Biomedical subjects

Glen T Schumock

Publications and source records attributed to Glen T Schumock.

At least 19 recordsLinked to original sources

PubMed2006

Monitoring of pharmacy staffing, workload, and productivity in community hospitals.

PURPOSE: The purpose of this survey was to identify and characterize pharmacy productivity monitoring systems used in community hospitals that were part of a national group purchasing organization (GPO). METHODS: A 50-item questionnaire was developed, pretested, and sent electronically to the directors of pharmacy at 242 member hospitals of Consorta, Inc., a national GPO. The questionnaire was designed to elicit information on (1) hospital pharmacy demographics, (2) systems used to measure hospital pharmacy productivity, and (3) staffing levels and workload. Hospital demographic data were also obtained for respondent and nonrespondent hospitals from the American Hospital Association's AHA Guide. Descriptive statistics, Student's t tests, and chi-square tests were used to characterize the data and compare respondents with nonrespondents. RESULTS: Responses were received from 110 hospitals (45.5%). No clinically significant differences were found when respondent and nonrespondent hospitals were compared based on AHA Guide data. The productivity workload ratios monitored most often by respondent hospitals were full-time equivalents (FTEs) per adjusted patient day, FTEs per dose dispensed, and FTEs per dose billed. Respondents reported a mean +/- S.D. of 21.90 +/- 18.83 actual FTEs and total doses dispensed, billed, or administered per year of 111,391.4 +/- 111,538.0. A major limitation of the productivity systems used in the hospitals was the inability of the systems to account for clinical services performed by the pharmacy staff. CONCLUSION: A survey of community hospitals indicated that although most engaged in productivity monitoring, systems for such measurement often failed to capture all relevant clinical workload data.

Hospitals, Community↗

PubMed2006

Projecting future drug expenditures--2006.

PURPOSE: Drug expenditure trends in 2004 and 2005, projected drug expenditures for 2006, and factors likely to influence drug costs are discussed. SUMMARY: Various factors are likely to affect drug costs, including drug prices, drugs in development, and generic drugs. In 2004 there was a continued moderation of the increase in drug expenditures. Drug expenditures increased by 8.7% from 2003 to 2004. Through the first nine months of 2005, expenditures increased by only 8.1% compared with 2004. This moderation can be attributed to several factors, including the continued trend toward higher prescription drug cost sharing for insured consumers, growing availability of generic drugs, and lack of "blockbuster" new drugs in recent years. Drug expenditures in 2006 will likely be influenced by similar factors, with few costly new products reaching the market, increased concern over product safety slowing the diffusion of those new agents that do reach the market, and several important patent expirations, leading to slower growth in expenditures. CONCLUSION: Forecasting and managing rising drug expenditures remains a challenge. Pharmacy managers must remain vigilant in monitoring drug costs in their health system and take a proactive role in pursuing efficient drug utilization. The dynamic health policy environment further complicates drug budgeting and must be considered, especially in integrated health systems responsible for managing inpatient, outpatient, and clinic drug costs. The comparison of health-system-specific data and trends with the national information presented in this article may provide a useful context when presenting institutional drug costs to senior management.

Biomedical Research↗

PubMed2005

Caveat medicus: consequences of federal investigations of marketing activities of pharmaceutical suppliers of prostate cancer drugs.

