Our objective was to assess how, and to what extent, a systems-level perspective is considered in decision-making processes for health interventions by illustrating how studies define the boundaries of the system in their analyses and by defining the decision-making context in which a systems-level perspective is undertaken.

We conducted a scoping review following the Joanna Briggs Institute methodology. MEDLINE, EMBASE, Cochrane Library, and EconLit were searched and key search concepts included decision making, system, and integration. Studies were classified according to an interpretation of the “system” of analysis used in each study based on a four-level model of the health system (patient, care team, organization, and/or policy environment) and using categories (based on intervention type and system impacts considered) to describe the decision-making context.

A total of 2,664 articles were identified and 29 were included for analysis. Most studies (16/29; 55%) considered multiple levels of the health system (i.e., patient, care team, organization, environment) in their analysis and assessed multiple classes of interventions versus a single class of intervention (e.g., pharmaceuticals, screening programs). Approximately half (15/29; 52%) of the studies assessed the influence of policy options on the system as a whole, and the other half assessed the impact of interventions on other phases of the disease pathway or life trajectory (14/29; 48%).

We found that systems thinking is not common in areas where health technology assessments (HTAs) are typically conducted. Against this background, our study demonstrates the need for future conceptualizations and interpretations of systems thinking in HTA.

Rising health expenditures lead to increasing budgetary pressures, which often manifest in budget managers seeking more for the same resources or trying to maintain the status quo with less. Consequently, enablers that drive efficiencies throughout the entire care pathway have come under increasing focus. This is particularly true in the operating room (OR) setting where considerations around operational efficiency, clinical excellence, and patient-centered care pose challenging questions. While a comprehensive solution set should be formulated, small parts of the solution can be applied now to prime systems for easy integration into future solutions. The objective of this analysis was to estimate the impact of combining custom healthcare solutions for cataract surgery from the perspective of a Russian hospital.

A decision-analytic model was developed to assess the aggregated impact of combining the following products or services for cataract surgery: an intraocular lens delivery-system; process-redesign; a phacoemulsification machine; and a phaco tip. The model and underlying assumptions were validated by clinical experts. OR time-savings was chosen as the variable of efficiency underpinning the analysis. Inputs were estimated from the literature, expert opinion, and the local cost databases. Two scenarios were defined that reflected technologies commonly used in surgical practice. The model scenarios assumed that a hospital performs 2,000 cataract procedures per year, with 100 percent adoption and equal acquisition costs.

Choosing a combination of healthcare solutions for cataract surgery was associated with an incremental benefit of RUB5,935,982 per year (EUR71,364) and generated an OR time saving of approximately 237 cataract procedures.

This analysis highlighted that, compared with treating technologies on an individual level, combining healthcare solutions commonly used for cataract surgery has the potential to drive efficiencies and cost savings for hospitals and to reduce surgical wait lists.

Foot reflexology is a type of complementary manual therapy that consists of applying pressure or massage to the sole of the foot to produce various therapeutic effects in other body areas or organs. This technique has been used in many different clinical indications, but there is uncertainty about its real effect. A health technology assessment (HTA) was conducted to analyze the efficacy and safety of foot reflexology within the framework of the “Health Protection Plan Against Pseudo-Therapies,” which was established in 2018 by the Spanish Ministry of Health and the Ministry of Science and Innovation.

A systematic review and metanalysis was conducted to synthesize the available scientific literature on the efficacy and safety of foot reflexology in people of any age with any disease or medical condition.

Sixty-eight randomized controlled studies were included. Pooled estimates indicated that foot reflexology had no effect on pain, fatigue, depression, quality of life, quality of sleep, or blood pressure, compared with non-reflexological foot massage. Improvements in pain (standardized mean difference [SMD] −1.11, 95% CI: −1.70 - −0.52), fatigue (SMD −0.93, 95% CI: −1.36 - −0.51), sleep quality (SMD −1.11, 95% CI: −1.68 - −0.34), and systolic (mean difference [MD] −7.36, 95% CI: −8.49 - −6.23) and diastolic (MD −5.07, 95% CI: −0.98 - −0.22) blood pressure were obtained when reflexology was compared with usual care or no intervention. In the case of anxiety levels, the benefit obtained with foot reflexology compared with any comparator (SMD −0.6, 95% CI: −0.98 - −0.22) was attenuated when compared with non-reflexological foot massage (SMD −0.2, 95% CI: −0.36 - −0.03). Very few studies reported on the safety of foot reflexology.

