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ECONOMICS OF INDIVIDUALIZATION IN COMPARATIVE EFFECTIVENESS RESEARCH AND A BASIS FOR A PATIENT-CENTERED HEALTH CARE

Basu, Anirban
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
EN
Relevância na Pesquisa
46.21%
The United States aspires to use information from comparative effectiveness research (CER) to reduce waste and contain costs without instituting a formal rationing mechanism or compromising patient or physician autonomy with regard to treatment choices. With such ambitious goals, traditional combinations of research designs and analytical methods used in CER may lead to disappointing results. In this paper, I study how alternate regimes of comparative effectiveness information help shape the marginal benefits (demand) curve in the population and how such perceived demand curves impact decision-making at the individual patient level and welfare at the societal level. I highlight the need to individualize comparative effectiveness research in order to generate the true (normative) demand curve for treatments. I discuss methodological principles that guide research designs for such studies. Using an example of the comparative effect of substance abuse treatments on crime, I use novel econometric methods to salvage individualized information from an existing dataset.

Comparative Effectiveness Research For Antipsychotic Medications: How Much Is Enough?: If comparative effectiveness research is to guide policy, then it must include evaluations of changes in policy

Meltzer, David O.; Basu, Anirban; Meltzer, Herbert Y.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
EN
Relevância na Pesquisa
46.19%
Second-generation antipsychotics have attracted practitioners’ and policy-makers’ attention, because of concerns over their health effects and costs. Comparative effectiveness data from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)—a high-profile National Institutes of Health (NIH)–funded study—have been used to argue for restricting coverage for these costly drugs. But concerns about the design of CATIE and its associated cost-effectiveness analysis and uncertainty about the precision of these findings raise questions about this interpretation. Our work suggests that additional research to increase the precision of comparisons of the effectiveness of antipsychotics would be well worth the cost.

Using Meta-analyses for Comparative Effectiveness Research

Conn, Vicki S.; Ruppar, Todd M.; Phillips, Lorraine J.; Chase, Jo-Ana D.
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /07/2012 EN
Relevância na Pesquisa
46.21%
Comparative effectiveness research seeks to identify the most effective interventions for particular patient populations. Meta-analysis is an especially valuable form of comparative effectiveness research because it emphasizes the magnitude of intervention effects rather than relying on tests of statistical significance among primary studies. Overall effects can be calculated for diverse clinical and patient-centered variables to determine the outcome patterns. Moderator analyses compare intervention characteristics among primary studies by determining if effect sizes vary among studies with different intervention characteristics. Intervention effectiveness can be linked to patient characteristics to provide evidence for patient-centered care. Moderator analyses often answer questions never posed by primary studies because neither multiple intervention characteristics nor populations are compared in single primary studies. Thus meta-analyses provide unique contributions to knowledge. Although meta-analysis is a powerful comparative effectiveness strategy, methodological challenges and limitations in primary research must be acknowledged to interpret findings.

Role of practice-based research networks in comparative effectiveness research

Hartung, Daniel M; Guise, Jeanne-Marie; Fagnan, Lyle J; Davis, Melinda M; Stange, Kurt C
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /01/2012 EN
Relevância na Pesquisa
46.18%
Comparative effectiveness research fundamentally reorients how clinical evidence is generated and used with the goal of providing actionable information to decision-makers. To achieve this, it is vital that decision-makers and the research enterprise are engaged from research inception, to evidence generation and translation. Practice-based research networks are affiliated clinicians in diverse communities with the goal of conducting research to improve care. Practice-based research networks have the potential to advance all phases of the comparative effectiveness research cycle. The aim of this paper is to explore current and potential roles of practice-based research networks in conducting comparative effectiveness research.

