An increasing number of economic evaluations are being conducted alongside clinical trials. While this practice offers the prospect of collecting comprehensive and accurate cost data, it requires considerable time and effort. In the case of clinical data, key analytic decisions such as which data to collect and sample size are often made with reference to smaller (pilot) trials. However, this approach is not normally followed in the case of economic evaluation.

This study was based on a recently completed health technology assessment comparing conventional radiotherapy with continuous hyperfractionated accelerated radiotherapy (CHART) for patients with head and neck cancer or carcinoma of the bronchus. In the full health technology assessment, cost data were available for 526 head and neck patients (314 CHART and 212 conventional therapy) and 286 bronchus patients (175 CHART and 109 conventional therapy). In order to simulate a pilot study, data were extracted for the patients recruited to both trials in the first 3 months. These were then compared with the full data set in order to assess whether such a pilot study would have given useful guidance on: a) the usefulness of undertaking a full study; b) the sample size required; and c) the important resource items for which comprehensive data collection would be required.

Pilot studies can be helpful in determining the likely advantages of undertaking full economic evaluations and in identifying important resource items. Therefore, it is important that clinical researchers and research funding bodies create the necessary time window to enable such studies to take place. However, formal sample size calculations are more difficult to perform on limited data, since they also require knowledge of the unit cost (or prices) to be attached to the resource items and the correlation between costs and clinical effects.

Although medical malpractice litigation in the United States has generated extensive professional and scholarly attention, few analyses of the issue have explored its underlying causes. This essay develops and employs an historical framework to explain the late 20th century phenomenon and concludes that widespread medical malpractice suits are the result of a combination of short-term topical causes and long-term cultural changes that are ignored or left untouched by most reform efforts. Most importantly, however, the development and proliferation of new and improved medical technologies has played a pivotal role throughout the entire history of the litigation, an effect that has become most prominent and important in the last third of the 20th century.

This article is based on the report, Anticipating and Assessing Health Care Technology, written in the Netherlands between 1985–1988. The project was carried out because of increasing concern in the Dutch Ministry of Health (STG, then WVC) about the costs and benefits of new technologies for health care. At that time, there were no established models for early identification, so the project was not only the most extensive such effort to that date, but had to develop its own methods. Overseen by a special commission, the project staff identified many future and emerging technologies in health care and assessed selected technologies. Although the actual information produced was quickly dated and the project was discontinued in 1988, it did stimulate the Ministry of Health to ask the Dutch Health Council (Gezondheidsraad) to continuously identify important new technologies. The reports also demonstrated the potential usefulness of such an effort to Dutch policy makers, and probably to those in other countries as well.

We propose a method for selecting quality-of-life instruments for use in phase III trials using the convergent validity of patient responses collected in phase I and II clinical trials.Two generic and two disease-specific instruments were administered to patients with breast cancer undergoing peripheral blood progenitor cell mobilization and transplantation. They included the visual analog scale from the EuroQoL EQ5D instrument, the SF-36, the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, and the Functional Assessment of Cancer Therapy instrument. No single instrument was found to have superior convergent validity in all domains, but the EORTC-QLQ-C30 seemed to perform better than the SF-36.

Evidence-informed patient choice involves providing people with research-based information about the effectiveness of health care options and promoting their involvement in decisions about their treatment. Although the concept seems desirable, the processes and outcomes of evidence-informed patient choice are poorly understood, and it should be carefully evaluated.

Forces from communities and from health care are pushing toward more consumer involvement in health care internationally. This article addresses the philosophies and rationales behind this trend and traces the history and development of consumer advocacy in health care.

Priority setting for the evaluation of health technologies in the Netherlands is exclusively based on the scientific merits of individual research proposals. This process has not resulted in satisfactory allocation of resources. Therefore, societal criteria for setting priorities for health technology assessment have been proposed as an adjunct to scientific criteria. These societal criteria include the burden of disease, uncertainty about the (cost-)effectiveness of the intervention at issue, the potential benefits of the research project, and its potential impact on health care. To realize the full potential of this model for priority setting, a number of methodological issues need to be addressed. Joint efforts of researchers and policy makers in this field are necessary for future progress.

The purpose of this study was to identify the determinants of choice of surgical procedure (anterior colporrhaphy, colposuspension, or needle suspension) to treat stress incontinence in women. We used multilevel modeling of data on 271 patients in 18 hospitals in England in 1993–94. Patient-related factors included sociodemographic details, anatomical diagnosis, symptom severity, symptom impact, previous treatment, parity, comorbidity, and general health status. Surgeon-related factors were specialty, grade, and annual volume of procedures undertaken. Hospital teaching status was considered. Some patient-related factors were associated with choice of procedure: women with a concomitant genital prolapse, with a history of high parity, and with no previous nonsurgical treatment were more likely to undergo an anterior colporrhaphy than a colposuspension or needle suspension (although this finding could be confounded by surgical specialty). In addition, women were more likely to be treated by colposuspension if their surgeon specialized in incontinence surgery (measured by annual volume of cases). Finally, being treated by needle suspension depended on there being a consultant surgeon familiar with the procedure at the hospital attended. While choice of surgical procedure depends partly on the patient's anatomical diagnosis, it is also dependent on the specialty of the surgeon whom she consults and the hospital that she attends. This variability, in turn, could have implications for the patient (as the relative effectiveness of the different procedures is unknown) and for the purchasers of care (as the relative cost-effectiveness of procedures is also unknown).

