Search

Objectives To enhance the generalizability of the evidence it reviews, the US Food and Drug Administration (FDA) has encouraged manufacturers to expand the submission of real-world evidence (RWE). The extent to which this evidence, which is generated outside of research settings, can support decision making remains unclear. We described the current use of RWE for medical devices, assessed manufacturers’ challenges in generating and using it for regulatory and coverage decisions, and identified opportunities to expand its use. Methods We conducted 27 solo and group interviews with FDA officials and representatives of device manufacturers, payers, and health technology assessment organizations. All interviews used a semistructured protocol and were transcribed to allow thematic analysis. Results Accessing and linking real-world data sources, identifying unique devices, capturing longitudinal data, limited staff expertise, and uncertain return on investment have hampered efforts to use real-world data. Many companies in our sample were conducting research using real-world data, but none had submitted RWE as the primary evidence supporting a premarket approval. FDA guidance was helpful, but regulatory requirements remained ambiguous and examples of successful regulatory decisions based on RWE were limited. Payers mainly used RWE to supplement experimental evidence in coverage decisions, evaluated both types of evidence in similar ways, and had concerns about the rigor of RWE. Conclusions Technical challenges may slow efforts to generate and use RWE in the near term. Additional regulatory guidance and examples, greater use of rigorous study designs and analytic methods, and continued stakeholder engagement could accelerate the use of RWE.

OBJECTIVE: To test the hypothesis that health systems provide better care to patients with high needs by comparing differences in quality between system‐affiliated and nonaffiliated physician organizations (POs) and to examine variability in quality across health systems. DATA SOURCES: 2015 Medicare Data on Provider Practice and Specialty linked physicians to POs. Medicare Provider Enrollment, Chain, and Ownership System (PECOS) and IRS Form 990 data identified health system affiliations. Fee‐for‐service Medicare enrollment and claims data were used to examine quality. STUDY DESIGN: This cross‐sectional analysis of beneficiaries with high needs, defined as having more than twice the expected spending of an average beneficiary, examined six quality measures: continuity of care, follow‐up visits after hospitalizations and emergency department (ED) visits, ED visits, all‐cause readmissions, and ambulatory care‐sensitive hospitalizations. Using a matched‐pair design, we estimated beneficiary‐level regression models with PO random effects to compare quality of care in system‐affiliated and nonaffiliated POs. We then limited the sample to system‐affiliated POs and estimated models with system random effects to examine variability in quality across systems. PRINCIPAL FINDINGS: Among 2 323 301 beneficiaries with high needs, 52.3% received care from system‐affiliated POs. Rates of ED visits were statistically significantly different in system‐affiliated POs (117.5 per 100) and nonaffiliated POs (106.8 per 100, P

BACKGROUND: Federally qualified health centers have aligned clinical services and systems with local hospitals, but little is known about the specific care integration strategies health centers use or their impact on care. We examined the use of strategies by health centers to integrate care with hospitals and emergency departments (EDs) and their association with performance on measures of health center–hospital communication. METHODS: We administered a web-based survey to health center medical directors in 12 states and Washington, DC in 2017. The survey collected ten self-reported measures of communication between health centers and hospitals/EDs and the extent to which health centers used different strategies to improve care integration. We examined health center and market characteristics that predict higher vs. lower integration activity and used logistic regression to assess the relationship between integration activity and communication. RESULTS: Between 56 and 81 percent of health centers participated in quality improvement projects, health promotion initiatives, guideline alignment, or executive meetings with hospitals; far fewer established notification agreements regarding hospital/ED utilization. Health centers that were larger, were located in rural areas or states with Medicaid accountable care programs, reported fewer staff shortages, and had fewer minority patients were associated with greater integration activity. Higher levels of integration activity were associated with better performance on most communication measures in both inpatient and ED settings (p < 0.05). Integration activity was not associated with health centers’ receipt of notifications after patients’ ED visits. CONCLUSION: Health centers differ in the use of strategies to integrate care with hospitals. Overall, integration activity is associated with better communication.

We examine whether primary care continuity of care (PCCOC) improved for Medicare beneficiaries under a 3-year demonstration to help federally qualified health centers (FQHCs) become patient-centered medical homes (PCMH). We used a difference-in-differences analysis to compare changes over time in PCCOC for beneficiaries in 503 demonstration sites to those in 827 comparison sites. We measured PCCOC using the claims-based usual provider of care (UPC) index (range 0–1) indicating the proportion of visits to the most commonly seen provider or practice over a 1-year period. Average baseline UPC index values were 0.77 at the provider level and 0.88 at the practice level, with similar values for demonstration and comparison sites. UPC decreased more over time in demonstration clinics than comparison clinics, but the magnitude of these changes were small. FQHCs already have high levels of PCCOC. These levels did not increase in association with the 3-year PCMH demonstration. Continuity for practices is higher than for providers, suggesting that Medicare beneficiaries may see multiple providers within one FQHC.

Introduction Primary care providers who lack reliable referral relationships with specialists may be less likely than those who do have such relationships to conduct cancer screenings. Community health centers (CHCs), which provide primary care to disadvantaged populations, have historically reported difficulty accessing specialty care for their patients. This study aimed to describe strategies CHCs use to integrate care with specialists and examine whether more strongly integrated CHCs have higher rates of screening for colorectal and cervical cancers and report better communication with specialists. Methods Using a 2017 survey of CHCs in 12 states and the District of Columbia and administrative data, we estimated the association between a composite measure of CHC/specialist integration and 1) colorectal and cervical cancer screening rates, and 2) 4 measures of CHC/specialist communication using multivariate regression models. Results Integration strategies commonly reported by CHCs included having specialists deliver care on-site (80%) and establishing referral agreements with specialists (70%). CHCs that were most integrated with specialists had 5.6 and 6.8 percentage-point higher colorectal and cervical cancer screening rates, respectively, than the least integrated CHCs (P < .05). They also had significantly higher rates of knowing that specialist visits happened (67% vs 42%), knowing visit outcomes (65% vs 42%), receiving information after visits (47% vs 21%), and timely receipt of information (44% vs 27%). Conclusion CHCs use various strategies to integrate primary and specialty care. Efforts to promote CHC/specialist integration may help increase rates of cancer screening.