Comparative effectiveness research in chronic obstructive pulmonary disease

Mularski, Richard A; McBurnie, Mary Ann; Lindenauer, Peter K; Lee, Todd A; Vollmer, William M; Au, David H; Carson, Shannon S; Krishnan, Jerry A
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /01/2012 EN
Relevância na Pesquisa
46.24%
Chronic obstructive pulmonary disease affects millions worldwide. It is America’s third leading cause of death, and results in significant morbidity and cost. Although many therapies exist and are being developed to alleviate symptoms and decrease morbidity and mortality in chronic obstructive pulmonary disease, most have only been studied in placebo-controlled efficacy studies in highly selected populations. Comparative effectiveness and translational research in chronic obstructive pulmonary disease will require the development of infrastructures to support collaboration between researchers and the stakeholders who generate, disseminate and use new knowledge. Methodologies need to evolve to both prioritize research questions and to conduct collaborative comparative effectiveness research studies. Given the impracticality of testing every clinical intervention in comparative pragmatic trials for comparative effectiveness research in chronic obstructive pulmonary disease, we advocate expanding methodology that includes the use of observational databases with serially performed effectiveness analyses and quasi-experimental designs that include following healthcare changes longitudinally over time to assess benefit, harm, subgroups and cost.

The Missing Link in Preconceptional Care: The Role of Comparative Effectiveness Research

Salihu, Hamisu M.; Salinas, Abraham; Mogos, Mulubrhan
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /07/2013 EN
Relevância na Pesquisa
46.21%
This paper discusses an important element that is missing from the existing algorithm of preconception care, namely, comparative effectiveness research (CER). To our knowledge, there has been limited assessment of the comparative effectiveness of diverse interventions that promote preconception health, conditions under which these are most effective, for which particular populations, and their comparative costs. CER can improve the decision making process for the funding, development, implementation, and evaluation of comprehensive preconception care programs, specifically by identifying the most effective interventions with acceptable costs to society. This paper will examine the framework behind preconception care and how the inclusion of comparative effectiveness research and evaluation into the existing algorithm of preconception care could foster improvement in maternal and child health. We discuss challenges and opportunities regarding the utilization of CER in the decision making process in preconception health, and finally, we provide recommendations for future directions.

Comparative Effectiveness Research in the United States: A Catalyst for Innovation

Ali, Riaz; Hanger, Morgan; Carino, Tanisha
Fonte: Engage Healthcare Communications, LLC Publicador: Engage Healthcare Communications, LLC
Tipo: Artigo de Revista Científica
Publicado em //2011 EN
Relevância na Pesquisa
46.32%
Recent calls for value in the US healthcare system have spurred an increase in comparative effectiveness research, which generates evidence on competing treatment options to inform healthcare stakeholders. As a large healthcare purchaser, the federal government has made several significant investments in comparative effectiveness research. Notably, in 2009 the American Recovery and Reinvestment Act allocated $1.1 billion for comparative effectiveness research, and in 2010 the Patient Protection and Affordable Care Act established a federal institute to organize the federal investment in comparative effectiveness research going forward. Over the past several years, comparative effectiveness research from the public and private sectors has begun to provide a foundation for innovation within the insurance and life sciences industries. Health plans and other payers are experimenting with nuanced coverage and reimbursement policies informed by comparative effectiveness evidence. Anticipating changes in payer, patient, and provider behaviors, drug manufacturers are refocusing their efforts on the development of novel and better-differentiated medications. As more comparative research becomes available in the future, continued innovation in payer and manufacturer strategies appears likely.

Establishing the Infrastructure to Conduct Comparative Effectiveness Research Toward the Elimination of Disparities: A Community-Based Participatory Research Framework

Wilson, Danyell S.; Dapic, Virna; Sultan, Dawood H.; August, Euna M.; Green, B. Lee; Roetzheim, Richard; Rivers, Brian
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
EN
Relevância na Pesquisa
46.23%
In Tampa, Florida, researchers have partnered with community- and faith-based organizations to create the Comparative Effectiveness Research for Eliminating Disparities (CERED) infrastructure. Grounded in community-based participatory research, CERED acts on multiple levels of society to enhance informed decision making (IDM) of prostate cancer screening among Black men. CERED investigators combined both comparative effectiveness research and community-based participatory research to design a trial examining the effectiveness of community health workers and a digitally enhanced patient decision aid to support IDM in community settings as compared with “usual care” for prostate cancer screening. In addition, CERED researchers synthesized evidence through the development of systematic literature reviews analyzing the effectiveness of community health workers in changing knowledge, attitudes and behaviors of African American adults toward cancer prevention and education. An additional systematic review analyzed chemoprevention agents for prostate cancer as an emerging technique. Both of these reviews, and the comparative effectiveness trial supporting the IDM process, add to CERED’s goal of providing evidence to eliminate cancer health disparities.

