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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

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

Background Previous studies have disagreed on whether patients who receive primary care from federally qualified health centers (FQHCs) have different utilization patterns than patients who receive care elsewhere. Our objective was to compare patterns of healthcare utilization between Medicare beneficiaries who received primary care from FQHCs and Medicare beneficiaries who received primary care from another source. Methods We compared characteristics and ambulatory, emergency department (ED), and inpatient utilization during 2013 between 130,637 Medicare beneficiaries who visited an FQHC for the majority of their primary care in 2013 (FQHC users) and a random sample of 1,000,000 Medicare fee-for-service (FFS) beneficiaries who did not visit an FQHC (FQHC non-users). We then created a propensity-matched sample of 130,569 FQHC users and 130,569 FQHC non-users to account for differences in observable patient characteristics between the two groups and repeated all comparisons. Results Before matching, the two samples differed in terms of age (42% below age 65 for FQHC users vs. 16% among FQHC non-users, p

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.

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.

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.

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.

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.

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.

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.

Background Lowering low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) in patients with diabetes mellitus (DM) can significantly reduce the risk of cardiovascular disease (CVD). However, to our knowledge, previous studies have not assessed variability in both the benefit and harm from pursuing LDL-C and BP target levels. Methods Our sample comprised individuals 30 to 75 years old with DM participating in the National Health and Nutrition Examination Survey III. We used Monte Carlo methods to simulate a treat-to-target strategy, in which patients underwent treatment intensification with the goal of achieving LDL-C and BP target levels of 100 mg/dL and 130/80 mm Hg, respectively. Patients received up to 5 titrations of statin therapy and 8 titrations of antihypertensive therapy. Treatment adverse effects and polypharmacy risks and burdens were incorporated using disutilities. Health outcomes were simulated using a Markov model. Results Treating to targets resulted in gains of 1.50 (for LDL-C) and 1.35 (for BP) quality-adjusted life-years (QALYs) of lifetime treatment-related benefit, which declined to 1.42 and 1.16 QALYs after accounting for treatment-related harms. Most of the total benefit was limited to the first few steps of medication intensification or to tight control for a limited group of very high-risk patients. However, because of treatment-related disutility, intensifying beyond the first step (LDL-C) or third step (BP) resulted in either limited benefit or net harm for patients with below-average risk. Conclusion The benefits and harms from aggressive risk factor modification vary widely across the US population of individuals with DM, depending on a patient's underlying CVD risk, suggesting that a personalized approach could maximize a patient's net benefit from treatment.

Although treating to lipid targets ("treat to target") is widely recommended for coronary artery disease (CAD) prevention, some have advocated administering fixed doses of statins based on a person's estimated net benefit ("tailored treatment").To examine how a tailored treatment approach to statin therapy compares with a treat-to-target approach.Simulated model of population-level effects of treat-to-target and tailored treatment approaches to statin therapy.Statin trials from 1994 to 2009 and nationally representative CAD risk factor data.U.S. persons aged 30 to 75 years with no history of myocardial infarction.Lifetime effects of 5 years of treatment.Societal and patient.Tailored treatment based on a person's 5-year CAD risk (simvastatin, 40 mg, for 5% to 15% CAD risk and atorvastatin, 40 mg, for CAD risk15%) versus treat-to-target approaches that escalate statin dose per National Cholesterol Education Program [NCEP] III guidelines (including an intensive approach that advances treatment whenever intensification is optional by NCEP III criteria).Quality-adjusted life-years (QALYs).Compared with the standard NCEP III approach, the intensive NCEP III approach treated 15 million more persons and saved 570,000 more QALYs over 5 years. The tailored strategy treated a similar number of persons, as did the intensive NCEP III approach, but saved 500,000 more QALYs and treated fewer persons with high-dose statins.No circumstances were found in which a treat-to-target approach was preferable to tailored treatment.Model assumptions were based on available clinical data, which included few persons 75 years or older.A tailored treatment strategy prevents more CAD events while treating fewer persons with high-dose statins than low-density lipoprotein cholesterol-based target approaches. Results were robust, even with assumptions favoring a treat-to-target approach.Department of Veteran Affairs Health Services ResearchDevelopment Service's Quality Enhancement Research Initiative.