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Biomedical subjects

Donald E Fry

Publications and source records attributed to Donald E Fry.

At least 19 recordsLinked to original sources
PubMed2007

Enhancement of claims data to improve risk adjustment of hospital mortality.

CONTEXT: Comparisons of risk-adjusted hospital performance often are important components of public reports, pay-for-performance programs, and quality improvement initiatives. Risk-adjustment equations used in these analyses must contain sufficient clinical detail to ensure accurate measurements of hospital quality. OBJECTIVE: To assess the effect on risk-adjusted hospital mortality rates of adding present on admission codes and numerical laboratory data to administrative claims data. DESIGN, SETTING, AND PATIENTS: Comparison of risk-adjustment equations for inpatient mortality from July 2000 through June 2003 derived by sequentially adding increasingly difficult-to-obtain clinical data to an administrative database of 188 Pennsylvania hospitals. Patients were hospitalized for acute myocardial infarction, congestive heart failure, cerebrovascular accident, gastrointestinal tract hemorrhage, or pneumonia or underwent an abdominal aortic aneurysm repair, coronary artery bypass graft surgery, or craniotomy. MAIN OUTCOME MEASURES: C statistics as a measure of the discriminatory power of alternative risk-adjustment models (administrative, present on admission, laboratory, and clinical for each of the 5 conditions and 3 procedures). RESULTS: The mean (SD) c statistic for the administrative model was 0.79 (0.02). Adding present on admission codes and numerical laboratory data collected at the time of admission resulted in substantially improved risk-adjustment equations (mean [SD] c statistic of 0.84 [0.01] and 0.86 [0.01], respectively). Modest additional improvements were obtained by adding more complex and expensive to collect clinical data such as vital signs, blood culture results, key clinical findings, and composite scores abstracted from patients' medical records (mean [SD] c statistic of 0.88 [0.01]). CONCLUSIONS: This study supports the value of adding present on admission codes and numerical laboratory values to administrative databases. Secondary abstraction of difficult-to-obtain key clinical findings adds little to the predictive power of risk-adjustment equations.

Clinical Laboratory Information Systems↗
PubMed2006

Chemical threats.

The use of chemical agents as military weapons has been recognized for many centuries but reached the most feared and publicized level during World War I. Considerable political effort has been exercised in the twentieth century to restrict military strategies with chemicals. However, considerable concern currently exists that chemical weapons may be used as agents in civilian terrorism. The distribution of acetaminophen tablets contaminated with potassium cyanide and the release of sarin in the Tokyo sub-way system show that larger-scale deployment of chemical agents can be a reality. This reality makes it necessary for civilian disaster-planning strategies to incorporate an understanding of chemical agents, their effects, and the necessary treatment.

Chemical Terrorism↗
PubMed2006

The hazards of using administrative data to measure surgical quality.

Administrative claims data have been used to measure risk-adjusted clinical outcomes of hospitalized patients. These data have been criticized because they cannot differentiate risk factors present at the time of admission from complications that occur during hospitalization. This paper illustrates how valid risk-adjustment can be achieved by enhancing administrative data with a present-on-admission code, admission laboratory data, and admission vital signs. Examples are presented for inpatient mortality rates following craniotomy and rates of postoperative sepsis after elective surgical procedures. Administrative claims data alone yielded a risk-adjustment model with 10 variables and a C-statistic of 0.891 for mortality after craniotomy, and a model with 18 variables and a C-statistic of 0.827 for postoperative sepsis. In contrast, the combination of administrative data and clinical data abstracted from medical records increased the number of variables in the craniotomy model to 21 with a C-statistic of 0.923, and the number of variables in the postoperative sepsis model to 29 with a C-statistic of 0.858. Use of only administrative data resulted in unacceptable amounts of systematic bias in 24 per cent of hospitals for craniotomy and 19 per cent of hospitals for postoperative sepsis. Addition of a present-on-admission code, laboratory data, and vital signs reduced the percentage of hospitals with unacceptable bias to two percent both for craniotomy and for postoperative sepsis. These illustrations demonstrate suboptimal risk stratification with administrative claims data only, but show that present-on-admission coding combined with readily available laboratory data and vital signs can support accurate risk-adjustment for the assessment of surgical outcomes.

