Showing papers in "International Journal of Technology Assessment in Health Care in 2017"

What are user perspectives of exoskeleton technology? a literature review.

Abstract: Objectives: Exoskeletons are electromechanical devices that are worn by a human operator to increase their physical performance. Several exoskeletons have been developed to restore functional movements, such as walking, for those with paralysis due to neurological impairment. However, existing exoskeletons have limitations with respect to affordability, size, weight, speed, and efficiency, which may reduce their functional application. Therefore, the aim of this scoping review is to collect and narratively synthesize the perspectives of users of exoskeleton technology. Methods: A systematic literature search was conducted across several healthcare related online databases. Results: A total of 4,619 articles were identified, of which 51 were selected for full review. Only three studies were identified that met the inclusion criteria. Of these, one showed an incongruence between users’ expectations and experiences of device use; another reported perspectives on potential rather than actual device use, ranking design features in order of perceived importance; and the other reported ratings of ease of device use in training. Conclusions: The heterogeneity of studies included within this review, leave the authors unable to suggest consensus as to user perspectives of exoskeleton technology. However, it is apparent that users are able to suggest priorities for exoskeleton design and that users’ perspectives of exoskeleton technology might change in response to experience of use. The authors, therefore, suggest that exoskeleton design should be an iterative process, whereby user perspectives are sought, incorporated and refined by tangible experience, to ensure that devices developed are acceptable to and usable by the populations they seek to re-enable.

Conceptualizations of the societal perspective within economic evaluations: a systematic review.

Abstract: Objectives: The aim of this study was to investigate how the societal perspective is conceptualized in economic evaluations and to assess how intersectoral costs and benefits (ICBs), that is, the costs and benefits pertaining to sectors outside the healthcare sector, impact their results. Methods: Based on a search in July 2015 using PubMed, Embase, CINAHL, and PsychINFO, a systematic literature review was performed for economic evaluations which were conducted from a societal perspective. Conceptualizations were assessed in NVivo version 11 using conventional and directed content analysis. Trial-based evaluations in the fields of musculoskeletal and mental disorders were analyzed further, focusing on the way ICBs impact the results of economic evaluations. Results: A total of 107 studies were assessed, of which 74 (69.1 percent) provided conceptualizations of the societal perspective. These varied in types of costs included and in descriptions of cost bearers. Labor productivity costs were included in seventy-two studies (67.3 percent), while only thirty-eight studies (35.5 percent) included other ICBs, most of which entailed informal care and/or social care costs. ICBs within the educational and criminal justice sectors were each included five times. Most of the trial-based evaluations analyzed further (n = 21 of 28) reported productivity costs. In nine, these took up more than 50 percent of total costs. In several studies, criminal justice and informal care costs were also important. Conclusions: There is great variety in the way the societal perspective is conceptualized and interpreted within economic evaluations. Use of the term “societal perspective” is often related to including merely productivity costs, while other ICBs could be relevant as well.

Drug evaluation and decision making in catalonia: development and validation of a methodological framework based on multi-criteria decision analysis (mcda) for orphan drugs.

Abstract: Objectives: The aim of this study was to adapt and assess the value of a Multi-Criteria Decision Analysis (MCDA) framework (EVIDEM) for the evaluation of Orphan drugs in Catalonia (Catalan Health Service). Methods: The standard evaluation and decision-making procedures of CatSalut were compared with the EVIDEM methodology and contents. The EVIDEM framework was adapted to the Catalan context, focusing on the evaluation of Orphan drugs (PASFTAC program), during a Workshop with sixteen PASFTAC members. The criteria weighting was done using two different techniques (nonhierarchical and hierarchical). Reliability was assessed by re-test. Results: The EVIDEM framework and methodology was found useful and feasible for Orphan drugs evaluation and decision making in Catalonia. All the criteria considered for the development of the CatSalut Technical Reports and decision making were considered in the framework. Nevertheless, the framework could improve the reporting of some of these criteria (i.e., “unmet needs” or “nonmedical costs”). Some Contextual criteria were removed (i.e., “Mandate and scope of healthcare system”, “Environmental impact”) or adapted (“population priorities and access”) for CatSalut purposes. Independently of the weighting technique considered, the most important evaluation criteria identified for orphan drugs were: “disease severity”, “unmet needs” and “comparative effectiveness”, while the “size of the population” had the lowest relevance for decision making. Test–retest analysis showed weight consistency among techniques, supporting reliability overtime. Conclusions: MCDA (EVIDEM framework) could be a useful tool to complement the current evaluation methods of CatSalut, contributing to standardization and pragmatism, providing a method to tackle ethical dilemmas and facilitating discussions related to decision making.

