Building the Evidence Base for Medical Devices: Strategies and Pitfalls

2007 ◽  
pp. 19-22
Author(s):  
R. Taylor
Keyword(s):  
Medical Devices ◽  
Evidence Base

scholarly journals Post QALY: Scientific Approaches to Real World Formulary Decision Making

2020 ◽  
Vol 11 (2) ◽  
pp. 19
Author(s):  
Paul Langley ◽  
Stephen McKenna
Keyword(s):  
Decision Making ◽  
Medical Devices ◽  
Evidence Base ◽  
Pharmaceutical Products ◽  
Normal Science ◽  
Value Assessment ◽  
Scientific Methods ◽  
Article Type ◽  
The Us ◽  
The Uk

The purpose of this anniversary supplement for Innovations in Pharmacy is to consider and / or propose modern, scientific methods for determining the evidence base for the fair pricing and accessibility of pharmaceutical products and medical devices. At present, such decisions are based on the construction of imaginary value assessment models that fail to meet the standards of normal science. Such a business model has been adopted by the Institute for Clinical and Economic Review (ICER) in the US, NICE in the UK and in a number of other countries.   Article Type: Call for Papers

Assessment of medical devices: How to conduct comparative technology evaluations of product performance

2007 ◽  
Vol 23 (4) ◽  
pp. 455-463 ◽  
Author(s):  
Lawton R. Burns ◽  
Eric T. Bradlow ◽  
J. Andrew Lee ◽  
Anthony C. Antonacci
Keyword(s):  
Medical Devices ◽  
Hospital Costs ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Evidence Base ◽  
Product Performance ◽  
Value Based Purchasing ◽  
Large Hospital ◽  
Study Results ◽  
Performance Dimensions

Objectives: U.S. expenditures on medical devices ($70 billion in 2003) are one of the fastest growing components of hospital costs. Physicians’ selection of medical devices lacks an evidence base on the comparative clinical effectiveness of these products. Comparative studies (e.g., vendor 1 versus vendor 2, technology A versus technology B) are increasingly promoted in the public sector as a means of cost containment, value-based purchasing, and quality improvement. This study illustrates how hospitals and physicians can conduct comparative technology assessments of product performance.Methods: Surgeons evaluated comparable medical devices manufactured by eight different vendors in standardized surgical procedures. Devices included sutures and endomechanical products, which account for $2.5 billion of total device spending. Evaluations covered multiple performance dimensions, including ergonomics, functionality, clinical acceptability, and vendor preference.Results: One vendor's products garnered consistently high ratings from surgeons, while two other vendors garnered consistently low ratings. Differences in ratings were statistically significant and persist when controlling for physician background characteristics and prior experience. Study results were used by a large hospital group purchasing organization to select which vendors to contract with for these products.Conclusions: Comparative technology evaluations assist physicians and hospitals in making cost-effective purchases of devices. These evaluations provide robust information on the performance of products routinely used by clinicians. Such evaluations can be carefully designed to have scientific rigor and clinical credibility.

VP49 Real-world Evidence For Economic Evaluation Of Medical Devices

2019 ◽  
Vol 35 (S1) ◽  
pp. 87-88
Author(s):  
Benedetta Pongiglione ◽  
Aleksandra Torbica
Keyword(s):  
Medical Devices ◽  
Real World ◽  
Epidemiological Data ◽  
Evidence Base ◽  
National Registry ◽  
Economic Research ◽  
Data Mapping ◽  
Real World Data ◽  
World Data

IntroductionRandomized controlled trials (RCTs) are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. The low external validity of RCTs and the general shortage of clinical evidence available to support the use of many medical devices have emphasized the necessity for exploring the use of real-world data (RWD) as a complementary source to RCTs data for establishing a more robust evidence base on the effectiveness of medical devices. The aim of the present project is to assess in a comprehensive way the existing sources of real world data on medical devices in Europe.MethodsThe guidelines to the mapping exercise have been outlined in a research protocol. First, all national relevant sources (e.g. website of Ministry of Health, national institutions, research bodies) are screened, both in local language and English. Second, we perform a systematic search on PubMed using a set of key words for each case study, adapted to each country setting. Finally, we seek advice from key actors in the field of the device and clinical conditions, such as manufacturers or clinicians.ResultsInformation on existing sources of RWD for each case studies are provided in a template including details on the key features of the source (e.g. data producer, data collection period, sample size, study design, geographical coverage) and the main content of the dataset, distinguishing socio-demographic information, clinical and epidemiological data, data on resource use and health outcomes. The data mapping includes all countries of the project participants, i.e. Italy, UK, Netherlands, Switzerland, Germany, Hungary, and we enlarge the scope of our mapping including other countries: Spain, France, Denmark, Finland, Sweden, Poland and Hungary as well as international databases at pan-EU level. The number of available sources of RWD and their quality vary depending on case study and across countries. For example, in the case of orthopaedics, many countries have a national registry and administrative data, such as hospital discharge, contain useful information, although not as detailed. When a registry is not available, it is often the case that more observational studies are available; this occurs for example in France.ConclusionsIn this work we shows the importance of RWE and map in an accurate and comprehensive way which source of RWD are currently available and to what extent they are known and used in medical, epidemiological and economic research.

