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Background. Recombinant activated factor VII (rFVIIa), which has been approved by the Food and Drug Administration for the treatment of bleeding in patients with hemophilia, is increasingly being used to control or prevent bleeding in a variety of clinical situations. However, its widespread use is raising concerns in terms of its efficacy, safety, and cost. The objective of our study was to examine the 'on-label' and 'off-label' uses of rFVIIa in academic medical centers in the U.S. Methods. Our descriptive retrospective administrative database study included all patients with a hospital-based charge for rFVIIa during their inpatient stay. Patients with hemophilia were categorized as receiving rFVIIa for on-label use; all. other uses were considered off-label. We analyzed the variables of age, sex, ethnicity, principal payer, admission source and status, physician specialty, severity-of-illness score, principal and secondary diagnoses and procedures, and Diagnosis-Related Groups. We evaluated overall length of stay (LOS), LOS in the intensive care unit (ICU), total hospital costs and charges, and patient discharge status. Results. The analysis included 2,660 cases from 40 hospitals. Overall, 89% of rFVIIa usage was classified as off-label. Patients receiving rFVIIa for off-label use had a higher degree of severity of illness, longer overall LOS, longer ICU LOS, and a higher mortality rate. Despite the obvious differences between the two patient populations, hospital costs and charges were similar for both off-label and on-label uses. Conclusion. Most rFVIIa use in these academic medical centers is off-label, and its utilization is increasing. General surgeons, internists, and cardiothoracic surgeons are the specialists who prescribe this medication most frequently. Treated patients tend to be of high acuity (with complicated illnesses) and represent those with a broad array of disease states. This study describes a rapid method of evaluating the clinical use of high-impact pharmaceuticals such as rFVIIa, and we hope that it will be helpful in targeting future efforts in developing appropriate guidelines. [ABSTRACT FROM AUTHOR]

A study that was conducted to determine the incidence of postoperative ileus found that this complication was the major cause of delay in the discharge of patients from the hospital, with annual costs totaling $1.46 billion. [ABSTRACT FROM AUTHOR]

Objective: To rationalize decision-making concerning the growing and costly off-label use of recombinant human factor VII (rFVIla, NovoSeven(R) therapy. Options: Using rFVIla therapy for patients with bleeding or providing usual care (e.g., continued clotting factor replacement). Outcome: Morbidity and mortality related to continued bleeding or thrombosis. Evidence: A literature review was per- formed to assess the efficacy and safety of off- label rFVIIa therapy. An expert consensus panel reviewed the data. Most studies were case series or reports. Only four randomized trials were avail-able in the peer-reviewed literature at the time of the panel's deliberations. The Rand Corporation/University of California at Los Angeles Appropriateness Method was used to rate 41 clinical scenarios as 'appropriate,' 'uncertain,' or 'inappropriate' in a comparison of risks and benefits in an environment with constrained health care costs. Values: The panel comprised nine geographically diverse clinicians to represent the interests of clinical specialties, including anesthesiology/critical care, surgery, trans-fusion medicine/hematology, pharmacy, neurology/critical care, and practice environments. Benefits, Harms, and Costs: The panel's recommendations are expected to limit the use of rFVIIa to the most appropriate circumstances, thus minimizing associated risks and costs. These suggestions should be considered consistent with the quality and quantity of the available evidence and should be adjusted as new evidence emerges. Recommendations: The panel rated the use of rFVIIa as 'appropriate' in limited circumstances: (1) cardiac, thoracic aortic, or spinal surgery; hepatic resection; hysterectomy; or postpartum bleeding (when significant clotting factor replacement has failed); (2) for severe multiple trauma (only if surgery and substantial blood replacement are unsuccessful); and (3) for nontraumatic intracranial bleeding (only if less than four hours has elapsed since symptom onset or if traumatic bleeding is associated with anticoagulant use and hematoma expansion). Doses of 20 to 40 mcg/kg were recommended for non-emergent anticoagulant reversal. Doses of 41 to 90 mcg/kg were recommended for all other scenarios. [ABSTRACT FROM AUTHOR]

