The Emergence of Clinical Practice Guidelines

Highly recommend. Would love some commentary here from someone who is familiar with healthcare or test design. This article reads like an honorary SoP essay:

“Although guidelines themselves are not new, we argue, the proliferation of collectively produced guidelines since the 1980s represents a growing effort to bring order and coherence to a rapidly expanding and heterogeneous medical domain. Furthermore, this proliferation of guidelines is the product of multiple groups of actors arrayed in novel permutations and combinations that cannot be reduced to a simple dichotomy between physician and administrator.”

“Second, the results of medical research vastly complicated the world of medical practice and its regulation. Starting in the early twentieth century and accelerating after World War II, the expansion of research created new problems in translating this knowledge into better health care. Efforts to determine collectively the efficacy of so many new products and procedures intensified long-felt needs to standardize classification categories, instruments, measures, and research protocols. Just as the standardization of public health eventually influenced medical practice, testing protocols frequently found their way into clinical practice in such technically sophisticated fields as cancer research. Finally, research has produced many new and increasingly complex procedures and instruments that cannot be used effectively without elaborate protocols.”

“…the collective production of clinical practice standards was fraught with difficulties in the absence of sufficiently developed design, terminological, and outcome standards. A consensus on them could not emerge until medical leaders and academic elites had at least agreed on the units being discussed and the criteria used for discussing them. This process took more than a century.”

“The various activities of representative professional bodies in the United States make clear the difficulty of disentangling issues of professional competence from those of standardization at the levels of scientific classification and methodology, medical practice, or organizational structure.”

" The expansion of biomedical research had a variety of consequences. First, it vastly augmented the already large number of technological and pharmaceutical innovations with which doctors and growing numbers of administrators had to cope, and it amplified the pressure for collective forms of evaluation. Second, many large domains of research became sufficiently collaborative to generate standards and protocols. In particular, the spread of multicenter research required standardized categories and practices that allowed for the aggregation of data. This happened first in several biomedical domains whose interactions among many researchers, complex technologies, clinics, and laboratories necessitated some form of negotiated conventions, which we have termed elsewhere as regulatory objectivity (Cambrosio et al. 2006). Cancer treatment was a notable case in which research and clinical practice were closely associated. Here, chemotherapy was increasingly the result of research protocols that had become routine practices."

" A substantial minority of the “guidelines” published during the 1960s and 1970s dealt with issues ordinarily categorized as “bioethical” concerns, including the standardization of informed consent requirements. The products of medical research created a variety of ethically complex conditions and practices in clinical medicine—such as brain death, life-sustaining technologies, and in vitro fertilization—which seemed to require ethical guidance to supplement their very complex technical guidelines (Rothman 1991). These guidelines then became integral parts of the protocols defining these activities (Tournay 2006)."

“In the German-speaking countries, insurance companies created their own hospitals to deal with work-related accidents, in which rigorous procedural standards were established for surgeons (Eghigian 2000; Schlich 2002).”

" The NIH’s Consensus Development Program was one of the more influential institutions to come out of this activity surrounding technology assessment, and it had a significant though indirect role in the spread of practice guidelines. This program was designed to evaluate and disseminate reliable knowledge about subjects thought to be controversial or problematic. Despite being a form of collective expertise, consensus meetings were innovative by virtue of their formalized structure, resulting in a widely disseminated consensus statement. In its first decade, more than sixty conferences were conducted and frequently were well publicized. Some, like the early-breast-cancer-screening conference of 1977, came to conclusions that had significant effects on health policy (Wortman, Vinokur, and Sechrest 1988)."

" Although there certainly are real tensions around guidelines, they cannot be reduced to simple conflicts between administrators seeking to control costs and practitioners seeking to maintain autonomy. In most cases, such tensions cut across and divide professional groups. While they are committed to the most effective care for their patients, the medical producers of guidelines are beginning to take account of cost-effectiveness considerations (e.g., Bokemeyer et al. 2007; Lichtin 2005)… Nonetheless, the evidence is growing that guidelines actually do increase the use of medications and consequently the cost of health care (e.g., Dubois and Dean 2006)."

" Depending on the circumstances, guidelines may protect against criticism, legal action (if followed), or efforts to contain costs, or they may promote all of these. In some cases, like cancer therapy, guidelines and protocols define entire domains, which simply could not function in their current form without them (Keating and Cambrosio 2007)."