OBJECTIVE: To assess racial and ethnic disparities in care for Medicare fee‐for‐service (FFS) beneficiaries and whether disparities differ between health system‐affiliated physician organizations (POs) and nonaffiliated POs. DATA SOURCES: We used Medicare Data on Provider Practice and Specialty (MD‐PPAS), Medicare Provider Enrollment, Chain, and Ownership System (PECOS), IRS Form 990, 100% Medicare FFS claims, and race/ethnicity estimated using the Medicare Bayesian Improved Surname Geocoding 2.0 algorithm. STUDY DESIGN: Using a sample of 16 007 POs providing primary care in 2015, we assessed racial/ethnic disparities on 12 measures derived from claims (2 cancer screenings; diabetic eye examinations; continuity of care; two medication adherence measures; three measures of follow‐up visits after acute care; all‐cause emergency department (ED) visits, all‐cause readmissions, and ambulatory care‐sensitive admissions). We decomposed these “total” disparities into within‐PO and between‐PO components using models with PO random effects. We then pair‐matched 1853 of these POs that were affiliated with health systems to similar nonaffiliated POs. We examined differences in within‐PO disparities by affiliation status by interacting each nonwhite race/ethnicity with an affiliation indicator. DATA COLLECTION/EXTRACTION METHODS: Medicare Data on Provider Practice and Specialty identified POs billing Medicare; PECOS and IRS Form 990 identified health system affiliations. Beneficiaries age 18 and older were attributed to POs using a plurality visit rule. PRINCIPAL FINDINGS: We observed total disparities in 12 of 36 comparisons between white and nonwhite beneficiaries; nonwhites received worse care in 10. Within‐PO disparities exceeded between‐PO disparities and were substantively important (>=5 percentage points or>=0.2 standardized differences) in nine of the 12 comparisons. Among these 12, nonaffiliated POs had smaller disparities than affiliated POs in two comparisons (P

Objectives. To describe the types of social services provided at community health centers (CHCs), characteristics of CHCs providing these services, and the association between on-site provision and health care quality.Methods. We surveyed CHCs in 12 US states and the District of Columbia during summer 2017 (n = 208) to identify referral to and provision of services to address 8 social needs. Regression models estimated factors associated with the provision of social services by CHCs and the association between providing services and health care quality (an 8-item composite).Results. CHCs most often offered on-site assistance for needs related to food or nutrition (43%), interpersonal violence (32%), and housing (30%). Participation in projects with community-based organizations was associated with providing services on-site (odds ratio = 2.48; P = .018). On-site provision was associated with better performance on measures of health care quality (e.g., each additional social service was associated with a 4.3 percentage point increase in colorectal cancer screenings).Conclusions. Some CHCs provide social services on-site, and this was associated with better performance on measures of health care quality.Public Health Implications. Health care providers are increasingly seeking to identify and address patients’ unmet social needs, and on-site provision of services is 1 strategy to consider.

Background Health centers provide care to vulnerable and high-need populations. Recent investments have promoted use of health information technology (HIT) capabilities for improving care coordination and quality of care in health centers. This study examined factors associated with use of these HIT capabilities and the association between these capabilities and quality of care in a census of health centers in the United States. Methods Cross-sectional secondary data from the 2015 Health Resources and Services Administration's Uniform Data System was used to examine 6 measures of HIT capability related to care coordination and clinical decision support and 16 measures of quality (12 process measures, 3 outcome measures, 1 composite measure) for health centers in the United States. Adjusted logistic regressions were used to examine health center characteristics associated with use of HIT capabilities, and adjusted linear regressions were used to examine associations between HIT capabilities and quality of care. Results Many health centers reported using HIT for care coordination activities, including coordinating enabling services (67.3%) or engaging patients (81.0%). Health center size and medical home recognition were associated with significantly greater odds of using HIT for enabling services and engaging patients. These HIT capabilities were associated with higher overall quality and higher rates of six process measures (adult screening and maternal and child health) and hemoglobin A1c control. Conclusion Use of HIT for such activities as arranging enabling services and engaging patients are underleveraged tools for care coordination. There may be opportunities to further improve quality of care for vulnerable patients by promoting health centers' use of these HIT capabilities.

OBJECTIVE: To understand the process of practice transformation by identifying pathways for attaining patient‐centered medical home (PCMH) recognition. DATA SOURCES/STUDY SETTING: The CMS Federally Qualified Health Center (FQHC) Advanced Primary Care Practice Demonstration was designed to help FQHCs achieve NCQA Level 3 PCMH recognition and improve patient outcomes. We used a stratified random sample of 20 (out of 503) participating sites for this analysis. STUDY DESIGN: We developed a conceptual model of structural, cultural, and implementation factors affecting PCMH transformation based on literature and initial qualitative interview themes. We then used conventional cross‐case analysis, followed by qualitative comparative analysis (QCA), a cross‐case method based on Boolean logic algorithms, to systematically identify pathways (i.e., combinations of factors) associated with attaining—or not attaining—Level 3 recognition. DATA COLLECTION METHODS: Site‐level indicators were derived from semistructured interviews with site leaders at two points in time (mid‐ and late‐implementation) and administrative data collected prior to and during the demonstration period. PRINCIPAL FINDINGS: The QCA results identified five distinct pathways to attaining PCMH recognition and four distinct pathways to not attaining recognition by the end of the demonstration. Across these pathways, one condition (change leader capacity) was common to all pathways for attaining recognition, and another (previous improvement or recognition experience) was absent in all pathways for not attaining recognition. In general, sites could compensate for deficiencies in one factor with capacity in others, but they needed a threshold of strengths in cultural and implementation factors to attain PCMH recognition. CONCLUSIONS: Future efforts at primary care transformation should take into account multiple pathways sites may pursue. Sites should be assessed on key cultural and implementation factors, in addition to structural components, in order to differentiate interventions and technical assistance.

Objective To compare performance between Medicare Advantage (MA) and Fee-for-Service (FFS) Medicare during a time of policy changes affecting both programs. Data Sources/Study Setting Performance data for 16 clinical quality measures and 6 patient experience measures for 9.9 million beneficiaries living in California, New York, and Florida. Study Design We compared MA and FFS performance overall, by plan type, and within service areas associated with contracts between CMS and MA organizations. Case mix-adjusted analyses (for measures not typically adjusted) were used to explore the effect of case mix on MA/FFS differences. Data Collection/Extraction Methods Performance measures were submitted by MA organizations, obtained from the nationwide fielding of the Medicare Consumer Assessment of Healthcare Providers and Systems (MCAHPS) Survey, or derived from claims. Principal Findings Overall, MA outperformed FFS on all 16 clinical quality measures. Differences were large for HEDIS measures and small for Part D measures and remained after case mix adjustment. MA enrollees reported better experiences overall, but FFS beneficiaries reported better access to care. Relative to FFS, performance gaps were much wider for HMOs than PPOs. Excluding HEDIS measures, MA/FFS differences were much smaller in contract-level comparisons. Conclusions Medicare Advantage/Fee-for-Service differences are often large but vary in important ways across types of measures and contracts.

