A decision analysis was performed to assess the risks, costs, and effects of no prophylaxis, oral penicillin, and cephalexin regimens currently being debated for dental patients at risk for late prosthetic joint infection (LPJI). The analysis suggests that there is a very small risk of LPJI (29.3 cases per 106 dental visits), which is outweighed by a greater risk of death with an oral penicillin strategy than with a “no prophylaxis” strategy (2.31:1.93). An oral cephalosporin appears to spare life and limb but does so at an extremely high cost. Over $500,000 must be spent to spare one year of life, while $480,000 needs to be spent to prevent one case of LPJI. Some individual dental patients may still be at a much greater risk for LPJI than others. However, from the evidence to date, routine predental antibiotic prophylaxis for all prosthetic joint patients is a very expensive preventive strategy and is not cost-effective. However, clinical experience suggests that antibiotic prophylaxis may be appropriate in some situations.

Objectives: Traditional economic evaluations for most health technology assessments (HTAs) have previously not included environmental outcomes. With the growing interest in reducing the environmental impact of human activities, the need to consider how to include environmental outcomes into HTAs has increased. We present a simple method of doing so.

Methods: We adapted an existing clinical-economic model to include environmental outcomes (carbon dioxide [CO2] emissions) to predict the consequences of adding insulin to an oral antidiabetic (OAD) regimen for patients with type 2 diabetes mellitus (T2DM) over 30 years, from the United Kingdom payer perspective. Epidemiological, efficacy, healthcare costs, utility, and carbon emissions data were derived from published literature. A scenario analysis was performed to explore the impact of parameter uncertainty.

Results: The addition of insulin to an OAD regimen increases costs by 2,668 British pounds per patient and is associated with 0.36 additional quality-adjusted life-years per patient. The insulin-OAD combination regimen generates more treatment and disease management-related CO2 emissions per patient (1,686 kg) than the OAD-only regimen (310 kg), but generates fewer emissions associated with treating complications (3,019 kg versus 3,337 kg). Overall, adding insulin to OAD therapy generates an extra 1,057 kg of CO2 emissions per patient over 30 years.

Conclusions: The model offers a simple approach for incorporating environmental outcomes into health economic analyses, to support a decision-maker's objective of reducing the environmental impact of health care. Further work is required to improve the accuracy of the approach; in particular, the generation of resource-specific environmental impacts.

Of the four randomized controlled trials of mass mammography completed to date, the New York HIP trial used obsolete technology and was not designed to assess mammography in the absence of physical examination; the Swedish Two-County trial had serious methodological flaws; the U.K. trial was incompletely documented but showed no significant benefit; and the Malmö trial, which was perfect in design and execution, showed no benefit.

Paradoxicially, with each successive trial and an increasing sophistication of mammography, the benefit of screening was becoming not greater but less. This may be summarized by comparing the number of women who would have to be offered mammography for one breast cancer death prevented or postponed in the respective trials: 5,000 in the HIP trial, 13,000 in the Two-County trial, 18,000 in the U.K. trial, and 68,000 in the Malmä trial.

The enthusiasts in favor of mass mammography have created an atmosphere of false optimism. They have not informed the public about the very small potential benefit nor about the risks associated with screening, especially the risks of false positive diagnoses and of unnecessary surgical operations. This is an unacceptable situation, and the ethical vacuum in which population screening takes place needs to be filled with guidelines to protect women who are “targeted” for screening.

Objectives: Despite the considerable and growing body of research about the clinical effectiveness of long-term psychoanalytic treatment, relatively little attention has been paid to economic evaluations, particularly with reference to the broader range of societal effects. In this cost-utility study, we examined the incremental cost-effectiveness ratio (ICER) of psychoanalysis versus psychoanalytic psychotherapy.

Methods: Incremental costs and effects were estimated by means of cross-sectional measurements in a cohort design (psychoanalysis, n = 78; psychoanalytic psychotherapy, n = 104). Quality-adjusted life-years (QALYs) were estimated for each treatment strategy using the SF-6D. Total costs were calculated from a societal perspective (treatment costs plus other societal costs) and discounted at 4 percent.

