The clinical use of guidelines<sup>30 Grimshaw J., Russell I. Effect of clinical guidelines on medical practice: A systematic review of rigorous evaluations Lancet 1993 ;  342 : 1317-1322  [cross-ref]

Cliccare qui per andare alla sezione Riferimenti</sup> and algorithms favorably influences patient outcome.<sup>31 Grimm R.H., Shimoni K., Harlan W.R. , e al. Evaluation of patient-care protocol use by various providers N Engl J Med 1975 ;  292 : 507-511  [cross-ref]

Cliccare qui per andare alla sezione Riferimenti, 75 Safran C., Rind D., Davis R. , e al. Effects of a knowledge-based electronic patient record on adherence to practice guidelines MD Comput 1996 ;  13 : 55-63

Cliccare qui per andare alla sezione Riferimenti, 88 Wirtschafter D.D., Scalise M., Henke C. , e al. Do information systems improve the quality of clinical research? Results of a randomized trial in a cooperative multi-institutional cancer group Comput Biomed Res 1981 ;  14 : 78-90  [cross-ref]

Cliccare qui per andare alla sezione Riferimenti</sup> The most detailed and explicit algorithms in clinical decision making use rule-based computer systems.<sup>9 Cannon S.R., Gardner R.M. Experience with a computerized interactive protocol system using HELP Comp Biom Res 1980 ;  13 : 399-409  [cross-ref]

Cliccare qui per andare alla sezione Riferimenti, 40 Johnston M., Langton K., Haynes B. , e al. Effects of computer-based clinical decision support systems on clinician performance and patient outcome Ann Intern Med 1994 ;  120 : 135-142

Cliccare qui per andare alla sezione Riferimenti, 53 McDonald C.J. Protocol-based computer reminders, the quality of care and the non-perfectability of man N Engl J Med 1976 ;  295 : 1351-1355  [cross-ref]

Cliccare qui per andare alla sezione Riferimenti, 55 McDonald C.J., Hui S.L., Tierney W.M. Effects of computer reminders for influenza vaccination on morbidity during influenza epidemics Md Comput 1992 ;  9 : 304-312

Cliccare qui per andare alla sezione Riferimenti, 56 McDonald C.J., Wilson G.A., McCabe G. Physician response to computer reminders JAMA 1980 ;  244 : 1579-1581

Cliccare qui per andare alla sezione Riferimenti</sup> 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.<sup>22 East T.D., Böhm S.H., Wallace C.J. , e al. A successful computerized protocol for clinical management of pressure control inverse ratio ventilation in ARDS patients Chest 1992 ;  101 : 697-710  [cross-ref]

Cliccare qui per andare alla sezione Riferimenti, 24 East T., Morris A., Gardner R. Computerized management of mechanical ventilation Textbook of Critical Care Philadelphia: WB Saunders Company (1995).  895-911

Cliccare qui per andare alla sezione Riferimenti, 57 Morris A. Protocol management of ARDS New Horizons 1993 ;  1 : 593-602

Cliccare qui per andare alla sezione Riferimenti, 62 Morris A., Wallace C., Menlove R. , e al. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO₂ removal for ARDS [erratum 149(3, Pt 1):838, 1994 Letters to the editor 151:255–256, 1995, 151:1269–1270, 1995, and 156:1016–1017, 1997] Am J Respir Crit Care Med 1994 ;  149 : 295-305

Cliccare qui per andare alla sezione Riferimenti</sup> Survival of these patients has compared favorably with reported survival from centers in which traditional care methods without decision support are used.<sup>62 Morris A., Wallace C., Menlove R. , e al. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO₂ removal for ARDS [erratum 149(3, Pt 1):838, 1994 Letters to the editor 151:255–256, 1995, 151:1269–1270, 1995, and 156:1016–1017, 1997] Am J Respir Crit Care Med 1994 ;  149 : 295-305

Cliccare qui per andare alla sezione Riferimenti</sup> These computerized ARDS mechanical ventilation protocols were exported from the LDS hospital Health Evaluation through the Logical Processing (HELP) computer system<sup>24 East T., Morris A., Gardner R. Computerized management of mechanical ventilation Textbook of Critical Care Philadelphia: WB Saunders Company (1995).  895-911

Cliccare qui per andare alla sezione Riferimenti, 46 Kuperman G.J., Garder R.M., Pryor T.A. HELP: A Dynamic Hospital Information System Computers and Medicine New York: Springer-Verlag (1991). 