In the course of recent health care fraud investigations against TAP Pharmaceuticals (Lake Forest, IL) and AstraZeneca International (London, United Kingdom), each pled guilty to one violation of the Prescription Drug Marketing Act, settled claims related to alleged violations of the False Claims Act without admitting guilt, and paid fines, settlements for liabilities, and reimbursements of dollar 850 million and dollar 355 million, respectively. In a unique aspect of these cases, federal investigators brought criminal charges against 14 TAP employees and investigated the billing practices of several urologists. These investigations resulted in guilty pleas from both urologists and industry employees relative to the Prescription Drug Marketing Act or the False Claims Act and probationary sentences with payments of fines and restitution to the government for urologists who cooperated with federal investigations. One uncooperative urologist was found guilty of violating the Federal False Claims Act and sentenced to 6 months of home arrest, excluded from Medicare for 5 years, required to provide 600 hours of free medical care to indigent patients and patients covered by Medicare or Medicaid, and paid fines and restitution to the government. The cases against TAP and AstraZeneca have been followed by federal and state investigations of allegedly illegal marketing practices of other pharmaceutical firms and have resulted in negotiated settlements of dollar 3.8 billion and dollar 71.5 million, respectively. Believing that an Average Wholesale Price-based reimbursement system was an important driving factor for these marketing activities, Medicare has shifted to an Average Sales Price-based reimbursement system. This is expected to greatly impact the practice of outpatient oncology nationwide.

Antineoplastic Agents↗

PubMed2005

Costs and cost effectiveness of a health care provider-directed intervention to promote colorectal cancer screening among Veterans.

PURPOSE: Colorectal cancer screening is underused, particularly in the Veterans Affairs (VA) population. In a randomized controlled trial, a health care provider-directed intervention that offered quarterly feedback to physicians on their patients' colorectal cancer screening rates led to a 9% increase in colorectal cancer screening rates among veterans. The objective of this secondary analysis was to assess the cost effectiveness of the colorectal cancer screening promotion intervention. METHODS: Providers in the intervention arm attended an educational workshop on colorectal cancer screening and received confidential feedback on individual and group-specific colorectal cancer screening rates. The primary end point was completion of colorectal cancer screening tests. Sensitivity analyses investigated cost-effectiveness estimates varying the data collection methods, costs of labor and technology, and the effectiveness of the intervention. RESULTS: Rates of colorectal cancer screening for the intervention versus control arms were 41.3% v 32.4%, respectively (P < .05). The incremental cost-effectiveness ratio was dollar 978 per additional veteran screened based on feedback reports generated from manual review of records. However, if feedback reports could be generated from information technology systems, sensitivity analyses indicate that the cost-effectiveness estimate would decrease to dollar 196 per additional veteran screened. CONCLUSION: An intervention based on quarterly feedback reports to physicians improved colorectal cancer screening rates at a VA medical center. This intervention would be cost effective if relevant data could be generated by existing information technology systems. Our findings may have broad applicability because a 2005 Medicare initiative will provide the VA electronic medical record system as a free benefit to all US physicians.

Aged↗

PubMed2005

The Research on Adverse Drug Events and Reports (RADAR) project.

CONTEXT: In 1998, a multidisciplinary team of investigators initiated RADAR (Research on Adverse Drug events And Reports), a clinically based postmarketing surveillance program that systematically investigates and disseminates information describing serious and previously unrecognized adverse drug and device reactions (ADRs). OBJECTIVE: To describe the structure, operations, and preliminary findings from the RADAR project and related dissemination efforts by pharmaceutical suppliers and the US Food and Drug Administration (FDA). DESIGN: After identifying a serious and unexpected clinical event suitable for further investigation, RADAR collaborators postulated clinical hypotheses and derived case series and incidence estimates from physician queries, published and unpublished clinical trials, published case reports, FDA databases, and manufacturer sales figures. RESULTS: RADAR investigators identified 16 types of serious ADRs among 1699 patients, of whom 169 (10%) died as a result of the reaction. Initial cases were identified by 7 RADAR investigators, 4 collaborating physicians, 2 attorneys, and by reviewing 3 published reports. Additional sources included queries of occupational health programs and medical directors of interventional cardiology laboratories (3 types of ADRs), published manuscripts and clinical trials (11 types of ADRs), review of medical records at a RADAR site (2 types of ADRs), unpublished clinical trial reports (3 types of ADRs), and reports from attorneys, family members, or patients (4 types of ADRs). Incidence estimates, ranging from 0.4% to 33%, were derived from 5 clinical trial reports, 2 physician queries, and 2 observational databases. Laboratory support for hypotheses included identification of 3 neutralizing antibodies and 3 histopathological findings. ADR reports were disseminated as 8 revised package inserts, 7 "dear doctor" letters, and 9 peer-reviewed articles. CONCLUSION: A new, clinically based, hypothesis-driven approach to postmarketing surveillance may supplement existing regulatory surveillance systems and improve patient safety.