Tying comparative effectiveness information to decision-making and the future of comparative effectiveness research designs: the case for antipsychotic drugs

Basu, Anirban; Meltzer, Herbert Y
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /03/2012 EN
Relevância na Pesquisa
46.24%
The outcome of comparative effectiveness research on antipsychotic drugs, specifically the National Institute of Mental Health-funded CATIE trial, has raised questions regarding the value of second-generation antipsychotic drugs and has sparked a debate regarding their accessibility through public insurance. We reviewed the evidence on the impact of access restrictions for antipsychotic drugs in Medicaid programs and found that such restrictions resulted in increases in overall costs and a possible decline in the quality of care. We attribute this unwanted outcome to limitations in comparative effectiveness research designs that fail to inform either clinical or policy decision-making. We enumerate these limitations and illustrate the potential for more innovative comparative effectiveness research designs that may be in line with clinical decision-making using an original analysis of the CATIE trial data. The value of genomic information in enabling better trial design is also discussed.

Beyond “Safe and Effective”: The Role of the Federal Government in Supporting and Disseminating Comparative-Effectiveness Research

Francis, Margaret
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Relevância na Pesquisa
46.24%
Over the past century, medical advancements have resulted in tremendous health gains for Americans. Although the federal government has played a prominent role in ensuring that new treatments are safe and effective, questions about which medical treatments work best under which circumstances have largely remained unanswered. Thus, the federal government’s recent major investments in comparative-effectiveness research have potential to play a significant role helping both patients and health care providers navigate the vast array of available treatment options, as well as to improve the quality, efficiency, and delivery health care system-wide. Yet, the controversial nature of the government’s foray into comparative-effectiveness research also suggests that the path toward realizing these goals may be treacherous. This paper describes the rationales for federal support of comparative-effectiveness research and potential models for that involvement, analyzes the federal government’s recent investments in the research, and concludes with predictions about the probable outcomes of these investments. While increased federal support for comparative-effectiveness research is unlikely to achieve all of the benefits anticipated by its supporters...

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

Murthy, Srinivas; Bourgeois, Florence Tanya; Mandl, Kenneth David
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
EN_US
Relevância na Pesquisa
46.21%
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)...

Quasi-Experimental Health Policy Research: Evaluation of Universal Health Insurance and Methods for Comparative Effectiveness Research

Garabedian, Laura Faden
Fonte: Harvard University Publicador: Harvard University
Tipo: Thesis or Dissertation
EN_US
Relevância na Pesquisa
66.09%
This dissertation consists of two empirical papers and one methods paper. The first two papers use quasi-experimental methods to evaluate the impact of universal health insurance reform in Massachusetts (MA) and Thailand and the third paper evaluates the validity of a quasi-experimental method used in comparative effectiveness research (CER).

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

Witt, Claudia M; Aickin, Mikel; Cherkin, Daniel; Che, Chun Tao; Elder, Charles; Flower, Andrew; Hammerschlag, Richard; Liu, Jian-Ping; Lao, Lixing; Phurrough, Steve; Ritenbaugh, Cheryl; Rubin, Lee Hullender; Schnyer, Rosa; Wayne, Peter M; Withers, Shelly
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica
EN_US
Relevância na Pesquisa
56.1%
Background: There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods: The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results: Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion: The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies...

Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial

Wang, Chenchen; Iversen, Maura D; McAlindon, Timothy; Harvey, William F; Wong, John B; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Rones, Ramel; Gamache, Tressa; Schmid, Christopher H
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica
EN_US
Relevância na Pesquisa
66.31%
Background: Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. Methods/Design A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores...