BACKGROUND: Crystalloids, nonprotein colloids (NPCs), and albumin are used for many indications. The use of the least costly agent in situations where these products are clinically interchangeable can reduce health care costs. OBJECTIVES: To characterize the prescribing of albumin and NPC. To evaluate the appropriateness and cost implications of their use. METHODS: An observational study conducted in 15 academic health centers from April 11 through May 6, 1994, to assess the appropriateness of albumin and NPC use, based on 'model' consensus-derived indication guidelines. RESULTS: A total of 969 case report forms were evaluated. Albumin and NPCs were administered in 83% and 17% of the cases, respectively. Albumin and NPCs were administered mostly in the intensive care (50%) or operating room (31%) settings. The most common prescribers of these products were surgeons (45%) and anesthesiologists (20%). In 87% of cases, albumin or NPC was administered to reach a defined end point (eg, to achieve a target physiological state or to resolve a pathophysiological condition). Only one albumin recipient experienced an adverse event; no adverse events were noted with NPC administration. Approximately $203,000 was spent on albumin and NPC therapy for the 969 cases; $49,702 (24%) was spent on appropriate administrations, $124,939 (62%) on inappropriate administrations, and $28,014 (14%) on unevaluated indications. CONCLUSIONS: Evaluated against model guidelines, most of the albumin and NPC use in the study was found to be inappropriate. The need for institutions to define and implement guidelines that focus on the cost-efficient use of these agents is recommended in an increasingly cost-conscious health care environment. [ABSTRACT FROM AUTHOR]

Objective: To summarize consensus recommendations for off-label uses of standard intravenous immunoglobulin (IVIG), as developed by a University Hospital Consortium (UHC) Expert Panel. These findings are intended to help guide clinicians in the appropriate and efficient use of IVIG.Participants: The UHC-sponsored panel included eight physicians (board certified in critical care, hematology, immunology, neurology, oncology, pediatrics, or rheumatology) and two hospital pharmacists.Evidence: MEDLINE and EMBASE were searched to identify all English-language review articles (n = 201) and original reports (n = 1904) on IVIG (human use only, excluding editorials, letters, and comments) published between January 1982 and March 1994. Relevant original reports (250) and review articles (87) were evaluated by the first author (T.A.R.). Extracted data included laboratory and clinical findings, objective measures, or clinical impressions. The evidence quality was graded by study design according to the US Preventive Services Task Force.Consensus Process: Before the panel meeting, a draft literature review and recommendations were produced by one of the authors (T.A.R.). The recommendations herein represent consensus (100% agreement) based on the published evidence.Conclusions: The UHC Expert Panel made specific recommendations for 53 off-label indications and the following general recommendations: (1) Usually IVIG is indicated only if standard approaches have failed, become intolerable, or are contraindicated; (2) IVIG products should be considered therapeutically equivalent and interchangeable; (3) interproduct pharmaceutical differences should be considered with the patient's clinical and physiological status when selecting an IVIG product; and (4) currently, IVIG manufacturers cannot guarantee freedom from viral contamination in the finished product. [ABSTRACT FROM AUTHOR]

A new approach to clarify the ruthenium effect on the precipitation of topologically close packed (TCP) phases is described in the paper. It is based on focused ion beam – scanning electron microscopy (FIB – SEM) dual beam methodology as well as three-dimensional imaging. The high-temperature capabilities of nickel base superalloys can be improved by alloying with refractory elements. With excessive refractory element content or excessive exposure to high temperature, brittle TCP phases precipitate resulting in a drop of strength. The undesirable phase transformation can be suppressed by addition of ruthenium. Although the effect is well known, its real mechanism remains open. In the present paper, the volume fraction and particle density, as well as the exact three-dimensional morphology of TCP phases as measured by FIB-SEM will be presented. The effect of ruthenium content and time of exposure is studied quantitatively. The results show that increased Ru additions slow down all stages of phase transformation and also reduce the equilibrium TCP volume fraction. The Ru effect might be due to either reduced driving force for precipitation or reduced interfacial energy.

Karl Matuszewski, MS, PharmD, discusses the need for hospitals to evaluate the cost-effectiveness of new technology. [ABSTRACT FROM AUTHOR]

