Automated ambulatory medical records systems (AAMRSs) have been operational for over 20 years but have not been adopted by more than a small fraction of their potential users. This paper presents a detailed analysis of the uses and benefits of the COSTAR-based AAMRS at the Harvard Community Health Plan and of the factors which have inhibited the dissemination of COSTAR. We conclude that AAMRSs have been an orphan technology and cite trends in health care that favor the future development of AAMRSs.

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.

Objectives: Australia relies on managed entry agreements (MEAs) for many medicines added to the national Pharmaceutical Benefits Scheme (PBS). Previous studies of Australian MEAs examined public domain documents and were not able to provide a comprehensive assessment of the types and operation of MEAs. This study used government documents approved for release to examine the implementation and administration of MEAs implemented January 2012 to May 2016.

Methods: We accessed documents for medicines with MEAs on the PBS between January 2012 and May 2016. Data were extracted on Anatomical Therapeutic Classification (ATC), type of MEA (financial, financial with outcomes, outcomes, and subcategories within each group), implementation and administration methods, source of MEA recommendation, and type of economic analysis.

Results: Of all medication indication pairs (MIPs) recommended for listing, one-third had MEAs implemented. Our study of eighty-seven MIPs had 170 MEAs in place. The Government's expert health technology assessment (HTA) committee recommended MEAs for 90 percent of the eighty-seven MIPs. A total of 81 percent of MEAs were simple financial agreements: the majority either discounts (32 percent) or reimbursement caps (43 percent). Outcome-based MEAs were least common (5 percent). Ninety-two percent of MEAs were implemented and operated through legal agreements. Approximately half of the MIPs were listed on the basis of accepted claims of cost-minimization. Forty-nine percent of medicines were in ATC L group.

Conclusion: Advice from HTA evaluations strongly influences the implementation of ways to manage uncertainties while providing access to medicines. The government relied primarily on simple financial agreements for the managed entry of medicines for which there were perceived risks.

Objectives: Do utility scores based on patient preferences and scores based on community preferences agree? The purpose is to assess agreement between directly measured standard gamble (SG) utility scores and utility scores from the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) systems.

Methods: Patients were assessed repeatedly throughout the process of waiting to see a surgeon, waiting for surgery, and recovery after total hip arthroplasty (THA). Group mean scores are compared using paired t-tests. Agreement is assessed using the intraclass correlation coefficient (ICC).

Results: The mean SG, HUI2, and HUI3 (SD) scores at assessment 1 are 0.62 (0.31), 0.62 (0.19), and 0.52 (0.21); n=103. At assessment 2, the means are 0.67 (0.30), 0.68 (0.30), and 0.58 (0.22); n=84. There are no statistically significant differences between group mean SG and HUI2 scores. Mean SG and HUI3 scores are significantly different. ICCs are low.

Conclusions: At the mean level for the group, SG and HUI2 scores match closely. At the individual level, agreement is poor. HUI2 scores were greater than HUI3 scores. HUI2 and HUI3 are appropriate for group level analyses relying on community preferences but are not a good substitute for directly measured utility scores at the individual leve.

Objectives: Endobronchial ultrasound (EBUS), encompassing endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and Endobronchial ultrasound transbronchial lung biopsy (EBUS-TBLB) has been proven to be a useful modality in the staging and diagnosis of lung cancer. However, there are limited publications on the cost-effectiveness of EBUS and no economic evaluations relevant to the Singapore setting. An economic evaluation using our hospital's data was used to assess the cost implications of EBUS substituting where clinically appropriate: transthoracic needle aspiration; (TTNA), fluoroscopy-guided transbronchial lung biopsy (TBLB), and mediastinoscopy in the diagnosis and staging of lung cancer.

Methods: Relationship between the clinical and economic implications of alternative modalities was modeled using data inputs that were relevant to the Singapore setting. Two decision analytic models were constructed to evaluate the cost of EBUS compared with TTNA, TBLB, and staging mediastinoscopy. Only direct costs were imputed.

Results: In the base–case analysis, TTNA was the most economical strategy (SGD3,335 = US$2,403) where clinically suitable for the diagnosis of lung cancer as compared to the other options: TBLB (SGD4,499) and EBUS-TBLB (SGD4,857). On the other hand, EBUS-TBNA resulted in expected cost savings of SGD1,214 per positive staging of lung cancer as compared to mediastinoscopy.

Conclusions: The use of EBUS-TBNA could result in cost savings of SGD1,214 per positive staging of lung cancer as compared to mediastinoscopy. Whereas TTNA was the most economical intervention for the diagnosis of lung cancer as compared to the other options, its main limitation lies in its suitability only for peripheral lung lesions and high complication rate.

This paper discusses the challenges facing health technology assessment (HTA) in Europe, based on an explicit analysis of the characteristics of an “optimal” HTA system. It has three objectives: a) to elaborate an explicit system of policy goals and the characteristics of an optimal HTA system that facilitates the achievement of these goals; b) to identify the general institutional incentive barriers (government and market failures) that prevent the attainment of an optimal HTA system in Europe; and c) to argue that evaluation of the implications of health technologies for equity and inequality in health is an essential part of this optimal system and a considerable challenge for HTA decision makers, especially as national governments realign policy toward equity goals.

