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At least 1,531 records · Page 85Linked to original sources
PubMed1999

Aerobic and anaerobic energy conversion during high-intensity exercise.

PURPOSE: The aim of the study is to compare data on anaerobic and aerobic energy conversion during exercise of high intensity leading to exhaustion. Several different data sources are used, including data extracted from mathematical analyses of world and Olympic running records, data from laboratory tests, and data based on biochemical information. METHODS: Theoretical relationships are derived and comparisons are made of the ratio of aerobic to total energy contributions as functions of time. RESULTS: The ratio is shown to depend not only on the duration of the high-intensity exercise but also in part on a factor lambda, which governs the rate of anaerobic and aerobic energy release. A further important factor is the value of the parameter Q/lambda, which is the ratio of anaerobic capacity to maximum sustainable aerobic power. Values in the range 55 s < Q/lambda < 72 s and 0.030 s(-1) < lambda < 0.042 s(-1) are shown to provide the best correlation of data. The results indicate that the ratio of maximal anaerobic power to maximum aerobic power lies in the range from 2.0 to 2.6. CONCLUSION: Data extracted from the mathematical models of running are generally more consistent than the body of experimental data. This may indicate that the inherent difficulties of laboratory techniques relating to the measurement of anaerobic energy conversion are giving rise to significant experimental errors.

Aerobiosis↗
PubMed1995

Administrative databases' complication coding in anterior spinal fusion procedures. What does it mean?

STUDY DESIGN: A review of a cohort of 310 consecutive patients who underwent anterior spinal fusion was performed to evaluate the accuracy of hospital ICD-9-CM complication coding. OBJECTIVES: To better understand the clinical significance of conclusions suggested by studies that rely on electronic administrative databases for their data source. SUMMARY OF BACKGROUND DATA: Despite their availability, there have been no studies to date that have evaluated the accuracy of ICD-9-CM administrative databases as they relate to the actual clinical experience in spinal procedures. METHODS: A physician and a research technician independently reviewed the primary medical records for the occurrence of complications. This data was compared with the hospital-acquired ICD-9-CM coded complications. RESULTS: The physician reviewer identified 152 complications in 119 patients, with 32 different types of complications. The research abstracter identified 175 complications in 130 patients, with 34 different types of complications identified. Hospital ICD-9-CM coding identified 105 complications in 80 patients, including only 11 different ICD-9-CM codes. Overall, 27% of ICD-9-CM complication codes were listed as "unspecified or unclassified complications, reactions, or misadventures," and contained no meaningful clinical information. Cardiac and pulmonary complications were over-estimated and wound infections and genitourinary and gastrointestinal complications were underestimated by ICD-9-CM coding. CONCLUSIONS: Studies of complications of spinal procedures using data derived from hospital ICD-9-CM complication codes may be intrinsically flawed because the data available to researchers from these electronic databases may be inaccurate.

Adolescent↗
PubMed2003

Coagulation, fibrinolysis, and fibrin deposition in acute lung injury.