Cliccare qui per andare alla sezione Riferimenti, 69 Pryor T.A., Gardner R.M., Clayton P.D. , e al. The HELP system J Med Syst 1983 ;  7 : 87-102  [cross-ref]

Cliccare qui per andare alla sezione Riferimenti</sup> 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.<sup>43 Kinder A, East T, Littman W, et al: A computerized decision support system for management of mechanical ventilation in patients with ARDS: An example of exportation of a knowledge base. Proceedings of the 17th Annual Symposium on Computer Applications in Medical Care, Washington, DC, 1993, p 888.

Cliccare qui per andare alla sezione Riferimenti, 43 East TD: A Randomized Clinical Trial of Computerized Protocols. AHCPR grant #HS06594

Cliccare qui per andare alla sezione Riferimenti</sup> 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<sup>20 East T. Role of the computer in the delivery of mechanical ventilation Principles and Practice of Mechanical Ventilation New York, NY: McGraw-Hill, Inc (1994).  1005-1038

Cliccare qui per andare alla sezione Riferimenti, 21 East T.D., Böhm S.H., Peng L. , e al. Exquisite management of pressure control inverse ratio ventilation by a computerized protocol [Abstract] Am Rev Respir Dis 1990 ;  141 : A240

Cliccare qui per andare alla sezione Riferimenti, 34 Henderson S, East TD, Morris AH, et al: Performance evaluation of computerized clinical protocols for management of mechanical ventilation in ARDS patients. Proceedings of the 13th Annual Symposium on Computer Applications in Medical Care (SCAMC) Nov 5–8. Washington, DC, 1989, pp 588–592.

Cliccare qui per andare alla sezione Riferimenti, 62 Morris A., Wallace C., Menlove R. , e al. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO₂ removal for ARDS [erratum 149(3, Pt 1):838, 1994 Letters to the editor 151:255–256, 1995, 151:1269–1270, 1995, and 156:1016–1017, 1997] Am J Respir Crit Care Med 1994 ;  149 : 295-305

Cliccare qui per andare alla sezione Riferimenti</sup> and computerized protocols for antibiotic treatment of hospitalized patients<sup>11 Classen D.C., Evans R.S., Pestotnik S.L. , e al. The timing of prophylactic administration of antibiotics and the risk of surgical-wound infection N Engl J Med 1992 ;  326 : 281-286  [cross-ref]

Cliccare qui per andare alla sezione Riferimenti, 12 Classen D.C., Pestotnik S.L., Evans R.S. , e al. Adverse drug events in hospitalized patients: Excess length of stay, extra costs, and attributable mortality JAMA 1997 ;  277 : 301-306

Cliccare qui per andare alla sezione Riferimenti, 27 Evans R, Classen D, Pestotnik S, et al: A decision support tool for antibiotic therapy. In Proceedings 19th Annual Symposium on Computer Applications in Medical Care (SCAMC) Oct 28–Nov 2. New Orleans, 1995, pp 651–655.

Cliccare qui per andare alla sezione Riferimenti, 66 Pestotnik S., Classen D., Evans R. , e al. Implementing antibiotic practice guidelines through computer-assisted decision support: Clinical and financial outcomes Ann Intern Med 1996 ;  124 : 884-890

Cliccare qui per andare alla sezione Riferimenti</sup> 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,<sup>62 Morris A., Wallace C., Menlove R. , e al. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO₂ removal for ARDS [erratum 149(3, Pt 1):838, 1994 Letters to the editor 151:255–256, 1995, 151:1269–1270, 1995, and 156:1016–1017, 1997] Am J Respir Crit Care Med 1994 ;  149 : 295-305

Cliccare qui per andare alla sezione Riferimenti</sup> 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.<sup>43 Kinder A, East T, Littman W, et al: A computerized decision support system for management of mechanical ventilation in patients with ARDS: An example of exportation of a knowledge base. Proceedings of the 17th Annual Symposium on Computer Applications in Medical Care, Washington, DC, 1993, p 888.

Cliccare qui per andare alla sezione Riferimenti, 43 East TD: A Randomized Clinical Trial of Computerized Protocols. AHCPR grant #HS06594

Cliccare qui per andare alla sezione Riferimenti</sup>

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.<sup>6 Beauchamp T., Childress J.   Principles of Biomedical Ethics New York: Oxford University Press, Inc (1989). 

Cliccare qui per andare alla sezione Riferimenti, 41 Jonsen A., Siegler M., Winslade W.   Clinical Ethics New York, NY: McGraw-Hill, Inc (1992). 

Cliccare qui per andare alla sezione Riferimenti, 59 Morris A. Algorithm-based decision making Principles and Practice of Intensive Care Monitoring New York: McGraw-Hill, Inc (1998).  1355-1381

Cliccare qui per andare alla sezione Riferimenti, 76 Sharpe V., Faden A.   Medical Harm Cambridge, UK: Cambridge University Press (1998). 

Cliccare qui per andare alla sezione Riferimenti</sup> 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.