Acute otitis media (AOM) is one of the most common childhood infections. Recurrent AOM (rAOM) is defined as the presence of three or more AOM episodes in a period of six months. We describe the methodology used to update the recommendation of the 2018 Spanish National Antimicrobial Therapeutic Guide on the use of antibiotic treatments for rAOM in children.

We followed the GRADE-ADOLOPMENT approach to update the recommendation on antibiotic treatment for rAOM. Firstly, the research question was framed in a Population, Intervention, Comparison, and Outcome format. A comprehensive search strategy was developed, the results of which were screened according to the inclusion criteria. The selected studies were reviewed, and the quality of the evidence was assessed. Subsequently, an Evidence to Decision (EtD) framework was created and the new evidence was presented to the Guideline Development Group (GDG), which updated the recommendation on rAOM treatment in children.

Among the 1,934 references identified by the database searches, only one guideline from the National Institute for Health and Care Excellence (NICE91, updated in 2022) met our inclusion criteria. This CPG included five individual studies comparing antibiotic treatments for rAOM. None of the studies demonstrated a significant advantage for any treatment. The overall quality of the evidence for these comparisons was considered low. A GRADE EtD framework was elaborated using the NICE91 recommendations but contextualized to the Spanish National Health System. Based on the evidence, the GDG did not modify the current recommendation provided in 2018.

The overall quality of the available evidence regarding antibiotic use for rAOM in children was considered low. Further research is therefore needed to resolve the controversy and increase confidence in the appropriateness of using antibiotics in the treatment of rAOM, thereby improving the quality of life of children with this condition.

Single-arm studies, particularly single-arm trials (SATs), are increasingly being used in submissions for marketing authorization and health technology assessment. As reviewers of evidence, we sought to better understand the validity of SATs, compared with observational single-arm studies (case series), and how to assess them in our reviews.

We conducted a highly pragmatic literature review to create a convenience sample of recent systematic reviews published from January to July 2023 to establish the following: (i) what single-arm study designs are included; (ii) what quality assessment tools are used; and (iii) whether there is a difference in effect size and variability among different study designs. A single reviewer identified reviews of interventions that included single-arm studies and extracted information on the numbers of included SATs and case series, and the quality assessment tools used. Any misclassifications by review authors were identified. For meta-analyses, outcome data were extracted and a subgroup analysis comparing SATs and case series was conducted.

Work is still underway to complete this investigation. So far, it appears that a large proportion of systematic reviews misclassify SATs and case series studies and few use appropriate quality assessment tools. There is not yet any evidence of a systematic difference between SATs and case series in terms of effect size.

Findings suggest that there is poor understanding of SATs in the review community. There are limited specific quality assessment tools for SATs and review authors frequently use inappropriate tools to assess them. More research is likely to be needed to investigate the relative validity of SATs and single-arm observational studies.

International agencies advocate for population-based cancer screening to prevent cancer-related deaths. The Arturo Lopez Perez Oncology Institute is interested in implementing screening programs, but international recommendations differ on program details such as screening tests, target population, age range, and frequency. A review of international evidence-based recommendations is essential for advising stakeholders on the effective implementation of screening programs.

A rapid scoping review was performed to identify international recommendations on cancer screening programs. Evidence-based recommendations derived from the World Health Organization and the European Union were analyzed. We also searched for evidence-based recommendations from the following health technology assessment agencies with specific sections for evaluating screening strategies: the Canadian Agency for Drugs and Technologies in Health (Canada), the Institute for Quality and Efficiency in Health Care (Germany), the Medical Services Advisory Committee (Australia), and the National Institute of Health and Care Excellence (UK). Additionally, we explored international cancer screening programs implemented by health systems in the aforementioned countries or in countries with implemented screening programs. Finally, we searched for recommendations from scientific societies on cancer screening strategies. This iterative process was repeated for five different cancers.