Objective: Depression screening should be increased when prevailing knowledge underscoring medication-associated mental health risk is highest. Depression screening in primary care practices when medications with mental health risk were prescribed was estimated while considering the absence and presence of clinical decision support systems., Materials and Methods: A cross-sectional, descriptive study using the National Ambulatory Medical Care Survey (NAMCS) data from 2008 to 2010 was conducted. Primary care physician visits were classified based on whether a medication prescribed had a contraindication, severe warning, moderate warning, adverse event only, or no documented mental health risk. Adjusted odds of depression screening for each risk warning level were estimated while controlling for important sociodemographic factors and presence of computerized systems for medication warnings and guideline recommendations., Results: Depression screening at primary care practice visits when medications were prescribed was 2.1% and increased to 2.8% or higher when medications had a moderate or severe mental health risk warning or medication-disease contraindication. Depression screening was increased at visits when at least one medication was prescribed that had a contraindication (AOR = 6.31, P < 0.001), severe warning (AOR = 2.04, P = 0.003), or moderate warning (AOR = 2.50, P = 0.012) for mental health risk, but not for mental health adverse event only warnings alone (AOR = 1.54, P = 0.074)., Discussion: Depression screening is increased when medications were prescribed with a documented mental health risk. Presence of clinical decision support systems may help discern between minor and major medication-associated mental health risks., Conclusions: Appropriately, positioned warning systems with targeted content, workflow redesign, and health information exchange may improve depression screening in at-risk patients., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: Published and manufacturer-provided data regarding potential cross-reactivity between antibacterial and nonantibacterial sulfonamide agents are reviewed., Summary: An estimated 3-6% of the general population is allergic to sulfonamides and thus at risk for type I and other hypersensitivity reactions to sulfamethoxazole and other sulfonamide antibacterial agents. Concerns have been raised that a history of sulfa allergy may be associated with an increased risk of adverse reactions to a wide range of nonantibacterial sulfonamides, including certain antivirals, carbonic anhydrase inhibitors, cyclooxygenase-2- selective nonsteroidal antiinflammatory drugs, loop and thiazide diuretics, and sulfonylureas; concerns have also been raised that patients who have experienced an allergic reaction to one nonantibacterial sulfonamide may be at risk for an adverse reaction to others. Structurally, none of the nonantibiotic sulfonamides exhibit both of the features shown to be responsible for sulfonamide reactions (i.e., an N-containing ring attached to the N1 nitrogen of the sulfonamide group and an arylamine group at the N4 position), and only two agents (amprenavir and fosamprenavir) have the latter characteristic. A comprehensive literature search (1966-December 2011) identified nine case reports indicating possible cross-reactivity to sulfonamide medications; however, in most cases, adequate patient testing was not conducted to firmly establish either sulfa allergy or sulfonamide cross-sensitivity. The weight of evidence suggests that withholding nonantibacterial sulfonamides from patients with prior reactions to antibacterial sulfonamides or other nonantibacterial sulfonamides is not clinically justified., Conclusion: A review of the professional literature and manufacturer-provided data did not find convincing evidence of broad cross-reactivity between antibacterial and nonantibacterial sulfonamide agents.

Purpose: The unlabeled uses of intravenous immune globulin (IVIG) were reviewed., Summary: A literature review was conducted to identify studies examining the unlabeled uses of IVIG. A review of 138 clinical trial abstracts identified 10 trials examining 2 labeled uses (635 patients) and 128 trials examining 61 different off-label uses (6781 patients). The most common off-label indications included multiple sclerosis, graft-versus-host disease in transplant patients, prevention of antiphospholipid syndrome in miscarriage, Guillain-Barré syndrome, and progression of human immunodeficiency virus after delivery. The studies appeared to support many of the acceptable off-label uses cited by various guideline groups. A total of 276 case reports were identified, with 268 reports representing 156 different off-label uses (362 patients). Seven meta-analyses were identified, evaluating recurrent miscarriage, in vitro fertilization failure, infection in preterm infants, multiple sclerosis, immune thrombocytopenic purpura, and pemphigoid. With the exception of recurrent miscarriage and infection in preterm infants, the off-label use of IVIG for these indications was associated with positive outcomes. An examination of IVIG guidelines by specialty society, payer, and other review organizations revealed that the biomedical evidence supporting off-label uses is being interpreted in different ways. Health care institutions are strongly urged to approve and closely monitor specific uses of IVIG to reserve dwindling supplies for the "best-evidence" uses. Clinicians should be aware of the limits of knowledge in many off-label uses and exercise restraint in prescribing for unproven indications., Conclusion: A literature review identified more than 150 unlabeled uses of IVIG. The evidence for these uses is being interpreted in different ways by various reviewing organizations.

