Comparative Effectiveness Research: An Empirical Study of Trials Registered in ClinicalTrials.gov

Background The $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program. Methods We conducted an observational study of clinical trials addressing priority research topics defined by the Institute of Medicine and conducted in the US between 2007 and 2010. Trials were identified in ClinicalTrials.gov. Main outcome measures were the prevalence of comparative effectiveness research, nature of comparators selected, funding sources, and impact of these factors on results. Results 231 (22.3%; 95% CI 19.8%–24.9%) studies were CE studies and 804 (77.7%; 95% CI, 75.1%–80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%–39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%–44.1%) no control. The most common treatments examined in CE studies were drug interventions (37.2%), behavioral interventions (28.6%), and procedures (15.6%). Study findings were favorable for the experimental treatment in 34.8% of CE studies and greater than twice as many (78.6%) non-CE studies (P<0.001). CE studies were more likely to receive government funding (P = 0.003) and less likely to receive industry funding (P = 0.01), with 71.8% of CE studies primarily funded by a noncommercial source. The types of interventions studied differed based on funding source, with 95.4% of industry trials studying a drug or device. In addition, industry-funded CE studies were associated with the fewest pediatric subjects (P<0.001), the largest anticipated sample size (P<0.001), and the shortest study duration (P<0.001). Conclusions In this sample of studies examining high priority areas for CE research, less than a quarter are CE studies and the majority is supported by government and nonprofits. The low prevalence of CE research exists across CE studies with a broad array of interventions and characteristics.National Library of Medicine (U.S.) (5G08LM009778)National Institutes of Health (U.S.

‘Should a mammographic screening programme carry the warning: Screening can damage your health!’?

The balanced presentation afforded by convening a Citizens' Jury when considering a major question such as the introduction of a breast screening programme is advocated. This method would enable account to be taken of all the costs, both human and financial, to all those affected, both participating and organizing, as well as the benefits. Provision of such a democratic opportunity enables consideration to be given to a broad range of factors, by selection of an appropriate range of witnesses, with the advantage of involving the lay public in this decision-making process. Attendance by health correspondents, medical journalists and other media representatives enables publicization of a democracy in action whilst helping to inform the wider debate. Such an exercise could inform whether the NHS BSP should continue in its current form. © 1999 Cancer Research Campaig

Something is Amiss in Denmark: A Comparison of Preventable Hospitalisations and Readmissions for Chronic Medical Conditions in the Danish Healthcare System and Kaiser Permanente

Background: As many other European healthcare systems the Danish healthcare system (DHS) has targeted chronic condition care in its reform efforts. Benchmarking is a valuable tool to identify areas for improvement. Prior work indicates that chronic care coordination is poor in the DHS, especially in comparison with care in Kaiser Permanente (KP), an integrated delivery system based in the United States. We investigated population rates of hospitalisation and readmission rates for ambulatory care sensitive, chronic medical conditions in the two systems. Methods: Using a historical cohort study design, age and gender adjusted population rates of hospitalisations for angina, heart failure, chronic obstructive pulmonary disease, and hypertension, plus rates of 30-day readmission and mortality were investigated for all individuals aged 65+ in the DHS and KP. Results: DHS had substantially higher rates of hospitalisations, readmissions, and mean lengths of stay per hospitalisation, than KP had. For example, the adjusted angina hospitalisation rates in 2007 for the DHS and KP respectively were 1.01/100 persons (95%CI: 0.98-1.03) vs. 0.11/100 persons (95%CI: 0.10-0.13/100 persons); 21.6% vs. 9.9% readmission within 30 days (OR = 2.53; 95% CI: 1.84-3.47); and mean length of stay was 2.52 vs. 1.80 hospital days. Mortality up through 30 days post-discharge was not consistently different in the two systems. Conclusions: There are substantial differences between the DHS and KP in the rates of preventable hospitalisations and subsequent readmissions associated with chronic conditions, which suggest much opportunity for improvement within the Danish healthcare system. Reductions in hospitalisations also could improve patient welfare and free considerable resources for use towards preventing disease exacerbations. These conclusions may also apply for similar public systems such as the US Medicare system, the NHS and other systems striving to improve the integration of care for persons with chronic conditions

