Results Summary and Professional Abstract
Final Research Report
View this project's final research report.
Article Highlight: Patients undergoing long-term treatment for kidney failure often also experience depression. In this PCORI-funded study, more patients reported modest improvements in their depressive symptoms with the drug sertraline than patients who received cognitive behavioral therapy, the study’s researchers report in the Annals of Internal Medicine. However, patients who opted for the daily medication experienced more adverse events, such as nausea and dizziness.
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. The comments and responses included the following:
- Some reviewers felt that the lack of a placebo arm was a serious limitation. The researchers edited the background section to note that six previous trials have compared cognitive behavioral therapy (CBT) and drug therapy in treating depression in patients undergoing dialysis, so the researchers felt the more important knowledge gap in this population was in the comparative effectiveness of CBT versus antidepressant drug therapy. The researchers acknowledged as a limitation that their study design did not allow them to demonstrate that either treatment was superior to placebo or to no treatment.
- Reviewers commented that 12 weeks is a very short duration of follow-up. The researchers agreed and acknowledged this as a limitation of the study. But they noted that patients who do not respond to antidepressant medication within 12 weeks are unlikely to do so, and they added that previous trials of CBT and antidepressant drug therapy in dialysis patients have also followed patients for 12 weeks and sometimes less.
- Reviewers noted that a very low proportion of patients initially included in the study used the tools presented and wondered whether that reflected the acceptability of the tools. The researchers clarified that while they approached more than 2500 dialysis patients, the large majority did not have depressive symptoms. Therefore, they were appropriately excluded from the clinical trial. Many patients with depressive symptoms were also appropriately excluded because they were already receiving treatment for depression or did not have symptoms of sufficient severity to qualify. Ultimately, the researchers said, the proportion of patients included in this clinical trial was similar to that of other similar, successful trials.
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