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.

Objective: There is increasing empirical evidence for the existence of bias in the publication of primary clinical research, with statistically significant results being published more readily, more quickly, and in higher impact journals. Meta-analysis of individual patient data (IPD) may represent a gold standard of “secondary” clinical research, giving the best possible summary of current evidence for a particular question, but publication of these may also be subject to bias. This study aimed to explore which factors might be associated with publication of IPD meta-analyses and to identify potential sources of bias.

Methods: For all known IPD meta-analysis projects in cancer, the responsible investigator was surveyed by means of a questionnaire to determine descriptive characteristics of the meta-analysis, the nature of the results, and details of the publication history.

Results: There is no good evidence that overall publication status of meta-analyses in cancer is dependent on the statistical or clinical significance of the results. However, those meta-analyses with nonsignificant results did seem to take longer to publish and were published in lower impact journals compared with those with more striking results.

Conclusions: Based on the current data, there seems to be no strong association between the results of IPD meta-analyses in cancer and publication.

This pilot study is the first known attempt to test the willingness-to-pay or willingness-to-accept (WTP/WTA) method of assessment on a community-based primary prevention program against cardiovas cular disease. The results indicate that the population's perceived WTA outweighs the program's costs by at least three to one. However, the methodological problems of using the WTP/WTA method in community-based programs are far from solved, and further research in this area is required.

Objectives: The objective of this study is to profile the health technology assessments (HTAs) produced in Canada and other selected countries and assess their potential to inform policy making about health systems in jurisdictions other than the ones for which they were produced, and to develop and pilot test prototypes for packaging and assessing the relevance of HTAs for health system managers and policy makers.

Methods: We compiled an inventory of all HTAs that were produced by nine HTA agencies between September 2003 and August 2006; coded the title and abstract of each HTA according to the technologies assessed, methods used, and whether or not context-specific actionable messages were provided; developed a prototype for a structured, decision-relevant HTA summary and for a relevance-assessment form; and pilot-tested the prototypes using semistructured telephone interviews with a purposive sample of Canadian healthcare managers and policy makers.

Results: Our review of the 223 HTAs identified that: (i) 44 HTAs addressed health system arrangements (20 percent); (ii) 205 incorporated a systematic review (92 percent), whereas only 12 incorporated a sociopolitical assessment using explicit methods (5 percent); and (iii) 50 contained context-specific actionable messages (22 percent). Our interviews identified significant support for both the general idea of an HTA summary and the prototype's specific elements, but mixed views about using peer assessments of relevance.

Conclusions: Those involved in supporting the use of HTAs in policy making about health systems may wish to produce structured decision-relevant summaries for their systematic review-containing HTAs to increase the prospects for their HTAs being used outside the jurisdiction for which they were produced.

Objectives: The aim of this study was to assess whether a multicomponent cognitive behavioral group intervention is preferable to usual care in terms of (healthcare) costs and effects on fear of falling and activity avoidance.

Methods: This economic evaluation was embedded in a randomized controlled trial among 540 community-living adults in the Netherlands, aged 70 years and older who reported fear of falling and fear-induced activity avoidance. The participants allocated to the intervention group received a multicomponent cognitive behavioral group intervention consisting of eight weekly sessions and a booster session. The sessions were aimed at instilling realistic views of falls, reducing fall risk, and increasing activity and safe behavior. Participants in the control group received usual care. Cost outcome measures were healthcare costs, and patient and family costs. Clinical outcomes were fear of falling and activity avoidance. All outcomes were assessed at baseline and at 2, 8, and 14 months by means of registration forms, self-administered questionnaires, and interviews by telephone.

Results: Participants were randomly allocated to intervention (n = 280) and control groups (n = 260). Costs for the intervention program were on average €276 per person. Total costs per person were comparable (€4,925 in intervention group and €4,828 in control group). Furthermore, favorable effects of the program were observed for fear of falling and activity avoidance.

Conclusions: This study showed that the intervention program is preferable to usual care in terms of costs and effects. The program had comparable costs and significantly reduced fear of falling and associated activity avoidance among older community-living persons.

