Does assessing the value for money of therapeutic medical devices require a flexible approach?

Commentary: Europe needs a central, transparent, and evidence based regulation process for devices

(2013) M. Eikermann et al.   BMJ-British Medical Journal

Probabilistic choice models in health-state valuation research: background, theories, assumptions and applications

(2013) Alexander MM Arons et al.   Expert Review of Pharmacoeconomics & Outcomes Research

Quantifying the Learning Curve in the Use of a Novel Vascular Closure Device

(2012) Frederic S. Resnic et al.   JACC-Cardiovascular Interventions

A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions

(2012) Bruce M. Psaty et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

(2012) Robert M. Califf   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Regulation of medical devices outside the European Union

(2012) Susan Lamph   JOURNAL OF THE ROYAL SOCIETY OF MEDICINE

Device regulator is told to improve its safety monitoring after breast implant debacle

(2012) I. Torjesen   BMJ-British Medical Journal

How safe are metal-on-metal hip implants?

(2012) D. Cohen   BMJ-British Medical Journal

FDA Ponders Regulation and Innovation

(2011) Rebecca Voelker   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

A Framework for Addressing Structural Uncertainty in Decision Models

(2011) Christopher H. Jackson et al.   MEDICAL DECISION MAKING

A Short History of Markov Chain Monte Carlo: Subjective Recollections from Incomplete Data

(2011) Christian Robert et al.   STATISTICAL SCIENCE

Methods to elicit experts’ beliefs over uncertain quantities: application to a cost effectiveness transition model of negative pressure wound therapy for severe pressure ulceration

(2011) Marta O. Soares et al.   STATISTICS IN MEDICINE

Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts

(2011) C. Heneghan et al.   BMJ Open

Bayesian statistical method was underused despite its advantages in the assessment of implantable medical devices

(2010) Leslie Pibouleau et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

A Framework for Evidence Evaluation and Methodological Issues in Implantable Device Studies

(2010) Art Sedrakyan et al.   MEDICAL CARE

EBM, HTA, and CER: Clearing the Confusion

(2010) BRYAN R. LUCE et al.   MILBANK QUARTERLY

Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices

(2009) Sanket S. Dhruva   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

The challenges faced in the design, conduct and analysis of surgical randomised controlled trials

(2009) Jonathan A Cook   Trials

Characterizing Structural Uncertainty in Decision Analytic Models: A Review and Application of Methods

(2009) Laura Bojke et al.   VALUE IN HEALTH

Bias modelling in evidence synthesis

(2008) Rebecca M. Turner et al.   JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES A-STATISTICS IN SOCIETY

Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices

(2008) William H. Maisel   NEW ENGLAND JOURNAL OF MEDICINE

The validity of generic and condition-specific preference-based instruments: the ability to discriminate asthma control status

(2008) Helen M. McTaggart-Cowan et al.   QUALITY OF LIFE RESEARCH

Assessing the Clinical and Cost-Effectiveness of Medical Devices and Drugs: Are They That Different?

(2008) Rod S. Taylor et al.   VALUE IN HEALTH

Economic Evaluation for Devices and Drugs—Same or Different?

(2008) Michael Drummond et al.   VALUE IN HEALTH