There was no evidence for any specific effect of reflexology for any condition when compared with non-reflexological foot massage, except for a positive effect on anxiety levels.

To assess the adherence of economic evaluations to the recommendations on principles of economic evaluation as stated in the country-specific guidelines for three countries across different income groups, namely, Canada, South Africa, and Egypt.

Searches were undertaken in three databases to identify economic evaluations meeting predefined inclusion criteria. Methodological and reporting standards listed in the country-specific guidelines were converted into discrete binary variables to calculate mean adherence scores. Quality appraisal was done using Drummond's checklist. Stratified analysis was undertaken to identify independent variables affecting adherence.

We identified forty-four, seventy-nine, and sixteen economic evaluations for Canada, South Africa, and Egypt, respectively. The mean adherence score was the highest for Canada (71%), followed by South Africa (65%) and Egypt (60%). Adherence to guidelines was positively correlated with quality of studies, r = .72. Furthermore, the mean adherence score was significantly (p < .05) higher for studies using a cost-utility analysis design (72%), having local/national funding aid (72%), undertaken by a health economist (71%) and for pharmacoeconomic evaluations (70%).

The quality of economic evaluations improves with adherence to country-specific guidelines. Locally funded and health-economist led health technology assessments (HTAs) should be encouraged for greater adherence to the guidelines. The HTA researchers and the HTA bodies should lay emphasis on adherence to the country-specific guidelines for improving the quality of HTA evidence.

The process of health technology assessment (HTA) is an opportunity to identify gaps in the existing knowledge on the technology assessed. In January 2020, the Evaluation Unit of the Canary Islands Health Service, belonging to the Spanish Network of Agencies for Assessing National Health System Technologies and Performance, started a structured strategy to include in its HTA reports information on research priorities for the assessed technologies from the perspective of patients, clinicians, and researchers. The aim of this poster is to explain the methodology behind this strategy.

The following three-step process was proposed:

1. (i) Identify the knowledge gaps regarding the technology from systematic reviews on effectiveness, safety, and cost effectiveness, in addition to ethical, patient, social, legal, and organizational aspects analyzed for the HTA report;

2. (ii) Search for specific studies on research needs regarding the technology on the websites of specialized initiatives such as the Core Outcome Measures in Effectiveness Trials (COMET) and the James Lind Alliance; and

3. (iiii) If no needs are identified in the previous two steps, consult a group of clinicians or researchers and patients related to the technology being assessed with two online survey rounds using the Delphi method. The first round identifies the research needs and the second round prioritizes the identified needs.

Since the methodology to identify future research needs during a HTA process was designed, it has been used in three HTA reports during 2020 with satisfactory results. Only one of the three reports required a Delphi study.

The proposed strategy provides a comprehensive list of knowledge gaps on health technologies that need to be addressed in the near future from the point of view of patients, clinicians, and researchers.

Delirium is a prevalent syndrome in the hospital setting and the elderly are the most affected. The objective was to assess the safety, clinical effectiveness, and cost effectiveness of interventions for preventing delirium among people aged 65 years or older at hospital admission.

A systematic review of available scientific literature (randomized controlled trials) on the safety, effectiveness, and cost effectiveness of the interventions was conducted. The overall effect size for each type of intervention was estimated through a meta-analysis. A cost-effectiveness study in the context of the Spanish National Healthcare System was performed.

Forty-nine studies were included for the effectiveness and safety assessment (25 on pharmacological interventions, 12 on perioperative interventions, 2 on non-pharmacological interventions, and 10 on multicomponent interventions). The following interventions reduced delirium incidence relative to usual care or placebo: hypnotics and sedatives (13 studies; risk ratio [RR] 0.54: 95% confidence interval [CI] 0.36–0.80); perioperative interventions aimed at limiting opioid use (two studies; RR 0.50, 95% CI: 0.29–0.86); controlling the intensity of general anesthesia (three studies; RR 0.77, 95% CI: 0.59–0.99); and multicomponent interventions (10 studies; RR 0.62, 95% CI: 0.54–0.72). In addition, multicomponent interventions reduced the duration (mean difference −1.18, 95% CI: −1.95 - −0.40) and severity of delirium (standardized mean difference −0.98, 95% CI: −1.46 - −0.49), while dexmedetomidine reduced the duration of delirium (mean difference −0.70, 95% CI: −1.03 - −0.37).