Hospital deaths and adverse events in Brazil

<p>Abstract</p> <p>Background</p> <p>Adverse events are considered a major international problem related to the performance of health systems. Evaluating the occurrence of adverse events involves, as any other outcome measure, determining the extent to which the observed differences can be attributed to the patient's risk factors or to variations in the treatment process, and this in turn highlights the importance of measuring differences in the severity of the cases. The current study aims to evaluate the association between deaths and adverse events, adjusted according to patient risk factors.</p> <p>Methods</p> <p>The study is based on a random sample of 1103 patient charts from hospitalizations in the year 2003 in 3 teaching hospitals in the state of Rio de Janeiro, Brazil. The methodology involved a retrospective review of patient charts in two stages - screening phase and evaluation phase. Logistic regression was used to evaluate the relationship between hospital deaths and adverse events.</p> <p>Results</p> <p>The overall mortality rate was 8.5%, while the rate related to the occurrence of an adverse event was 2.9% (32/1103) and that related to preventable adverse events was 2.3% (25/1103). Among the 94 deaths analyzed, 34% were related to cases involving adverse events, and 26.6% of deaths occurred in cases whose adverse events were considered preventable. The models tested showed good discriminatory capacity. The unadjusted odds ratio (OR 11.43) and the odds ratio adjusted for patient risk factors (OR 8.23) between death and preventable adverse event were high.</p> <p>Conclusions</p> <p>Despite discussions in the literature regarding the limitations of evaluating preventable adverse events based on peer review, the results presented here emphasize that adverse events are not only prevalent, but are associated with serious harm and even death. These results also highlight the importance of risk adjustment and multivariate models in the study of adverse events.</p

The crossroads of evidence-based medicine and health policy: implications for urology

As healthcare spending in the United States continues to rise at an unsustainable rate, recent policy decisions introduced at the national level will rely on precepts of evidence-based medicine to promote the determination, dissemination, and delivery of “best practices” or quality care while simultaneously reducing cost. We discuss the influence of evidence-based medicine on policy and, in turn, the impact of policy on the developing clinical evidence base with an eye to the potential effects of these relationships on the practice and provision of urologic care

Evaluation of a task-based community oriented teaching model in family medicine for undergraduate medical students in Iraq

BACKGROUND: The inclusion of family medicine in medical school curricula is essential for producing competent general practitioners. The aim of this study is to evaluate a task-based, community oriented teaching model of family medicine for undergraduate students in Iraqi medical schools. METHODS: An innovative training model in family medicine was developed based upon tasks regularly performed by family physicians providing health care services at the Primary Health Care Centre (PHCC) in Mosul, Iraq. Participants were medical students enrolled in their final clinical year. Students were assigned to one of two groups. The implementation group (28 students) was exposed to the experimental model and the control group (56 students) received the standard teaching curriculum. The study took place at the Mosul College of Medicine and at the Al-Hadba PHCC in Mosul, Iraq, during the academic year 1999–2000. Pre- and post-exposure evaluations comparing the intervention group with the control group were conducted using a variety of assessment tools. RESULTS: The primary endpoints were improvement in knowledge of family medicine and development of essential performance skills. Results showed that the implementation group experienced a significant increase in knowledge and performance skills after exposure to the model and in comparison with the control group. Assessment of the model by participating students revealed a high degree of satisfaction with the planning, organization, and implementation of the intervention activities. Students also highly rated the relevancy of the intervention for future work. CONCLUSION: A model on PHCC training in family medicine is essential for all Iraqi medical schools. The model is to be implemented by various relevant departments until Departments of Family medicine are established

Association of Communication Between Hospital-based Physicians and Primary Care Providers with Patient Outcomes

Background: Patients admitted to general medicine inpatient services are increasingly cared for by hospital-based physicians rather than their primary care providers (PCPs). This separation of hospital and ambulatory care may result in important care discontinuities after discharge. We sought to determine whether communication between hospital-based physicians and PCPs influences patient outcomes. Methods: We approached consecutive patients admitted to general medicine services at six US academic centers from July 2001 to June 2003. A random sample of the PCPs for consented patients was contacted 2 weeks after patient discharge and surveyed about communication with the hospital medical team. Responses were linked with the 30-day composite patient outcomes of mortality, hospital readmission, and emergency department (ED) visits obtained through follow-up telephone survey and National Death Index search. We used hierarchical multi-variable logistic regression to model whether communication with the patient’s PCP was associated with the 30-day composite outcome. Results: A total of 1,772 PCPs for 2,336 patients were surveyed with 908 PCPs responses and complete patient follow-up available for 1,078 patients. The PCPs for 834 patients (77%) were aware that their patient had been admitted to the hospital. Of these, direct communication between PCPs and inpatient physicians took place for 194 patients (23%), and a discharge summary was available within 2 weeks of discharge for 347 patients (42%). Within 30 days of discharge, 233 (22%) patients died, were readmitted to the hospital, or visited an ED. In adjusted analyses, no relationship was seen between the composite outcome and direct physician communication (adjusted odds ratio 0.87, 95% confidence interval 0.56 – 1.34), the presence of a discharge summary (0.84, 95% CI 0.57–1.22), or PCP awareness of the index hospitalization (1.08, 95% CI 0.73–1.59). Conclusion: Analysis of communication between PCPs and inpatient medical teams revealed much room for improvement. Although communication during handoffs of care is important, we were not able to find a relationship between several aspects of communication and associated adverse clinical outcomes in this multi-center patient sample

