Phase 4 Multinational Multicenter Retrospective and Prospective Real-World Study of Nivolumab in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck.

This study examined the real-world use of nivolumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). This was a multinational retrospective study (VOLUME) assessing treatment effectiveness and safety outcomes and a prospective study (VOLUME-PRO) assessing HRQoL and patient-reported symptoms. There were 447 and 51 patients in VOLUME and VOLUME-PRO, respectively. Across both studies, the median age was 64.0 years, 80.9% were male, and 52.6% were former smokers. Clinical outcomes of interest included real-world overall survival (rwOS) and real-world progression-free survival (rwPFS). The median rwOS was 9.2 months. Among patients with at least one assessment, 21.7% reported their best response as 'partial response', with 3.9% reporting 'complete response'. The median duration of response (DoR) and median rwPFS were 11.0 months and 3.9 months, respectively. At baseline, VOLUME-PRO patients reported difficulties relating to fatigue, physical and sexual functioning, dyspnea, nausea, sticky saliva, dry mouth, pain/discomfort, mobility, and financial difficulties. There were improvements in social functioning and financial difficulties throughout the study; however, no other clinically meaningful changes were noted. No new safety concerns were identified. This real-world, multinational, multicenter, retrospective and prospective study supports the effectiveness and safety of nivolumab for R/M SCCHN patients.

Prevalence and quality-of-life burden of vasomotor symptoms associated with menopause: A European cross-sectional survey.

OBJECTIVES: To determine, in a European cohort, the prevalence and health-related quality-of-life (QOL) burden of moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women, and among subgroups of women not taking hormone therapy (HT). STUDY DESIGN: Screening surveys were sent to a random sample of women aged 40-65 years; those meeting the inclusion criteria completed the full questionnaire. Women with successfully treated VMS or breast cancer or who were receiving HT for medical conditions were excluded. MAIN OUTCOME MEASURES: Frequency and duration of VMS, perceptions of menopause, seeking advice from a healthcare professional, treatment for VMS symptoms, perceptions of HT use, out-of-pocket costs, and other approaches to coping with menopause. The Menopause-Specific QOL (MENQOL) questionnaire and Work Productivity and Activity Impairment (WPAI) questionnaire were included. RESULTS: Of 11,452 women who completed the screening survey, 5178 were postmenopausal and 2035 completed the full questionnaire. Prevalence of moderate-to-severe VMS ranged from 31 % in France to 52 % in Italy. The majority were in the HT-caution or HT-averse group, despite being eligible for HT. Most common menopausal symptoms reported in the MENQOL were "feeling tired or worn out," with aching in muscles and joints reported as the most common symptom in Spain. Weight gain was the most bothersome symptom in all countries, except for Spain, where low backache was more bothersome. Hot flashes and night sweats had a greater impact on daily than on working activities, as measured by the WPAI. CONCLUSIONS: A high proportion of European women reported experiencing moderate-to-severe VMS, with associated symptoms influencing QOL.

Switching from originator infliximab to biosimilar versus continuing on originator in inflammatory bowel disease: results from the observational Project NORTH study.

OBJECTIVE: Project NORTH compared real-world clinical and economic outcomes in Swedish patients with inflammatory bowel disease (IBD) who switched from originator infliximab to its biosimilar. MATERIALS AND METHODS: Data from electronic medical records and Swedish national registries were linked. Switchers (patients switching from originator infliximab to its biosimilar between 1 April 2014, and 31 December 2017) and non-switchers (patients who received originator infliximab and did not switch to a biosimilar by 31 December 2017) were followed up until 31 October 2019. RESULTS: Baseline concomitant medication use, disease duration, and inflammatory markers were lower among switchers than non-switchers. At 6 months, the proportion of patients with stable disease was higher among switchers than non-switchers (71/109 [65%] vs 54/107 [50%]; p = .0385); differences were not significant in subsequent follow-ups. At 6 and 24 months, 98% and 93% of switchers, respectively, used concomitant medications versus 96% and 79% of non-switchers. Throughout the study, all-cause treatment discontinuation occurred in 74 (67%) switchers and 105 (95%) non-switchers. At 36-months, mean (SD) number of IBD-related in-patient care days was higher among non-switchers (2.95 [4.71]) than switchers (1.40 [4.20]), as were total medical costs (€16,740 vs €3,872). CONCLUSIONS: No substantial differences in clinical outcomes or healthcare resource utilization were observed between switchers and non-switchers. Several analyses indicate that non-switchers might have more poorly controlled/severe disease than switchers at baseline. Overall, numerous difficulties might arise when executing a high-quality, real-world study, including possible selection bias for patients with better disease control for NMS, limiting the generalizability of the results.

Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden.

OBJECTIVE: To determine prevalence and health-related quality of life (HRQOL) of moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women in Europe, the US, and Japan, and among subgroups of women not taking hormone therapy (HT). METHODS: Screening surveys were sent to a random sample of women aged 40 to 65 years; full questionnaires followed to those who completed them and met inclusion criteria. Women with successfully treated VMS, breast cancer, or on HT for medical conditions were excluded. The Menopause-Specific QOL (MENQOL) and Work Productivity and Activity Impairment (WPAI) questionnaires were included in the questionnaire. RESULTS: Of 25,161 women completing the screening survey, 11,771 were postmenopausal and 3,460 met inclusion criteria and completed the full questionnaire. Prevalence of moderate-to-severe VMS was 40%, 34%, and 16% in Europe, the US, and Japan, respectively. A large proportion were HT averse, albeit eligible (Europe 56%, US 54%, Japan 79%). In total, 12%, 9%, and 8% in Europe, the US, and Japan, respectively, were HT-contraindicated. A high proportion were HT-cautious (Europe 70%, US 69%, Japan 52%). Most common menopausal symptoms reported in the MENQOL were feeling tired or worn out (Europe/US 74%, Japan 75%), aching in muscles and joints (Europe 69%, US 68%, Japan 61%), difficulty sleeping (Europe 69%, US 66%, Japan 60%), and hot flashes (Europe 67%, US 68%, Japan 62%). Overall, the most bothersome symptom was weight gain. As measured by the WPAI, hot flashes and night sweats had a greater impact on daily activities than on working activities. CONCLUSIONS: A high proportion of women experienced moderate-to-severe VMS, with associated symptoms impacting QOL.

A Prospective, non-intErventional Registry Study of PatiEnts initiating a Course of drug Therapy for overactIVE bladder (PERSPECTIVE): Rationale, design, and methodology.

INTRODUCTION: Pharmacotherapy of overactive bladder (OAB) typically involves treatment with an antimuscarinic or mirabegron, a ß3-adrenoceptor agonist, but real-world evidence on their use, including treatment access, persistence, and switching, is limited. Here, we describe the design of a prospective, multicenter, non-interventional registry of patients beginning a new course of OAB pharmacological therapy in routine clinical practice. METHODS: Adults with an OAB diagnosis for at least 3 months who either initiated a new course of mirabegron or antimuscarinic, or who switched therapy were enrolled into PERSPECTIVE (a Prospective, non-intErventional Registry Study of PatiEnts initiating a Course of drug Therapy for overactIVE bladder). The primary objective was to identify factors associated with improved OAB treatment effectiveness from a patient perspective. Secondary objectives were to compare persistence rates, reasons for discontinuation, and switching patterns between patients taking mirabegron or antimuscarinics. Healthcare centers and sites involving medical specialties who routinely participate in the care and treatment of patients with OAB (e.g., gynecology, urology, and primary care practices) were targeted for recruitment. Patient-reported outcomes (PROs), including quality of life, symptom bother, and treatment satisfaction from OAB-validated scales, were collected at baseline, months 1, 3, 6, and 12, and when patients switched or discontinued their current OAB medication. CONCLUSIONS: PERSPECTIVE is the first real-world observational study in the United States and Canada on clinical and patient perspectives in OAB management. Recruitment was reflective of centers where patients are treated for OAB to maximize generalizability to the real-world population. TRIAL REGISTRATION: ClinicalTrials.gov, ID number NCT02386072 (date of registration March 6, 2015).

Healthcare-seeking behaviour of primary caregivers for acute otitis media in children aged 6 months to <30 months in Panama: results of a cross-sectional survey.