Community health centers (CHCs) historically have reported challenges obtaining specialty care for their patients, but recent policy changes, including Medicaid eligibility expansions under the Affordable Care Act, may have improved access to specialty care. The objective of this study was to assess current levels of difficulty accessing specialty care for CHC patients, by insurance type, and to identify specific barriers and strategies that CHCs are using to overcome these barriers.Cross-sectional survey, administered during summer 2017, of medical directors at CHCs in 9 states and the District of Columbia, all of which expanded Medicaid.Surveys were administered to medical directors at 361 CHCs (response rate, 55%) to assess the difficulty of accessing specialty care by insurance type and to identify the specialties for which it was most difficult to obtain new patient visits. The survey also elicited ratings of commonly reported barriers to obtaining specialty care and identified strategies used by CHCs to access specialty care for patients. Descriptive results are presented.Nearly 60% of CHCs reported difficulty obtaining new patient specialty visits for their Medicaid patients, most often for orthopedists. Barriers to specialty care reported by CHCs included that few specialists in Medicaid managed care organization (MCO) networks were accepting new patients (69.4%) and MCO administrative requirements for obtaining specialist consults (49.0%). To enhance access to specialists, CHCs reported that they entered into referral agreements, developed appointment reminder systems, and participated in data exchange and other community-based initiatives.Medicaid patients at CHCs face many barriers to accessing specialty care. Payment policies and network adequacy rules may need to be reexamined to address these challenges.

RESEARCH OBJECTIVE: A clinically integrated network is a group of health care providers that join together for the stated purpose of improving care and reducing costs. The Federal Trade Commission has established standards for clinically integrated networks for purposes of determining whether cooperation among otherwise competing organizations to jointly negotiate fees runs afoul of antitrust law. However, little is known about how CINs are implemented on the ground and how health systems use CINs to compete in health care markets. STUDY DESIGN: We conducted explanatory case studies of 24 health systems using in‐depth interviews of c‐suite executives (n = 162), descriptive surveys, and document review. The interview protocols focused on topics such as market context; origin of the health system; structural organization and governance; and the influence of the health system on hospital and physician organization operations. We developed a codebook based on the interview guides. After a multistage process of testing and refining codes, two researchers independently coded the interview data. A high threshold of interrater reliability was achieved (pooled kappa across all codes was 0.84). We used comparative case study analysis to compare and contrast the development of CINs in our sample of health systems. POPULATION STUDIED: Using secondary data sources, we identified the health system affiliations of all physician organizations publicly reporting performance data in four states that host a health care measurement and improvement collaborative. From the universe of health systems, we selected a purposive sample of 24 health systems to achieve variability on important attributes (eg, size and performance). PRINCIPAL FINDINGS: Respondents in half of the health systems described the use of a CIN, although the organizational structures and the functions of the CINs varied widely. CINs can be classified into three basic types—those made up of primarily closely affiliated practices, those made up of primarily loosely affiliated practices, and those that represent partnerships among health systems. CONCLUSIONS: Health systems are using CINs to adapt to competitive environments and changing payment policies in several ways. CINs allow health systems to (1) move care into lower‐cost settings while retaining referral pathways for their tertiary facilities; (2) extend their geographic reach without the capital and administrative costs of acquiring and onboarding; (3) maximize negotiating leverage while reducing contracting burden; and (4) offer advantages (such as EHR and quality reporting support) to physicians while allowing them to remain in independent practice. IMPLICATIONS FOR POLICY OR PRACTICE: Research on competition in health care markets has concentrated on mergers and acquisitions; however, many health systems have begun to use an affiliation approach to expansion and integration with other providers in their market. This approach allows independent physician practices to benefit from some of the strengths of a larger HS without capital outlays or administrative burden to the HS, and to reduce transactional costs for the providers. It remains unclear whether this new model of integration is achieving the purported objectives of improved quality and reduced costs. CINs may have the same negative impact on health care prices as have traditional mergers and acquisitions, and will face considerable challenges in coordinating care across providers that are not fully integrated. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

The Global Payment Program (GPP) seeks to improve health care for California's uninsured by using federal funds to make prospective payments to public health care systems for providing inpatient, outpatient, and nontraditional services. This report presents the final evaluation of the program. Through the GPP, public health care systems have put in place a variety of strategies and offered a wider range of services during its first three years.

In an effort to provide care that is more accessible, team-based, coordinated, and patient-focused, primary care practices are increasingly adopting patient-centered medical home (PCMH) models of care. In 2008, the Indian Health Service (IHS) launched its own PCMH initiative, Improving Patient Care (IPC), to improve the quality of care for American Indians and Alaska Natives (AI/ANs) who seek care in its clinics. The IHS provides comprehensive health care services to roughly 2.2 million AI/ANs from more than 567 federally recognized tribes across the United States. RAND researchers examine the peer-reviewed and grey literature and identify common PCMH implementation strategies and challenges to better understand the kinds of methods used by clinics across the United States-particularly small clinics and those located in rural or remote locations. The research team then held telephone discussions with representatives from seven IHS clinics that had received PCMH recognition as of July 2017. The discussions with clinic leaders sought to identify how components of the PCMH model had been implemented at their clinics; challenges associated with PCMH implementation; and key lessons and recommendations that could benefit clinics that have not yet received PCMH recognition.

We examined differences in patient outcomes associated with 3 patient-centered medical home (PCMH) recognition programs-National Committee for Quality Assurance (NCQA) Level 3, The Joint Commission (TJC), and Accreditation Association for Ambulatory Health Care (AAAHC)-among Medicare beneficiaries receiving care at federally qualified health centers (FQHCs).We used data from CMS' FQHC Advanced Primary Care Practice Demonstration, in which participating FQHCs received assistance to achieve NCQA Level 3 PCMH recognition. We assessed the impact of the 3 recognition programs on utilization, quality, and Medicare expenditures using a sample of 1108 demonstration and comparison FQHCs.Using propensity-weighted difference-in-differences analyses, we compared changes in outcomes over 3 years for beneficiaries attributed to FQHCs that achieved each type of recognition relative to beneficiaries attributed to FQHCs that did not achieve recognition.Recognized FQHCs, compared with nonrecognized FQHCs, were associated with significant 3-year changes in FQHC visits, non-FQHC primary care visits, specialty visits, emergency department (ED) visits, hospitalizations, a composite diabetes process measure, and Medicare expenditures. Changes varied in direction and strength by recognition type. In year 3, compared with nonrecognized sites, NCQA Level 3 sites were associated with greater increases in ambulatory visits and quality and greater reductions in hospitalizations and expenditures (P .01), TJC sites were associated with significant reductions in ED visits and hospitalizations (P.01), and AAAHC sites had changes in the opposite direction of what we anticipated.Heterogeneous changes in beneficiary utilization, quality, and expenditures by recognition type may be explained by differences in recognition criteria, evaluation processes, and documentation requirements.