We found a total of 32 favorable or unfavorable recommendations for breast, cervical, colorectal, lung, gastric, and prostate cancer screening. Breast and cervical cancer had the highest number of favorable recommendations, with complete agreement on the type of test and only small differences regarding age range and periodicity. On the other hand, we found some recommendations against population-based screening for prostate and gastric cancer and limited agreement for both test type and target population. Direct comparisons between the recommendations served as a guide to elaborate a cancer screening program based on the most recommended strategies.

This rapid scoping review allowed us to assess the consistency of cancer screening recommendations. Major differences were found mainly between recommendations from international agencies and scientific societies. As a result, a cancer screening program was designed based on the most recommended strategies.

Most patients with long-term conditions (LTC) receive regular blood tests to monitor disease progression and response to treatment and to detect complications. There is currently no robust evidence to inform recommendations on monitoring. Creating this evidence base is challenging because the benefits and harms of testing are dependent on what is done in response to the test results.

We identified a list of commonly used tests. We defined a series of filtering questions to determine whether there was evidence to support the rationale of monitoring, such as “Can the general practitioner do anything in response to an abnormal test result?” Through a series of rapid reviews we identified evidence to answer each question. The evidence was presented at a consensus meeting where clinicians and patients voted for inclusion, exclusion, or further analysis. A process evaluation was performed alongside this. Further analyses were performed using routinely collected healthcare data and by performing incidence analyses, emulating randomized controlled trials (RCTs), and modeling disease progression.

We tested this methodology on three common LTCs: chronic kidney disease (CKD), type 2 diabetes mellitus (T2DM), and hypertension. We found sufficient evidence to include hemoglobin A1C and estimated glomerular filtration rate (eGFR) for monitoring patients with T2DM; hemoglobin and eGFR for patients with CKD; and eGFR for patients with hypertension. The consensus panel excluded four tests, while 10 tests were selected for further analysis. The emulated RCTs will investigate the effect of regular monitoring with certain tests on health outcomes among routinely monitored patients. In addition, we will investigate the signal-to-noise ratio of each test over time using a modeling approach.

The cost effectiveness of the evidence-based testing panels needs to be tested in clinical practice. We are currently developing an intervention package and are planning to run a feasibility trial. This program of work has the potential to change how LTCs are monitored in primary care, ultimately improving patient outcomes and leading to more efficient use of healthcare resources.

Since 2009, the Chinese government has launched a new health system reform that affected primary healthcare significantly. We aimed to analyze the factors associated with job satisfaction among village clinic doctors since the new healthcare reform, and to provide a reference for the next stage of reform.

We systematically searched one English (PubMed) and two Chinese literature databases (CNKI and Wanfang Data). Cross-sectional studies containing information related to job satisfaction among village clinic doctors in China were included. The total job satisfaction among village clinic doctors was estimated using a random effects meta-analysis. Differences in study-level characteristics among groups were estimated using subgroup analysis and meta-regression.

We identified 17 cross-sectional studies investigating a total of 28,468 village clinic doctors in China. The pooled job satisfaction value was 0.40 (95% confidence interval [CI]: 0.32, 0.49). The results showed that lower job satisfaction was reported in the period from 2016 to 2020 (0.33, 95% CI: 0.23, 0.42) than in the period from 2010 to 2015 (0.51, 95% CI: 0.33, 0.70). The main factors influencing job satisfaction among village clinic doctors were salary (odds ration [OR] 1.71, 95% CI: 1.23, 2.36), number of training sessions (OR 2.56, 95% CI: 1.68, 3.90), age (OR 3.45, 95% CI: 2.22, 5.35), and level of education (OR 0.68, 95% CI: 0.40, 1.15).

Since the new health system reform, only 40 percent of village clinic doctors in China are satisfied with their work and it is likely this figure will continue to decrease. Those with higher salaries, more training sessions, and greater age had higher job satisfaction. In contrast, village clinic doctors with a higher level of education had lower job satisfaction.

An evidence synthesis developed to inform decision-making on the use of vitamin D for preventing and treating COVID-19 showed that current available evidence is of low to very low quality. We set up a rigorous living evidence to inform health decisions (LE-IHD) approach to provide timely updates of this health technology assessment (HTA) report and aid decision-making.