Ethics of smart house welfare technology for older adults: a systematic literature review.

Abstract: Background: The University College of Southeast Norway has an on-going project to develop a smart house welfare system to allow older adults and people with disabilities to remain in their homes for as long as they wish in safe, dignified, living conditions. Objectives: This article reviews reported ethical challenges to implementing smart houses for older adults. Methods: A systematic literature review identified twenty-four articles in English, French, Spanish, and Norwegian, which were analyzed and synthesized using Hofmann's question list to investigate the reported ethical challenges. Results: Smart houses offer a promising way to improve access to home care for older adults and people with disabilities. However, important ethical challenges arise when implementing smart houses, including cost-effectiveness, privacy, autonomy, informed consent, dignity, safety, and trust. Conclusions: The identified ethical challenges are important to consider when developing smart house systems. Due to the limitations of smart house technology, designers and users should be mindful that smart houses can achieve a safer and more dignified life-style but cannot solve all the challenges related to ageing, disabilities, and disease. At some point, smart houses can no longer help persons as they develop needs that smart houses cannot meet.

Why patients should be involved in health technology assessment.

Abstract: Objectives: Some countries make considerable effort to involve patients and patient groups in their health technology assessment (HTA) processes; others are only just considering or are yet to consider patient involvement in HTA Methods: This commentary offers four arguments why patient involvement should be prioritized by those HTA agencies that do not yet involve patients: (1) from a patients’ rights perspective, (2) based on patient and community values, (3) centering on evidentiary contributions, and (4) from a methodological perspective Results: The first argument builds on the Alma-Ata Declaration, which holds that patients have a right and duty to have a say in the planning and delivery of their health care, individually and collectively Where HTA is used to determine access to technologies and services, we argue that patients have a right to be heard The second argues that decisions about treatments and services need to be aligned with the core values and morals of the patients whom the health system serves The third argues that patients have unique knowledge and insights about living with a health condition and their needs for services and treatments regarding that condition, which can add to the knowledge base and value of the HTA process The fourth argues that involvement of patients can facilitate methodological advancement of HTA, in areas such as early scientific advice and managed entry with evidence development Conclusions: An HTA process that includes patient perspectives can, therefore, provide added value to patients, policy makers and healthcare professionals alike

Health technology performance assessment: real-world evidence for public healthcare sustainability.

Abstract: Objective: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Since they are designed to show the best possible results with typically Phase III studies conducted under ideal and highly controlled conditions to seek high internal validity and maximize the chance of demonstrating clinical benefit, they often do not reflect likely effectiveness in routine clinical care. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Since financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/ disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health. Method: Extensive literature review, refinement with experts across countries and public consultation. Results: A comprehensive guideline was developed, which has been adopted by the Brazilian government. Conclusion: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real world evidence to optimize available resources not only in Brazil but across countries.

Secure internet of things-based cloud framework to control zika virus outbreak.

Abstract: Objectives: Zika virus (ZikaV) is currently one of the most important emerging viruses in the world which has caused outbreaks and epidemics and has also been associated with severe clinical manifestations and congenital malformations. Traditional approaches to combat the ZikaV outbreak are not effective for detection and control. The aim of this study is to propose a cloud-based system to prevent and control the spread of Zika virus disease using integration of mobile phones and Internet of Things (IoT). Methods: A Naive Bayesian Network (NBN) is used to diagnose the possibly infected users, and Google Maps Web service is used to provide the geographic positioning system (GPS)-based risk assessment to prevent the outbreak. It is used to represent each ZikaV infected user, mosquito-dense sites, and breeding sites on the Google map that helps the government healthcare authorities to control such risk-prone areas effectively and efficiently. Results: The performance and accuracy of the proposed system are evaluated using dataset for 2 million users. Our system provides high accuracy for initial diagnosis of different users according to their symptoms and appropriate GPS-based risk assessment. Conclusions: The cloud-based proposed system contributed to the accurate NBN-based classification of infected users and accurate identification of risk-prone areas using Google Maps.

GRADE EVIDENCE TO DECISION (EtD) FRAMEWORK FOR COVERAGE DECISIONS

Abstract: Objectives Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones. Methods We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. Results The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. Conclusions The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.

Evaluation of patient and public involvement initiatives in health technology assessment: a survey of international agencies.