Adult↗
PubMed2006

Linking processes and outcomes to improve surgical performance: a new approach to morbidity and mortality peer review.

Peer review of surgical cases resulting in death or potentially avoidable complications is a longstanding tradition, but intensive reviews of individual cases rarely produces tangible improvements in clinical outcomes. The systematic comparison of care received by patients who experienced adverse outcomes to care received by patients who had uneventful surgical courses is a promising alternative to intensive case review. However, the results of these studies may be misleading because physicians often choose interventions based on their perceptions of patients' preoperative risks, and higher adverse outcome rates among patients with higher preoperative risk may distort comparisons of alternative interventions. The creation of a control sample by carefully matching each patient who experienced an adverse outcome to a patient who had a similar preoperative risk but did not experience an adverse outcome can overcome this problem and provide excellent insight into how to improve clinical performance most effectively and efficiently. By using currently available electronic data to compute each patient's risk of an adverse outcome, a series of cases with adverse outcomes can be matched to an equal number of controls. Peer review committees can then direct focused data collection and analyses of potentially critical processes of care to determine which, if any, are associated with significantly poorer clinical results. A simulated scenario is analyzed in detail to illustrate the ability of this technique to correctly determine best practices when other approaches fail to do so.

General Surgery↗
PubMed2005

Use of antimicrobial prophylaxis for major surgery: baseline results from the National Surgical Infection Prevention Project.

HYPOTHESIS: Surgical site infections (SSIs) are a major contributor to patient injury, mortality, and health care costs. Despite evidence of effectiveness of antimicrobials to prevent SSIs, previous studies have demonstrated inappropriate timing, selection, and excess duration of administration of antimicrobial prophylaxis. We herein describe the use of antimicrobial prophylaxis for Medicare patients undergoing major surgery. DESIGN: National retrospective cohort study with medical record review. SETTING: Two thousand nine hundred sixty-five acute-care US hospitals. PATIENTS: A systematic random sample of 34,133 Medicare inpatients undergoing coronary artery bypass grafting; other open-chest cardiac surgery (excluding transplantation); vascular surgery, including aneurysm repair, thromboendarterectomy, and vein bypass operations; general abdominal colorectal surgery; hip and knee total joint arthroplasty (excluding revision surgery); and abdominal and vaginal hysterectomy from January 1 through November 30, 2001. MAIN OUTCOME MEASURES: The proportion of patients who had parenteral antimicrobial prophylaxis initiated within 1 hour before the surgical incision; the proportion of patients who were given a prophylactic antimicrobial agent that was consistent with currently published guidelines; and the proportion of patients whose antimicrobial prophylaxis was discontinued within 24 hours after surgery. RESULTS: An antimicrobial dose was administered to 55.7% (95% confidence interval [CI], 54.8%-56.6%) of patients within 1 hour before incision. Antimicrobial agents consistent with published guidelines were administered to 92.6% (95% CI, 92.3%-92.8%) of the patients. Antimicrobial prophylaxis was discontinued within 24 hours of surgery end time for only 40.7% (95% CI, 40.2%-41.2%) of patients. CONCLUSION: Substantial opportunities exist to improve the use of prophylactic antimicrobials for patients undergoing major surgery.

Aged↗
PubMed2005

Occupational blood-borne diseases in surgery.

BACKGROUND: Human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infections are transmitted by blood exposure. Surgeons have been concerned about the risks of blood exposure in the operating room as a potential source of occupational infections from these viruses. The actual risk and frequency of operating room transmission remains poorly understood by many surgeons. METHODS: The pertinent recent literature on the pathophysiology, diagnosis, prevention, and treatment of HIV, HBV and HCV were reviewed to address the current understanding of these viruses as occupational risks to surgeons. RESULTS: HIV transmission to surgeons has not been documented in the United States by the Centers for Disease Control. HIV transmission from a surgeon to a patient in the environment of the operating room, as well as transmission from an HIV-infected surgeon to a patient, has not been documented. HBV infection of surgeons has declined with the general acceptance of the HBV vaccine. HCV infection remains a real risk for transmission in the operating room, given that no vaccine is currently available and that the overall number of chronically infected patients remains quite high. CONCLUSION: The risk of occupational infection from known viral pathogens for surgeons is low, but it is not zero. Effective barriers, modified patterns of behavior, and prompt responses to blood exposure events are the best methods for prevention.