BACKGROUND: Regular primary care visits may allow an opportunity to deliver high-value, proactive care. However, no previous study has examined whether more temporally regular primary care visits predict better outcomes. OBJECTIVE: To examine the relationship between the temporal regularity of primary care (PC) visits and outcomes. DESIGN: Retrospective cohort study. PARTICIPANTS: We used Medicare claims for 378,862 fee-for-service Medicare beneficiaries, who received PC at 1328 federally qualified health centers from 2010 to 2014. MAIN MEASURES: We created five beneficiary groups based upon their annual number of PC visits. We further subdivided those groups according to whether PC visits occurred with more or less regularity than the median value. We compared these 10 subgroups on three outcomes, adjusting for beneficiary characteristics: emergency department (ED) visits, hospitalizations, and total Medicare expenditures. We also aggregated to the clinic level and divided clinics into tertiles of more, less, and similarly regular to predicted. We compared these three groups of clinics on the same three outcomes of care. KEY RESULTS: Within each visit frequency group, beneficiaries in the subgroup with fewer regular visits had more ED visits, more hospitalizations, and higher costs. Among beneficiaries with the most frequent PC visits, the less regular subgroup had more ED visits (1.70 vs. 1.31 per person-year), more hospitalizations (0.69 vs. 0.57), and greater Medicare expenditures ($20,731 vs. $17,430, p

The Global Payment Program seeks to improve health care for California's uninsured by providing funds to cover both traditional and non-traditional services, settings, and providers. The 12 participating public health care systems seek to reduce the use of services in high-intensity settings by designing systems of care that emphasize primary care and supportive services. This is the report of the midpoint evaluation of the program.

Better working conditions for clinicians and staff could help primary care practices implement delivery system innovations and help sustain the US primary care workforce. Using longitudinal surveys, we assessed the experience of clinicians and staff in 296 clinical sites that participated in the Centers for Medicare and Medicaid Services (CMS) Federally Qualified Health Center (FQHC) Advanced Primary Care Practice Demonstration. Participating FQHCs were expected to achieve, within three years, patient-centered medical home recognition at level 3-the highest level possible. During 2013-14, clinicians and staff in these FQHCs reported statistically significant declines in multiple measures of professional satisfaction, work environment, and practice culture. There were no significant improvements on any surveyed measure. These findings suggest that working conditions in FQHCs have deteriorated recently. Whether findings would be similar in other primary care practices is unknown. Although we did not identify the causes of these declines, possible stressors include the adoption of health information technology, practice transformation, and increased demand for services.

From 2011 through 2014, the Federally Qualified Health Center Advanced Primary Care Practice Demonstration provided care management fees and technical assistance to a nationwide sample of 503 federally qualified health centers to help them achieve the highest (level 3) medical-home recognition by the National Committee for Quality Assurance, a designation that requires the implementation of processes to improve access, continuity, and coordination.We examined the achievement of medical-home recognition and used Medicare claims and beneficiary surveys to measure utilization of services, quality of care, patients' experiences, and Medicare expenditures in demonstration sites versus comparison sites. Using difference-in-differences analyses, we compared changes in outcomes in the two groups of sites during a 3-year period.Level 3 medical-home recognition was awarded to 70% of demonstration sites and to 11% of comparison sites. Although the number of visits to federally qualified health centers decreased in the two groups, smaller reductions among demonstration sites than among comparison sites led to a relative increase of 83 visits per 1000 beneficiaries per year at demonstration sites (P0.001). Similar trends explained the higher performance of demonstration sites with respect to annual eye examinations and nephropathy tests (P0.001 for both comparisons); there were no significant differences with respect to three other process measures. Demonstration sites had larger increases than comparison sites in emergency department visits (30.3 more per 1000 beneficiaries per year, P0.001), inpatient admissions (5.7 more per 1000 beneficiaries per year, P=0.02), and Medicare Part B expenditures ($37 more per beneficiary per year, P=0.02). Demonstration-site participation was not associated with relative improvements in most measures of patients' experiences.Demonstration sites had higher rates of medical-home recognition and smaller decreases in the number of patients' visits to federally qualified health centers than did comparison sites, findings that may reflect better access to primary care relative to comparison sites. Demonstration sites had larger increases in emergency department visits, inpatient admissions, and Medicare Part B expenditures. (Funded by the Centers for Medicare and Medicaid Services.).

Patient-centered medical home (PCMH) models of primary care have the potential to expand access, improve population health, and lower costs. Federally qualified health centers (FQHCs) were early adopters of PCMH models.We measured PCMH capabilities in a diverse nationwide sample of FQHCs and assessed the relationship between PCMH capabilities and Medicare beneficiary outcomes.Cross-sectional, propensity score-weighted, multivariable regression analysis.A convenience sample of 804 FQHC sites that applied to a nationwide FQHC PCMH initiative and 231,163 Medicare fee-for-service beneficiaries who received a plurality of their primary care services from these sites.PCMH capabilities were self-reported using the National Committee for Quality Assurance's (NCQA's) 2011 application for PCMH recognition. Measures of utilization, continuity of care, quality, and Medicare expenditures were derived from Medicare claims covering a 1-year period ending October 2011.Nearly 88% of sites were classified as having PCMH capabilities equivalent to NCQA Level 1, 2, or 3 PCMH recognition. These more advanced sites were associated with 228 additional FQHC visits per 1000 Medicare beneficiaries (95% CI: 176, 278), compared with less advanced sites; 0.02 points higher practice-level continuity of care (95% CI: 0.01, 0.03); and a greater likelihood of administering two of four recommended diabetes tests. However, more advanced sites were also associated with 181 additional visits to specialists per 1000 beneficiaries (95% CI: 124, 232) and 64 additional visits to emergency departments (95% CI: 35, 89)-but with no differences in inpatient utilization. More advanced sites had higher Part B expenditures ($111 per beneficiary [95% CI: $61, $158]) and total Medicare expenditures of $353 [95% CI: $65, $614]).Implementation of PCMH models in FQHCs may be associated with improved primary care for Medicare beneficiaries. Expanded access to care, in combination with slower development of key PCMH capabilities, may explain higher Medicare expenditures and other types of utilization.

