Final Research Report

View this project's final research report.

Peer-Review Summary

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 raised questions about the structure and validity of the primary outcome of utility, a combination of efficacy and quit rate. One reviewer expressed concern that the measure had been biased because one of the medications tested had a much higher cost and therefore, higher quit rate that would affect it. The researchers noted that as a pragmatic trial, the study needed to include the available medication choices patients had. Other reviewers asked for a stronger rationale and explanation for how the researchers developed the utility function and what weighting they used. The researchers explained that they sought input from three clinical experts to determine the weighting between efficacy and quit rates, helping to establish the clinical meaning in the utility outcome.
  • Reviewers suggested that a crossover design may have been better. The researchers agreed that in the future it could be helpful to use an adaptive crossover design where patients could be randomized a second time if they do not respond well to their initial treatment.
  • Reviewers suggested that it would be useful to report patients’ prior experiences with the medications tested, or at least to note the medications they had used previously. The researchers said this information was not tracked, so they could not report on patients’ prior experiences with the tested medications.

Conflict of Interest Disclosures

Project Information

Richard J. Barohn, MD
University of Kansas Medical Center
$1,724,314
10.25302/05.2020.CER.130602496
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)

Key Dates

December 2013
March 2019
2013
2018

Study Registration Information

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022