Objectives: The aim of this study was to describe 8-year results from post-implementation surveillance of neuroreflexotherapy (NRT), a health technology proven effective for treating neck and back pain.

Methods: Post-implementation surveillance included all patients undergoing NRT across five regions within the Spanish National Health Service (SNHS). Validated methods were used to assess pain, disability, adverse events, use of health resources, and patient satisfaction. Logistic regression models were developed to identify the variables associated with the risk of a pain episode requiring more than one NRT intervention. The number of relapses among discharged patients during the 8-year period was calculated.

Results: Between January 1, 2004, and June 30, 2012, 9,023 patients (median age: 53 years), presenting 11,384 subacute (25.2 percent) and chronic (74.8 percent), neck or back pain episodes, were discharged after receiving NRT. Spinal pain improved in 89 percent of cases, 83 percent abandoned drugs, and 0.02 percent required spine surgery. The only adverse event was skin discomfort (8.0 percent of patients). Number of patient complaints was 0, and answers to a standardized questionnaire reflected a high degree of satisfaction (response rate: 76.7 percent). Of the pain episodes, 18.9 percent required more than one NRT intervention; logistic regression models identified the variables associated with this. Over the 8-year period, the proportion of discharged patients referred for treatment due to relapse at the same level for neck, thoracic, and low back pain, was 16.4 percent, 6.5 percent, and 14.5 percent respectively.

Conclusions: Post-marketing surveillance for a non-pharmacological technology is feasible within the SNHS. These results support generalizing NRT across the entire SNHS under the current validated application conditions.

Objectives: Post-listing assessment of pharmaceuticals depends on national habits. In England, the assessment is based on estimates of cost per quality-adjusted life-year. These are made some considerable time after listing (negative list). In France, effectiveness, and then efficiency, is assessed immediately after listing (positive list). We propose a new formal method—the REAL method—that can help make early comparisons of the effectiveness of medical treatments.

Methods: Relative efficacies are first obtained from randomized controlled trials (RCTs). Members of the Transparency Committee (French National Authority for Health) are then consulted by questionnaire on the transposability of these results to real life. The RCT results and experts’ ratings are entered into an effect model to obtain estimates of relative effectiveness, using unidimensional scaling, and bootstrap procedures.

Results: Application of the REAL method to the example of a new drug to treat Parkinson's disease and three comparators used in the same indication provided graphs of the distributions of their relative efficacy and relative effectiveness. The new drug was found to provide no added value.

Conclusions: The REAL method is a rational, transparent, and practical procedure for comparing the effectiveness of pharmaceuticals in an immediate post-listing setting.

Objectives: The aim of this study was to describe the evolution of a cost-utility model used to inform the UK National Institute for Health and Clinical Excellence's (NICE) most recent decisions on the cost-utility of drug treatments for Alzheimer's disease (AD), and to explore the impact of structural assumptions on the cost-utility results.

Methods: Changes informed by noted limitations of the decision model used in NICE's previous decisions (in 2006) were made cumulatively to the original decision model for donepezil compared with best supportive care (for patients with mild to moderate AD). Deterministic and probabilistic analyses were undertaken for each cumulative change of the model. The expected value of perfect information (EVPI) of parameter estimates and structural assumptions was also calculated.

Results: Cumulative changes to the decision model highlighted how the results of the original model (incremental cost-effectiveness ratio of £81,000 per quality-adjusted life-year gained) related to those of the new model (where donepezil was estimated to be cost-saving), mainly due to uncertainty in the incremental cost of donepezil treatment over best supportive care (ranging from -£600 to £3,000 per patient). The partial EVPI analysis reflected this finding where further information on treatment discontinuations and cost parameter estimates were shown to be valuable in terms of reducing decision uncertainty.

Conclusions: Assessing the evolution of the cost-utility model helped to identify and explore structural differences between cohort-based models and is likely to be useful for decision models in other disease areas. This approach makes the structural uncertainty explicit, forcing decision makers to address structural uncertainty in addition to parameter uncertainty.

Objectives: This study presents findings from a study that explores the merits of different methods for assessing the international use of UK funded research by the National Institute of Health Research Health Technology Assessment (NIHR HTA) Programme.

