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Post-introduction observation of healthcare technologies after coverage: the Spanish proposal.
Abstract
Objectives: When a new health technology has been approved by a health system, it is difficult to guarantee that it is going to be efficiently adopted, adequately used, and that effectiveness, safety, and consumption of resources and costs are in line with what was expected in preliminary investigations. Many governmental institutions promote the idea that efficient mechanisms should be established aimed at developing and incorporating continuous evidence into health technologies management. The purpose of this article is to stimulate the discussion on systematic post-introduction observation of health technologies. Methods: Literature review and input of HTA experts. Results: The study addresses the key issues related to post-introduction observation and presents a summary of the guide commissioned by the Spanish Ministry of Health, Social Policy and Equality to the Galician HTA agency for the prioritization and implementation of systematic post-introduction observation in Spain. The manuscript describes the prioritization tool developed as part of this project and discusses the main aspects of protocol development, observation implementation, and assessment of results. Conclusions: The observation of prioritized health technologies after they are introduced in standard clinical practice can provide useful information for health organizations. However, implementing the observation of health technologies can require specific policy frameworks, commitment from different stakeholders, and dedicated funding.

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  • References (22)
  • Cited By (4)
Edward L. Hannan63
Estimated H-index: 63
(University at Albany, SUNY)
The 2 primary types of studies that are used to test new drugs or procedures or compare competing drugs or types of procedures are randomized clinical trials (RCTs) and observational studies (OS). Although it would appear that RCTs always trump OS because they eliminate selection bias, there are many possible limitations to both types of studies, and these limitations must be carefully assessed when comparing the results of RCTs and OS. This state-of-the art review describes these limitations an...
132 Citations Download PDF Cite
John Stevens1
Estimated H-index: 1
4 Citations Source
2006 in PharmacoEconomics [IF: 4.01]
Karl Claxton50
Estimated H-index: 50
(University of York),
Mark Sculpher71
Estimated H-index: 71
(University of York)
Decisions to adopt, reimburse or issue guidance on the use of health technologies are increasingly being informed by explicit cost-effectiveness analyses of the alternative interventions. Healthcare systems also invest heavily in research and development to support these decisions. However, the increasing transparency of adoption and reimbursement decisions, based on formal analysis, contrasts sharply with research prioritisation and commissioning. This is despite the fact that formal measures o...
182 Citations Source Cite
2006 in Hepatology [IF: 15.04]
Henrik Toft Sørensen95
Estimated H-index: 95
(Boston University),
Timothy L. Lash45
Estimated H-index: 45
(Boston University),
Kenneth J. Rothman67
Estimated H-index: 67
(Boston University)
Observational analogs of randomized clinical trials (RCTs) are well accepted in the study of disease risk factors, diagnosis, and prognosis. There is controversy about observational studies when the focus is on the intended benefit due to lack of blinding and poor control for unmeasured confounding. Well-designed randomized clinical trials are costly both in time and money. Therefore, existing databases are used increasingly and are often the only feasible source with which to examine delayed he...
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1999 in JAMA [IF: 47.66]
John M. Eisenberg36
Estimated H-index: 36
SOON AFTERRENELAENNEC INVENTED THE STETHOSCOPE in1816, itwasmetwith“suspicionanddistrust . . . by those who were practicing medicine when it was introduced.” As late as the 1850s, skeptics described the new diagnostic aid as “a dangerous instrument.” While most agree that health care technology has advanced physicians’ ability to improve their patients’ health and quality of life, there has been considerable disagreement about which technologies to use, how much is too much, and whether the tech...
77 Citations Source Cite
Paul Trueman16
Estimated H-index: 16
(Brunel University London),
David Grainger8
Estimated H-index: 8
(Eli Lilly and Company),
Kristen E. Downs1
Estimated H-index: 1
Objectives: The aim of this study was to describe the current issues surrounding Coverage with Evidence Development (CED). CED is characterized by restricted coverage for a new technology in parallel with targeted research when the stated goal of the research or data collection is to provide definitive evidence for the clinical or cost-effectiveness impact of the new technology. Methods: Presented here is information summarized and interpreted from presentations and discussions at the 2008 Healt...
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2010 in Medical Care [IF: 3.34]
Judith A. Turner78
Estimated H-index: 78
(University of Washington),
William Hollingworth35
Estimated H-index: 35
(University of Bristol),
Bryan A. Comstock28
Estimated H-index: 28
(University of Washington)
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11 Citations Source Cite
Sunil V. Rao60
Estimated H-index: 60
(Durham University),
Richard E. Shaw48
Estimated H-index: 48
,
Ralph G. Brindis70
Estimated H-index: 70
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Limited data are available on the off-label use of drug-eluting stents (DESs) in clinical practice. We used data from the American College of Cardiology National Cardiovascular Data Registry to describe the rates and outcomes of DES use in 4 common off-label situations: ST-elevation myocardial infarction, in-stent restenosis, coronary artery bypass grafts, and chronic total occlusions. The rates of in-hospital adverse events for each off-label situation were determined and compared with the expe...
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2011 in JAMA [IF: 47.66]
Sana M. Al-Khatib49
Estimated H-index: 49
(Duke University),
Anne S. Hellkamp43
Estimated H-index: 43
,
Jeptha P. Curtis52
Estimated H-index: 52
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Context Practice guidelines do not recommend use of an implantable cardioverter-defibrillator (ICD) for primary prevention in patients recovering from a myocardial infarction or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure. Objective To determine the number, characteristics, and in-hospital outcomes of patients who receive a non–evidence-based ICD and examine the distribution of these implants by site, physician specialt...
186 Citations Download PDF Cite
  • References (22)
  • Cited By (4)
Leonor Varela-Lema4
Estimated H-index: 4
,
Teresa Queiro-Verdes1
Estimated H-index: 1
,
José Antonio Baz-Alonso4
Estimated H-index: 4
(University Hospital Complex Of Vigo)
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Rationale, aims and objectives Transcatheter aortic valve implantation constitutes an example of a technology introduced into the Galician Health Care System basket and subjected to a post-introduction observational study after coverage. This paper aims to describe the process and results of this experience, illustrating the main challenges and opportunities in using these studies for supporting decision making. Methods The study protocol was developed by a multidisciplinary team consisting of e...
2 Citations Source Cite
2013 in Personalized Medicine [IF: 1.03]
Jonathan A Lal6
Estimated H-index: 6
,
Anil Vaidya1
Estimated H-index: 1
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Iñaki Gutiérrez-Ibarluzea8
Estimated H-index: 8
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We see a backlog in the effective and efficient integration of personalized medicine applications such as genome-based information and technologies into healthcare systems. This article aims to expand on the steps of a published innovative model, which addresses the bottleneck of real-time integration into healthcare. We present a deconstruction of the Learning-Adapting-Leveling model to simplify the steps. We found out that throughout the technology transfer pipeline, contacts, assessments and ...
5 Citations Source Cite
2017 in Frontiers in Pharmacology [IF: 3.83]
Iñaki Gutiérrez-Ibarluzea8
Estimated H-index: 8
(Basque Government),
Marco Chiumente1
Estimated H-index: 1
,
Hans-Peter Dauben1
Estimated H-index: 1
Source Cite
Background:Many governments and insurers are driving down the cost of medical devices, including glucose meters, by the central management of purchasing decisions. We report patients’ responses to an “enforced” change in brand of glucose meter, one year after the introduction of a national sole supplier arrangement for funded glucose meters and strips.Method:Specialist diabetes clinic attendees from two geographical locations completed a questionnaire one year after the final meter changeover da...
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