Following the LE-IHD framework, we developed a baseline synthesis and evidence monitoring on the effects of high-dose vitamin D for the prevention and treatment of severe COVID-19 on all-cause mortality, COVID-19-related hospitalization, intensive care unit admission, length of hospital stay, quality of life, adverse events, and long COVID-19. The evidence identification, screening, and selection processes were supported by Epistemonikos technological enablers and the Living Overview of Evidence platform. We searched for ongoing studies in trial registries every three months. New eligible studies were assessed using a systematic and reproducible process to update the HTA report.

For the baseline synthesis we identified nine randomized control trials (RCTs) assessing high dose vitamin D2, vitamin D3, and their metabolites, which provided very low quality evidence on all the outcomes of interest. Up to date evidence monitoring identified seven studies reporting on all-cause mortality and intensive care unit admission, eight studies reporting on length of hospital stay, and six studies reporting on adverse events. The living evidence synthesis has been updated twice. At the time of the conference, we will report on 10 months of monitoring results and any substantial updates to the HTA report.

For HTA reports based on low and very low quality evidence (uncertain results), the living evidence approach allows for timely updating of conclusions. The LE-IHD framework facilitates the planning and execution of living evidence syntheses to inform health decisions. This living evidence synthesis is being developed as part of a project to strengthen decision-making capacity in the Spanish health system.

Developmental dysplasia of the hip (DDH) is a congenital disease in which there is abnormal development of the hip in infancy. Ultrasound screening has the potential to enable earlier identification and diagnosis of DDH, facilitating earlier and less invasive treatment. Ultrasound screening programs can be selective or universal, but the optimal method is unclear.

The aim of this review was to examine the comparative effectiveness of universal and selective ultrasound screening for DDH in infants. The domains of the Health Technology Assessment Core Model® selected for assessment were consistent with a rapid relative effectiveness assessment approach (i.e., focusing on the clinical benefit of the intervention) and included the following: (i) the health problem; (ii) a description of the technology; and (iii) clinical effectiveness and safety outcomes. An expert advisory group comprising nominated representatives from key stakeholder groups was convened for the purposes of quality assurance and to assist in interpreting the evidence.

DDH severity can range from mild dysplasia to complete dislocation, with incidence varying internationally. Ultrasound screening can result in unnecessary treatment given the potential for spontaneous correction of hip instability. Furthermore, treatment may give rise to complications. Appropriate governance of a screening program and associated training may reduce the risk of unnecessary treatment. Limited high quality evidence from four studies was identified. This evidence suggested that increased rates of non-surgical intervention were associated with universal ultrasound screening, compared with selective screening, without a corresponding reduction in the incidence of late DDH or requirement for surgical intervention.

The relative benefit of universal ultrasound screening, compared with selective screening, remains unclear. Screening all infants has the potential to lead to unnecessary treatment, with the risk of clinically significant consequences. Consideration could be given to implementing a selective ultrasound screening program, with appropriate governance, end-to-end care, quality assurance, and outcome monitoring.

Sickle cell disease (SCD) is characterized by recurrent painful ischemic vaso-occlusive episodes (VOEs). Acute episodes of pain, often termed sickle cell pain crises or vaso-occlusive crises (VOCs), are one of the most common and debilitating manifestations of SCD. Here we present a systematic review of 31 trials of 202,758 patients with SCD.

This study followed the guidelines of Riley et al. for conducting a systematic review and meta-analysis of prognostic factor studies and was reported according to PRISMA guidelines. Literature searches were conducted in the PubMed, Embase, and LILACS databases. The websites of the Annual Academy for Sickle Cell and Thalassemia Conferences, the European Hematology Association, and the American Society of Hematology were also searched. Additionally, manual searches were conducted in Google Scholar, Epistemonikos, and the reference lists of included studies. The searches were performed on 22 March 2023.

