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Objective: To establish a baseline for the incidence of sepsis by severity and presence on admission in acute care hospital settings before implementation of a broad sepsis screening and response initiative. Methods: A retrospective cohort study using hospital discharge abstracts of 5672 patients, aged 18 years and above, with sepsis-associated stays between February 2012 and January 2013 at an academic medical center and 5 community hospitals in Texas. Results: Sepsis was present on admission in almost 85% of cases and acquired in-hospital in the remainder. The overall inpatient death rate was 17.2%, but was higher in hospital-acquired sepsis (38.6%, medical; 29.2%, surgical) and Stages 2 (17.6%) and 3 (36.4%) compared with Stage 1 (5.9%). Patients treated at the academic medical center had a higher death rate (22.5% vs. 15.1%, P

The purpose of this study was to determine whether stress myocardial perfusion (SPECT) optimized with stress-only (SO) imaging is comparable to cardiac CT angiography (CTA) for evaluating patients with acute chest pain (ACP).This was a prospective randomized observational study in 598 ACP patients who underwent CTA versus SPECT. The primary endpoint was length of hospital stay, and secondary endpoints were test feasibility, time to diagnosis, diagnostic accuracy, radiation exposure, and overall cost. Median follow-up was 6.5 mo, with a 3.8% cardiac event rate defined as death or an acute coronary syndrome.Of 2,994 patients screened, 1,703 (56.9%) were not candidates for CTA because of prior cardiac disease (41%) or imaging contraindications (16%). Time to diagnosis (8.1 ± 8.5 vs. 9.4 ± 7.4 h) and length of hospital stay (19.7 ± 27.8 vs. 23.5 ± 34.4 h) were significantly shorter with CTA than with SPECT (P = 0.002). However, time to diagnosis (7.0 ± 6.2 vs. 6.8 ± 5.9 h, P = 0.20), length of stay (15.5 ± 17.2 vs. 16.7 ± 15.3 h, P = 0.36), and hospital costs ($4,242 ± $3,871 vs. $4,364 ± 1781, P = 0.86) were comparable with CTA versus SO SPECT, respectively. SO was also superior to conventional SPECT regarding all of the above metrics and significantly reduced radiation exposure (5.5 ± 4.4 vs. 12.5 ± 2.7 mSv, P0.0001).Stress SPECT when optimized with SO imaging is similar to CTA in time to diagnosis, length of hospital stay, and cost, with improved prognostic accuracy and less radiation exposure. Our results emphasize the importance of SO imaging, particularly in low-intermediate-risk emergency room patients who are a population likely to have a normal test result.

The hypothesis that spondylolysis (SL) and/or isthmic spondylolisthesis (IS) cause low back pain (LBP) is widely accepted representing surgical indication in symptomatic cases. If SL/IS cause LBP, individuals with these conditions should be more prone to LBP than those without SL/IS. Therefore, the goal of the study was to assess whether the published primary data demonstrate an association between SL/IS and LBP in the general adult population. Systematic review of published observational studies to identify any association between SL/IS and LBP in adults. The methodological quality of the cohort and case–control studies was evaluated using the Newcastle-Ottawa scale. Fifteen studies met inclusion criteria (one cohort, seven case–control, seven cross-sectional). Neither the cohort study nor the two highest-quality case–control studies detected an association between SL/IS and LBP; the same is true for the remaining studies. There is no strong or consistent association between SL/IS and LBP in epidemiological studies of the general adult population that would support a hypothesis of causation. It is possible that SL/IS coexist with LBP, and observed effects of surgery and other treatment modalities are primarily due to benign natural history and nonspecific treatment effects. We conclude that traditional surgical practice for the adult general population, in which SL/IS is assumed to be the cause of non-radicular LBP whenever the two coexist, should be reconsidered in light of epidemiological data accumulated in recent decades.

Background Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. Study Design We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. Results Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power Conclusions Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.

To test the hypothesis that compared with daily soap and water bathing, 2% chlorhexidine gluconate bathing every other day for up to 28 days decreases the risk of hospital-acquired catheter-associated urinary tract infection, ventilator-associated pneumonia, incisional surgical site infection, and primary bloodstream infection in surgical ICU patients.This was a single-center, pragmatic, randomized trial. Patients and clinicians were aware of treatment-group assignment; investigators who determined outcomes were blinded.Twenty-four-bed surgical ICU at a quaternary academic medical center.Adults admitted to the surgical ICU from July 2012 to May 2013 with an anticipated surgical ICU stay for 48 hours or more were included.Patients were randomized to bathing with 2% chlorhexidine every other day alternating with soap and water every other day (treatment arm) or to bathing with soap and water daily (control arm).The primary endpoint was a composite outcome of catheter-associated urinary tract infection, ventilator-associated pneumonia, incisional surgical site infection, and primary bloodstream infection. Of 350 patients randomized, 24 were excluded due to prior enrollment in this trial and one withdrew consent. Therefore, 325 were analyzed (164 soap and water versus 161 chlorhexidine). Patients acquired 53 infections. Compared with soap and water bathing, chlorhexidine bathing every other day decreased the risk of acquiring infections (hazard ratio = 0.555; 95% CI, 0.309-0.997; p = 0.049). For patients bathed with soap and water versus chlorhexidine, counts of incident hospital-acquired infections were 14 versus 7 for catheter-associated urinary tract infection, 13 versus 8 for ventilator-associated pneumonia, 6 versus 3 for incisional surgical site infections, and 2 versus 0 for primary bloodstream infection; the effect was consistent across all infections. The absolute risk reduction for acquiring a hospital-acquired infection was 9.0% (95% CI, 1.5-16.4%; p = 0.019). Incidences of adverse skin occurrences were similar (18.9% soap and water vs 18.6% chlorhexidine; p = 0.95).Compared with soap and water, chlorhexidine bathing every other day decreased the risk of acquiring infections by 44.5% in surgical ICU patients.