This paper analyzes a sample interventional cardiologist's demographic, academic, and professional characteristics to provide an understanding of their technological device adoption styles. The study sample consisted of 15 physicians from two large Midwestern hospitals, one an academic medical center and the other a medium-sized community hospital. Interventional cardiologists were identified through their online physician profile and respective departments. A questionnaire was developed to assess each physician's self-perceived adoption style, their awareness of the new technology, their participation in clinical trials, organizational support, and how various factors influence their adoption of new technology. Lastly, a database of bare metal and drug eluting stents was examined to document the number of stents used by each physician. Pragmatic and observational findings are presented from the questionnaire, physician profile, to database on stent use. The paper concludes with a discussion of the managerial and forecasting implications and methods to promote technology adoption.

Gene therapy is envisioned as a potentially definitive treatment for a variety of diseases that have a genetic etiology. We reviewed trials of clinical gene therapy for nonmalignant, single-gene, and multifactorial disorders and infectious diseases, and found limited evidence suggesting that gene therapy may benefit patients who have severe, combined, immunodeficiency disorder; cystic fibrosis; coronary artery disease or peripheral arterial disease; or hemophilia. Effective gene therapy requires the targeted transfer of exogenous genetic material into human cells and the subsequent regulated expression of the corresponding gene product. Because no phase 3 randomized controlled trials have been completed that fulfill these criteria, it is difficult to correlate signs of clinical benefit with the administration of gene therapy in any disease. Additional clinical and basic research is needed to determine the future role of gene therapy.

Objectives: Indications for the use of stents are evolving and their optimal place in therapy remains to be defined. The objective was to compare the 1-year clinical and economic outcomes of percutaneous transluminal coronary agioplasty (PTCA) with and without the use of stents., Methods: This retrospective database analysis was conducted using data from 60 US academic medical centers in 1996 and 1997. Outcomes of interest included in-hospital mortality (both on sentinel and readmission visits), readmission rates, revascularization procedures, length of stay, and the cost of sentinel and readmission hospitalization., Results: A total of 27,020 patients either did (n = 13,254) or did not (n = 13,766) receive coronary stents in conjunction with PTCA. The median cost of hospitalization for the stent group was about dollar 1,409 higher (mean, dollar 1,200) than the no-stent group and the length of stay was similar (4.3 days vs. 4.5 days, respectively, P = .2628). Mortality rates on readmission (0.9% stent vs. 0.8% no-stent, P = NS) did not differ. However, patients in the stent group had better mortality rates compared to the no-stent group during the sentinel visit (1.7% vs. 2.7%, P < .001). Stent use was not associated with a significantly lower risk of a revascularization procedure on readmission to the same institution (OR 0.95, 95% CI 0.87-1.04, P = .28)., Conclusions: Stents were associated with a 1% decrease of inpatient mortality during the sentinel visit without impacting length of stay or readmission rates. This advantage was associated with a dollar 1,409 higher median cost of hospitalization in the stent group.

Background: The role of intravenous immunoglobulin (IVIG) in treating a variety of diseases is controversial and under active investigation for at least two reasons: first, a severe shortage of IVIG products exists in the US; second, numerous off-label (not specified in the Food and Drug Administration [FDA]-approved label) uses for IVIG have been, and continue to be, described in the literature. However, most off-label uses are not supported by evidence from properly designed clinical trials., Objective: To assess inpatient use of IVIG in a sample of US academic health centers and to compare it with published evidence-based model guidelines for IVIG use., Methods: Data on the use of IVIG and subsequent clinical outcomes in 251 patients were collected prospectively from 12 institutions. Recommendations from consensus guidelines were used to categorize patients who received IVIG into one of four groups: labeled uses; off-label, recommended; off-label, recommended as alternative; and off-label, not recommended. Outcomes were scored according to guideline criteria., Results: One hundred seven patients (43%) received IVIG for indications contained in the FDA-approved product label, 130 patients (52%) received IVIG for off-label indications, and 14 (5%) received undefined treatment. Among all patients administered IVIG, 31 (12%) were treated for off-label recommended reasons; 64 (26%) received off-label recommended as alternative therapy; and 35 (14%) received off-label not recommended therapy, as defined by model guidelines. Outcomes were not significantly different between the groups., Conclusions: Our findings suggest that IVIG continues to be used to treat a wide variety of conditions not specified in the product label. Furthermore, a substantial proportion of the reported off-label uses are not recommended according to evidence-based guidelines.