In total, 31 studies were included in this systematic review. There was considerable heterogeneity in the definition of prognostic factors of interest across the included studies. Findings revealed a link between VOCs and reduced health-related quality of life (HRQoL), severe pain, and a high rate of hospitalization. Although VOCs were related to an increased mortality risk, the mortality rate remained relatively low, with acute chest syndrome being a common cause of death. Despite the study heterogeneity, consistent evidence highlighted the impact of VOCs on SCD-related hospitalizations (pooled hospitalization rate due to VOEs of 47%, 95% confidence Interval: 33, 61; 16 studies, 139,752 participants).

This study suggests that VOCs reduce HRQoL, cause severe pain, and lead to high rates of hospitalization in patients with SCD. Furthermore, VOEs were related to an increased mortality risk. Future research should prioritize more well-designed comparative prospective studies and standardization of the definition of VOCs. A better understanding of VOCs as a prognostic factor could enhance HRQoL, alleviate healthcare system burden, and inform more effective interventions for patients with SCD.

The Institute for Health Sciences of Aragon (IACS) has coordinated the development of a clinical practice guideline (CPG), funded by the Spanish Ministry of Health, for managing antidiabetic drugs in patients with type 2 diabetes mellitus. We conducted a living systematic review to provide a continuously updated evidence summary for formulating living recommendations on intensifying basal insulin therapy by comparing glucagon-like peptide-1 (GLP-1) receptor agonists with rapid-acting insulin.

In 2021, the IACS joined the Living Evidence to Inform Health Decisions (LE-IHD) project, which includes the use of technological tools to identify early emerging evidence on a defined topic. We conducted searches in the centralized Living Overview of Evidence (LOVE) and Epistemonikos databases. Specifically, the LOVE topic of interest from which the articles were selected was “glucagon-like peptide analogs and agonists for diabetes mellitus”. We applied the GRADE approach to rate the certainty of evidence and to develop clinical practice recommendations.

The initial baseline report included six randomized controlled trials (RCTs). We have continuously monitored the evidence and performed a monthly screening. Only one RCT was identified in the first update. The Guideline Development Group (GDG) decided to formulate a strong recommendation in favor of GLP-1 receptor agonists. The GDG considered the reduction in the risk of severe hypoglycemia events among patients treated with GLP-1 receptor agonists, compared with rapid insulin, particularly significant as well as the greater improvement in patient quality of life. Since the guideline was formulated, no new evidence has been identified that would change the recommendation.

Adoption of the living systematic approach underscores the commitment to providing continuously updated recommendations within CPGs. Utilizing the GRADE approach, the Guideline Development Group decided to formulate a strong recommendation in favor of GLP-1 receptor agonists over rapid insulin. No new evidence has emerged to alter this recommendation. The living systematic review will remain active, ensuring continuous monitoring until the final draft CPG is disseminated.

Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder that can interfere with school and academic life, work, and even personal relationships. One of the alternative medications is lisdexamfetamine (LDX), a prodrug amphetamine preparation that lasts an average of 13 hours due to its gradual conversion. Since LDX is used continuously, it is necessary to evaluate its long-term efficacy and safety.

A rapid health technology assessment (HTA) was performed. Searches were conducted in the PubMed, Embase, Web of Science, and Cochrane Library databases using descriptors and their respective synonyms to identify studies on the long-term efficacy and safety of LDX in people with ADHD. Interventional and control group studies with a follow-up period of more than five weeks were included. Secondary studies were excluded. The reference lists of included studies were screened to identify potentially eligible publications that were not found in the database searches. Study selection was carried out in two stages, with screening of titles and abstracts and then assessment of full-text articles for eligibility.

This rapid HTA included 32 studies. The population included patients aged five to 55 years, and the longest follow-up was 108 weeks. In general, the literature reported a decrease in symptoms in the first five to six weeks of treatment, stabilizing thereafter. After 108 weeks, the mean change in ADHD Rating Scale-IV hyperactivity/impulsivity was -25.8 (95% confidence interval [CI]: -27.0, -24.5; p<0.001) and -13.1 (95% CI: -13.8, -12.4; p< 0.001) for the ADHD Rating Scale-IV inattention subscale. However, psychiatric disorder system organ class adverse events were frequent, including irritability, anxiety, and aggression, in addition to suicide attempts in severe cases.

