Final Research Report
View this project's final research report.
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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:
- Reviewers asked why the study tested equivalence, that the two intervention models were the same, rather than noninferiority, that the online intervention was at least as good as in-person care. The researchers explained that their aim was to determine whether the two models of care were similar in impact on patient outcomes, in both positive and negative directions. They noted that this type of trial required more participants and more resources to conduct.
- Reviewers asked how researchers determined what would be a clinically significant result. The researchers said initial definition of margins for equivalence stemmed from previous clinical trials on psoriasis medications and then from evaluations by clinicians and patients of whether the margins would be considered clinically meaningful.
- Reviewers asked for a per-protocol sensitivity analysis to compare with the primary intention-to-treat analysis the researchers used. Reviewers asked that any differences between the results of these analyses be highlighted and the effects on interpretation be explained. The researchers said they discussed this issue extensively with a senior statistician. They explained that they did not specify a per-protocol analysis in their statistical plan because it was unlikely to change the study conclusions given the low rate of missing data and the low number of online patients who ended up needing to see a provider in person. The researchers offered to perform the additional analysis, which extended beyond the study’s original protocol, perhaps with additional time and funding.
- Reviewers asked for an expanded explanation for how patients and providers engaged, and researchers interviewed them. They also asked for additional information on how patient interviews contributed to data collection and analysis. The reviewers wondered about the process of extracting themes from patient interviews and asked how researchers integrated qualitative and quantitative results. The researchers expanded on the methods for patient engagement and contribution in the report. The researchers said themes emerged from reviewing patient interviews and were not pre-specified. The researchers added a table showing patient quotations and how they interpreted those quotations. The researchers also explained that quantitative and qualitative results were not integrated but that they reported them separately.
- For both study groups, within-group improvement from baseline was small. Reviewers suggested that it was possible that the study compared two relatively ineffective strategies to find them to be similar in their effect. The researchers agreed that the improvement from baseline was small, but said the results reflect the reality for psoriasis patients in the United States since most patients were already on systemic therapies that kept their disease burden low. At present, seeing a dermatologist in person in a clinic is considered the most effective method for managing psoriasis.
- Reviewers asked whether the development of collaborative connected health (CCH), an online approach to psoriasis care, occurred following a complex intervention framework that could be adopted in other parts of the country. The researchers stated they did use such a framework and a phased approach in developing the CCH, which has already been used in other disease areas following a process of patient and other stakeholder feedback.
Conflict of Interest Disclosures
^April W. Armstrong was affiliated with the University of Colorado Denver when this project was funded.
- Has Results
- Completed; PCORI Public and Professional Abstracts, and Final Research Report Posted
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