Adverse Drug Reaction Reporting Systems↗

PubMed2005

Opportunities for disease state management in prostate cancer.

In this paper, we examine how the management of prostate cancer lends itself to a disease state management (DSM)-based approach, and propose a framework that emphasizes the patient-provider-caregiver triad in managing the long-term implications of the condition. There is often no clearly superior approach to the management of patients with prostate cancer (eg, watchful waiting and hormonal therapy), and each option entails different trade-offs in quality of life. Ideally, the physician and patient discuss the options, issues, and patient preferences for treatment through the shared decision-making process. A family caregiver such as the spouse of the patient is often involved in the treatment decision and in the long-term management of the cancer experience. In order to develop a DSM program supporting both patient and caregiver, educational, psychosocial, and health care system support needs should be tailored to each phase of cancer treatment/management. To embrace the unique aspects of prostate cancer management, the proposed framework emphasizes communication among the patient-caregiver-provider triad, inclusion of family caregivers in the program, cancer phase-specific support, and psychosocial services as a basis for implementation and evaluation of a DSM program in prostate cancer.

Delivery of Health Care↗

PubMed2005

Factors that influence prescribing within a therapeutic drug class.

RATIONALE, AIMS AND OBJECTIVES: The decision to prescribe one drug instead of another within the same therapeutic class may be influenced by a variety of drug-related, direct, or indirect factors; but little is known about which considerations are most important in such choices. The low-molecular-weight heparins (LMWHs) represent a class of drugs that are commonly used and for which therapeutic equivalence has been debated in the literature. The purpose of this study was to identify and compare factors perceived by doctors and clinical pharmacists to be influential in prescribing decisions among LMWHs. METHODS: Doctors and clinical pharmacists were interviewed to elicit information and to rank factors that influence the prescribing and use of LMWHs in community hospitals in the United States. For each factor, the mean and median of the rating were determined along with the frequency distribution across ratings. The non-parametric Mann-Whitney U-test was used to examine differences between doctors and clinical pharmacists. RESULTS: Both groups considered efficacy, formulary status, and policies restricting drug use to be highly influential in the decision to use one LMWH instead of another. Compared to clinical pharmacists, doctors rated personal experience as more influential, whereas they rated drug cost and prescribing guidelines lower. CONCLUSIONS: These findings suggest that doctors and clinical pharmacists differentiate between LMWHs based on differences between products and because of hospital administrative programs (such as drug formularies). This information may be of value in designing programs to alter medication use.

Choice Behavior↗

PubMed2005

Granulocyte colony--stimulating factor for chemotherapy-induced neutropenia in patients with small cell lung cancer : the 40% rule revisited.

Recombinant granulocyte colony-stimulating factor (G-CSF) [filgrastim and lenograstim] and pegylated G-CSF (pegfilgrastim) have been shown to reduce the severity and duration of chemotherapy-associated febrile neutropenia (FN) when administered prophylactically to cancer patients receiving chemotherapeutic regimens. The American Society of Clinical Oncology (ASCO) evidence-based clinical guidelines published in 1994, 1996 and 1997 recommended primary prophylaxis with G-CSF for cancer patients. The 2000 ASCO update, with the same recommendation, highlights the importance of economic considerations in decision making for CSFs. This paper reviews the available cost-effectiveness evidence on the use of G-CSF as primary prophylaxis against FN in patients with small cell lung cancer (SCLC).Cost-effectiveness ratios from a healthcare payer perspective supported the use of filgrastim as primary prophylaxis for people with SCLC, on the basis of both clinical and economic benefits, treated with chemotherapeutic regimens that have an FN rate in the range of 40-60%. However, when indirect and patient out-of-pocket costs attributable to severe FN are included, available evidence suggests that the risk threshold may be reduced by more than half. Given that FN rates associated with chemotherapeutic regimens for SCLC are generally <40%, then few circumstances would warrant the use of G-CSFs (filgrastim and lenograstim) under the current rule. However, inclusion of indirect costs would lower the cost-effectiveness threshold. Future cost-effectiveness studies of medications such as pegfilgrastim should attempt to capture the societal perspective by incorporating productivity-related costs and using base-case rates of FN reported in the literature.