It appears that long-term use of LDX has been associated with good clinical results in the treatment of ADHD, with treatment effectiveness remaining stable during the time observed (two-year follow-up). However, adverse events, especially psychiatric disorders, require attention as they can be confused with symptoms of the disease.

One obstacle to the development of clinical practice guidelines (CPGs) for rare diseases (RDs) is the lack of scientific evidence. This can be partially overcome by involving patients in the development of CPGs. Our aim was to develop a process for involving patients with RDs in all stages of CPG development to ensure that their needs and expectations are addressed.

A literature search was conducted in the MEDLINE, Cochrane Library, and Embase databases and the websites of the European Organization for Rare Diseases, the National Organization for Rare Disorders, and INAHTA. Eligible articles reported methods for involving patients in CPGs, other clinical decision support tools, and research studies. A fit-for-purpose data extraction template was created to capture the following data: author, year, country, type of study, characteristics of the target population, and strategies for participation, engagement, and involvement of patients. Data were synthesized according to methods for recruiting, involving, or engaging patients and obtaining information from them. The entire process was performed by pairs of researchers.

A total of 1,113 records were identified once duplicates were deleted. Of these, 55 were included. The review collected data on types of patients (patient representatives or patient experts) and their recruitment, which could be classified as open or nominated. The various involvement strategies included consultation, participation, and communication. Differences between involving and engaging patients in the CPGs development process were noted. Procedures for obtaining the opinion of patients included surveys, interviews, workshops, and focus groups, among others. The review also provided information on the importance of involving patients in the dissemination and implementation stages of CPG development and the methods for doing so.

When patients with RDs are actively involved in all phases of CPG development, they can contribute to the identification, prioritization, and inclusion of topics pertinent to RDs as questions to be addressed in the CPGs. These aspects might otherwise be overlooked by clinical experts and researchers. Therefore, involving patients with RDs is a promising approach to addressing gaps in the management of these diseases.

Arboviruses transmitted by the A. aegypti mosquito are a public health problem in Brazil. Citronella, known for its repellent properties, has been suggested as a possible sustainable and natural preventive measure against the arbovirus triad. This study aimed to carry out a rapid review of the efficacy and safety of the repellent properties of citronella for the A. aegypti mosquito.

The rapid review followed methods proposed by the Joanna Briggs Institute. Searches were conducted in the following literature databases: PubMed, LILACS, Embase, Scopus, Web of Science, and the Cochrane Library. Quality assessment was carried out using the AMSTAR-2 tool. The review aimed to determine the efficacy and safety of citronella (C. nardus) as a repellent for the A. aegypti mosquito, compared with usual methods.

Citronella repels A. aegypti mosquitoes for between 12 and 480 minutes, depending on the concentration and formulation of the product. Considering its protection time, reapplying the product doubles the protective effect. Adding vanillin to the formula reduces the product’s volatility. Citronella is not absorbed through the skin like DEET products, making it less toxic.

Citronella-based products can be used as a complementary measure of protection against arboviruses. Additional investigations are needed on the percentage of essential oil present in homemade formulations. Studies addressing the safety of citronella are imperative for its use in the public health system. Controlled studies evaluating its degree of repellency are also needed.

Approximately 65 million people worldwide have Long COVID. Long COVID is a complex condition with more than 200 symptoms, which can substantially affect the lives of individuals. The evidence base for Long COVID is evolving rapidly and, therefore, an up-to-date understanding of the prevalence and risk factors of Long COVID is necessary to inform service delivery and allocation of healthcare resources.

A systematic literature review was conducted. Long COVID epidemiological literature published after October 2021 was identified in the MEDLINE, Embase, and Cochrane Library databases. Data extraction and quality appraisal were completed by one reviewer and checked for accuracy and omissions by a second reviewer. The following subgroups of interest were identified: general population; children and older adults; individuals who are medically vulnerable; and individuals with a history of severe COVID-19. Narrative synthesis of the prevalence and symptoms of Long COVID and of risk factors associated with the development of Long COVID was conducted.

