Objectives: The purpose of this study is to compare the approaches used for valuing family caregiver and care recipient time devoted to providing and receiving care.

Methods: Valuation approaches were operationalized within a cohort of cystic fibrosis care recipients (n = 110). Base-case analyses, grounded in human capital theory, applied earnings estimates to caregiving time to impute the market value of time lost from labor. Unpaid labor and leisure time was valued with a replacement cost (homemaker's wage rate). Total time costs were computed and sensitivity analyses were conducted to describe the effects of alternative valuation methods on total costs.

Results: The mean time cost per care recipient–caregiver dyad over 28 days was $2,026CAD. The majority (76 percent) of time costs were due to losses from unpaid labor and leisure time. Varying the valuation of paid labor time did not result in significantly different total time costs (p = .0877). However, varying the method of valuing unpaid labor and leisure time did significantly affect total costs (p < .0001).

Conclusions: Care recipients and caregivers primarily lost time from unpaid labor and leisure in the treatment of cystic fibrosis. Moreover, when the above losses were aggregated, the method of valuation greatly influenced overall results. The findings clearly indicate that omitting caregiver and unpaid labor and leisure costs may result in an inaccurate assessment of ambulatory and home-based healthcare programs.

Objectives: This study describes the diffusion of advanced diagnostic devices in India and assess implications for efficiency in resource use and equity.

Methods: Commodity-level import statistics, household survey data, and interviews with medical device sellers are used to assess the spread of diagnostic devices. Published qualitative evidence, case studies of diagnostic service providers, and cross-country analyses are used to identify the reasons underlying the spread of medical devices in India. Case studies of public and private providers and data from 150 hospitals in one Indian state are used to assess efficiency in resource use and the distributive impacts of diagnostic devices.

Results: High-end medical device inflows rose during the 1990s, with both supply- and demand-side factors influencing this trend. Although our results suggest that the overall quantity of advanced diagnostics in India is not excessive, there is some evidence of inefficiency in public facilities and possibly unethical practices in private diagnostic facilities. The unequal geographical distribution of magnetic resonance imaging facilities, coupled with inefficient use of medical devices in public facilities suggests inequality in access.

Conclusions: The study points to major regulatory gaps and health system inefficiencies and suggests ways in which these gaps can be addressed.

Objectives: There is relatively little evidence on the test–retest reliability of utility scores derived from multiattribute measures. The objective was to estimate test–retest reliability for Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) utility scores in patients recovering from hip fracture.

Methods: We enrolled an inception cohort of hip fracture patients within 3 to 5 days of surgery. Baseline assessments included the Functional Independence Measure (FIM™), Folstein Mini-Mental State Examinations, and the HUI2 and HUI3 questionnaire. Follow-up assessments at 1, 3, and 6 months also included a global change question. Test–retest reliability was assessed as agreement between 3- and 6-month scores using the intraclass correlation coefficient (ICC). Two approaches were used to classify patients as stable; a third approach based on the generalizability theory was also used. Patients were classified as stable if their FIM™ overall scores changed by 10 points or fewer and if they classified themselves as having experienced no or only a little change according to their global change question.

Results: Complete data at both the 3- and 6-month assessments based on self-report were available for 196 patients; 141 patients with complete data were classified as stable. The ICCs for HUI2 and HUI3 for stable patients were 0.71 and 0.72; the ICCs derived from the generalizability theory were 0.76 and 0.77.

Conclusions: Test–retest reliability for HUI in this cohort was similar to reliability estimates for other preference-based multiattribute and generic health-profile measures—in the acceptable range for making valid group-level comparisons.

Objectives: Even when policy makers show interest and evidence-informed and convincing HTA studies are available, use of assessment products is not guaranteed. In this article, we report our experience with knowledge brokering to foster evidence-informed policy making on cost-effective treatment and reimbursement of assisted reproduction in The Netherlands.