Antineoplastic Agents↗

PubMed2004

Pure red-cell aplasia and epoetin therapy.

BACKGROUND: Between 1988 and 1998, antibody-associated pure red-cell aplasia was reported in three patients who had undergone treatment with recombinant human erythropoietin (epoetin). Between 1998 and 2000, 13 such cases were reported from France--12 in patients who had received the Eprex formulation of epoetin alfa and 1 in a patient who had received Neorecormon (a formulation of epoetin beta); both are products that are marketed outside the United States. METHODS: We obtained reports of epoetin-associated pure red-cell aplasia from the Food and Drug Administration and from the manufacturers of Eprex, Epogen (another formulation of epoetin alfa), and Neorecormon. The numbers of case reports and estimates of exposure-adjusted incidence were analyzed according to the product, the cause of anemia, the route of administration, the country in which pure red-cell aplasia was identified, and the date on which pure red-cell aplasia was reported. RESULTS: Between January 1998 and April 2004, 175 cases of epoetin-associated pure red-cell aplasia were reported for Eprex, 11 cases for Neorecormon, and 5 cases for Epogen. Over half these cases had occurred in France, Canada, the United Kingdom, and Spain. Between 2001 and 2003, the estimated exposure-adjusted incidence was 18 cases per 100,000 patient-years for the Eprex formulation without human serum albumin, 6 per 100,000 patient-years for the Eprex formulation with human serum albumin, 1 case per 100,000 patient-years for Neorecormon, and 0.2 case per 100,000 patient-years for Epogen. After procedures were adopted to ensure appropriate storage, handling, and administration of Eprex to patients with chronic kidney disease, the exposure-adjusted incidence decreased by 83 percent worldwide. CONCLUSIONS: After the peak incidence of Eprex-associated pure red-cell aplasia was reached in 2001, interventions designed in response to drug-monitoring programs worldwide resulted in a reduction of more than 80 percent in the incidence of pure red-cell aplasia due to Eprex.

Adolescent↗

PubMed2004

Impact of prescribing guidelines for inpatient anticoagulation.

BACKGROUND: Anticoagulants are widely used and represent a class of drugs that are problem-prone and have a high potential for adverse patient outcomes. As such, these drugs may be amenable to the use of prescribing guidelines. However, relatively little has been published on the effect of such guidelines on clinical outcomes or costs of care. OBJECTIVE: To assess whether guidelines improve the appropriateness of prescribing, clinical outcomes, and costs associated with use of anticoagulants in a sample of community hospitals in the US. METHODS: A retrospective analysis was performed of data voluntarily collected by 15 hospitals before (July-September 2001) and after (March-May 2002) implementation of anticoagulant prescribing guidelines. Statistical analyses of both patient- and hospital-level variables were conducted. RESULTS: Implementation of the guidelines resulted in a significant increase in the proportion of anticoagulants that were prescribed appropriately (59.8% vs 86.9%; p < 0.001). The guidelines also resulted in a shift in the type of anticoagulants prescribed (decreased use of unfractionated heparin and increased use of low-molecular-weight heparins). There was suggestive evidence, although not statistically significant, that the guidelines resulted in fewer anticoagulant-associated adverse events (total bleeding RR 0.71) and lower costs (savings of $56.15 per patient per day). CONCLUSIONS: While limitations existed with the study design, sufficient benefits were identified to warrant hospitals to consider use of these or similar guidelines on a routine basis. Clearly, additional study in this area would be useful.

Adolescent↗

PubMed2004

Guidelines for acute decompensated heart failure treatment.

