Innovation to research: Some transitional obstacles in critical care units

T o an outside observer, a critical care unit (CCU) seems to be a marvelous venue for research. It has a group of severely ill patients who undergo rapid changes in organ function. The changes are monitored minutely, and there are many healthcare providers present who observe, intervene, and record. Although many interventions are tried, positive outcomes are not assured. With so many interventions attempted, it seems appropriate to record the circumstances of the patient, the reasoning for the intervention, and the outcome. The collection of data about each specific intervention could then be analyzed and criteria developed for proper application of the intervention in the CCU. This surely sounds like research with the laudable goal of improving patient care. On occasion, there will be short circuits in this systematic approach to the development of new healthcare practices. Physicians believe that good process is more likely to lead to good outcomes; however, good outcome takes precedence over good process. Thus, an intervention may be found to be extremely successful, and it will be adapted as standard of care without formal evaluation. Other interventions may not provide anticipated outcomes and may actually be detrimental to patients. These interventions are rapidly discarded. In the middle of the highly positive and negative interventions are the interventions that are intermittently successful. Determining the proper application of these interventions to maximize patient benefit and minimize patient harm is the goal of clinical research. Although this is straightforward, this kind of research may be particularly difficult to accomplish in a CCU. In a CCU, many marginally therapeutic interventions are tried. These are attempted after mainstream therapies have proven to be unsuccessful, and the lack of success may be the basis of admission to the CCU. Marginally effective therapies are then used in the hopes that the particular patient the physician is caring for is the one who will derive benefit from the intervention. The alternative to a marginal therapy is no therapy, and no therapy is believed to lead to patient death. Phrases such as “there is no harm in trying,” “we must not give up hope,” and “you never know unless you try” all exemplify the acceptance of action (however unlikely to be helpful) as the correct response to patient illness in a CCU. The patient may receive intervention upon intervention in the hopes that at least one will affect the patient’s outcome in a positive manner. When this occurs, there is the difficult task of sorting through all the interventions to determine which ones were successful. Thus, it may be challenging to discern the cause-andeffect relationship that is to be the focus of research. It can be argued that patients in such critical states cannot be placed in a research study because adherence to the protocol might limit patient improvement. Physicians need the flexibility to act quickly, unhindered by study guidelines. A CCU is perhaps the embodiment of Jonsen’s (1) rule of rescue. The CCU is the place where long shots are routine. A successful long shot may have started as a small variation in technique in response to a specific patient. This response to a critically ill patient was not intended as new therapy but rather an innovation that happened to be useful in a particular set of patient circumstances. if the innovation remains as a possible response to specific criteria, it may properly be viewed as a variation of good care. If, however, the innovation is successful a sufficient number of times, it may become a standard response in a particular CCU. Thus, what was once marginal can become mainstream without having undergone the rigorous analysis involved in the scientific method. The scientific method is the accepted research tool in the profession of medicine. It is understood that medical knowledge is modified, clarified, and increased by the information developed from research projects designed according to the principles of the scientific method. It is further understood that discussion of new discoveries includes consideration of the limitations of the newly acquired information. Limitations of the new information will shape the physician’s understanding of its applicability. When a patient is severely ill and there seems to be no other option, it may be acceptable to try the new therapy as a last, best hope. Physicians can claim, and rightly so, that an innovative response is permissible because of the dire straits of the patient. The innovation is based on intuition, the art of medicine. To require all intuitions to undergo a full evaluative research protocol would significantly hinder medical progress in general but also would prevent the creative responses necessary to provide care that is tailored to a specific patient’s best interests. However, innovations can become habits and habits can become standards of care without the critical evaluation of a research protocol. Thus, critically ill patients may be at risk of receiving “state of the art care” that places them at unevaluated and unknown risk. From the Center for the Study of Bioethics, Medical College of Wisconsin, Milwaukee, WI.