Results Summary and Professional Abstract
Right For Me: Study Protocol (right)
A patient partner highlights the study protocol of this project to guide the shared decision making process between women and their healthcare providers about birth control options. Video posted with permission, courtesy of Rachel Lee Thompson.
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 questioned the use of some of the secondary measures, specifically decision regret and values concordance, that did not seem to be validated or have established minimally clinically important differences. The researchers noted that they did not know of measures of shared decision making that had previously determined minimally clinically important differences. The researchers acknowledged that a limitation of the study was their inability to find already validated measures for some of the constructs in their study. They assured the reviewers that they considered these measures. The researchers also stated that they were collaborative in their approach to deciding on outcome measures, incorporating feedback from patient partners and from listening sessions they conducted. Co-investigators, who had expertise in patient-reported outcome measures, developed measures for adherence and values concordance. The decision regret measure would evaluate whether patients felt they made the right choice in their contraceptive method and whether they felt that there was any harm related to their contraceptive choice. The researchers felt that these topics were important in assessing contraceptive decision-making.
- The reviewers asked whether the results were adjusted for multiple comparisons when evaluating the statistical significance of the finding that participants with lower health literacy benefited most from the shared decision making intervention. They also cautioned the researchers to not overstate the significance of these results since the primary analysis comparing the two interventions for the full sample was not significant. The researchers undertook additional analyses to adjust for multiple comparisons and the differences they saw in patient subgroups were no longer statistically significant. The researchers limited their discussion of this finding in their report but offered to provide results to readers upon request.
- The reviewers questioned whether some of the eligibility decisions led to the lack of significant results, including the heterogeneity of participating clinics and including in the sample even women who were not intending to discuss contraception during their doctors’ visits. The researchers considered the variability of the clinics to be a pragmatic decision. The researchers responded that often healthcare providers raise the issue of contraceptive decisions opportunistically, even when a patient is not considering changing methods. Moreover, decisions made in this context, even when the decisions are to stay with the current contraceptive method, are just as important to capture as decisions made when the goal of the clinic visit is to discuss contraception. Study participants who reported not having any conversation about contraception with their doctor during the clinic visit were not included in subsequent analyses on the clinic visit since they had no information.
- The reviewers expressed concern about potential confounders in study results given that the researchers obtained baseline outcome measures on a different population than the post-intervention outcome measures. The reviewers could not identify any adjustments made to account for using two different samples. The researchers corrected the text and adjusted for any differences in the distribution of covariates between the pre-intervention cohort and the post-intervention cohort.
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