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Post-introduction observation of healthcare technologies after coverage: the Spanish proposal.
Published on Jul 1, 2012in International Journal of Technology Assessment in Health Care 1.33
· DOI :10.1017/S0266462312000232
Leonor Varela-Lema4
Estimated H-index: 4
,
Alberto Ruano-Ravina19
Estimated H-index: 19
(University of Santiago de Compostela)
+ 6 AuthorsLaura Sampietro-Colom13
Estimated H-index: 13
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.
  • References (22)
  • Cited By (4)
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References22
Published on Jun 1, 2008in Jacc-cardiovascular Interventions 9.88
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...
136 Citations Source Cite
Published on Jan 1, 2004
Clifford S. Goodman1
Estimated H-index: 1
,
Falls Church1
Estimated H-index: 1
84 Citations
Published on Jan 1, 1976
John Stevens1
Estimated H-index: 1
4 Citations
Published on Jan 1, 2006in PharmacoEconomics 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...
186 Citations Source Cite
Published on Nov 1, 2006in Hepatology 14.08
Henrik Toft Sørensen96
Estimated H-index: 96
(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...
116 Citations Source Cite
Published on Nov 17, 1999in JAMA 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...
58 Citations Source Cite
Published on Jun 1, 2010in Medical Care 3.34
Judith A. Turner78
Estimated H-index: 78
(University of Washington),
William Hollingworth36
Estimated H-index: 36
(University of Bristol)
+ 1 AuthorsRichard A. Deyo112
Estimated H-index: 112
11 Citations Source Cite
Published on May 1, 2006in American Journal of Cardiology 3.17
Sunil V. Rao61
Estimated H-index: 61
(Durham University),
Richard E. Shaw48
Estimated H-index: 48
+ 3 AuthorsEric D. Peterson141
Estimated H-index: 141
(Durham University)
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...
87 Citations Source Cite
Published on Jan 5, 2011in JAMA 47.66
Sana M. Al-Khatib49
Estimated H-index: 49
(Duke University),
Anne S. Hellkamp43
Estimated H-index: 43
+ 7 AuthorsStephen C. Hammill58
Estimated H-index: 58
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 Source Cite
Cited By4
Published on Feb 1, 2015in Journal of Evaluation in Clinical Practice 1.48
Leonor Varela-Lema4
Estimated H-index: 4
,
Teresa Queiro-Verdes1
Estimated H-index: 1
+ 12 AuthorsGonzalo Pradas-Montilla1
Estimated H-index: 1
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
Published on Sep 1, 2013in Personalized Medicine 1.03
Jonathan A Lal6
Estimated H-index: 6
,
Anil Vaidya1
Estimated H-index: 1
+ 2 AuthorsAngela Brand16
Estimated H-index: 16
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
Published on Jan 24, 2017in Frontiers in Pharmacology 3.83
Iñaki Gutiérrez-Ibarluzea8
Estimated H-index: 8
(Basque Government),
Marco Chiumente1
Estimated H-index: 1
,
Hans-Peter Dauben1
Estimated H-index: 1
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Christy Macdonald , Helen Lunt14
Estimated H-index: 14
+ 1 AuthorsKendall D5
Estimated H-index: 5
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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