The economic analysis of a multicomponent preventive intervention estimated an average cost of EUR7,282 per patient, which was EUR140 per patient more expensive than usual care. The incremental cost-effectiveness ratio was EUR21,391 per quality-adjusted life-year, which is below the acceptability threshold used in Spain. The literature review yielded two economic evaluations that estimated the cost effectiveness of a multicomponent intervention in the United Kingdom and found that the multicomponent intervention was a dominant strategy.

This meta-analysis suggests that multicomponent interventions and dexmedetomidine are effective in reducing the incidence of delirium in hospitalized patients and that multicomponent interventions could be a cost-effective strategy in Spain.

As health technology assessment (HTA) seeks to combine complex sets of evidence, values, and perspectives to support open, accountable, and transparent decision making, uncertainty is inherent. Uncertainty is present in the clinical and economic inputs that inform HTA and is a critical factor during context-specific deliberations where the evidence is weighed and decisions are made, taking uncertainty into account through either financial or evidence-generation mechanisms. The presence and impact of uncertainty must also be communicated to all relevant stakeholders during the HTA output stage. This article summarizes the 2021 HTAi Global Policy Forum discussion on “Considering and Communicating Uncertainty in HTA” that debated some of the key challenges and opportunities regarding uncertainty in HTA. Through a combination of small and large group discussions, core themes related to the topic of uncertainty in HTA were identified. These discussions revealed that: utilization of a life cycle/HTA management approach helps manage uncertainty; genuine stakeholder input and engagement (and not just consultation) can clarify uncertainty; tolerance of risk, the relationship of risk to uncertainty, and the context in which uncertainty is considered is critical; transparent and early dialogues could be increased to further reduce the uncertainty during HTA; and communicating uncertainty in HTA outputs is critical. The paper ends with suggested next steps that HTA agencies and stakeholders (such as industry, patients, regulators, payers, and others) might take to move the field forward. The paper promotes further discussion on aspects of uncertainty that should be more openly discussed, debated, and addressed.

Cognitive and functional deterioration is common in hospital setting and occurs in 40 percent of admitted older patients. One of its main causes is physical inactivity. The objective of our health technology assessment was to assess the safety and clinical effectiveness of a structured multicomponent intervention of physical exercise (Vivifrail) for the prevention of the cognitive and functional deterioration in hospitalized patients aged 70 years or older and to estimate costs and the budgetary impact for the Spanish National Health Service.

A systematic review of available scientific literature (including experimental and observational designs) on the safety and effectiveness of Vivifrail was performed. A costing study and budgetary impact analysis of the incorporation of Vivifrail as a therapeutic alternative to standard care with a time horizon of 5 years was performed.

One randomized controlled trial (RCT) (n = 370) showed positive effects of Vivifrail compared to usual care in functional capacity (mean difference (MD) = 2.20, 95% confidence interval (CI) 1.78 to 2.62), cognitive state (MD = 1.80, 95% CI 1.24 to 2.36), and quality of life (MD = 13.20, 95% CI 12.70 to 13.70). Regarding other variables, the Vivifrail increased the grip strength of the dominant hand (MD = 2.30; 95% CI = 1.79 to 2.81), verbal fluency (MD = 2.15; 95% CI = 1.56 to 2.74), performance of double tasks (MD = 0.10; 95% CI = 0.07 to 0.13), executive function (MD = −31.07; 95% CI = −49.23 to −12.91) and emotional state (MD = −2.00; 95% CI = −2.50 to −1.50).

The total cost of implementing Vivifrail in a 1,000-bed general hospital would be EUR18,000 per year (adjusted to 2020 currency), with approximately 150 patients older than 75 years benefited. This represents a cost of EUR120 per patient.