Statistical Methods for Comparative Effectiveness Research of Medical Devices

Kunz, Lauren Margaret
Fonte: Harvard University Publicador: Harvard University
Tipo: Thesis or Dissertation; text Formato: application/pdf
EN
Relevância na Pesquisa
46.21%
A recent focus in health care policy is on comparative effectiveness of treatments--from drugs to behavioral interventions to medical devices. Medical devices bring a unique set of challenges for comparative effectiveness research. In this dissertation, I develop statistical methods for comparative effectiveness estimation and illustrate the methodology in the context of three different medical devices. In chapter 2, I review approaches for causal inference in the context of observational cohort studies, utilizing a potential outcomes framework demonstrated using data for patients undergoing revascularization surgery with radial versus femoral artery access. Propensity score methods; G-computation; augmented inverse probability of treatment weighting; and targeted maximum likelihood estimation are implemented and their causal and statistical assumptions evaluated. In chapter 3, I undertake a theoretical and simulation-based assessment of differential follow-up information per treatment arm on inference in meta-analysis where applied researchers commonly assume similar follow-up duration across treatment groups. When applied to the implantation of cardiovascular resynchronization therapies to examine comparative survival, only 3 of 8 studies report arm-specific follow-up. I derive the bias of the rate ratio for an individual study using the number of deaths and total patients per arm and show that the bias can be large...

Addressing "waste" in diagnostic imaging: Some implications of comparative effectiveness research

Elshaug, A.; Bessen, T.; Moss, J.; Hiller, J.
Fonte: Elsevier Publicador: Elsevier
Tipo: Artigo de Revista Científica
Publicado em //2010 EN
Relevância na Pesquisa
66.21%
Comparative effectiveness research is intended to provide evidence to improve patient outcomes through the use of the most appropriate health technology affordable. The authors present 5 case studies, focusing on the use of plain radiography in common clinical scenarios, to illustrate the considerable scope for comparative effectiveness research within medical imaging and the different levels of evidence currently in existence to guide the improved use of medical imaging. These are blunt ankle injury, breast cancer follow-up, low back pain, routine daily chest x-rays in intensive care, and screening for breast cancer. Although there are established models for evaluating new technologies, especially pharmaceuticals, against the most commonly used current technology, the evaluation of technologies in current clinical practice is in an early phase of development. Because evaluation resources are limited, one major challenge is developing ways to identify established technologies for evaluation to refine the indications for their use. A set of criteria with which to identify established technologies that may not be delivering value for money is described, and their use is illustrated in relation to the 5 case studies. These criteria could be incorporated into literature search strategies...

An Approach to Assess Generalizability in Comparative Effectiveness Research: A Case Study of the Whole Systems Demonstrator Cluster Randomized Trial Comparing Telehealth with Usual Care for Patients with Chronic Health Conditions

Steventon, Adam; Grieve, Richard; Bardsley, Martin
Fonte: SAGE Publications Publicador: SAGE Publications
Tipo: Artigo de Revista Científica
Publicado em /11/2015 EN
Relevância na Pesquisa
46.23%
Background. Policy makers require estimates of comparative effectiveness that apply to the population of interest, but there has been little research on quantitative approaches to assess and extend the generalizability of randomized controlled trial (RCT)–based evaluations. We illustrate an approach using observational data. Methods. Our example is the Whole Systems Demonstrator (WSD) trial, in which 3230 adults with chronic conditions were assigned to receive telehealth or usual care. First, we used novel placebo tests to assess whether outcomes were similar between the RCT control group and a matched subset of nonparticipants who received usual care. We matched on 65 baseline variables obtained from the electronic medical record. Second, we conducted sensitivity analysis to consider whether the estimates of treatment effectiveness were robust to alternative assumptions about whether “usual care” is defined by the RCT control group or nonparticipants. Thus, we provided alternative estimates of comparative effectiveness by contrasting the outcomes of the RCT telehealth group and matched nonparticipants. Results. For some endpoints, such as the number of outpatient attendances, the placebo tests passed, and the effectiveness estimates were robust to the choice of comparison group. However...