Blood-Borne Pathogens↗
PubMed2005

Acute hyperglycemia and the innate immune system: clinical, cellular, and molecular aspects.

OBJECTIVE: To extract from the biomedical literature the reported effects of acute hyperglycemia on the major components of the innate immune system and to describe the clinical benefits of strict blood glucose control in certain patients. DATA SOURCE AND SELECTION: A Medline/PubMed search (1966 to July 2004) with manual cross-referencing was conducted, including all relevant articles investigating the effects of acutely elevated glucose levels on innate immunity. All publication types, languages, or subsets were searched. DATA EXTRACTION AND SYNTHESIS: Original and selected review articles, short communications, letters to the editor, and chapters of selected textbooks were extracted. Most recent and relevant clinical trials were reviewed for the introductory section to provide the clinical background to this topic. The selected bench laboratory articles were then divided into three main categories based on the timing of events: a) the early phase of the innate immune reaction; b) the cytokine network; and c) the phagocytic phase. The most obvious findings related to hyperglycemia included reduced neutrophil activity (e.g., chemotaxis, formation of reactive oxygen species, phagocytosis of bacteria), despite accelerated diapedesis of leukocytes into peripheral tissue, as well as specific alterations of cytokine patterns with increased concentrations of the early proinflammatory cytokines tumor necrosis factor-alpha and interleukin-6. Furthermore, a reduction of endothelial nitric oxide formation takes place, thus decreasing microvascular reactivity to dilating agents such as bradykinin, and complement function (e.g., opsonization, chemotaxis) is impaired, despite elevations of certain complement factors. CONCLUSIONS: Acute, short-term hyperglycemia affects all major components of innate immunity and impairs the ability of the host to combat infection, even though certain distinctive proinflammatory alterations of the immune response can be observed under these conditions.

Acute Disease↗
PubMed2004

Benefit/risk profile of drotrecogin alfa (activated) in surgical patients with severe sepsis.

BACKGROUND: The Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial examined the safety and efficacy of drotrecogin alfa (activated) (Xigris) in adult patients with severe sepsis. A clinical evaluation committee examined clinical data for each patient enrolled in PROWESS. However, there were no surgeons on the committee, and thus questions remained regarding the safety and efficacy of drotrecogin alfa (activated) in surgical patients. METHODS: Masked to treatment, a Surgical Evaluation Committee adjudicated the presence and type of operation, timing of surgery, infection, and adequacy of source control of surgical patients included in PROWESS. RESULTS: Twenty-eight percent of PROWESS cases were confirmed as surgical. The absolute risk reduction for mortality in all surgical patients was 3.2% and 9.1% for patients undergoing intraabdominal procedures. Serious bleeding during the infusion and 28-day period was similar between surgical and nonsurgical patients. CONCLUSIONS: Consistent with the overall PROWESS results, drotrecogin alfa (activated) has a favorable benefit/risk profile in surgical patients.

Anti-Infective Agents↗
PubMed2004

Safety of drotrecogin alfa (activated) in surgical patients with severe sepsis.

BACKGROUND: We conducted a retrospective evaluation of the overall safety of drotrecogin alfa (activated) in surgical patients with severe sepsis enrolled in PROWESS. METHODS: A blinded Surgical Evaluation Committee (SEC) verified surgical patients as having undergone a significant operative procedure within 30 days prior to enrollment. Serious and treatment-emergent bleeding events, both during the study drug infusion period (120 h) and the entire 28-day study period were analyzed by surgical status and by treatment assignment. Statistical analysis was performed using Fisher's exact test. RESULTS: Serious bleeding rates during infusion in the surgical patients were 3.1% (7/228) and 0% (0/246) in the drotrecogin alfa (activated) and placebo groups, respectively (p = 0.006). Treatment-emergent bleeding rates during infusion in the surgical patients were 16.7% (38/228) and 7.7% (19/246) in the drotrecogin alfa (activated) and placebo groups, respectively (p = 0.003). None of the treatment-emergent bleeding events was fatal. Of seven drotrecogin alfa (activated) serious bleeding events, six were procedure-related. The serious bleeding rates within each treatment group were statistically indistinguishable between the medical and surgical patients. However, the medical patients had numerically higher treatment-emergent bleeding rates than the surgical patients within each treatment group. Despite this observation, overall surgical patients received more transfusions of red blood cells, of platelets, and of fresh frozen plasma than their medical counterparts. CONCLUSIONS: Although treatment of surgical patients with drotrecogin alfa (activated) for severe sepsis is associated with a higher incidence of serious bleeding and subsequent treatment- emergent bleeding events, the magnitude of this increase is small and clinically acceptable.