Objective: To evaluate the status of transmyocardial laser revascularization (TMLR) from an evidence-based perspective to help hospitals make resource management decisions., Study Design: Qualitative systematic review of the clinical literature., Methods: We searched the reference databases MEDLINE, BIOSIS, EMBASE, SciSearch, and Current Contents to identify all articles related to TMLR published between January 1985 and March 1997. We collected, analyzed, and summarized clinical studies in evidence tables., Results: The cumulative evidence available in the medical literature regarding the safety and effectiveness of TMLR encompasses approximately 2000 patients treated worldwide, primarily those with medically refractory angina. Preliminary data suggest that TMLR has an acceptable survival rate and effectively relieves angina in approximately 75% of patients. Data showing improved myocardial perfusion, cardiac function, or prognosis are inconclusive. The mechanism by which TMLR relieves angina is not yet known., Conclusions: Early evidence regarding TMLR suggests it will be useful for treating patients with end-stage coronary artery disease. Definitive recommendations await critical analysis of the results of ongoing randomized clinical trials, post-market surveillance studies, and third-party payer acceptance.

Objective: To review the current literature regarding the role of recombinant human growth hormone (rhGH) in the treatment of AIDS-associated wasting and to briefly describe alternative therapies., Data Sources: A literature search was performed on MEDLINE and AIDSLINE for the period from January 1985 through September 1997. Key words used in the search strategy were growth hormone, human immunodeficiency virus, acquired immune deficiency syndrome, wasting, and weight gain., Study Selection and Data Extraction: All articles were considered for possible inclusion in this review. Abstracts were included only when they were judged to add critical information. Thereafter, the inclusion was restricted to English-language articles and abstracts on clinical trials and human studies in AIDS-associated wasting., Data Synthesis: Body wasting, characterized by an involuntary loss of body cell mass, is a well-recognized feature of many chronic diseases, including infection with HIV AIDS-associated wasting is a metabolic disorder characterized by weight loss, depletion of lean body mass (LBM), and preservation of body fat, leading to muscle weakness and organ failure. rhGH has been approved by the Food and Drug Administration for use in treating AIDS-associated wasting. The adverse event profile is similar to that of other rhGH products. The recommended dosage of rhGH is 4-6 mg administered by subcutaneous injection daily. It offers a more expensive alternative to appetite stimulants such as megestrol acetate and dronabinol., Conclusions: Trials with rhGH on the control of wasting in patients with AIDS have been encouraging, but with limited conclusive evidence of sustainable positive outcomes. Studies demonstrate that rhGH increases LBM and decrease adipose tissue, but how these translate into long-term outcomes such as decreased hospitalization, morbidity, and mortality has yet to be determined. A formal health economic assessment is needed to properly determine the impact of rhGH on the healthcare system.

Objective: To review the recently published medical literature for the practical and efficient use of muromonab-CD3 (OKT-3) and antithymocyte globulin (ATG) in renal transplantation., Data Sources: MEDLINE and EMBASE were searched (1985-February 1996). Key words used were antithymocyte globulin (ATG, Atgam), muromonab-CD3 (OKT-3, Orthoclone), and kidney transplantation. Thereafter, the search was restricted to English-language articles, clinical trials, and human studies., Study Selection and Data Extraction: The search was reviewed for articles of interest, and pertinent references from these articles were further reviewed to supplement the initial search. The review focused on antibody therapy as induction and/or rejection therapy in renal transplantation., Data Synthesis: Although ATG and OKT-3 are effective in delaying and reducing the occurrence of acute rejection, their impact on long-term graft survival has not been established. Improved graft survival has, however, been demonstrated in patients at high risk for rejection. These risks are described in the review. As first-line or steroid-resistant rejection therapy, ATG and OKT-3 have proven efficacious. Some studies have shown improved graft survival with OKT-3. Although serious infections may occur, OKT-3 has been shown to be effective in reversing rejections resistant to both steroids and ATG. Therefore, reserving OKT-3 for steroid- or ATG-resistant rejections may be preferred over the first-line use of OKT-3, which is limited by the development of antimurine antibodies with subsequent uses. However, the benefits of first-line antibody therapy may outweigh the risks of developing these antibodies in patients for whom high-dose steroids may not be the most appropriate treatment. Other factors that need to be considered are adverse effects, which appear to be lower with ATG, cost, and total hospital charges. The accuracy of treatment outcomes analysis among these studies is limited by variations in the immunosuppressive regimens of the study centers, doses of concomitant therapies, use of prophylactic antibiotics, and time to follow-up., Conclusions: While important benefits are realized from using antibody therapies in renal transplantation, their use is often associated with excess immunosuppression and increased treatment costs. Despite encouraging results from published trials, questions regarding the extent of their prophylactic use and impact on long-term outcomes need to be answered. The current literature contains no prospective, controlled, randomized comparisons of OKT-3 and ATG with standardized regimens of conventional immunosuppressive agents and antirejection protocols. The majority of studies use OKT-3 as part of the treatment protocol. Well-designed studies using ATG are lacking. Further research is needed to refine treatment protocols for ATG and OKT-3 to determine the optimal timing and dosing for these agents.

