Surgical procedures and devices should be evaluated in the same way as medical therapy - PubMed (original) (raw)
Surgical procedures and devices should be evaluated in the same way as medical therapy
H Buchwald. Control Clin Trials. 1997 Dec.
Abstract
This paper is a personal essay that starts and ends with the message that surgical procedures and devices should be evaluated in the same way as medical therapies, namely, by randomized clinical trials (RCTs). I discuss, with particular attention to surgical procedures and devices, the objections raised against RCTs in medical decision-making, a schema for utilizing the traditional phases of RCTs in the evaluation of surgical procedures and devices, the importance of RCTs to FDA approval, financial compensation, and health care costs, the impact of RCTs on clinical practice, the role of RCTs in academia, teaching, and research, and the surgeon's obligation to participate in a leadership role in RCTs. The belief is expressed that national funding of health care should mandate allocations for RCTs and that such expenditures, as well as the spending of health care dollars on the basis of the outcomes of such trials, will not only improve patient management in the shortest time but will eventually reduce health care costs. The RCT, by selecting effective and safe surgical procedures and devices, as well as diets and drugs, is the best means science has to assess the validity of patient management.
Similar articles
- Women's Representation in RCTs Evaluating FDA-Supervised Medical Devices: A Systematic Review.
Epstein NK, Harpaz M, Abo-Molhem M, Yehuda D, Tau N, Yahav D. Epstein NK, et al. JAMA Intern Med. 2024 Aug 1;184(8):977-979. doi: 10.1001/jamainternmed.2024.1011. JAMA Intern Med. 2024. PMID: 38857016 - Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs.
Golish SR. Golish SR. Trials. 2017 Jul 24;18(1):348. doi: 10.1186/s13063-017-2032-2. Trials. 2017. PMID: 28738891 Free PMC article. - FDA medical device approval: things you didn't learn in medical school or residency.
Buch B. Buch B. Am J Orthop (Belle Mead NJ). 2007 Aug;36(8):407-12. Am J Orthop (Belle Mead NJ). 2007. PMID: 17849025 - Sutureless Aortic Valve Replacement for Treatment of Severe Aortic Stenosis: A Single Technology Assessment of Perceval Sutureless Aortic Valve [Internet].
Desser AS, Arentz-Hansen H, Fagerlund BF, Harboe I, Lauvrak V. Desser AS, et al. Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2017 Aug 25. Report from the Norwegian Institute of Public Health No. 2017-01. Oslo, Norway: Knowledge Centre for the Health Services at The Norwegian Institute of Public Health (NIPH); 2017 Aug 25. Report from the Norwegian Institute of Public Health No. 2017-01. PMID: 29553663 Free Books & Documents. Review. - Analytical Chemistry in the Regulatory Science of Medical Devices.
Wang Y, Guan A, Wickramasekara S, Phillips KS. Wang Y, et al. Annu Rev Anal Chem (Palo Alto Calif). 2018 Jun 12;11(1):307-327. doi: 10.1146/annurev-anchem-061417-125556. Epub 2018 Mar 26. Annu Rev Anal Chem (Palo Alto Calif). 2018. PMID: 29579404 Review.
Cited by
- Ethics and evidence based surgery.
Stirrat GM. Stirrat GM. J Med Ethics. 2004 Apr;30(2):160-5. doi: 10.1136/jme.2003.007054. J Med Ethics. 2004. PMID: 15082810 Free PMC article. Review. - Framework for design and evaluation of complex interventions to improve health.
Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Campbell M, et al. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. BMJ. 2000. PMID: 10987780 Free PMC article. No abstract available. - Frequency of equivocation in surgical meta-evidence: a review of systematic reviews within IBD literature.
Delaney JD, Holbrook JT, Dewar RK, Laws PJ, Engel AF. Delaney JD, et al. BMJ Open. 2017 Dec 19;7(12):e018715. doi: 10.1136/bmjopen-2017-018715. BMJ Open. 2017. PMID: 29259063 Free PMC article. Review. - Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study.
Potter S, Mills N, Cawthorn SJ, Donovan J, Blazeby JM. Potter S, et al. Trials. 2014 Mar 14;15:80. doi: 10.1186/1745-6215-15-80. Trials. 2014. PMID: 24628821 Free PMC article.