The Vivifrail could improve functional and cognitive capacity, although available evidence on the Vivifrail is very scarce. More well designed and executed RCT and cost-effectiveness study confirming or refuting the promising findings are needed for a new assessment.

Various strategies to suppress the Coronavirus have been adopted by governments across the world; one such strategy is diagnostic testing. The anxiety of testing on individuals is difficult to quantify. This analysis explores the use of soft intelligence from Twitter (USA, UK & India) in helping better understand this issue.

A total of 650,000 tweets were collected between September and October 2020, using Twitter API using hashtags such as ‘#oxymeter’, ‘#oximeter’, ‘#antibodytest’, ‘#infraredthermometer’, ‘#swabtest’, ‘#rapidtest’, and ‘#antigen’. We applied natural language processing (TextBlob) to assign sentiment and categorize the tweets by emotions and attitude. WordCloud was then used to identify the single topmost 500 words in the whole tweet dataset.

Global analysis and pre-processing of the tweets indicate that 21 percent, seven percent and four percent of tweets originated from the USA, UK, and India respectively. The tweets from #antibody, #rapid, #antigen, and #swabtest were positive sentiments, whereas #oxymeter, #infraredthermometer were mostly neutral. The underlying emotions of the tweets were approximately 2.5 times more positive than negative. The most used words in the tweets included ‘hope’ ‘insurance’, ‘symptoms’, ‘love’, ‘painful’, ‘cough’, ‘fast test’, ‘wife’, and ‘kids’.

The finding suggests that it may be reasonable to infer that people are generally concerned about their personal and social wellbeing, wanting to keep themselves safe and perceive testing to deliver some component of that feeling of safety. There are several limitations to this study such as it was restricted to only three countries, and includes only English language tweets with a limited number of hashtags.

We evaluated the early impact of a new hospital-based health technology assessment (HB-HTA) program, called Smart Innovation, at the University of Washington Medical Center (UWMC).

We compared the UWMC's utilization trends for two surgical procedures to control hospitals by evaluating the difference before and after adoption decisions: (i) a new filter for transcatheter aortic valve replacement (TAVR) procedures that treat aortic valve stenosis and (ii) microwave ablation (MWA) for treating hepatocellular carcinoma. We used descriptive statistics to assess the difference between the UWMC and controls for TAVR and MWA procedures and multivariate difference-in-differences (DID) analyses to test for statistical significance.

The UWMC experienced a 10 percent reduction in TAVR procedures compared with controls following the implementation of the TAVR Sentinel filter. The DID regression model indicated a 1.5 reduction in the number of TAVR procedures per quarter at the UWMC between the pre- and post period, which was not statistically significant (p-value: .87). The UWMC experienced a 51 percent reduction in utilization when compared with controls for MWA procedures in the pre- and post periods. The DID model for MWA indicated an 18.8 decrease in utilization per quarter during the study period for the UWMC, which was statistically significant (p-value: .0007). For MWA procedures, the UWMC experienced a $647,658 dollar reduction in total costs in the post period compared with controls.

When the UWMC used HB-HTA methods for technology adoption, there was a reduction in utilization and total costs when compared with controls; however, when the UWMC adopted a new technology without using HB-HTA methods, there was no difference in utilization.

The use of real-world data, as an alternative to randomized controlled trials, is becoming increasingly common in the evaluation of new health technologies. With this rise in real-world literature, such data will also enter evidence synthesis models. While it can be beneficial to utilize data from all available sources, this can introduce the problem of double-counting of participants.

Using a number of case-studies, we discuss and illustrate various issues around double-counting. These include synthesis of studies using the same database or the same subset of participants, overlapping use of intervention arms across studies and the use of registry data from the participants overlapping with those in randomized controlled trials. The implications in research are considered along with common methods used currently to overcome these issues.

Double-counting of participants in evidence synthesis can artificially inflate precision, potentially leading to inappropriate conclusions. Common methods currently used to help mitigate the impact of double-counting includes stratifying analysis to different timelines, using the most comprehensive study in the evidence synthesis model or using the study that has the largest sample size. However, in all of these cases, sensitivity analyses would need to be considered to ensure robust results.