Methods: The study adopted an exploratory approach and used three core methods: (i) Academic use was explored through bibliometric and citation analysis of the top ten most cited health technology assessment (HTA) reports. (ii) Internet use was assessed using Webtrends software to identify the proportion of international visits of the top ten most downloaded HTA reports from January 1, 2004 to June 30, 2010. (iii) International HTA use was assessed by searching the Center for Reviews and Dissemination (CRD) HTA database to explore the citation of NIHR HTA reports in reports by non-UK HTA agencies.

Results: Bibliometric analysis identified published output and international citations with 41 percent of the 549 journals citing NIHR HTA reports being based in the United States. Nine of ten most downloaded reports from the NIHR HTA Web site (www.hta.ac.uk) had in excess of 50 percent of visits outside the United Kingdom. Four of five selected NIHR HTA reports were cited in twenty-eight other HTA reports, eighteen of these outside the United Kingdom.

Conclusions: Assessing international use is important when exploring the uptake of research evidence. Methods used in identifying research impact, such as bibliometrics and Webtrends, are helpful in generating evidence of international use. HTA agencies should consider these techniques and international use when assessing the uptake of findings from research they undertake and/or commission.

Objectives: The aim of this study was to elucidate, whether shift from first generation antipsychotics (FGA) to olanzapine can affect health-related quality of life (HRQoL) of residually symptomatic schizophrenic outpatients.

Methods: Patients were randomized to either olanzapine or to continuation on their FGA. The 15D-measured HRQoL at baseline and end-point (after 12 weeks) was compared.

Results: Patients (n = 21) randomized to olanzapine achieved better HRQoL than those (n = 21) who continued on their FGA. This difference on the 15D (0.048 on a 0–1 scale; p = .037) was clinically important and comparable to that resulting from common surgical interventions, for example, hip or knee replacement.

Conclusions: HRQoL of stable outpatients with residual symptoms or adverse effects may improve substantially after shift from FGAs to olanzapine.

Objectives: The aim of this study was to assess whether publications of importance for improving the health system and its technologies are highly cited intrascientifically.

Methods: Bibliometric assessment of the 596 publications used as sources in the fifty SBU Alerts from 2001to 2004 from the Swedish Council on Technology Assessment in Health Care was carried out using the Thomson Scientific citation indexes. Normalized citation scores were calculated for all included studies. Additional factors such as the time and place of the research, subject categories, and journal source were analyzed.

Results: On average, the sources in SBU Alert have been cited eight times more than the world average consistently during the time period and across research areas. Articles used as its scientific basis are often published in a few, high impact, general medical journals. However, many of the articles are published in field-specific journals with low impact factors. Most articles used in SBU Alert are published by authors based in the United States or the United Kingdom. However, Swedish, Danish, and Dutch publications are overrepresented in its science base, whereas Japanese, Taiwanese, Indian, and Russian publications are underrepresented.

Conclusions: Publications used as sources in a Swedish system for identification and early assessment of new methods in health care are also highly cited within the scientific community. This finding increases the appropriateness of using bibliometric indicators in evaluations of clinical research and suggests that decision makers through SBU Alert are getting scientifically sound advice.

Objectives: The news media plays a central role in providing information regarding new medical technologies and exerts an influence on their social perception, understanding, and assessments. This study, therefore, analyzes how healthcare robotics are portrayed in the German print news media. It examines whether the risks and opportunities of new medical technologies are presented in a balanced manner and investigates whether or not print media coverage of these technologies is affected by science-fiction discourse, in which robots appear mostly as a threat to humans.

Methods: Ten years of German print media coverage (2000–2010) have been studied by means of systematic, standardized content analysis.

Results: Reporting focuses predominantly on beneficial advancements in medical practice and the advantages of robotics for patients, medical staff, and society. The results show that the dominant relationship between robots and humans that is transmitted in print media in medical contexts is positive, with robots mostly portrayed as assistants, colleagues, or even friends. Only a small number of articles report ethical questions and risks.

Conclusions: In contrast to science-fiction discourse, the German print media provides a positive picture of robotics to the lay public.

Objectives: The International Network of Agencies for Health Technology Assessment (INAHTA) has been tracking activities associated with the clinical use of positron emission tomography (PET) in its members' healthcare systems since 1997 and published its first Joint Project report on PET in 1999. Part 1 of this Joint Project report presents survey results on diffusion, assessment activities, and policy for clinical use related to PET among INAHTA members since 1999.

