Journal of Vascular and Interventional Radiology
Volume 14, Issue 9, Part 2 , Pages S391-S394 , September 2003

General Principles for Evaluation of New Interventional Technologies and Devices

References 

  1. Oxman AD , Sackett DL , Guyatt GH . Users' guide to the medical literature. I. How to get started . JAMA . 1993;270:2093–2095
  2. Guyatt GH , Sackett DL , Cook DJ . Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? . JAMA . 1993;270:2598–2602
  3. Guyatt GH , Sackett DL , Cook DJ . Users' guides to the medical literature. II. How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patients? . JAMA . 1994;271:59–63
  4. Woolf SH . Practice guidelines, a new reality in medicine. II. Methods of developing guidelines . Arch Intern Med . 1992;152:946–952
  5. Cook DJ , Guyatt GH , Laupacis A , Sackett DL . Rules of evidence and clinical recommendations on the use of antithrombotic agents . Chest . 1992;102(suppl):305S–311S
  6. Interventional Cardiology Devices Branch, Division of Cardiovascular, Respiratory and Neurology Devices, Office of Device Evaluation of the Food and Drug Administration. Guidance for the submission of research and marketing applications for interventional cardiology devices. May 1993.
  7. Begg CB , McNeil BJ . Assessment of radiologic tests: Control of bias and other design considerations . Radiology . 1988;167:565–569
  8. Guyatt G , Drummond M , Feeny D , et al.   Guidelines for the clinical and economic evaluation of health care technologies . Soc Sci Med . 1986;22:393–408
  9. McLean GK , Burke DR , Marinelli DL . Comment on the clinical appropriateness of an emerging technology . Radiology . 1989;172:941–942
  10. Peto R , Pike MC , Armitage P , et al.   Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design . Br J Cancer . 1976;34:585–612
  11. Schulz KF , Chalmers I , Hayes RJ , Altman DG . Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials . JAMA . 1995;273:408–412
  12. Grunkemeier GL , Starr A . Alternatives to randomization in surgical studies . J Heart Valve Dis . 1992;1:142–151
  13. Bonchek LI . Are randomized trials appropriate for evaluating new operations? . N Engl J Med . 1979;301:44–45
  14. Grimes DA . Technology follies: the uncritical acceptance of medical innovation . JAMA . 1993;269:3030–3033
  15. McLean GK . Percutaneous peripheral atherectomy . J Vasc Interv Radiol . 1993;4:465–480
  16. Vroegindeweij D , Tielbeek AV , Buth J , Schol FPG , Hop WCJ , Landman GHM . Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery disease: two-year follow-up with color-flow duplex scanning . J Vasc Surg . 1995;21:255–269
  17. Tielbeek AV , Vroegindeweij D , Buth J , Landman GHM . Comparison of balloon angioplasty and Simpson atherectomy for lesions in the femoropopliteal artery: angiographic and clinical results of a prospective randomized trial . J Vasc Interv Radiol . 1996;7:837–844
  18. Baim DS , Dent KM , King SB , et al.   Evaluating new devices: acute (in-hospital) results from the new approaches to coronary intervention registry . Circulation . 1994;89:471–481
  19. Hertzer NR . The natural history of peripheral vascular disease: implications for its management . Circulation . 1991;83(suppl):I12–I19
  20. The Standards of Reporting Trials Group . A proposal for structured reporting of randomized controlled trials . JAMA . 1994;272:1926–1931
  21. Begg C , Cho M , Eastwood S , et al.   Improving the quality of reporting in randomized trials: the CONSORT statement . JAMA . 1996;276:637–639

 This article first appeared in J Vasc Interv Radiol 1997; 8:133–136.

 1 Curtis W. Bakal, MD, Gary J. Becker, MD, Dana R. Burke, MD, Patricia E. Cole, MD, Michael D. Dake, MD, Richard J. Gray, MD, Margaret E. Hansen, MD, Ziv J. Haskal, MD, Robert W. Holden, MD, Michael D. Katz, MD, Lindsay S. Machan, MD, Nilesh H. Patel, MD, and Richard Shlansky-Goldberg, MD.

PII: S1051-0443(07)61256-1

doi: 10.1097/01.RVI.0000094614.61428.67

Journal of Vascular and Interventional Radiology
Volume 14, Issue 9, Part 2 , Pages S391-S394 , September 2003

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