scholarly journals Almost half of references in reports on new and emerging nondrug health technologies are grey literature

2019 ◽  
Vol 107 (1) ◽  
Author(s):  
Kelly Farrah ◽  
Monika Mierzwinski-Urban
Keyword(s):  
Medical Devices ◽  
Laboratory Tests ◽  
Evidence Synthesis ◽  
Grey Literature ◽  
Regulatory Agencies ◽  
Literature Searching ◽  
Health Technologies ◽  
Clinical Trial Registries ◽  
Horizon Scanning ◽  
The Us

Objective: The research investigated how frequently grey literature is used in reports on new and emerging nondrug health technologies, which sources are most cited, and how grey literature searching is reported.Methods: A retrospective review of references cited in horizon scanning reports on nondrug health technologies—including medical devices, laboratory tests, and procedures—was conducted. A quasi-random sample of up to three reports per agency was selected from a compilation of reports published in 2014 by international horizon scanning services and health organizations.Results: Twenty-two reports from 8 agencies were included in the analysis. On average, 47% (288/617) of references listed in the bibliographies of the horizon scanning reports were grey literature. The most frequently cited type of grey literature was information from manufacturers (30% of all grey literature references), regulatory agencies (10%), clinical trial registries (9%), and other horizon scans or evidence synthesis reports (9%). The US Food and Drug Administration (FDA) and ClincalTrials.gov were the most frequently cited specific sources, constituting 7% and 8% of grey literature references, respectively. Over two-thirds (15/22) of the analyzed reports provided some details on search methodology; all 15 of these reported searching some grey literature.Conclusions: In this sample, grey literature represented almost half of the references cited in reports on new and emerging nondrug health technologies. Of these grey literature references, almost half came from three sources: the manufacturers, ClinicalTrials.gov, and the FDA. There was wide variation in the other sources cited. Literature search methodology was often insufficiently reported for analysis.

OP491 Beyond Horizon-Scanning And Early Identification Of Innovative Technologies – Development Of An Active Monitoring Framework

2020 ◽  
Vol 36 (S1) ◽  
pp. 11-11
Author(s):  
Patricia Aluko ◽  
Fernando Zanghelini ◽  
Oladapo Ogunbayo
Keyword(s):  
Evidence Synthesis ◽  
Regulatory Approval ◽  
Sensitive Information ◽  
Active Monitoring ◽  
Health Technologies ◽  
Horizon Scanning ◽  
Monitoring Process ◽  
Advanced Therapies ◽  
Monitoring Framework ◽  
Completion Date

IntroductionWhile horizon-scanning systems aim to identify innovative and potentially disruptive health technologies in development, a key challenge is variation in information collation and tracking of the pace of change prior to regulatory approval. An active and efficient monitoring process is crucial for timely notification of health technology assessment (HTA) stakeholders to enhance faster market and patient access. The National Institute for Health Research Innovation Observatory (NIHRIO) identifies and notifies its key HTA stakeholders in England of technologies that are within three to five-year timeframe to regulatory approval. Regular review of each technology is required to meet this remit.MethodsA standardized monitoring framework was developed based on the knowledge and experience of the evidence synthesis specialists in NIHRIO, supplemented by literature to ensure consistency of setting review periods. This framework used predefined criteria that integrated the technology innovation (advanced therapies, orphan status, regulatory awards), trial data (phase, status, completion date, preliminary results) and estimated approval timelines obtained from the company or other sources (for example, press releases).ResultsThe framework has been piloted and early findings showed improved consistency in the monitoring process between different analysts. It ensures that each technology is reviewed at least once a year; review timelines are set at three, six, nine or twelve months based on the predefined criteria. Estimated timeframes obtained from the companies are used to triangulate and streamline review periods, improving efficiency of the monitoring process.ConclusionsFindings from the pilot work with the framework demonstrated improved consistency and efficiency of the technology monitoring process, which can be easily implemented to provide early awareness in an accurate and timely manner for HTA. This framework was designed using a systematic and transparent approach that integrated different data sources to set review periods. While most of the data used in defining the criteria are publicly available, commercially sensitive information provided by companies were also used which may not always be readily available. Implications for horizon-scanning organizations will be discussed.

scholarly journals Roles and Rules of Some Regulatory Agencies around the World during COVID-19 Pandemic

2021 ◽  
pp. 178-187
Author(s):  
Aseel Bin Sawad ◽  
Fatema Turkistani
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Cure Models ◽  
The Us ◽  
The World ◽  
Us Fda ◽  
Health Canada ◽  
Official Sources

