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Medical Guidelines and Performance Measures: The Need to Keep Them Free of Industry Influence

, M.D. * , **

Mens Sana Monographs

Medknow Publications

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      Most cited references 32

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      Efficacy and safety of recombinant human activated protein C for severe sepsis.

      Drotrecogin alfa (activated), or recombinant human activated protein C, has antithrombotic, antiinflammatory, and profibrinolytic properties. In a previous study, drotrecogin alfa activated produced dose-dependent reductions in the levels of markers of coagulation and inflammation in patients with severe sepsis. In this phase 3 trial, we assessed whether treatment with drotrecogin alfa activated reduced the rate of death from any cause among patients with severe sepsis. We conducted a randomized, double-blind, placebo-controlled, multicenter trial. Patients with systemic inflammation and organ failure due to acute infection were enrolled and assigned to receive an intravenous infusion of either placebo or drotrecogin alfa activated (24 microg per kilogram of body weight per hour) for a total duration of 96 hours. The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion. Patients were monitored for adverse events; changes in vital signs, laboratory variables, and the results of microbiologic cultures; and the development of neutralizing antibodies against activated protein C. A total of 1690 randomized patients were treated (840 in the placebo group and 850 in the drotrecogin alfa activated group). The mortality rate was 30.8 percent in the placebo group and 24.7 percent in the drotrecogin alfa activated group. On the basis of the prospectively defined primary analysis, treatment with drotrecogin alfa activated was associated with a reduction in the relative risk of death of 19.4 percent (95 percent confidence interval, 6.6 to 30.5) and an absolute reduction in the risk of death of 6.1 percent (P=0.005). The incidence of serious bleeding was higher in the drotrecogin alfa activated group than in the placebo group (3.5 percent vs. 2.0 percent, P=0.06). Treatment with drotrecogin alfa activated significantly reduces mortality in patients with severe sepsis and may be associated with an increased risk of bleeding.
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        Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock.

        In 2003, critical care and infectious disease experts representing 11 international organizations developed management guidelines for severe sepsis and septic shock that would be of practical use for the bedside clinician, under the auspices of the Surviving Sepsis Campaign, an international effort to increase awareness and improve outcome in severe sepsis. The process included a modified Delphi method, a consensus conference, several subsequent smaller meetings of subgroups and key individuals, teleconferences, and electronic-based discussion among subgroups and among the entire committee. We used a modified Delphi methodology for grading recommendations, built on a 2001 publication sponsored by the International Sepsis Forum. We undertook a systematic review of the literature graded along five levels to create recommendation grades from A to E, with A being the highest grade. Pediatric considerations were provided to contrast adult and pediatric management. Key recommendations, listed by category and not by hierarchy, include early goal-directed resuscitation of the septic patient during the first 6 hrs after recognition; appropriate diagnostic studies to ascertain causative organisms before starting antibiotics; early administration of broad-spectrum antibiotic therapy; reassessment of antibiotic therapy with microbiology and clinical data to narrow coverage, when appropriate; a usual 7-10 days of antibiotic therapy guided by clinical response; source control with attention to the method that balances risks and benefits; equivalence of crystalloid and colloid resuscitation; aggressive fluid challenge to restore mean circulating filling pressure; vasopressor preference for norepinephrine and dopamine; cautious use of vasopressin pending further studies; avoiding low-dose dopamine administration for renal protection; consideration of dobutamine inotropic therapy in some clinical situations; avoidance of supranormal oxygen delivery as a goal of therapy; stress-dose steroid therapy for septic shock; use of recombinant activated protein C in patients with severe sepsis and high risk for death; with resolution of tissue hypoperfusion and in the absence of coronary artery disease or acute hemorrhage, targeting a hemoglobin of 7-9 g/dL; appropriate use of fresh frozen plasma and platelets; a low tidal volume and limitation of inspiratory plateau pressure strategy for acute lung injury and acute respiratory distress syndrome; application of a minimal amount of positive end-expiratory pressure in acute lung injury/acute respiratory distress syndrome; a semirecumbent bed position unless contraindicated; protocols for weaning and sedation/analgesia, using either intermittent bolus sedation or continuous infusion sedation with daily interruptions/lightening; avoidance of neuromuscular blockers, if at all possible; maintenance of blood glucose or =7.15; use of deep vein thrombosis/stress ulcer prophylaxis; and consideration of limitation of support where appropriate. Pediatric considerations included a more likely need for intubation due to low functional residual capacity; more difficult intravenous access; fluid resuscitation based on weight with 40-60 mL/kg or higher needed; decreased cardiac output and increased systemic vascular resistance as the most common hemodynamic profile; greater use of physical examination therapeutic end points; unsettled issue of high-dose steroids for therapy of septic shock; and greater risk of hypoglycemia with aggressive glucose control. Evidence-based recommendations can be made regarding many aspects of the acute management of sepsis and septic shock that are hoped to translate into improved outcomes for the critically ill patient. The impact of these guidelines will be formally tested and guidelines updated annually and even more rapidly as some important new knowledge becomes as available.
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          Practice guidelines developed by specialty societies: the need for a critical appraisal.

          There is increasing concern about the quality, reliability, and independence of practice guidelines. Because no information is available on the methodological quality of the guidelines developed by specialty societies, we undertook a survey on those published in peer-reviewed journals. Practice guidelines produced by specialty societies and published in English between January, 1988, and July, 1998, where identified through MEDLINE. Their quality was assessed in terms of whether they reported: the type of professionals and stakeholders involved in the development process; the strategy to identify primary evidence; and an explicit grading of recommendations according to the quality of supporting evidence. Overall, 431 guidelines were eligible for the study. Most did not meet the criteria: 67% did not report any description of the type of stakeholders, 88% gave no information on searches for published studies, and 82% did not give any explicit grading of the strength of recommendations. There was improvement over time for searches (from 2% to 18%, p<0.001) and explicit grading of evidence (from 6% to 27%, p<0.001). All three criteria for quality were met in only 22 (5%) guidelines. Despite improvement over time, the quality of practice guidelines developed by specialty societies is unsatisfactory. Explicit methodological criteria for the production of guidelines shared among public agencies, scientific societies, and patients' associations need to be set up. Common standards of reporting, following the same principles that led to the CONSORT statement for randomised clinical trials, should be promoted.
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            Author and article information

            Affiliations
            [* ] Critical Care Medicine Department, National Institutes of Health, Bethesda, MD
            [** ] Clinical Center, National Institutes of Health, Bethesda, MD
            Author notes
            Address correspondence to: Peter Q. Eichacker,Critical Care Medicine Department, NIH Building 10, Room 7D43, Bethesda, MD 20892. E-mail: < peichacker@ 123456mail.nih.gov >
            Journal
            Mens Sana Monogr
            Mens Sana Monogr
            MSM
            Mens Sana Monographs
            Medknow Publications (India )
            0973-1229
            1998-4014
            Jan-Dec 2008
            : 6
            : 1
            : 22-28
            22013347
            3190551
            MSM-6-22
            10.4103/0973-1229.33005
            © Mens Sana Monographs

            This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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            Editorial

            Neurology

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