BACKGROUND: Acute otitis media (AOM) is the most common bacterial childhood infection. However, caregivers with children having mild episodes often do not seek healthcare services, which may lead to an under-appreciation of the disease experienced by the community. The objectives of this survey were to estimate the proportion of primary caregivers who went to a healthcare facility when they suspected that their child aged 6 to <30 months was having an AOM episode during the past 6 months and to assess what factors influenced their decision. METHODS: This observational, cross-sectional survey of primary caregivers (≥18 years), with at least one child aged 6 to <30 months was performed in 19 healthcare facilities in Panama (March to May 2013). A 28-item paper questionnaire was administered to assess demographic data, AOM symptoms, as well as potential healthcare-seeking behaviour and factors influencing this behaviour. Potential confounding effects were individually assessed using Chi-squared or Cochran-Mantel-Haenszel tests, and all together in logistic regression models. RESULTS: The total number of eligible participants was 1330 (mean age 28.5 ± 8.0 years). Of these, 245 participants had at least one child whom they suspected had an AOM episode during the past 6 months. Of the 245 participants, 213 (86.9%) sought healthcare at a facility. Several factors were associated with healthcare usage: perceived severity of illness (p = 0.001), occupational status of the caregiver (p = 0.002), household income (p = 0.016) and length of time since the last suspected AOM episode (p = 0.032). CONCLUSIONS: When confronted with a child with obvious symptoms of AOM, the majority of caregivers reported seeking healthcare. This behaviour appeared to be associated with factors related to the severity of the illness, the length of time since the last episode, as well as with the income and occupational status of the caregivers themselves. As many episodes of AOM present with non-specific respiratory symptoms, our results apply only to caregivers who were confronted with children with an obvious symptom.

Impact of Etanercept Therapy on Disease Activity and Health-Related Quality of Life in Moderate Rheumatoid Arthritis Patients Population from a National British Observational Cohort.

OBJECTIVES: To describe a population with moderate rheumatoid arthritis (RA) before biologic initiation and assess change in disease status, health-related quality of life (HRQOL), and adverse events in etanercept (ETN)-treated patients. METHODS: Data on adult patients with moderate RA (3.2 < Disease Activity Score in 28 Joints [DAS28] ≤ 5.1) were retrospectively analyzed from the British Society for Rheumatology Biologics Register comparing a nonbiologic-treated group (nBG) using at least one traditional disease-modifying antirheumatic drug to a biologic group (BG) treated with ETN. The HRQOL was assessed by using the Health Assessment Questionnaire disability index score. To mitigate confounding, we controlled for drivers of progression. Appropriate univariate, multivariate, and regression analyses were used. RESULTS: A total of 1754 patients with RA were assessed (211 BG and 1543 nBG). Compared with the nBG, the BG tended toward higher disease activity, such as significantly higher tender joints and DAS28. The BG compared with the nBG had 1) a greater reduction in DAS28 and Health Assessment Questionnaire scores; 2) disease remission occurring more often (odds ratio = 2.7; P = 0.006); and 3) progression occurring in fewer patients (odds ratio = 0.3; P = 0.002). BG patients had a higher incidence of "other serious infection" and "other central nervous system-related events," with no significant differences in associated hospitalization rates or deaths. CONCLUSIONS: Among patients with moderate RA from a clinical practice registry, ETN-treated patients had significantly higher disease activity at the time of biologic initiation but significantly reduced disease activity and better HRQOL after 6 months compared with nBG patients, although the possibility of unmeasured confounding remains. The ETN group reported significantly higher incidences of "other serious infections" and "other central nervous system-related events" without higher hospitalization rates.

A practice-based research network focused on comparative effectiveness research in type 2 diabetes management.

