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  • 2017
  • In 2017, the FDA cohosted a multi-stakeholder public workshop with the Centers of Excellence of Regulatory Science and Innovation (CERSI) entitled Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation . (fda.gov)
  • The FDA 's Center for Devices and Radiological Health (CDRH) strategic priorities for 2016 and 2017 include partnering with patients as one of their three key areas of focus. (centerwatch.com)
  • CDRH
  • This list is intended to provide greater clarity to industry and researchers about areas in which CDRH would find patient preference studies most informative. (fda.gov)
  • Background: In response to 2012 guidance in which the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) stated the importance of patient-centric measures in regulatory benefit-risk assessments, the Medical Device Innovation Consortium (MDIC) initiated a project. (rti.org)
  • Patient engagement has become a top strategic priority for the US Food and Drug Administration (FDA)'s Center for Devices and Radiological Health (CDRH). (springer.com)
  • According to CDRH, preference data indicated that a group of patients were willing to accept the risks of the surgically implanted device in exchange for the weight-loss benefits. (springer.com)
  • predict
  • Deciding about breast reconstruction requires a patient to predict how she would feel after the procedure, a process called affective forecasting. (clinicaltrials.gov)
  • ii Recently, a third answer has been proposed: using statistical modelling, we can attempt to predict patients' preferences with respect to treatment and then make treatment decisions on the basis of these predicted preferences. (bmj.com)
  • I agree entirely with Sharadin's 'debunking' response to this concern: we can use statistical correlations to predict others' preferences without thereby assuming any causal claim (although I am worried that blocking the conversational implicatures may be far harder in emotionally charged life-and-death contexts than at dinner parties). (bmj.com)
  • anesthesia
  • However, for informed consent patients need to be told not only the risks and benefits of the cataract surgery itself but also the risk and benefits of the alternative anesthesia modalities. (bmj.com)
  • Outcomes Research
  • Jean Slutsky, chief engagement and dissemination officer, Patient-Centered Outcomes Research Institute (PCORI), described the shift in focus: "Traditionally, medical research has largely been investigator-initiated and has not taken into account the decisional needs of patients or other stakeholders. (centerwatch.com)
  • methods
  • A lack of reliable methods for evaluating preference concordance has resulted in a paucity of research in this area. (clinicaltrials.gov)
  • Epistemic problems are problems for the use of advance directives and surrogacy that are grounded in those methods' epistemic credentials, where a method's epistemic credentials can helpfully be thought of as how well that method does at reflecting incapacitated patients' actual preferences. (bmj.com)
  • iv Non-epistemic problems are problems for the use of advance directives and surrogates that arise independently of those methods' epistemic credentials, that is, they are not grounded in facts about how well those methods do when it comes to accurately reflecting incapacitated patients' actual preferences. (bmj.com)
  • METHODS: Questionnaires were distributed in clinic and via mail to LB-experienced and LB-naive patients who underwent FS at Vancouver General Hospital, Vancouver, British Columbia. (hindawi.com)
  • Methods: A public-private partnership of experts from medical device industry, government, academia and non-profits collaborated on development of the MDIC patient centered benefit-risk framework. (rti.org)
  • Methods: Regulators and patients with RA were interviewed to gather initial insights into opinions on the use of PPI in regulatory decisions regarding medical products. (eur.nl)
  • risks
  • Patients may prefer a drug that doesn't have the spectacular results of another medication used for the same purpose, but that has lower associated risks or fewer side effects. (centerwatch.com)
  • These findings suggest that patients may prefer combined, rather than single, graphic risk presentation formats and that augmented bar charts and icon displays may be useful for conveying comparative information about small risks to clinical decision makers. (springer.com)
  • centers
  • Creating a patient-centered environment involves redefining the culture of research organizations and trial centers to move the focus to the patient experience. (centerwatch.com)
  • support patient engagement
  • The National Health Council is conducting numerous projects to support patient engagement methodology and policy. (centerwatch.com)
  • Transformative health care delivery programs depend heavily on health information technology to improve and coordinate care, maintain patient registries, support patient engagement, develop and sustain data infrastructure necessary for multi-payer value-based payment, and enable analytical capacities to inform decision making and streamline reporting. (coursera.org)
  • Intervention
  • Over a two-year period, 25 patients that had undergone conventional femoral angiography and presented for repeat angiography or subsequent neurovascular intervention were offered radial access. (ahajournals.org)
