ÌÇÐÄvlog

Object moved to here.

Practical Guide to Adjuncts to Clinical Trials in Surgery | Research, Methods, Statistics | JAMA Surgery | ÌÇÐÄvlog

ÌÇÐÄvlog

[Skip to Navigation]
Sign In
1.
Agency for Healthcare Research and Quality. Six domains of health care quality. Published 2022. Accessed March 1, 2022. .
2.
McIsaac  DI, MacDonald  DB, Aucoin  SD.  Frailty for perioperative clinicians: a narrative review.   Anesth Analg. 2020;130(6):1450-1460. doi:
3.
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:
4.
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:
5.
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:
6.
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:
7.
Julien  HM, Eberly  LA, Adusumalli  S.  Telemedicine and the forgotten America.  Ìý°ä¾±°ù³¦³Ü±ô²¹³Ù¾±´Ç²Ô. 2020;142(4):312-314. doi:
Guide to Statistics and Methods
Randomized Clinical Trials in Surgery
October 26, 2022

Practical Guide to Adjuncts to Clinical Trials in Surgery

Author Affiliations
  • 1Department of Surgery, City of Hope National Medical Center, Duarte, California
  • 2Department of Emergency Medicine, Denver Health and University of Colorado School of Medicine, Denver
  • 3Department of Epidemiology, Colorado School of Public Health, Aurora
  • 4Statistical Editor, JAMA Surgery
  • 5Division of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania
JAMA Surg. 2023;158(1):95-96. doi:10.1001/jamasurg.2022.4904

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.

×