PURPOSE: To establish a real-world research platform focused on comparative effectiveness research and health care decision making in diabetes care in order to obtain a detailed understanding of individualized patient management in primary care. METHODS: Diabetes FORWARD (Foundation of Real-World Assessment and Research in Diabetes) is a North American research platform being organized to conduct longitudinal, noninterventional investigations of an anticipated 10,000 patients with type 2 diabetes mellitus (T2DM). Recruitment will be stratified to reflect typical (primarily primary care) clinical T2DM populations. Streamlined data collection relying on electronic medical records (retrospective) and periodic surveys (prospective) will reduce the burden of study participation and, therefore, enhance enrollment by busy primary care and endocrinology practices. Physician data will include baseline demographic and practice information. Patient data will include demographics, T2DM characteristics and treatment, resource utilization information, and patient-reported outcomes. Responses can be tracked within the observation window in near-real time, allowing immediate, noninterventional reaction at the point of nonresponse. EXPECTED OUTCOMES: Diabetes FORWARD is expected to provide important real-world data describing how actual clinical T2DM management differs across sites, settings, and clinicians, and its impact on glycemic control, treatment adherence and persistence, and clinical outcomes. These data will also help to identify the effect of diabetes management on the onset and progression of retinopathy, neuropathy, nephropathy, and cardiovascular disease at 6-month intervals. CONCLUSION: To our knowledge, Diabetes FORWARD is the first diabetes-focused, practice-based research network in the United States and Canada. The current study will provide robust data that should reflect typical management of T2DM in clinical practice in North America.

Impact of transdermal oxybutynin on work productivity in patients with overactive bladder: results from the MATRIX study.

BACKGROUND: Overactive bladder syndrome (OAB) is a common condition affecting a significant number of working adults, resulting in increased healthcare utilization, reduced quality of life and decreased work productivity. The MATRIX study was a large, prospective, community-based, observational US study aimed at evaluating the impact of oxybutynin transdermal system (OXY-TDS). In this paper, we report on productivity findings among working adults in MATRIX. METHODS: This study enrolled 2878 adults (aged > or =18 years) with symptoms of OAB from 327 practice sites throughout the US. All subjects received OXY-TDS (3.9 mg/day up to 6 months). Baseline versus end-of-study productivity was measured using the Work Productivity Questionnaire (WPQ). The WPQ includes a subset of questions from the Work Limitations Questionnaire (WLQ) and consists of four scales: (i) physical; (ii) time management; (iii) mental; and (iv) output demands. Overall productivity was measured by the work productivity index score (WPQ Index; a summary score based on scales) and work productivity loss score (WPLS; a measure of reduced output compared with healthy workers). Psychometric performance of the WPQ instrument is also reported, since this study represents the first use of the tool. RESULTS: Of the participants, 52% were of working age (18-65 years) and 38.6% were employed. A total of 1112 working adults participated in MATRIX and were included in this analysis. They had a mean age of 52.4 years; 92.2% were female and 80.9% were Caucasian. Subjects who reported that they were most affected by OAB were also most impaired at work. After OXY-TDS treatment, participants experienced significant improvements in mean scores for all four WPQ scales (p < or = 0.0002) and the mean WPQ Index decreased from 8.2 to 5.5 (p < 0.0001). In addition, the WPLS decreased from 7.7% to 5.2% (p < 0.0001), indicating improvement in work function with OXY-TDS treatment. CONCLUSION: OAB contributes to decreased work productivity due to job interruptions as well as fatigue. OXY-TDS may result in productivity improvement when patients receive 3.9 mg/day via twice weekly patch application for up to 6 months.

Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications.

BACKGROUND: The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 is a reliable and valid instrument to assess patients' satisfaction with medication, providing scores on four scales--side effects, effectiveness, convenience and global satisfaction. In naturalistic studies, administering the TSQM with the side effects domain could provoke the physician to assess the presence or absence of adverse events in a way that is clinically atypical, carrying the potential to interfere with routine medical care. As a result, an abbreviated 9-item TSQM (TSQM-9), derived from the TSQM Version 1.4 but without the five items of the side effects domain was created. In this study, an interactive voice response system (IVRS)-administered TSQM-9 was psychometrically evaluated among patients taking antihypertensive medication. METHODS: A total of 3,387 subjects were invited to participate in the study from an online panel who self-reported taking a prescribed antihypertensive medication. The subjects were asked to complete the IVRS-administered TSQM-9 at the start of the study, along with the modified Morisky scale, and again within 7 to 14 days. Standard psychometric analyses were conducted; including Cronbach's alpha, intraclass correlation coefficients, structural equation modeling, Spearman correlation coefficients and analysis of covariance (ANCOVA). RESULTS: A total of 396 subjects completed all the study procedures. Approximately 50% subjects were male with a good racial/ethnic mix: 58.3% white, 18.9% black, 17.7% Hispanic and 5.1% either Asian or other. There was evidence of construct validity of the TSQM-9 based on the structural equation modeling findings of the observed data fitting the Decisional Balance Model of Treatment Satisfaction even without the side effects domain. TSQM-9 domains had high internal consistency as evident from Cronbach's alpha values of 0.84 and greater. TSQM-9 domains also demonstrated good test-retest reliability with high intraclass correlation coefficients exceeding 0.70. As expected, the TSQM-9 domains were able to differentiate between individuals who were low, medium and high compliers of medication, with moderate to high effect sizes. There was evidence of convergent validity with significant correlations with the medication adherence scale. CONCLUSION: The IVRS-administered TSQM-9 was found to be a reliable and valid measure to assess treatment satisfaction in naturalistic study designs, in which there is potential that the administration of the side effects domain of the TSQM would interfere with routine clinical care.

