Proponents of the capability approach argue that the effect of health technologies should be measured in terms of capabilities, that is, the freedom to live as desired. The ICECAP-A, initially developed in the UK, has been used internationally to measure capability wellbeing. This study examined whether participants from Australia, Canada, Germany, the UK, and the USA similarly interpret and respond to the ICECAP-A.

A multigroup confirmatory factor analysis was conducted. Four types of measurement invariance were tested: configural invariance, metric invariance, scalar invariance, and residual invariance. Measurement invariance was assessed by studying the comparative fit index (CFI) and the root mean square error of approximation (RMSEA) and standardized root mean squared residual (SRMR) fit indices. For this study, data from the multi-instrument comparison database were used to compare response patterns of participants from Australia (n=1,430), Canada (n=1,330), Germany (n=1,269), the UK (n=1,356), and the USA (n=1,460).

The configural invariant model showed adequate fit (CFI 0.992, RMSEA 0.076, SRMR 0.016), and metric invariance was established (change in variables: CFI -0.002, RMSEA -0.014, SRMR 0.015). Scalar invariance (and consequently residual invariance) was not established (change in variables: CFI -0.036, RMSEA 0.046, SRMR 0.018). Post-hoc analysis indicated that full measurement invariance could be established by excluding the German sample, with improved fit index values for configural invariance (CFI 0.994, RMSEA 0.069, SRMR 0.015), metric invariance (change in variables: CFI-0.000, RMSEA -0.020, SRMR 0.006), scalar invariance (change in variables: CFI -0.007, RMSEA 0.011, SRMR 0.006), and residual invariance (change in variables: CFI -0.002, RMSEA 0.009, RMR 0.006).

Response patterns to the German and English versions of the ICECAP-A differed. Caution should be exercised when using these two versions in the same study. Further research is required to determine whether these differences are due to linguistic variations from translation, or whether they indicate fundamental differences in participant understanding and responses to the different versions of the ICECAP-A.

Achieving health equity through access to new health technologies has not been consistently considered within the health technology assessment (HTA) remit. HTA bodies now recognize that achieving health equity (or reducing health inequities) is a distinct value element for new technologies beyond the restrictive focus on clinical benefits and costs, but they lack familiarity with methods to reliably measure such effects.

We conducted a targeted literature review in indexed databases (Embase and MEDLINE) to identify relevant literature on methods for measuring health equity in HTAs published in the English language within the last five years. We mapped the literature based on key HTA stages: topic selection (eligible patient population); scoping (description of pre-decision health equities); evidence synthesis (equity impacts on health outcomes from introducing the intervention); comparative clinical comparisons including indirect treatment comparisons and cost-effectiveness analyses (including assessment of equity and efficiency trade-offs); and re-assessment (for conditional marketing). Equity-informed HTA decision frameworks and checklists were separately summarized. A narrative synthesis was performed.

The databases returned 2,800 unique publications. After screening 50 percent of the abstracts (30 publications) were found to be relevant. We applied additional selection criteria based on quality and information availability. Findings across the studies were grouped in a health equity methodological map as follows: understanding baseline epidemiological data in the targeted population; assessing diversity in trial populations and need for additional robust real-world evidence; effectiveness methods (subgroup analyses, incorporation of observational data with trials, simulation studies); and expanded economic modeling (distributional cost-effectiveness analysis, augmented cost-effectiveness analysis, extended cost-effectiveness analysis) or the use of multicriteria decision analysis. Two equity checklists and frameworks for HTA were also identified.

Greater familiarity with health equity methods will drive its routine implementation in HTA and decision-making. This road map provides a summary of available health equity methodologies across the full HTA cycle and can be used as a guide for future HTA case studies. Decision-makers should directly engage with patients to learn about the experiences of diverse and disadvantaged patient groups.

This study aimed to develop an algorithm to map the clinically popular European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) to the prevailing health technology assessment outcome measure, the EuroQol 5D-5L questionnaire (EQ-5D-5L), to investigate the quality of life in patients with non-small cell lung cancer (NSCLC).

Mapping models were estimated using EQ-5D-5L, the EQ visual analogue scale (EQ-VAS), and the QLQ-C30 results from patients with NSCLC. This study used data at baseline from all three quality of life scores (n=289) to estimate the mapping algorithm. Linear regression was conducted on each domain of the QLQ-C30 as follows: physical functioning, global health status, emotional function, diarrhea, financial difficulties, insomnia, fatigue, and pain. Quality of life data collected at six (n=176) and 12 weeks (n=60) were used to evaluate the validity of the estimated mapping algorithm. The EQ-VAS was used to compare correlations with the algorithm.