Results: Psychoanalysis was more costly than psychoanalytic psychotherapy, but also more effective from a health-related quality of life perspective. The ICER—that is, the extra costs to gain one additional QALY by delivering psychoanalysis instead of psychoanalytic psychotherapy—was estimated at €52,384 per QALY gained.

Conclusions: Our findings show that the cost-utility ratio of psychoanalysis relative to psychoanalytic psychotherapy is within an acceptable range. More research is needed to find out whether cost-utility ratios vary with different types of patients. We also encourage cost-utility analyses comparing psychoanalytic treatment to other forms of (long-term) treatment.

Objectives: Calculations of healthcare costs rarely disclose the specific approach used to allocate the cost of hospitalizations by diagnosis. However, the type of approach used can have a major impact on the findings in the case of significant comorbidities. The present analyses compared three approaches for attributing Medicare DRG reimbursements (which were used as surrogates for average costs) for hospitalization by diagnosis.

Methods: Medical resource utilization data from the National Hospital Discharge Survey were analyzed using each of three allocation approaches: a) attributing 100% of the cost of hospitalization to the disease when it was the first-listed diagnosis; b) attributing a portion of the cost of hospitalization to the disease, depending on its position in the list of diagnoses and the relevance of any comorbidities; and c) an incremental analysis of cost based upon the hospitalization experiences of an age and gender matched cohort. These three approaches were applied to the cost of hospitalization for chronic obstructive pulmonary disease (COPD).

Results: The first approach projected 206,098 hospitalizations at $3,449 per hospitalization for a projected U.S. annual total of $711 million. The second approach projected 681,547 hospitalizations at $3,205 per hospitalization for a projected U.S. annual total of $2.2 billion. The third approach also projected 681,547 hospitalizations, but at $2,361 per hospitalization, for a projected U.S. annual total of $1.6 billion.

Conclusions: Expanding from the example on COPD, the limitations of each approach are described and their applications to other conditions are presented.

Objectives and Methods: Many authors have argued that ethical, legal, and social issues (“ELSIs”) should be explicitly integrated into health technology assessment (HTA), yet doing so poses challenges. This discussion may be particularly salient for technologies viewed as ethically complex, such as genetic screening. Here we provide a brief overview of contemporary discussions of the issues from the HTA literature. We then describe key existing policy evaluation frameworks in the fields of disease screening and public health genomics. Finally, we map the insights from the HTA literature to the policy evaluation frameworks, with discussion of the implications for HTA in genetic screening.

Results and Conclusions: A critical discussion in the HTA literature considers the definition of ELSIs in HTA, highlighting the importance of thinking beyond ELSIs as impacts of technology. Existing HTA guidance on integrating ELSIs relates to three broad approaches: literature synthesis, involvement of experts, and consideration of stakeholder values. The thirteen key policy evaluation frameworks relating to disease screening and public health genomics identified a range of ELSIs relevant to genetic screening. Beyond straightforward impacts of screening, these ELSIs require consideration of factors such as the social and political context surrounding policy decisions. The three broad approaches to addressing ELSIs described above are apparent in the screening/genomics literatures. In integrating these findings we suggest that the method chosen for addressing ELSIs in HTA for genetic screening may determine which ELSIs are prioritized; and that an important challenge is the lack of guidance for evaluating such methods.

A decision analytic model often comprises a significant part of a health technology assessment. As health technology assessment in the hospital setting evolves, there is an increased need for modeling methods that account for patient care pathways and interactions between patients and their environment. For example, an evaluation of a computed tomography (CT) scanner for a new indication would need to consider the current and increased demand of the machine and how that may affect service in other areas of the hospital. This problem solving approach views “problems” through a systems perspective.

Objectives: The objective of this study is to describe the frequency of inappropriate empirical antibiotic therapy in secondary intra-abdominal infection and to identify the possible relationship between inappropriateness and some clinical outcomes.

