Innovative digital health technologies (DHTs) may present new aspects of value that are not appropriately accounted for in current health technology assessments. In discovering what value means in the context of DHTs, multi-stakeholder collaboration is essential.

A scoping literature review was conducted to identify current value assessment criteria and proposed methodologies across three health systems: United States of America, United Kingdom, and Germany. A Delphi exercise was conducted with stakeholders from the following groups: users, healthcare practitioners, decision-makers, supply-side actors, and influencers. Based on a review of assessment frameworks in the study countries and consultations with experts from each stakeholder group, researchers proposed value constructs in five domains: health inequalities, data rights and governance, technical and security, economic characteristics, clinical characteristics, and user preferences. In Delphi round one, participants commented on the proposed constructs and submitted their own. A thematic analysis identifying key concepts and themes of the participant proposed constructs and comments was used to incorporate this information for round two. Then, participants rated each value construct on an ‘importance’ Likert scale in two decision contexts: user-facing DHTs and system-facing DHTs. In round three, participants were presented with the consensus judgement for each construct, with the opportunity to change their answer. Value constructs with equal to or greater than 70 percent consensus were included in the final framework. Rounds four and five were, respectively, value judgements on a Likert scale and a presentation of consensus for a therapeutic area to test the final framework.

Initially 32 value constructs were proposed by researchers, 20 of which were changed or removed based on round one feedback. Additional constructs were added based on participant suggestions resulting in forty-five value constructs in round two. The final framework will be available after round three closes on 20 December 2022.

The multi-stakeholder Delphi approach ensures that all suggestions and value judgements are weighted equally across stakeholder groups. The resultant value framework can be used to inform policymaking around health technology assessment of DHTs.

We sought to examine patients’ perceptions of disease burden and treatment impact, and what patients value over the course of the asthma experience.

Patient focus groups were conducted in three countries, the USA (n = 8 patients), the United Kingdom (n = 7 patients), and Germany (n = 7 patients), to examine aspects of disease burden and patient experience (physical, emotional, clinical, economic, and social). Cause and effect were also explored. Global Initiative for Asthma guidelines were used to screen patients by severity, based on age, sex, time since diagnosis, number of attacks, oral corticosteroid use, and number of therapies needed to control symptoms. Patients classified and ranked aspects of disease burden, including whether it was continuous or episodic in nature, and discussed the interventions used to manage their asthma.

The overall burden of illness was driven by the combined effect of the disease and treatment burdens. All patients highlighted the negative impact of oral corticosteroids. Patients believed that they were the key actors in their asthma management (not healthcare professionals), and reported the physical and emotional burdens as being the most dominant. Understanding of the terms “attack” or “exacerbation” differed significantly between patients, and did not necessarily match the clinical definitions. Patients considered asthma to be an individualized condition that drives lifestyle changes; disease management drives burden and vice versa. Patients perceived that burden was continuous over time, with specific phases of variable duration—before, during, and after an attack—whereas other stakeholders had a more episodic focus. Patients expected more holistic and personalized approaches for managing their asthma.

The research indicated a misalignment between what patients value and what clinicians, payers, and regulators consider in their assessments and decisions. Greater alignment among the different stakeholders, and more inclusion of patients’ values in decision making, will improve outcomes.

In 2020, Canada spent 12.9 percent of its GDP on healthcare, of which 3 percent was on medical devices. Early adoption of innovative surgical devices is mostly driven by physicians and delaying adoption can deprive patients of important medical treatments. This study aimed to identify the criteria in Canada used to decide on the adoption of a surgical device and identify challenges and opportunities.

This scoping review was guided by the Joanna Briggs Institute Manual for Evidence Synthesis and PRISMA-ScR reporting guidelines. The search strategy included Canada’s provinces, different surgical fields, and adoption. Embase, Medline, and provincial databases were searched. Grey literature was also searched. Data were analyzed by reporting the criteria that were used for technology adoption. Finally, a thematic analysis by subthematic categorization was conducted to arrange the criteria found.

Overall, 155 studies were found. Seven were hospital-specific studies and 148 studies were from four provinces with publicly available Web sites for technology assessment committees (Alberta, British Columbia, Ontario, and Quebec). Seven main themes of criteria were identified: economic, hospital-specific, technology-specific, patients/public, clinical outcomes, policies and procedures, and physician specific. However, standardization and specific weighted criteria for decision making in the early adoption stage of novel technologies are lacking in Canada.