The estimated algorithm had a root mean squared error of 0.0937 and an adjusted R-squared of 0.7227. The correlations between the estimated and the observed EQ-5D-5L values at baseline, six weeks, and 12 weeks were 0.8546, 0.8493, and 0.8846, respectively. The estimated and observed values had a high correlation. Also, the bias between the predicted and the observed EQ-5D-5L values at six and 12 weeks was 0.0113 and 0.0292, respectively. Hence, the mapping algorithm had a good predictive validity.

The mapping algorithm can be used to convert a cancer-specific health-related quality of life measure to a preference-based health-related utility measure, which is useful in health technology assessment. Mapping EORTC-QLQ-C30 onto the EQ-5D-5L enables the estimated EQ-5D-5L scores of patients with cancer to be used in economic evaluations such as cost-utility analyses.

Gaucher disease is characterized by a deficiency of the enzyme glucocerebrosidase and requires lifelong enzyme replacement therapy. Imiglucerase is the standard treatment, which improves patient survival and quality of life. While defined daily doses (DDD) offer a standardized metric, the relative efficacy of adhering strictly to these guidelines, compared with tailored lower doses, has not been fully explored.

A retrospective cohort study was conducted on 1,234 patients to investigate the survival outcomes associated with various levels of adherence to DDDs of imiglucerase, factoring in demographic diversity and comorbidity profiles, and to evaluate the feasibility of a more personalized dosing approach in the management of Gaucher disease. DDD adherence was categorized as equal to DDD, higher than DDD, or lower than DDD. Kaplan-Meier survival analysis, log-rank tests, and Cox proportional hazards models were used to assess survival probabilities over 16 years. Data on age, sex, comorbidities, and other demographic factors were collected to adjust for potential confounders.

Over the 16-year period, our Kaplan-Meier survival analysis revealed distinct survival probabilities across the three groups based on their adherence to DDD of imiglucerase. Patients who received doses lower than DDD (n=880) had a survival probability of 91.8 percent. In contrast, those receiving doses equal to the DDD (n=15) had a 100 percent survival probability, since no events were observed in this group. The greater than DDD group (n=339) exhibited a survival probability of 81 percent. A log-rank test indicated a borderline statistical significance (p=0.058) in the survival distributions among the various DDD adherence levels, with a favorable trend in the lower dose group.

Our research indicates that lower than usual doses of imiglucerase may improve survival rates in patients with Gaucher disease. This finding suggests that reduced dosages could lead to better clinical outcomes with fewer side effects, highlighting the potential benefits of personalized dosing strategies. Further studies are needed to confirm these preliminary results and optimize dosing protocols.

Stakeholders in the drug life cycle recognize the importance of integrating patient experience data (PED) into healthcare decision-making. PED includes patient input, patient reported outcomes (PROs), patient reported experiences, and patient preference information. However, it remains unclear if, how, and to what extent PED are used in reimbursement decisions in Belgium.

A document analysis was performed to evaluate and compare the reporting of PED in Belgian reimbursement documents for COVID-19, oncology, and cardiology. Documents of medicinal products that received a European marketing authorization between 1 January 2015 and 30 September 2023 and were reimbursed in Belgium were included. Data were analyzed descriptively and qualitatively.

Preliminary results showed that PED was generally either not reported or not explicitly reported in Belgian reimbursement documents. In some documents, patient reported outcome measures (PROMs) were mentioned. Additionally, few documents stated PROs such as quality of life. PROMs, PROs, and quality of life outcomes appeared in the reimbursement dossier section describing the therapeutic value of the product. From the preliminary findings it seems that PED were more often present in oncology documents. The reimbursement dossiers did not report whether or how PED were used to inform a particular reimbursement decision.

Preliminary findings suggest that PED are not systematically included in Belgian reimbursement documents. To improve transparent submission and reporting of PED in reimbursement dossiers, guidance from reimbursement agencies as well as checklists and evaluation templates are needed.

The number of economic evaluations of public health intervention is gradually increasing, which corresponds to the increasing interest of policymakers in public health interventions. However, there are some methodological challenges and debates regarding economic evaluations of public health interventions due to the nature and complexity of public health programs. One of the challenges is related to the outcome measure used.