Methods: From earlier work in the field of knowledge brokering, we foresaw the need for a deliberative strategy to manage the inherent tension between scientific rigor demanded by researchers and responsiveness to real-time needs demanded by policy makers. Therefore, we structured the process in three distinct steps: (i) agreement about the main messages from the research, (ii) analysis of the policy context and of the meaning of the main messages for the actors involved, and (iii) an invitational meeting to make recommendations for action.

Results: One of the recommendations that would require changes in ministerial policy was followed up instantly, whereas the other recommendation is still under debate. The Dutch Society of Obstetrics and Gynecology activated the revision of two guidelines. The patient organization uses the new scientific insights in informing members and the public. Closing the loop, The Netherlands Organisation for Health Research and Development (ZonMw) funded research to close knowledge gaps that became apparent in the process.

Conclusions: Knowledge brokering is a promising approach to bring HTA into practice. We conclude that the methodologies to feed research results into the policy process are still in an incipient stage and need further development.

This paper explores the characteristics of health technology assessment (HTA) systems and practices in Asia. Representatives from nine countries were surveyed to understand each step of the HTA pathway. The analysis finds that although there are similarities in the processes of HTA and its application to inform decision making, there is variation in the number of topics assessed and the stakeholders involved in each step of the process. There is limited availability of resources and technical capacity and countries adopt different means to overcome these challenges by accepting industry submissions or adapting findings from other regions. Inclusion of stakeholders in the process of selecting topics, generating evidence, and making funding recommendations is critical to ensure relevance of HTA to country priorities. Lessons from this analysis may be instructive to other countries implementing HTA processes and inform future research on the feasibility of implementing a harmonized HTA system in the region.

Objectives: Promoting the adoption of clinical practice guidelines is a challenging task. Research shows that adopters' beliefs about guidelines and the process of their development are important predictors of guideline use. Our objective is to report on the development and refinement of an instrument designed to measure oncologists' assessments of guidelines in oncology.

Method: A theoretically derived instrument was drafted. Oncologists were asked to complete a questionnaire for each draft guideline they were asked to review. Factor analyses and multilevel modeling techniques were undertaken to explore the properties of the instrument and refine it.

Results: A total of 488 Ontario clinicians were sent 1,494 new questionnaires regarding 34 clinical practice guidelines produced between 1999 and 2002. A refined eighteen-item questionnaire with four stable factors that predicted 60 percent of the variance emerged. The factors are interpreted as guideline quality, applicability, acceptability, and comparative value. The four factors predicted oncologists' endorsements of draft guidelines and, with the exception of quality, predicted their intentions to use the guidelines. As expected, variation in the factor scores could be attributed more to the differences among the oncologist who completed the survey than to the differences among the guidelines themselves.

Conclusions:An instrument composed of four stable and theoretically relevant factors emerged. The findings support the hypothesis that beliefs about guideline attributes and development attributes relate to oncologists' endorsement of and intentions to use guidelines. Our next step is to link the responses of the survey with actual clinical behavior.

Diabetic retinal disease remains a leading cause of visual disability among those of working age. Controlled trials have demonstrated that timely diagnosis and photocoagulation treatment can reduce significantly the likelihood of visual impairment in affected diabetic patients. Using a prospective simulation model, we show that an annual screening and treatment program saves thousands of years of vision and reduces medical expenditures over the lifetime of a cohort of Swedish Type I diabetic patients.

Healthcare policy, medical practice, and cost of care are no longer considered distinct entities. Each is an integral factor in determining not only what, but how, patient care will be delivered. Clinical practice guidelines are the lynchpin that connects them. This paper addresses the various components of the clinical practice guideline—cost alliance.

Objective: To examine the bidirectional influence of choice of care on costs and of cost of care on decision making.

Methods: The literature was used to identify cost-related factors that influence development of guidelines and change in physician practice behavior. In a MEDLINE search with modifiers to the keywords “clinical practice guidelines,” particular attention was paid to identifying surveys of practitioners. An analysis, prompted by a recently published guideline, of treating penetrating intraperitoneal colon injuries by different surgical approaches (primary repair versus diverting colostomy) exemplified how implementation of a guideline can affect the cost of care. Inpatient cost estimates, adjusted for medical inflation and cost-to-charge ratios and reported in 1999 U.S. dollars, were developed using data from 1996 and 1997 discharge databases from California and Massachusetts.

