The Centers for Disease Control and Prevention published the first Assisted Reproductive Technology (ART) Pregnancy Success Rate Report in 1997. This article presents a description of the law that initiated the public report, a description of the surveillance system used to accumulate data for the report, and some of the results from ART cycles intitiated in 1995.

Investment in health can offer additional benefits to development independent of economic improvement. Many technologies have been useful in improving the health of the people in the past. However, rapid and often unpredictable change has contributed to the inequity, inefficiency, and rising cost of health care. This paper outlines why a needs-based approach to assessing any new technology in the health sector is essential. To respond to changing needs, capacities within the health care system, several of which are described here, must be strengthened. Needs-based technology planning and implementation is affordable and feasible and is crucial in order that both health as a basic human right and good health at low cost can be attained.

Pragmatic or practice-oriented comparative effectiveness trials may be conducted to fill the evidence gaps that are revealed after the private sector has performed the trials needed for bringing their product to the market. A tool of increasing importance to identify such evidence gaps is resulting from health technology assessments (HTA) whereby the data derived from clinical research are examined in a systematic manner with reference to effect, safety, as well as additional parameters. Practice-oriented trials are informative for healthcare decision makers, practice-changing and may even be cost-saving for the healthcare payers. There are however only a limited number of funding sources for such trials. Public and private healthcare payers should stimulate the conduct of practice-oriented trials in their effort to maximize patient benefit within the limitation of the available resources. Pragmatic randomized trials can be performed at low cost when based on existing coded electronic health records and as well health registries. Public health decision makers are increasingly taking advantage of results from health technology assessments to support priority setting. In accordance with this it would appear reasonable that decision makers should get more involved in priority setting and funding also in the field of clinical research in order to provide further evidence needed for assessments, reassessments, and subsequent qualified decisions and resource allocations in health care. A closer dialogue and collaboration between the clinical research and HTA communities would facilitate a more efficient utilization of such opportunities.

Modern industrial society and its industrial processes can sometimes discourage the practice of traditional medicine. The existence and use of traditional Chinese medicine for several thousands of years indicates that it has sound elements. As has been true with features of other ancient, highly developed civilizations, the discipline of traditional Chinese medicine offers a valuable resource in the treatment and prevention of disease. Its scientific aspects and valuable experiences must continue to be developed according to Western scientific methodology. China has initiated a program to utilize modern industrialized technology in the integration of the traditional Chinese and modern Western medical systems. The policy and process aimed at integrating traditional Chinese medicine with Western medicine are presented in this paper.These measures have resulted in considerable utilization and development of the traditional Chinese medicine system, and have had a major impact on the development of public health care, as well as medical technology and science. The positive interactions between these fields of study and existing problems are discussed, and some comments on future expectations are presented.

Orthognathic surgery is a rapidly growing biotechnologic interaction involving alterations of facial form and dental occlusion. This article describes some of the important and complex psychological, sociological, ethical, and public policy issues involved. Advances in the latter issues are necessary for advancement of the field.

Prenatal care is all of the care that a pregnant woman receives from organized health care services, as well as from family, relatives, and friends. It begins with planning for pregnancy, and should be seen by those who give it as part of a process that continues through labor and delivery and into the neonatal period. The primary aim of prenatal care is promotion of maternal and fetal health, viewed as a unit until the pregnancy reaches full term (3). This encompasses the goals of reducing maternal and infant mortality and morbidity, detecting early factors that heighten the perinatal risk in both individual pregnancies and vulnerable groups, intervening to improve outcomes, educating all who provide or receive prenatal care, and helping women make their pregnancies and birth a positive life experience.

Objectives: The aim of this study was to assess current evidence supporting the use of percutaneous heart valves (PHV) in degenerative aortic valve and congenital pulmonary outflow tract disease, as compared to conservative medical therapy or traditional surgical valve replacement.

Methods: A systematic review of the literature on PHV was performed.