Abstract: Objectives: Although there is increased awareness of patient and public involvement (PPI) among health technology assessment (HTA) organizations, evaluations of PPI initiatives are relatively scarce. Our objective as members of Health Technology Assessment International's (HTAi's) Patient and Citizen Involvement Group (PCIG) was to advance understanding of the range of evaluation strategies adopted by HTA organizations and their potential usefulness. Methods: In March 2016, a survey was sent to fifty-four HTA organizations through the International Network of Agencies for Health Technology Assessment (INAHTA) and contacts of members of HTAi's PCIG. Respondents were asked about their organizational structure; how patients and members of the public are involved; whether and how PPI initiatives have been evaluated, and, if so, which facilitators and challenges to evaluation were found and how results were used and disseminated. Results: Fifteen (n = 15) programs from twelve countries responded (response rate 27.8 percent) that involved patients (14/15) and members of the public (10/15) in HTA activities. Seven programs evaluated their PPI activities, including participant satisfaction (5/7), process (5/7) and impact evaluations (4/7). Evaluation results were used to improve PPI activities, identify education and training needs, and direct strategic priorities. Facilitators and challenges revolved around the need for stakeholder buy-in, sufficient resources, senior leadership, and including patients in evaluations. Conclusions: A small but diverse set of HTA organizations evaluate their PPI activities using a range of strategies that reflect the range of rationales and approaches to PPI in HTA. It will be important for HTA organizations to

Assessing patient's perception of oral teleconsultation.

Abstract: Objectives: The evaluation of telemedicine from the patient's point of view has focused on the patient pathway and patient satisfaction However, research in this field does not provide us with the means to assess a patient's perception of the procedure if their reasoning ability is impaired In this study, we use direct observation of a patient's behavior and mood to assess their perception of an oral teleconsultation procedure Methods: This study has been conducted in the context of a pilot project using an asynchronous teleconsultation to improve access to dental care for the dependent elderly, disabled people, and prisoners, some of whom may be cognitively impaired We use a direct observation form consisting of five behavioral variables and eight affect variables to reflect the patient's experience of the oral teleconsultation procedure Results: A total of 135 patients were evaluated; 10 refused the procedure Psychotic patients (n = 33) had a somewhat negative experience during the oral teleconsultation procedure Patients who were not psychotic had a positive experience; this decreased as we moved from the autonomous to the semi-autonomous and then to the dependent sub-group Some gender differences were also noted Conclusions: Improving evidence on evaluating the acceptance of the cognitively impaired is required to improve the technology development process so that it can be translated into an improved patient experience and adherence Although the study was specifically focused on teledentistry, the approach described in this study could be adapted to other forms of teleconsultation

Contribution of stakeholder engagement to the impact of a health technology assessment: an irish case study.

Abstract: 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.

Developments in value frameworks to inform the allocation of healthcare resources.

Abstract: 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

Taking patient heterogeneity and preferences into account in health technology assessments.

Abstract: OBJECTIVES The INTEGRATE-HTA project provided methodology to evaluate complex technologies. This study provides guidance on how to retrieve and critically appraise available evidence on moderators and predictors of treatment effects and on patient preferences for treatment outcomes as a source of complexity. METHODS Search filters for PubMed were developed by hand-searching a large volume of articles reporting on relevant aspects. Search terms were retrieved from selected papers and algorithmically combined to find the optimal combination of search terms. For the development of the appraisal checklists literature was searched in PubMed and Google Scholar together with citation chasing. For the CHecklist for the Appraisal of Moderators and Predictors (CHAMP) a Delphi procedure was used to value a set of eligible appraisal criteria retrieved from the literature. RESULTS Search filters were developed optimized for different accuracy measures. The final version of CHAMP consists of a seventeen questions covering the design, analysis, results and transferability of results of moderator and predictor analysis. The final checklist for appraisal of literature on patient preferences for treatment outcomes consist of six questions meant to help the user to identify relevant quality issues together with a guidance toward existing tools concerning the appraisal of specific preference elicitation methods. CONCLUSIONS Incorporating knowledge on subgroups for whom a specific treatment will produce more benefit holds the promise of better targeting and, ultimately, enhancing overall effectiveness and efficiency of healthcare technology. Finally, incorporating information on preferences for treatment outcomes will foster health technology assessment that addresses outcomes that are important to patients.

Examining evidence in u.s. payer coverage policies for multi-gene panels and sequencing tests.