Early technology assessment of new medical devices

2008 ◽  
Vol 24 (01) ◽  
pp. 36-44 ◽  
Author(s):  
Jan B. Pietzsch ◽  
M. Elisabeth Paté-Cornell
Keyword(s):  
Medical Devices ◽  
Technology Assessment ◽  
Early Stage ◽  
Probability Distributions ◽  
The United States ◽  
Evidence Base ◽  
Quantitative Model ◽  
Alternative Designs ◽  
Management Alternatives ◽  
Early Technology Assessment

Objectives:In the United States, medical devices represent an eighty-billion dollar a year market. The U.S. Food and Drug Administration rejects a significant number of applications of devices that reach the investigational stage. The prospects of improving patient condition, as well as firms' profits, are thus substantial, but fraught with uncertainties at the time when investments and design decisions are made. This study presents a quantitative model focused on the risk aspects of early technology assessment, designed to support the decisions of medical device firms in the investment and development stages.Methods:The model is based on the engineering risk analysis method involving systems analysis and probability. It assumes use of all evidence available (both direct and indirect) and integrates the information through a linear formula of aggregation of probability distributions. The model is illustrated by a schematic version of the case of the AtrialShaper, a device for the reduction of stroke risk that is currently in the preprototype stage.Results:The results of the modeling provide a more complete description of the evidence base available to support early-stage decisions, thus allowing comparison of alternative designs and management alternatives.Conclusions:The model presented here provides early-stage decision-support to industry, but also benefits regulators and payers in their later assessment of new devices and associated procedures.

ADAPTIVE APPROACHES TO LICENSING, HEALTH TECHNOLOGY ASSESSMENT, AND INTRODUCTION OF DRUGS AND DEVICES

2014 ◽  
Vol 30 (3) ◽  
pp. 241-249 ◽  
Author(s):  
Don Husereau ◽  
Chris Henshall ◽  
Jamil Jivraj
Keyword(s):  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Technology Development ◽  
Single Point ◽  
Full Range ◽  
Health Technology ◽  
Evidence Base ◽  
Case Examples ◽  
Adaptive Approaches

Background: Adaptive approaches to the introduction of drugs and medical devices involve the use of an evolving evidence base rather than conventional single-point-in-time evaluations as a proposed means to promote patient access to innovation, reduce clinical uncertainty, ensure effectiveness, and improve the health technology development process.Methods: This report summarizes a Health Technology Assessment International (HTAi) Policy Forum discussion, drawing on presentations from invited experts, discussions among attendees about real-world case examples, and background paper.Results: For adaptive approaches to be understood, accepted, and implemented, the Forum identified several key issues that must be addressed. These include the need to define the goals of and to set priorities for adaptive approaches; to examine evidence collection approaches; to clarify the roles and responsibilities of stakeholders; to understand the implications of adaptive approaches on current legal and ethical standards; to determine costs of such approaches and how they will be met; and to identify differences in applying adaptive approaches to drugs versus medical devices. The Forum also explored the different implications of adaptive approaches for various stakeholders, including patients, regulators, HTA/coverage bodies, health systems, clinicians, and industry.Conclusions: A key outcome of the meeting was a clearer understanding of the opportunities and challenges adaptive approaches present. Furthermore, the Forum brought to light the critical importance of recognizing and including a full range of stakeholders as contributors to a shared decision-making model implicit in adaptive pathways in future discussions on, and implementation of, adaptive approaches.

scholarly journals Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data

2019 ◽  
Vol 214 ◽  
pp. 209-211
Author(s):  
Rachael L. Fleurence ◽  
Christopher B. Forrest ◽  
Jeffrey Shuren
Keyword(s):  
Medical Devices ◽  
Real World ◽  
Evidence Base ◽  
Real World Data ◽  
World Data

Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

1991 ◽  
Vol 49 ◽  
pp. 104-105
Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar
Keyword(s):  
Medical Devices ◽  
Blood Cells ◽  
White Blood Cells ◽  
Consumer Products ◽  
Ultrastructural Changes ◽  
Ultraviolet A ◽  
Uv Spectrum ◽  
Lymphoma Cells ◽  
Murine Lymphoma ◽  
Transmission Electron

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.