Specific criteria for decision making in the early adoption stage of novel surgical technologies are lacking. These criteria need to be identified, standardized, and applied in order to provide innovative, and the most effective healthcare to Canadians.

Increased capacity for utilization of Health Technology Assessment (HTA) is key to ensuring high-impact; affordable health technologies reach the people who need them most. It also enables an environment for research in access to lifesaving technologies and innovations. The number of people suffering from one or more chronic diseases is rapidly increasing and the existing systems of care are not adequately addressing this increase. Increased HTA visibility provides an opportunity for a formal connection of Health Technologies (HTs), building a new working relationship among patients and healthcare professionals, health system strengthening, engagement of patients /consumers and health care professionals for follow up on existing HTs, and assessing new Health Technology innovations.

We reviewed existing HTA literature, and hosted a meeting of fifty participants at the first HTA meeting representing different health stakeholders including patients. The meeting explored innovative synergies that addressed best practices in health policy and technological decision making, and opportunities for integrating HTA in Uganda's Health system.

Induced practical skills in coordinating a number of uncoordinated health technologies to over forty participants, an HTA strategy developed to complement national HTA initiatives and to generate information and tools to facilitate the start of hospital-based HTA initiatives in hospitals countrywide and regionally, to improve quality and efficiency of current initiatives. An HTA association, “Uganda Association of Health Technology Assessment - UAHTA” was formed, and a work plan for piloting hospital based HTA was developed.

A Health Technology Assessment (HTA) system will enable comprehensive patient-centered, integrated (as opposed to simultaneous but independent) assessment of complex health technologies. There is a need for increased capacity and partnerships towards evidence generation, and accountability measures.

Following a first field evaluation conducted in 2013, we found that hemolysis can be induced by infusion pumps during blood transfusion. Actually, limited data is available on the risk of hemolysis associated with the most used infusion pumps in Quebec hospitals: InfusomatSpace (peristaltic), Plum A+TM (piston) and ColleagueCXE (shuttle).

Staff from the blood bank and the Health Technology Assessment (HTA) unit in our hospital collaborated in 2016 to assess the hemolysis and potassium level (that is, a blood test sensitive to hemolysis) induced by the use of the three infusion pumps mentioned above. Measurements were taken for each pump at five flow rates, from 30 to 450 ml/hour, and were compared with measurements taken before using the pumps. Tests were conducted with 135 red blood cell (RBC) units. RBC units were aged from 10 to 28 days.

The shuttle- and piston-type pumps resulted in low hemolysis levels. The peristaltic-type pump produced significantly more hemolysis. However, the absolute value of hemolysis remained within the range recommended by the regulatory agencies in North America and Europe. Potassium levels did not increase with the use of the pumps.

The collaboration between the blood bank and the HTA unit led to the conclusion that modern infusion pumps widely used in Quebec hospitals produce non-threatening levels of hemolysis during blood transfusion. This finding is important to ensure safe practices.

Un vínculo claro entre la evaluación y la toma de decisión constituye un principio de buena práctica en evaluación de tecnologías sanitarias (ETESA) reconocido a nivel internacional. El objetivo del Foro de Políticas en Latino-América (LatamPF) 2019 de Health Technology Assessment International fue explorar los diferentes modelos que vinculan la ETESA y la toma de decisión y discutir su potencial aplicabilidad en Latino-América.

Este manuscrito está basado en un documento base y en el trabajo deliberativo realizado por los miembros (54 participantes, 12 países) que asistieron al LatamPF, a través de la metodología design thinking.

Los participantes coincidieron en que la relación inapropiada entre la ETESA y la toma de decisión atenta hoy contra la legitimidad de las decisiones, expone al proceso de ETESA a una excesiva influencia política y judicial, y condiciona que algunos actores se sientan relegados del proceso de evaluación y toma de decisión. Se identificaron los atributos del proceso de ETESA más prioritarios y factibles de ser mejorados en la región, y con el mayor potencial para generar un cambio positivo en los sistemas de salud. La mayor parte de estos están vinculados con la apropiada institucionalización de la ETESA, ampliar la participación de los diferentes actores y mejorar la transparencia de los procesos de ETESA.