Methods: A retrospective descriptive multicenter study was conducted using hospital secondary databases developed at two university hospitals located in northeast Spain. Participants were patients 18 years of age or older who were diagnosed with community-acquired intra-abdominal infections between January 1, 1998, and December 31, 2000, identified through computerized patient records using ICD-9 codes. Appropriateness of empirical treatment was defined according to the recommendations of the literature. The clinical outcome of each patient was classified as one of the following: (i) resolved with initial therapy, (ii) required second-line antibiotics, (iii) required re-operation, or (iv) in-hospital death. The Fisher's exact test or the Chi-squared test for categorical variables and the t-test or Mann–Whitney test for continuous variables were used for comparing groups. Conditional logistic and linear regression analyses were also applied.

Results: Of 376 cases, 51 cases (13.6 percent, 95 percent confidence interval, 10–17 percent) received inappropriate empirical antibiotic therapy according to the scientific literature. Inappropriate initial empirical treatment was significantly associated with the need for a second line of antibiotics (p<.001), although not with re-operation, mortality, or length of hospitalization.

Conclusions: Approximately 14 percent of the patients received inappropriate empirical antibiotic treatment. Worse clinical outcomes consistently were observed in the group of patients receiving inappropriate empirical treatment. The appropriateness of antibiotic treatment for a given infection, in light of the availability of clearly defined clinical guidelines is an easily evaluated aspect of the quality of care.

Objectives: To compare methods and results among four health technology assessment organizations in different countries.

Methods: All assessment reports published between 1999 and 2001 by VATAP (United States), NICE (United Kingdom), CCOHTA (Canada), and AETS (Spain), were reviewed. Detailed information about the organization, the technology assessed, the methods used, and the recommendations made were collected. A descriptive analysis of the variables, as well as comparisons of means and proportions, was performed.

Results: Sixty-one reports assessing seventy-six technologies were published: nine (11.8 percent) by VATAP, thirty-nine (51.3 percent) by NICE, twenty (26.3 percent) by CCOHTA, and eight (10.5 percent) by AETS. A total of 64.5 percent of the technologies assessed were related to a high prevalence disease in the corresponding country. Most of the assessments addressed treatments (73.7 percent) and were mostly drugs (56.6 percent) and devices (23.7 percent). Most organizations used reviews of effectiveness and economic evaluations (64.5 percent), systematic reviews (21.1 percent), and original economic evaluations (36.7 percent). In 38.1 percent, the technology was recommended; the rest of the cases had no formal recommendations.

Conclusions: Critical issues for future technology assessment efforts are making assessment processes more consistent, transparent, and evidence-based; formalizing the inclusion of economic and ethical considerations; and making more explicit the prioritization process for selecting technologies for assessment and reassessment.

Objectives: The aim of this study was to explore stakeholders’ points of views regarding the applicability and relevance of a framework for user involvement in health technology assessment (HTA) at the local level. We tested this framework in the context of the assessment of alternative measures to restraint and seclusion among hospitalized adults and those living in long-term-care facilities.

Methods: Twenty stakeholders (health managers, user representatives, and clinicians) from seven regions of Quebec participated in a semi-structured interview. A thematic analysis of the transcribed interviews was performed.

Results: The findings highlighted the relevance and applicability of the framework to this specific HTA. According to interviewees, direct participation of users in the HTA process allows them to be part of the decision-making process. User consultation makes it possible to consider the views of a wide variety of people, such as marginalized and vulnerable groups, who do not necessarily meet the requirements for participating in HTA committees. However, some user representatives emphasized that user consultation should be integrated into a more holistic and participatory perspective. The most frequent barrier associated with user involvement in HTA was the top-down health system, which takes little account of the user's perspective.

Conclusions: The proposed framework was seen as a reference tool for making practitioners and health managers aware of the different mechanisms of user involvement in HTA and providing a structured way to classify and describe strategies. However, there is a need for more concrete instruments to guide practice and support decision making on specific strategies for user involvement in HTA at the local level.

