Technological Innovation Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper (1989) / Chapter Skim
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4. The Development of Clinical Procedures
4. The Development of Clinical Procedures
Pages 34-39
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From page 34... ...
Radical innovations frequently arise in academic or academic-associated centers, where physical and professional resources are available and clinical development is stimulated. The development of incremental innovations usually occurs in a much more decentralized fashion, involving numerous physicians refining and motiving an existing procedure in everyday clinical practice.
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From page 35... ...
one Courage to rail-, nave aescr~oea tne scenic and emotional controversies that may arise during the development of clinical procedures such as kidney dialysis and transplantation. Their work indicates that radical innovations usually are first applied to life-threatening or very serious diseases, which often have no alternative treatment (501.
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From page 36... ...
In addition, the analytical underpinnings of clinical investigations, in terms of sample bias, observer objectivity or standards for adequate follow-up, were often still rather weak. As Bunker et al conclude in their important work on the Costs, Risks and Benefits of SurgeIy: "In this respect, surgery shared with other branches of medicine at the time a process for groping for effective therapies, a process that did not have the help of extensive knowledge in the basic biological sciences or the understanding of sophisticated experimental designs to permit logical inductions from multivar~ate clinical circumstances" (21~.
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From page 37... ...
Examples of procedures that diffused into health care and only later were to be found ineffective for treating certain conditions, include prefrontal lobotomies for schizophrenia, colectomies for epilepsy, and more recently, EC/IC bypass surgery to prevent stroke. In a recent article Eddy and Billings provide an extensive argument for the often weak evidence underlying a number of important present-day clinical procedures (36~.
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From page 38... ...
Controls may include standard accepted surgery or alternative treatments involving drugs or devices; it is generally accepted today that use of sham-operations is unethically. Surgical procedures will also depend much more strongly on the technical skills of the surgeon, who might be better at one Ape of surgery than another.
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From page 39... ...
compared the patient population in their cardiovascular disease databank with the patients enrolled in some large RCrs of coronary artery surgery. They found that only S% of their patients met the eligibility criteria for the European Cooperative Surgery Study, 13% met the criteria for the large Veterans Administration (VA)
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