Results: No randomized controlled trials (RCT) on PHV have been published so far. Only observational data from series and data presented at cardiology meetings are available. Both percutaneous aortic valve (PAV) and percutaneous pulmonary valve (PPV) seem feasible in the hands of an experienced team. Safety, however, seems to be a problem in PAV, as shown by the high 30-day and 6-month mortality rates.

Conclusions: Due to safety concerns, PAV reimbursement is not recommended and patients should only be subjected to PAV insertion within the boundaries of an RCT. In contrast, PPV implantation seems to be a safe and promising technology for which reimbursement under strict conditions may be recommended.

When I was a doctoral student in health care administration at the University of Chicago, I worked with Odin Anderson, who introduced me to Osier Peterson and Bjprn Smedby. Odin first took me to Sweden in 1966. In early 1970, I met Lee Lusted and heard about clinical decision analysis. My interests, then as now, were the costs and outcomes of hospital care, although the methods I have used to address these problems have varied over time.

Background: In unselected patients, the incidence of restenosis is lower after placement of drug-eluting stents (DES) than bare-metal stents (BMS) without difference in safety at a time horizon of 4 years. However, DES appears less effective in “off label” patients.

Objectives: The aim of the study was to assess available evidence of DES efficacy and safety by patient category to establish when DES placement may be recommended for reimbursement by the French national health insurance.

Methods: Based on a systematic review by patient category (January 2002 to August 2009), two health technology assessment (HTA) reports and thirty-eight clinical studies not covered by the HTA reports (eleven meta-analysis including ours, eleven randomized trials and sixteen cohort studies) were selected. After assessment of the methodological quality, the studies mostly comparing DES with BMS were reviewed by a panel of health professionals who defined a priori the most relevant end points of safety and efficacy.

Results: Seven to fourteen patients treated with DES were needed to avoid one target lesion revascularization (TLR) in patients with lesions >15 mm long, vessel diameter <3 mm, or diabetes, and with some complex lesions (total coronary occlusion, BMS in-stent restenosis multivessel disease, unprotected left main stenosis). DES appeared as safe as other alternatives over a follow-up of up to 4 years when dual antiplatelet therapy was continued for at least 1 year, but statistical power remains limited to conclude for some clinical features.

Conclusions: For reimbursement, DES use should be limited to certain categories of patients. Treatment of particular cases requires a multidisciplinary approach.

The term “assessment of medical technologies” does not appear to have a unique meaning that always applies to its use. It seems wise, then, to state what will be meant by the term in this chapter. “Medical technology” is regarded here as including drugs, devices, procedures, (whether preventive, diagnostic, or therapeutic) that bear more or less directly on patients. Thus, an educational program for patients might be a technology, but a training program for dietitians would not. A surgical procedure or a prosthesis would; but a scale for assessing quality of life would not. “Assessment,” as used here, refers to a complex set of activities that comprise data acquisition, analysis, and interpretation concerning properties of medical technologies. Assessment tends to be comparative, either explicitly (as to a control group) or implicitly (as looking toward “usual experience”). In any case, the goal of assessment is to increase understanding of such properties of a medical technology as its applicability, convenience, efficacy, safety, effectiveness, cost, etc.

Respiratory movements are controlled by two pairs of neuronal groups in the brain stem: nucl. tractus solitarius and nucl. paraambigualis. These neuronal pools receive drive inputs from the forebrain and hypothalamus, and from central and peripheral chemoreceptors (9). Whether there is endogenous spontaneous respiratory rhythmic activity has been a matter of controversy, but this has recently been discovered in brainstem preparations of the neonatal rat in studies by Onimaru and Homma (27).

Economic guidelines recommend methods that should be employed in conducting economic evaluations of healthcare programs. The nature of the efficiency or equity goal underpinning economic guidelines is unclear. What is also unclear is how the methods recommended in the guidelines are linked to the underlying efficiency or equity goal being targeted. If it is unclear what efficiency/equity objectives are being pursued, then it is unlikely that even full implementation of economic guidelines will improve resource allocation.

Objectives: The aim of this study was to assess potential cost-effectiveness of using a prostate cancer specific functional imaging technology capable of identifying residual localized disease versus small volume metastatic disease for asymptomatic men with low but detectable prostate specific antigen (PSA) elevation following radical prostatectomy.

