A5043496407- Health Systems, Economic Evaluations, Quality of Life
- Clinical practice guidelines implementation
- Healthcare cost, quality, practices
- Delphi Technique in Research
- Pharmaceutical Economics and Policy
- Meta-analysis and systematic reviews
- Health Policy Implementation Science
- Health and Medical Research Impacts
- Healthcare Policy and Management
- Statistical Methods in Clinical Trials
- Ethics in Clinical Research
- Biomedical Ethics and Regulation
- Cancer Genomics and Diagnostics
- Primary Care and Health Outcomes
- Economic and Financial Impacts of Cancer
- Pharmaceutical studies and practices
- BRCA gene mutations in cancer
- Complementary and Alternative Medicine Studies
- Global Public Health Policies and Epidemiology
- Radiomics and Machine Learning in Medical Imaging
- Diagnosis and Treatment of Venous Diseases
- Gastroesophageal reflux and treatments
- Diabetic Foot Ulcer Assessment and Management
- Ethics in medical practice
- Colorectal Cancer Treatments and Studies
Tufts Medical Center
2022-2024
Center for Medical Technology Policy
2012-2023
University of Liverpool
2018
Johns Hopkins University
1991-2017
University of Ottawa
2005-2017
University of Maryland, Baltimore
2012-2017
National Institute for Health Research
2017
Assistance Publique – Hôpitaux de Paris
2017
University of Alabama at Birmingham
2017
Sorbonne Université
2017
Decision makers in health care are increasingly interested using high-quality scientific evidence to support clinical and policy choices; however, the quality of available is often found be inadequate. Reliable essential improve efficient use limited resources. The widespread gaps evidence-based knowledge suggest that systematic flaws exist production evidence, part because there no consistent effort conduct trials designed meet needs decision makers. Clinical for which hypothesis study...
<b>Background</b> The CONSORT statement is intended to improve reporting of randomised controlled trials and focuses on minimising the risk bias (internal validity). applicability a trial's results (generalisability or external validity) also important, particularly for pragmatic trials. A trial (a term first used in 1967 by Schwartz Lellouch) can be broadly defined as whose purpose inform decisions about practice. This extension such applicability. <b>Methods </b>At two, two-day meetings...
Background The use of core outcome sets (COS) ensures that researchers measure and report those outcomes are most likely to be relevant users their research. Several hundred COS projects have been systematically identified date, but there has no formal quality assessment these studies. Core Outcome Set-STAndards for Development (COS-STAD) project aimed identify minimum standards the design a study agreed upon by an international group, while other specific guidance exists final reporting...
Background Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes importance to health service users and other people making choices about care in a particular topic area are measured routinely. Over 200 COS date have been developed, but clarity these reports is suboptimal. studies will not achieve their goal if complete transparent. Methods Findings In recognition issues, an international group included experienced developers, methodologists, journal...
Abstract Calls are increasing for American health care to be organized as a learning system, defined by the Institute of Medicine system “in which knowledge generation is so embedded into core practice medicine that it natural outgrowth and product healthcare delivery process leads continual improvement in care.” We applaud this conception, paper, we put forward new ethics framework it. No such has previously been articulated. The goals our twofold: support transformation help ensure...
Objective: To assess internists' familiarity with, confidence in, and attitudes about practice guidelines issued by various organizations. Design: Cross-sectional, self-administered survey. Participants: Questionnaires were mailed to a stratified random sample of 2600 members the American College Physicians (ACP) in 1992. Of 2513 internists who met our eligibility criteria, 1513 responded (60%). Measurements Results: Familiarity with varied from 11% responders for ACP guideline on exercise...
Randomized trials have traditionally been broadly categorized as either an effectiveness trial or efficacy trial, although we prefer the terms "pragmatic" and "explanatory." Schwartz Lellouch described these 2 approaches toward clinical in 1967. [1][1] These authors coined
<h3>CLINICAL SCENARIO</h3> You are relieved to find that the last patient in your busy primary care clinic is a previously well 48-year-old woman with acute dysuria. There has been no polydipsia, fever, or hematuria; physical examination reveals suprapubic tenderness; and urinalysis shows pyuria but casts. arrange cultures antibiotic treatment for lower urinary tract infection. On her way out door, observes friend just started taking "female hormones," she wonders whether should too. Her...
