Current practices of donor recruitment for medical fertilization procedures are analyzed in the light of Marcel Mauss' essay on the gift in primitive societies. In this perspective, donor policies seem primarily designed to spare infertile recipients the obligation to recognize the donor's contribution to these procedures, thus avoiding the kinship issues that they raise. Questions of meaning concerning donation, social recognition of the donor's role, and clarification of the relational issues underlying fertilization procedures are nevertheless essential elements in establishing their social legitimacy.

Objectives: Fatigue is the most common symptom reported by cancer patients. The inclusion of health-related quality of life (HRQL) measures in routine clinical care of cancer patients may improve the management of fatigue. The primary objective of this study is to provide evidence on the magnitude of change in fatigue subscale scores using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) that is clinically important.

Methods: Consecutive patients with advanced primary lung cancer attending a Canadian tertiary care cancer and, prior to undergoing palliative chemotherapy, were enrolled in the study. Patients completed a battery of questionnaires [FACT-F, Qualitative Patients Self-report of Fatigue Level (QPSRF)] at baseline, follow-up and 2 weeks after their final cycle of chemotherapy. Clinicians assessed the patients using the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at baseline and each follow-up visit. FACT-F change scores were computed as the mean change in score (end of study score minus baseline score).

Results: A total of 43 patients with mean age of 59 years were enrolled in the study. Results revealed a mean change in FACT-F subscale score of 5.0 (SE 1.06) for those who rated themselves as more tired, 1.28 (SE 1.00) for those who rated themselves as the same (no change), and −1.52 (SE 0.84) for those patients who rated themselves as less tired.

Conclusions: We provide evidence on the magnitude of change in FACT-F score that is associated with the perception by patients of improvement in fatigue and magnitude of change in score that is associated with worsening in fatigue.

Objectives: The impact of learning effects on the variability of costs of new health technologies in a prospective payment system (PPS) through the case of intensity modulated radiation therapy (IMRT) was studied.

Methods: A series of consecutive patients treated in nine medical centers was enrolled in a prospective study. Direct costs were assessed from the perspective of the healthcare providers. We used a two-level model to explain the variability of costs: patients nested within centers. Learning effects at the center level were considered through a fixed effect (the learning curve slope) and a random effect (the initial cost level). Covariates were introduced to explain the patterns of variation in terms of patient characteristics.

Results: The mean direct cost of IMRT was €5,962 (range, €2,414–€24,733). Manpower accounted for 53 percent of this cost. Learning effects explained 42 percent of the variance between centers (which was 88 percent of the total variance) and were associated with a substantial decrease in treatment costs. The mean initial treatment direct cost was €6,332 in centers with a previous experience of IMRT, whereas it was €14,192 in centers implementing IMRT for the first time. Including logistics costs and overhead, the full cost of IMRT was €10,916. Average reimbursement was €6,987.

Conclusions: Learning effects are a strong confounding factor in the analysis of costs of innovative health technologies involving learning effects. In a PPS, innovative health technology involving learning effects necessitates specific reimbursement mechanisms.

The costs included in economic evaluations of health care vary from study to study. Based on the theory of cost-benefit analysis, the costs that should be included in an economic evaluation are those not already included in the measurement of willingness to pay (net willingness to pay above any treatment costs paid by the individual) in a cost-benefit analysis or in the easurement of effectiveness in a cost-effectiveness analysis. These costs can be defined as the onsumption externality of the treatment (the change in production minus consumption for those included in the treatment program). For a full economic evaluation, the consequences for those included in the treatment program and a caring externality (altruism) should also be added.

Objectives: The aim of this paper is to develop a methodological framework to facilitate the application of Multi-Criteria Decision Analysis (MCDA) for a comprehensive economic evaluation of disease management programs (DMPs).

Methods: We studied previously developed frameworks for the evaluation of DMPs and different methods of MCDA and we used practical field experience in the economic evaluation of DMPs and personal discussions with stakeholders in chronic care.