OBJECTIVE: To describe the development of guidelines for the treatment of acute decompensated heart failure (ADHF) in the emergency department/observation unit (ED-OU) setting for hospitals that are part of a group purchasing organization (GPO). DATA SOURCES: A MEDLINE search (1966-March 2003) using the following search terms: cardiotonic agents; diuretic; dobutamine; heart failure, congestive; milrinone; natriuretic peptide, brain; nesiritide; nitroglycerin; vasodilator agents, was conducted. STUDY SELECTION AND DATA EXTRACTION: Relevant articles in the English language were identified. All randomized studies and meta-analyses for each category of drugs were included. DATA SYNTHESIS: A group consensus method was used to develop guidelines. An expert panel reviewed and revised the guidelines. The final guidelines were approved June 1, 2003, and are described here. They are organized based upon a patient's symptomatology at the time the diagnosis of ADHF is made. Patients with evidence of volume overload require intravenous diuretics and/or intravenous vasodilators to alleviate the symptoms of ADHF. Patients with signs and symptoms of low cardiac output require inotropic support to manage their ADHF. A timeline for diagnosis, treatment, reassessment, and disposition is provided and encourages an early, aggressive approach to treating patients with ADHF. CONCLUSIONS: Hospitalization for ADHF is common and costly. Consensus guidelines for the treatment of ADHF did not previously exist, resulting in inconsistent and inefficient treatment. Consequently, hospitals struggling with the treatment of ADHF may find these guidelines and the process by which they were developed useful.

Acute Disease↗

PubMed2004

Factors that influence prescribing decisions.

BACKGROUND: Strategies to control the quality and cost of medication use are largely dependent on the ability to alter selection of medications. Previous models of prescribing behavior have focused on physicians. In the hospital setting, clinical pharmacists and formulary committee members are also key players in drug therapy decision-making. Differences between physicians, formulary committee members, and clinical pharmacists have not been compared. Knowledge of these differences could have importance in predicting the effectiveness of strategies designed to influence drug use in this setting. OBJECTIVE: To describe and compare the opinions of physicians, clinical pharmacists, and formulary committee members with respect to key factors that influence medication prescribing in community hospitals. METHODS: Physicians, clinical pharmacists, and formulary committee members were solicited to participate. A trained interviewer administered a standardized questionnaire designed to elicit opinions of participants regarding the importance of factors thought to influence drug prescribing. Responses were described using descriptive statistics, and differences between the groups were determined by post hoc analysis. RESULTS: A total of 150 individuals participated in the study. Safety, effectiveness, formulary status, and restrictions on prescribing were considered highly influential by all participants. Physicians rated the availability of drug samples and personal experience higher (more influential on prescribing) than clinical pharmacists and formulary committee members. Clinical pharmacists and formulary committee members rated the influence of recommendations by clinical pharmacists, prescribing guidelines, and cost or cost comparisons higher than physicians. Factors that were drug-related or that involved policy-related programs tended to be more influential than indirect factors. CONCLUSIONS: Those who seek to implement programs to alter medication use should recognize and employ factors that are most influential in the decision-making process. Further, it may be important to consider differences that exist between key participants in the medication use process.

Decision Making↗

PubMed2004

Impact of oral direct thrombin inhibitors on anticoagulation clinics.

OBJECTIVES: To characterize the services and activities performed by anticoagulation clinics (ACCs) across the United States, examine the anticipated impact that oral direct thrombin inhibitors (DTIs) will have on the clinical services of ACCs, and elicit possible management strategies to realign services provided by ACCs and opportunities for restructuring clinical services. METHODS: A survey was developed in consultation with content experts in the field, pretested by several ACC providers, and subsequently refined. Surveys were mailed to 400 randomly selected ACC-based providers. RESULTS: The final usable response rate was 34.5% (115 of 333 surveys). Respondents anticipated that the number of patient visits/month would decrease from a median of 336 (interquartile range [IQR] 151-775) to 150 (IQR 71-350, p<0.001) after the introduction of oral DTIs. In addition, time spent on many direct and indirect patient care activities currently performed by ACCs was expected to decline. Respondents indicated that ACCs may find new roles by providing guidance on individual suitability for therapy, managing the transition to oral DTIs, providing education for patients and health care providers on thrombotic disease state management, monitoring patients for recurrent thrombosis and risk of bleeding complications, monitoring patient compliance, and providing counseling and safety surveillance for patients receiving treatment with oral DTIs. CONCLUSION: The advent of oral DTIs is likely to have a significant impact on the structure and delivery of antithrombotic services. Clinics that are proactive and redesign their patient care services to consider emerging anticoagulant agents will be more likely to remain relevant and viable.