Budget impact analysis of rapid screening for Staphylococcus aureus colonization among patients undergoing elective surgery in US hospitals .

OBJECTIVE: To evaluate the economic impact of performing rapid testing for Staphylococcus aureus colonization before admission for all inpatients who are scheduled to undergo elective surgery and providing subsequent decolonization therapy for those patients found to be colonized with S. aureus. METHODS: A budget impact model that used probabilistic sensitivity analysis to account for the uncertainties in the input variables was developed. Primary input variables included the marginal effect of S. aureus infection on patient outcomes among patients who underwent elective surgery, patient demographic characteristics, the prevalence of nasal carriage of S. aureus, the sensitivity and specificity of the rapid diagnostic test for S. aureus colonization, the efficacy of decolonization therapy for nasal carriage of S. aureus, and cost data. Data sources for the input variables included the 2003 Nationwide Inpatient Sample data and the published literature. RESULTS: In 2003, there were an estimated 7,181,484 patients admitted to US hospitals for elective surgery. Our analysis indicated preadmission testing and subsequent decolonization therapy for patients colonized with S. aureus would have produced a mean annual cost savings to US hospitals of $231,538,400 (95% confidence interval [CI], -$300 million to $1.3 billion). The mean annual number of hospital-days that could have been eliminated was estimated at 364,919 days (95% CI, 67,893-926,983 days), and a mean of 935 in-hospital deaths (95% CI, 88-3,691) could have been avoided per year. Sensitivity analysis indicated a 64.5% probability that there would be cost savings to US hospitals as a result of preadmission testing and subsequent decolonization therapy. CONCLUSION: The addition of preadmission testing and decolonization therapy to standard care would result in significant cost savings, even after accounting for variations in the model input values.

Resource utilisation, charges and mortality following hospital inpatient admission for congestive heart failure among the elderly in the US.

OBJECTIVES: This study examined resource utilisation, charges and mortality among congestive heart failure (CHF) patients over the course of the first year following initial hospital discharge for CHF in the US. METHODS: The Medicare Standard Analytic Files for the years 1998 through to 2001 were used for the analysis. The study sample included patients with an inpatient hospitalisation between the 1st January 1999 and the 31st December 2000 with a primary ICD-9 diagnosis code of CHF. Statistical analysis including univariate and multivariate regression analysis were conducted. RESULTS: Within 1 year following initial CHF discharge, 50% of patients had at least one all-cause readmission and 20% had at least one CHF-related readmission. The mean total charges among all patients was $36,230 (SD $55,086). Of the patients 20% incurred more than $55,000 in medical charges during the year after discharge; 10% incurred charges exceeding $90,000. More than one-half of the CHF patients visited the emergency department within 3 months of hospital discharge, and within 1 year almost one-third of the CHF patients (31.4%) died. CONCLUSIONS: The charges, morbidity and mortality associated with CHF patients are significant. Reducing these risks through more effective disease management offers the potential for substantial cost savings.

National trends in Staphylococcus aureus infection rates: impact on economic burden and mortality over a 6-year period (1998-2003).