Results: The framework includes different objectives and criteria that are relevant for the evaluation of DMPs, indicators that can be used to measure how DMPs perform on these criteria, and distinguishes between the development and implementation phase of DMPs. The objectives of DMPs are categorised into a) changes in the process of care delivery, b) changes in patient lifestyle and self-management behaviour, c) changes in biomedical, physiological and clinical health outcomes, d) changes in health-related quality of life, and e) changes in final health outcomes. All relevant costs of DMPs are also included in the framework. Based on this framework we conducted a MCDA of a hypothetical DMP versus usual care.

Conclusions: We call for a comprehensive economic evaluation of DMPs that is not just based on a single criterion but takes into account multiple relevant criteria simultaneously. The framework we presented here is a step towards standardising such an evaluation.

Objectives: This study assesses the impact of the English National Health Service (NHS) Health Technology Assessment (HTA) program using the “payback” framework.

Methods: A survey of lead investigators of all research projects funded by the HTA program 1993–2003 supplemented by more detailed case studies of sixteen projects.

Results: Of 204 eligible projects, replies were received from 133 or 65 percent. The mean number of peer-reviewed publications per project was 2.9. Seventy-three percent of projects claimed to have had had an impact on policy and 42 percent on behavior. Technology Assessment Reports for the National Institute for Health and Clinical Excellence (NICE) had fewer than average publications but greater impact on policy. Half of all projects went on to secure further funding. The case studies confirmed the survey findings and indicated factors associated with impact.

Conclusions: The HTA program performed relatively well in terms of “payback.” Facilitating factors included the program's emphasis on topics that matter to the NHS, rigorous methods and the existence of “policy customers” such as NICE.

Objectives: Leukemia, together with lymphoma and multiple myeloma, are hematological malignancies, malignancies of the blood-forming organs. There are four major types of leukemia: acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL). There is a growing amount of literature of the health economic aspects of leukemia. However, no comprehensive review is yet performed on the health economic evidence for the disease. Hence, our aim was to review and analyze the existing literature on economic evaluations of the different types of leukemia.

Methods: A systematic literature search used electronic databases to identify published cost analyses and economic evaluations of leukemia treatments. After reviewing all identified studies, sixty studies were considered relevant for the purpose of the review.

Results: The identified studies were published after 1990, with a few exceptions. Many of the identified economic evaluations in leukemia, particularly for ALL and AML, may be defined as cost-minimization analyses, where only the costs of different treatment strategies are compared. In CML, a new treatment, imatinib, was introduced in 2001 and several cost-effectiveness analyses have since then been conducted comparing imatinib with previous first line treatments.

Conclusions: This review indicates that there is a shortage of cost-effectiveness information in leukemia. The introduction of new therapies will stress the need for new economic evaluations in this group of diseases. More information about the total costs, that is, including indirect costs, and quality of life effects would be valuable in future evaluations in leukemia.

Background: In recent years, there has been a surge in the development of frameworks to assess the value of different types of health technologies to inform healthcare resource allocation. The reasons for, and the potential of, these value frameworks were discussed during the 2017 Health Technology Assessment International (HTAi) Policy Forum Meeting.

Methods: This study reflects the discussion, drawing on presentations from invited experts and Policy Forum members, as well as a background paper.

Results: The reasons given for a proliferation of value frameworks included: rising healthcare costs; more complex health technology; perceived disconnect between price and value in some cases; changes in societal values; the need for inclusion of additional considerations, such as ethical issues; and greater empowerment of clinicians and patients in defining and using value frameworks. Many Policy Forum participants recommended learning from existing frameworks. Furthermore, there was a desire to agree on the core components of value frameworks, defining the additional value elements as necessary and considering how they might be measured and used in practice. Furthermore, adherence to the principles of transparency, predictability, broad stakeholder involvement, and accountability were widely supported, along with being forward looking, explicit, and consistent across decisions.

Conclusions: Value frameworks continue to evolve with significant implications for global incentives for innovation and access to health technologies. There is a role for the HTA community to address some of the key areas discussed during the meeting, such as defining the core components for assessing the value of a health technology.