This article shares findings from a study of the public behavioral health care system in the District of Columbia, including the prevalence of mental health disorders and substance use, the organization and financing of public behavioral health services, utilization of public behavioral health services, and priorities for improvement. The authors' analyses found that prevalence of mental health conditions resembles patterns nationally, among both adults and youth. Substance use disorders are more prevalent among adults and comparatively lower for the youth population, compared to national patterns. Potentially 60 percent of adults and 72 percent of adolescents enrolled in Medicaid managed care may have unmet need for depression services. Based on claims data, 45 percent of children and 41 percent of adults enrolled in Mental Health Rehabilitation Services programs have gaps in care that exceed six months during a 12-month period. Participants in focus groups and stakeholder interviews highlighted such challenges as gaps in care and difficulties in coordination of care for particular populations and services. High-level priorities include reducing unmet need for public mental health care, tracking and coordinating care, improving the availability and accessibility of substance use treatment services, and upgrading the data infrastructure.

Gastroenterology and cardiology services are common and costly among Medicare beneficiaries. Episode-based payment, which aims to create incentives for high-quality, low-cost care, has been identified as a promising alternative payment model. This article describes research related to the design of episode-based payment models for ambulatory gastroenterology and cardiology services for possible testing by the Center for Medicare and Medicaid Innovation at the Centers for Medicare and Medicaid Services (CMS). The authors analyzed Medicare claims data to describe the frequency and characteristics of gastroenterology and cardiology index procedures, the practices that delivered index procedures, and the patients that received index procedures. The results of these analyses can help inform CMS decisions about the definition of episodes in an episode-based payment model; payment adjustments for service setting, multiple procedures, or other factors; and eligibility for the payment model.

Insufficient evidence regarding the effectiveness of medical treatments has been identified as a key source of inefficiency in the U.S. healthcare system. Variation in the use of diagnostic tests and treatments for patients with similar symptoms or conditions has been attributed to clinical uncertainty, since the published scientific evidence base does not provide adequate information to determine which treatments are most effective for patients with specific clinical needs. The federal government has made a dramatic investment in comparative effectiveness research (CER), with the expectation that CER will influence clinical practice and improve the efficiency of healthcare delivery. To do this, CER must provide information that supports fundamental changes in healthcare delivery and informs the choice of diagnostic and treatment strategies. This article summarizes findings from a qualitative analysis of the factors that impede the translation of CER into clinical practice and those that facilitate it. A case-study methodology is used to explore the extent to which these factors led to changes in clinical practice following five recent key CER studies. The enabling factors and barriers to translation for each study are discussed, the root causes for the failure of translation common to the studies are synthesized, and policy options that may optimize the impact of future CER-particularly CER funded through the American Recovery and Reinvestment Act of 2009-are proposed.

This article describes the results of a simulation analysis of a payment model for specialty oncology services that is being developed for possible testing by the Center for Medicare and Medicaid Innovation at the Centers for MedicareMedicaid Services (CMS). CMS asked MITRE and RAND to conduct simulation analyses to preview some of the possible impacts of the payment model and to inform design decisions related to the model. The simulation analysis used an episode-level dataset based on Medicare fee-for-service (FFS) claims for historical oncology episodes provided to Medicare FFS beneficiaries in 2010. Under the proposed model, participating practices would continue to receive FFS payments, would also receive per-beneficiary per-month care management payments for episodes lasting up to six months, and would be eligible for performance-based payments based on per-episode spending for attributed episodes relative to a per-episode spending target. The simulation offers several insights into the proposed payment model for oncology: (1) The care management payments used in the simulation analysis-$960 total per six-month episode-represent only 4 percent of projected average total spending per episode (around $27,000 in 2016), but they are large relative to the FFS revenues of participating oncology practices, which are projected to be around $2,000 per oncology episode. By themselves, the care management payments would increase physician practices' Medicare revenues by roughly 50 percent on average. This represents a substantial new outlay for the Medicare program and a substantial new source of revenues for oncology practices. (2) For the Medicare program to break even, participating oncology practices would have to reduce utilization and intensity by roughly 4 percent. (3) The break-even point can be reduced if the care management payments are reduced or if the performance-based payments are reduced.

This article describes research related to the design of a payment model for specialty oncology services for possible testing by the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services (CMS). Cancer is a common and costly condition. Episode-based payment, which aims to create incentives for high-quality, low-cost care, has been identified as a promising alternative payment model for oncology care. Episode-based payment systems can provide flexibility to health care providers to select among the most effective and efficient treatment alternatives, including activities that are not currently reimbursed under Medicare payment policies. However, the model design also needs to ensure that high-quality care is delivered and that beneficial treatments are not withheld from patients. CMS asked MITRE and RAND to conduct analyses to inform design decisions related to an episode-based oncology model for Medicare beneficiaries undergoing chemotherapy treatment for cancer. In particular, this study focuses on analyses of Medicare claims data related to the definition of the initiation of an episode of chemotherapy, patterns of spending during and surrounding episodes of chemotherapy, and attribution of episodes of chemotherapy to physician practices. We found that the time between the primary cancer diagnosis and chemotherapy initiation varied widely across patients, ranging from one day to over seven years, with a median of 2.4 months. The average level of total monthly payments varied considerably across cancers, with the highest spending peak of $9,972 for lymphoma, and peaks of $3,109 for breast cancer and $2,135 for prostate cancer.

For the years 2013 and 2014, the Affordable Care Act authorized enhanced payments for qualifying providers of primary care services participating in the Medicaid program that would be funded entirely by federal dollars. RAND researchers conducted a nine-state independent case study into stakeholder experiences planning for, implementing, and evaluating the impact of the policy to inform the design of similar, future payment policies.