Abstract: Author(s): Chambers, James D; Saret, Cayla J; Anderson, Jordan E; Deverka, Patricia A; Douglas, Michael P; Phillips, Kathryn A | Abstract: OBJECTIVES:The aim of this study was to examine the evidence payers cited in their coverage policies for multi-gene panels and sequencing tests (panels), and to compare these findings with the evidence payers cited in their coverage policies for other types of medical interventions. METHODS:We used the University of California at San Francisco TRANSPERS Payer Coverage Registry to identify coverage policies for panels issued by five of the largest US private payers. We reviewed each policy and categorized the evidence cited within as: clinical studies, systematic reviews, technology assessments, cost-effectiveness analyses (CEAs), budget impact studies, and clinical guidelines. We compared the evidence cited in these coverage policies for panels with the evidence cited in policies for other intervention types (pharmaceuticals, medical devices, diagnostic tests and imaging, and surgical interventions) as reported in a previous study. RESULTS:Fifty-five coverage policies for panels were included. On average, payers cited clinical guidelines in 84 percent of their coverage policies (range, 73-100 percent), clinical studies in 69 percent (50-87 percent), technology assessments 47 percent (33-86 percent), systematic reviews or meta-analyses 31 percent (7-71 percent), and CEAs 5 percent (0-7 percent). No payers cited budget impact studies in their policies. Payers less often cited clinical studies, systematic reviews, technology assessments, and CEAs in their coverage policies for panels than in their policies for other intervention types. Payers cited clinical guidelines in a comparable proportion of policies for panels and other technology types. CONCLUSIONS:Payers in our sample less often cited clinical studies and other evidence types in their coverage policies for panels than they did in their coverage policies for other types of medical interventions.

Performance of ovid medline search filters to identify health state utility studies.

Abstract: Objectives: This study was designed to assess the sensitivity of three Ovid MEDLINE search filters developed to identify studies reporting health state utility values (HSUVs), to improve the performance of the best performing filter, and to validate resulting search filters. Methods: Three quasi-gold standard sets (QGS1, QGS2, QGS3) of relevant studies were harvested from reviews of studies reporting HSUVs. The performance of three initial filters was assessed by measuring their relative recall of studies in QGS1. The best performing filter was then developed further using QGS2. This resulted in three final search filters (FSF1, FSF2, and FSF3), which were validated using QGS3. Results: FSF1 (sensitivity maximizing) retrieved 132/139 records (sensitivity: 95 percent) in the QGS3 validation set. FSF1 had a number needed to read (NNR) of 842. FSF2 (balancing sensitivity and precision) retrieved 128/139 records (sensitivity: 92 percent) with a NNR of 502. FSF3 (precision maximizing) retrieved 123/139 records (sensitivity: 88 percent) with a NNR of 383. Conclusions: We have developed and validated a search filter (FSF1) to identify studies reporting HSUVs with high sensitivity (95 percent) and two other search filters (FSF2 and FSF3) with reasonably high sensitivity (92 percent and 88 percent) but greater precision, resulting in a lower NNR. These seem to be the first validated filters available for HSUVs. The availability of filters with a range of sensitivity and precision options enables researchers to choose the filter which is most appropriate to the resources available for their specific research.

Technology assessment in hospitals: lessons learned from an empirical experiment.

Abstract: Objectives: Hospital Based Health Technology Assessment (HBHTA) practices, to inform decision making at the hospital level, emerged as urgent priority for policy makers, hospital managers, and professionals. The present study crystallized the results achieved by the testing of an original framework for HBHTA, developed within Lombardy Region: the IMPlementation of A Quick hospital-based HTA (IMPAQHTA). The study tested: (i) the HBHTA framework efficiency, (ii) feasibility, (iii) the tool utility and completeness, considering dimensions and sub-dimensions. Methods: The IMPAQHTA framework deployed the Regional HTA program, activated in 2008 in Lombardy, at the hospital level. The relevance and feasibility of the framework were tested over a 3-year period through a large-scale empirical experiment, involving seventy-four healthcare professionals organized in different HBHTA teams for assessing thirty-two different technologies within twenty-two different hospitals. Semi-structured interviews and self-reported questionnaires were used to collect data regarding the relevance and feasibility of the IMPAQHTA framework. Results: The proposed HBHTA framework proved to be suitable for application at the hospital level, in the Italian context, permitting a quick assessment (11 working days) and providing hospital decision makers with relevant and quantitative information. Performances in terms of feasibility, utility, completeness, and easiness proved to be satisfactory. Conclusions: The IMPAQHTA was considered to be a complete and feasible HBHTA framework, as well as being replicable to different technologies within any hospital settings, thus demonstrating the capability of a hospital to develop a complete HTA, if supported by adequate and well defined tools and quantitative metrics.

Using the health technology assessment toolbox to facilitate procurement: the case of smart pumps in a canadian hospital.