Ghana is one of the few African countries to enact legislation and earmark significant funding to establish universal health coverage (UHC) through the National Health Insurance Scheme, although donor funds have declined recently. Given a disproportionate level of spending on medicines, health technology assessment (HTA) can support resource allocation decisions in the face of highly constrained budgets, as commonly found in low-resource settings. The Ghanaian Ministry of Health, supported by the International Decision Support Initiative (iDSI), initiated a HTA study in 2016 to examine the cost-effectiveness of antihypertensive medicines. We aimed to summarize key insights from this work that highlights success factors beyond producing purely technical outputs. These include the need for capacity building, academic collaboration, and ongoing partnerships with a broad range of experts and stakeholders. By building on this HTA study, and with ongoing interactions with iDSI, HTAi, WHO, and others, Ghana will be well positioned to institutionalize HTA in resource allocation decisions and support progress toward UHC.

The availability and efficacy of recombinant deoxyribonucleic acid yeast-derived hepatitis-B vaccine, at a price much lower than the previously available plasma-derived hepatitis-B vaccines against hepatitis-B virus infections, motivate a new cost-benefit analysis of hepatitis-B vaccination. Spanish data were used to calculate direct and indirect costs of hepatitis-B infection and the costs and benefits of different vaccination strategies in defined risk groups of the Spanish population. A vaccination program will reduce direct expenditures for hepatitis B if the attack rate in the target population is higher than 4.9%. If indirect costs are included, the threshold for cost saving is reduced to 0.9%. The results are sensitive to the price of the vaccine, the duration of protection, assumptions about consequences for quality of life, and to indirect costs.

The objective of this study was to test whether the relatively new, noninvasive technique of extracorporeal shock-wave lithotripsy (ESWL) for renal stones resulted in a measurably better outcome from the patients' point of view than percutaneous surgery. The claimed superiority of ESWL was not demonstrated with the data available.

Objectives: To assess the relative cost-effectiveness of laparoscopic methods of inguinal hernia repair compared with open flat mesh and open non-mesh repair.

Methods: Data on the effectiveness of these alternatives came from three systematic reviews comparing: (i) laparoscopic methods with open flat mesh or non-mesh methods; (ii) open flat mesh with open non-mesh repair; and (iii) methods that used synthetic mesh to repair the hernia defect with those that did not. Data on costs were obtained from the authors of economic evaluations previously conducted alongside trials included in the reviews. A Markov model was used to model cost-effectiveness for a five-year period after the initial operation. The outcomes of the model were presented using a balance sheet approach and as cost per hernia recurrence avoided and cost per extra day at usual activities.

Results:Open flat mesh was the most cost-effective method of preventing recurrences. Laparoscopic repair provided a shorter period of convalescence and less long-term pain compared with open flat mesh but was more costly. The mean incremental cost per additional day back at usual activities compared with open flat mesh was €38 and €80 for totally extraperitoneal and transabdominal preperitoneal repair, respectively.

Conclusions:Laparoscopic repair is not cost-effective compared with open flat mesh repair in terms of cost per recurrence avoided. Decisions about the use of laparoscopic repair depend on whether the benefits (reduced pain and earlier return to usual activities) outweigh the extra costs and intraoperative risks. On the evidence presented here, these extra costs are unlikely to be offset by the short-term benefits of laparoscopic repair.

Objectives: The objective of this study was to explore the degree to which databases other than MEDLINE contribute studies relevant for inclusion in rapid health technology assessments (HTA).

Methods: We determined the extent to which the clinical, economic, and social studies included in twenty-one full and four rapid HTAs published by three Canadian HTA agencies from 2007 to 2012 were indexed in MEDLINE. Other electronic databases, including EMBASE, were then searched, in sequence, to assess whether or not they indexed studies not found in MEDLINE. Assessment topics ranged from purely clinical (e.g., drug-eluting stents) to those with broader social implications (e.g., spousal violence).