This narrative review explored the advantages and disadvantages of using the quality-adjusted life-year (QALY) as an outcome measure in economic evaluations of public health interventions.

The QALY is a preferred outcome measure in cost-utility analyses because of its simplicity, clarity, face validity, and ease of application. The QALY provides a measure of overall health and allows for comparability across different cases. However, there are some criticisms of using the QALY in economic evaluations of public health interventions. Many public health programs aim to affect not only health outcomes, but also other aspects such as participation and empowerment. In addition, public health programs might have positive externalities. The QALY is unable to detect minor changes resulting from community-based health interventions and does not capture equity aspects of public health interventions.

It is necessary to establish a common framework for a transparent and consistent decision-making process that accounts for the multidimensional and complex outcomes of public health interventions.

Influenza causes seasonal epidemics and is a significant burden. Annual vaccination is an effective way to prevent influenza and its complications. However, vaccination coverage remains low in North Africa and the Middle East. Quadrivalent vaccines offer protection but require monetary investments. This study aimed to quantify the costs and benefits of subunit quadrivalent influenza vaccination among healthy adults in the selected countries.

A decision tree was used to model the costs and outcomes of treatment with an inactivated subunit quadrivalent vaccine, compared with no vaccine, in healthy adults from the societal and payer perspectives. Outcomes measured include productive days gained through reduced absenteeism and the proportion of the population acquiring influenza. Each country’s expected health resource utilization costs for influenza were determined through literature searches and consultations with clinical experts. Deterministic and probabilistic sensitivity analyses were undertaken to characterize the effects of parameter uncertainty on our results.

We found that in every country the proportion of people who acquired influenza was 2.4 times lower in vaccinated individuals than in the unvaccinated. This resulted in between 0.9 and 1.5 more productive days worked for vaccinated individuals. The average cost savings from the societal perspective ranged from USD12.36 to USD276.85 per person. Deterministic sensitivity analysis indicated that influenza prevalence was the strongest driver of the model results. A probabilistic sensitivity analysis of over 1,000 simulations resulted in cost savings 54.4 to 99.3 percent of the time.

Vaccination with a subunit quadrivalent influenza vaccine results in cost savings when compared with no vaccination in every country studied. We therefore conclude that, in terms of cost effectiveness, vaccination with a subunit quadrivalent influenza vaccine is dominant over no vaccination in Algeria, Egypt, Saudi Arabia, Turkey, and the United Arab Emirates.

Newborn bloodspot screening (NBS) is used to identify rare, serious health conditions. The choice of conditions to screen for can be contentious, with no internationally agreed panel. Multicriteria decision analysis (MCDA), involving a priori identification and weighting of criteria, has been proposed as an approach to assess and rank conditions for inclusion in newborn screening panels or for further assessment.

The aim of this review was to summarize existing MCDA-like processes used internationally in the context of NBS conditions. Publications were identified using a scoping methodology including electronic database and gray literature searches. Information on the methodology used to derive criteria and weightings, the criteria used, the scoring systems, and the weightings were extracted. The results were synthesized narratively.

Five publications reporting on the use of MCDA or MCDA-like processes in the context of NBS were identified. In three publications, the aim of the MCDA processes was to select conditions for inclusion in an NBS panel. Two referred to the potential use of MCDA to inform prioritization of candidate conditions for future evaluation. While the criteria used were broadly consistent across studies, assigned weightings varied. Key challenges noted in the studies in relation to applying MCDA included the subjectivity associated with the choice and weighting of criteria, the absence of data to inform criteria, and its low discriminatory power.

Choosing criteria and weightings for MCDA processes regarding NBS can be a highly deliberative process that is intrinsically linked to the values and perspectives of those involved. Given the lack of international consensus on criteria and weightings, MCDA processes to aid decision-making would likely require a de novo tool or careful adaptation of an existing tool to reflect local contexts.

Depression is associated with serious disease burden. Despite the multitude of antidepressant options available, the adherence rate is often low. Accounting for patient preferences can potentially boost adherence to antidepressant medication and elevate patient satisfaction. However, limited evidence exists regarding patient preferences for antidepressant selection. This study aims to elicit patient preferences regarding the benefits, risks, and cost attributes of antidepressants in China.