Results: The results showed that a substantial savings in hospital costs was achieved when a primary repair surgical technique, as advocated by the guideline, was used. The effect of cost influences on the development of clinical practice guidelines was established by demonstrating the cyclical effect between usual and customary practices, guideline implementation, changing practice patterns, and the economic considerations influencing the process.

Conclusions: A growing, albeit uneasy, alliance between costs and clinical practice guidelines is evident.

Objectives: Depression is associated with high healthcare utilization and related costs. Effective treatments might reduce the economic burden. The objective of this study was to establish the cost-utility of a minimal psychological intervention (MPI) aimed at reducing depression and improving quality of life in elderly persons with diabetes or chronic obstructive pulmonary disease and co-occurring minor, mild, or moderate depression.

Methods: Trial-based cost-utility analysis was used to compare the MPI with usual care. Annual costs and quality-adjusted life-years (QALYs) based on the Euroqol (EQ5D) and on depression-free days were calculated.

Results: Annual costs and effects were not significantly different for the MPI group and care as usual. Bootstrap analysis indicated a dominant intervention, with a probability of 63 percent that the MPI is less costly and more effective than usual care.

Conclusions: The cost-effectiveness analysis does not support dissemination of the MPI in its current form. The economic evaluation study showed limited probability that MPI is cost-effective over usual care. Further adjustments to the MPI are needed to make the intervention suitable for dissemination in regular care. Trial registration: isrctn.org, identifier: ISRCTN92331982.

Objectives: This study compared the relative cost-effectiveness of daily recombinant human deoxyribonuclease (rhDNase), with alternate day rhDNase and hypertonic saline (HS) for treating children with cystic fibrosis (CF).

Methods: A randomized controlled trial with a crossover design allocated 40 CF children consecutively to 12 weeks of daily rhDNase, alternate day rhDNase, or HS. The primary outcome measure was forced expiratory volume in 1 second (FEV1), a measure of lung function. All health resource use was prospectively documented for each patient and multiplied by unit costs to give a total health service cost for each 12-week treatment period. The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves and net benefit statistics for each treatment comparison, for various hypothetical levels of the decision maker's ceiling ratio.

Results: Compared with HS, there was a 14% improvement in FEV1 for daily rhDNase (95% CI, 5% to 23%), and a 12% improvement (95% CI, 2% to 22%) for alternate day rhDNase. For a ceiling ratio of £200 per 1% gain in FEV1, the mean net benefits of daily and alternate day rhDNase compared with HS were £1,158 (95% CI, −£621 to 2,842) and £1,188 (95% CI, −847 to 3,343), respectively; the mean net benefit of daily compared with alternate day rhDNase was *minus;£30 (95% CI, −£2,091 to 1,576).

Conclusions: If decision makers are prepared to pay £200 for a 1% gain in FEV1 over a 12-week period, then on average either rhDNase strategy is cost-effective.

Objectives: We conducted a systematic review of quantitative research regarding patients’ preferences, perspectives and values for ventilation among chronic obstructive pulmonary disease (COPD) patients. Our objective was to explore the feasibility and desirability of incorporating patient preferences within the health technology assessment (HTA) process by working through a case study.

Methods: Medical and economic databases were searched for studies published in English from 1990 through March 4, 2011. Studies were selected based on title and abstract. Due to the heterogeneity of the studies, data were analyzed using a narrative synthesis approach.

Results: Among 1833 identified citations, twelve studies met our inclusion criteria. Ten of these studies pertained to COPD patient preferences for ventilation. Results indicate that a significant proportion of COPD patients are willing to forgo ventilation, particularly when it is expressed as “indefinite life support” (60–78 percent) rather than as temporary modality. Results indicate that patient preferences for mechanical or noninvasive ventilation cannot be predicted by covariates (e.g., age, quality of life) or by others who are frequently called upon to make decisions are their behalf.