El LatamPF ha identificado barreras y recomendado acciones para reforzar el vínculo entre ETESA y la decisión. A su vez, existe en estos momentos una ventana de oportunidad en la región, ya que el tema es visualizado como una prioridad por gran parte de los actores de la sociedad. Por ello, los diferentes actores de los sistemas sanitarios deberían ahora tomar esta oportunidad para avanzar en el fortalecimiento del vínculo entre ETESA y toma de decisión.

The Hospital de Clínicas de Porto Alegre (HCPA), a public teaching hospital, has a Hospital-based Health Technology Assessment (HB-HTA) unit to support the decision-making process on technology incorporation, rationalization or disinvestment. In 2017, the plastic adhesive drape was standardized at HCPA for use in cardiovascular, digestive, orthopedic, and neurological surgery for the purpose of preventing surgical site infection (SSI). This study evaluated whether the plastic adhesive drape technology is more effective than the no adhesive drapes in the surgical procedures in which it is used in the HCPA, so as to support the medical board's decision regarding the rationalization of use.

The primary outcome was the surgical site infection rate (SSI). Searches were performed in PubMed, Cochrane and national and international health agencies: World Health Organization (WHO), National Institute for Health and Care Excellence (NICE), Centers for Disease Control and Prevention (CDC), Society for Healthcare Epidemiology of America (SHEA), Brazilian National Commission for the Incorporation of Technologies (CONITEC) and Brazilian National Health Surveillance Agency (ANVISA) databases. The search strategy combined terms related to the technology and types of surgery in which it is used in the HCPA. The quality of the included studies was assessed. Additionally, data on technology utilization and costs in the hospital were analyzed.

Technology assessment followed AdHopHTA project recommendations. Data from the hospital showed that the technology has been used in fifteen surgical specialties, different from the proposed incorporation, with a progressive increase in consumption from 2017 to 2018. The literature review included a systematic review with seven clinical trials, which concluded that the plastic adhesive drape lacks benefits, with potential for increased risk of SSI. The evidence was of moderate quality.

The expenses associated with the use of the technology were considered unjustified as it is not reimbursed by the Brazilian Ministry of Health and its disinvestment was recommended. The Medical Board approved the disinvestment of the technology based on the evidence found by the HB-HTA unit, and the medical staff complied with the decision.

There is a lack of adoption and diffusion of health innovations needed to drive the implementation of important breakthroughs in value-based health care. To stimulate organizational changes, decision-makers need to see potential benefit at an early stage. The aim of the present study was to assess the potential effects of a conceptualized intention to provide digital home-based care and compare it to the current provision of such care. The new intervention aims to strengthen the municipality's care services by offering a digital communication platform to recipients of home-based health services and their dependents. The platform is designed to be implemented nationally and is in line with home service needs identified in several white papers.

An interdisciplinary team united to determine and quantify potential effects of the project. Effects of the digitalized service were distinguished in priced quantitative, unpriced quantitative and qualitative effects. A ten-year present value calculation with a calculation rate of four percent was used for the estimates. A risk analysis was also carried out.

The present value calculation resulted in estimated savings equal to EUR 25.8 million , with present value investments costs of EUR 5.5 million over ten years. This resulted in net present value per invested euro in the public sector equal to EUR 3.2. Overall assessment of uncertainty related to the intervention's socio-economic profitability was deemed average. Based on data quantified estimates from the conceptual phase, the project succeeded in the decision-making and funding needed to proceed into the next developmental phase of the project.

The present approach to early assessment may provide much desired decision support in an early innovation phase when data are still missing. Our experience is that early stakeholder involvement and the early assessment and quantification of value gains are of utmost importance to overcome the critical barriers to organization health innovations.

There is a general consensus on the need to involve patients and the public in Health Technology Assessment (HTA) but questions remain about the best strategies for involving them into HTA structures and activities. The aim of this study was to update a systematic review (published in 2011) on patient and public engagement in HTA.