Objectives: Extended-release therapies avoid the need for children with attention-deficit/hyperactivity disorder (ADHD) to take medication at school. Recently a transdermal delivery system has been developed which can allow symptom control all day long but with greater dosing flexibility. This study explored the parents' preferences regarding oral and transdermal therapy.

Methods: A nonsystematic and qualitative literature review and in-depth interviews with parents and physicians helped identify salient treatment attributes for a discrete choice experiment. Treatment attributes included mode of administration (tablet or transdermal), speed of onset (30–90 min); duration (lasts until 3–9 pm) and ability to tailor the drug to different needs (no flexibility, limited flexibility, easy to adjust to different days). A convenience sample of parents of children treated for ADHD (n = 200) were recruited using a recruitment agency. Data were analyzed using generalized estimating equations (GEE).

Results: Parents' preferred once-a-day oral therapy (odds ratio [OR] = 1.76 [95 percent confidence interval {CI}, 1.43 – 2.18]); rapid speed of onset (OR = 1.22 [95 percent CI, 1.07 – 1.39]), and symptom control until 9 pm (OR = 3.79 [95 percent CI, 2.98 – 4.82]). Analyses identified that 30 percent of parents preferred transdermal treatment and this subgroup preferred treatments with a fast onset of action.

Conclusions: This survey demonstrates that parents of ADHD children have different preferences for the ADHD treatments prescribed for their children. A distinct subgroup of parents prefer the transdermal therapy. These parents were less likely to be working and so monitoring compliance and doing after school activities may have been easier.

Objectives: A patient reported outcome (PRO) is “any report of the status of a patient's health condition that comes directly from the patient without interpretation of the patient's response by a clinician or anyone else” (USFDA 2009). PROs are discussed widely, and many regard the patients’ perspective on treatment benefit as very valuable. Although many PROs have shown satisfactory measurement properties including reliability, validity, and responsiveness, there is great concern about risk of bias, that is, in clinical trials.

Methods: Differences in perspectives of PRO measurement in rare diseases are given arising from methodology, clinical, HTA, and patient advocacy views.

Results: PROs are playing an important role in dealing with treatment benefit especially in small sample size as occurring often in rare diseases. Challenges remain especially regarding lack of responsiveness of generic measures, limited capture of all patient relevant aspects, study design and high risk of bias.

Conclusions: PROs seem a valuable instrument to detect patient relevant aspects in rare diseases. They should be seen in addition to other approved assessment methods as randomized controlled trials but not as their substitute.

Italy has a national health service (SSN) dating to 1978. Italy's system of government is characterized by a rather high degree of decentralization of power, and the health system is likewise decentralized. Most of the responsibilities for health care have been ceded to the regions. The state retains only limited coordinating and supervisory powers. The state has a financial responsibility for the national health service, but state contributions are limited and expenditures in excess of this made by the region must be financed from other sources. Health reforms of 1992–93 aimed at making the regions more sensitive to the need to control aggregate expenditure and to monitor measures to promote efficiency, quality, and citizen-patient satisfaction. The diffusion of individual health technologies has been relatively uncontrolled in many regions in Italy, although tight central constraints on capital spending have contained diffusion of new technology. Regulation of placement of services is a planning function and is the responsibility of both the Ministry of Health and the regions. Health technology assessment (HTA) activities have been expanding since the early 1990s, but these activities tend to be untargeted, uncoordinated, and without priorities. Nonetheless, the principal actors in the SSN at national, regional, and local levels are becoming more sensitive to the need to apply criteria of clinical and cost-effectiveness and to be more rigorous in deciding what services to guarantee. There are reasons to be guardedly optimistic about the future of HTA in Italy.

The papers on the 16 European countries presented in this issue show their great diversity of health systems. Health technology assessment (HTA) has been institutionalized in a number of members of the European Union and has a growing impact on health policy. A remaining challenge is to see HTA visible and useful at the European level, which requires more active coordination of national and regional activities. A network of HTA programs and researchers has been established. The HTA-Europe Steering Committee has suggested a number of actions by the European Commission to promote further coordination. The most important conclusion of the HTA-Europe report is that a permanent coordinating structure is needed at the European level.

Objectives: Magnetic resonance imaging (MRI) and computerized tomography (CT) scanners are high-tech equipment with the highest utilizations and expenditures in Taiwan. This study investigates the factors that affect MRI and CT utilization, such as whether supply-side factors have more impact than demand-side factors, and the effect of utilization control policies.

Methods: This study used the nationwide CT and MRI claim data for the years 1998 to 2001 from the Bureau of National Health Insurance (BNHI) in Taiwan. Multiple regression analysis was the statistical method used to determine the relative factors that influence CT and MRI utilization.