Objectives: Depression is common in diabetes and linked to a wide range of adverse outcomes. UK policy indicates that depression should be treated using conventional psychological treatments in a stepped care framework. This review aimed to identify current economic evidence of psychological treatments for depression among people with diabetes.

Method: Electronic search strategies (conducted in MEDLINE, EMBASE, PsycINFO, CINAHL, NHS EED) combined clinical and economic search terms to identify full economic evaluations of the relevant interventions. Prespecified screening and inclusion criteria were used. Standardized data extraction and critical appraisal were conducted and the results summarized qualitatively.

Results: Excluding duplicates, 1,516 studies for co-morbid depression and diabetes were screened. Four economic evaluations were identified. The studies found that the interventions improved health status, reduced depression and were cost-effective compared with usual care. The studies were all U.S.-based and evaluated collaborative care programs that included psychological therapies. Critical appraisal indicated limitations with the study designs, analysis and results for all studies.

Conclusions: The review highlighted the paucity of evidence in this area. The four studies indicated the potential of interventions to reduce depression and be cost-effective compared with usual care. Two studies reported costs per QALY gained of USD 267 to USD 4,317, whilst two studies reported the intervention dominated usual care, with net savings of USD 440 to USD 612 and net gains in patient free days or QALYs.

The approach of providing passive protection to young infants by immunizing pregnant women can bypass the problems of immunological immaturity in the neonate, avoid or delay active immunization of the infant in the first year of life, and prevent transmission of an infection from the mother to the neonate. Optimal vaccines for this approach should induce high immunoglobulin G antibody titers that quickly reach their maximum level after immunization and persist at protective levels for several years, thus providing passive protection in subsequent pregnancies. Specific applications of this approach include the worldwide practice of maternal immunization with tetanus toxoid vaccine and ongoing studies of maternal immunization to prevent Haemophilus influenzae type b, group B strepto-coccal, pneumococcal, meningococcal, and human immunodeficiency virus infection in the infant. Addressing the cultural, sociological, and legal aspects of maternal immunization will be required to ensure the success of this approach.

Objectives: Pediatric cardiology has an expanding role in fetal and pediatric screening. The aims of this study were to observe how district hospitals use a pediatric telecardiology service, and to compare the costs and outcomes of patients referred to specialists by means of this service or conventionally.

Methods: A telemedicine service was set up between a pediatric cardiac center in London and four district hospitals for referrals of second trimester women, newborn babies, and older children. Clinicians in each hospital decided on the role for their service. Clinical events were audited prospectively and costed, and patient surveys were conducted.

Results: The hospitals differed in their selection of patient groups for the service. In all, 117 telemedicine patients were compared with 387 patients seen in London or in outreach clinics. Patients selected for telemedicine were generally healthier. For all patients, the mean cost for the initial consultation was £411 for tele-referrals and £277 for conventional referrals, a nonsignificant difference. Teleconsultations for women and children were significantly more expensive because of technology costs, whereas for babies, ambulance transfers were much more costly. After 6-months follow-up, the difference between referral methods for all patients was nonsignificant (telemedicine, £3,350; conventional referrals, £2,172), and nonsignificant within the patient groups.

Conclusions: Telemedicine was perceived by cardiologists, district clinicians, and families as reliable and efficient. The equivocal 6-month cost results indicate that investment in the technology is warranted to enhance pediatric and perinatal cardiology services.

A more conservative approach to the treatment of traumatic dental injuries has been made possible by knowledge concerning the pathogensis of external root resorption, increased knowledge about wound healing processes in the pulp and periodintium, as well as by advances in restorative dentistry (reattachment of crown fragments with a dentin bonding system, the use of adhesive bridges, and advances in autotransplantation and implantation). However, a rethinking by the public, clinicians, and third-party payers is necessary for these procedures to gain wider acceptance. The present article describes the state of the art of treating dental trauma in the hope that these advances cam become an accepted part of the dental trauma armamentarium and not merely scientific curiosities.

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: Many of the currently used health technologies have never been systematically assessed or are misused, overused or superseded. Therefore, they may be ineffective. Active identification of ineffectiveness in health care is gaining importance to facilitate best care for patients and optimal use of limited resources. The present research analyzed processes and experiences of programs for identifying ineffective health technologies. The goal of this study was to elucidate factors that facilitate implementation.