Duration of Initiative 48 months and currently ongoing. Setting The Houston Methodist Hospital System and affiliated hospitals (3 facilities with 2 hospital-run skilled nursing facilities in and around Houston), St. Joseph's Regional Health Center (1 acute care hospital and 2 skilled nursing facilities in Bryan, Texas), Hospital Corporation of America (2 acute care facilities in Houston, 1 acute care facility in McAllen, Texas [Rio Grande Valley]), Kindred Healthcare (2 long term acute care facilities in Houston), Select Medical Specialty Hospitals (2 long term acute care facilities in Houston). Whom This Should Concern Hospital administrators, quality and safety officers, performance improvement and patient safety professionals, clinic managers, infection control and prevention staff, and other physicians, nurses, and clinical staff.

Background If trials of therapeutic interventions are to serve society9s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world9s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial9s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

Objective To develop a preliminary version of a post-doctor visit self-assessment tool that patients with hypertension can use to evaluate their communication behaviors. High-quality communication between patient and doctor may have a positive effect on blood pressure control in hypertensive patients. Patients’ communicative behaviors such as asking questions influence those of doctors, but most existing measurement tools assess doctors’ behaviors rather than patients’. Methods The tool is intended for use by African American or Caucasian American adults with hypertension, regardless of literacy level. The project included theory-based development of the item pool, usability testing (8 individuals), and cognitive response testing (13 additional individuals). Main results After multiple iterations, the preliminary version includes 138 items in 7 theory-based domains. Conclusion and Practice Implications The self-assessment tool is ready for testing of item and scale reliability and validity and consequent item reduction. This tool could prove useful in trials evaluating whether patients with hypertension who learn to be better communicators are more likely to achieve blood pressure control. In addition, because it asks patients to reflect on their use of specific behaviors that can be learned, the tool might also help patients in clinical practice to assume more active roles during their medical interactions.

Racial/ethnic health care disparities are well described in people living with HIV/AIDS, although the processes underlying observed disparities are not well elucidated.A retrospective analysis nested in the University of Alabama at Birmingham 1917 Clinic Cohort observational HIV study evaluated patients between August 2004 and January 2007. Factors associated with appointment nonadherence, a proportion of missed outpatient visits, were evaluated. Next, the role of appointment nonadherence in explaining the relationship between African American race and virologic failure (plasma HIV RNA50 copies/mL) was examined using a staged multivariable modeling approach.Among 1221 participants, a broad distribution of appointment nonadherence was observed, with 40% of patients missing at least 1 in every 4 scheduled visits. The adjusted odds of appointment nonadherence were 1.85 times higher in African American patients compared with whites [95% confidence interval (CI) = 1.61 to 2.14]. Appointment nonadherence was associated with virologic failure (odds ratio = 1.78, 95% CI = 1.48 to 2.13) and partially mediated the relationship between African American race and virologic failure. African Americans had 1.56 times the adjusted odds of virologic failure (95% CI = 1.19 to 2.05), which declined to 1.30 (95% CI = 0.98 to 1.72) when controlling for appointment nonadherence, a hypothesized mediator.Appointment nonadherence was more common in African American patients, associated with virologic failure, and seemed to explain part of observed racial disparities in virologic failure.

OBJECTIVES: Percutaneous endoscopic gastrostomy (PEG) tube placement is a widely used method for long-term enteral feeding of demented patients unable to take sufficient food by mouth. National time trends in PEG tube use over the last decade have not been previously reported. The objective of this study was to determine whether use of PEG tubes for patients with dementia has changed over time and by race. DESIGN: Retrospective cohort study. SETTING: All Veterans Affairs hospitals. PARTICIPANTS: Using an administrative database of the Veterans Health Administration, all veterans with dementia and all veterans who received a PEG tube were identified between fiscal years 1990–2001. MEASUREMENTS: Proportion of PEG tube placement for dementia patients over time and by race. RESULTS: Four hundred thirteen thousand six hundred twenty-seven dementia patients aged 60 and older were identified, of whom 6,464 (1.6%) received a PEG tube. Use of PEG tubes for dementia patients increased during the first half of the decade but subsequently decreased almost to baseline after peaking in 1996 (1990: 1.2%, 1996: 1.8%, 2001: 1.3%). Time trends in the use of PEG tube feeding for dementia patients varied by race. Specifically, the relative risk for PEG tube placement in African-American dementia patients increased from 1.65 (95% confidence interval (CI)51.25–2.17, FY 1990) to 1.97 (95% CI51.62–2.4, FY 2001). CONCLUSION: Although the overall use of PEG tube feeding for dementia patients decreased over time, rates in use and changes in use over time varied significantly by race. Reasons for the differential use of this procedure should be explored.