Objectives: Immune thrombocytopenia (ITP) causes increased platelet destruction and suboptimal platelet production, increasing risk of bleeding. This analysis uses a Bayesian metaregression model to indirectly compare effectiveness of the thrombopoietin mimetics romiplostim and eltrombopag for increasing platelet counts, and contrasts the results with those of non-Bayesian approaches.

Methods: Ten databases were searched during 2010. Placebo-controlled trials of 24 weeks’ duration were included. An indirect comparison was undertaken using Bayesian metaregression, which includes all trials in a single model. This was compared with previous analyses in which data for each intervention were combined using simple pooling, logistic regression or meta-analysis, followed by indirect comparison of pooled values using the Bucher method.

Results: Two trials of romiplostim and one of eltrombopag were included. The indirect evidence suggests romiplostim significantly improves overall platelet response compared with eltrombopag. Bayesian metaregression gave an odds ratio (OR) for eltrombopag versus romiplostim of 0.11 (95 percent credible interval 0.02–0.66); p values and Bayesian posterior probabilities ranged from 0.01 to 0.05 for all analyses. There was no significant difference in durable platelet response in any of the analyses, although the direction of effect favored romiplostim (OR = 0.15; 95 percent credible interval, 0.01–1.88); p values and Bayesian posterior probabilities ranged from 0.08 to 0.40 across analyses. Results were relatively consistent between analyses.

Conclusions: Bayesian metaregression generated similar results to other indirect comparison methods, and may be considered the most robust as it incorporates all data in a single model and accounts appropriately for parameter uncertainty.

Cataract is the most common reason for visual problems in old age. The introduction of intraocular lens (IOL) implantation revolutionized cataract surgery. Since the IOL technique was established in Sweden in the early 1980s, the demand for surgery has been increasing, leading to lengthy waiting lists. To shorten some of the most troublesome waiting lists, national and local governments (county councils) in Sweden introduced a maximum waiting time guarantee in 1992. The assessment of the guarantee made in this article shows that ophthalmic surgery units vary in their adoption of the guarantee, leading to different levels of goal achievement in waiting times for their patients. The less successful units could be divided into two groups: one where the units have a low operation rate, and one where the units chose not to follow the recommendations in priority setting made in the guarantee.

Background: The Alberta Hip and Knee Replacement Project developed a new evidence-based clinical pathway (NCP) for total hip (THR) and knee (TKR) replacement. The aim was to facilitate the delivery of services in a timely and cost-effective manner while achieving the highest quality of care for the patient across the full continuum of care from patient referral to an orthopedic surgeon through surgery, recovery, and rehabilitation. The purpose of this article is to provide an overview of the study design, rationale, and execution of this project as a model for health technology assessment based on comparative effectiveness of alternative clinical pathways.

Methods: A pragmatic randomized controlled trial study design was used to evaluate the NCP compared with the standard of care (SOC) for these procedures. The pragmatic study design was selected as a rigorous approach to produce high quality evidence suitable for informing decisions between relevant interventions in real clinical practice. The NCP was evaluated in three of the nine regional health authorities (RHAs) in Alberta with dedicated central intake clinics offering multidisciplinary care teams, constituting 80 percent of THR and TKR surgeries performed annually in Alberta. Patients were identified in the offices of twenty orthopedic surgeons who routinely performed THR or TKR surgeries. Evaluation outcome measures were based on the six dimensions of the Alberta Quality Matrix for Health (AQMH): acceptability, accessibility, appropriateness, effectiveness, efficiency and safety. Data were collected prospectively through patient self-completed questionnaires at baseline and 3 and 12 months after surgery, ambulatory and inpatient chart reviews, and electronic administrative data.

Results: The trial design was successful in establishing similar groups for rigorous evaluation. Of the 4,985 patients invited to participate, 69 percent of patients consented. A total of 3,434 patients were randomized: 1,712 to SOC and 1,722 to the NCP. The baseline characteristics of patients in the two study arms, including demographics, comorbidity as measured by CDS and exposure to pain medications, and health-related quality of life, as measured by Western Ontario and McMaster Universities Osteoarthritis Index and Short Form-36, were similar.

