Technology Assessment Reports Research Articles

Documentation of hip prostheses used in NorwayA critical review of the literature from 1996–2000

We have conducted a systematic review of the scientific literature concerning outcome and clinical effectiveness of prostheses used for primary total hip replacement (THR) in Norway. The study is based on two Health Technology Assessment reports from the UK (Faulkner et al. 1998, Fitzpatrick et al. 1998), reviewing the literature from 1980 to 1995. Using a similar search strategy, we have evaluated the literature from 1996 through 2000. We included 129 scientific and medical publications which were assessed according to a specific appraisal protocol. The majority (72%) were observational studies, whereas only 9% were randomized studies. We could not retrieve any peer-reviewed documentation for one third of the implants. The Charnley prosthesis had by far the best and most comprehensive evidence base with better than 90% implant survival after about 10 years. Survival of the Charnley prosthesis declines by about 10% during each of the two following decades. Except for the Charnley and Lubinus IP, no other prosthesis on the market in Norway has given long-term results (> 15 years). 5 other cemented implants have given comparable results at about 10 years of follow-up. Some uncemented stems have shown promising medium-term outcome, but no combination of uncemented cup and stem fulfilled the benchmark criterion of > or = 90% implant survival at 10 years, which we propose as a minimum requirement for unrestricted clinical use for prostheses used in primary THR. New or undocumented implants should be introduced through a four-step model including preclinical testing, small series evaluated by radiosterometry, randomized clinical trial involving comparison with a well-documented prosthesis, and finally, surveillance of clinical use through registers.

Literature searching for clinical and cost-effectiveness studies used in health technology assessment reports carried out for the National Institute for Clinical Excellence appraisal system.

To contribute to making searching for Technology Assessment Reports (TARs) more cost-effective by suggesting an optimum literature retrieval strategy. A sample of 20 recent TARs. All sources used to search for clinical and cost-effectiveness studies were recorded. In addition, all studies that were included in the clinical and cost-effectiveness sections of the TARs were identified, and their characteristics recorded, including author, journal, year, study design, study size and quality score. Each was also classified by publication type, and then checked to see whether it was indexed in the following databases: MEDLINE, EMBASE, and then either the Cochrane Controlled Trials Register (CCTR) for clinical effectiveness studies or the NHS Economic Evaluation Database (NHS EED) for the cost-effectiveness studies. Any study not found in at least one of these databases was checked to see whether it was indexed in the Science Citation Index (SCI) and BIOSIS, and the American Society of Clinical Oncology (ASCO) Online if a cancer review. Any studies still not found were checked to see whether they were in a number of additional databases. The median number of sources searched per TAR was 20, and the range was from 13 to 33 sources. Six sources (CCTR, DARE, EMBASE, MEDLINE, NHS EED and sponsor/industry submissions to National Institute for Clinical Excellence) were used in all reviews. After searching the MEDLINE, EMBASE and NHS EED databases, 87.3% of the clinical effectiveness studies and 94.8% of the cost-effectiveness studies were found, rising to 98.2% when SCI, BIOSIS and ASCO Online and 97.9% when SCI and ASCO Online, respectively, were added. The median number of sources searched for the 14 TARs that included an economic model was 9.0 per TAR. A sensitive search filter for identifying non-randomised controlled trials (RCT), constructed for MEDLINE and using the search terms from the bibliographic records in the included studies, retrieved only 85% of the known sample. Therefore, it is recommended that when searching for non-RCT studies a search is done for the intervention alone, and records are then scanned manually for those that look relevant. Searching additional databases beyond the Cochrane Library (which includes CCTR, NHS EED and the HTA database), MEDLINE, EMBASE and SCI, plus BIOSIS limited to meeting abstracts only, was seldom found to be effective in retrieving additional studies for inclusion in the clinical and cost-effectiveness sections of TARs (apart from reviews of cancer therapies, where a search of the ASCO database is recommended). A more selective approach to database searching would suffice in most cases and would save resources, thereby making the TAR process more efficient. However, searching non-database sources (including submissions from manufacturers, recent meeting abstracts, contact with experts and checking reference lists) does appear to be a productive way of identifying further studies.

Drug-eluting stents improve angioplasty outcomes, according to a new ECRI* technology assessment report.