OBJECTIVE To use the findings of a systematic review of scientific evidence to develop consensus guidelines on nonmedical interventions that address cognitive function and core deficits in children with autism spectrum disorders (ASDs) and to recommend priorities for future research. METHODS The guidelines were developed by a Technical Expert Panel (TEP) consisting of practitioners, researchers, and parents. A systematic overview of research findings was presented to the TEP; guideline statements were drafted, discussed, debated, edited, reassessed, and presented for formal voting. RESULTS The strength of evidence of efficacy varied by intervention type from insufficient to moderate. There was some evidence that greater intensity of treatment (hours per week) and greater duration (in months) led to better outcomes. The TEP agreed that children with ASD should have access to at least 25 hours per week of comprehensive intervention to address social communication, language, play skills, and maladaptive behavior. They agreed that applied behavioral analysis, integrated behavioral/developmental programs, the Picture Exchange Communication System, and various social skills interventions have shown efficacy. Based on identified gaps, they recommend that future research focus on assessment and monitoring of outcomes, addressing the needs of pre/nonverbal children and adolescents, and identifying the most effective strategies, dose, and duration to improve specific core deficits. CONCLUSIONS The creation of treatment guidelines and recommendations for future research represents an effort by leading experts to improve access to services for children with ASDs while acknowledging that the research evidence has many gaps.

Developing clinically meaningful summary measures of health-care quality is key to inferring quality of care. Current summary measures use a number of different approaches to weight their individual measures but rarely use weights based on clinical 'importance'. Such an approach would help to focus quality improvement efforts on areas likely to have the largest impact on health outcomes. Using coronary artery bypass graft (CABG) surgery as a case study, we weight and combine 11 process, complication, and survival measures to summarize differences in quality-adjusted life expectancy 1 year following surgery for a sample of hospitals. We use a fully Bayesian analysis to estimate 1-year survival outcomes using a hierarchical exponential survival model. We then estimate the expected utility of the year following surgery for each patient using complication probabilities fitted from hierarchical models and utility values from the literature. We estimate quality-adjusted life years (QALYs) for each hospital as the utility-weighted average 1-year survival probability and then estimate 'incremental QALYs' by taking the difference in QALYs for each hospital relative to a comparison group that reflects the average performance of all hospitals in the state. We illustrate our framework by estimating incremental QALYs for 14 hospitals performing CABG surgery in Massachusetts in 2003 and find that a composite measure based on QALYs can change the classification of quality outliers relative to conventional mortality measures.

This report contains an independent evaluation of the Federally Qualified Health Center (FQHCs) Advanced Primary Care Practice (APCP) Demonstration for the Centers for Medicare and Medicaid. The evaluation studied the processes and challenges involved in transforming FQHCs into patient-centered medical homes and assessed the effects of the FQHC APCP Demonstration model on access, quality, and cost of care.

The purpose of this study was to discern radiologists' perceptions regarding the implementation of a decision support system intervention as part of the Medicare Imaging Demonstration project and the effect of decision support on radiologists' interactions with ordering clinicians, their radiology work flow, and appropriateness of advanced imaging.A focus group study was conducted with a diverse sample of radiologists involved in interpreting advanced imaging studies at Medicare Imaging Demonstration project sites. A semistructured moderator guide was used, and all focus group discussions were recorded and transcribed verbatim. Qualitative data analysis software was used to code thematic content and identify representative segments of text. Participating radiologists also completed an accompanying survey designed to supplement focus group discussions.Twenty-six radiologists participated in four focus group discussions. The following major themes related to the radiologists' perceptions after decision support implementation were identified: no substantial change in radiologists' interactions with referring clinicians; no substantial change in radiologist work flow, including protocol-writing time; and no perceived increase in imaging appropriateness. Radiologists provided suggestions for improvements in the decision support system, including increasing the usability of clinical data captured, and expressed a desire to have greater involvement in future development and implementation efforts.Overall, radiologists from health care systems involved in the Medicare Imaging Demonstration did not perceive that decision support had a substantial effect, either positive or negative, on their professional roles and responsibilities. Radiologists expressed a desire to improve efficiencies and quality of care by having greater involvement in future efforts.

This article reviews the experience of a large, heterogeneous integrated delivery network that incorporated physician quality metrics into pay-for-performance contracts. The authors present criteria for including measures in pay-for-performance contracts and offer a practical approach to determining withhold return or bonus distribution based on improvement and performance. They demonstrate interventions undertaken to improve performance, including the development of a claims-based registry. Empirical data show that the network performance improved more than the comparable state and national performance during the period of this observational study. The authors conclude that pay for-performance contracts led to development of medical management programs including a claims-based registry and nonphysician interventions, which helped significantly improve selected HEDIS scores.

Background We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases. Patients and methods Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n = 248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE. Results There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively. Conclusions SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.

The Patient-Centered Outcomes Research Institute sponsored the establishment of PCORnet, the National Patient-Centered Clinical Research Network, to improve the efficiency and utility of clinical trials and observational research. This report contains the results of a formative evaluation of PCORnet's implementation, including the development of its governance, data, and research infrastructure; collaboration activity; and stakeholder engagement.

The Department of Health and Human Services, acting through the Centers for Medicare and Medicaid Services, implemented a three-year project intended to support the transformation of federally qualified health centers (FQHCs) into advanced primary care practices (APCPs) in support of Medicare beneficiaries. RAND is assessing the effects on access, quality, and cost of care provided to Medicare and Medicaid beneficiaries.

In December 2009, Department of Health and Human Services was directed to implement a three-year demonstration to support federally qualified health centers in becoming advanced primary care practices for Medicare beneficiaries. RAND was asked to study the processes and challenges involved and assess the effects on access, quality, and cost of care provided to Medicare and Medicaid beneficiaries. This is the first report in a series of three.

Our goal was to calculate resource use associated with administration of zoledronic acid, compared with pamidronate, as palliative care for patients with metastatic bone lesions. We conducted a time-and-motion study of therapy administration at each of three outpatient chemotherapy infusion sites participating in clinical trials of zoledronic acid and pamidronate. We developed a data-collection instrument to record all staff effort and patient resource use in drug administration. The main outcome measures were (a) direct costs of therapy administration per patient and (b) opportunity benefits expressed as the availability of resources gained per year. The average visit time for patients receiving the study dose of zoledronic acid, 4 mg, was 1 h, 6 min, compared to 2 h, 52 min for patients receiving a 90-mg dose of pamidronate. Infusion time accounted for much of the difference. In the base-case analysis, total direct costs per patient were $728 for zoledronic acid and $776 for pamidronate. The opportunity benefit for infusion of zoledronic acid vs pamidronate in the base case was 1.8 chairs per day, or 426 chairs per 240-workday year. Results were sensitive to changes in infusion facility size, days of operation, and average number of patients treated. Shorter infusion time associated with the administration of zoledronic acid, compared with pamidronate, yields substantial time savings for patients, as well as opportunity benefits for outpatient oncology facilities.