Results: CT : population ratio, hospital-based physician : population ratio, female ratio, pediatric (≤14 years) : population ratio, and family income significantly influenced CT utilization. MRI : population ratio and hospital-based physician : population ratio, female ratio, and family income significantly influenced MRI utilization. However, the proportion of the aged (≥65 years of age) did not significantly influence CT or MRI utilization after controlling for other factors. The rates of CT and MRI utilization for the outpatient and inpatient settings and the repeated uses of CT or MRI have decreased significantly after a utilization review was implemented by BNHI, which suggests that CT and MRI have been overused.

Conclusions: Increases in supply-side factors significantly increase CT/MRI utilization, and supply-side factors impact CT/MRI utilization more than demand-side factors. The results show that the utilization instant report policy effectively decreases repeated uses of CT/MRI.

Objectives: Several instruments for measuring health-related quality of life (HRQOL) have been developed, and others are under construction. The problem is whether the different HRQOL measures show comparable results. We first compared the functional relationship of the Nottingham Health Profile (NHP) and the 15-dimensional measure of HRQOL (15D) in hip and knee replacement patients. The hypothesis was that condition or intervention does not affect the functional relationship between NHP and 15D changes.

Methods: We assessed the agreement of the instruments by comparing observed changes in the 15D and its fitted values derived by regressing the 15D by the NHP dimensions. Patients (n = 452) were recruited consecutively from seven Finnish orthopedic departments during April 1991–May 1992. HRQOL was measured prior to surgery and 6, 12, and 24 months postoperatively.

Results: There was a different functional relationship between the HRQOL instruments in hip and knee patients; they agreed upon the direction of changes in HRQOL in 84% and showed opposite signs in 12%. The NHP showed significantly more improvement in quality of life than the 15D.

Conclusions: The two instruments were in slight but significant disagreement. Estimates of effectiveness can vary according to the instrument used. Comparisons of effectiveness in healthcare programs measured by differing instruments need information on the functional discrepancies between the instruments in the conditions and interventions in which they are applied.

Objectives: A recent study showed that estimates of cost-effectiveness submitted to National Institute for Health and Clinical Excellence (NICE) by manufacturers had significantly lower incremental cost-effectiveness ratios (ICERs) than those submitted by university-based Assessment Groups. This study extends that analysis.

Methods: Data were abstracted from relevant NICE documentation for thirty-two of eighty-two possible appraisals.

Results: The results from the analysis showed that sources of the difference in ICERs appear to be the effectiveness estimates relating to the comparator technology and the cost estimates relating to the technology under evaluation. That is, manufacturers estimated lower average benefits for the comparator technology and lower costs relating to the technology under evaluation compared with estimates submitted by the Assessment Groups.

Conclusions: These findings may be particularly important, given the introduction of the “Single Technology Appraisal.” Considerable difficulties were encountered when undertaking this study, highlighting, above all else, the complexity of explaining why results from economic evaluations purporting to answer the same question diverge.

Objectives: Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease.

Methods: Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise.

Results: Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions’ values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of “alleviating or preventing patient suffering,” “serving the whole population equitably,” “upholding healthcare system sustainability,” and “making decisions informed by evidence and context” but may help share the ethical reasoning behind decisions. Incorporating “Priorities” (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives.

Conclusions: Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.

Objectives: The objective of this study was to develop a model to assess the cost-effectiveness of a new treatment for patients with depression.

Methods: A Markov simulation model was constructed to evaluate standard care for depression as performed in clinical practice compared with a new treatment for depression. Costs and effects were estimated for time horizons of 6 months to 5 years. A naturalistic longitudinal observational study provided data on costs, quality of life, and transition probabilities. Data on long-term consequences of depression and mortality risks were collected from the literature. Cost-effectiveness was quantified as quality-adjusted life-years (QALYs) gained from the new treatment compared with standard care, and the societal perspective was taken. Probabilistic analyses were conducted to present the uncertainty in the results, and sensitivity analyses were conducted on key parameters used in the model.

Results: Compared with standard care, the new hypothetical therapy was predicted to substantially decrease costs and was also associated with gains in QALYs. With an improved treatment effect of 50 percent on achieving full remission, the net cost savings were 20,000 Swedish kronor over a 5-year follow-up time, given equal costs of treatments. Patients gained .073 QALYs over 5 years. The results are sensitive to changes in assigned treatment effects.

Conclusions: The present study provides a new model for assessing the cost-effectiveness of treatments for depression by incorporating full remission as the treatment goal and QALYs as the primary outcome measure. Moreover, we show the usefulness of naturalistic real-life data on costs and quality of life and transition probabilities when modeling the disease over time.

Objectives: The aim of this study was to assess empirically the social and ethical risks associated with implantable radio-frequency identification (RFID) devices.

Methods: Qualitative research included observational studies in twenty-three U.S. hospitals that have implemented new patient identification systems and eighty semi-structured interviews about the social and ethical implications of new patient identification systems, including RFID implants.

Results: The study identified three primary social and ethical risks associated with RFID implants: (i) unfair prioritization of patients based on their participation in the system, (ii) diminished trust of patients by care providers, and (iii) endangerment of patients who misunderstand the capabilities of the systems.

Conclusions: RFID implants may aggravate inequalities in access to care without any clear health benefits. This research underscores the importance of critically evaluating new healthcare technologies from the perspective of both normative ethics and empirical ethics.