Abstract: Objectives: The aim of this study was to present the experience of a Canadian hospital-based health technology assessment (HTA) unit that performed the traditional functions of the HTA process along with many other activities to facilitate the choice of smart pumps Methods: A rapid literature review was initiated, but little evidence was found Moreover, the evidence provided was too far from our hospital context To help our decision makers, we offered them a list of various services based on the skills of our HTA unit staff Results: To involve our HTA unit in the choice of the new smart pumps led to a strong collaboration between hospital services After a rapid review on smart pumps, we proceeded to establish the clinical needs, followed by an evaluation of technical features To ascertain clinical needs, we participated in the establishment of a conformity list for the tender, a failure and mode-effect analysis, an audit on the use of actual smart pumps, and simulation exercises with nurses and doctors to evaluate the ease of use and ergonomics With regard to technical tests, these were mainly conducted to identify potential dysfunction and to assess the efficiency of the pump This experience with smart pumps was useful for evidence-based procurement and led to the formulation of a nine-step process to guide future work Conclusions: HTA units and agencies are faced with rapid development of new technologies that may not be supported by sufficient amount of pertinent published evidence Under these circumstances, approaches other than evidence-based selection might provide useful information Because these activities may be different from those related to classic HTA, this widens the scope of what can be done in HTA to support decision making

Reducing potentially inappropriate prescribing for older people in primary care: cost-effectiveness of the opti-script intervention.

Abstract: Objectives This study examines the cost-effectiveness of the OPTI-SCRIPT intervention on potentially inappropriate prescribing in primary care. Methods Economic evaluation, using incremental cost-effectiveness and cost utility analyses, conducted alongside a cluster randomized controlled trial of twenty-one general practices and 196 patients, to compare a multifaceted intervention with usual practice in primary care in Ireland. Potentially inappropriate prescriptions (PIPs) were determined by a pharmacist. Incremental costs, PIPs, and quality-adjusted life-years (QALYs) at 12-month follow-up were estimated using multilevel regression. Uncertainty was explored using cost-effectiveness acceptability curves. Results The intervention was associated with a nonsignificant mean cost increase of €407 (95 percent CIs, -357-1170), a significant mean reduction in PIPs of 0.379 (95 percent CI, 0.092-0.666), and a nonsignificant mean increase in QALYs of 0.013 (95 percent CIs, -0.016-0.042). The incremental cost per PIP avoided was €1,269 (95 percent CI, -1400-6302) and the incremental cost per QALY gained was €30,535 (95 percent CI, -334,846-289,498). The probability of the intervention being cost-effective was 0.602 at a threshold value of €45,000 per QALY gained and was at least 0.845 at threshold values of €2,500 per PIP avoided and higher. Conclusions While the OPTI-SCRIPT intervention was effective in reducing potentially inappropriate prescribing in primary care in Ireland, our findings highlight the uncertainty with respect to its cost-effectiveness. Further studies are required to explore the health and economic implications of interventions targeting potentially inappropriate prescribing.

Health technology disinvestment worldwide: overview of programs and possible determinants.

Abstract: Objectives In the past decade, there has been a growing interest in health technology disinvestment. A disinvestment process should involve all relevant stakeholders to identify and deliver the most effective, safe, and cost-effective healthcare interventions. The aim of the present study was to describe the state of the art of health technology disinvestment around the world and to identify parameters that could be associated with the implementation of disinvestment programs. Methods A systematic review of the literature was performed from database inception to November 2014, together with the collection of original data on socio-economic indicators from forty countries. Results Overall, 1,456 records (1,199 from electronic databases and 257 from other sources) were initially retrieved. After analyzing 172 full text articles, 38 papers describing fifteen disinvestment programs/experiences in eight countries were included. The majority (12/15) of disinvestment programs began after 2006. As expected, these programs were more common in developed countries, 63 percent of which had a Beveridge model healthcare system. The univariate analysis showed that countries with disinvestment programs had a significantly higher level of Human Development Index, Gross Domestic Product per capita, public expenditure on health and social services, life expectancy at birth and a lower level of infant mortality rate, and of perceived corruption. The existence of HTA agencies in the country was a strong predictor (p = .034) for the development of disinvestment programs. Conclusions The most significant variables in the univariate analysis were connected by a common factor, potentially related to the overall development stage of the country.

Health technology assessment of public health interventions: a synthesis of methodological guidance.

Abstract: Objectives: The evaluation of public health interventions poses some challenges. As a consequence, health technology assessment (HTA) methods for public health interventions (PHI) have to be adapted. This study aimed to summarize the available guidance on methods for HTA of PHI. Methods: We systematically searched for methodological guidance on HTA of PHIs. Our focus was on research synthesis methods to evaluate effectiveness. Relevant information was synthesized narratively in a standardized way. Results: Only four guidance documents were identified specifically for HTAs of PHI. The approaches used for HTAs of PHIs are broader and more flexible than those for medical interventions. For this reason, there is a tendency to identify the intervention components and context factors that influence the effectiveness and transferability of an intervention rather than to assess its effectiveness in general. The details in the guidance vary without justification. Unjustified heterogeneity between the different guidance approaches is most pronounced for quality assessment, assessment of applicability, and methods to integrate qualitative and quantitative evidence. Descriptions for the assessment of integrity, heterogeneity, sustainability, context factors, and applicability are often vague. Conclusions: The heterogeneity in approaches indicates that there is currently no consensus on methods to deal with the challenges of the PHI evaluations. A possible explanation for this may be that the methods are not sufficiently developed, and advantages and disadvantages of a certain method in relation to the research question (e.g., broad/focused) have not yet been sufficiently evaluated.

Electronic devices for cognitive impairment screening: a systematic literature review.

Abstract: OBJECTIVES: The reduction in cognitive decline depends on timely diagnosis. The aim of this systematic review was to analyze the current available information and communication technologies-based instruments for cognitive decline early screening and detection in terms of usability, validity, and reliability. METHODS: Electronic searches identified 1,785 articles of which thirty-four met the inclusion criteria and were grouped according to their main purpose into test batteries, measures of isolated tasks, behavioral measures, and diagnostic tools. RESULTS: Thirty one instruments were analyzed. Fifty-two percent were personal computer based, 26 percent tablet, 13 percent laptop, and 1 was mobile phone based. The most common input method was touchscreen (48 percent). The instruments were validated with a total of 4,307 participants: 2,146 were healthy older adults (M = 73.59; SD = 5.12), 1,104 had dementia (M = 74.65; SD = 3.98) and 1,057 mild cognitive impairment (M = 74.84; SD = 4.46). Only 6 percent were administered at home, 19 percent reported outcomes about usability, and 22 percent about understandability. The methodological quality of the studies was good, the weakest methodological area being usability. Most of the instruments obtained acceptable values of specificity and sensitivity. CONCLUSIONS: It is necessary to create home delivered instruments and to include usability studies in their design. Involvement of people with cognitive decline in all phases of the development process is of great importance to obtain valuable and user-friendly products. It would be advisable for researchers to make an effort to provide cutoff points for their instruments.

Integrate-hta: a low- and middle-income country perspective

Abstract: Objectives: The INTEGRATE-HTA project recommends that complexity be taken into account when conducting health technology assessments (HTAs) and suggests a five-step process for doing that. This study examines whether the approach suggested by INTEGRATE-HTA could be useful, appropriate, and feasible in the context of low- and middle-income countries (LMIC) given some of the typical challenges that healthcare systems face in those countries. Methods: A nonexhaustive literature review was performed on the implementation in low and middle income countries of the five aspects recommended by the INTEGRATE-HTA project, using the following search terms: national health planning, health sector strategy, health sector performance, assessment criteria, health (management) information, complexity, context, stakeholder consultation. Results: HTA is being practiced in LMIC in various ways and through different mechanisms, for example in health sector reviews, even though it is usually not referred to as HTA. It does not necessarily follow the five steps distinguished in the INTEGRATE-HTA model (scoping; defining the initial logic model; providing concepts and methods to identify, collect, and synthesize evidence in relation to various dimensions; extracting and presenting evidence in respect of agreed assessment criteria; providing guidance to draw conclusions and formulate recommendations). Conclusions: The conditions for functional HTA are not always fulfilled in LMICs. At least four aspects would require special attention: (a) the scope and quality of routine health information that can support and be fed into health technology assessments and strategic planning; (b) consensus on health system performance assessment frameworks and their main criteria, in particular the inclusion of social disparities/equity and sustainability; (c) institutional capacity to set evidence-based priorities based on a variety of explicit criteria; (d) political will to engage with stakeholders in a transparent and inclusive consultation process about health priorities.

Gene expression profiling and expanded immunohistochemistry tests to guide selection of chemotherapy regimens in breast cancer management: a systematic review.