BACKGROUND: We evaluated historical trends in the Staphylococcus aureus infection rate, economic burden, and mortality in US hospitals from 1998 through 2003. METHODS: The Nationwide Inpatient Sample was used to assess trends over time of S. aureus infection during 1998-2003. Historical trends were determined for 5 strata of hospital stays, including all inpatient stays, surgical procedure stays, invasive cardiovascular surgical stays, invasive orthopedic surgical stays, and invasive neurosurgical stays. RESULTS: During the 6-year study period from 1998 through 2003, the rate of S. aureus infection increased significantly for all inpatient stays (from 0.74% to 1.0%; annual percentage change (APC), 7.1%; P=.004), surgical stays (from 0.90% to 1.3%; APC, 7.9%; P=.001), and invasive orthopedic surgical stays (from 1.2% to 1.8%; APC, 9.3%; P<.001). For invasive neurosurgical stays, the rate of S. aureus infection did not change from 1998 to 2000 but increased at an annual rate of 11.0% from 2000 to 2003 (from 1.4% to 1.8%; P=.034). The total economic burden of S. aureus infection for hospitals also increased significantly for all stay types, with the annual percentage increase ranging from 9.2% to 17.9% (P<.05 for all). In 2003, the total economic burden of S. aureus infection was estimated to be $14.5 billion for all inpatient stays and $12.3 billion for surgical patient stays. However, there were significant decreases in the risk of S. aureus-related in-hospital mortality from 1998 to 2003 for all inpatient stays (from 7.1% to 5.6%; APC, -4.6%; P=.001) and for surgical stays (from 7.1% to 5.5%; APC, -4.6%; P=.002). CONCLUSIONS: The inpatient S. aureus infection rate and economic burden of S. aureus infections for US hospitals increased substantially from 1998 to 2003, whereas the in-hospital mortality rate decreased.

Chiropractic users and nonusers: differences in use, attitudes, and willingness to use nonmedical doctors for primary care.

OBJECTIVE: To determine the differences in attitudes and other determinants of care-seeking behavior between persons who have used chiropractic services and persons who have not. A second objective is to determine the interest in members of these 2 groups in choosing nonmedical doctors for providing routine services. METHODS: In 1998, a nationwide telephone survey of randomly selected households in the United States was done, including 400 adults who have used chiropractic services and 400 adults who have not. Survey participants were asked about their use, knowledge, and attitudes about chiropractic care, attitudes about personal role in health care, current source of obtaining usual and routine care, and willingness to consider use of nonmedical doctors as the usual source of such care. The analysis compares persons who have used with those who have not used chiropractic services by using a chi2 test to determine significance of differences between the responses of the 2 groups. A multivariate analysis is done of willingness to use alternative providers for routine care. RESULTS: Persons who have seen a doctor of chiropractic before have different attitudes and preferences about health and health care than others who have never seen a doctor of chiropractic. Almost all of persons in both groups have medical doctors that they use for routine care, and a sizeable portion of both groups would be willing to consider using a nonmedical doctor for this role. Although willingness to use a chiropractor in this role is much higher among persons who have used a chiropractor before, both groups would prefer physician assistants and nurse practitioners to chiropractors in this role. CONCLUSION: For persons participating in this survey, unwillingness to accept the idea of a chiropractor in a primary care role may be largely due to poor knowledge about chiropractic care.

The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology.

Skin disease is one of the top 15 groups of medical conditions for which prevalence and health care spending increased the most between 1987 and 2000, with approximately 1 of 3 people in the United States with a skin disease at any given time. Even so, a national data profile on skin disease has not been conducted since the late 1970s. This study closes the gap by estimating the prevalence, economic burden, and impact on quality of life for 22 leading categories of skin disease. The estimated annual cost of skin disease in 2004 was 39.3 billion dollars, including 29.1 billion dollars in direct medical costs (costs of health services and products) and 10.2 billion dollars in lost productivity costs (defined as costs related to consumption of medical care, costs associated with impaired ability to work, and lost future earning potential because of premature death). Based on a methodology of willingness to pay for symptom relief, the additional economic burden of skin disease on quality of life amounted to an estimated 56.2 billion dollars. Including the economic burden on quality of life, the total economic burden of skin disease to the US public in 2004 was approximately 96 billion dollars.

The burden of Staphylococcus aureus infections on hospitals in the United States: an analysis of the 2000 and 2001 Nationwide Inpatient Sample Database.