Administration, Oral↗

PubMed2003

Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports project.

PURPOSE: To describe the clinical findings, occurrence rates, causality evidence, and dissemination media for serious cancer drug-associated adverse drug reactions (ADRs) reported in the postmarketing setting. METHODS: ADRs were termed serious if they resulted in death or severe organ failure. ADR information for oncology drugs from package insert (PI) revisions, so-called Dear Doctor letters, and journal articles was evaluated to identify serious ADRs reported from 2000 to 2002. Timing and content of information disseminated was assessed. RESULTS: Twenty-five serious ADRs associated with 22 oncology drugs were identified after approval. Approximately half of these serious ADRs are associated with drugs approved before 1995. ADRs were described in articles in medical journals (17 ADRs), PI revisions (18 ADRs), and Dear Doctor letters (12 ADRs). PI revisions occurred less than 1 year after peer-reviewed publication for four ADRs. These revisions often differed for similar ADRs that occurred with drugs of the same class. Five of the seven ADRs lacking PI changes occurred with off-label use, for which PI change is not recommended by US Food and Drug Administration (FDA) policy. No cancer drug was withdrawn from the market during the observation period. CONCLUSION: Our findings demonstrate that serious ADRs may be discovered as long as 36 years after a drug receives FDA approval. This suggests a need for continued vigilance and efficient strategies for dissemination of information about ADRs associated with cancer drugs.

Adverse Drug Reaction Reporting Systems↗

PubMed2003

Penetration of medication safety technology in community hospitals.

Results of a survey of medication safety technology in community hospitals are presented. A written questionnaire was mailed to pharmacy directors at 88 hospitals located in 21 states. Items in the questionnaire addressed current and planned use of technology intended to improve medication safety. Fifty-six usable responses were received for a response rate of 63.6%. Medication safety was considered one of the most important issues facing pharmacy departments. Barriers identified by respondents to the implementation of medication safety initiatives included lack of time and personnel. Most hospitals had implemented one or more different types of medication safety technology. Computer-generated or electronic medication administration records, pharmacy computer systems interfaced with laboratory values, and unit-based medication dispensing cabinets were the most common medication safety technologies used. Pharmacy managers perceived these technologies to have resulted in a reduction in the rate of medication errors in respondent hospitals.

Hospitals, Community↗

PubMed2003

Evidence of the economic benefit of clinical pharmacy services: 1996-2000.

We sought to summarize and assess original evaluations of the economic impact of clinical pharmacy services published from 1996-2000, and to provide recommendations and methodologic considerations for future research. A systematic literature search was conducted to identify articles that were then blinded and randomly assigned to reviewers who confirmed inclusion and abstracted key information. Results were compared with those of a similar review of literature published from 1988-1995. In the 59 included articles, the studies were conducted across a variety of practice sites that consisted of hospitals (52%), community pharmacies and clinics (41%), health maintenance organizations (3%), and long-term or intermediate care facilities (3%). They focused on a broad range of clinical pharmacy services such as general pharmacotherapeutic monitoring (47%), target drug programs (20%), disease management programs (10%), and patient education or cognitive services (10%). Compared with the studies of the previous review, a greater proportion of evaluations were conducted in community pharmacies or clinics, and the types of services evaluated tended to be more comprehensive rather than specialized. Articles were categorized by type of evaluation: 36% were considered outcome analyses, 24% full economic analyses, 17% outcome descriptions, 15% cost and outcome descriptions, and 8% cost analyses. Compared with the studies of the previous review, a greater proportion of studies in the current review used more rigorous study designs. Most studies reported positive financial benefits of the clinical pharmacy service evaluated. In 16 studies, a benefit:cost ratio was reported by the authors or was able to be calculated by the reviewers (these ranged from 1.7:1-17.0:1, median 4.68:1). The body of literature from this 5-year period provides continued evidence of the economic benefit of clinical pharmacy services. Although the quality of study design has improved, whenever possible, future evaluations of this type should incorporate methodologies that will further enhance the strength of evidence of this literature and the conclusions that may be drawn from it.