Abstract: OBJECTIVES: The aim of this report was to assess the clinical effectiveness of two Gene expression profiling (GEP) and two expanded immunohistochemistry (IHC) tests compared with current prognostic tools in guiding the use of adjuvant chemotherapy in patients with early breast cancer. METHODS: A systematic review of the evidence on clinical effectiveness of OncotypeDX, IHC4, MammaPrint and Mammostrat, compared with current clinical practice using clinicopathological parameters, in women with early breast cancer was conducted. Ten databases were searched to include citations to May 2016. RESULTS: Searches identified 7064 citations, of which 41 citations satisfied the criteria for the review. A narrative synthesis was performed. Evidence for OncotypeDX demonstrated the impact of the test on decision-making and there was some support for OncotypeDX predicting chemotherapy benefit. There were relatively lower levels of evidence for the other three tests included in the analysis. MammaPrint, Mammostrat and IHC4 tests were limited to a small number of studies. Limitations in relation to study design were identified for all tests. CONCLUSIONS: The evidence base for OncotypeDX is considered to be the most robust. Methodological weaknesses relating to heterogeneity of patient cohorts and issues arising from the retrospective nature of the evidence were identified. Further evidence is required for all of the tests using prospective randomised controlled trial data.

Most important barriers and facilitators regarding the use of health technology assessment.

Abstract: Objectives: Several studies have reported multiple barriers to and facilitators for the uptake of health technology assessment (HTA) information by policy makers. This study elicited, using best-worst scaling (BWS), the most important barriers and facilitators and their relative weight in the use of HTA by policy makers. Methods: Two BWS object case surveys (one for barriers, one for facilitators) were conducted among sixteen policy makers and thirty-three HTA experts in the Netherlands. A list of twenty-two barriers and nineteen facilitators was included. In each choice task, participants were asked to choose the most important and the least important barrier/facilitator from a set of five. We used Hierarchical Bayes modeling to generate the mean relative importance score (RIS) for each factor and a subgroup analysis was conducted to assess differences between policy makers and HTA experts. Results: The five most important barriers (RIS > 6.00) were “no explicit framework for decision-making process,” “insufficient support by stakeholders,” “lack of support,” “limited generalizability,” and “absence of appropriate incentives.” The six most important facilitators were: “availability of explicit framework for decision making,” “sufficient support by stakeholders,” “appropriate incentives,” “sufficient quality,” “sufficient awareness,” and “sufficient support within the organization.” Overall, perceptions did not differ markedly between policy makers and HTA experts. Conclusions: Our study suggests that barriers and facilitators related to “policy characteristics” and “organization and resources” were particularly important. It is important to stimulate a pulse at the national level to create an explicit framework for including HTA in the decision-making context.

Exploring values of health technology assessment agencies using reflective multicriteria and rare disease case.

Abstract: Objectives: Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease. Methods: Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise. Results: Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions’ values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of “alleviating or preventing patient suffering,” “serving the whole population equitably,” “upholding healthcare system sustainability,” and “making decisions informed by evidence and context” but may help share the ethical reasoning behind decisions. Incorporating “Priorities” (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives. Conclusions: Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.

Attitudes of orthopedic specialists toward effects of medical device purchasing.

Abstract: Objectives: The aim of this study was to assess viewpoints of end-users concerning the purchasing process of high-risk medical devices and to discuss the relevance of health technology assessments (HTAs) at the hospital level and other potential areas for improvement of purchasing processes. Methods: We used a cross-sectional study and assessed the attitudes and thoughts of orthopedic specialists. The study took place between June and October 2015 in Mexico. Results: We collected data from 187 orthopedic surgeons. Involvement of orthopedic specialists in purchasing was reported by 86 percent. However, clinical practice was perceived as negatively influenced by purchasing outcomes by 92 percent. The problems were described as: material failure; effectiveness of medical devices; obsolete medical device technology; incomplete provision of implant / instrument sets; delayed provision of implants and instruments. Conclusions: To prevent sub-standard outcomes of purchasing decisions, this study and the current literature suggest that technologies should be assessed during the purchasing process, end-users should be adequately involved, and decisions should be based on multiple criteria including clinical impact in the short-term (e.g., primary stability of implant) and long-term (e.g., survival of implant). The focus on Mexico is particularly novel and provides insights into a health system where HTA is mainly present at the macro level and can be used for the listing of medical device technologies in the standard list. This study concludes that Mexican stakeholders of the purchasing process underestimate the contribution of HTAs at the level of purchasing decisions. HTA in Mexico has improved over the past years but still requires more advancement.

Patient-centered decision making: lessons from multi-criteria decision analysis for quantifying patient preferences.

