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Results from the National Sepsis Practice Survey: use of drotrecogin ? (activated) and other therapeutic decisions.

ABSTRACT: We sought to evaluate factors associated with choices about provided care for patients with septic shock, including the use of drotrecogin ? (activated) (DAA).We administered a mail-based survey to a random sample of intensivists. Study vignettes presented patients with septic shock with identical severity of illness scores but different ages, body mass indices, and comorbidities. Respondents estimated outcomes and selected care beyond standardized initial care (eg, antibiotics) for each hypothetical patient.For most vignettes (99.1%), respondents added care, most commonly low tidal volume ventilation (87.6%) and enteral nutrition (73.3%). Choosing to administer DAA was not associated with predictions about mortality or bleeding. Vignettes with early-stage lung cancer were less likely to receive DAA. Time since medical school graduation was also associated with lower odds of selecting DAA. Most respondents (52.6%) chose identical care for all 4 completed vignettes.There was wide variability in the therapeutic choices of respondents. The use of DAA was not associated with perceived risk of mortality or bleeding, as recommended by consensus guidelines. Physicians appear to base treatment decisions in septic shock on a consistent pattern of practice rather than estimates of patient outcome.

SUBMITTER: O'Brien JM

PROVIDER: S-EPMC2978258 | biostudies-literature | 2010 Dec

REPOSITORIES: biostudies-literature

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Results from the National Sepsis Practice Survey: use of drotrecogin α (activated) and other therapeutic decisions.

O'Brien James M JM Aberegg Scott K SK Ali Naeem A NA Diette Gregory B GB Lemeshow Stanley S

Journal of critical care 20100619 4

<h4>Purpose</h4>We sought to evaluate factors associated with choices about provided care for patients with septic shock, including the use of drotrecogin α (activated) (DAA).<h4>Materials and methods</h4>We administered a mail-based survey to a random sample of intensivists. Study vignettes presented patients with septic shock with identical severity of illness scores but different ages, body mass indices, and comorbidities. Respondents estimated outcomes and selected care beyond standardized i ...[more]

PMID: 20646906

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Project description:IntroductionPrevious cost-effectiveness analyses (CEA) reported that Drotrecogin alfa (DrotAA) is cost-effective based on a Phase III clinical trial (PROWESS). There is little evidence on whether DrotAA is cost-effective in routine clinical practice. We assessed whether DrotAA is cost-effective in routine practice for adult patients with severe sepsis and multiple organ systems failing.MethodsThis CEA used data from a prospective cohort study that compared DrotAA versus no DrotAA (control) for severe sepsis patients with multiple organ systems failing admitted to critical care units in England, Wales, and Northern Ireland. The cohort study used case-mix and mortality data from a national audit, linked with a separate audit of DrotAA infusions. Re-admissions to critical care and corresponding mortality were recorded for four years. Patients receiving DrotAA (n = 1,076) were matched to controls (n = 1,650) with a propensity score (Pscore), and Genetic Matching (GenMatch). The CEA projected long-term survival to report lifetime incremental costs per quality-adjusted life year (QALY) overall, and for subgroups with two or three to five organ systems failing at baseline.ResultsThe incremental costs per QALY for DrotAA were £30,000 overall, and £16,000 for the subgroups with three to five organ systems failing. For patients with two organ systems failing, DrotAA resulted in an average loss of one QALY at an incremental cost of £15,000. When the subgroup with two organ systems was restricted to patients receiving DrotAA within 24 hours, DrotAA led to a gain of 1.2 QALYs at a cost per QALY of £11,000. The results were robust to other assumptions including the approach taken to projecting long-term outcomes.ConclusionsDrotAA is cost-effective in routine practice for severe sepsis patients with three to five organ systems failing. For patients with two organ systems failing, this study could not provide unequivocal evidence on the cost-effectiveness of DrotAA.

