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 for the makeup of the stakeholder panel and suggested that its makeup be compared with the racial and ethnic attributes of the study population. The researchers said that their stakeholder panel included 17 people: 11 physicians, 5 patients, and 1 oncology case manager who was also a cancer survivor. The researchers noted that the panelists included 14 women and 3 men, 2 African Americans and 1 Asian.
  • The reviewers asked if including stage III and IV endometrial cancer patients had any impact on findings, noting that the researchers had not included such patients at the outset. The researchers explained that a substantial number of patients diagnosed with stage I cancer were found to have stage III or IV after pathological analysis, but they were included in analyses because their original clinical diagnoses were at stage I or II. This subset of patients was somewhat less likely to have chosen concomitant stress urinary incontinence (SUI) surgery with their cancer surgery and more likely to have lower quality of life, but the researchers said these differences were not statistically significant. Adjusting for the stage III and IV patients did not substantially alter the association between concomitant SUI surgery and improved quality of life.
  • The reviewers asked about the process used to communicate with patients who did not speak English, noting that any adaptation of forms and questionnaires raises concerns about the reliability and validity of the translations. The researchers said their hospital’s professional translating services prepared a Spanish version of the consent form. The researchers found validated Spanish-speaking versions of the study surveys online, except for one survey which their hospital’s professional translating services had translated. The study’s Institutional Review Board approved all Spanish versions of the surveys. Each study site had bilingual staff who were able to answer questions for patients who spoke Spanish.
  • The reviewers asked why patients were screened for SUI multiple times in their first oncology visit given that the oncologist and patient were most likely focused on cancer treatment. The reviewers explained that patients in their focus groups asked for this because they recalled feeling overwhelmed and wanting time to think about incontinence.
  • Reviewers asked for an explanation regarding the treatment of Group 2, identified as non-surgical SUI treatment. The researchers explained that based on stakeholder input, women who saw a urogynecologist but did not have surgery would fit into this category, but did receive some type of treatment, such as behavioral interventions.

Project Information

Katina Robison, MD
Women & Infants Hospital of Rhode Island
$2,694,860
10.25302/11.2020.CER.140922034
Cancer of the Uterus and Treatment of Stress Urinary Incontinence

Key Dates

April 2015
June 2020
2015
2020

Study Registration Information

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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
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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