Currently, there are no published guidelines on how to address the issue of double-counting. With the increased use of real-world data in evidence synthesis, double-counting has the potential to become a significant issue. Therefore, it is of significant importance that methodologies and guidelines are developed to address this.

COVID-19 has exposed population and health systems’ vulnerability to a highly infectious disease. People with diabetes have a higher risk of COVID-19 hospitalization and death than those without. Medicines that control blood glucose reduce this risk. We quantified COVID-19 hospital admissions and deaths averted by diabetes medicines in the UK during the March-May 2020 wave.

We estimated COVID-19 hospital and intensive care unit (ICU) admissions averted and COVID-19 hospital deaths avoided by diabetes medicines, considering a counterfactual where those medicines were not available. We used published UK-data sources on diabetes prevalence, proportion of patients achieving diabetes control with medicines, COVID-19 infection risk, probabilities for COVID-19 hospital admission, subsequent ICU admission and hospital death. We calculated the relative risk reduction of controlled vs. uncontrolled diabetes on COVID-19 hospital or ICU admission (71% and 66%, respectively), and hospital death (38%) from the UK Open Safely data.

Diabetes medicines are estimated to have averted 17,417 hospital admissions, 2,752 ICU-admissions and 438 hospital deaths due to COVID-19 compared to a counterfactual where those medicines had not been available in the UK.

Effective medicines to control diabetes contribute to population and health systems resilience against COVID-19. Health technology assessment and policy makers should recognize that adoption and usage of health technology reduces societies’ vulnerability to similar shocks.

For the assessment of videorasterstereography compared with radiography for monitoring idiopathic scoliosis, new tools given by the INTEGRATE-HTA methodology were included within the frame set by the authority. In contrast to the usual linear approach by covering the single domains' safety and efficacy, costs, and ethical, legal, socio-cultural and organizational issues (ELSOI) separately, the methodology is based on the assumption of interactions of different aspects of the domains. From the very beginning, these interactions are captured systematically using various tools and are repeatedly discussed with stakeholders.

Relevant databases were systematically searched for studies and question catalogues were processed in order to be able to search for specific aspects in orienting bibliographic research. An initial logic model was developed and successively expanded. A synoptic table showing multiple mapping of aspects to domains, a complexity checklist, and a semantic complex highlighting the socio-cultural impact of the disease were newly developed.

Four diagnostic studies with high risk of bias were included. For the clinical outcome, Cobb angle standard deviations up to 8.2 degrees and average measurement differences up to 8.8 degrees were determined. These differences in measurement accuracy correspond to those observed for purely radiographic measurements in other studies. In addition to freedom from radiation as the greatest advantage, there were clear arguments in favor of videorasterstereography when considering ELSOI, for example less harm.

Using INTEGRATE-HTA contributes to identify interactions between domains and to significantly expand the perspective on a technology. It improves patient-centered understanding and facilitates discussions.

We aimed to perform a systematic review of economic evaluations of drug-coated balloons (DCBs) and drug-eluting stents (DESs) in peripheral artery disease (PAD) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings.

A systematic review was performed using four electronic databases to identify health economic evaluation studies reporting on the use of DCBs and DESs in PAD. The methodological and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists.

Six articles were included in this review of the 1,728 publications identified. Four studies were cost-effectiveness analyses and two cost–utility analyses. According to the Cooper hierarchy scale, the studies used good-quality data sources. The level of evidence used for clinical effect sizes, safety data, baseline clinical data, and costs was of high quality in general. In contrast, an evaluation of the reporting quality suggested that essential information was lacking.

The present study demonstrates that clinical data used in economic evaluations of DCBs and DESs in PAD are from clinical studies of high quality in general. However, the quality of reporting represents a concern when interpreting the results provided by these economic studies.

Focal-onset-seizures (FOS) are commonly experienced by individuals with epilepsy and have a significant impact on quality of life (QoL). This study aimed to develop a mapping algorithm to predict the 6 dimension short form questionnaire (SF-6D) values in adults with FOS for use in economic evaluations of a new treatment, cenobamate.

An online survey, including questions on sociodemographic, disease history, the short form (SF) 36, and an epilepsy-specific measure (quality of life in epilepsy problems questionnaire, QOLIE-31-P) was administered to individuals with drug-resistant FOS in the top 5 EU countries (UK, Spain, Germany, Italy and France). A range of regression models were fitted to SF-6D scores including direct and response mapping approaches.