This systematic review sought to identify the best available evidence regarding strategies for allocating scarce resources during mass casualty events (MCEs). Specifically, the review addresses the following questions: (1) What strategies are available to policymakers to optimize the allocation of scarce resources during MCEs? (2) What strategies are available to providers to optimize the allocation of scarce resources during MCEs? (3) What are the public's key perceptions and concerns regarding the implementation of strategies to allocate scarce resources during MCEs? (4) What methods are available to engage providers in discussions regarding the development and implementation of strategies to allocate scarce resources during MCEs?We searched Medline, Scopus, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Global Health, Web of Science®, and the Cochrane Database of Systematic Reviews from 1990 through 2011. To identify relevant non-peer-reviewed reports, we searched the New York Academy of Medicine's Grey Literature Report. We also reviewed relevant State and Federal plans, peer-reviewed reports and papers by nongovernmental organizations, and consensus statements published by professional societies. We included both English- and foreign-language studies.Our review included studies that evaluated tested strategies in real-world MCEs as well as strategies tested in drills, exercises, or computer simulations, all of which included a comparison group. We reviewed separately studies that lacked a comparison group but nonetheless evaluated promising strategies. We also identified consensus recommendations developed by professional societies or government panels. We reviewed existing State plans to examine the current state of planning for scarce resource allocation during MCEs. Two investigators independently reviewed each article, abstracted data, and assessed study quality.We considered 5,716 reports for this comparative effectiveness review (CER); we ultimately included 170 in the review. Twenty-seven studies focus on strategies for policymakers. Among this group were studies that examined various ways to distribute biological countermeasures more efficiently during a bioterror attack or influenza pandemic. They provided modest evidence that the way these systems are organized influences the speed of distribution. The review includes 119 studies that address strategies for providers. A number of these studies provided evidence suggesting that commonly used triage systems do not perform consistently in actual MCEs. The number of high-quality studies addressing other specific strategies was insufficient to support firm conclusions about their effectiveness. Only 10 studies included strategies that consider the public's perspective. However, these studies were consistent in their findings. In particular, the public believes that resource allocation guidelines should be simple and consistent across health care facilities but should allow facilities some flexibility to make allocation decisions based on the specific demand and supply situation. The public also believes that a successful allocation system should balance the goals of ensuring the functioning of society, saving the greatest number of people, protecting the most vulnerable people, reducing deaths and hospitalizations, and treating people fairly and equitably. The remaining 14 studies provided strategies for engaging providers in discussions about allocating and managing scarce medical resources. These studies did not identify one engagement approach as clearly superior; however, they consistently noted the importance of a broad, inclusive, and systematic engagement process.Scientific research to identify the most effective adaptive strategies to implement during MCEs is an emerging area. While it remains unclear which of the many options available to policymakers and providers will be most effective, ongoing efforts to develop a focused, well-organized program of applied research should help to identify the optimal methods, techniques, and technologies to strengthen our nation's capacity to respond to MCEs.

Background Ongoing efforts to profile physicians on their relative cost of care have been criticized because they do not account for differences in patients' socioeconomic status (SES). The importance of SES adjustment has not been explored in cost-profiling applications that measure costs using an episode of care framework. Objectives We assessed the relationship between SES and episode costs and the impact of adjusting for SES on physicians' relative cost rankings. Research design We analyzed claims submitted to 3 Massachusetts commercial health plans during calendar years 2004 and 2005. We grouped patients' care into episodes, attributed episodes to individual physicians, and standardized costs for price differences across plans. We accounted for differences in physicians' case mix using indicators for episode type and a patient's severity of illness. A patient's SES was measured using an index of 6 indicators based on the zip code in which the patient lived. We estimated each physician's case mix-adjusted average episode cost and percentile rankings with and without adjustment for SES. Results Patients in the lowest SES quintile had $80 higher unadjusted episode costs, on average, than patients in the highest quintile. Nearly 70% of the variation in a physician's average episode cost was explained by case mix of their patients, whereas the contribution of SES was negligible. After adjustment for SES, only 1.1% of physicians changed relative cost rankings >2 percentiles. Conclusions Accounting for patients' SES has little impact on physicians' relative cost rankings within an episode cost framework.

Item does not contain fulltext Despite widespread enthusiasm about the potential impact of new investments in comparative effectiveness research, recent history suggests that scientific evidence may be slow to change clinical practice. Reflecting on studies conducted over the past decade, we identify five causes that underlie the failure of many comparative effectiveness studies to alter patient care. These are financial incentives, such as fee-for-service payment, that may militate against the adoption of new clinical practices; ambiguity of study results that hamper decision making; cognitive biases in the interpretation of new information; failure of the research to address the needs of end users; and limited use of decision support by patients and clinicians. Policies that encourage the development of consensus objectives, methods, and evidentiary standards before studies get under way and that provide strong incentives for patients and providers to use resources efficiently may help overcome at least some of these barriers and enable comparative effectiveness results to alter medical practice more quickly.

