Results Summary and Professional Abstract
|This project's final research report is expected to be available by December 2021.|
Results of This Project
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 whether the researchers used validated algorithms to measure the study outcomes: psychiatric hospitalization, kidney disorders, or diabetes. The researchers indicated that they did not use algorithms to measure outcomes, instead using billing codes to determine the presence or absence of a particular outcome. The researchers went on to say that in the report they described the multiple diagnostic and procedure billing codes that they included for each outcome. The reviewers responded by asking for comparisons between the researchers’ methods of identifying the clinical outcomes and existing algorithms created by other authors. The researchers explained further that they created their outcomes definitions from scratch and with input from their clinician-collaborators rather than relying on existing definitions. The reviewers noted that readers would be interested in the comparative definitions of the clinical outcomes so that readers could understand the breadth and accuracy of the definitions that the researchers used. The researchers responded by adding the sensitivity and specificity of previously developed algorithms or definitions of the clinical outcomes, particularly diabetes.
- The reviewers noted that the study data set was restricted to patients with private health insurance so the results of the study might not generalize to patients on public insurance. The researchers explained that although they had originally planned to include Medicaid patient data, the foundation supplying those data discontinued their supply due to funding problems. The researchers added a limitation to the discussion to point out that the lack of Medicaid data meant that most of the most severely affected patients with bipolar disorder were not represented in the study.
- The reviewers expressed concern about the requirement that patients maintain continuous drug exposure and maintain monotherapy, to stay in the study. While acknowledging that these elements were analytic strengths, the reviewers said that these expectations both led to reduced follow-up due to patients changing or adding medications, or not refilling their prescriptions one month. The researchers noted that these were the results of the initial study, which they explored further in focus groups, and that they adjusted their subsequent analyses based on these findings. The researchers concluded that low adherence to monotherapy is a major public health concern requiring system-wide interventions.
Conflict of Interest Disclosures
View the COI disclosure form.