Dose-Response Relationship, Drug↗
PubMed2004

Static and dynamic assessment of biomarkers in surgical patients with severe sepsis.

BACKGROUND: Severe sepsis, defined as a systemic inflammatory response to infection associated with acute organ dysfunction, is common among surgical patients and is a major cause of morbidity and mortality. Severe sepsis has been associated with changes in inflammatory and hemostatic biomarkers. In patients undergoing surgical procedures there may be additional stimulation of cytokine release and activation of the coagulation system. The purpose of this study was to characterize the baseline differences in biomarkers between surgical and non-surgical patients. In addition, we assessed the dynamic changes in biomarkers and coagulation parameters in surgical patients with severe sepsis enrolled in PROWESS and treated with placebo or drotrecogin alfa (activated). METHODS: A blinded PROWESS surgical evaluation committee (SEC) verified patients as having undergone a relevant operative procedure within 30 days of enrollment for inclusion in the surgical cohort of PROWESS. At baseline and on study days 1-7, biomarkers and coagulation parameters available for analysis were D-dimer, interleukin-6 (IL-6), protein C activity, protein S activity, anti-thrombin III (ATIII), activated partial thromboplastin time (aPTT), and prothrombin time (PT). Platelet count was determined at baseline only. Baseline values were compared between SEC-defined surgical and all other non-surgical patients, and between pre- and post-operative surgical patients from the PROWESS trial. Changes from baseline were compared between drotrecogin alfa (activated)-treated and placebo-treated surgical patients. Statistical analyses were performed using ANOVA on the ranked values. RESULTS: The SEC verified 474 (28%) of the 1,690 PROWESS patients as surgical. Median D-dimer, IL-6, aPTT and PT values were significantly higher at baseline for surgical patients than non-surgical patients (p < 0.001). Surgical patients had significantly lower median protein C, protein S, and ATIII activity at baseline than non-surgical patients (p < 0.001). Surgical patients treated with drotrecogin alfa (activated) showed a significant decrease in D-dimer levels on study days 1-5 (p < 0.05), and a more rapid increase in Protein C levels on study days 1-4 (p < 0.05) compared to placebo. CONCLUSIONS: Surgical patients with severe sepsis appear to have a higher severity of illness at baseline as demonstrated by derangements in biomarkers and coagulation markers compared to non-surgical patients. Surgical patients treated with drotrecogin alfa (activated)showed reduced D-dimer concentrations and a more rapid increase in protein C concentrations during the infusion period.

APACHE↗
PubMed2002

Evaluation of aminoaciduria in severely traumatized patients.

BACKGROUND: It has been documented in the literature that hypocalcemia, hypoaminoacidemia, and hyperaminoaciduria are sequelae of trauma. The aminoaciduria of patients with different types and severity of traumatic injuries was investigated. METHODS: Eight severely traumatized patients (ISS range, 20-43 years) and eight age-, gender-, and weight-matched controls were studied. Plasma and urine were collected 2.5-72 h after admission. Quantification of 28 amino acids in plasma and urine was performed by reversed-phase high-performance liquid chromatography. Urine concentrations of amino acids were indexed to creatinine. RESULTS: The patients' mean serum concentrations of 4 amino acids (arginine, threonine, isoleucine, and glutamine) were significantly decreased, 2 others (tryptophan and glutamic acid) were significantly increased, and 22 were unchanged (p-value< or =0.05). Fractional (urinary) excretion of 11 amino acids was increased in the patients. The patients' serum total calcium and albumin concentrations were decreased, but the mean ionized calcium concentration was not significantly different from the controls. CONCLUSIONS: The results of this study showed that aminoaciduria involving many amino acids is common for patients with different traumatic injuries and that the aminoaciduria is correlated with a reduction of the total serum calcium concentration.

Adult↗