Ours is an era in which patients seek greater engagement health care choices, increasing the demand for high-quality information about clinical options. Providing support informed choice not straightforward, however, because of challenges faced by clinicians, systems, and consumers. Greater use written or electronic tools can help to clarify choices patients, but decision aids cannot replace human element facilitating choice. The ideal solution couple with counseling understand potential...
Aims: Stakeholder engagement is fundamental to comparative effectiveness research (CER), but lacks consistent terminology. This paper aims define stakeholder and present a conceptual model for involving stakeholders in CER. Materials & methods: The definitions were developed from literature search, expert input experience with the Center Comparative Effectiveness Research Cancer Genomics, proof-of-concept platform involvement priority setting CER study design. Results: Definitions...
Abstract The rise of quality improvement research and comparative effectiveness in health care settings constitutes progress toward the goal what Institute Medicine has called a “learning healthcare system,” which we are “drawing closer to clinical practice by building knowledge development application into each stage delivery process.” As move deliberately integrated system, distinction between two is increasingly blurred, although sharp U.S. regulations ethics literature remains place. In...
Several hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes are most likely be relevant users of their research. The uptake a COS by will depend in part on the transparency robustness methods used development study, which would increased use standardised protocol. This article describes COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement for content study was developed...
Percutaneous transluminal angioplasty has been adopted widely as a treatment for patients with peripheral vascular disease of the lower extremities. However, effect this procedure on overall management and outcomes not clearly delineated. In particular, it is known whether replaced other treatments disease.
The American Reinvestment and Recovery Act gives comparative-effectiveness research (CER) a large boost in funding over the next 2 years. Despite consensus that better information about relative effectiveness of different medical interventions is needed to improve quality value care, some view CER with skepticism. Recently, Partnership Improve Patient Care, coalition 36 industry, patient-advocacy, clinician organizations, raised concerns will not take adequate account individual patient...
In April 2005 the Centers for Medicare and Medicaid Services (CMS) posted on its Web site a draft guidance document describing new approach to coverage policy called "coverage with evidence development" (CED). CED offered an option of promising drugs, biologics, devices, diagnostics, procedures that would not otherwise meet Medicare's evidentiary standards being "reasonable necessary." An updated was 12 July 2006, clarifying several key statutory, regulatory, operational issues. This paper...
Doctors, patients, and other decision makers need access to the best available clinical evidence, which can come from systematic reviews, experimental trials, observational research. Despite methodological challenges, high-quality studies have an important role in comparative effectiveness research because they address issues that are otherwise difficult or impossible study. In addition, many policy decisions do not require very high levels of certainty provided by large, rigorous randomized...
The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name AL should be broadened. Against this background ongoing debate, we examine environmental changes will likely make pathways preferred approach in future. key drivers include: growing patient demand for timely access to promising therapies, emerging science leading fragmentation treatment populations, rising payer influence on product...
Internationally, many health care interventions were diffused prior to the standard use of assessments safety, effectiveness and cost-effectiveness. Disinvestment from ineffective or inappropriately applied practices is a growing priority for systems reasons improved quality sustainability resource allocation. In this paper we examine key challenges disinvestment these explore potential policy-related avenues advance agenda. We five in area policy driven disinvestment: 1) lack resources...
Context: The discussion about improving the efficiency, quality, and long‐term sustainability of U.S. health care system is increasingly focusing on need to provide better evidence for decision making through comparative effectiveness research (CER). In recent years, several other countries have established agencies evaluate technologies broader management strategies inform policy decisions. This article reviews experiences from Britain, France, Australia, Germany. Methods: draws experience...
There is a growing appreciation that our current approach to clinical research leaves important gaps in evidence from the perspective of patients, clinicians, and payers wishing make evidence-based health policy decisions. This has been major driver rapid increase interest comparative effectiveness (CER), which aims compare benefits, risks, sometimes costs alternative health-care interventions 'the real world'. While broad range experimental nonexperimental methods will be used conducting...
Comparative effectiveness research (CER) has received substantial attention as a potential approach for improving health outcomes while lowering costs of care, and the relevance quality clinical services research. The Institute Medicine defines CER 'the conduct synthesis systematic comparing different interventions strategies to prevent, diagnose, treat, monitor conditions. purpose this is inform patients, providers, decision-makers, responding their expressed needs, about which are most...
Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable stems from a vicious cycle undervaluation, resulting inconsistent regulatory standards and reimbursement, well insufficient investment research development, scrutiny biomarker publications by journals, evidence analytical validity utility. We offer recommendations designed to serve roadmap break this call for national dialogue, changes...