Project description:IntroductionCritically ill patients and families rely upon physicians to provide estimates of prognosis and recommendations for care. Little is known about patient and clinician factors which influence these predictions. The association between these predictions and recommendations for continued aggressive care is also understudied.MethodsWe administered a mail-based survey with simulated clinical vignettes to a random sample of the Critical Care Assembly of the American Thoracic Society. Vignettes represented a patient with septic shock with multi-organ failure with identical APACHE II scores and sepsis-associated organ failures. Vignettes varied by age (50 or 70 years old), body mass index (BMI) (normal or obese) and co-morbidities (none or recently diagnosed stage IIA lung cancer). All subjects received the vignettes with the highest and lowest mortality predictions from pilot testing and two additional, randomly selected vignettes. Respondents estimated outcomes and selected care for each hypothetical patient.ResultsDespite identical severity of illness, the range of estimates for hospital mortality (5th to 95th percentile range, 17% to 78%) and for problems with self-care (5th to 95th percentile range, 2% to 74%) was wide. Similar variation was observed when clinical factors (age, BMI, and co-morbidities) were identical. Estimates of hospital mortality and problems with self-care among survivors were significantly higher in vignettes with obese BMIs (4.3% and 5.3% higher, respectively), older age (8.2% and 11.6% higher, respectively), and cancer diagnosis (5.9% and 6.9% higher, respectively). Higher estimates of mortality (adjusted odds ratio 1.29 per 10% increase in predicted mortality), perceived problems with self-care (adjusted odds ratio 1.26 per 10% increase in predicted problems with self-care), and early-stage lung cancer (adjusted odds ratio 5.82) were independently associated with recommendations to limit care.ConclusionsThe studied clinical factors were consistently associated with poorer outcome predictions but did not explain the variation in prognoses offered by experienced physicians. These observations raise concern that provided information and the resulting decisions about continued aggressive care may be influenced by individual physician perception. To provide more reliable and accurate estimates of outcomes, tools are needed which incorporate patient characteristics and preferences with physician predictions and practices.

Project description:IntroductionSince the launch of drotrecogin alfa activated (DrotAA), institutions and individual countries have published data on its use in clinical practice, based on audit or registry data. These studies were limited in size and geographic locale and included patients with greater disease severity and higher mortality than those in clinical trials. The purpose of this study was to compare baseline characteristics and clinical outcomes (using appropriate statistical adjustments) of patients treated or not treated with DrotAA from the international PROGRESS (Promoting Global Research Excellence in Severe Sepsis) cohort study of severe sepsis.MethodsPROGRESS was a global, non-interventional, multi-center, prospective, observational study of patients having a diagnosis of severe sepsis treated in intensive care units at a participating institution. All treatment modalities were as per standard of care at the participating institutions. Baseline characteristics and hospital mortality were analyzed and regression techniques used to develop propensity and outcome models adjusted for baseline imbalances between groups.ResultsOverall, 14,543 patients from 37 countries were enrolled and 12,492 had complete data for analysis. Germany was the highest enrolling country (1,810; 14.5%) and the US had the most DrotAA patients (206, 23.3%); 882 (7%) overall received DrotAA therapy. DrotAA-treated patients were younger (median age 58 vs. 61 years), had greater organ dysfunction (cardiovascular: 90% vs. 74%; respiratory: 90% vs. 81%; renal: 60% vs. 45%; metabolic: 63% versus 42%; 3 or more organ dysfunctions: 84% vs. 67%) and had a higher median APACHE II score (26 vs. 23, all with P < 0.001). Although in-hospital mortality was similar for DrotAA and non-DrotAA-treated patients (49.6% vs. 49.7%, respectively), after adjusting for imbalances, patients receiving DrotAA had a 28% (0.60 to 0.86, 95% Confidence Intervals) reduction in the odds of death and a relative risk reduction of 17% (P = 0.0003).ConclusionsIn the PROGRESS registry, DrotAA-treated patients were younger, more severely ill, and had fewer co-morbidities than patients not treated with DrotAA. After adjustment for group differences, a significant reduction in the odds of death was observed for patients that received DrotAA compared with those that did not.

Project description:BackgroundEarly rehabilitation improves outcomes, and increased use of physical therapist services in the intensive care unit (ICU) has been recommended. Little is known about the implementation of early rehabilitation programs or physical therapists' preparation and perceptions of care in the United States.ObjectiveA national survey was conducted to determine the current status of physical therapist practice in the ICU.DesignThis study used a cross-sectional, observational design.MethodsSelf-report surveys were mailed to members of the Acute Care Section of the American Physical Therapy Association. Questions addressed staffing, training, barriers, and protocols, and case scenarios were used to determine perceptions about providing rehabilitation.ResultsThe response rate was 29% (667/2,320). Staffing, defined as the number of physical therapists per 100 ICU beds, was highest in community hospitals (academic: median=5.4 [range=3.6-9.2]; community: median=6.7 [range=4.4-10.0]) and in the western United States (median=7.5 [range=4.2-12.9]). Twelve percent of physical therapists reported no training. Barriers to providing ICU rehabilitation included insufficient staffing and training, departmental prioritization policies, and inadequate consultation criteria. Responses to case scenarios demonstrated differences in the likelihood of consultation and physical therapists' prescribed frequency and intensity of care based on medical interventions rather than characteristics of patients. Physical therapists in academic hospitals were more likely to be involved in the care of patients in each scenario and were more likely to perform higher-intensity mobilization.LimitationsMembers of the Acute Care Section of the American Physical Therapy Association may not represent most practicing physical therapists, and the 29% return rate may have contributed to response bias.ConclusionsAlthough staffing was higher in community hospitals, therapists in academic and community hospitals cited insufficient staffing as the most common barrier to providing rehabilitation in the ICU. Implementing strategies to overcome barriers identified in this study may improve the delivery of ICU rehabilitation services.

Project description:IntroductionSerial alterations in protein C levels appear to correlate with disease severity in patients with severe sepsis, and it may be possible to tailor severe sepsis therapy with the use of this biomarker. The purpose of this study was to evaluate the dose and duration of drotrecogin alfa (activated) treatment using serial measurements of protein C compared to standard therapy in patients with severe sepsis.MethodsThis was a phase 2 multicenter, randomized, double-blind, controlled study. Adult patients with two or more sepsis-induced organ dysfunctions were enrolled. Protein C deficient patients were randomized to standard therapy (24 μg/kg/hr infusion for 96 hours) or alternative therapy (higher dose and/or variable duration; 24/30/36 μg/kg/hr for 48 to 168 hours). The primary outcome was a change in protein C level in the alternative therapy group, between study Day 1 and Day 7, compared to standard therapy.ResultsOf 557 patients enrolled, 433 patients received randomized therapy; 206 alternative, and 227 standard. Baseline characteristics of the groups were largely similar. The difference in absolute change in protein C from Day 1 to Day 7 between the two therapy groups was 7% (P = 0.011). Higher doses and longer infusions were associated with a more pronounced increase in protein C level, with no serious bleeding events. The same doses and longer infusions were associated with a larger increase in protein C level; higher rates of serious bleeding when groups received the same treatment; but no clear increased risk of bleeding during the longer infusion. This group also experienced a higher mortality rate; however, there was no clear link to infusion duration.ConclusionsThe study met its primary objective of increased protein C levels in patients receiving alternative therapy demonstrating that variable doses and/or duration of drotrecogin alfa (activated) can improve protein C levels, and also provides valuable information for incorporation into potential future studies.Trial registrationClinicalTrials.gov identifier: NCT00386425.

Dataset Information

Results from the National Sepsis Practice Survey: use of drotrecogin ? (activated) and other therapeutic decisions.

Publications

Results from the National Sepsis Practice Survey: use of drotrecogin α (activated) and other therapeutic decisions.

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