Results: MEDLINE contributed the majority of studies in all but two HTA reports, indexing a mean of 89.6 percent of clinical studies across all HTAs, and 88.3 percent of all clinical, economic, and social studies in twenty-four of twenty-five HTAs. While EMBASE contributed unique studies to twenty-two of twenty-five HTAs, three rapid HTAs did not include any EMBASE studies. In some instances, PsycINFO and CINAHL contributed as many, if not more, non-MEDLINE studies than EMBASE.

Conclusions: Our findings highlight the importance of assessing the topic-specific relative value of including EMBASE, or more specialized databases, in HTA search protocols. Although MEDLINE continues to be a key resource for HTAs, the time and resource limitations inherent in the production of rapid HTAs require that researchers carefully consider the value and limitations of other information sources to identify relevant studies.

Objectives: Colloquial evidence (CE) has been described as the informal evidence that helps provide context to other forms of evidence in guidance development. Despite challenges around quality, and the potential biases, the use of CE is becoming increasingly important in assessments where scientific literature is sparse and to also capture the experience of all stakeholders in discussions, including that of experts and patients. We aimed to ascertain how CE was being used at the National Institute for Health and Care Excellence (NICE).

Methods: Relevant data corresponding to the use of CE was extracted from all NICE technical and process manuals by two reviewers and quality assured and analyzed by a third reviewer. This was considered in light of the results of a focused literature review and a combined checklist for quality assessment was developed.

Results: At NICE, CE is utilised across all guidance producing programmes and at all stages of development. CE could range from information from experts and patient/carers, grey literature (including evidence from websites and policy reports) and testimony from stakeholders through consultation. Six tools for critical appraisal of CE were available from the literature and a combined best practice checklist has been proposed.

Conclusions: As decisions often need to be made in areas where there is a lack of published scientific evidence, CE is employed. Therefore to ensure its appropriateness the development of a validated CE data quality check-list to assist decision makers is essential and further research in this area is a priority.

Objectives: Immediate post-mastectomy breast reconstruction (IBR) is a procedure that has proven advantages, but it also entails risks. The aim of this study was to identify risk factors for reconstruction failure.

Methods: A review was made of all the IBR carried out at a general hospital from 2002 to 2009. Retrospective information was obtained about postoperative complications and the characteristics of patients and treatments applied. The minimum follow-up period was 9 months. Cox's regression analysis was performed on the variables related to the reconstruction failure requiring the removal of the prosthesis, with an explanatory model in which all the study variables were introduced and a predictive model that contained only the variables known before the intervention.

Results: A total of 115 IRB interventions carried out on 112 women with breast cancer were analyzed. The mean follow-up period was 25.5 months. In sixty cases (52.2 percent), there were no complications; in sixteen cases (13.9 percent) minor complications appeared, and in 39 (33.9 percent) the complications were moderate. In twenty-six cases (22.6 percent), a reconstruction failure occurred. Cox's regression model revealed that the reconstruction failures were related to the patient's age (Hazard Ratio 1.08), to neoadjuvant chemotherapy (HR 6.24) and to postoperative tamoxifen (HR 3.10). The predictive model included the age of the patient (HR 1.05) and the use of neoadjuvant chemotherapy (HR 5.11).

Conclusions: A significant proportion of the patients receiving IBR developed reconstruction failure. Multivariate analysis identified three variables related to this complication, two of which were known before the intervention.

Objectives: The Turkish healthcare system is currently undergoing reform, and efficient use of resources has become a key factor in determining the allocation of resources. The objective of this study was to analyze strengths, weaknesses, opportunities, and threats (SWOT) in the development of a health technology assessment (HTA) program in Turkey.

Methods: A SWOT analysis was performed using a literature review and interviews with key people in the Turkish Ministry of Health and Ministry of Labor and Social Security.