The analysis included 361 people. In the previous 28 days, the mean number of FOS experienced was three, (range: 0–43) and longest seizure-free period was 14 days (range: 1–28). Mean responses on all SF-36 dimensions were lower than general population norms. Mean SF-6D and QOLIE-31-P scores were 0.584 and 45.72, respectively. The best performing model was the ordinary least squares (OLS), with root mean squared error (RMSE) and mean absolute error (MAE) values of 0.0977 and 0.0742, respectively. Explanatory variables which best predicted SF-6D included seizure frequency, seizure severity, seizure freedom, and age.

People with drug-resistant FOS have poor QoL. The mapping algorithm enables the prediction of SF-6D values from clinical outcomes in individuals with drug-resistant FOS. It can be applied to outcome data from clinical trials to facilitate cost-utility analysis.

There is no health system that has the resources to evaluate all technologies. The presence of a clear process to prioritize health technologies for assessment by health technology assessment (HTA) agencies is a good practice principle recognized at the international level. The objective of Health Technology Assessment International's 2020 Latin American Policy Forum (LatamPF) was to explore how to improve the way HTA agencies in Latin America identify and prioritize technologies for assessment.

This paper is based on a background document, a survey, and the deliberations of the members of the LatamPF (forty-six participants from eleven countries) using a design thinking methodology.

Participants agreed that a lack of clear prioritization mechanisms results in HTA processes and decisions that are perceived to be of low transparency and overly exposed to political or interest group pressures. The LatamPF identified barriers and recommended actions to improve HTA prioritization mechanisms in Latin America. The criteria identified as the most important to be taken into consideration by HTA agencies in the region when prioritizing a technology for assessment were: the burden of illness, the potential clinical benefit, the alignment with national health priorities, the potential impact on equity, a lack of treatment alternatives for patients, and the potential economic impact.

Forum participants agreed that the establishment of transparent prioritization processes is a key element for all health systems. Improvements in these processes will strengthen HTA and provide greater legitimacy to decision making.

Surgical site infections (SSIs) are preventable adverse events placing a large burden on service providers. Reusable electrocardiogram lead-and-wire systems can hold infection vectors after cleaning. Single-patient-use cable-and-lead systems (spECG) may help prevent cross-contamination and SSIs. SSIs are commonly included in incentive schemes as quality-of-care indicators. Readmissions within 30 days due to SSI are not reimbursed by the UK's National Health Service (NHS). Reducing SSIs could improve patient care and result in cost-of-care savings. The cost-benefit of implementing spECG was investigated in this study.

NHS Digital 2019 data for cardiac surgeries were assessed for SSIs occurring during the index event or 90 days post discharge. Data from 88 centers performing 1,000 surgeries or more were used to update a published health economic model of the cardiac surgery care pathway. The population was on average 68 years old, 18 percent female, 33 percent obese, and 28 percent diabetic. Costs are reported in 2019 GBP (2019 EUR) and were sourced from NHS reports.

In total, 2,580 in-hospital SSIs were reported from 317,825 cardiac surgeries, resulting in an increased length-of-stay (LOS) of between 4.4 to 29.4 days. The 1,975 SSI-related, post-discharge readmissions’ mean LOS was 13.9 days. Cost-of-care was GBP8,127 (EUR9,259) per patient, in line with NHS data. Implementing spECG reduced per-case-costs to GBP8,094 (EUR9,221), saving GBP33 (EUR38): a 3.5-fold return-on-investment. Savings-drivers were fewer SSIs, reduced LOS, and fewer readmissions (a reduction of 29% within 30-days, resulting in cost-offsets of approximately GBP230 (EUR262)/readmission).

This study suggests that the implementation of spECG could provide cost-benefit in reducing the burden of SSIs related to cardiac surgery. In addition to cost-of-care, the readmissions would have additionally burdened hospitals, as 29 percent would not have been reimbursed. Health-economic analyses should consider not only potential cost-savings of innovative products, but also incorporate quality-of-care indicators. This further aligns payer considerations with the common end-goal of providing maximum benefit to patients.