Computerized protocols and bedside decision support.

The clinical use of guidelines 30 and algorithms favorably influences patient outcome. 31,75,88 The most detailed and explicit algorithms in clinical decision making use rule-based computer systems. 9,40,53,55,56 Bedside computerized protocols that standardize clinical decisions for mechanical ventilation for patients who have acute respiratory distress syndrome (ARDS) have been used at the LDS hospital for several hundred thousand hours in hundreds of ARDS patients since 1987. 22,24,57,62 Survival of these patients has compared favorably with reported survival from centers in which traditional care methods without decision support are used. 62 These computerized ARDS mechanical ventilation protocols were exported from the LDS hospital Health Evaluation through the Logical Processing (HELP) computer system 24,46,69 to 11 other hospitals using both stand-alone personal computers and commercial-integrated ICU patient data-management systems. These 11 hospitals were uninvolved in the development of these protocols. They used the bedside computerized protocols to support 100 ARDS patients in a randomized clinical trial completed in 1998. 43,43 We are currently refining a new computerized protocol that will standardize clinical decisions for IV fluid and for hemodynamic support. This computerized protocol will be used in acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) patients to be enrolled in a randomized clinical trial of pulmonary artery catheters (the National Institutes of Health [NIH] National Heart, Lung, and Blood Institute [NHLBI] ARDS Network's fifth randomized clinical trial). Many clinicians are concerned that protocol supported care will become rote or cookbook care and will be generated without attention to the specific and changing needs of the individual patient. This is a legitimate concern. Several decision support products that include guidelines, critical paths, or other tools are primarily time driven and do risk the production of patient-invariant care (Table 1). In contrast, the computerized protocols for mechanical ventilation for patients who have ARDS 20,21,34,62 and computerized protocols for antibiotic treatment of hospitalized patients 11,12,27,66 are driven by patient data (or status) . The antibiotic protocol delivers specific, individualized treatment suggestions or recommendations. The mechanical ventilation protocol delivers specific, individualized treatment instructions (actual physician's orders). Although the clinical decisions are standardized by the protocol instructions, the treatment delivered is individualized and is patient specific. This follows from the unique expression of the disease mounted by each individual patient. For example, a PEEP-responsive patient will receive a different therapy than will a PEEP-unresponsive patient, even though the rules for decision making are identical for both patients. The maintenance of individualized patient care while clinical decisions are standardized seems one of the most attractive attributes of the point-of-care clinical use of computerized protocols. Such protocols constitute an explicit method for making clinical decisions. Because they are explicit and are defined in detail, they allow duplication of the decision-making method when they are exported to other clinical sites. Protocols developed for experimental purposes could be transferred to the clinical care environment. The initial protocol developed by my colleagues and me for standardization of clinical decision making for mechanical ventilation of ARDS patients was, at the request of clinicians after 2 years of experimental use, 62 extended to ARDS patients not enrolled in the trial. They were subsequently transferred to other clinical investigative centers, including three community hospitals and two city-county hospitals. 43,43 Adequate experience has been gathered, therefore, to conclude that clinical care with computerized bedside protocols is achievable. It meets the requirements of reasonableness, face value, clinical experience, patient-specific instructions, and appropriate patient outcome. In addition, it complies with the ethical imperatives of modern clinical care. 6,41,59,76 What, then, are the potential advantages that this decision-support approach, with bedside computerized protocols, brings to the health care delivery system, and what contributions to clinical care and to clinical research might be anticipated from its widespread application? I have organized my response to this question within two broad categories: one, the reduction of error and two, the reduction of unnecessary variation, leading to the establishment of rigorous experimental outcomes laboratories and to reduction of variation in clinical practice.