American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Important Announcement for the Special Study

In order to achieve the intended impact on clinical practice and benefit patients, a Commission on Cancer (CoC) Special Study was launched on April 17, 2017, to assess optimal post-treatment surveillance testing for the detection of prostate cancer recurrence. We would like to thank all the registrars who have started working on the study and participated in the webinars thus far.

As of May 25, the number of eligible patients submitted is less than anticipated. We have also heard from many of you with concerns that many sites do not have 12 eligible patients. Based on the questions and feedback received to date from registrars, we understand that the issues are due to the strictness of the eligibility criteria. If the study were to continue with existing eligibility criteria, we expect that the final sample would be much lower than originally anticipated, which poses a major problem for the special study. Therefore, we have decided to make changes to the eligibility criteria. The changes are summarized below.

  1. Patient Eligibility Question #1: The requirement for medical records will decrease from 5 years to 3 years in the first patient level eligibility criteria question, “Is there evidence that medical records are available for this patient for 5 years or until distant recurrence or death?”
  2. The replacement patient queue will include patients diagnosed in the years 2008–2010. Previously, only patients diagnosed between 2005–2008 were included in the study.

Due to the holiday weekend, these changes will go into effect on May 30, 2017, at 11:59 pm (CST). We have updated the Instructions Document and list with these changes. All questions or concerns can be directed to specialstudy@facs.org.

Specifics of the Change

  • Due to these changes, the deadline for the study will be extended to August 28, 2017
  • Sites are still only required to enter data on and submit 12 eligible patients
  • Sites originally identified as exempt (no eligible patients, reference year after 2009, VA/DoD) will remain exempt.
  • Sites that have already submitted all their cases and completed the study will not be affected
  • Sites currently working on the study with less than 12 patients in their list will receive additional patients to achieve a total of 12
  • Sites that submit patients as ineligible will receive patients from 2008–2010 as replacements

We sincerely apologize for any inconvenience caused. This change was made with both the success of the study and registrar’s workload in mind. We hope that loosening the requirement for eligibility and opening the years of diagnosis to include 2008-2010 patients will ease the burden of collecting medical records. We greatly appreciate your participation and patience through these changes.

We will be happy to answer your questions about the changes on next Tuesday’s webinar. The webinar is scheduled for Tuesday, May 30, 2017, 11:00 am–12:00 noon (CDT). In order to participate, please register. We greatly appreciate your participation and patience through these changes.

Sincerely,

Ronald C. Chen, MD, MPH
Principal Investigator

Lawrence N. Shulman, MD
Chair, Commission on Cancer

David Winchester, MD, FACS
Medical Director, Cancer Programs