Bacterial biofilm behavior in water-supply lines of dental units

1992 ◽  
Vol 50 (1) ◽  
pp. 882-883
Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams
Keyword(s):  
Water Supply ◽  
Medical Devices ◽  
Biofilm Formation ◽  
Bacterial Biofilm

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.

Classifying Disfluencies in Preschool- and School-Age Spanish–English Bilinguals Who Do Not Stutter: An Exploratory Study

2020 ◽  
Vol 5 (1) ◽  
pp. 119-130
Author(s):  
Raúl Rojas ◽  
Farzan Irani
Keyword(s):  
Exploratory Study ◽  
Evidence Base ◽  
Medium Effect ◽  
Bilingual Children ◽  
Linear Regression Models ◽  
Cross Sectional ◽  
Total Percentage ◽  
Narrative Production ◽  
Language Measures ◽  
Mean Length Of Utterance

Purpose This exploratory study examined the language skills and the type and frequency of disfluencies in the spoken narrative production of Spanish–English bilingual children who do not stutter. Method A cross-sectional sample of 29 bilingual students (16 boys and 13 girls) enrolled in grades prekindergarten through Grade 4 produced a total of 58 narrative retell language samples in English and Spanish. Key outcome measures in each language included the percentage of normal (%ND) and stuttering-like (%SLD) disfluencies, percentage of words in mazes (%MzWds), number of total words, number of different words, and mean length of utterance in words. Results Cross-linguistic, pairwise comparisons revealed significant differences with medium effect sizes for %ND and %MzWds (both lower for English) as well as for number of different words (lower for Spanish). On average, the total percentage of mazed words was higher than 10% in both languages, a pattern driven primarily by %ND; %SLDs were below 1% in both languages. Multiple linear regression models for %ND and %SLD in each language indicated that %MzWds was the primary predictor across languages beyond other language measures and demographic variables. Conclusions The findings extend the evidence base with regard to the frequency and type of disfluencies that can be expected in bilingual children who do not stutter in grades prekindergarten to Grade 4. The data indicate that %MzWds and %ND can similarly index the normal disfluencies of bilingual children during narrative production. The potential clinical implications of the findings from this study are discussed.

Bang for Your Buck: A Single-Case Experimental Design Study of Practice Amount and Distribution in Treatment for Childhood Apraxia of Speech

2019 ◽  
Vol 62 (9) ◽  
pp. 3160-3182 ◽  
Author(s):  
Edwin Maas ◽  
Christina Gildersleeve-Neumann ◽  
Kathy Jakielski ◽  
Nicolette Kovacs ◽  
Ruth Stoeckel ◽  
...  
Keyword(s):  
Single Case ◽  
Evidence Base ◽  
Distributed Practice ◽  
Single Subject ◽  
Single Subject Design ◽  
Apraxia Of Speech ◽  
Childhood Apraxia Of Speech ◽  
Opposite Pattern ◽  
Massed Practice ◽  
Treatment Conditions

Purpose The aim of this study was to examine 2 aspects of treatment intensity in treatment for childhood apraxia of speech (CAS): practice amount and practice distribution. Method Using an alternating-treatments single-subject design with multiple baselines, we compared high versus low amount of practice, and massed versus distributed practice, in 6 children with CAS. Conditions were manipulated in the context of integral stimulation treatment. Changes in perceptual accuracy, scored by blinded analysts, were quantified with effect sizes. Results Four children showed an advantage for high amount of practice, 1 showed an opposite effect, and 1 showed no condition difference. For distribution, 4 children showed a clear advantage for massed over distributed practice post treatment; 1 showed an opposite pattern, and 1 showed no clear difference. Follow-up revealed a similar pattern. All children demonstrated treatment effects (larger gains for treated than untreated items). Conclusions High practice amount and massed practice were associated with more robust speech motor learning in most children with CAS, compared to low amount and distributed practice, respectively. Variation in effects across children warrants further research to determine factors that predict optimal treatment conditions. Finally, this study adds to the evidence base supporting the efficacy of integral stimulation treatment for CAS. Supplemental Material https://doi.org/10.23641/asha.9630599

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