Methods: INAHTA members were surveyed in 2003–2004.

Results: Twenty-seven INAHTA agencies (69 percent response rate) from nineteen countries responded to the survey. Dedicated PET systems are the most universally installed systems to date. Mobile scanners and modified gamma cameras are used occasionally as lower cost alternatives, and interest in PET–computed tomography hybrid models is rising despite limited assessment of impact on service planning. PET was used and assessed most commonly for managing patients with cancer. All respondents reported having some form of public funding for clinical PET frequently linked to data collection for the purpose of gathering evidence to refine clinical use and guide resource allocation toward indications that maximize clinical and cost-effectiveness.

Conclusions: The use of HTA within a continuous quality improvement framework can help optimize scarce resources for evaluation and use of high cost diagnostic technologies such as PET, particularly where potential clinical or cost-effectiveness is considerable but conclusive evidence is lacking.

Introduction: Genetic factors affecting warfarin maintenance dose have been well established, but patient acceptance is a necessary consideration for the successful clinical implementation of warfarin pharmacogenetic testing (WPGT). In this study, we aimed to determine the attitudes toward WPGT among Singaporean Chinese.

Methods: A total of 194 warfarin patients and 187 members of the public completed a structured survey on paper and the Internet, respectively. Attitudes were expressed as willingness to undergo WPGT (single item with 5-point response) and expectations and concerns about WPGT (two multi-item scales). Relationships between attitudes and socio-demographic and clinical variables were explored using Fisher's exact test, Student's t-test, one-way analysis of variance or Pearson's correlation.

Results: Majority of respondents were willing to or neutral about undergoing WPGT. Both patients and public had relatively high expectations (mean [SD]: 3.77 [0.63], and 3.97 [0.55], respectively) and moderately high concerns (mean [SD]: 3.30 [0.69] and 3.33 [0.68], respectively) about WPGT. Willingness to undergo WPGT was associated with gender, educational status, length of warfarin treatment, and number of chronic diseases among warfarin patients, and with history of adverse drug reactions and number of chronic diseases among the public. Higher expectation of WPGT was associated with higher willingness (p < .001 in both populations), while higher concern was associated with lower willingness to undergo WPGT among the public (p = .004) but not among patients (p = .072).

Conclusion: Patient acceptance is not a major barrier to clinical implementation of WPGT but patient education is necessary and the ethical, social, and legal issues should be addressed.

Objectives: The National Institutes of Health (NIH) Consensus Development Conference (CDC) was instituted to provide evidence-based guidance on controversial medical issues to researchers, health practitioners, and the public; however, the degree of impact this activity has on stimulating relevant research is unclear. This study examines the impact of CDC statements on the initiation of related NIH-funded research projects.

Methods: Six CDCs from 1998 to 2001 were examined. Research initiatives related to the Conferences' topics were collected through two discrete methods: (i) the overall number of relevant pre- and postconference research activities was compiled using NIH's Information for Management, Planning, Analysis, and Coordination II (IMPAC II) and the Department of Health and Human Services' (DHHS) Computer Retrieval of Information on Scientific Projects (CRISP) grant application and award databases; (ii) for each CDC, the sponsoring institute's conference coordinator and other identified Program Directors were queried for their knowledge of new conference-specific research initiatives sponsored by their institute. The main outcome measure was the total number of requests for applications, requests for proposals, program announcements, broad agency announcements, notices, and funded investigator-initiated research program grants (RO1s) for a given Consensus topic in the 3 years before (baseline measure) and following (measure of impact) a CDC.

Results: As identified through NIH's IMPAC II and DHHS' CRISP grants and announcements databases, the total number of relevant postconference research initiatives increased for five of six CDCs when compared with baseline activity levels; research activities remained constant for the sixth. When inclusion criteria were restricted to institute-identified research initiatives, two of six CDC topics had overall increases in relevant research activity in the postconference period.

Conclusions: CDCs appear to have a positive impact on the stimulation of related NIH-funded research initiatives. Future outcomes evaluations using prospective data collection methods and more robust participation by sponsoring and cosponsoring institutes should strengthen the reliability of the association between new research initiatives on a given topic and their causal relationship to a given CDC.

