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Surface/specialty coil devices and gating techniques in magnetic resonance imaging.

Surface and other specialty coil devices and gating techniques are used in conjunction with MRI procedures to enhance image quality. Surface coils improve image quality by virtue of the improved signal-to-noise ratio, which results in better anatomic detail and tissue contrast. These coils may be advantageous for many kinds of imaging procedures, particularly for small structures that require greater spatial resolution. Although safety is not considered an issue, certain precautions must be taken to avoid skin burns. Gating techniques have been used to eliminate movement artifacts and associated image blurring. Cardiac-gated imaging has enabled the acquisition of high resolution diagnostic quality cardiac images with conventional MRI. Studies of gated cardiac imaging have demonstrated the technical capacity of MR scanning for evaluating ischemic heart disease, cardiomyopathy, pericardial diseases, intracardiac and paracardiac masses, thoracic-aortic diseases, and congenital heart disease. Cardiac imaging also has been found valuable in reducing motion artifacts in MRI of the chest, brain, spine, and liver. Gated imaging studies demonstrated that MRI respiratory gating improves thoracic and abdominal imaging; however, inherent time delays limit its usefulness. No patient-related risks appear to be involved when gating procedures are used appropriately. The use of gating techniques may add substantial time to the imaging procedure. Surface coil and gated MRI techniques have been found to be better than the conventional MRI studies when they improve the quality of the exam and its diagnostic capabilities.

Evaluation Studies as Topic↗

Technology assessment in healthcare: a review and description of a "best practice" technology assessment process.

BACKGROUND: Technology assessment has become a rapidly growing component of the healthcare system. It has assumed a functional role in operational settings and is rapidly impacting decisions involving purchasing, coverage, and reimbursement. This review is intended to assist the healthcare decision maker in considering the application of technology assessment in healthcare, so as to maximize the efficiency of future purchasing decisions. METHODS: This "best practice" was synthesized after identifying key institutions performing technology assessment in healthcare and analyzing their working processes, including literature review, consensus panel discussions, and expert opinion. RESULTS: We describe this best practice on a reiterative loop that consists of five processes: awareness, strategic appropriateness, analysis versus need, acquisition and implementation, and reassessment. Typical barriers to adoption of technology assessment are also identified and discussed. CONCLUSIONS: This review suggests a common terminology for the core processes involved in technology assessment, thereby facilitating a more uniform understanding among the different components of the healthcare system (i.e., payer, provider, and society) while recognizing their different perspectives.

Academies and Institutes↗

Building bridges between academic research and policy formulation: the PRUFE framework - an integral part of Ontario's evidence-based HTPA process.

Healthcare expenditure in Ontario has been escalating at increasing rates and a growing proportion of this has come from medical devices and other technologies. A comprehensive evidence-based process for the assessment of new health technologies in Ontario was recently established (the Health Technology Policy Analysis [HTPA] process). Requests for funding for new technologies are directed through a department of the Ministry called the Medical Advisory Secretariat (MAS) who, using a systematic and evidence-based approach, provides information on the safety, effectiveness, and cost effectiveness of the technology to the Ontario Health Technology Advisory Committee (OHTAC). If the OHTAC determines that the evidentiary base for making recommendations is too uncertain, a request is made to reduce this uncertainty through the conduct of a 'real world' Ontario-based study. The Program for Assessment of Technology in Health (PATH) reduction of Uncertainty through Field Evaluation (PRUFE) framework is an iterative process for collecting new information, updating prior knowledge and providing new 'real world' evidence back to the Ministry regarding the cost effectiveness of new health technologies. MAS/OHTAC has undertaken evidence-based analyses for >50 new technologies. The PRUFE framework has been successful for reducing uncertainty and controlling healthcare expenditures while providing access and improving patient outcomes.

Biomedical Research↗

Health technology assessment: the contribution of qualitative research.

