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Practical Guide to Adjuncts to Clinical Trials in Surgery

To identify the key insights or developments described in this article
1 Credit CME

Choosing outcome parameters is essential for success of any clinical trial. The Institute of Medicine (IOM) has put forth a framework of 6 parameters that define health care quality: safe, effective, patient-centered, timely, efficient, equitable.1 Safety and effectiveness are primary goals and will be discussed in other articles in this series. Here, we discuss adjunct outcome parameters that optimize patient-centered, timely, efficient, and equitable components (Box). We also discuss novel data collection methods, including web- and app-based data collection and data from wearables. Secondary outcome parameters allow interventions with similar primary end points (survival or functional outcome) to be distinguished in value. The parameters discussed also provide mechanistic analysis and finding inclusion criteria for future trials that decrease sample size and increase likelihood of success.

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Article Information

Corresponding Author: Yuman Fong, MD, Department of Surgery, City of Hope Medical Center, 1500 E Duarte Rd, Pavilion 2nd Floor, Ste 2207, Duarte, CA 91010 (yfong@coh.org).

Published Online: October 26, 2022. doi:10.1001/jamasurg.2022.4904

Conflict of Interest Disclosures: Dr Fong reported receiving fees as a scientific adviser from Medtronics, Johnson & Johnson, and Vergent and royalties from Merck and Imugene. No other disclosures were reported.

References
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Agency for Healthcare Research and Quality. Six domains of health care quality. Published 2022. Accessed March 1, 2022. https://www.ahrq.gov/talkingquality/measures/six-domains.html.
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McIsaac  DI , MacDonald  DB , Aucoin  SD .  Frailty for perioperative clinicians: a narrative review.   Anesth Analg. 2020;130(6):1450-1460. doi:10.1213/ANE.0000000000004602PubMedGoogle ScholarCrossref
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Stadler  ZK , Come  SE .  Review of gene-expression profiling and its clinical use in breast cancer.   Crit Rev Oncol Hematol. 2009;69(1):1-11. doi:10.1016/j.critrevonc.2008.05.004PubMedGoogle ScholarCrossref
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Ignatiadis  M , Sledge  GW , Jeffrey  SS .  Liquid biopsy enters the clinic—implementation issues and future challenges.   Nat Rev Clin Oncol. 2021;18(5):297-312. doi:10.1038/s41571-020-00457-xPubMedGoogle ScholarCrossref
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Mitchell  JM , Patterson  JA .  The inclusion of economic endpoints as outcomes in clinical trials reported to ClinicalTrials.gov.   J Manag Care Spec Pharm. 2020;26(4):386-393. doi:10.18553/jmcp.2020.26.4.386PubMedGoogle ScholarCrossref
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Sun  V , Dumitra  S , Ruel  N ,  et al.  Wireless monitoring program of patient-centered outcomes and recovery before and after major abdominal cancer surgery.   JAMA Surg. 2017;152(9):852-859. doi:10.1001/jamasurg.2017.1519PubMedGoogle ScholarCrossref
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Julien  HM , Eberly  LA , Adusumalli  S .  Telemedicine and the forgotten America.   Circulation. 2020;142(4):312-314. doi:10.1161/CIRCULATIONAHA.120.048535PubMedGoogle ScholarCrossref
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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