The cornerstone of diabetes care is management of risk factors for vascular complications, particularly control of blood pressure, cholesterol, and blood glucose. Most treatment guidelines call for lowering hemoglobin A1c below 7 percent, blood pressure below 130/80, and low-density lipoprotein (LDL)-cholesterol below 100 mg/dL (2.59 mmol/L) (Grundy et al. 2004; American Diabetes Association 2008;). Despite demonstrating substantial health benefits, trials that have compared tight control strategies to conventional approaches have also consistently shown that a large proportion of patients fail to reach targets for A1c (Abraira et al. 1995; UKPDS Study Group 1998a; Patel et al. 2008;) and blood pressure (Hansson et al. 1998; UKPDS Study Group 1998b;) even after a battery of treatments. In one of the largest trials of blood glucose control, the United Kingdom Prospective Diabetes Study (UKPDS) (UKPDS Study Group 1998a), for example, the median A1c in the intensive treatment group over the course of the study was 7.5 percent, meaning that most patients were unable to achieve or maintain the 7 percent target, even though these patients were early in the course of diabetes. In the Hypertension Optimal Treatment (HOT) trial (Hansson et al. 1998), over half of subjects randomized to the lowest diastolic blood pressure (DBP) target failed to reach it. Successful control of diabetes risk factors depends on a number of factors, including a patient's baseline value of the risk factor, the efficacy of treatment, pathophysiological factors, treatment contraindications and side effects, and each patient's willingness to accept multiple and potentially burdensome treatments. Guidelines often emphasize the benefits of treating to targets without consideration of their costs and side effects, and often without reference to the potential diminishing effects of adding a third, fourth, or fifth medication. Discontinuation rates from A1c-lowering therapies in the UKPDS ranged from 10 to 25 percent over a 3-year period (UKPDS Study Group 1995), suggesting that the side effects or inconvenience of these treatments are significant even among clinical trial volunteers. Little quantifiable information exists on the necessary resources and potential harms associated with a strategy of treating to target levels of risk factors. For patients having multiple uncontrolled risk factors, the overall treatment burden could be substantial. Although trials of intensive risk factor control often report improved health outcomes on average, these trials often fail to provide information that is critical for guiding decision making and policy making in the real world (Hayward, Hofer, and Vijan 2006). First, these studies rarely report the incremental efficacy of each successive treatment in the intensification regimen, and without these data, the benefits of repeatedly adding or titrating medications cannot meaningfully be weighed against their harms. Second, because trial patients tend to be healthier, more adherent, and more likely to be screened for nonresponse and intolerance to treatment (Nallamothu, Hayward, and Bates 2008), the rate at which targets are reached in real-world settings is likely to be significantly lower than that observed in the clinical literature, and the polypharmacy requirements could be much higher. We therefore developed a simulation model that integrates three of the key determinants of attaining targets—efficacy of treatment, individual variation in treatment response, and treatment tolerance—to estimate the impact of a treat-to-target strategy for a nationally representative diabetic population. We assess the attainability of targets across three risk factors and the level of polypharmacy required. We conclude with a discussion of the implications of our findings for patient care and quality measurement.

Provider profiling and performance-based incentive programs have expanded in recent years but need a theoretical framework for measuring and comparing the ``value'' of clinical care across medical providers. Cost-effectiveness analysis provides such a framework but has rarely been used outside of the treatment choice context. The authors present a profiling framework based on cost-effectiveness methods and illustrate their approach using data on in-hospital survival and the cost of care for a heart attack from a sample of Massachusetts hospitals during fiscal year 2003. They model each outcome using hierarchical models that allow performance to vary across hospitals as a function of a latent quality effect and an effect of case mix. They also estimate incremental outcomes by conditioning on each hospital's pair of random effects, using indirect standardization to estimate ``expected'' outcomes, and then taking their difference. Incremental cost and effectiveness outcomes are combined using incremental net monetary benefits. Using cost-effectiveness methods to profile hospital ``value'' permits the comparison of the benefit of a service relative to the cost using existing societal weights.

Health plans have begun to combine data on the quality and cost of medical providers in an attempt to identify and reward those that offer the greatest 'value.' The analytical methods used to combine these measures in the context of provider profiling have not been rigorously studied. We propose three methods to measure and compare the value of hospital care following acute myocardial infarction by combining a single measure of quality, in-hospital survival, and the cost of an episode of acute care. To illustrate these methods, we use administrative data for heart attack patients treated at 69 acute care hospitals in Massachusetts in fiscal year 2003. In the first method we reproduce a common approach to value profiling by modeling the two case mix-standardized outcomes independently. In the second approach, survival is regressed on patient risk factors and the average cost of care at each hospital. The third method models survival and cost for each hospital jointly and combines the outcomes on a common scale using a cost-effectiveness framework. For each method we use the resulting parameter estimates or functions of the estimates to compute posterior tail probabilities, representing the probability of being classified in the upper or lower quartile of the statewide distribution. Hospitals estimated to have the highest and lowest value according to each method are compared for consistency, and the advantages and disadvantages of each approach are discussed.

The aims of this study were to examine labor supply effects of interventions for major depressive disorder and to compare these effects with a summary measure of clinical effectiveness.Research articles published in English-language journals from 1980 through May 2004 were searched by using five research databases. Only randomized trials that included a placebo group or a usual care group were eligible for the study, regardless of the specific type of intervention. Valid trials were those that enrolled adult patients with major depressive disorder and assessed changes in labor output by using a measure of time worked or labor market participation. From a total of 706 trials uncovered from the database searches, only four met all inclusion criteria. Trial outcomes were transformed into standardized effect sizes on the basis of Cohen's d. Hierarchical linear models were used to separately pool work outcomes and clinical outcomes.An improvement of .34 standard deviation was found in the size of the clinical effect of interventions compared with placebo or usual care among 1,261 unique patients with depression. An improvement of .12 standard deviation was found in the size of the effect on labor supply among 1,848 unique patients.Although the interventions studied were associated with reduced symptoms of depression and increased labor output, the labor benefits were small according to standard benchmarks used in interpreting the substantive significance of values of Cohen's d. The difference in effects may have been due to different underlying efficacies, brief durations of follow-up, or extrinsic factors that affect labor supply.

Background Research on individual differences in health-related quality of life (HRQOL) can identify intervention targets and important covariates in analyses of treatment outcomes. Objectives The objectives of this study were to describe HRQOL trajectories for women with metastatic breast cancer in a randomized trial of bisphosphonates and to identify characteristics associated with variations in HRQOL. Research design We conducted a prospective quality-of-life study within a randomized, controlled trial. Subjects We studied women with metastatic breast cancer receiving zoledronic acid or pamidronate disodium to reduce the incidence of skeletal-related events (SREs). Main outcome measures HRQOL was measured at fixed time points during the trial. Individual growth-curve modeling was used to describe longitudinal trajectories and to identify predictors of trajectories. Results For most domains of HRQOL, the mean trajectory reflected a mild increase, which leveled off later in the trial. Older age and full-time employment were associated with higher baseline HRQOL. Longer time from cancer diagnosis to randomization, lower Eastern Cooperative Oncology Group (ECOG) status (score of 2 ["inactive"]), and a history of SREs were associated with lower baseline HRQOL. Significant differences across geographic regions were observed for all domains. Active ECOG status (score of 0-1) at baseline was predictive of greater increases in all domains of HRQOL except Social/Family Well-Being. Age, geographic region, and time from first bone metastases to randomization were associated with longitudinal changes in some domains. Conclusions Women with metastatic breast cancer receiving bisphosphonates for prevention of SREs experienced an overall increase in HRQOL. Variations among women's experiences are explained partly by such characteristics as a history of SREs.

Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards.From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials.Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions--from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50])--demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items.Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed.