The approach of providing passive protection to young infants by immunizing pregnant women can bypass the problems of immunological immaturity in the neonate, avoid or delay active immunization of the infant in the first year of life, and prevent transmission of an infection from the mother to the neonate. Optimal vaccines for this approach should induce high immunoglobulin G antibody titers that quickly reach their maximum level after immunization and persist at protective levels for several years, thus providing passive protection in subsequent pregnancies. Specific applications of this approach include the worldwide practice of maternal immunization with tetanus toxoid vaccine and ongoing studies of maternal immunization to prevent Haemophilus influenzae type b, group B strepto-coccal, pneumococcal, meningococcal, and human immunodeficiency virus infection in the infant. Addressing the cultural, sociological, and legal aspects of maternal immunization will be required to ensure the success of this approach.

A more conservative approach to the treatment of traumatic dental injuries has been made possible by knowledge concerning the pathogensis of external root resorption, increased knowledge about wound healing processes in the pulp and periodintium, as well as by advances in restorative dentistry (reattachment of crown fragments with a dentin bonding system, the use of adhesive bridges, and advances in autotransplantation and implantation). However, a rethinking by the public, clinicians, and third-party payers is necessary for these procedures to gain wider acceptance. The present article describes the state of the art of treating dental trauma in the hope that these advances cam become an accepted part of the dental trauma armamentarium and not merely scientific curiosities.

Clinical practice guidelines are expanding their scope of authority from clinical decision making to collective policy making, and promise to gain ground as resource allocation tools in coming years. A close examination of how guidelines approach patient selection criteria offers insight into their ethical implications when used as resource allocation or rationing instruments. The purposes of this paper are: a) to examine the structure of allocative reasoning found in clinical guidelines; b) to identify the ethical principles implied and compare how guidelines enact these principles with how explicit systems-level rationing exercises and health policy analyses have approached them; and c) to offer some preliminary suggestions for how these ethical issues might be addressed in the process of guideline development. The resulting framework can be used by guideline developers and users to understand and address some of the ethical issues raised by guidelines for the use of scarce technologies.

Objectives: The aim of this study was to synthesize best practices for addressing clinical heterogeneity in systematic reviews and health technology assessments (HTAs).

Methods: We abstracted information from guidance documents and methods manuals made available by international organizations that develop systematic reviews and HTAs. We searched PubMed® to identify studies on clinical heterogeneity and subgroup analysis. Two authors independently abstracted and assessed relevant information.

Results: Methods manuals offer various definitions of clinical heterogeneity. In essence, clinical heterogeneity is considered variability in study population characteristics, interventions, and outcomes across studies. It can lead to effect-measure modification or statistical heterogeneity, which is defined as variability in estimated treatment effects beyond what would be expected by random error alone. Clinical and statistical heterogeneity are closely intertwined but they do not have a one-to-one relationship. The presence of statistical heterogeneity does not necessarily indicate that clinical heterogeneity is the causal factor. Methodological heterogeneity, biases, and random error can also cause statistical heterogeneity, alone or in combination with clinical heterogeneity.

Conclusions: Identifying potential modifiers of treatment effects (i.e., effect-measure modifiers) is important for researchers conducting systematic reviews and HTAs. Recognizing clinical heterogeneity and clarifying its implications helps decision makers to identify patients and patient populations who benefit the most, who benefit the least, and who are at greatest risk of experiencing adverse outcomes from a particular intervention.

Objective: Our study aims to provide a practical contribution to the field of medical technology assessment within a new paradigm. This paradigm indicates the need for more comprehensive technology assessments in the development stage of a new technology.

Method: We introduce a method, based on Saaty's Analytic Hierarchy Process, which quantitatively supports discussions between the various actors that shape the technology's development and diffusion. These discussions focus on technical, medical, social, and economical requirements relevant to the design and diffusion of the new technology.

Discussion: In contrast to more traditional technology assessments, our method encompasses the perspectives of the diverse actors in the social context of technology development and diffusion. It influences their decision making on technology design and diffusion in order to improve this technology's later clinical as well as social effectiveness.

Objectives: Obesity and dyslipidemia are risk factors for ischemic heart disease, and prevention and treatment in primary care can reduce these risks. The objective of this cost-effectiveness analysis was to compare the costs and effects (in terms of life years gained) of providing nutritional counseling by a general practitioner (GP) or a dietician.

Methods: A total of 60 GPs, who accepted to participate, were randomized either to give nutritional counseling or to refer patients to a dietician for counseling. The life years gained was estimated using a Cox regression model. Costs were estimated on the basis of registered use of time (dieticians) or agreed salaries (GPs).

Results: The effect of nutritional counseling comparing GPs and dieticians is greatest when counseling is performed by a GP—0.0919 years versus 0.0274 years. These effects appear to be moderate, but they are significant. It is also proven that the GP group was the most cost-effective—the cost of gaining 1 extra life year was estimated to be 8,213 DKK compared with the dietician group, for which the incremental cost-effectiveness ratio was estimated to be 59,987 DKK.

Conclusions: The effects were moderate, but other studies of other patient groups and interventions report effects within the same magnitude. The GP group was the most cost-effective, but it must be concluded that both counseling strategies were relatively cost-effective. Even though the cost of gaining an extra life year was estimated to be 59,987 DKK in the dietician group, this might be an acceptable price.

The Pan American Health Organization (PAHO), Regional Office of the World Health Organization (WHO) for the Americas, has tried to promote health technology assessment (HTA) in Latin America for 25 years. A certain awareness of HTA developed in several countries because of these efforts. In the late 1990's, there was a strong movement for health reform in Latin America, and HTA became part of that movement. Countries that now are actively institutionalizing HTA include Brazil, Mexico, Chile, and Argentina. Other countries, such as Costa Rica, Colombia, Cuba, Peru, Panamá, Paraguay, Trinidad and Tobago, and Uruguay, are following these trends and some others seem to be moving in this direction within the next few years.

Objectives: This study was designed to assess the sensitivity of three Ovid MEDLINE search filters developed to identify studies reporting health state utility values (HSUVs), to improve the performance of the best performing filter, and to validate resulting search filters.

Methods: Three quasi-gold standard sets (QGS1, QGS2, QGS3) of relevant studies were harvested from reviews of studies reporting HSUVs. The performance of three initial filters was assessed by measuring their relative recall of studies in QGS1. The best performing filter was then developed further using QGS2. This resulted in three final search filters (FSF1, FSF2, and FSF3), which were validated using QGS3.

Results: FSF1 (sensitivity maximizing) retrieved 132/139 records (sensitivity: 95 percent) in the QGS3 validation set. FSF1 had a number needed to read (NNR) of 842. FSF2 (balancing sensitivity and precision) retrieved 128/139 records (sensitivity: 92 percent) with a NNR of 502. FSF3 (precision maximizing) retrieved 123/139 records (sensitivity: 88 percent) with a NNR of 383.

Conclusions: We have developed and validated a search filter (FSF1) to identify studies reporting HSUVs with high sensitivity (95 percent) and two other search filters (FSF2 and FSF3) with reasonably high sensitivity (92 percent and 88 percent) but greater precision, resulting in a lower NNR. These seem to be the first validated filters available for HSUVs. The availability of filters with a range of sensitivity and precision options enables researchers to choose the filter which is most appropriate to the resources available for their specific research.

Objectives: A treatment pathway model was developed to examine the costs and benefits of the current bowel cancer service in England and to evaluate potential alternatives in service provision. To use the pathway model, various parameters and probability distributions had to be specified. They could not all be determined from empirical evidence and, instead, expert opinion was elicited in the form of statistical quantities that gave the required information. The purpose of this study is to describe the procedures used to quantify expert opinion and note examples of good practice contained in the case study.

Methods: The required information was identified and preparatory discussion with four experts refined the questions they would be asked. In individual elicitation sessions they quantified their opinions, mainly in the form of point and interval estimates for specified variables. New methods have been developed for quantifying expert opinion and these were implemented in specialized software that uses interactive graphics. This software was used to elicit opinion about quantities related to measurable covariates.

Results: Assessments for thirty-four quantities were elicited and available checks supported their validity. Eight points of good practice in eliciting and using expert judgment were evident. Parameters and probability distributions needed for the pathway model were determined from the elicited assessments. Simulation results from the pathway model were used to inform policy on bowel cancer service provision.

Conclusions: The study illustrates that quantifying and using expert judgment can be acceptable in real problems of practical importance. For full benefit to be gained from expert knowledge, elicitation must be conducted carefully and should be reported in detail.

Objective: The objective of this study was to examine the economics of administering calcium and vitamin D3 to post-menopausal women in Sweden. We focus primarily on the cost-effectiveness of treating older women for whom clear evidence of efficacy is available. We supplement this information, however, with estimates of the cost-effectiveness of treating certain high-risk groups of younger women, while acknowledging the greater uncertainty involved.

Methods: We developed a Markov model for analyzing the occurrence and timing of hip fractures, based almost entirely on peer-reviewed data from Sweden. In a 3-year randomized clinical trial, the combination of calcium and vitamin D3 was shown to reduce the risk of hip fractures by 27%. Costs for treating hip fractures were based on 1,080 women who were hospitalized in Stockholm.

Results: Treatment of 70-year-old women was cost saving at efficacy as low as two-thirds that seen in the clinical trials, and upwards. Even at modest rates of efficacy, treatment of the high-risk 50- and 60-year-old cohorts was generally cost-effective and in some cases even cost saving. Particularly cost-effective was treatment of women with identified osteoporosis or a maternal family history of hip fracture.

Conclusion: Simulation results suggest a role for lifetime treatment of older women with calcium and vitamin D3 in Sweden. While there is more uncertainty underlying the treatment of younger women, our simulation results suggest that treatment may also be cost saving or at least cost-effective for many cohorts of high-risk 50- and particularly 60-year-old women, in particular those with osteoporosis or a maternal family history of hip fracture.

Objectives: The Secondary Prevention of Heart disEase in geneRal practicE (SPHERE) trial has recently reported. This study examines the cost-effectiveness of the SPHERE intervention in both healthcare systems on the island of Ireland.

Methods: Incremental cost-effectiveness analysis. A probabilistic model was developed to combine within-trial and beyond-trial impacts of treatment to estimate the lifetime costs and benefits of two secondary prevention strategies: Intervention - tailored practice and patient care plans; and Control - standardized usual care.

Results: The intervention strategy resulted in mean cost savings per patient of €512.77 (95 percent confidence interval [CI], −1086.46–91.98) and an increase in mean quality-adjusted life-years (QALYs) per patient of 0.0051 (95 percent CI, −0.0101–0.0200), when compared with the control strategy. The probability of the intervention being cost-effective was 94 percent if decision makers are willing to pay €45,000 per additional QALY.

Conclusions: Decision makers in both settings must determine whether the level of evidence presented is sufficient to justify the adoption of the SPHERE intervention in clinical practice.

The Quebec Council on Health Care Technology Assessment was created in 1988. Its functions are to promote, support, and produce health care technology assessments and to advise the Minister of Health. An independent review of the council’s first four years of operation was commissioned. The evaluation team concluded that the council showed very good results in terms of the scope, quality, and impact of its production and succeeded in establishing its credibility. However, the evaluation team suggested that the council adopt a more active strategy toward the promotion and diffusion of its reports. Some critical determinants of success of the Quebec experience in technology assessment are discussed.

To increase access to care for cataract patients in Sweden, it was decided, starting in 1992, that all cataract patients listed for surgery and with priority should have their cataract extraction performed within three months. To evaluate the effect of this waiting time guarantee, a National Cataract Register (NCR) was initiated in late 1991. In 1992, 81% of all cataract extractions performed in Sweden were reported to the NCR; in 1993 this figure was 92%. Reasons for this high participation ratio are discussed. In 1993, 74.4% (range between different clinics, 40–99%) of the patients with priority had their operation performed within three months. Great variation in visual acuity and age was found in patients with priority among the different surgical units.

Objectives: Information technology is a rapidly expanding branch of science which has affected other sciences. One example of using information technology in medicine is the Electronic Medical Records system. One medical university in Iran decided to introduce such system in its hospital. This study was designed to identify the factors which influence the quality of medical documentation when paper-based records are replaced with electronic records.

Methods: A set of 300 electronic medical records was randomly selected and evaluated against eleven checklists in terms of documentation of medical information, availability, accuracy and ease of use. To get the opinion of the care-providers on the electronic medical records system, ten physicians and ten nurses were interviewed by using of semi-structured guidelines. The results were also compared with a prior study with 300 paper-based medical records.

Results: The quality of documentation of the medical records was improved in areas where nurses were involved, but those parts which needed physicians' involvement were actually worse. High workloads, shortage of bedside hardware and lack of software features were prominent influential factors in the quality of documentation. The results also indicate that the retrieval of information from the electronic medical records is easier and faster, especially in emergency situations.

Conclusions: The electronic medical records system can be a good substitute for the paper-based medical records system. However, according to this study, some factors such as low physician acceptance of the electronic medical record system, lack of administrative mechanisms (for instance supervision, neglecting physicians and/or nurses in the development and implementation phases and also continuous training), availability of hardware as well as lack of specific software features can negatively affect transition from a paper-based system to an electronic system.

Objectives: How to contain medical expenditures is a universal problem. The Japanese government has increased patient co-payments to control it. The purpose of this study is to clarify whether the increase in co-payments to 30 percent prevented patients with hypertension or diabetes mellitus from receiving necessary care in the Employee Health Insurance System.

Methods: The subjects were 211 patients with hypertension and 66 patients with diabetes mellitus who regularly visited physicians from October 2001 to March 2002 and were defined as a cohort that needed health care, and their medical indicators were examined between April and September 2002 (prestage) and between April and September 2003 (poststage).

Results: In the hypertensive patients with no complications, the compliance rate was 89.9 percent and 88.0 percent in the prestage, and poststage, respectively, showing no significant change. In the hypertensive patients with complications, the compliance rate was 90.5 percent and 92.1 percent in the prestage and poststage, respectively, showing no significant change. In the diabetic patients with complications, the compliance rate was 77.5 percent and 79.2 percent, in the prestage and poststage, respectively, with no significant change. In the diabetic patients with no complications, however, the compliance rate was 83.7 percent and 66.7 percent, in the prestage and poststage, respectively. A significant decrease was observed among diabetic patients without complications.

Conclusions: Increasing co-payments reduced necessary preventive care in diabetic patients without complications.

Objectives: This study examines the content and role of ethical analysis in health technology assessment (HTA) and horizon scanning publications. It proposes that ethical analysis in HTA is of at least two different types: an ethics of HTA and an ethics in HTA.

Methods: I examine the critical differences between these approaches through the examples of the analysis of genetic screening for breast cancer and home blood glucose testing in diabetes. I then argue that, although both approaches subscribe to similar views concerning HTA and ethics, they use different theoretical and methodological traditions to interpret and explain them.

Results and Conclusions: I conclude by suggesting that we need the interpretive insights of both these approaches, taken together, to explain why ethics has not been able yet to contribute fully to HTA and to demonstrate the scope and complexity of ethical work in this domain.