Objectives: This paper aims to describe the added value of combining cost-effectiveness and ethical evaluations when the preferences of the decision maker toward cost-effectiveness evaluation outcomes are not known, with the French national neonatal screening of cystic fibrosis (CF) as a case-study.

Methods: A cost-effectiveness analysis comparing four CF neonatal screening strategies, with or without DNA testing, was performed. Ethical positions toward their outcomes were described. In addition, a post-hoc analysis of the ethical issues being considered relevant from the decision-makers’ perspective was conducted.

Results: Two strategies were found equally cost-effective. Among them, choosing the non-DNA or a DNA-based strategy constrains the decision maker to render a judgement between different ethical issues or disagreements associated with the screening program.

Conclusions: The analysis supports the relevance of combining cost-effectiveness and ethics evaluation in developing health policy, as a way to reveal or clarify the motives associated with health. The choice of the decision maker to favor the DNA-based strategy, which was not originally recommended, creates the opportunity to make explicit the role played by ethical issues in the decision.

The unique task and contribution of health technology assessment (HTA) is to help identify those health technologies and their uses that are most likely to preserve and restore a population’s health in a way that is consonant with its values, including, for example, equity and access to high-quality care (1). Such a task is challenging for at least two reasons. First, because of the vast and constantly evolving number and diversity of health technologies and their applications. Second, because of the usual wide variety of competing views within communities and their stakeholders regarding what strategies are likely to be conducive to the goal of preserving and restoring population health. Although perhaps tempting, it would be a grave mistake to hold that the controversies that result from such competing views can be resolved by taking recourse to the facts only. For such controversies are usually fueled by different notions of health and disease and different specifications of values such as equity and individual and collective responsibility for health. For this reason, they cannot be resolved in a satisfactory way without also addressing those normative issues and their interplay with empirical analysis.*

Traditional and complementary medicines are increasingly considered possible options for prevention and symptomatic treatment of the novel coronavirus, COVID-19. With renewed attention on these therapies from researchers and policy makers alike, the well-documented challenges of evaluating their safety and efficacy are once again of global concern. Between 2005 and 2018, the World Health Organization conducted a series of surveys, in which 88 percent of responding member states confirmed that their biggest challenge in traditional medicine was the need for technical guidance on research and evaluation. As a first step in pursuing this need, our commentary summarizes thirteen international and regional guidance documents by three broad categories on evaluating safety, efficacy, and product quality for market-based approval and distribution of these treatments. We highlight the paucity of updated international recommendations on these subjects and identify gaps that could inform the current evidence base. All available guidance note the need for evidence surrounding the efficacy of these treatments and practices but are also quick to caution against methodological difficulties in the conduct of such evaluations. Evidence suggests that improved evaluation methods on efficacy and effectiveness are crucial toward expanding future research into establishing the cost-effectiveness of these therapies, in the context of shifting acceptance, interest, and integration of traditional medicines into health systems, and as another step toward Universal Health Coverage.

Objectives: The aim of this study is to describe and illustrate a method to obtain early estimates of the effectiveness of a new version of a medical device.

Methods: In the absence of empirical data, expert opinion may be elicited on the expected difference between the conventional and modified devices. Bayesian Mixed Treatment Comparison (MTC) meta-analysis can then be used to combine this expert opinion with existing trial data on earlier versions of the device. We illustrate this approach for a new four-pole implantable cardioverter defibrillator (ICD) compared with conventional ICDs, Class III anti-arrhythmic drugs, and conventional drug therapy for the prevention of sudden cardiac death in high risk patients. Existing RCTs were identified from a published systematic review, and we elicited opinion on the difference between four-pole and conventional ICDs from experts recruited at a cardiology conference.

Results: Twelve randomized controlled trials were identified. Seven experts provided valid probability distributions for the new ICDs compared with current devices. The MTC model resulted in estimated relative risks of mortality of 0.74 (0.60–0.89) (predictive relative risk [RR] = 0.77 [0.41–1.26]) and 0.83 (0.70–0.97) (predictive RR = 0.84 [0.55–1.22]) with the new ICD therapy compared to Class III anti-arrhythmic drug therapy and conventional drug therapy, respectively. These results showed negligible differences from the preliminary results for the existing ICDs.

Conclusions: The proposed method incorporating expert opinion to adjust for a modification made to an existing device may play a useful role in assisting decision makers to make early informed judgments on the effectiveness of frequently modified healthcare technologies.