Conclusions: We found that it is indeed feasible to conduct a systematic review of quantitative preference-related evidence for an HTA topic. However, the process of conducting this preference-related case study also revealed several challenges because there is a high degree of variation in taxonomy, instrumentation, and study design. Therefore, we do not recommend it as a routine part of the HTA process, but we suggest that it is a promising area to pursue for preference-sensitive technological decisions.

Objectives: The aim of this study was to illustrate the contribution of stakeholder engagement to the impact of health technology assessment (HTA) using an Irish HTA of a national public access defibrillation (PAD) program.

Background: In response to draft legislation that proposed a PAD program, the Minister for Health requested that Health Information and Quality Authority undertake an HTA to inform the design and implementation of a national PAD program and the necessary underpinning legislation. The draft legislation outlined a program requiring widespread installation and maintenance of automatic external defibrillators in specified premises.

Methods: Stakeholder engagement to optimize the impact of the HTA included one-to-one interviews with politicians, engagement with an Expert Advisory Group, public and targeted consultation, and positive media management.

Results: The HTA quantified the clinical benefits of the proposed PAD program as modest, identified that substantial costs would fall on small/medium businesses at a time of economic recession, and that none of the programs modeled were cost-effective. The Senator who proposed the Bill actively publicized the HTA process and its findings and encouraged participation in the public consultation. Participation of key stakeholders was important for the quality and acceptability of the HTA findings and advice. Media management promoted public engagement and understanding. The Bill did not progress.

Conclusions: The HTA informed the decision not to progress with legislation for a national PAD program. Engagement was tailored to ensure that key stakeholders including politicians and the public were informed of the HTA process, the findings, and the advice, thereby maximizing acceptance. Appropriate stakeholder engagement optimizes the impact of HTA.

The National Health Service (NHS) provides universal health coverage for all British citizens. Most services are free of charge, although modest copayments are sometimes applied. About 11% of the population also has private insurance. General practitioners, generally the first point of contact for accessing the system, are independent contractors who serve as gatekeepers for specialist and hospital services and enjoy substantial clinical autonomy. Hospitals are public and are regionalized, but the 1990 reforms made them self-governing trusts that contract with local purchasers (health authorities and general practitioner fundholders). Reforms beginning in 1990 moved the NHS away from a centralized administrative structure to more pluralistic arrangements in which competition, as well as management, influences how services develop. Health technology and health technology assessment (HTA) have gained increasing attention in the NHS during this period, as part of a wider NHS Research and Development (R&D) Strategy. The strategy promotes a knowledge-based health service with a strong research infrastructure and the capacity to critically review its own needs. HTA is the largest and most developed of the programs within the strategy. It has a formal system for setting assessment priorities involving widespread consultation within the NHS, and a National Co-ordinating Centre for Health Technology Assessment. The stategy supports related centers such as the U.K. Cochrane Centre and the NHS Centre for Reviews and Dissemination. A hallmark of the HTA program is strong public participation. The United Kingdom has made a major commitment to HTA and to seeking effective means of reviewing and disseminating evidence.

Objectives: Interventions to support patient self-care of their condition aim to improve patient health and reduce health service costs. Consequently, they have attracted considerable policy interest. There is some evidence of clinical effectiveness but less attention has been paid to whether these interventions are cost-effective. This study examines the quality and quantity of existing evidence of the cost-effectiveness.

Methods: A systematic review was carried out to assess the extent and quality of economic evaluations of self-care support interventions. Thirty-nine economic evaluations were assessed against a quality checklist developed to reflect the special features of these interventions.

Results: The majority of the studies claimed that self-care support interventions were cost-effective or cost saving. The overall quality of economic evaluations was poor because of flaws in study designs, especially a narrow definition of relevant costs and short follow-up periods.

Conclusions: The current evidence base does not support any general conclusion that self-care support interventions are cost-effective, but ongoing trials may provide clearer evidence.

Objectives: The objective of this study is to review the implementation of health technology assessment (HTA) at the local and hospital levels in low- and middle-income countries (LMIC). This review will provide a starting point for identifying the conditions for HTA implementation in hospitals in LMIC through the analysis of experiments conducted in these countries.