Objective: Collecting and synthesizing relevant data on COVID-19 from official sources of some different regulatory agencies around the world. Methods: The information and actions related to responding to the COVID-19 situation were collected from the websites of some regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada (HC), Swiss Agency for Therapeutic Products (Swissmedic), and the Australian Therapeutic Goods Administration (TGA). Results: All the regulatory agencies help in expediting the development of COVID-19 treatments and medical devices. These agencies also developed an international regulatory collaboration to develop cure models for the pandemic. While some of the agencies conduct the COVID-19 testing, like the US FDA, the others do not. The agencies also differ in their approaches towards resolving the pandemic. FDA and EMA are more aggressive in a way that they prioritize more testing and hospitalization coverage. However, as of the 22nd of June 2021, the FDA authorized the highest number (388) of diagnostic COVID-19 test kits followed by TGA (128), and EMA (88). Conclusions: Although the regulatory agencies differ in their approaches towards resolving pandemic COVID-19, all regulatory agencies help in expediting the development of COVID-19 treatments and medical devices.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

scholarly journals Hepatitis B: diagnosis, prevention, and treatment

1997 ◽  
Vol 43 (8) ◽  
pp. 1500-1506 ◽  
Author(s):  
Norman Gitlin
Keyword(s):  
Risk Factors ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Chronic Infection ◽  
Laboratory Tests ◽  
Chronic Viral Hepatitis ◽  
Hbv Infection ◽  
B Virus ◽  
The Us ◽  
Prevention And Treatment

Abstract Hepatitis B virus (HBV) infection occurs worldwide and is an important cause of acute and chronic viral hepatitis in the US. In this review, I describe the virus, risk factors for infection, clinical features of infection, results of laboratory tests during infection, and standard and emerging treatment for chronic infection. Although 95% of adult patients recover completely from HBV infection, 90% of children ≤4 years of age develop chronic infection. Active vaccination is highly efficacious.

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

CONGRESSIONAL STUDY QUESTIONS VALUE OF OUTCOMES RESEARCH

PEDIATRICS ◽  
1995 ◽  
Vol 95 (5) ◽  
pp. 669-669
Author(s):  
J. F. L.
Keyword(s):  
Technology Assessment ◽  
Government Printing ◽  
Unintended Effects ◽  
Policy Makers ◽  
Health Technologies ◽  
Large Databases ◽  
The Us ◽  
Us Government ◽  
Office Of Technology Assessment ◽  
Care Costs

The 320-page report, "Identifying Health Technologies that Work: Searching for Evidence," by the Office of Technology Assessment, has significant implications for both researchers and health policy makers ... The Office of Technology Assessment found that the hopes for effectiveness research are not misplaced, but they have been overly optimistic and often misdirected, the report concludes. It will not necessarily reduce health care costs significantly ... The analysis of large databases ... has proved not to be a particularly useful tool in providing valid, believable answers about comparative effectiveness. The report suggests that experimental research based on randomized, controlled trials might provide more valid results. Clinical practice guidelines themselves came under fire in the Office of Technology Assessment report because of how they are developed and disseminated. Simply issuing them to physicians often has no effect, and unless they promote "extremely compelling" practices or are issued by credible organizations, they may have the unintended effects as clinicians try to circumvent them ... The report is available for $20 from the US Government Printing Office. S/N 052-003-01389-4. Call 202/512-1800.

Cybersecurity risks and gaps in hospital clinical care: Summary review (for the non-cyber professional) (Preprint)

2021 ◽  
Author(s):  
Liat Wasserman
Keyword(s):  
Medical Devices ◽  
Clinical Medicine ◽  
Clinical Care ◽  
Journal Articles ◽  
Policy Changes ◽  
Electronic Data ◽  
Pubmed Database ◽  
The Us ◽  
Security Incidents ◽  
Hospital Equipment