Drug-eluting stents improve angioplasty outcomes, according to a new ECRI* technology assessment report.

Recommended psychosocial interventions for alcohol dependence: lessons in exclusion from the empirically supported treatment literature

This year (2003) saw the Health Technology Board for Scotland publish its third Health Technology Assessment Report, entitled Prevention of Relapse in Alcohol Dependence (Slattery et al., 2003). It recommended four evidence‐based psychosocial interventions to be available to NHS patients, and recommended that other psychosocial interventions be avoided. This paper, while welcoming the support for NHS substance misuse services for people experiencing alcohol dependence, addresses the potentially reductionist consequences of such recommendations by making reference to the literature on ‘empirically supported psychological treatments’. Evidence‐based interventions are located within the experimentalist school of psychology, and alternative perspectives within epistemology and psychotherapy are considered. The search for beneficial treatments is concluded to be praiseworthy, however cautions about the privileging of experimental perspectives above all others are made.

Using research in practice.

Using research in practice.

Hyperbaric oxygen for treating wounds: a systematic review of the literature.

To determine whether hyperbaric oxygen (HBO) therapy is an effective adjunct treatment for hypoxic wounds. We identified studies from technology assessment reports on HBO and a MEDLINE search from mid-1998 to August 2001. We accepted randomized controlled trials (RCTs), cohorts, and case series that reported original data, included at least 5 patients, evaluated the use of HBO for wound care, and reported clinical outcomes. Demographics, wound conditions, HBO regimen, adverse events, and major clinical outcomes were extracted from each study. Fifty-seven studies, 7 RCTs, 16 nonrandomized studies, and 34 case series involving more than 2000 patients are included in this review. None of the studies used wound tissue hypoxia as a patient inclusion criterion. The study results suggest that HBO may be beneficial as an adjunctive therapy for chronic nonhealing diabetic wounds, compromised skin grafts, osteoradionecrosis, soft tissue radionecrosis, and gas gangrene compared with standard wound care alone. Serious adverse events associated with HBO include seizures and pressure-related traumas, such as pneumothorax. A few deaths in the studies were associated with these adverse events. The overall study quality is poor, with inadequate or no controls in most studies. The studies suggest that HBO may be helpful for some wounds, but there is insufficient evidence to ascertain the appropriate time to initiate therapy and to establish criteria that determine whether patients will benefit. Serious adverse events may occur. High-quality RCTs that evaluate the short- and long-term risks and benefits of HBO are necessary to better inform clinical decisions.

The value of positron emission tomography in the clinical evaluation of dementia.

Positron emission tomography (PET) has been promoted as a means of improving the diagnosis of Alzheimer's disease (AD), but the evidence to support its incremental value is unclear. To assess the evidence regarding the use of PET in the clinical evaluation of AD, a systematic review of the English-language literature indexed in MEDLINE (1975-January 2001), the Cochrane Library (issue 4, 2000), and health technology assessment (HTA) reports was conducted. Articles identified by this review process were graded for methodological and reporting quality using a standardized grading scheme. Sixteen original articles and seven HTA reports were identified. In general, the articles addressed: using PET to differentiate AD from normal aging or non-Alzheimer's dementias, PET imaging compared with single positron emission computed tomography imaging, using PET to predict the progression of dementia, and agreement and reliability in the interpretation of PET images. Serious problems with study design and methodology in all articles were identified. Previous HTA reports have generally recommended that PET not be used in the clinical evaluation of dementia. In conclusion, there is little evidence to support the addition of PET to the routine clinical evaluation of patients with suspected or established dementia. Suggestions for future research in this area are offered.

Overview of economic evaluation of positron-emission tomography

Since the 1990s positron-emission tomography (PET) in Germany has been used increasingly in clinical diagnostics in the areas of oncology, cardiology, and neurology/ psychiatry. As the use of PET requires a complex and expensive infrastructure, analysis of the cost-effectiveness of PET compared to common diagnostic methods is becoming increasingly important. This contribution summarizes and discusses the results of a health technology assessment report on the cost-effectiveness of PET.