Conclusions: The Alberta Hip and Knee Replacement Project demonstrates the feasibility and advantages of applying a pragmatic randomized controlled trial to ascertain comparative effectiveness. This is a model for health technology assessment that incorporates how clinical pathways can be effectively evaluated.

Objectives: We were interested in health coverage in women's magazines in the United States and how it compared with articles in medical journals, women's health interests, and women's greatest health risks.

Methods: We examined 12 issues of Good Housekeeping (GH) and Woman's Day (WD) and 63 issues of the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA). We tallied the most common health questions of women presenting to the University of Michigan's Women's Health Resource Center (WHRC) during the same period.

Results: Less than a fifth of the magazine articles dealt with health-related topics. Of those, a third dealt with diet, with the majority emphasizing weight loss rather than eating for optimal health. Few of the articles cited research studies, and even fewer included the name of the journal in which the study was published. In JAMA and NEJM, less than one-fifth of original research studies dealt with women's health topics, most commonly pregnancy-related issues, hormone replacement therapy, breast and ovarian cancer, and birth defects. At the same time, the most common requests for information at the WHRC related to pregnancy, fertility, reproductive health, and cancer.

Conclusion: The topics addressed in women's magazines do not appear to coincide with the topics addressed in leading medical journals, nor with women's primary health concerns or greatest health risks. Information from women's magazines may be leading women to focus on aspects of health and health care that will not optimize risk reduction.

Objectives: A systematic review of the cost-effectiveness of abdominal aortic aneurysm (AAA) repair was conducted. Although open surgery has been considered the gold standard for prevention of AAA rupture, emerging less-invasive endovascular treatments have led to increased interest in evaluating the cost and cost-effectiveness of treatment options.

Methods: A systematic review of studies published in MEDLINE between 1999 and 2005 reporting the cost and/or cost-effectiveness of endovascular and/or open surgical repair of nonruptured AAAs was conducted. Case series studies with less than fifty patients per treatment were excluded.

Results: Of twenty eligible articles, three were randomized controlled trials, twelve case series, four Markov models, and one systematic review. Regardless of time frame, all studies found that endovascular repair costs more than open surgery. Although the high cost of the endovascular prosthesis was partially offset by reduced intensive care, hospital length of stay, operating time, blood transfusions, and perioperative complications, hospital costs were still greater for endovascular than open surgical repair. For patients medically fit for open surgery, mid-term costs were greater for endovascular repair with no difference in overall survival or quality of life. For patients medically unfit for open surgery, endovascular repair costs more than no intervention with no difference in survival.

Conclusions: Although conclusions regarding the cost-effectiveness of AAA treatment options are time dependent and vary by institutional perspective, from a societal perspective, endovascular repair is not currently cost-effective for patients with large AAA regardless of medical fitness.

Objectives: The European Code Against Cancer recommends individuals aged ≥50 should participate in colorectal cancer screening. CT-colonography (CTC) is one of several screening tests available. We systematically reviewed evidence on, and identified key factors influencing, cost-effectiveness of CTC screening.

Methods: PubMed, Medline, and the Cochrane library were searched for cost-effectiveness or cost-utility analyses of CTC-based screening, published in English, January 1999 to July 2010. Data was abstracted on setting, model type and horizon, screening scenario(s), comparator(s), participants, uptake, CTC performance and cost, effectiveness, ICERs, and whether extra-colonic findings and medical complications were considered.