BACKGROUND Healthcare is facing a growing threat of cyberattacks. Myriad data sources illustrate the same trends that healthcare is one of the industries with the highest risk of cyber infiltration and is seeing the rate of security incidents surge within just a few years. The circumstances thus begged the question: are US hospitals prepared for the risks that accompany clinical medicine in cyberspace? OBJECTIVE This study aimed to identify the major topics and concerns present in today’s hospital cybersecurity field, intended for the non-cyber professionals audience in hospital settings. METHODS Via a structured literature search of the National Institutes of Health’s PubMed database (including the MEDLINE database) and Tel Aviv University’s DaTa database, 35 journal articles were identified to form the core of the study. 86 additional sources were examined to inform the study findings RESULTS The literature review revealed a basic landscape of hospital cybersecurity, including the top ten methods of attack, the primary reasons hospitals are frequent targets, and the consequences hospitals face following attacks. The cyber technologies common in clinical medicine, as well as their risks, were also examined, with the major categories highlighted being medical devices, telemedicine software, and electronic data. By infiltrating any of these three components of clinical care, cyber attackers can access a trove of valuable information and manipulate, steal, ransom, or otherwise compromise the records, or can use the access to catapult themselves to access other parts of a hospital’s network. Multiple secondary issues that can increase the cyber risks associated with devices, telemedicine, and electronic data were also identified. Finally, strategies that hospitals tend to employ to combat the cyber risks were explored and found to be subpar. There exist within hospitals’ cybersecurity measures serious vulnerabilities and gaps that many of today’s hospitals fail to address. The COVID-19 pandemic was used to further illustrate this issue. CONCLUSIONS Comparison of the risks, strategies, and gaps revealed that many hospitals in the US are unprepared for cybersecurity risks. The focus of their efforts are misdirected, with external - often governmental - efforts negligible. Policy changes, such as training employees in cyber protocols, adding advanced technical protections, and collaborating with a variety of experts, are necessary. Overall, hospitals must recognize that, in cyber incidents, the real victims are the patients. They are the ones at risk, physically and in information confidentiality, when medical devices, hospital equipment, or treatments are compromised.

Reviews of evidence

2018 ◽  
pp. 221-232
Author(s):  
Alan J. Silman ◽  
Gary J. Macfarlane ◽  
Tatiana Macfarlane
Keyword(s):  
Information Overload ◽  
Evidence Synthesis ◽  
Scientific Evidence ◽  
Epidemiological Studies ◽  
Future Research ◽  
Scientific Journals ◽  
Search Terms ◽  
The Us ◽  
Scientific Topic

The preceding chapters have focused on the generation of scientific evidence using epidemiological studies. Here the emphasis is on bringing together evidence (evidence synthesis) to inform future research and health policies. The chapter considers levels and quality of scientific evidence and describes in detail how to conduct a systematic review. It reviews the ways of summarizing and evaluating evidence from epidemiological studies. Summary of evidence is needed in everyday clinical practice and for public health. We live in a time of information overload, and it is impossible to read all the available scientific journals, even on a narrow scientific topic. Simply using search terms such as ‘cancer’ will result in millions of results in Google Scholar or PubMed (a service of the US National Library of Medicine®) database. Given the ever-increasing volume of medical literature and time constraints, summary of evidence plays a big role in decision-making.

Effectiveness of interventions for optimising adherence to treatments for the prevention and management of scars: A systematic review

2020 ◽  
pp. 026921552097852
Author(s):  
Jessica Killey ◽  
Megan Simons ◽  
Zephanie Tyack
Keyword(s):  
Grey Literature ◽  
Intervention Group ◽  
Original Data ◽  
Theoretical Frameworks ◽  
Burn Scar ◽  
Clinical Trial Registries ◽  
Core Components ◽  
Adherence Interventions ◽  
Randomised Controlled

Objectives: To identify the adherence interventions used with people receiving treatments to prevent or manage scarring, the effectiveness of these interventions, and the theoretical frameworks on which these interventions were based. Data sources: Databases (PubMed, Embase, Web of Science, CINAHL, PsychINFO and OTseeker) were searched (09.10.2020) with no date or language restrictions. Grey literature databases, clinical trial registries and references lists of key papers were also searched. Review methods: Eligible randomised controlled trials included people using treatments for scarring following skin wounds, interventions that may improve adherence, and outcomes measuring adherence. Risk of bias (selection, performance, detection, attrition, reporting) and certainty of evidence (inconsistency, imprecision, indirectness, publication bias) were assessed. Results: Four randomised trials were included with 224 participants (17 children) with burn scars. Interventions involved educational (three trials) or technology-based components (four trials) and ranged in length from two weeks to six months. All four trials reported greater adherence rates in the intervention group compared with standard practice [standardised mean difference = 1.50 (95% confidence interval (CI) = 0.91–2.08); 2.01 (95% CI 1.05–2.98); odds ratio = 0.28 (95% CI = 0.11–0.69)]. One trial did not report original data. The certainty of evidence was very low. Conclusion: Adherence interventions using education or technology for people receiving burn scar treatment may improve adherence. Further studies are needed particularly in children, with a focus on including outcomes of importance to patients (e.g. quality of life) and identifying core components of effective adherence interventions using theoretical frameworks.

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