  • There was 100% patient preference for radial access and no minor (hematoma or pseudoaneurysm) or major access site complications (bleeding requiring transfusion, pseudoaneurysm requiring intervention, arteriovenous fistula, delayed occlusion). (ahajournals.org)
  • Background Deprescribing is a patient-centered intervention with inherent uncertainties and requires shared decision making and patient involvement. (springer.com)
  • PPPs
  • As part of his stimulating discussion, Sharadin 1 diagnoses such unease as a worry that using PPPs disrespects patients' autonomy, by treating their most intimate and significant desires as if they were caused by their demographic traits. (bmj.com)
  • benefit and risk
  • The project was used to develop a framework to help the Food and Drug Administration (FDA) and industry sponsors understand how patient preferences regarding benefit and risk might be integrated into the review of innovative medical devices. (rti.org)
  • healthcare
  • This course is one of three related courses in the HI-FIVE training program, which has topics on population health, care coordination and interoperability, value-based care, healthcare data analytics, and patient-centered care. (coursera.org)
  • We also emphasise the need for good quality information and the document lists useful resources that healthcare professionals can point patients towards. (healthcanal.com)
  • objective
  • Utility outcome studies permit the objective standardization of the health state preference of a health condition or disease state. (springer.com)
  • decisions
  • Patients do not make decisions based on whether a particular medication is profitable for the company that develops and markets it. (centerwatch.com)
  • Many times, patients are incapable of making such decisions. (bmj.com)
  • Two, list ways a patient can use technology to drive care decisions. (coursera.org)
  • Results: According to the participants, PPI could lead to regulators considering patients' needs, lifestyles and well-being when making decisions. (eur.nl)
  • A patient brings a unique context and perspective to medical decisions that the physician cannot emulate: the choices made will impact the patient forever. (acc.org)
  • data
  • Under this program, the Regenstrief Institute and Indiana University developed a Web-based program for patients' to express their preferences for who can access data in their electronic health records (EHR). (clinicaltrials.gov)
  • Produced a bioethical report on 'points to consider' to inform electronic health record designers concerning giving patients granular control over access to their health data. (clinicaltrials.gov)
  • Reprogrammed the user interface of Careweb®, a data viewing system used by clinicians in Eskenazi Health, the third largest safety net health system in the U.S., and the Indiana Network for Patient Care, the oldest, largest, and most comprehensive health information exchange in the country. (clinicaltrials.gov)
  • The 2 goals of this poster presentation are to provide a simplified approach to performing radial access for neurovascular and to present data on patient preference and outcomes for radial access. (ahajournals.org)
  • studies
  • These efforts will help focus the FDA, device industry, researchers, and others toward designing and conducting patient preference studies in high impact areas. (fda.gov)
  • Are there ongoing studies or published studies that adequately address these preference-sensitive areas in a regulatory context? (fda.gov)
  • Despite its importance, there have been few studies comparing different formats for presenting probabilistic information to patients, especially when small probabilities are involved. (springer.com)
  • Of 341 studies screened, we included 22, involving a total of 17 751 participants: 6 studied prolongation of life (POL), 12 studied absolute risk reduction (ARR) and 14 studied number needed to treat (NNT) as measures of risk reduction communicated to the patients. (edu.au)
  • Research on information materials to inform patients in preference studies is needed to increase the value of PPI in regulatory decision making. (eur.nl)
  • willingness
  • The number of visits to medical institutions and increasing age were also found to be associated with patients' willingness to deprescribe. (springer.com)
  • Stroke
  • These patients are usually more concerned about stroke prevention than serious bleeding with research showing they are willing to accept 4.4 major bleeds to prevent one stroke. (healthcanal.com)
  • interventional
  • Radial access for neuro interventional procedures is preferred by patients over traditional femoral access and can be performed with a high degree of technical success and low rates of complications. (ahajournals.org)
  • Results
  • Their results surprisingly showed that patients preferred retrobulbar blockade anaesthesia over topical anaesthesia in preparing for cataract surgery, raising the question whether ophthalmologists are moving in the proper dir. (bmj.com)
  • Berlin, Germany, and Seattle, WA, U.S.A. - Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced that results of a survey on colorectal cancer (CRC) screening preferences conducted by Jennifer Taber et al. (epigenomics.com)