Results: Regarding recent reforms in health care, investments for information network and databank are the strengths, but the traditional “expert-based” decision making, poor availability of data, and poor quality of data could be seen as some of the weaknesses. Another major weakness is lack of general awareness of HTA. Increasing demand for transparency in decision making, demand for evidence, and demand for credibility by decision makers are some of the opportunities, and current healthcare reforms, i.e., restructuring of healthcare and general health insurance, could also be seen as major opportunities. These opportunities unfortunately could be threatened by lack of funding, and resources are challenged by large, recent national investments.

Conclusions: There is a good opportunity for Turkey to use the skills in HTA currently being developed through activities in Europe and the Americas to assist in the development of a much more cost-effective and transparent healthcare system in Turkey.

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.

Background: Most industrialized countries, including France, have undertaken to generalize colorectal cancer screening using guaiac fecal occult blood tests (G-FOBT). However, recent researches demonstrate that immunochemical fecal occult blood tests (I-FOBT) are more effective than G-FOBT. Moreover, new generation I-FOBT benefits from a quantitative reading technique allowing the positivity threshold to be chosen, hence offering the best balance between effectiveness and cost. We aimed at comparing the cost and the clinical performance of one round of screening using I-FOBT at different positivity thresholds to those obtained with G-FOBT to determine the optimal cut-off for I-FOBT.

Methods: Data were derived from an experiment conducted from June 2004 to December 2005 in Calvados (France) where 20,322 inhabitants aged 50–74 years performed both I-FOBT and G-FOBT. Clinical performance was assessed by the number of advanced tumors screened, including large adenomas and cancers. Costs were assessed by the French Social Security Board and included only direct costs.

Results: Screening using I-FOBT resulted in better health outcomes and lower costs than screening using G-FOBT for thresholds comprised between 75 and 93 ng/ml. I-FOBT at 55 ng/ml also offers a satisfactory alternative to G-FOBT, because it is 1.8-fold more effective than G-FOBT, without increasing the number of unnecessary colonoscopies, and at an extra cost of €2,519 per advanced tumor screened.

Conclusions: The use of an automated I-FOBT at 75 ng/ml would guarantee more efficient screening than currently used G-FOBT. Health authorities in industrialized countries should consider the replacement of G-FOBT by an automated I-FOBT test in the near future.

Objectives: Since 1988, four government-funded health technology assessment (HTA) agencies have been established in Canada. This paper is a descriptive review of reports issued by these organizations during the period from 1988 to 1998.

Methods: Publications from the national and three provincial HTA agencies in Canada were obtained and reviewed. Only the 117 assessment reports that were reported to have undergone external review were included in this analysis. Each report was classified on a standard abstraction form according to criteria such as technology type(s), assessment focus, whether a specific policy question was clearly stated and relevant decision maker(s) identified, description of search strategy and selection criteria, sources of data and assessment methods used, whether recommendations or conclusions were made, and duplication or overlap of reports. The trends in these qualities over the 10-year period were also examined.

Results: Therapeutic technologies have received the most attention from all four agencies, although the focus on devices, drugs, and procedures varied between agencies. The policy question under investigation was clearly identified in 82% of reports, and 71% clearly identified the decision maker toward whom the assessment was targeted. Efficacy or effectiveness was examined in 81% of reports, and costs were assessed in 65% of studies. These were the two most frequently examined aspects. Almost all assessments were descriptive literature reviews; 9% included meta-analyses and 32% had cost analyses or economic evaluations. Forty-four percent of reports had a clear description of the literature search strategy, and selection criteria were clearly specified in 38% of studies, but there was considerable variation among agencies in the level of description of these methods. Conclusions were clearly stated in 83% of the assessments' conclusions, and 13% had recommendations. When analyzed longitudinally, it is apparent that the quality of reports has improved markedly during the past decade. This was determined by examining the clarity of specifying the policy question(s) under investigation, the identification of the target audience of decision makers for the information, and by evaluating the thoroughness of the description of the methods used in the assessment.

Conclusions: Canadian government agencies have contributed a considerable quantity of health technology assessments. There has been very little duplication of technologies evaluated, and the quality of the assessment reports has markedly improved during the past decade.