The way choice is presented has an impact on decision-making. This is the case also in the context of neonatal intensive care units (NICUs), particularly in the challenging cases that concern the limit of viability. The objective of this article is to examine the role of nudging in the shared decision-making in neonatology and elaborate on the respective moral challenges.

Nudging is not morally neutral. There are two key sources of ethical issues at the heart of nudging. The first one concerns the lack of transparency, while the second concerns the background value judgments that are imminent whenever nudging is used for achieving a particular end. To solve the underlying conflict, a virtue ethics approach combined with the accountability for reasonableness framework is suggested to guide the use of the tool of nudging.

NICU professionals ought to use the tool of nudging transparently in line with their act of profession and their practically wise judgment.

Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model® provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement (“access evidence”).

Tools were developed to systematically scope, assess, plan, and summarize access evidence generation. The tools were based mainly on the first four HTA Core Model® domains and rolled-out in selected development teams in 2017. Five months after full implementation, the impact of tools was assessed in an internal survey.

Systematic access evidence generation started with the Access Evidence Questionnaire, to scope evidence requirements and identify evidence gaps. Findings were summarized in the Access Evidence Metric, which assessed the alignment of available/planned evidence against HTA bodies’ requirements and developed scope mitigation strategies. The Access Evidence Plan was then used to plan and document (additional) evidence generation. Once generated, evidence was summarized in the Access Evidence Dossier. A survey of twenty-seven Roche employees involved in evidence generation showed that the tools made discussions around access strategies and evidence more efficient and transparent.

The HTA Core Model® provided a useful framework around which to optimize internal evidence generation and assessment. The benefits of using a standardized HTA approach in industry mirror those expected from implementing the HTA Core Model® in HTA agencies.

Early assessment can assist in allocating resources for innovation effectively and produce the most beneficial technology for an institution. The aim of the present study was to identify methods and discuss the analytical approaches applied for the early assessment of innovation in a healthcare setting.

Knowledge synthesis based on a structured search (using the MEDLINE, Embase, and Cochrane databases) and thematic analysis was conducted. An analytical framework based on the stage of innovation (developmental, introduction, or early diffusion) was applied to assess whether methods vary according to stage. Themes (type of innovation, study, analysis, study design, method, and main target audience) were then decided among the authors. Identified methods and analysis were discussed according to the innovation stage.

A total of 1,064 articles matched the search strategy. Overall, thirty-nine articles matched the inclusion criteria. The use of methods has a tendency to change according to the stage of innovation. Stakeholder analysis was a prominent method in the innovation stages and particularly in the developmental stage, as the introduction and early diffusion stage has more availability of data and may apply more complex methods. Barriers to the identified methods were also discussed as all of the innovation stages suffered from lack of data and substantial uncertainty.

Although this review has identified applicable approaches for early assessment in different innovation stages, research is required regarding the value of the available data and methods and tools to enhance interactions between different parties at different stages of innovation.

The aim of this overview was to systematically identify and synthesize existing evidence from systematic reviews on the impact of prehospital physician involvement.

The Medline, Embase, and Cochrane library were searched from 1 January 2000 to 17 November 2017. We included systematic reviews comparing physician-based with non–physician-based prehospital treatment in patients with one of five critical conditions requiring a rapid response.

Ten reviews published from 2009 to 2017 were included. Physician treatment was associated with increased survival in patients with out-of-hospital cardiac arrest and patients with severe trauma; in the latter group, the result was based on more limited evidence. The success rate of prehospital endotracheal intubation (ETI) has improved over the years, but ETI by physicians is still associated with higher success rates than intubation by paramedics. In patients with severe traumatic brain injury, intubation by paramedics who were not well skilled to do so markedly increased mortality.

Current evidence is hinting at a benefit of physicians in selected aspects of prehospital emergency services, including treatment of patients with out-of-hospital cardiac arrest and critically ill or injured patients in need of prehospital intubation. Evidence is, however, limited by confounding and bias, and comparison is hampered by differences in case mix and the organization of emergency medical services. Future research should strive to design studies that enable appropriate control of baseline confounding and obtain follow-up data for the proportion of patients who die in the prehospital setting.