The pragmatism in health care has made health technology assessment (HTA) restrict its scope to a particular set of problems, c.q. methods. The "multidisciplinary and comprehensive nature" of HTA, as the concept is presented in certain definitions, is lacking. Health care is also dominated by a positivistic-rationalistic approach of evaluation. In contrast, social studies of evaluations learn that a major difference has to be made between scientific research on (potential) impact of a technology and valuing these effects. In this contribution, we will discuss how the positivistic scientific bias of current HTA practice can be made up with other research traditions. More specifically, we focus on the question of how social scientists and particularly how qualitative research can contribute to HTA, complementary to positivistic studies of evidence and efficacy.

Biomedical Research↗

Methodology of OTA's report on drug labeling in developing countries.

This article discusses the methodology of the OTA Project on Drug Labeling in Developing Countries. This report describes (a) the process of the project; (b) observations from a field visit to Thailand; (c) the development of the multinational pharmaceutical industry; and (d) influences on multinational pharmaceutical companies from their home countries, host countries, international organizations, self-regulation, and public interest groups. The results of the assessment will appear in the final report to Congress.

Consumer Advocacy↗

Single and double lung transplantation.

Lung transplantation currently involves the allografting of one or both lungs from a cadaver or brain-dead donor to selected patients with progressive end-stage pulmonary disease for whom there are no other viable treatment options. Expanding experience since 1986 in Canada, the United States, and Europe has demonstrated that both SLT and DLT can provide adequate pulmonary function and palliation for extended periods in some patients with otherwise fatal lung disease. A more rapid expansion of this technology has been constrained by the scarcity of suitable donors and the current limits of organ preservation time. Lung transplantation has evolved as a clinical procedure achieving a favorable risk-benefit ratio and acceptable 1- and 2-year survival rates. Lung transplantation is applied as a therapeutic option for patients with end-stage pulmonary disease. However, the transplant community has not yet reached consensus regarding patient selection criteria or absolute contraindications to LT. Specific selection criteria for the optimal treatment of all LT candidates do not exist as yet and are currently evolving. The majority of candidates have had pulmonary fibrosis, bronchiectasis, emphysema, pulmonary hypertension, or CF. Additional clinical information and experience will be useful in refining evaluation of risk-benefit ratios of SLT and DLT, which may vary for specific subsets of patients.

Clinical Trials as Topic↗

Institutional and patient criteria for heart-lung transplantation.

Heart-lung transplantation is a complex, expensive, and resource-intensive procedure. It is performed more often where there is coexistence of end-stage pulmonary disease with advanced cardiac disease that is not secondary to pulmonary hypertension (e.g., some forms of congenital heart disease, some situations with Eisenmenger's syndrome, and possibly the coexistence of end-stage heart and end-stage lung disease). Available data indicate that some disease states are associated with a higher probability of successful outcome after HLT than are others. Objectively validated and reliable patient selection criteria cannot be obtained from the current medical literature. Expert opinion provided to OHTA contained varying degrees of detail and uniformity with respect to patient selection (Tables 11 and 12). While most agree that "irreversible cardiopulmonary disease" is an indication for this procedure, there are no published data that have provided details as to how patients so designated were selected as candidates for HLT. For example, for chronic obstructive pulmonary disease (emphysema), neither expert opinion nor published studies of HLT provided data indicating the stage of the disease at which a decision to transplant is reasonable and objectively justifiable. A similar lack of detail for cystic fibrosis, bronchiectasis, pulmonary fibrosis, sarcoidosis, asbestosis, and other diseases was noted. Thus, there are insufficient data regarding transplant recipients to permit the development of objective criteria for a threshold for HLT in the various disease states. The circumstances are more problematic regarding suggested contraindications for HLT. While objective survival rates obtained from registry data indicated that survival bore little relationship to recipient age, various opinions provided to OHTA specified a maximum age for HLT candidates, ranging from under 45 years to 60 years. Adverse factors and contraindications, such as "other significant disease," "recurrent pulmonary emboli," "hepatic disease," "infection," and "insulin-dependent diabetes" were nonspecific and unsupported by published, objective evidence. More ambiguous contraindications included "psychiatric illness," "poor family support structure," "history of noncompliance with medical regimens," and lack of "emotional stability." While psychiatric, psychologic, or sociologic evaluations of potential HLT recipients undeniably have relevance to patient selection, use of such criteria should be supported at least by evidence of generally consistent application across the transplant community. Of note was the recommended requirement that the recipient possess "adequate financial resources," which implies that the benefits of HLT are not expected to be equitably provided to the public.(ABSTRACT TRUNCATED AT 400 WORDS)

Actuarial Analysis↗

Bayesian methods in health technology assessment: a review.