To determine whether patients' decisions are an important determinant of nonuse of invasive cardiac procedures and whether decisions vary by race.Observational prospective cohort.Patients (N= 681) enrolled at the exercise treadmill or the cardiac catheterization laboratories at a large Veterans Affairs hospital.Doctors' recommendations and patients' decisions were determined by both direct observation of doctor and patient verbal behavior and by review of medical charts. Performance of coronary angiography, angioplasty, and bypass surgery were determined by chart review for a minimum of 3 months follow-up.Coronary angiography was recommended after treadmill testing for 83 of 375 patients and 72 patients underwent angiography. Among 306 patients undergoing angiography, recommendations for coronary angioplasty or bypass surgery were given to 113 and 45 patients and were completed for 98 and 33 patients, respectively. Recommendations were not significantly different by race. However, 4 of 83 (4.8%) patients declined or did not return for recommended angiograms and this was somewhat more likely among black and Hispanic patients, compared with white patients (13% and 33% vs 2%; P =.05). No patients declined angioplasty and 2 of 45 (4.4%) patients declined or did not return for recommended bypass surgery. Other recommended procedures were not completed after further medical evaluation (n = 32). There was no difference (P.05) by race/ethnicity in doctor-level reasons for nonreceipt of recommended invasive cardiac procedures.Patient decisions to decline recommended invasive cardiac procedures were infrequent and may explain only a small fraction of racial disparities in the use of invasive cardiac procedures.

Objectives The objectives of this study were to determine racial differences in mortality in a national cohort of patients hospitalized with congestive heart failure (CHF) within a financially “equal-access” healthcare system, the Veterans Health Administration (VA), and to examine racial differences in patterns of healthcare utilization following hospitalization. Background To explain the observed paradox of increased readmissions and lower mortality in black patients hospitalized with CHF, it has been postulated that black patients may have reduced access to outpatient care, resulting in a higher number of hospital admissions for lesser disease severity. Methods In a retrospective study of 4,901 black and 17,093 white veterans hospitalized with CHF in 153 VA hospitals, we evaluated mortality at 30 days and 2 years, and healthcare utilization in the year following discharge. Results The risk-adjusted odds ratios (OR) for 30-day and 2-year mortality in black versus white patients were 0.70 (95% confidence interval [CI] 0.60 to 0.82) and 0.84 (95% CI 0.78 to 0.91), respectively. In the year following discharge, blacks had the same rate of readmissions as whites. Blacks had a lower rate of medical outpatient clinic visits and a higher rate of urgent care/emergency room visits than whites, although these differences were small. Conclusions In a system where there is equal access to healthcare, the racial gap in patterns of healthcare utilization is small. The observation of better survival in black patients after a CHF hospitalization is not readily explained by differences in healthcare utilization.

Initiatives to reduce hospital care were part of the reorganization of the Department of Veterans Affairs (VA) medical care system undertaken in the mid-1990s. We examined changes in the use of VA health services and survival from 1994 through 1998 among VA beneficiaries with serious chronic diseases. We postulated that if access to hospital care was reduced too much, or if decreased hospital use was not offset by improvements in ambulatory care, urgent care visits would increase or survival rates would fall.We tracked changes in risk-adjusted VA bed-day rates, rates of medical visits, rates of visits for testing and consultation, and rates of urgent care visits per patient-year among VA beneficiaries in nine disease cohorts (a total of 342,300 beneficiaries). Trends in non-VA hospital use by VA beneficiaries 65 years of age or older who were enrolled in fee-for-service Medicare were also studied. VA and Medicare vital-status data were used to calculate one-year survival rates.From 1994 through 1998, VA bed-day rates fell by 50 percent, rates of medical-clinic visits and visits for testing and consultation increased moderately, and rates of urgent care visits fell by 35 percent. The sharp decline in the use of VA hospitals was not compensated for by increases in the use of Medicare-reimbursed non-VA hospital care by veterans eligible for both VA care and Medicare, and the use of non-VA hospitals actually declined in four cohorts. The survival rates were essentially unchanged over the study period.The marked decline in VA hospital use from 1994 through 1998 did not curtail access to needed services and was not associated with serious consequences for chronically ill VA beneficiaries.

The USFDA is an agency of the US Department of Health and Human Services and is the nation’s oldest consumer protection agency whose function it is to review drugs before marketing, monitor marketed drugs, monitor drug manufacturing and advertising, protect drug quality, and to conduct applied research. It is charged with overseeing of not only human drugs and biologics, but also veterinary drugs, foods, medical devices, and radiopharmaceuticals, and as such serves as a watchdog over industry. This chapter discusses the historical development of the FDA, and what the FDA is today. The phases of research development (phase 0 through phase 5) leading to the marketing of a new drug, the role of the FDA in surgical interventions and medical device approval, and the FDA’s role in advertising and adverse event reporting are discussed.

