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. Those comments and responses included the following:

  • The reviewers asked why Lactobacillus rhamnosus GG was chosen as the probiotic since it is not known as a microorganism found in the bladder. The researchers explained that they chose this probiotic because it has been widely used, is easily obtained over the counter, and has a history of being safe, tolerated, and effective.
  • The reviewers asked why the researchers used a 10 percent reduction in symptoms as the cutoff to represent a clinically meaningful effect. The researchers said that the threshold has not been previously reported in scientific literature. Rather, the research team determined this level before starting the trial based on the experience and expertise of clinicians and patients.
  • The reviewers commented on the lack of dosing information and noted that the study did not show that Lactobacillus rhamnosus GG established itself in bladders. The researchers agreed that they did not provide dosing information in this pilot trial but said they plan to study dosing in a future study.
  • The reviewers asked why the researchers chose not to conduct a randomized trial or include a control group. The researchers said because of the preliminary nature of this work, it was best to treat participants as their own controls to have the greatest power of detecting any effect. The study also established safety and tolerability of the treatment. The researchers said this trial will inform future randomized trials. The researchers did acknowledge the limitations of a quasi-experimental design in the study limitations.

Conflict of Interest Disclosures

Project Information

Suzanne Groah, MD, MPH
MedStar Health Research Institute
$1,827,721
10.25302/12.2020.AD.131008215
The Impact of Self-Management with Probiotics on Urinary Symptoms and the Urine Microbiome in Individuals with Spinal Cord Injury and Spina Bifida

Key Dates

July 2014
August 2020
2014
2020

Study Registration Information

Tags

Has Results
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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
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
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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
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Last updated: March 4, 2022