Validity, Significance, Strengths, Limitations, and Evidentiary Value of Real-World Clinical Data for Combination Therapy in Alzheimer's Disease: Comparison of Efficacy and Effectiveness Studies

Atri, Alireza; Rountree, Susan D.; Lopez, Oscar L.; Doody, Rachelle S.
Fonte: S. Karger AG Publicador: S. Karger AG
Tipo: Artigo de Revista Científica
EN_US
Relevância na Pesquisa
56.1%
Background: Randomized controlled efficacy trials (RCTs), the scientific gold standard, are required for regulatory approval of Alzheimer's disease (AD) interventions, yet provide limited information regarding real-world therapeutic effectiveness. Objective: To compare the nature of evidence regarding the combination of approved AD treatments from RCTs versus long-term observational controlled studies (LTOCs). Methods: Comparisons of strengths, limitations, and evidence level for monotherapy [cholinesterase inhibitor (ChEI) or memantine] and combination therapy (ChEI + memantine) in RCTs versus LTOCs. Results: RCTs examined highly selected populations over months. LTOCs collected data across multiple AD stages in large populations over many years. RCTs and LTOCs show similar patterns favoring combination over monotherapy over placebo/no treatment. Long-term combination therapy compared to monotherapy reduced cognitive and functional decline and delayed time to nursing home admission. Persistent treatment was associated with slower decline. While LTOCs used control groups, adjusted for multiple covariates, had higher external validity, and favorable ethical, practical and cost considerations, their limitations included potential selection bias due to lack of placebo comparisons and randomization. Conclusions: Naturalistic LTOCs provide complementary long-term level II evidence to complement level I evidence from short-term RCTs regarding therapeutic effectiveness in AD that may otherwise be unobtainable. A coordinated strategy/consortium to pool LTOC data from multiple centers to estimate long-term comparative effectiveness...

Evaluation of Tiger Conservation in India: the use of comparative effectiveness research

Post, Gerald
Fonte: Universidade Duke Publicador: Universidade Duke
Tipo: Masters' project Formato: 694289 bytes; application/pdf
EN_US
Relevância na Pesquisa
56.2%
Tigers, the largest of the felids, are now a globally threatened species with only approximately 3000 wild tigers surviving. India contains about 60% or 2000 of the animals, yet despite aggressive conservation efforts the number of tigers is declining. The causes of the decline are prey depletion, habitat destruction and poaching. Over the past 30 years of tiger conservation efforts in the various protected areas within India, success has been incredibly variable, with few documented cases of parks were the numbers of tigers have risen, but many more cases of parks where tiger populations have plummeted. There are very few scientific papers that assess the effectiveness of conservation efforts and when it is considered, implementation rather than outcome is evaluated. Recent literature suggests that evaluating outcomes in more predictive of conservation success. This thesis attempts to use comparative research effectiveness techniques, a methodology used to evaluate medical therapy effectiveness, to evaluate tiger conservation in India. Various tiger conservation experts were polled and a list of 7 successful protected areas—Kanha, Corbett, Pench, Kaziranga, Bhadra, Bandipur, and Nagarhole—and 5 failed protected areas—Palamau...

Incorporating Comparative Effectiveness Research Results into the U.S. Medicare Program

Savitz, Samuel
Fonte: Universidade Duke Publicador: Universidade Duke
Publicado em /12/2010 EN
Relevância na Pesquisa
66.21%
Comparative Effectiveness Research (CER) is a method of evaluation that compares the effectiveness of two or more medical treatments by assessing comparative health outcomes. Historically, there has been a lack of implementation of the findings from CER. Typically, the approval process for a new treatment judges it on the criterion of whether it works efficaciously with little to no consideration of the relative effectiveness with existing treatments. This process for approving new treatments fails to measure how treatments of a similar type perform relative to one another and does not account for the costs of alternative treatments. My primary research question asks how the IPAB can successfully incorporate CER into clinical practice decisions within the Medicare system. I will evaluate this question by looking at the data for three specific medical conditions that will serve as case studies. Specifically, I will examine: 1) the use of stents in the treatment coronary artery disease; 2) knee-arthroplasty; and 3) prostate cancer treatment. I chose these three conditions because they each have extensive CER literature and there are reasonable alternative treatments. Further, the conditions are different in meaningful ways that will make my findings more generalizable. One such way is that intervention is far less discretionary for a patient in need of treatment for a coronary artery blockage...