Over 3,000 documents were identified, of which 51 primary research studies met the inclusion criteria and were deemed of fair or good quality. Long COVID prevalence estimates ranged from 1.8 to 53.1 percent in the general population; 0.1 to 65.7 percent in children; 5.6 to 80.8 percent in older adults; 12.4 to 29.7 percent in medically vulnerable individuals; and 9.8 to 94.6 percent in individuals with a history of severe COVID-19. A wide range of symptoms were identified, with fatigue and neurological and respiratory symptoms being commonly reported. Female sex and increased age were identified as risk factors for developing Long COVID.

Long COVID is a complex condition involving a wide range of symptoms, which may result in significant reductions in quality of life and functioning in some individuals, a substantial burden on healthcare systems, and broader economic impacts. In planning healthcare delivery for this population, a focus on multidisciplinary holistic care will be necessary.

The use of systematic reviews (SRs) of interventions is commonplace in health technology assessment (HTA). However, SRs synthesizing other data types, such as prevalence, are rarely used. These SRs may complement the HTA process by gathering complementary evidence essential for developing trustworthy recommendations. We aimed to discuss the importance and application of SRs of prevalence in the context of HTA.

A methodological working group, the Prevalence Estimates Reviews – Systematic Review Methodology Group (PERSyst), was created to provide guidance on how to improve the development of SRs and meta-analyses of prevalence. As part of the group’s work, a guide for HTA developers regarding the value of SRs of prevalence was developed.

There are many benefits to including SRs of prevalence in the process of HTA. These include providing data for estimating burden of disease; helping to set priorities regarding technology assessment; informing the absolute impact on health outcomes from association measures (e.g., relative risk) reported in clinical studies; and providing data for estimating resource requirements for and feasibility of implementing health technologies under consideration. Within the GRADE framework, prevalence estimates are necessary to assess the quality of diagnostic test accuracy evidence and to support decision-making using the Evidence to Decision framework.

Although not commonly used, SRs of prevalence are an important tool in the process of HTA. There is a need for standardization of methodologies and guidance on how to use these reviews in the HTA process.

While implementing an evidence-based guideline for venous thromboembolism (VTE) prophylaxis in a Brazilian tertiary hospital, we identified an unmet need for patients undergoing major orthopedic surgery. The Brazilian Unified Health System (SUS) does not provide access to direct oral anticoagulants (DOACs) or enoxaparin. Therefore, an assessment of the efficacy, safety, and budgetary impact of these medications from a hospital perspective is warranted.

Our Health Technology Assessment Center performed an overview of systematic reviews (SR) to compare the efficacy and safety of DOACs with enoxaparin. The Cochrane Library, Embase, and MEDLINE databases were searched in May 2023. The relative risks of symptomatic VTE, clinically relevant bleeding, and mortality were collected. The AMSTAR-2 tool was used to assess the methodological quality of included SRs. Treatment costs and estimates of the number of patients undergoing knee or hip arthroplasty were derived from historical institutional data.

Of the 32 SRs included in the analysis, seven performed a network meta-analysis. All SRs had at least one flaw in a critical methodological domain, mainly in not providing the list of excluded studies. Regarding mortality rates, most SRs did not detect any differences between the treatments. The risk of experiencing VTE was lower with DOACs in eight SRs for hip arthroplasty and in five SRs for knee arthroplasty. The risk of major bleeding was similar between the treatments in all but two SRs. Substituting enoxaparin for DOACs led to a cost reduction of BRL490 (USD98) per patient, which could save BRL29,890 (USD6,038) per year.

Patients undergoing hip and knee arthroplasties are at high risk for the occurrence of VTE. Our overview of SRs showed that the efficacy and safety of DOACs are well recognized. DOACs reduce the risk of VTE, but to date patients in Brazil do not have access to these medicines through the SUS. By providing DOACs, hospitals could ensure adequate prophylaxis without increasing costs.