BACKGROUND: Previous studies have investigated the impact of Staphylococcus aureus infections on individual hospitals, but to date, no study using nationally representative data has estimated this burden. METHODS: This is a retrospective analysis of the 2000 and 2001 editions of the Agency for Healthcare Research and Quality's Nationwide Inpatient Sample database, which represents a stratified 20% sample of hospitals in the United States. All inpatient discharge data from 994 hospitals in 28 states during 2000 and from 986 hospitals in 33 states during 2001, representing approximately 14 million inpatient stays, were analyzed to determine the association of S aureus infections with length of stay, total charges, and in-hospital mortality. RESULTS: Staphylococcus aureus infection was reported as a discharge diagnosis for 0.8% of all hospital inpatients, or 292 045 stays per year. Inpatients with S aureus infection had, on average, 3 times the length of hospital stay (14.3 vs 4.5 days; P<.001), 3 times the total charges (48,824 US dollars vs 14,141 US dollars; P<.001), and 5 times the risk of in-hospital death (11.2% vs 2.3%; P<.001) than inpatients without this infection. Even when controlling for hospital fixed effects and for patient differences in diagnosis-related groups, age, sex, race, and comorbidities, the differences in mean length of stay, total charges, and mortality were significantly higher for hospitalizations associated with S aureus. CONCLUSIONS: Staphylococcus aureus infections represent a considerable burden to US hospitals, particularly among high-risk patient populations. The potential benefits to hospitals in terms of reduced use of resources and costs as well as improved outcomes from preventing S aureus infections are significant.

Barriers to expanding primary care roles for chiropractors: The role of chiropractic as primary care gatekeeper.

OBJECTIVE: To examine the feasibility of broader and more frequent primary care roles for chiropractors. DATA COLLECTION: Literature review and analysis of existing databases. Six types of barriers were examined, including legal, financial, professional, accessibility or geographic location, consumer preference, and self-imposed barriers. RESULTS: Although research into the barriers of an expanded primary care role for chiropractors is inconclusive, several inferences can be drawn from this analysis. First, prevailing state practice acts preclude only a limited number of activities that are necessary for chiropractors to serve in a primary care capacity. The self-perception by a portion of the chiropractic profession that as neuromusculoskeletal system specialists, they are either uninterested or ill-prepared for providing primary care serves as a second barrier. Third, payment provisions that do not permit chiropractors to be reimbursed for primary care services significantly limit their ability to expand primary care capacity. Fourth, consumer perceptions of chiropractors as neuromusculoskeletal system specialists are a persistent barrier to expanding status. Given the current importance of managed care, the fifth and most crucial barrier for chiropractic may be managed care organizations' lack of interest in having chiropractors in primary care roles. CONCLUSION: Research on the barriers to a more expanded primary care role for chiropractors is incomplete. The available research helps little in ruling out plausible barriers that might make it possible to narrow the scope of subsequent research.

The burden of selected digestive diseases in the United States.

BACKGROUND & AIMS: Gastrointestinal (GI) and liver diseases inflict a heavy economic burden. Although the burden is considerable, current and accessible information on the prevalence, morbidity, and cost is sparse. This study was undertaken to estimate the economic burden of GI and liver disease in the United States for use by policy makers, health care providers, and the public. METHODS: Data were extracted from a number of publicly available and proprietary national databases to determine the prevalence, direct costs, and indirect costs for 17 selected GI and liver diseases. Indirect cost calculations were purposefully very conservative. These costs were compared with National Institutes of Health (NIH) research expenditures for selected GI and liver diseases. RESULTS: The most prevalent diseases were non-food-borne gastroenteritis (135 million cases/year), food-borne illness (76 million), gastroesophageal reflux disease (GERD; 19 million), and irritable bowel syndrome (IBS; 15 million). The disease with the highest annual direct costs in the United States was GERD ($9.3 billion), followed by gallbladder disease ($5.8 billion), colorectal cancer ($4.8 billion), and peptic ulcer disease ($3.1 billion). The estimated direct costs for these 17 diseases in 1998 dollars were $36.0 billion, with estimated indirect costs of $22.8 billion. The estimated direct costs for all digestive diseases were $85.5 billion. Total NIH research expenditures were $676 million in 2000. CONCLUSIONS: GI and liver diseases exact heavy economic and social costs in the United States. Understanding the prevalence and costs of these diseases is important to help set priorities to reduce the burden of illness.