Current interest in early warning can be understood as a natural response to the regularity with which health service planners have been overwhelmed by new technology. Planning the rational introduction of a new technology should be facilitated by advance warning of its imminent arrival on the market. Current approaches to early warning tend to rely on the insights and expectations of scientific and clinical experts in the field in question. In this paper it is argued that such an approach fails to recognize important changes that have occurred both in the innovation process itself, and in theoretical understanding of it. With the more complex roles that governments now play, and with the increasingly articulate demands of consumers, the innovation process has become more complex. At the same time, it is now clear that the innovation process embodies a multitude of choices. Approaches to early warning must be compatible with these new perspectives.

The paper outlines the context in which patient's views have been emphasized and the evidence from survey research about the criteria users employ to evaluate health care. Evidence from qualitative research shows that users are ambivalent about modern medicine and are particularly sceptical about the value of drugs and medicine.

The objectives of the feasibility study were to evaluate sources of information for an eventual Danish system for early identification and assessment of emerging health technology, to identify potential users of the system, and to clarify their specific need for information concerning emerging health technology. The methods used were questionnaires to informants within and outside the health services and to decision makers on different levels in the health services, and follow-up telephone interviews. Our study reveals a strong, and to some extent unsatisfied, need among policy makers, planners, and managers in the Danish health services for information concerning emerging health technology. The requested information should in particular concern indication for use, number of patients affected, clinical effectiveness and side effects, running cost, and investments. The time horizon most relevant to the decision makers seems to be only zero to 2 years. Furthermore, we found that numerous sources are available that frequently display information on emerging technology important to the health services. The challenges seem to be to select information of sufficient importance and quality, and to combine information, since very few, if any, single primary sources cover all the requested information. In conclusion, we recommend the establishment of a Danish national system for early identification and assessment of emerging health technology, consisting of a small secretariat that collaborates nationally and internationally, the latter in particular on identification of technology and on development of methods for early assessment.

This review assesses the evidence regarding the effectiveness of bone density measurement (BDM) screening and related interventions—hormone replacement therapy (HRT) and intranasal salmon calcitonin (SCT[N])—in menopausal women to prevent fractures in later life. Data sources included systematic reviews of evidence and relevant primary studies identified through literature searches on MEDLINE and EMBASE. Study selection included trials of BDM screening programs, prospective studies exam-ining the predictive value of BDM, randomized controlled trials, cohort studies, and case-controlstudies of HRT and SCT(N). The evidence was evaluated using a classification system incorporatingstudy design and quality. Outcomes were measured in terms of relative risk of fracture for a 1 SDdecrease in bone mineral density below the age-adjusted mean, relative risks or odds ratios forfractures associated with treatments, and proportion of hip fractures potentially prevented by BDMscreening linked to treatments. Fair evidence from prospective cohort studies suggests that BDMcan predict the risk of fractures, but not with high accuracy. Fair evidence from low-quality randomizedcontrolled trials and observational studies suggests that HRT and SCT(N) are efficacious in preventingfractures. Good evidence supports the efficacy of these treatments in preserving bone mass, butthere is fair evidence that the effect wears off after cessation of therapy. There is little evidence onthe impact of screening menopausal women with BDM in association with HRT or SCT(N) treatment.Estimates based on combining existing evidence regarding the predictive value of BDM and efficacyof HRT suggests that 1–7% of hip fractures might be prevented.

There are inherent limitations in using assessments of patient satisfaction to make inferences about the quality of medical care. Such evaluations tend to be subjective, subject to reporting biases, and difficult to interpret when they are being used to motivate and guide quality improvement efforts. Newer methods of eliciting both reports and ratings from consumers, such as the Consumer Assessment of Health Plans (CAHPS) project, can provide reliable, valid, interpretable, and actionable data about selected aspects of health care. The use of these methods and continued use of new qualitative methods, such as cognitive interviewing, should allow us to continue increasing the prominence of consumer-based information in quality assessment and improvement efforts.

An economic evaluation of energy-absorbing flooring designed to prevent hip fractures revealed a payback period of 10½ years if only direct costs avoided were evaluated and just over 11 months when direct and indirect costs were included. Cost-effectiveness ratios of less than $0 per hip fracture prevented and life year saved were also estimated.

Health care for the elderly in Japan is financed through a pool to which all insurers contribute. We analyzed insurers' financial data to evaluate this redistribution system. Cost sharing affected financial performance substantially. The current formula for cost-sharing redistributes elderly health care costs unequally and should be changed.

As the International Human Genome Project nears the term of a long gestation, the ethical and social implications of complex new genetic technologies will require a new breed of clinicians for a safe delivery. Clinical genetic care has been time intensive as performed by medical specialists. Empowering individuals to take advantage of new opportunities for genetic testing to prevent disease will require clinician education and decision support in the context of individual values.

The purpose of this survey was to assess potential information sources for identifying new health care technologies. A three-round Delphi study was conducted, involving 38 selected experts who suggested and assessed potential sources by applying agreed criteria. Twenty-six potential information sources were considered. Timeliness, time efficiency, and sensitivity were important criteria in determining which were the most important sources. The eight recommended sources were: pharmaceutical journals, pharmaceutical and biotechnology companies, specialist medical journals, key medical journals, medical engineering companies, private health care providers, newsletters and bulletins from other health technology assessment agencies, and groups of expert health professionals. There is a need to use a combination of sources because the most useful sources will vary according to the type of technology under consideration.

This paper examines the determinants of hip fracture costs and further evaluates potential savings in costs when the occurrence of hip fracture is prevented. The costs of hip fracture are comprised of direct costs from health care and the social welfare system. Data were collected for 1,080 postmenopausal women admitted from private residence for primary hip fracture surgery during the year of 1992 in the city of Stockholm, Sweden. It was found that the cost of hip fracture is significantly related to age, mortality the year after a fracture, type of fracture, costs 1 year before a fracture, and hospital admission. The savings in direct costs for an average woman surviving the year after a fracture amount to SEK 210,000.