The feasibility of using ethnicity as a primary tool for antenatal selective screening for sickle cell disorders: pointers from the research evidence

The Department of Health has announced a linked antenatal and neonatal screening programme for haemoglobinopathies by 2004 in a comprehensive national plan for the National Health Service in Britain. In response the National Screening Committee has commenced development work on how such a programme can best be implemented, including investigation of the effectiveness of a question about ethnic origin as a basis for selection. In addition, two recent health technology assessment reports have assessed alternative options for antenatal and neonatal haemoglobinopathy screening programmes in the United Kingdom. Both reports and commentators have emphasised the importance of developing a standardised instrument for collecting ethnicity data and recommended early development of such work. An examination of the evidence base on the use of ethnicity as a primary screening tool reveals substantial variability in practice and in the quality of data collected, with risk group misclassification as high as 20% against a recommended target of under 5.5%. The literature on the conceptual basis and structure of ethnicity questions, method of assignment in data collection, and level of resolution on categorisation is reviewed to identify the most appropriate content and format of a screening question for the haemoglobinopathies. Question options are evaluated, including the use of an extended 2001 Census classification and a ‘non-North European’ identifier and a candidate question based on ‘family origins’ is offered for debate. Finally, issues relating to the testing of the efficiency of an ethnicity question and the operationalising of its use for antenatal sickle cell screening are discussed.

Funding the New Biologics – Introduction

863 In up to 20% of cases, Crohn’s disease remains active despite conventional medical therapy. Disorders of this type are usually not fatal, but result in significant disability, and thereby incur disproportionately great indirect medical and other costs to the patient and his or her family. Because treatment options are limited and there is a desire to avoid repeated surgical procedures, new biological agents, such as infliximab, are welcomed by physicians and patients. Infliximab is expensive, however, and a recent Canadian economic analysis has suggested that its use exceeds recognized benchmarks of cost effectiveness. This analysis was rigorous, used the best available clinical data, and included sophisticated sensitivity analyses, but was subject to important limitations dictated by the available data. For example, it assessed only direct medical costs and employed a short time horizon, which might have resulted in an underestimation of the long term benefits of averting surgery. Some of the assumptions that were used in the design of the model relied on American epidemiological data and expert opinion, instead of empirical Canadian data. The use of quality-adjusted life-years in the calculation of clinical costs and benefits might not be appropriate for patients with relatively high indirect medical costs, as is the case with Crohn’s disease. It might be better to compare the benefits of a specific medical strategy with those obtained by alternative uses of the health care resources. The manner by which quality-adjusted life-years were calculated in the Canadian Coordinating Office for Health Technology Assessment report has also been discussed. Currently accepted standards of cost effectiveness, including incremental cost utility ratios, are inherently arbitrary. It is possible that, in general, new biological agents could never meet such standards and would thus be declared cost ineffective, despite the fact that they are of proven benefit for certain important subgroups of patients. It has been suggested that a new way of evaluating these agents must be devised. Because the cost of the medication itself is an important component of overall health care costs, innovative cost-sharing schemes should be considered. It would also be helpful to identify specific subgroups of patients for whom new and expensive agents are appropriate. Clinical experience with infliximab is limited, and further economic analyses will be required as new data become available. Policy makers will need to consider not only economic but also humanitarian factors when deciding whether to provide funding for medications that offer hope to patients whose prognoses are otherwise dismal.

Advances in Breast Oncology: The 2002 ASCO Meeting

SummaryAt this year's American Society of Clinical Oncology (ASCO) meeting, a number of important advances in breast cancer diagnosis, treatment and prevention were reported. In this article, we review these current developments, focusing particularly on the ASCO technology assessment report - which discussed the adjuvant use of aromatase inhibitors in breast cancer - and other significant studies which were presented or updated: the role of taxanes in neoadjuvant and adjuvant therapy; currentconcepts regarding the timing of hormonal therapy during adjuvant chemotherapy; and cyclooxygenase-2 (COX-2) as a target for disruption in breast cancer treatment and prevention. With regards to advances in surgery, we review studies which were presented concerning the evolving role of sentinel lymph node biopsy in the management of the axilla in breast cancer, and review the latest meta-analysis on this subject presented at the meeting.