OBJECTIVES: To review: a) the role of extravascular fibrin deposition in the pathogenesis of acute lung injury; b) the abnormalities in the coagulation and fibrinolysis pathways that promote fibrin deposition in the acutely injured lung; and c) the pathways that contribute to the regulation of the fibrinolytic system via the lung epithelium, including newly recognized posttranscriptional and urokinase-dependent pathways. Another objective was to determine how novel anticoagulant or fibrinolytic strategies may be used to protect against acute inflammation or accelerated fibrosis in acute lung injury. DATA SOURCES: Published medical literature. DATA SUMMARY: Alveolar fibrin deposition is characteristic of diverse forms of acute lung injury. Intravascular thrombosis or disseminated intravascular coagulation can also occur in the acutely injured lung. Extravascular fibrin deposition promotes lung dysfunction and the acute inflammatory response. In addition, transitional fibrin in the alveolar compartment undergoes remodeling leading to accelerated pulmonary fibrosis similar to the events associated with wound healing, or desmoplasia associated with solid neoplasms. In acute lung injury, alveolar fibrin deposition is potentiated by consistent changes in endogenous coagulation and fibrinolytic pathways. Procoagulant activity is increased in conjunction with depression of fibrinolytic activity in the alveolar compartment. Initiation of the procoagulant response occurs as a result of local overexpression of tissue factor associated with factor VII. Depression of fibrinolytic activity occurs as a result of inhibition of urokinase plasminogen activator (uPA) by plasminogen activators, or series inhibition of plasmin by antiplasmins. Locally increased amplification of plasminogen activator inhibitor-1 (PAI-1) is largely responsible for this fibrinolytic defect. Newly described pathways by which lung epithelial cells regulate expression of uPA, its receptor uPAR, and PAI-1 at the posttranscriptional level have been identified. These pathways operate by cis-trans interactions between mRNA binding proteins; regulatory sequences within these mRNAs control their stability. The regulatory mechanisms seem to involve multiple protein-mRNA interactions, and the phosphorylation state of the proteins appears to determine whether complex formation of, or dissociation from, the regulatory sequences occurs. uPA is capable of inducing its own expression in lung epithelial cells as well as that of uPAR and PAI-1-the effects involve posttranscriptional regulatory components. These and related observations have led to the implementation of anticoagulant or fibrinolytic strategies to protect the lung against acute lung injury. The success of new fibrinolytic strategies to block pleural loculation suggests that a similar approach might be used to prevent accelerated pulmonary fibrosis, which can occur in association with many forms of acute lung injury. CONCLUSIONS: Disordered coagulation and fibrinolysis promote extravascular fibrin deposition in acute lung injury. It is this deposition that characterizes acute lung injury and repair. Expression of uPA, uPAR, and PAI-1 by the lung epithelium, as well as the ability of uPA to induce other components of the fibrinolytic system, involves posttranscriptional regulation. These pathways may contribute to disordered fibrin turnover in the injured lung. The success of anticoagulant or fibrinolytic strategies designed to reverse the abnormalities of local fibrin turnover in acute lung injury supports the inference that abnormalities of coagulation, fibrinolysis, and fibrin deposition have a critical role in the pathogenesis of acute lung injury.

Animals↗
PubMed2004

Leukocyte and endothelial cell interactions in sepsis: relevance of the protein C pathway.

OBJECTIVE: To give an overview of leukocyte and endothelial cell interactions in sepsis and to explore the role of the protein C pathway in modulating the innate immune response via its anti-inflammatory properties. DATA SOURCE: Novel in vitro data and a MEDLINE search for the terms "activated protein C," "recombinant human activated protein C," "inflammation," "leukocyte adhesion," and "sepsis" were used, along with clinical trial databases from the PROWESS trial and a phase I human endotoxin trial evaluating recombinant human activated protein C (drotrecogin alfa [activated]). DATA EXTRACTION AND SYNTHESIS: The protein C pathway is positioned at the interface between the endothelium and the leukocyte response of the innate immune system. Activated protein C (APC) possesses profibrinolytic, anti-inflammatory, and anti-apoptotic properties, acting as an endothelial cell and microvascular modulator in opposition to thrombin and the proinflammatory cytokines. Distribution of the receptor for APC, endothelial protein C receptor, was detected on effector cells of the innate immune response. This suggests a further role for the protein C pathway in regulating inflammation. In neutrophils and eosinophils, an endothelial protein C receptor-mediated APC response leads to reduced migration in response to cytokine gradients. Endothelial protein C receptor may also suppress the apoptotic response in monocytes and enhance the expression of the adhesion integrin CD11b in granulocytes. The microvascular, anti-inflammatory influence of APC in sepsis is supported by suppression of endothelial cell adhesion molecules and the ability of APC to protect the endothelium from inflammatory insult. CONCLUSIONS: The coordinated effects of the protein C pathway on the endothelium and the leukocyte response of the innate immune system are supported by potential restriction of endothelial protein C receptor expression to cells of the innate immune system and by suppression of adhesion molecule expression on the endothelium by APC. Reduced neutrophil migration in response to cytokines is also mediated by endothelial protein C receptor. Further clinical studies will be needed to define the intrinsic role of the protein C pathway in coordinating the innate immune response in endothelium-based inflammation.