The aim of this research was to develop and evaluate an instrument for measuring dyspepsia-related health to serve as the primary outcome measure for randomized clinical trials. Building on our previous work we developed SODA (Severity of Dyspepsia Assessment), a multidimensional dyspepsia measure. We evaluated SODA by administering it at enrollment and seven follow-up visits to 98 patients with dyspepsia who were randomized to a 6-week course of omeprazole versus placebo and followed over 1 year. The mean age was 53 years, and six patients (6%) were women. Median Cronbach's alpha reliability estimates over the eight visits for the SODA Pain Intensity, Non-Pain Symptoms, and Satisfaction scales were 0.97, 0.90, and 0.92, respectively. The mean change scores for all three scales discriminated between patients who reported they were improved versus those who were unchanged, providing evidence of validity. The effect sizes for the Pain Intensity (.98) and Satisfaction (.87) scales were large, providing evidence for responsiveness. The effect size for the Non-Pain Symptoms scale was small (.24), indicating lower responsiveness in this study sample. SODA is a new, effective instrument for measuring dyspepsia-related health. SODA is multidimensional and responsive to clinically meaningful change with demonstrated reliability and validity.

PURPOSE: To examine variation in men’s long-term regret of treatment decisions, ie, surgical versus chemical castration, for metastatic prostate cancer and its associations with quality of life. METHODS: Survey of previously treated patients to assess treatment decisions and quality of life, supplemented with focus groups. Two items addressing whether a patient wished he could change his mind and the belief that he would have been better off with the treatment not chosen were combined in classifying survey respondents as either satisfied or regretful. χ2 and t tests were used to test associations between regret and treatment history, complications, and quality of life. RESULTS: Survey respondents included 201 men aged 45 to 93 years (median, 71 years), who had begun treatment (71% chemical castration, 29% orchiectomy) a median of 2 years previously. Most reported complications: hot flashes (70%), nausea (34%), and erectile dysfunction (81%). Most were satisfied with the treatment decision, but 23% expressed regret. Regretful men more frequently reported surgical (43%) versus chemical (36%) castration (P = .030) and nausea in the past week (54% v 32%; P = .010) but less frequently reported erectile dysfunction (56% v 72%; P = .048). Regretful men indicated poorer scores on every measure of generic and prostate cancer–related quality of life. Qualitative analyses revealed substantial uncertainty about the progress of their disease and the quality of the decisions in which patients participated. CONCLUSION: Regret was substantial and associated with treatment choice and quality of life. It may derive from underlying psychosocial distress and problematic communication with physicians when decisions are being reached and over subsequent years.

BACKGROUND: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. METHODS: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. RESULTS: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. CONCLUSIONS: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity.

To evaluate the validity of three criteria-based methods of quality assessment: unit weighted explicit process-of-care criteria; differentially weighted explicit process-of-care criteria; and structured implicit process-of-care criteria.The three methods were applied to records of index hospitalizations in a study of unplanned readmission involving roughly 2,500 patients with one of three diagnoses treated at 12 Veterans Affairs hospitals. Convergent validity among the three methods was estimated using Spearman rank correlation. Predictive validity was evaluated by comparing process-of-care scores between patients who were or were not subsequently readmitted within 14 days.The three methods displayed high convergent validity and substantial predictive validity. Index-stay mean scores, using explicit criteria, were generally lower in patients subsequently readmitted, and differences between readmitted and nonreadmitted patients achieved statistical significance as follows: mean readiness-for-discharge scores were significantly lower in patients with heart failure or with diabetes who were readmitted; and mean admission work-up scores were significantly lower in patients with lung disease who were readmitted. Scores derived from the structured implicit review were lower in patients eventually readmitted but significantly so only in diabetics.These three criteria-based methods of assessing process of care appear to be measuring the same construct, presumably "quality of care." Both the explicit and implicit methods had substantial validity, but the explicit method is preferable. In this study, as in others, it had greater inter-rater reliability.

BACKGROUND Valid, timely estimates of the costs of HIV care are needed by health planners and policy makers. OBJECTIVE To perform a methodologic critique of published estimates of resource utilization and costs of HIV care. DATA SOURCES MEDLINE database for 1990-1998. DATA SELECTION Included articles focused on adults with a spectrum of HIV disease in which the authors developed their own resource use and cost data. Thirty one articles met these criteria. DATA EXTRACTION Studies were compared based on: (1) utilization and cost estimates, in 1995 dollars; (2) study period; (3) research design; (4) sampling frame; (5) sample size and patient characteristics; (6) data sources and scope of services; and (7) methods used in the analysis. DATA SYNTHESIS The most recent estimates pertain to the first half of 1995, before the use of protease inhibitor therapy. We found wide variations in the estimates and identified three major sources for this: (1) patient samples that were restricted to subgroups of the national HIV-infected population; (2) utilization data that were limited in scope (e.g., inpatient care only); and (3) invalid methods for estimating annual or lifetime costs, particularly in dealing with decedents. CONCLUSIONS To accurately estimate resource use and costs for HIV care nationwide, a nationally representative probability sample of HIV-infected patients is required. Even in research that is not intended to provide national estimates, the scope of utilization data should be broadened and greater attention to methodologic issues in the analysis of annual and lifetime costs is needed.