Public hospitals in São Paulo can be held financially responsible for costs related to medications prescribed outside the recommendations of the Brazilian Unified Health System (SUS). The objective of this study was to describe these expenses in a public hospital and the measures implemented and evaluated to reduce this problem.

In January 2023, the Health Technology Assessment Center collected data on legal proceedings filed against a tertiary teaching hospital from January 2021 to November 2023. The data were obtained from monthly reports sent by the São Paulo State Department of Health (SES). The proceedings were categorized according to the type of technology and its availability in the SUS, costs, and the prescribing specialties. The indicators developed were used to plan improvement actions to guide care teams, negotiate with the SES, and resolve current legal proceedings.

The cost of legal proceedings for 136 patients was BRL4,410,278 (USD890,965). Four medicines for six patients constituted 56 percent of the total cost. A group created an informative folder explaining how to access the National List of Essential Medicines, prescribe medicines from the high-cost program, and make administrative requests. Other related actions were the creation of a standardized process for requesting medicines, monthly assessment of judicialization data, clinical discussions with prescribers, and educational activities with residents. The interventions reduced average monthly costs from BRL177,268 (USD35,811) to BRL85,493 (USD17,271) in the last trimester.

Knowledge and measurement of judicialization costs allowed the hospital to implement improvements to help avoid new legal proceedings and to understand the demands of medical specialties regarding situations not covered by SUS guidelines. The Health Technology Assessment Center’s work with managers made it possible to identify opportunities for improving the education of professionals regarding the procedures and technologies available in the SUS.

A program for integral, transversal, and multidisciplinary management of aortic stenosis (MITMEVA) is being implemented at the Clinic Barcelona University Hospital (CBUH) to provide adequate treatment for patients with aortic stenosis (AS). Eleven actions at different care points were implemented (e.g., awareness raising for the general population, a single entry path for patient referral, prehabilitation and rehabilitation, and a risk-sharing agreement). Preliminary results are presented.

A before-and-after implementation study was conducted with 131 patients under MITMEVA and 131 matched (for treatment, New York Heart Association classification, sex, age, and referral place) historical controls. Data were collected on resources used and quality of life and to calculate several key performance indicators (KPIs) (e.g., knowledge improvement in citizens, time from diagnosis to treatment, and patient involvement and satisfaction) for each implemented action. A descriptive analysis of KPIs and a Markov model were performed to simulate clinical and economic outcomes for patient health states over time after the first year until the tenth year after intervention.

The MITMEVA program increased quality-adjusted life-years by 1.78 (p=0.011) and reduced time from referral to first hospital visit by 24.7 percent (p=0.05), hospital complications by 19.7 percent (p=0.05), mean conventional ward stay from 12.8 to 8 days (p=0.01), and mean intensive care unit stay from 9.75 to 4.25 days, although the latter difference was not statistically significant (p=0.139). The mean cost per patient was reduced from EUR7,573.27 per patient to EUR6,024.61 per patient (p=0.01). The MITMEVA program was a dominant strategy. There was a 46 percent increase in correct AS symptom identification after delivering training on AS to the general population.

Integrated care approaches can potentially improve patient continuum of care if the strategies are deployed in a multidisciplinary and transversal way across healthcare actors. The MITMEVA program significantly improved clinical and economic outcomes and organization of care, benefiting patients and clinicians. Applying health technology assessment methods to such innovative projects can help prove the value of organizational innovations.

Reconstructing the value puzzle in health technology assessment (HTA) of new technologies is an ongoing discussion among different stakeholders. Little progress has been made toward consistently and transparently incorporating additional value elements, such as health equity, or moving the focus beyond the traditional value elements of clinical benefit and economic cost associated with the introduction of new technologies.

The objective was to conduct a series of pragmatic reviews of recent HTA guidance documents, international organizations, and previous systematic reviews to answer the following research questions.

• • Would increased familiarity with real-world evidence, advanced analytics, and expanded forms of economic modeling create the forum for HTA bodies to reconsider their processes and include health equity when assessing new products?