A best-worst scaling profile case experiment was conducted using a face-to-face survey administered to patients diagnosed with depression. Patients were recruited from general and psychiatric hospitals. We utilized a multiphase approach that integrated literature review, expert consultation, and best-worst scaling to develop attributes within choice sets. The attributes with each varying across two or three levels encompassed remission rate, sleep disorders, risk of headache or dizziness, risk of gastrointestinal adverse events, risk of liver or kidney injury, and monthly out-of-pocket costs. Each respondent answered seven choice tasks, including a dominant task. Data were analyzed using conditional logit, mixed logit, and generalized multinomial logit models. Subgroup analyses were conducted to explore preference heterogeneity.

A total of 331 participants completed the survey and met the inclusion criteria. Almost all attribute levels were statistically significant. Overall, the most desirable characteristics of antidepressant medications were higher remission rates (80% and 55% rates; p<0.05), lower risk of liver or kidney injury (1% rate; p<0.05), and fewer monthly out-of-pocket costs (CNY100 [USD13.93, EUR12.75]; p<0.05). Risks of gastrointestinal adverse events (60% and 35% rates) and insomnia were the least preferred features. Regarding attributes, efficacy, the risk of gastrointestinal adverse events, and sleep disorders were relatively important factors influencing patient choice. Preferences differed slightly by age, degree of education, personal annual income, and treatments currently received.

Our study suggests that efficacy, gastrointestinal adverse effects, sleep disorders, and treatment costs are critical drivers behind medication choices among patients with depression. Preference heterogeneity also exists regarding individual and therapeutic characteristics, which need more samples and further analyses to identify. These discoveries hold the potential to enrich the shared decision-making process between physicians and patients within healthcare settings.

With the aging population, chronic diseases have become a serious threat to public health in China. Adhering to the doctor’s advice is an effective strategy for controlling chronic diseases, and the preferences of patients with chronic disease has an important impact on compliance with medication. However, there is insufficient research exploring this aspect.

In this study patients with chronic disease were selected by stratified random sampling to participate in a survey carried out in three cities of a province in eastern China. The discrete choice experiment used a questionnaire of D-efficiency experimental design to measure the medication choices of patients with chronic disease. The main attributes included drug price, onset of action, adverse reactions, traditional Chinese or Western medicine, domestic drug, and reimbursed by medical insurance. The data were analyzed using a mixed logit model.

A total of 1,062 valid questionnaires were received. The 1,045 questionnaires that passed the consistency test covered three prefecture-level cities, nine counties, and 216 villages. All drug attributes were statistically significant for selection preferences. The preference of patients in rural areas with chronic disease was “quick onset of action” (β=2.491), “Western medicine” (β=0. 826), “medical insurance” (β=0.556), “domestic drugs” (β=0.286), and “very few adverse reactions” (β=0.170). “Drug price” also had an impact on medication preferences among patients in rural areas with chronic disease (β=−0.013).

Onset of action is the attribute of medications that is of most concern for patients in rural areas with chronic disease. Subgroup analysis showed that these patients were predominantly female, had a primary school education or lower, were younger than 69 years, were unemployed, and had an annual income between CNY10,000 (USD1,396.78) and CNY50,000 (USD6,983.92). They were willing to pay more for drugs with a quick onset of action, Western medicines, and drugs with reimbursed by medical insurance.

Integrated care (IC) is a patient-centered approach to the provision of health care that overcomes the fragmentation in the delivery of services that often occurs in older people with multiple comorbidities. Medical device innovations could help tackle this and other challenges of health systems when facing the adoption of high quality IC. Nevertheless, this should be accompanied by the right innovation funding scheme to encourage adoption.

A systematic search strategy to identify payment models for IC was performed in PubMed for the period from 2014 to 2023 using the International Foundation for Integrated Care Knowledge Tree tool. This was complemented with both a gray literature search in Google and a benchmark of payment models for innovative medicines. A scoping review was then performed identifying the following information: payment scheme; advantages and disadvantages for IC; inclusion of innovation; type of IC program or initiative described (sectors and providers); population (therapeutic area); country; and whether the information was conceptual or empirical.

According to the literature reviewed, five payment schemes used in IC were identified. However, they were rarely used in isolation; more often a mix of payment schemes was used. Based on conceptual and empirical articles, the combination of bundled payment, shared savings, and pay for performance (based on the quality of care delivered) seemed to be the most comprehensive payment scheme. However, references to inclusion of innovation were not mentioned even in this mixed system. Payment systems for innovative medicines were benchmarked for medical devices.

A mixed system of bundled payment, shared savings, and pay for performance appears to be the most complete payment model for IC, since it counteracts the limitations of individual funding schemes. No evidence was found on how to incentivize medical device innovation in the context of IC delivery. However, inspiration from current payment schemes for innovative medicines can provide a starting point for innovative medical device schemes.