Cost-Benefit Analysis↗

PubMed2003

A structured review of the relationship between microalbuminuria and cardiovascular events in patients with diabetes mellitus and hypertension.

STUDY OBJECTIVE: To quantify the relative risk of cardiovascular events associated with microalbuminuria in patients with both diabetes mellitus and hypertension. DESIGN: A structured literature search from January 1990-December 2002 using MEDLINE, IPA, and CINAHL. MEASUREMENTS AND MAIN RESULTS: We identified original studies that reported the presence or absence of microalbuminuria and estimates of risk associated with cardiovascular events in patients with both diabetes and hypertension. Abstracted information consisted of study design, patient demographics and risk factors, treatment regimens, and outcome variables. Point estimates and confidence intervals for relative risk were calculated from available data. Of 651 citations identified and reviewed based on title and abstract, 72 were selected for full review. Seven met the inclusion criteria. Because of lack of homogeneity among studies, the results were not conducive to pooling. Cardiovascular end points associated with the presence of microalbuminuria in these studies were all-cause mortality, cardiovascular mortality, and composite cardiovascular morbidity. The relative risk of cardiovascular end points associated with the presence of microalbuminuria ranged from 1.6 (95% confidence interval [CI] 1.2-2.2) to 7.9 (95% CI 2.5-25.3). CONCLUSION: From the limited information available, the risk of cardiovascular events and mortality is estimated to be 2-8 times higher when microalbuminuria is present in patients with diabetes and hypertension. Point estimates in relative risk of cardiovascular morbidity and mortality in patients with diabetes and hypertension were generally higher compared with studies estimating risk in those with only diabetes. Studies that examine the relationship between microalbuminuria (scaled as a continuous or ordinal variable) and cardiovascular events are necessary to clarify potential benefits of pharmacotherapies that reduce levels of urinary albumin.

Albuminuria↗

PubMed2003

Cost analyses of adjunct colony stimulating factors for older patients with acute myeloid leukaemia : can they improve clinical decision making?

Colony stimulating factors (CSF) have been shown to reduce the duration of neutropenia following intensive chemotherapy in a variety of settings, with many of these studies targeting older patients with leukaemia. We review the clinical and economic findings for use of growth factors for older adults with acute myelogenous leukaemia (AML). The cost analyses were based on the perspective of the third party payer. One study, conducted by the Southwest Oncology Group (SWOG) randomised 207 AML patients to receive granulocyte colony-stimulating factor (G-CSF) or placebo and found no significant difference in number of infections and in days of hospitalisation, 3 fewer days with an absolute neutrophil count <500 cells/microL with G-CSF, and an estimated incremental cost of only US 120 dollars with G-CSF over placebo (1997 costs). A second study, conducted by the Eastern Cooperative Oncology Group (ECOG), randomised 119 AML patients to receive granulocyte-macrophage colony-stimulating factor (GM-CSF) or placebo and found a reduction in severe infections, 4 fewer days with an absolute neutrophil count <500 cells/microL, no significant difference in the duration of hospitalisation, and estimated cost savings of US 2310 dollars with GM-CSF (1997 costs). These data may be useful to physicians faced with concerns over clinical and economic factors associated with CSF use as adjunct therapy for older persons with AML.

Aged↗