The aim of this study was to estimate the effectiveness of first-line biologic disease modifying drugs(boDMARDs), and their approved biosimilars (bsDMARDs), compared with conventional (csDMARD) treatment, in terms of ACR (American College of Rheumatology) and EULAR (European League against Rheumatism) responses.

Systematic literature search, on eight databases to January 2017, sought ACR and EULAR data from randomized controlled trials (RCTs) of boDMARDs / bsDMARDs (in combination with csDMARDs, or monotherapy). Two adult populations: methotrexate (MTX)-naïve patients with severe active RA; and csDMARD-experienced patients with moderate-to-severe active RA. Network meta-analyses (NMA) were conducted using a Bayesian Markov chain Monte Carlo simulation using a random effects model with a probit link function for ordered categorical.

Forty-six RCTs met the eligibility criteria. In the MTX-naïve severe active RA population, no biosimilar trials meeting the inclusion criteria were identified. MTX plus methylprednisolone (MP) was most likely to achieve the best ACR response. There was insufficient evidence that combination boDMARDs was superior to intensive (two or more) csDMARDs. In the csDMARD-experienced, moderate-to-severe RA population, the greatest effects for ACR responses were associated with tocilizumab (TCZ) monotherapy, and combination therapy (plus MTX) with bsDMARD etanercept (ETN) SB4, boDMARD ETN and TCZ. These treatments also had the greatest effects on EULAR responses. No clear differences were found between the boDMARDs and their bsDMARDs.

In MTX-naïve patients, there was insufficient evidence that combination boDMARDs was superior to two or more csDMARDs. In csDMARD-experienced patients, boDMARDs and bsDMARDs were comparable and all combination boDMARDs / bsDMARDs were superior to single csDMARD.

Cardiac surgery has seen substantial scientific progress over recent decades. Health economic evaluations have become important tools for decision makers to prioritize scarce health resources. The present study aimed to identify and critically appraise the reporting quality of health economic evaluations conducted in the field of cardiac surgery.

A literature search was performed to identify health economic evaluations in cardiac surgery. The consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement was used to assess the quality of reporting of studies.

A total 4,705 articles published between 1981 and 2016 were identified; sixty-nine studies fulfilled the inclusion criteria. There was a trend toward a greater number of publications and reporting quality over time. Six (8.7 percent) studies were conducted between 1981 and 1990, nine (13 percent) between 1991 and 2000, twenty-four (34.8 percent) between 2001 and 2010, and thirty (43.5 percent) after 2011. The mean CHEERS score of all articles was 16.7/24; for those published between 1980 and 1990 the mean (SD) score was 10.2 (±1.4), for those published between 1991 and 2000 it was 11.2 (±2.4), between 2001 and 2010 it was 15.3 (±4.8), and after 2011 it was 19.9 (±2.9). The quality of reporting was still insufficient for several studies after 2000, especially concerning items “characterizing heterogeneity,” “assumptions,” and “choice of model.”

The present study suggests that, even if the quantity and the quality of health economics evaluation in cardiac surgery has increased, there remains a need for improvement in several reporting criteria to ensure greater transparency.

Procurement's important role in healthcare decision making has encouraged criticism and calls for greater collaboration with health technology assessment (HTA), and necessitates detailed analysis of how procurement approaches the decision task.

We reviewed tender documents that solicit medical technologies for patient care in Canada, focusing on request for proposal (RFP) tenders that assess quality and cost, supplemented by a census of all tender types. We extracted data to assess (i) use of group purchasing organizations (GPOs) as buyers, (ii) evaluation criteria and rubrics, and (iii) contract terms, as indicators of supplier type and market conditions.

GPOs were dominant buyers for RFPs (54/97) and all tender types (120/226), and RFPs were the most common tender (92/226), with few price-only tenders (11/226). Evaluation criteria for quality were technical, including clinical or material specifications, as well as vendor experience and qualifications; “total cost” was frequently referenced (83/97), but inconsistently used. The most common (47/97) evaluative rubric was summed scores, or summed scores after excluding those below a mandatory minimum (22/97), with majority weight (64.1 percent, 62.9 percent) assigned to quality criteria. Where specified, expected contract lengths with successful suppliers were high (mean, 3.93 years; average renewal, 2.14 years), and most buyers (37/42) expected to award to a single supplier.