Animals↗
PubMed2006

Economics of critical care: Medicare part A versus part B payments.

OBJECTIVE: To review the effect of Medicare part A payments (to hospitals) and part B payments (to providers) on critical care in the United States. DATA SOURCE AND SELECTION: Sources included U.S. government data and published literature reviewing the impact of Medicate payments on critical care. DATA EXTRACTION AND SYNTHESIS: Government data were reviewed to assess the history and status of reimbursement to hospitals and healthcare providers. These data, along with input from published literature, was used to assess the adequacy of current and projected Medicare reimbursements and the implications of these payments. CONCLUSION: Medicare payments to hospitals, particularly for critically ill patients, seem to fall short of the costs of caring for these patients. Reimbursements to providers seem more encouraging, although the opportunity exists to improve in this area as well.

Critical Care↗
PubMed2006

Facts and fallacies concerning the prevention of contrast medium-induced nephropathy.

OBJECTIVE: The aim of this article is to extract from recent medical literature and nephrologic practice the facts and fallacies concerning the possible prophylaxis of contrast medium-induced nephropathy. DATA SOURCES, STUDY SELECTION, AND DATA EXTRACTION: A MEDLINE/PubMed search (1985 to January 2006) was conducted, including all relevant articles investigating the pathogenesis and prevention of contrast medium-induced nephropathy from a nephrologic critical point of view. DATA SYNTHESIS: Considerable efforts have been made to develop pharmacologic therapy for the prevention of contrast medium-induced nephropathy, especially in patients at risk, such as elderly subjects and those with preexisting renal impairment, hypovolemia, or dehydration. There is general consensus that hydration protocols implemented before and after imaging with contrast medium may be effective in preventing contrast medium-induced nephropathy. However, definitive and convincing data related to amounts to be infused, infusion timing, and type of solutions (half-isotonic, isotonic saline solution, or bicarbonate) are lacking. Forced diuresis with furosemide or mannitol and use of dopamine, together with concomitant hydration, have been proved to be ineffective or even more risky in the event of inadequate maintenance of euvolemia. Various direct or indirect vasodilators have been investigated (atrial natriuretic peptide, calcium channel blockers, angiotensin-converting enzyme inhibitors, and endothelin receptor antagonists), yet results have been inconsistent and inconclusive. Recent large meta-analyses concerning the protective role of antioxidant action of N-acetylcysteine have led to the conclusion that the statistical significance of the results is borderline. Preventive hemodialysis has not proved to be useful; on the contrary, it might worsen the clinical conditions by inducing hypotension. Hemofiltration, despite some positive studies, is too complex and cannot be used extensively. CONCLUSIONS: : It is believed that prevention is actually achieved by correcting hypovolemia, dehydration, or both. Normalization of body fluids is probably the true objective to be achieved by preventive measures in all patients, not only in those at risk. Because limited data have been collected in intensive care units, at present, no firm or specific recommendations can yet be provided for the critically ill.

Animals↗
PubMed2004

The epidemiology of serious and fatal injury in San Diego County over an 11-year period.

BACKGROUND: Analysis of the mechanism and severity of injury over time may permit a more focused planning of acute care and trauma prevention programs. METHODS: A retrospective, population-based study examining severe traumatic injury in a single county was undertaken. Three overlapping data sets were used to form a composite injury data set. RESULTS: There were 55,664 patients included in the study. A total of 40,897 (73.5%) patients survived and 14,767 (26.5%) died. Of those patients who died, 8,910 (60.3%) died in the field and were not transported to a trauma center. There was an increase in the mean age of all trauma victims (3 years) and an increase of 5 years in fatally injured patients. The mean Injury Severity Score decreased from 14.7 to 11.6 (p < 0.01); however, Injury Severity Score for fatal patients remained constant (39.7). The overall injury rate remained unchanged (195 per 10(5)), whereas the fatal injury rate decreased by 22% (45.9 per 10(5)) over the 11-year study period. The leading cause of injury was motor vehicle crash, followed by assault. The leading cause of fatal injury was suicide, followed by homicide. CONCLUSION: A combination of three independent injury data sources generated a composite data set of serious and fatal injury. This regional injury analysis was the most comprehensive overview of injury in our region. Important observations included the following: there has been no change in the overall incidence of severe injury within our county; the incidence of fatal traumatic injury has significantly decreased; the leading causes of nonfatal injury do not correlate with the rank order of fatal injury; intentional injury was the leading cause of injury deaths; and scene fatalities represent a poorly studied group of patients who may benefit from primary prevention and injury control research.

Accidents, Traffic↗
PubMed2003

Effectiveness and cost-effectiveness of four treatment modalities for substance disorders: a propensity score analysis.

OBJECTIVE: To assess the effectiveness and cost-effectiveness of four treatment modalities for substance abuse. DATA SOURCES: The study used data from the Services Research Outcomes Study (SROS), a survey of 3,047 clients in a random sample of 99 drug treatment facilities across the United States. Detailed sociodemographic, substance use, and clinical data were abstracted from treatment records. Substance abuse outcome and treatment history following discharge from index facilities were assessed using a comprehensive interview with 1,799 of these individuals five years after discharge. Treatment success was defined in two ways: as abstinence and as any reduction in substance use. STUDY DESIGN: Effectiveness and cost-effectiveness of four modalities were compared: inpatient, residential, outpatient detox/methadone, and outpatient drug-free. Clients were stratified based on propensity scores and analyses were conducted within these strata. Sensitivity analyses examined the impact of future substance abuse treatment on effectiveness and cost-effectiveness estimates. PRINCIPAL FINDINGS: Treatment of substance disorders appears to be cost-effective compared to other health interventions. The cost per successfully treated abstinent case in the least costly modality, the outpatient drug-free programs, was 6,300 dollars (95 percent confidence intervals: 5,200-7,900 dollars) in 1990 dollars. There were only minor differences between various modalities of treatment with regard to effectiveness. However, modalities varied considerably with regard to cost-effectiveness. Outpatient drug-free programs were the most cost-effective. There was little evidence that relative effectiveness or cost-effectiveness of programs varied according to factors that were associated with selection into different programs. CONCLUSIONS: Substance disorders can be treated most cost-effectively in outpatient drug-free settings. Savings from transitioning to the most cost-effective treatment modality may free resources that could be reinvested to improve access to substance abuse treatment for a larger number of individuals in need of such treatment.

Adult↗
PubMed2003

Developing and testing a model to predict outcomes of organizational change.

OBJECTIVE: To test the effectiveness of a Bayesian model employing subjective probability estimates for predicting success and failure of health care improvement projects. DATA SOURCES: Experts' subjective assessment data for model development and independent retrospective data on 221 healthcare improvement projects in the United States, Canada, and The Netherlands collected between 1996 and 2000 for validation. METHODS: A panel of theoretical and practical experts and literature in organizational change were used to identify factors predicting the outcome of improvement efforts. A Bayesian model was developed to estimate probability of successful change using subjective estimates of likelihood ratios and prior odds elicited from the panel of experts. A subsequent retrospective empirical analysis of change efforts in 198 health care organizations was performed to validate the model. Logistic regression and ROC analysis were used to evaluate the model's performance using three alternative definitions of success. DATA COLLECTION: For the model development, experts' subjective assessments were elicited using an integrative group process. For the validation study, a staff person intimately involved in each improvement project responded to a written survey asking questions about model factors and project outcomes. RESULTS: Logistic regression chi-square statistics and areas under the ROC curve demonstrated a high level of model performance in predicting success. Chi-square statistics were significant at the 0.001 level and areas under the ROC curve were greater than 0.84. CONCLUSIONS: A subjective Bayesian model was effective in predicting the outcome of actual improvement projects. Additional prospective evaluations as well as testing the impact of this model as an intervention are warranted.

Bayes Theorem↗
PubMed1990

Restructuring: an emerging theory on the process of losing weight.

A qualitative research design (grounded theory) was used to analyse the experiences of dieters attending a weight loss programme. Two hundred hours of observations at a nationally known weight reduction centre, a review of selected documents from the organization and multiple in-depth interviews with 13 informants were the data sources for this study. Data generation took place over a 21-month period. A substantive theory of restructuring identified three stages in the process of losing weight. These stages and key elements of the weight loss process are presented.

Adaptation, Psychological↗
PubMed1981

The convenience sample as a source of data in the study of Down syndrome.

Epidemiologic and health care research on Down syndrome are frequently based on cases known to a specific hospital, clinic or social service agency. To determine if there are any systematic differences between such readily available cases and their birth cohort that might impair their use for research, we compared a total population of children with Down syndrome live-born in Montreal in 1975 and 1976 (n = 88) with two convenience samples drawn from this population: cases known to a hospital genetic counselling centre and cases participating in an early intervention programme. Complete information on maternal age and parity, birth weight and sex of child, presence or absence of congenital heart disease and residential placement was obtained for eighty-three members of the cohort. Analysis revealed that the cases known to the genetic counselling centre were more likely to have younger mothers caring for them at home than the remaining cases in the Down syndrome population; children participating in an early intervention programme were also more likely to be residing in their natural homes than those cases in the remaining comparison population. The majority of potential cases from the original population were not included in either case group. The findings suggest that "convenience" samples differ significantly from their parent population and that caution is required when applying data generated from selected groups to the remaining population.

Adolescent↗
PubMed2004

Factors associated with physician interventions to address adolescent smoking.

OBJECTIVE: To determine the percent of adolescent Medicaid patients with medical record documentation about tobacco use status and cessation assistance; and factors associated with providers documenting and intervening with adolescent smokers. DATA SOURCE: Secondary analysis of data collected in 1999 from medical records of Wisconsin Medicaid health maintenance organization (HMO) recipients 11 to 21 years old. STUDY DESIGN: Random reviews and data collection were related to visits from January 1997 to January 1999. Data collected included patient demographics, provider type, number of visits, and whether smoking status and cessation interventions were documented. DATA EXTRACTION METHODS: Medical charts were reviewed and a database was created using a data abstraction tool developed and approved by a committee to address tobacco use in Medicaid managed care participants. PRINCIPAL FINDINGS: Among adolescents seen by a physician from 1997 to 1999, tobacco use status was documented in 55 percent of patient charts. Most often tobacco use status was documented on history and physical or prenatal forms. Of identified adolescent smokers, 50 percent were advised to quit, 42 percent assisted, and 16 percent followed for smoking cessation. Pregnant patients were more likely to have tobacco use documented than nonpregnant patients (OR=10.8, 95 percent CI=4.9 to 24). The odds of documentation increased 21 percent for every one-year increase in patient age. CONCLUSIONS: Providers miss opportunities to intervene with adolescents who may be using tobacco. Medical record prompts, similar to the tobacco use question on prenatal forms and the tobacco use vital sign stamp, are essential for reminding providers to consistently document and address tobacco use among adolescents.

Adolescent↗
PubMed2004

Context or composition: what explains variation in SCHIP disenrollment?

OBJECTIVE: To investigate (1) the relative contributions of family and contextual characteristics to observed variation in disenrollment rates from the State Children's Health Insurance Program (SCHIP), and (2) whether context explains observed family-level patterns. DATA SOURCES: We use secondary data on 24,628 families enrolled in New Jersey's SCHIP program (NJ KidCare), and county-level data from the Area Resource File, the Census, and the NJ FamilyCare provider roster. STUDY DESIGN: Information on family characteristics, SCHIP plan, and dates of enrollment and disenrollment are taken from NJ KidCare administrative records, which provided surveillance data from January 1998 through April 2000. DATA COLLECTION/ANALYSIS: We estimate a multilevel discrete-time-hazards model of SCHIP disenrollment. FINDINGS: Families enrolled in plans involving cost-sharing, blacks, and those with only one enrolled child have higher than average rates of disenrollment. Disenrollment rates for blacks are lower in counties with a high share of black physicians. These characteristics account for part of the intercounty variation in disenrollment rates; remaining intercounty variation is largely explained by physician density or population density. POLICY IMPLICATIONS: It may be worthwhile to pay special attention to black families and counties with high disenrollment rates to address the reasons for their lower retention. Addressing cultural differences between physician and client and the geographic distribution of medical providers might reduce disenrollment.

Child↗
PubMed2004

Physical rehabilitation following medicare prospective payment for skilled nursing facilities.

OBJECTIVE: To examine the effect of the Medicare prospective payment system (PPS) for skilled nursing facilities (SNF) on the delivery of rehabilitation therapy to residents. DATA SOURCES: Resident-level data are based on the Resident Assessment Instrument Minimum Data Set for nursing facilities. All elderly residents admitted to SNFs in Michigan and Ohio in 1998 and 1999 form the study population (n=99,952). STUDY DESIGN: A differences-in-differences identification strategy is used to compare rehabilitation therapy for SNF residents before and after a change in Medicare SNF payment. Logistic and linear regression analyses are used to examine the effect of PPS on receipt of physical, occupational, or speech therapy and total therapy time. DATA EXTRACTION: Data for the present study were extracted from the University of Michigan Assessment Archive Project (UMAAP). One assessment was obtained for each resident admitted to nursing facilities during the study period. PRINCIPAL FINDINGS: The introduction of PPS for all U.S. Medicare residents in July of 1998 was associated with specific targeting of rehabilitation treatment time to the most profitable levels of therapy. The PPS was also associated with increased likelihood of therapy but less rehabilitation therapy time for Medicare residents. CONCLUSIONS: The present results indicate that rehabilitation therapy is sensitive to the specific payment incentives associated with PPS.

Aged↗
PubMed2004

The effect of HMOs on the inpatient utilization of medicare beneficiaries.

OBJECTIVE: To determine the effect of joining HMOs (health maintenance organizations) on the inpatient utilization of Medicare beneficiaries. DATA SOURCES: We linked enrollment data on Medicare beneficiaries to patient discharge data from the California Office of Statewide Health Planning and Development (OSHPD) for 1991-1995. DESIGN AND SAMPLE: A quasi-experimental design comparing inpatient utilization before and after switching from fee-for-service (FFS) to Medicare HMOs; with comparison groups of continuous FFS and HMO beneficiaries to adjust for aging and secular trends. The sample consisted of 124,111 Medicare beneficiaries who switched from FFS to HMOs in 1992 and 1993, and random samples of 108,966 continuous FFS beneficiaries and 18,276 continuous HMO enrollees yielding 1,227,105 person-year observations over five years. MAIN OUTCOMES MEASURE: Total inpatient days per thousand per year. PRINCIPAL FINDINGS: When beneficiaries joined a group/staff HMO, their total days per year were 18 percent lower (95 percent confidence interval, 15-22 percent) than if the beneficiaries had remained in FFS. Total days per year were reduced less for beneficiaries joining an IPA (independent practice association) HMO (11 percent; 95 percent confidence interval, 4-19 percent). Medicare group/staff and IPA-model HMO enrollees had roughly 60 percent of the inpatient days per thousand beneficiaries in 1995 as did FFS beneficiaries (976 and 928 versus 1,679 days per thousand, respectively). In the group/staff model HMOs, our analysis suggests that managed care practices accounted for 214 days of this difference, and the remaining 489 days (70 percent) were due to favorable selection. In IPA HMOs, managed care practices appear to account for only 115 days, with 636 days (85 percent) due to selection. CONCLUSIONS: Through the mid-nineties, Medicare HMOs in California were able to reduce inpatient utilization beyond that attributable to the high level of favorable selection, but the reduction varied by type of HMO.

Aged↗
PubMed2005

Do seniors understand their risk of moving to a nursing home?

OBJECTIVE: To determine whether seniors understand their risk of moving to a nursing home. Data Sources. We used longitudinal data from the Asset and Health Dynamics Among the Oldest Old (AHEAD) database. AHEAD is a nationally representative survey (n=8,203) of community dwellers aged 70+ years and their spouses. STUDY DESIGN: We followed respondents for 5 years from the date of the first interview fielded in 1993. Our primary dependent variable was whether respondents moved to a nursing home within 5 years of baseline; self-assessed probability of moving to a nursing home within 5 years, also assessed at baseline, was the primary explanatory variable. PRINCIPAL FINDINGS: We found that seniors who believed they were more likely to move to a nursing home within 5 years were indeed more likely to do so, and that most elders overestimated their likelihood of moving to a nursing home. CONCLUSIONS: Low rates of private long-term care insurance are not plausibly a result of seniors underestimating their personal risk of moving to a nursing home; such an assumption is inherent in many strategies to plan for the future long-term care needs of the baby boom generation.

Aged↗
PubMed2006

Impact of institutional review board practice variation on observational health services research.

OBJECTIVE: To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. DESIGN: Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. PRINCIPAL FINDINGS: Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. CONCLUSIONS: Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.

Ethics Committees↗
PubMed2006

Benefit-cost in the California treatment outcome project: does substance abuse treatment "pay for itself"?

OBJECTIVE: To examine costs and monetary benefits associated with substance abuse treatment. DATA SOURCES: Primary and administrative data on client outcomes and agency costs from 43 substance abuse treatment providers in 13 counties in California during 2000-2001. STUDY DESIGN: Using a social planner perspective, the estimated direct cost of treatment was compared with the associated monetary benefits, including the client's costs of medical care, mental health services, criminal activity, earnings, and (from the government's perspective) transfer program payments. The cost of the client's substance abuse treatment episode was estimated by multiplying the number of days that the client spent in each treatment modality by the estimated average per diem cost of that modality. Monetary benefits associated with treatment were estimated using a pre-posttreatment admission study design, i.e., each client served as his or her own control. DATA COLLECTION: Treatment cost data were collected from providers using the Drug Abuse Treatment Cost Analysis Program instrument. For the main sample of 2,567 clients, information on medical hospitalizations, emergency room visits, earnings, and transfer payments was obtained from baseline and 9-month follow-up interviews, and linked to information on inpatient and outpatient mental health services use and criminal activity from administrative databases. Sensitivity analyses examined administrative data outcomes for a larger cohort (N=6,545) and longer time period (1 year). PRINCIPAL FINDINGS: On average, substance abuse treatment costs $1,583 and is associated with a monetary benefit to society of $11,487, representing a greater than 7:1 ratio of benefits to costs. These benefits were primarily because of reduced costs of crime and increased employment earnings. CONCLUSIONS: Even without considering the direct value to clients of improved health and quality of life, allocating taxpayer dollars to substance abuse treatment may be a wise investment.

California↗