ECONOMIC ANALYSIS OF TREATMENT OF FUNCTIONAL DYSPEPSIA

The objective of this study was to assess the quality of economic analysis studies published in the medical and economical literature assessing the clinical management of functional dyspepsia. Bibliographic search in the main biomedical databases, in articles from bibliographic references, health technology assessment reports, and in gray literature. A specific protocol with economic and clinical items was designed for the evaluation. Overall, 18 of 162 studies met the inclusion criteria for the assessment. The compared treatment options were very diverse. The main methodologic deficiencies were in perspective of analysis, inclusion of indirect costs, and sources of clinical information. Specific checklists with clinical and economical items may help to better assess the quality of economic analysis in the field of functional dyspepsia. The methodologic rigor in the application of economic analysis techniques, as well as the use of appropriate clinical outcome measures, is essential to guarantee the reproducibility of the studies.

The Threaded Discussion Forum: A Case Study in Technology Integration

According to the Office of Technology Assessment report Teachers and Technology: Making the Connection, [T]eachers want to ensure that their students are learning. If technology can be a resource to enhance student achievement and interest in learning, teachers are more likely to invest the time and energy to learn to use it in their teaching (1995, 17). Among the myriad uses of technology in education today, the Internet is foremost. It is has become common for students to search the Internet for information or take part in on-line activities using interactive media. Indeed, the Internet represents one of the most impressive learning tools to date, particularly within the realm of communication. A variety of Internet communication tools can promote learning; one such tool is the threaded discussion forum. Discussion forums are areas of the Internet that provide a common meeting place where participants can contribute to a dialogue and access information asynchronously. The content found on a forum is presented via a collection of threaded posts, and user interfaces are designed to accommodate the browsing of existing threads and the submission of new posts.

Using health outcomes data to inform decision-making: government agency perspective.

In the developed world, the demand for healthcare is rising faster than supply, so that governments are faced with the need to allocate limited resources for maximum benefit. Many governments are responding to these pressures by developing health technology assessment agencies, which evaluate the cost effectiveness of new pharmaceutical and medical products relative to existing interventions. In England and Wales, the agency concerned with health technology assessment is the National Institute for Clinical Excellence (NICE). NICE brings together evidence of clinical and cost effectiveness to judge the value of the treatment relative to alternative uses of National Health Service (NHS) resources and makes recommendations on use of the treatment by the NHS in England and Wales. NICE evaluates technologies where they may result in significant impact on NHS resources or key healthcare policy. The health technology assessment includes a review of the clinical effectiveness, cost effectiveness and service impact of the technology under consideration. This health technology assessment report, together with submissions from the technology manufacturer, and patient and healthcare professionals groups, is then considered by an appraisal committee that formulates guidance to the NHS and is ultimately published by NICE. A number of countries have formal guidelines on the use of outcome measures and economic evaluations in the submissions required for health technology assessment prior to market access. These guidelines vary in both the detail and level of mandatory requirement to be followed by technology manufacturers. NICE has recently updated its guidance to technology manufacturers on their submissions. These guidelines, developed in consultation with the healthcare industry, provide detailed specification of the requirements of NICE for health outcomes data and economic evaluation. These details are described in more detail in this paper.

A Practical Approach to Evidence Grading

The Institute for Clinical Systems Improvement (ICSI) is a collaboration of 17 Minnesota medical groups. Among other activities, ICSI develops health care guidelines and technology assessment reports. To maintain focus on the underlying evidence, ICSI has developed an evidence and conclusion grading system for use by the practicing clinicians who write the documents and use them in making decisions about patient care. THE EVIDENCE GRADING SYSTEM IN DETAIL: The centerpiece of the evidence grading system is the conclusion grading worksheet, which calls for statement of a conclusion, summarization of research reports that support or dispute the conclusion, assignment of classes and quality markers to the research reports, and assignment of a grade to the conclusion. The system has been used in the writing of more than 40 guidelines and numerous technology assessment reports. An example of a worksheet from the congestive heart failure guideline is presented. The system has helped the drafting groups to attend to the evidence. The methods have proven to be well accepted by practicing physicians and to be practical, although staff expertise in epidemiology is needed to support the system. Grading of conclusions appears to be reliable, although this characteristic of the system has not been rigorously tested. The outputs are valued by users of the documents. Although some residual problems remain to be solved, the system appears to be successful in overcoming the complexity of some published systems for grading evidence while still yielding a defensible classification of conclusions based on the strength of the underlying evidence.