Comparative effectiveness of asthma interventions within a practice based research network

<p>Abstract</p> <p>Background</p> <p>Asthma is a chronic lung disease that affects more than 23 million people in the United States, including 7 million children. Asthma is a difficult to manage chronic condition associated with disparities in health outcomes, poor medical compliance, and high healthcare costs. The research network coordinating this project includes hospitals, urgent care centers, and outpatient clinics within Carolinas Healthcare System that share a common electronic medical record and billing system allowing for rapid collection of clinical and demographic data. This study investigates the impact of three interventions on clinical outcomes for patients with asthma. Interventions are: an integrated approach to care that incorporates asthma management based on the chronic care model; a shared decision making intervention for asthma patients in underserved or disadvantaged populations; and a school based care approach that examines the efficacy of school-based programs to impact asthma outcomes including effectiveness of linkages between schools and the healthcare providers.</p> <p>Methods/Design</p> <p>This study will include 95 Practices, 171 schools, and over 30,000 asthmatic patients. Five groups (A-E) will be evaluated to determine the effectiveness of three interventions. Group A is the usual care control group without electronic medical record (EMR). Group B practices are a second control group that has an EMR with decision support, asthma action plans, and population reports at baseline. A time delay design during year one converts practices in Group B to group C after receiving the integrated approach to care intervention. Four practices within Group C will receive the shared decision making intervention (and become group D). Group E will receive a school based care intervention through case management within the schools. A centralized database will be created with the goal of facilitating comparative effectiveness research on asthma outcomes specifically for this study. Patient and community level analysis will include results from patient surveys, focus groups, and asthma patient density mapping. Community variables such as income and housing density will be mapped for comparison. Outcomes to be measured are reduced hospitalizations and emergency department visits; improved adherence to medication; improved quality of life; reduced school absenteeism; improved self-efficacy and improved school performance.</p> <p>Discussion</p> <p>Identifying new mechanisms that improve the delivery of asthma care is an important step towards advancing patient outcomes, avoiding preventable Emergency Department visits and hospitalizations, while simultaneously reducing overall healthcare costs.</p

Older adults' attitudes about continuing cancer screening later in life: a pilot study interviewing residents of two continuing care communities

BACKGROUND: Individualized decision making has been recommended for cancer screening decisions in older adults. Because older adults' preferences are central to individualized decisions, we assessed older adults' perspectives about continuing cancer screening later in life. METHODS: Face to face interviews with 116 residents age 70 or over from two long-term care retirement communities. Interview content included questions about whether participants had discussed cancer screening with their physicians since turning age 70, their attitudes about information important for individualized decisions, and their attitudes about continuing cancer screening later in life. RESULTS: Forty-nine percent of participants reported that they had an opportunity to discuss cancer screening with their physician since turning age 70; 89% would have preferred to have had these discussions. Sixty-two percent believed their own life expectancy was not important for decision making, and 48% preferred not to discuss life expectancy. Attitudes about continuing cancer screening were favorable. Most participants reported that they would continue screening throughout their lives and 43% would consider getting screened even if their doctors recommended against it. Only 13% thought that they would not live long enough to benefit from cancer screening tests. Factors important to consider stopping include: age, deteriorating or poor health, concerns about the effectiveness of the tests, and doctors recommendations. CONCLUSION: This select group of older adults held positive attitudes about continuing cancer screening later in life, and many may have had unrealistic expectations. Individualized decision making could help clarify how life expectancy affects the potential survival benefits of cancer screening. Future research is needed to determine whether educating older adults about the importance of longevity in screening decisions would be acceptable, affect older adults' attitudes about screening, or change their screening behavior

A July Spike in Fatal Medication Errors: A Possible Effect of New Medical Residents

residencies and acquire increased responsibility for patient care. Many have suggested that these new medical residents may produce errors and worsen patient outcomes—the so-called “July Effect; ” however, we have found no U.S. evidence documenting this effect. OBJECTIVE: Determine whether fatal medication errors spike in July