Background. Utility techniques are the most commonly used means to assess patient preferences for health outcomes. However, whether utility techniques produce valid measures of preference has been difficult to determine in the absence of a gold standard. Objective. To introduce and demonstrate two methods that can be used to evaluate how well utility techniques measure patients' preferences. Subjects and Design. Patients treated for advanced prostate cancer (n = 57) first ranked eight health states in order of preference. Four utility techniques were then used to elicit patients' utilities for each health state. Measures. The rating scale, standard gamble, time trade-off, and a modified version of willingness-to-pay techniques were used to elicit patients' utilities. Technique performance was assessed by computing a differentiation and inconsistency score for each technique. Results. Differentiation scores indicated the rating scale permitted respondents to assign unique utility values to about 70% of the health states that should have received unique values. When the other techniques were used, about 40% or less of the health states that should have received unique utility scores actually did receive unique utility scores. Inconsistency scores, which indicate how often participants assign utility scores that contradict how they value health states, indicated that the willingness-to-pay technique produced the lowest rate of inconsistency (10%). However, this technique did not differ significantly from the rating scale or standard gamble on this dimension. Conclusions. Differentiation and inconsistency offer a means to evaluate the performance of utility techniques, thereby allowing investigators to determine the extent to which utilities they have elicited for a given decision problem are valid. In the current investigation, the differentiation and inconsistency methods indicated that all four techniques performed at sub-optimal levels, though the rating scale out-performed the standard gamble, time trade-off, and willingness-to-pay techniques.

BACKGROUND: The Department of Veterans Affairs (VA) established six mobile clinics to provide care for rural veterans. Each was operated by a parent VA Medical Center (VAMC). OBJECTIVE: To describe the use of a cost-accounting system which does not provide costs at the service or patient level to determine the costs of the mobile clinics. RESEARCH DESIGN: Costs per visit were compared among the mobile clinics with the parent VAMCs and with simulated fixed-location clinics. Cost data came from VA's Centralized Accounting for Local Management (CALM) data. Utilization data came from VA's outpatient file. RESULTS: Information was obtained from the VAMCs' fiscal services to reallocate costs among the CALM subaccounts to generate cost data that was comparable among the mobile clinics. Costs per visit for the mobile clinics were twice as high as those of the parent VAMCs. Costs per visit would be lower at fixed-location clinics unless the volume were substantially less than that provided by the mobile clinics. CONCLUSION: Differences between cost allocations for accounting purposes and research are likely to necessitate adjusting cost accounting data for research purposes. Fortunately, information from the accountants or primary data can lead to a cost database which is appropriate for research evaluations. In the mobile clinics study, the analysis of cost accounting data led to the conclusion that mobile clinics were not a cost-effective way in which to provide care to rural veterans.

In 1988 the Veterans' Benefits and Services Act attempted to solve the problem of the lack of adequate VA healthcare facilities in rural areas by establishing a demonstration program using mobile clinics. Six clinics operated in areas that were at least 100 miles from a VA healthcare facility during the time period between October 1, 1992 and May 28, 1994. This article evaluated the effect of the mobile clinics' structural limitations on clinical care, the increased number of sites on VA usage, and cost. Limited space for storage of medical records and the unavailability of laboratory, electrocardiographic, or radiographic facilities significantly affected clinical practice. However, even with these space limitations, veterans' use of healthcare in the areas served by the mobile clinics increased significantly in comparison to reference areas. The direct costs per visit averaged more than three times what the VA would have reimbursed the private sector.

BACKGROUND Little data exist supporting the association of quality of care and nonfatal adverse outcomes in hospitalized patients, yet those outcomes are routinely scrutinized in quality assessment efforts. OBJECTIVE To determine whether measurable differences in quality of care are associated with the occurrence of non-fatal, in-hospital, and treatment-related complications. DESIGN Retrospective cohort study. SUBJECTS A total of 2,268 patients who were discharged alive from 9 Southwestern Veterans Affairs Medical Centers with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or diabetes mellitus. MEASURES Retrospective chart review was performed to collect information on patient severity of illness, in-hospital complication occurrence, and process quality of care. Process quality was assessed as the adherence scores for admission work-up and for treatment during the hospital stay. Process quality represents the proportion of applicable admission or treatment criteria that were met by that patient's care providers. Once severity of illness was taken into account Cox proportional hazards regression was used to assess the independent contribution of process quality of care to complication occurrence. RESULTS Higher admission work-up adherence scores for COPD patients and higher treatment adherence scores for COPD and diabetes patients were associated with a lower risk of complication occurrence. The adjusted risk ratios of complications for higher versus lower adherence scores (with 95% CI) were 0.64 (0.43, 0.97) and 0.52 (0.33, 0.80) for admission and treatment, respectively, in COPD patients, and 0.51 (0.31, 0.83) for treatment in diabetics. No significant association was found in CHF patients. CONCLUSION Better admission work-up and treatment quality in COPD patients, as well as treatment quality in diabetic patients, are associated with lower risk of nonfatal treatment-related complications in the study population.

In the United States, geographic variation in hospital use is common. It is uncertain whether there are similar geographic variations in the health care system of the Department of Veterans Affairs (VA), which differs from the private sector because it predominantly serves men with annual incomes below $20,000, has a central system of administration, and uses salaried physicians. Thus, it might be less likely to have geographic variations.We used VA data bases to obtain information on patients treated for eight diseases (chronic obstructive pulmonary disease, pneumonia, congestive heart failure, angina, diabetes, chronic renal failure, bipolar disorder, and major depression). We analyzed their use of hospital and outpatient services by assessing the risk-adjusted numbers of hospital days (the average number of days a patient spent in the hospital per 12 months of follow-up, regardless of the number of hospital stays), hospital-discharge rates, and clinic-visit rates from 1991 through 1995 for the entire system and within the 22 geographically based health care networks.We found substantial geographic variation in hospital use for all eight cohorts of patients and all the years studied. Variations in the numbers of hospital days per person-year among the networks were greatest among patients with chronic obstructive pulmonary disease (ranging from a factor of 2.7 to a factor of 3.1) during a given year and smallest among patients with angina (ranging from a factor of 1.5 to a factor of 2.1). Levels of hospital use were highest in the Northeast and lowest in the West. The variation in the rates of clinic visits for principal medical care among the networks ranged from a factor of approximately 1.6 to a factor of 4.0; variations in the rates were greatest among patients with chronic renal failure and smallest among patients with chronic obstructive pulmonary disease. There was no clear geographic pattern in the rates of outpatient-clinic use.There are significant geographic variations in the use of hospital and outpatient services in the VA health care system. Because VA physicians are unable to increase their income by changing their patterns of practice, our findings suggest that their practice styles are similar to those of other physicians in their geographic regions.

Between 1992 and 1994, the Department of Veterans Affairs (VA) experimented with mobile clinics to provide health care for rural veterans. The objective was to assess the health status of rural mobile clinics' patients and compare this with patients receiving care in VA hospital-based clinics. This study hypothesized that hospital-based clinic patients would be more ill (i.e., have a greater reduction in health status). The Medical Outcomes Study (MOS) Short Form was used to evaluate patients' health status. Most patients sought care for the management of chronic disease. Patients in both groups had similar types of diseases. Mobile clinic patients were as ill as hospital-based patients (i.e., similar health status scores). This study shows that rural veterans have a case mix and a reduction in health status similar to that of VA hospital-based patients. Planners should account for this health reduction when planning the kinds of facilities and services needed in rural areas.

This article and the following article (Parts I and II) report the development of two clinical staging systems for HIV-infected individuals. The objective of the research reported here (Part I) was to construct a clinical staging system to predict progression to AIDS. We analyzed data from VA Cooperative Study Number 298, a multicenter, double-blind, randomized trial that compared immediate versus deferred zidovudine therapy in 338 HIV-infected individuals who did not have AIDS at enrollment. Baseline variables were tested in univariate Cox regression for their relationship to progression to AIDS, and those that appeared predictive were examined in multivariable analysis. Based on these analyses, we constructed a new clinical staging system based on CD4+ cell count, age, hemoglobin, oral hairy leukoplakia or oral thrush, and fever. The stages of the system were significant predictors of progression to AIDS (p = 0.0001, log-rank test). In conclusion, simple, valid, clinical staging systems for HIV-infected patients can be constructed using information that is readily available in clinical practice settings. Such systems provide better prognostic distinction than CD4+ cell count alone by taking into account the known prognostic effects of other variables.

Men who pursue active treatment for metastatic prostate cancer face a choice between medical or surgical castration. While both alternatives have documented side-effects (e.g. loss of libido, breast enlargement and tenderness, hot flashes, and nausea), their psychosocial impacts are not well understood. As part of a study of patients' treatment decision making, we have sought to construct a patient-based measure of the salient disease and treatment-related qualities of life experienced by these men subsequent to treatment. Focus groups (15 with patients, two with wives) were used to develop candidate Likert scale questionnaire items representing quality of life issues that patients said were important. These items were combined with assessments of symptoms, comorbidity, and generic measures of functional status and well-being in a mail survey of patients treated at the Houston VAMC and two other Houston hospitals (n = 201, response rate = 63%). Psychometric analyses (principal components and multitrait scaling) were used to identify distinct dimensions of life quality; correlations with generic measures, and symptom reports were used in validation analyses. Qualitative analyses of focus group data identified three major domains of life quality: self-perceptions, anxiety about the effects of treatment, and concern with the process of decision making and treatment. Psychometric analyses identified nine reliable and valid indicators of prostate cancer-related quality of life: body image, sexual problems, spouse affection, spouse worry, masculinity, cancer-related self-image, cancer distress, cancer acceptance, and regret of treatment decision. Internal consistency (alpha) ranged form 0.71 to 0.90. Correlations with reference scales (e.g. MOS Mental Health Index, Profile of Mood States) and symptom status supported concurrent validity. Prostate cancer patients perceive a number of important psychosocial consequences of their treatment. These consequences are represented by nine scales comprising a brief (35 items) disease and treatment sensitive health-related quality of life instrument, which we will use in monitoring the outcomes of patients' treatment choices.

To help resolve the current controversy over the validity of early readmission as an indicator of the quality of care, the authors critically reviewed the literature using meta-analysis to derive summary estimates of effect and evaluate inter-study heterogeneity.The authors selected reports meeting five criteria: (1) presentation of new data on medical-surgical hospitalization of adults; (2) measurement of outcome as a person-specific readmission; (3) readmission withinor = 31 days; (4) examination of some aspect of the process of inpatient care; (5) inclusion of a comparison group. One meta-analysis examined 13 comparisons of readmission rates after substandard versus normative care, another examined 9 comparisons of readmission rates after normative versus exceptional care, and the third examined all 22 comparisons together. Two authors applied inclusion criteria and extracted data on methods and findings. Two others classified studies on 11 methodological variables for the heterogeneity evaluation.The summary odds ratio for readmission after substandard care was 1.24 (0.99-1.57) relative to normative care; for readmission after normative care the summary odds ratio was 1.45 (0.90-2.33) relative to exceptional care. The individual odds ratios varied significantly (chi2, 21 df = 50.34, P = 0.0003). Most of the variance in study odds ratios could be explained by whether the study focused on the quality of patient care or the qualifications of patient care providers. The summary odds ratio for the 16 homogeneous comparisons focusing on the quality of patient care was 1.55 (1.25-1.92).Early readmission is significantly associated with the process of inpatient care. The risk of early readmission is increased by 55% when care is of relatively low quality, that is, substandard or normative instead of normative or exceptional.

Adverse outcome rates are increasingly used as yardsticks for the quality of hospital care. However, the validity of many outcome studies has been undermined by the application of one outcome to all patients in large, diagnostically diverse populations, many of which lack evidence of a link between antecedent process of care and the rate of the outcome, the underlying assumption of the analysis.To address this analytic problem, the authors developed a model that improves the ability to identify quality problems because it selects diseases for which there are processes of care known to affect the outcome of interest. Thus, for these diseases, the outcome is most likely to be causally related to the antecedent care. In this study of hospital readmissions, risk-adjusted models were created for 17 disease categories with strong links between process and outcome. Using these models, we identified outlier hospitals.The authors hypothesized that if the model improved on identifying hospitals with quality of care problems, then outlier status would not be random. That is, hospitals found to have extreme rates in one year would be more likely to have extreme rates in subsequent years, and hospitals with extreme rates in one condition would be more likely to have extreme rates in related disease categories. It was hypothesized further that the correlation of outlier status across time and across diseases would be stronger in the 17 disease categories selected by the model than in 10 comparison disease categories with weak links between process and outcome.The findings support all these hypotheses. Although the present study shows that the model selects disease-outcome pairs where hospital outlier status is not random, the causal factors leading to outlier status could include (1) systematic unmeasured patient variation, (2) practice pattern variation that, although stable with time, is not indicative of substandard care, or (3) true quality-of-care problems. Primary data collection must be done to determine which of these three factors is most causally related to hospital outlier status.

Following a 4-year controlled trial comparing early and later zidovudine treatment, we conducted an additional 3-year follow-up. Of the original 338 patients, 275 participated. Clinical outcome measures were AIDS and death. In the early therapy group (n = 170), 67 patients progressed to AIDS compared with 85 in the later therapy group (n = 168); the relative risk (RR) comparing early with later therapy was 0.72% (95% confidence interval [CI] 0.52-0.99; p = 0.044). The early therapy group had 74 deaths compared with 73 in the later therapy (RR = 0.98; 95% CI, 0.71-1.36; p = 0.91). The early group had a peak CD4+ count increase at 1-2 months and a delay of 1 year before CD4+ counts fell below baseline. For patients who received zidovudine for more than the median duration (20.3 months) before their first AIDS diagnosis, the RR for death was 2.08 (95% CI, 1.36-3.19, p = 0.001). Additional factors independently associated with poor prognosis following AIDS were a CD4+ count of < 100 cells/mm3 and increased severity of the first AIDS diagnosis, whereas use of another antiretroviral agent was associated with improved survival. We conclude that early zidovudine therapy delays progression to AIDS but does not affect survival. Patients who progress to AIDS while on prolonged zidovudine monotherapy many benefit from a change to other antiretroviral therapy(ies).

The reasons why many patients seemingly benefit from arthroscopic treatment of osteoarthritis of the knee remain obscure. The purpose of this pilot study was to determine if a placebo effect might play a role in arthroscopic treatment of this condition. After giving full informed consent, including full knowledge of the possibility and nature of a placebo surgery, five subjects were randomized to a placebo arthroscopy group, three subjects were randomized to an arthroscopic lavage group, and two subjects were randomized to a standard arthroscopic debridement group. The physicians performing the postoperative assessment and the patients remained blinded as to treatment. Patients who received the placebo surgery reported decreased frequency, intensity, and duration of knee pain. They also thought that the procedure was worthwhile and would recommend it to family and friends. Thus, there may be a significant placebo effect for arthroscopic treatment of osteoarthritis of the knee. The small numbers in this preliminary study preclude a valid statistical analysis, and no conclusions can be drawn regarding the superiority of one treatment over another. A larger study is needed to evaluate fully the efficacy of an arthroscopic procedure for this condition and to decide if it is reasonable to expend health care resources for this treatment; the larger study should include a placebo control group.

Unlike medications, the dissemination of surgical procedures into practice is not regulated. Before marketing, pharmaceutical products are required to be shown safe and efficacious in comparative clinical trials which utilize bias-reducing strategies designed to reduce the distortion of estimates of treatment effect by predispositions towards the investigational intervention or control. Unless an investigational device is involved, the corresponding process for surgical innovations is usually unregulated and therefore may not be based upon adequate evidence. Given these differences, we sought to evaluate the state of clinical research on invasive procedures. We conducted a systematic review of publications from 1999–2008 that reported the results of studies evaluating the effects of invasive therapeutic procedures, focusing on trials which appeared to influence practice. Our objective was to determine what proportion of studies evaluating surgical procedures use a comparative clinical trial design and methods to control bias. This paper reports our results and raises concerns about the methodological, and therefore the ethical, quality of clinical research used to justify the implementation of surgical procedures into practice.

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

The use of explicit criteria to evaluate how well processes of care conform to accepted standards is a key method of quality assessment. Synthesizing four decades of literature, we devised an inexpensive, 6-step method of developing reliable, content-valid, explicit process criteria. This paper describes the method using a set of congestive heart failure criteria. In step 1 of the Criteria Development Method, criteria are derived from state-of-the-art clinical literature. In step 2, criteria are refined by expert panels. In this study, panelists refined the items by mail in a three-round Delphi process. In step 3, decisions about unit-or differential item weighting are made; we derived differential item weights from the panelists' third-round ratings. Step 4 consists of flagging items which may yield little information, i.e., consensus items of low import, and nonconsensus items. Numeric flags were computed using third-round median ratings and their interquartile ranges. Selection of a scoring method to summarize scores and communicate results is done in step 5. In step 6, chart reviewers are trained, inter-rater reliability is measured, and items with poor reliability are culled. This straightforward developmental method can be used to devise explicit process criteria for use in ambulatory or hospital settings and to evaluate care delivered by different types of providers. The method yields reliable criteria representing accepted standards of current clinical practice. This high content validity is a sine qua non for convergent and predictive validity, both of which must be demonstrated in empirical studies in which the criteria are compared against external yardsticks.

Patient noncompliance with treatment regime undermines the effectiveness of medical care, resulting in an unpredictable progression of the primary disease and a greater likelihood of complications. Hemodialysis patients are well suited for studying noncompliance because their treatment is prolonged and intensive, and medical regimens are clear cut and easily determined with objective measures. Moreover, noncompliant behavior by these patients not only endangers their life in the long run, but also results in negative effects within a day or two. Despite severe consequences, noncompliance with their medical regimen is the norm for dialysis patients rather than the exception. A large-scale study of chronic, outpatient hemodialysis patients (N = 1230 patients, response rate = 96%) treated in a variety of facility types (N = 29 facilities) was conducted to investigate prevalence and associated demographic characteristics of noncompliance with four treatment regimens--protein and potassium restrictions in the diet, medication regimen, and fluid restrictions. Few patients were noncompliant with diet regimens (9% with protein and 2% with potassium restrictions) but half were noncompliant with medication taking (50.2%) and fluid restrictions (49.5%). The prevalence of noncompliance with medication and fluid regimens was consistent with previous studies of dialysis patients but the prevalence of noncompliance with diet was much lower than that reported elsewhere. Prevalence of noncompliant patients varied between studies according to the cut-point used to establish compliance criteria, where more stringent cut-points inflated the percentage and more lenient cut-points reduced the percentage. Thus, there is a need to establish uniform criteria in order to test real differences in compliance between patient groups vs simply differences in measurement.(ABSTRACT TRUNCATED AT 250 WORDS)

Time series analysis is one of the methods health services researchers, managers and planners have to examine and predict utilization over time. The focus of this study is univariate time series techniques, which model the change in a dependent variable over time, using time as the only independent variable. These techniques can be used with administrative healthcare databases, which typically contain reliable, time-specific utilization variables, but may lack adequate numbers of variables needed for behavioral or economic modeling. The inpatient discharge database of the Department of Veterans Affairs, the Patient Treatment File, was used to calculate monthly time series over a six-year period for the nation and across US Census Bureau regions for three hospital utilization indicators: Average length of stay, discharge rate, and multiple stay ratio, a measure of readmissions. The first purpose of this study was to determine the accuracy of forecasting these indicators 24 months into the future using five univariate time series techniques. In almost all cases, techniques were able to forecast the magnitude and direction of future utilization within a 10% mean monthly error. The second purpose of the study was to describe time series of the three hospital utilization indicators. This approach raised several questions concerning Department of Veterans Affairs hospital utilization.