Cryptography in America

In 1516, almost 20 years before his beheading for political and religious obstreperousness, Sir Thomas More wrote in “Utopia”: “… and it will fall out as in a complication of diseases, that by applying a remedy to one sore, you will provoke another; and that which removes the one ill symptom produces others. …” More was talking about the stratification of society as a result of privilege based on a landed economy. But his injunction applies equally well in the debate over cryptography and the Internet. Simply put, the future prosperity, academic freedoms, and civil liberties of U.S. citizens are being pitted against the interests of society to protect itself against the intrusions of criminals, terrorists, and unfriendly states. Some in government seek to protect society by barring international traffic in expert information and by providing law enforcement and security agencies with unlimited access to all encrypted traffic. However, many information scientists contend that such policies will impede research and teaching, isolate the U.S. expert community, and retard the development of the “information economy.” Proposals advocating domestic controls over cryptography would give government the authority to superintend the transactions of citizens and deprive the human rights community of the tools needed to monitor the fates of those who suffer repressions worldwide. The U.S. government has applied existing laws in questionable ways to stem the spread of this technology. Phil Zimmerman, author of the public domain encryption system PGP (Pretty Good Privacy) was threatened with prosecution for illegally exporting munitions after someone posted the software on the Internet. Ultimately the government dropped its dubious pursuit of a criminal indictment. Recently, a U.S. academic had to go to federal court to be allowed to speak about his research to audiences that might include non-U.S. citizens. A AAAS program to provide training in encryption to human rights groups abroad is hampered by government restrictions. If the United States unilaterally mediates the intellectual exchange of its information scientists, it will be an unprecedented assault on academic freedom in peacetime. And since U.S. information scientists do not constitute a monopoly of innovation, it would not achieve the intended result of impeding the diffusion of cryptography technology. If the government succeeds in gaining immediate access to the secret keys of companies and individuals, many innocent users in the information chain could be held criminally liable. In response, U.S. service providers and carriers would be forced to downgrade or deny encryption altogether. This could destroy the Internet as a tool of commerce. In September, despite the rejection by the House Commerce Committee of an amendment that would have prohibited the manufacture, sale, distribution, and export or import of encryption systems,[*][1] the House National Security and Intelligence committees had already approved equivalent amendments. The arena has now shifted to the House Rules Committee and to the Senate, which is considering similar restrictive legislation.[†][2] The science and technology communities have tried to inform the Administration and Congress of the critical issues shaping this debate, but they have not been widely heard. These efforts include a 1994 Office of Technology Assessment report, [‡][3] a 1996 National Research Council report,[§][4] and a spring 1997 report of an ad hoc group of senior cryptographers and computer scientists.[|][5] It is now time for scientists and technologists to confront the nation's legitimate security and criminal issues and to work in concert with Congress and the Administration to address these confounding puzzles. It will require all of our intelligence and rigor if we are to avoid Sir Thomas More's presentiment that by applying a remedy to one problem we may inflict a suppurating wound elsewhere on the body politic. [1]: #fn-1 [2]: #fn-2 [3]: #fn-3 [4]: #fn-4 [5]: #fn-5

Tracer les parcours d'influence de l'évaluation sur l'utilisation des technologies de la santé

Abstract: In Quebec, over the past ten years many medical technology assessment reports have been submitted to decision-makers in government agencies, hospitals, and professionnal associations. This article traces the ways evaluation may influence decision-making. Five topics are discussed: 1) the imperfect reciprocal relationship between evaluation and technology utilization, 2) the difficulty of moving theoretically and methodologically between central and local perspectives, 3) linkages between evaluation and health policies, 4) linkages between health policies and technology utilization, and finally, 5) follow-up strategies for assessing the influence of evaluation on technology utilization.

CONGRESSIONAL STUDY QUESTIONS VALUE OF OUTCOMES RESEARCH

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.

Treaty feasibility

Current efforts to mitigate greenhouse gas emissions may be in vain unless there is wider and more committed participation in a stronger international climate change treaty than the 1992 U.N. Framework Convention on Climate Change, according to a new Office of Technology Assessment report, the last of a three‐part series on the subject. In particular, the participation of China is crucial because of the amount of coal and oil the nation consumes and supplies, OTA reports.

Office of Technology Assessment Report on Tuberculosis

Office of Technology Assessment Report on Tuberculosis