Methods: Based on an overview article, a systematic literature search and unsystematic hand-search were conducted. Further information was gained from international experts.

Results: Seven programs were identified that include identification, prioritization and assessment of ineffective health technologies and dissemination of recommendations. The programs are quite similar regarding their goals, target groups and criteria for identification and prioritization. Outputs, mainly HTA reports or lists, are mostly disseminated by means of the internet. Top–down and bottom–up programs both have benefits in terms of implementation of recommendations, either as binding guidelines and decisions or as nonbinding information for physicians and other stakeholders. Crucial facilitators of implementation are political will, transparent processes and broad stakeholder involvement focusing on physicians.

Conclusions: All programs can improve the quality of health care and enable cost reduction in supportive surrounding conditions. Physicians and patients must be continuously involved in the process of evaluating health technologies. Additionally, decision makers must support programs and translate recommendations into concrete actions.

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.

Objectives: Obesity and dyslipidemia are risk factors for ischemic heart disease, and prevention and treatment in primary care can reduce these risks. The objective of this cost-effectiveness analysis was to compare the costs and effects (in terms of life years gained) of providing nutritional counseling by a general practitioner (GP) or a dietician.

Methods: A total of 60 GPs, who accepted to participate, were randomized either to give nutritional counseling or to refer patients to a dietician for counseling. The life years gained was estimated using a Cox regression model. Costs were estimated on the basis of registered use of time (dieticians) or agreed salaries (GPs).

Results: The effect of nutritional counseling comparing GPs and dieticians is greatest when counseling is performed by a GP—0.0919 years versus 0.0274 years. These effects appear to be moderate, but they are significant. It is also proven that the GP group was the most cost-effective—the cost of gaining 1 extra life year was estimated to be 8,213 DKK compared with the dietician group, for which the incremental cost-effectiveness ratio was estimated to be 59,987 DKK.

Conclusions: The effects were moderate, but other studies of other patient groups and interventions report effects within the same magnitude. The GP group was the most cost-effective, but it must be concluded that both counseling strategies were relatively cost-effective. Even though the cost of gaining an extra life year was estimated to be 59,987 DKK in the dietician group, this might be an acceptable price.

Objective: Our study aims to provide a practical contribution to the field of medical technology assessment within a new paradigm. This paradigm indicates the need for more comprehensive technology assessments in the development stage of a new technology.

Method: We introduce a method, based on Saaty's Analytic Hierarchy Process, which quantitatively supports discussions between the various actors that shape the technology's development and diffusion. These discussions focus on technical, medical, social, and economical requirements relevant to the design and diffusion of the new technology.

Discussion: In contrast to more traditional technology assessments, our method encompasses the perspectives of the diverse actors in the social context of technology development and diffusion. It influences their decision making on technology design and diffusion in order to improve this technology's later clinical as well as social effectiveness.

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: The aim of this study was to synthesize best practices for addressing clinical heterogeneity in systematic reviews and health technology assessments (HTAs).

Methods: We abstracted information from guidance documents and methods manuals made available by international organizations that develop systematic reviews and HTAs. We searched PubMed® to identify studies on clinical heterogeneity and subgroup analysis. Two authors independently abstracted and assessed relevant information.

Results: Methods manuals offer various definitions of clinical heterogeneity. In essence, clinical heterogeneity is considered variability in study population characteristics, interventions, and outcomes across studies. It can lead to effect-measure modification or statistical heterogeneity, which is defined as variability in estimated treatment effects beyond what would be expected by random error alone. Clinical and statistical heterogeneity are closely intertwined but they do not have a one-to-one relationship. The presence of statistical heterogeneity does not necessarily indicate that clinical heterogeneity is the causal factor. Methodological heterogeneity, biases, and random error can also cause statistical heterogeneity, alone or in combination with clinical heterogeneity.

Conclusions: Identifying potential modifiers of treatment effects (i.e., effect-measure modifiers) is important for researchers conducting systematic reviews and HTAs. Recognizing clinical heterogeneity and clarifying its implications helps decision makers to identify patients and patient populations who benefit the most, who benefit the least, and who are at greatest risk of experiencing adverse outcomes from a particular intervention.