBRT was not a common treatment option in North Carolina; however, there was interest in understanding how SBRT compared to other treatment options. The researchers agreed that the patients receiving SBRT were different from the North Carolina sample, but they collected the same data at the same time points for both groups.
- The reviewers suggested that aggregating the patient-centered outcomes into a single composite measure might be more meaningful to and useful to patients and their clinicians. The researchers disagreed, saying that it was not clear how a patient would interpret a composite outcome, particularly because two treatments could have similar composite outcomes but vary on individual outcomes. Different patients are likely to put different weights on those individual outcomes and make treatment decisions based on what outcomes are most important to them.
Conflict of Interest Disclosures
The Conflict of Interest Disclosures for this project will be posted here soon.