Results: Sixteen studies were identified from the United States (n = 11), Canada (n = 2), and France, Italy, and the United Kingdom (1 each). Markov state-transition (n = 14) or microsimulation (n = 2) models were used. Eleven considered direct medical costs only; five included indirect costs. Fourteen compared CTC with no screening; fourteen compared CTC with colonoscopy-based screening; fewer compared CTC with sigmoidoscopy (8) or fecal tests (4). Outcomes assessed were life-years gained/saved (13), QALYs (2), or both (1). Three considered extra-colonic findings; seven considered complications. CTC appeared cost-effective versus no screening and, in general, flexible sigmoidoscopy and fecal occult blood testing. Results were mixed comparing CTC to colonoscopy. Parameters most influencing cost-effectiveness included: CTC costs, screening uptake, threshold for polyp referral, and extra-colonic findings.

Conclusion: Evidence on cost-effectiveness of CTC screening is heterogeneous, due largely to between-study differences in comparators and parameter values. Future studies should: compare CTC with currently favored tests, especially fecal immunochemical tests; consider extra-colonic findings; and conduct comprehensive sensitivity analyses.

Objectives: The aim of this study was to obtain information on rapid health technology assessments (HTAs) prepared by members of the International Network of Agencies for Health Technology Assessment (INAHTA).

Methods: A questionnaire was prepared, drawing on earlier INAHTA documents for recording HTA impact. A request for responses was sent to member agencies, seeking information on rapid HTA reports prepared during 2006.

Results: Responses were provided on fifteen rapid HTAs, which covered both new and widely distributed technologies. The most common purpose for the HTAs (n = 8) was to inform coverage decisions, but other reasons included capital funding, formulary decisions, referral for treatment, program operation, guideline formulation, influence on routine practice, and indications for further research. All the rapid HTAs were considered by the agencies to have had some influence. The most common indications of influence were consideration by the decision maker, use of the HTA as reference material (both n = 10), and acceptance of recommendations or conclusions (n = 8).

Conclusions: Rapid HTAs are used for a broad range of technologies, to inform several types of decision, and are effective in informing the decision-making process. Supplementation of their findings by further assessments will be appropriate in some cases.

Objective: The objective of this paper is to determine prevalence and characteristics of acute care for elders (ACE) units and hospital characteristics associated with the presence of an ACE unit.

Methods: Data on characteristics and prevalence of ACE units were obtained by surveying all established geriatric medical divisions across U.S. medical schools. Data on hospital characteristics such as number of beds, revenue, number of Medicare inpatients, and average length of stay were obtained from the 1999 American Hospital Association Annual Survey Data. Descriptive statistics and t test were used to analyze the characteristics of ACE units. Stepwise logistic regression was used to analyze the hospital characteristics associated with the presence of an ACE unit.

Results: The survey identified 16 geriatric divisions and programs with ACE units. Hospitals that have ACE units differ significantly with respect to number of beds and total revenue, compared with institutions that do not have an ACE unit. Stepwise logistic regression indicated total hospital revenue was the only factor significantly associated with the presence of an ACE unit.

Conclusions: ACE units are attractive interdisciplinary models to address the particular needs of the elderly during their hospital stay. Low presence of ACE units warrants further research as to reasons more hospitals have not included them, given the available evidence for clinical, functional, and economic benefits.

Objectives: Health services research is a typical instance of applied research, meaning that its research findings should contribute to a more evidence-based health policy. A basic assumption for the usefulness of policy research is that it is of good scientific quality, but evaluation of health services research would be incomplete without an assessment of its societal relevance. However, there is no generally accepted framework in which criteria to assess societal relevance are defined.

Methods: In this study, we made an effort to specify criteria and indicators for policy relevance.

Results and Conclusions: In general, we concluded that it is important to define from the start of a research project, what kind of answers are being sought to the questions at hand, who the intended users of these answers will be, and how they can be reached. Furthermore, a productive dialogue between researchers and policy makers is indispensable for remaining in tune with policy thinking. In addition, we specified domains and a list of potential criteria for assessing policy relevance. For the purpose of quality assurance, these criteria have to be integrated into a quality improvement cycle. This means that the societal output of health services research should be related to the aims and missions at the level of projects, programs, and institutes. Furthermore, it is important that consensus is reached about (the weighting of) relevant indicators and that routines are developed for collecting information on these indicators.