Procurement's evaluative approach is distinctive. While aiming to go beyond price in the acquisition of most medical technologies, it adopts a narrow approach to assessing quality and costs, but also attends to factors little considered by HTA, suggesting opportunities for mutual lesson learning.

Patient involvement in drug evaluation decision making is increasing. The aim of the current study was to develop a multi-criteria decision analysis (MCDA) framework that would enable the inclusion of the patient perspective in the selection of appropriate criteria for MCDAs being used in the value assessments of oncologic drugs.

A literature review was conducted to identify and define criteria used in drug assessments from patient perspectives. The Evidence and Value: Impact on Decision Making methodology was used to develop a MCDA framework. Identified criteria were discussed by a sample of oncology patient association representatives who decided which criteria were important from patient perspectives. Selected criteria were rated by importance. The preliminary MCDA framework was tested through the assessment of a hypothetical oncology treatment. A discussion was carried out to agree on a final pilot MCDA framework.

Twenty-two criteria were extracted from the literature review. After criteria discussion, sixteen criteria remained. The most important criteria were comparative patient reported outcomes (PRO), comparative efficacy and disease severity. After the discussion generated by the scoring of the hypothetical oncology treatment, the final pilot MCDA framework included seven quantitative criteria (“disease severity”, “unmet needs”, “comparative efficacy / effectiveness”, “comparative safety / tolerability”, “comparative PROs”, “contribution of oncological innovation”) and one contextual criterion (“population priorities and access”).

The present study developed a pilot reflective MCDA framework that could increase patient's capability to participate in the decision-making process by providing systematic drug assessments from the patient perspective.

The recent development of value frameworks to inform healthcare resource allocation responds to a demand to make the decision-making process more inclusive and explicit. The objectives of the 2018 Latin American (LAtam) Health Technology Assessment International (HTAi) Policy Forum were to explore the current international experiences and to discuss the potential application of value frameworks in Latin America.

A background paper, presentations, and group discussions of Policy Forum members (43 participants, 12 LAtam countries represented) at the 2018 HTAi Policy Forum meeting informed this paper.

Participants agreed that HTA and decision making based on more comprehensive and inclusive value frameworks could improve health system effectiveness, efficiency, sustainability, and equity; promote transparency in the decision process; sustain a more comprehensive assessment of technologies; and facilitate stakeholder participation as well as accountability of decisions. Criteria that were identified as essential to be included in a value framework for LAtam were burden of illness and severity of the disease, effectiveness and safety of the technology, quality of the evidence, cost-effectiveness, and budget impact. Potential challenges identified for the application of value frameworks in LAtam, included scarcity of human resources and delays in the assessment process.

Forum participants agreed that the next steps should be to identify appropriate processes and methodologies, adapted to the context of each country, regarding the application of value frameworks to improve the link between HTA and decision making.

El reciente desarrollo de marcos de valor responde a una demanda por hacer más explícito e inclusivo el proceso de toma de decisiones sobre asignación de recursos sanitarios. El objetivo del Foro de Políticas en Latino América 2018 de Health Technology Assessment International fue explorar las experiencias internacionales y discutir la potencial aplicación de marcos de valor en la región.

Este manuscrito está basado en un documento base y en las presentaciones y discusiones mantenidas por los miembros del Foro (43 participantes, 12 países) durante el Foro del 2018.

Los participantes coincidieron en que un proceso de evaluación y toma de decisión basado en marcos de valor más inclusivos y abarcativos podría mejorar la efectividad, eficiencia, sustentabilidad y equidad; promover la transparencia y una evaluación más completa de las tecnologías, mejorar la rendición de cuentas de las decisiones y la participación de actores. Se identificaron como criterios esenciales para ser incluidos en marcos de valor en la región a la carga de enfermedad y severidad de la condición, la efectividad y seguridad de la tecnología, la calidad de la evidencia, la costo-efectividad e impacto presupuestario. Los potenciales desafíos para su implementación identificados incluyeron la escasez de recursos humanos y las demoras en el proceso de evaluación que se podrían producir.

Los participantes remarcaron que los próximos pasos deberían ser identificar procesos y metodologías apropiadas, adaptadas al contexto de cada país, para facilitar la aplicación de marcos de valor y mejorar el vínculo entre la evaluación y la toma de decisiones.