Methods: Markov modeling was used to estimate the incremental impact on healthcare system costs (2012 USD) and quality-adjusted life-years (QALYs) of two alternative strategies: (i) using the new diagnostic to guide therapy versus (ii) current usual care—using a combination of computed tomography, magnetic resonance imaging, and bone scan to guide therapy. Costs were based on estimates from literature and Medicare reimbursement. Prostate cancer progression, survival, utilities, and background risk of all-cause mortality were obtained from literature. Base-case diagnostic sensitivity (75 percent), specificity (90 percent), and cost (USD 2,500) were provided by our industry partner GE Healthcare.

Results: The new diagnostic strategy provided an average gain of 1.83 (95 percent uncertainty interval [UI]: 1.24–2.64) QALYs with added costs of USD 15,595 (95 percent UI: USD -6,330–44,402) over 35 years. The resulting incremental cost-effectiveness ratio was USD 8,516/QALY (95 percent UI: USD -2,947–22,372). Results were most influenced by the utility discounting rate and test performance characteristics; however, the new diagnostic provided clinical benefits over a wide range of sensitivity and specificity.

Conclusion: This analysis suggests a diagnostic technology capable of identifying whether men with biochemical recurrence after radical prostatectomy have localized versus metastatic disease would be a cost-effective alternative to current standard work-up. The results support additional investment in development and validation of such a diagnostic.

Background: The aim of this study was to assess the quality of reporting sample size calculation and underlying design assumptions in pivotal trials of high-risk medical devices (MDs) for neurological conditions.

Methods: Systematic review of research protocols for publicly registered randomized controlled trials (RCTs). In the absence of a published protocol, principal investigators were contacted for additional data. To be included, trials had to investigate a high-risk MD, registered between 2005 and 2015, with indications stroke, headache disorders, and epilepsy as case samples within central nervous system diseases. Extraction of key methodological parameters for sample size calculation was performed independently and peer-reviewed.

Results: In a final sample of seventy-one eligible trials, we collected data from thirty-one trials. Eighteen protocols were obtained from the public domain or principal investigators. Data availability decreased during the extraction process, with almost all data available for stroke-related trials. Of the thirty-one trials with sample size information available, twenty-six reported a predefined calculation and underlying assumptions. Justification was given in twenty and evidence for parameter estimation in sixteen trials. Estimates were most often based on previous research, including RCTs and observational data. Observational data were predominantly represented by retrospective designs. Other references for parameter estimation indicated a lower level of evidence.

Conclusions: Our systematic review of trials on high-risk MDs confirms previous research, which has documented deficiencies regarding data availability and a lack of reporting on sample size calculation. More effort is needed to ensure both relevant sources, that is, original research protocols, to be publicly available and reporting requirements to be standardized.

The assessment of drugs in Sweden has a long tradition that goes back to the seventeenth century when the Collegium Medicorum was established in 1663. One of its duties was to control the production of drugs in pharmacies. In 1688, Sweden got its first pharmacopoeia. In 1917, the Pharmaceutical Laboratory was founded as an advisory body of the National Board of Health and Welfare. The laboratory, now called the Department of Drugs, became responsible for evaluating drug applications, including information on their pharmaceutical and chemical properties, pharmacological actions, and clinical effects.

No European country (as far as the author knows) has a comprehensive strategy for technology assessment and implementation. Many countries undertake some aspects of such a strategy, but none cover all of them. Such a strategy would need to include the technical, clinical, economic and social evaluation of technologies, and the use of this information to set policies and to ensure that they are implemented. Despite the considerable differences in health systems financing and organization there is a surprising degree of similarity in the way we approach technology assessment; more variability exists in the mechanisms used to regulate and control the introduction and use of medical technologies.

Objectives: The cost-effectiveness of computed tomographic (CT) scanning after acute stroke was investigated to assess the contribution of brain imaging to the diagnosis and management of stroke and to estimate the costs, benefits, and risks of different imaging strategies to provide data to inform national and local policy on the use of brain imaging in stroke.