Methods: A systematic review of the literature was conducted to document the local-/hospital-level HTA experiments performed in LMIC.

Results: This systematic review showed that few experiments of local HTA in LMIC have been published to date, with only five articles found in our survey. These documents report studies of clinical effectiveness and economic evaluation at the local level in certain Asian and Latin American countries. In addition, pharmaceuticals and medical devices were the most common topics covered by HTA at the local level in these countries.

Conclusions: Currently, HTA plays an increasingly important role in healthcare systems in supporting decision making for healthcare policies and practices. This systematic review contributes to identify priorities in the process and methodology of HTA implementation at the local/hospital level in LMIC. The paucity of HTA in LMIC is often assumed to be due to the lack of formally tasked HTA agencies, to politics and to shortage of resources.

Objectives: The aim of this study was to critically examine the current guidance for conducting ethics analysis in health technology assessment (HTA) and to offer recommendations for how to improve this practice.

Methods: MEDLINE, Philosopher's Index, and Google Scholar were searched for articles and reports using the keywords “ethics” and “health technology assessment” and related terms. Bibliographies of all relevant articles were also examined for additional references. A philosophical analysis of the existing guidance was conducted.

Results: We offer three recommendations for improving ethics analysis in HTA. First, ethical and legal issues must be clearly separated so that all policy-relevant questions that the technology raises can be considered clearly and systematically. Second, analysts must make better use of ethics theory and discuss better how particular theoretical approaches and associated analytic tools are selected to make transparent which alternative approaches were considered and why they were rejected. Third, the necessity for philosophical expertise to adequately conduct ethics analysis needs to be acknowledged.

Conclusions: To act on these recommendations for ethics analysis, we offer these three steps forward: acknowledge and use relevant expertise, further develop models for conducting and reporting ethics analyses, and make use of untapped resources in the literature.

Objectives: The aim of this article is to describe the diffusion of magnetic resonance imaging (MRI) in Iran, including regional variations during the period of 1990 to 2005 and international comparisons.

Methods: Data on the diffusion of MRI were obtained from the Medical Equipment Office of the Ministry of Health (MOH) and, using self-administered questionnaires, from forty-one universities specializing in medical sciences. Data were gathered from the year of first purchase up to mid-2005. Information for international comparisons was obtained from the Organization for Economic Cooperation and Development health data of 2006.

Results: Iran purchased its first MRI unit in 1990. Since then, the number of MRI units has increased remarkably. The diffusion curve of MRI in Iran follows an S-shaped curve with a very slow speed in the period of 1991–95. Accelerated adoption occurred later coinciding with a significant influence from the private sector, especially from 1999. Iran had ninety-three MRI units in 2005, and the number of MRI units per million in the population was 1.36.

Conclusions: The number of MRI units in provinces is not in direct proportion to the number of their inhabitants. Rational adoption and equitable diffusion of MRI may require the MOH and regulatory bodies to improve their ability in health technology assessment and integrate it into the policy making regarding adoption, diffusion, and utilization of health technologies.

Health technology is an indispensable part of any nation's healthcare system. During the past 50 years, all member states that comprise the European Union have increased their technological base for health care, both in terms of knowledge and by investments in equipment, devices, and pharmaceuticals. Generally, this process has gone well. However, several problems have emerged related to the acquisition, diffusion, and use of modern health technology. Concerns have been also raised about the effectiveness and efficiency of already established procedures in health care.

There is currently no generally accepted formula for the optimal timing of health technology assessments (HTAs). This paper presents some of the relevant issues and then reviews the existing literature on timing of HTAs. It finds that the literature that specifically addresses these issues is limited. There is a consensus that HTAs should be initiated at an early stage of the development of a new health technology, and repeated during the life cycle of the technology. However, the questions of reliably identifying new technologies at an early stage in their development and of deciding on a detectable critical point for starting evaluation are not resolved. It is proposed that a system of categorization and prioritization of health technologies should be developed to allow decisions to be made as to when a strongly precautionary approach is required and how the limited resources available for HTA could be optimally deployed.