As health care costs continue to escalate, the assessment and management of medical technologies have become vitally important to health care providers. Evaluation and comparison of the safety, effectiveness, efficiency, cost, and clinical outcomes of new and existing technologies provide the critical information necessary to make appropriate clinical resource decisions in an increasingly cost-conscious environment. Technologies to be assessed include pharmaceuticals, devices, medical and surgical procedures, and health care delivery systems. Clinical trial results, literature reviews, expert opinions, and group consensus are used in preparing technology use decisions, which often include the preparation of background information, specific recommendations, use guidelines, and reimbursement analyses.

Objective: To characterize and evaluate hematopoietic colony-stimulating factor (CSF) use, including cost implications, in US academic health centers., Design: An observational study of patients who received granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) from September 1 to October 15, 1993., Setting: Thirty academic health centers in the US., Participants: Five hundred sixty-five patients were evaluated., Main Outcome Measures: The appropriateness of CSF use was assessed, based on consensus-derived indication guidelines and the Food and Drug Administration-approved product labeling. Indication, type of CSF, and dosage were considered in determining the appropriateness of CSF therapy., Results: Based on indication evaluation criteria, 71% of CSF use was appropriate, 7% was inappropriate, and 22% was unproven, although the majority of unproven use was deemed promising by the expert panel. Based on dosage evaluation criteria, 51% of CSF use was appropriate, 27% was inappropriate, and 22% was for promising and other unproven indications. More than 90% of the patients studied received G-CSF. Approximately 3.4% of patients who received G-CSF had an adverse event, compared with 22% of those who received GM-CSF. Approximately $791,000 was spent on CSF therapy in the 565 patients: $401,000 (51%) on appropriate indications and doses, $160,000 (20%) on inappropriate doses for appropriate indications, $124,000 (16%) on promising indications, and $106,000 (13%) on unproven or inappropriate indications., Conclusions: Substantial costs are incurred currently for CSF therapy without adequate literature support. Further studies are warranted to justify promising but unproven uses of CSFs, as well as to clarify proper dosing, monitoring, and relative safety of CSFs.

Using survey data collected from 24 University Hospital Consortium member institutions, this paper examines the role of pharmacy in quality-improvement and cost-reduction initiatives in academic health center intensive care units. The results illustrate that most institutions are not taking full advantage of the services a clinical pharmacy has to offer, and that using these services could improve the quality and cost-efficiency of care.

Objective: To develop contemporary, comprehensive guidelines for the appropriate and efficient use of albumin, nonprotein colloid, and crystalloid solutions., Design: A systematic, literature-based, consensus exercise employing a modified Delphi method., Participants: Thirty-one medical and allied health professionals from 26 University Hospital Consortium (Oak Brook, Ill) member institutions were initially chosen to participate. Participants were selected on the basis of their recognized research in the use of albumin, nonprotein colloid, and crystalloid solutions, and/or experience in the review of appropriateness of such use. A total of 24 participants completed the exercise., Main Outcome Measures: Group responses were statistically analyzed in an iterative consensus development process. Five separate questionnaire rounds were designed to establish criteria for the appropriate use of albumin, nonprotein colloid, and crystalloid solutions., Results: Consensus guidelines were developed outlining the appropriate use of these products for 12 clinical indications, including hemorrhagic shock, nonhemorrhagic (maldistributive) shock, hepatic resection, thermal injury, cerebral ischemia, nutritional intervention, cardiac surgery, hyperbilirubinemia of the newborn, cirrhosis and paracentesis, nephrotic syndrome, organ transplantation, and plasmapheresis., Conclusions: The Delphi method, a systematic, literature-based consensus process, was shown to be useful in the development of complex clinical practice guidelines for the use of albumin, nonprotein colloid, and crystalloid solutions. It is anticipated that the guidelines will assist health care providers to develop local institutional policies and procedures for the appropriate and efficient use of albumin and albumin alternatives. Institutions reviewing and updating existing local guidelines may use the University Hospital Consortium guidelines as a model for comparison.