BACKGROUND: Bayesian methods may be defined as the explicit quantitative use of external evidence in the design, monitoring, analysis, interpretation and reporting of a health technology assessment. In outline, the methods involve formal combination through the use of Bayes's theorem of: 1. a prior distribution or belief about the value of a quantity of interest (for example, a treatment effect) based on evidence not derived from the study under analysis, with 2. a summary of the information concerning the same quantity available from the data collected in the study (known as the likelihood), to yield 3. an updated or posterior distribution of the quantity of interest. These methods thus directly address the question of how new evidence should change what we currently believe. They extend naturally into making predictions, synthesising evidence from multiple sources, and designing studies: in addition, if we are willing to quantify the value of different consequences as a 'loss function', Bayesian methods extend into a full decision-theoretic approach to study design, monitoring and eventual policy decision-making. Nonetheless, Bayesian methods are a controversial topic in that they may involve the explicit use of subjective judgements in what is conventionally supposed to be a rigorous scientific exercise. OBJECTIVES: This report is intended to provide: 1. a brief review of the essential ideas of Bayesian analysis 2. a full structured review of applications of Bayesian methods to randomised controlled trials, observational studies, and the synthesis of evidence, in a form which should be reasonably straightforward to update 3. a critical commentary on similarities and differences between Bayesian and conventional approaches 4. criteria for assessing the reporting of a Bayesian analysis 5. a comprehensive list of published 'three-star' examples, in which a proper prior distribution has been used for the quantity of primary interest 6. tutorial case studies of a variety of types 7. recommendations on how Bayesian methods and approaches may be assimilated into health technology assessments in a variety of contexts and by a variety of participants in the research process. METHODS: The BIDS ISI database was searched using the terms 'Bayes' or 'Bayesian'. This yielded almost 4000 papers published in the period 1990-98. All resultant abstracts were reviewed for relevance to health technology assessment; about 250 were so identified, and used as the basis for forward and backward searches. In addition EMBASE and MEDLINE databases were searched, along with websites of prominent authors, and available personal collections of references, finally yielding nearly 500 relevant references. A comprehensive review of all references describing use of 'proper' Bayesian methods in health technology assessment (those which update an informative prior distribution through the use of Bayes's theorem) has been attempted, and around 30 such papers are reported in structured form. There has been very limited use of proper Bayesian methods in practice, and relevant studies appear to be relatively easily identified. RESULTS: Bayesian methods in the health technology assessment context 1. Different contexts may demand different statistical approaches. Prior opinions are most valuable when the assessment forms part of a series of similar studies. A decision-theoretic approach may be appropriate where the consequences of a study are reasonably predictable. 2. The prior distribution is important and not unique, and so a range of options should be examined in a sensitivity analysis. Bayesian methods are best seen as a transformation from initial to final opinion, rather than providing a single 'correct' inference. 3. The use of a prior is based on judgement, and hence a degree of subjectivity cannot be avoided. However, subjective priors tend to show predictable biases, and archetypal priors may be useful for identifying a reasonable range of prior opinion.

Bayes Theorem↗

Who, what, where, when, why and how: technology assessment in a hospital setting.

Biomedical engineers have long seen that they have a role in the fields of equipment planning and technology assessment. This role has not been universally understood. Through sustained efforts we have shown that we can contribute to and should be involved in equipment planning. Efforts are now under way to demonstrate the need for and the role that biomedical engineering can play in technology assessment and ultimately in strategic planning. The paper examines the Canadian healthcare scene within the context of the Province of British Columbia, and more specifically the opportunities and challenges in the fields of technology management presented to an in-house biomedical engineering group at a hospital society in Greater Vancouver.

Biomedical Engineering↗