We searched papers published between January 2009 (end of the initial search) and November 2016 in eight databases and HTA journals using specific search strategies. We identified other publications through citation tracking, Internet search engines, HTA agencies websites, and discussion with experts in the field. Studies in English or French were included if they met the following criteria: (i) qualitative, quantitative or mixed-methods study; (ii) describing patients or public involvement; and (iii) in the HTA field. We extracted information using a pre-established grid including: characteristics of studies, type of activities for involving patients or public, effects on decisions, and factors facilitating or limiting involvement.

We identified a total of 4,762 new publications from the main search strategy. Among them, twenty-eight articles (reporting on twenty-three studies) met the inclusion criteria, whereas seventeen articles were included in the previous systematic review. Research designs are qualitative (18/23), quantitative (3/23) or mixed (2/23). Two main strategies for involving patients and public are generally described. The first is when public representatives participate directly in decision-making processes (participation) and the second is when patient or public input is sought to inform decisions (consultation or indirect participation).

The number of studies on patient and public involvement in HTA has increased in recent years. Findings from this update are mainly consistent with those of the previous systematic review. However, studies are still needed to assess the effectiveness of different strategies for involving patients and the public in HTA.

Recruitment and retention of participants in randomized controlled trials (RCTs) is challenging, and is why many RCTs fail or are not completed on time. Digital approaches such as social media, data mining, email or text messaging could improve recruitment and/or retention, but how well they match these purposes is unclear. We used systematic methods to map the digital approaches that have been investigated during the past 10 years.

We searched Medline, Embase, other databases and relevant web sites in July 2018 to identify comparative studies of digital approaches for recruiting and/or retaining participants in clinical or health RCTs. Two reviewers screened references against protocol-specified eligibility criteria. Studies included were coded by one reviewer (with 20 percent checked by a second reviewer) using pre-defined keywords to describe characteristics of the studies, populations and digital approaches evaluated.

We identified 9,133 potentially relevant references, of which 100, reporting 101 unique studies, met the criteria for inclusion in the map. Among these, 95 percent of studies investigated recruitment but only 11 percent investigated retention. Study areas included health promotion and public health (36 percent), cancer (17 percent), circulatory system disorders (13 percent) and mental health (10 percent). Most study designs were observational (89 percent). The most frequent digital approaches for recruitment were internet sites (53 percent of recruitment studies), social media (42 percent), television or radio (31 percent) and/or email (31 percent). For retention these were email (63 percent of retention studies) or text messaging (38 percent). Time and costs of recruitment were reported in 17 percent and 30 percent of recruitment studies respectively, whilst costs were reported in 19 percent of retention studies.

A wide range of digital approaches has been studied, in many combinations. Evidence gaps include lack of experimental studies; studies on retention; and studies for specific populations (e.g. children or older people) and outcomes (e.g. user satisfaction). More robust experimental studies, perhaps conducted as studies-within-a-trial (SWAT), are needed to address knowledge gaps and ensure that estimates of digital tool effectiveness and efficiency are reliable.

Lack of evidence regarding safety and effectiveness at market entry is driving the need to consider adopting a lifecycle approach to evaluating medical devices, but it is unclear what lifecycle evaluation means. This research sought to explore the tacit meanings of “lifecycle” and “lifecycle evaluation” as embodied within evaluation models/frameworks used for medical devices.

Drawing on qualitative evidence synthesis methods and using an inductive approach, novel methods were developed to identify, appraise, analyze, and synthesize lifecycle evaluation models used for medical devices. Data was extracted (including purpose; audience; characterization; outputs; timing; and type of model) from key texts for coding, categorization, and comparison, exploring embodied meaning across four broad perspectives.

Fifty-two models were included in the synthesis. They demonstrated significant heterogeneity of meaning, form, scope, timing, and purpose. The “lifecycle” may represent a single stage, a series of stages, a cycle of innovation, or a system. “Lifecycle evaluation” focuses on the overarching goal of the stakeholder group, and may use a single or repeated evaluation to inform decision-making regarding the adoption of health technologies (Healthcare), resource allocation (Policymaking), investment in new product development or marketing (Trade and Industry), or market regulation (Regulation). The adoption of a lifecycle approach by regulators has resulted in the deferral of evidence generation to the post-market phase.

Using a “lifecycle evaluation” approach to inform reimbursement decision-making must not be allowed to further jeopardize evidence generation and patient safety by accepting inadequate evidence of safety and effectiveness for reimbursement decisions.