Results Summary and Professional Abstract
|This project's final research report is expected to be available by March 2020.|
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:
- The reviewers expressed concern that the study did not adjust for baseline differences between the Complete CHOICE and Enhanced Care groups, which could have contributed to the results for the unintended pregnancy outcome. The researchers explained that they performed several analyses to assess the relationship between baseline variables and the outcome, and that their multivariable model adjusted for confounders. The researchers added a description of the statistical methods that they used and the results from these analyses to the report.
- Reviewers asked whether the research team collecting outcome measures were masked to study condition and if not, why not. The researchers explained that masking was not possible because recruitment to the different conditions occurred at different times. They added the lack of masking of study condition to their limitations section.
- The report indicated that the analyses did not account for missing data, so reviewers asked that the researchers make explicit that almost 10 percent of their participants did not have 12-month outcome data. The researchers explained that they did use multiple imputation to account for missing data for the primary outcome and added a description of the imputation to their methods.
- The reviewers noted that the study design did not take into account the fact that the use of long-acting reversible contraceptives (LARC) has increased over time and that rates of unintended pregnancy have decreased. They also noted that choosing to run the Complete CHOICE phase of the study after the Enhanced Care phase of the study at the same sites gave a major advantage to the Complete CHOICE arm. The researchers disagreed that the observed benefits of the Complete CHOICE program were due primarily to timing since they saw improved LARC use and reduced unintended pregnancy during the Complete CHOICE program implementation period. However, the researchers did acknowledge that other factors may have contributed to the overall results in their conclusions.
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