Abstract: Objectives: Patient preferences should be a central consideration in healthcare decision making. However, stories of patients challenging regulatory and reimbursement decisions has led to questions on whether patient voices are being considered sufficiently during those decision making processes. This has led some to argue that it is necessary to quantify patient preferences before they can be adequately considered. Methods: This study considers the lessons from the use of multi-criteria decision analysis (MCDA) for efforts to quantify patient preferences. It defines MCDA and summarizes the benefits it can provide to decision makers, identifies examples of MCDAs that have involved patients, and summarizes good practice guidelines as they relate to quantifying patient preferences. Results: The guidance developed to support the use of MCDA in healthcare provide some useful considerations for the quantification of patient preferences, namely that researchers should give appropriate consideration to: the heterogeneity of patient preferences, and its relevance to decision makers; the cognitive challenges posed by different elicitation methods; and validity of the results they produce. Furthermore, it is important to consider how the relevance of these considerations varies with the decision being supported. Conclusions: The MCDA literature holds important lessons for how patient preferences should be quantified to support healthcare decision making.

Introduction of health technology assessment for medicines in slovakia.

Abstract: Objectives: The aim of our study was to describe approaches to health technology assessment (HTA) for medicines in the Slovak healthcare system and the related decision-making processes concerning reimbursement for medicines. Methods: Analysis of the Slovak legislative framework related to HTA and the reimbursement process for medicines was performed. Additionally, current practices of the Working Group for Pharmacoeconomics, Clinical Outcomes and Health Technology Assessment of the Slovak Ministry of Health were evaluated. Results: In Slovakia, there is always at least one treatment available in each determined therapeutic class with no co-payment. HTA is becoming an established method for the evaluation of cost-effectiveness of medicines in Slovak healthcare policy. The majority of decision makers within Slovakia support the idea of increased use of and the quality and efficiency of HTA methods. However, it is crucial to overcome several practical barriers to facilitate progress in the field of HTA in the Slovak Republic. Conclusions: It can be seen that participation within the European Network for Health Technology Assessment (EUnetHTA JA 2 and EUnetHTA JA 3 projects) has significantly improved the quality of the process of HTA in Slovakia. Further legislative activities in this field are required due to the approved strategy for European Union cooperation on HTA.

Drug disinvestment frameworks: components, challenges, and solutions.

Abstract: Objectives Value assessments of marketed drug technologies have been developed through disinvestment frameworks. Components of these frameworks are varied and implementation challenges are prevalent. The objective of this systematic literature review was to describe disinvestment framework process components for drugs and to report on framework components, challenges, and solutions. Methods A systematic literature search was conducted using the terms: reassessment, reallocation, reinvestment, disinvestment, delist, decommission or obsolescence in MEDLINE, EMBASE, NLM PubMed, the Cochrane Library, and CINAHL from January 1, 2000, until November 14, 2015. Additional citations were identified through a gray literature search of Health Technology Assessment international (HTAi) and the International Network of Agencies for Health Technology Assessment (INAHTA) member Web sites and from bibliographies of full-text reviewed manuscripts. Results Sixty-three articles underwent full text review and forty were included in the qualitative analysis. Framework components including disinvestment terms and definitions, identification and prioritization criteria and methods, assessment processes, stakeholders and dissemination strategies, challenges, and solutions were compiled. This review finds that stakeholders lack the political, administrative, and clinical will to support disinvestment and that there is not one disinvestment framework that is considered best practice. Conclusions Drug technology disinvestment components and processes vary and challenges are numerous. Future research should focus on lessening value assessment challenges. This could include adopting more neutral framework terminology, setting fixed reassessment timelines, conducting therapeutic reviews, and modifying current qualitative decision-making assessment frameworks.

Exploration and preferential ranking of patient benefits of medical devices: a new and generic instrument for health economic assessments.

Abstract: Objectives: For medical devices, benefits other than direct clinical effects may have a large impact on the patients’ well-being, but a standardized method for measuring these benefits is unavailable. The objective was to explore potential patient benefits provided by medical devices, and to assess the relative preferences of these benefits in the general Swedish population. Methods: To identify attributes of patient benefit, healthcare personnel within a wide range of disease areas were interviewed. The generalized attributes were then validated among healthcare personnel, patient organizations, and manufacturers; in two pilot studies in the general population; and in two rounds of cognitive interviews. The general population's preferences of the attributes were measured with a usability-tested questionnaire in a final responding sample of 3,802 individuals, representative of the Swedish population. Results: Twenty attributes were identified, encompassing aspects of integrity, sense of security, social participation, and convenience. When measuring the relative preferences, the response rate was 37.0 percent, and the results showed that the attributes with the highest preferences concerned reliability, reduced need for assistance, and sense of control of the illness/disability. Conclusions: A set of twenty attributes of patient benefit relevant to users of medical devices was identified and validated. A questionnaire for patient-reported assessment of the benefits provided by a medical device was developed, based on the attributes. The questionnaire, designated MedTech20, provides a generic measurement method for the evaluation of medical devices used in a wide range of diseases/disabilities.