• • Which methods innovations would facilitate changes in HTA methods and processes to consistently and transparently assess health equity value elements?

Results were documented and qualitatively synthesized by outlining missed opportunities and highlighting potential barriers to integrating equity-informed HTA processes.

Our findings were grouped into three main parts: HTA guidance summaries, trends summarized by key organizations (HTAi, ISPOR, and others), and peer reviewed publications. HTA bodies have increasingly emphasized health equity concerns and the importance of standardizing methods to support health equity considerations but have not recommended explicit quantitative methods. Our database search found previous systematic literature reviews explicitly referring to methods of integrating real-world evidence into comparative effectiveness assessments, whereas modeling techniques such as distributional, augmented, or cost-effectiveness analyses, and multicriteria decision-making can integrate health equity effects for both patients and healthcare systems.

Our research showcases the gap between recognizing health equity as a missing element in HTA and incorporating methods to implement such considerations into real-life decision-making. Greater familiarity with health equity methods may move the discussion from “whether” to “how” additional value elements such as health equity can inform decision-making.

A program for integral, transversal, and multidisciplinary management of aortic stenosis (MITMEVA) was implemented at the Clinic Barcelona University Hospital to provide adequate and personalized treatment for patients with aortic stenosis (AS). MITMEVA includes 11 actions in the AS care pathway. This study aimed to test the scalability of MITMEVA by gathering the perspectives of relevant stakeholders in two other Catalan hospitals.

A mixed method study design was used to collect and analyze the views of relevant stakeholders on the scalability of the MITMEVA project. Qualitative and quantitative methods were used to answer the research question. All participants were interviewed individually using a semi-structured interview guide. The interviews were transcribed and analyzed by performing a content analysis with Atlas.ti software. Quantitative data were gathered and analyzed by adjusting the Intervention Scalability Assessment Tool (ISAT).

Nine participants were interviewed from two tertiary hospitals in Catalonia and eight ISAT questionnaires were completed. From the content analysis, 11 of the 15 themes identified related to actions implemented in the MITMEVA program. The results pointed toward a positive view of implementation of the MITMEVA program in general, showing a good scalability for all the ISAT domains. On a scale of zero to three, most domains were scored two or above.

The qualitative and quantitative results indicated that the MITMEVA program has potential for scaling up to other Catalan hospitals to improve the management of AS. Generally, stakeholders from the two participating hospitals were positive about the project. However, small adjustments will be needed to account for the culture and organizational characteristics of the hospitals when scaling up the MITMEVA program.

Health technology assessment (HTA) agencies assess the value of innovative therapies and publish recommendations for practice. However, is publishing HTA products sufficient to generate value in the real world? The objectives of our work were to: (i) determine whether innovative therapies for lung cancer produce the expected results in the real-world setting; and (ii) assess whether recommendations are followed in real-world practice.

Clinical administrative data were used in this two-phase project. In the first phase, a descriptive portrait of the use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) for treating lung cancer was produced. Their value was assessed by comparing overall survival of treated patients observed in the province of Québec to the published literature. The second phase focused on the initial evaluation of patients diagnosed with lung cancer and treated first by surgery. The delay between first evidence of cancer and surgery was assessed, and the utilization of 27 healthcare services was analyzed and assessed according to our recommendations (algorithms) for lung cancer management.

From the date the first EGFR-TKI was listed, it took about five years before these drugs were fully integrated into clinical practice. The median overall survival of patients in Québec who used an EGFR-TKI (three indications) was similar to that in most published studies, supporting previous reimbursement decisions. The median delay between first evidence of cancer and surgery was longer than the 60-day consensus target. Utilization of most healthcare services was heterogeneous between regions. Bronchoscopy on its own seemed overused in many regions, whereas non-surgical approaches as a first method for invasive mediastinal evaluation should have been more systematically applied.

At a relatively low cost, real-world evidence can serve as a powerful tool to validate reimbursement decisions and measure the state of clinical practice. By sharing results with stakeholders, it will enable clinical teams to reflect upon their practice and implement local improvement strategies.