Health technology assessment of medical devices often faces the challenge that approval studies have an insufficient study design. The European Medical Device Regulation (MDR), which has been in force since May 2021, places stricter requirements on clinical studies for high-risk medical devices. One important way of implementing the regulation is through guidance documents from the Medical Device Coordination Group (MDCG).

Our objective was to systematically identify and analyze recommendations for the design of pivotal studies of high-risk therapeutic medical devices from the MDCG and other regulatory authorities of high-income countries. We systematically searched the websites of regulatory authorities and included both cross-device and device-specific recommendations on clinical trial design for cardiovascular, orthopedic, and diabetes related high-risk medical devices. We extracted and compared the recommendations according to the following seven topics: definitions of study types and level of evidence; need for clinical investigations; appropriate choice of study methodology; general aspects; statistical methods; consideration of context and learning curve; and reporting.

We included 30 documents from regulatory authorities. Eight documents from the European Union (EU) focused mainly on procedural issues and reporting. Guidance on appropriate levels of evidence and choice of study methodology for design and analysis of clinical investigations was missing. Eleven guidance documents were from the United States Food and Drug Administration, which provided detailed recommendations on almost all topics regarding study design as well as new methods. The remaining documents originated from four other countries and the International Medical Device Regulators Forum. A document from Australia included device-specific recommendations but hardly any general recommendations on clinical trials.

The recommendations published to date in the EU are insufficient to support stakeholders in choosing or assessing appropriate study designs to implement the evidence requirements of the European MDR. Detailed guidance from the MDCG is needed to create a common understanding between manufacturers, notified bodies, MDR expert panels, and competent authorities regarding what sufficiency of clinical data means.

There are few studies on the use medicinal herbs by pregnant women in Brazil, even though there is a wealth of knowledge about medicinal herbs among Brazilians of Indigenous, African, and European ancestry. The aim of this study was to assess the prevalence and type of herbs used by pregnant women living in the Amazon region.

This was a cross-sectional study conducted with 811 pregnant women attending 10 public antenatal clinics in Manaus, Amazonas state, Brazil. The consumption of medicinal herbs was assessed through individual 24-hour dietary recall.

A total of 811 women in their second trimester (16 to 20 weeks) of pregnancy were included and 69 (8.5%) reported that they used herbs to make teas. There was a significant difference between users and non-users of medicinal teas, with a higher proportion of overweight women in the group that used teas (46.4% versus 31.9%; p=0.005). Nearly half (47.8%) of those who used medicinal teas consumed herbs with sedative effects, 23 percent consumed herbs for the relief of urinary tract symptoms, and 13 percent used herbs with digestive properties. Most women reported using natural herbs from their own gardens.

Approximately 10 percent of Brazilian women in the Amazon region consumed medicinal herbs to alleviate common symptoms of pregnancy. The most frequently used plants had sedative, urinary tract, or gastrointestinal effects. Most plants were obtained in natura from local gardens. Many of these plants have known adverse effects and their use is contraindicated during pregnancy.

Evaluating genetic and genomic applications is critical for their adoption in healthcare practice, but this has several challenges, including limited evidence on clinical and non-clinical benefits and rapid development processes. Since these challenges lack comprehensive discussion, this study aimed to identify and analyze all the barriers emerging in the health technology assessment (HTA) of genetic and genomic tests.

The protocol of this study was registered in the Open Science Framework database. A systematic search of the PubMed, Scopus, and Web of Science bibliographic databases was undertaken to identify all studies that specifically discussed any difficulty, gap, or barrier in the HTA evaluation of genetic or genomic technologies. No restrictions were imposed on HTA domain, study type, or publication date. Gaps and challenges were then grouped into domains outlined in the EUnetHTA HTA Core Model®. A narrative synthesis of the results was performed for each HTA domain.

Of the 457 publications identified, 23 were included. Article designs exhibited considerable diversity, ranging from systematic reviews to semi-structured interviews, and stakeholder involvement varied from universities to national research groups. The challenges we found referred to the general HTA framework or, in most cases, to specific domains. More than 25 percent of the challenges were associated with economic aspects, with cost-effectiveness analysis being the focal point of debate. In addition, clinical effectiveness, in terms of non-health outcomes, lack of evidence, and clinical utility, was also frequently discussed, accounting for 23 percent of the challenges identified.

Our study systematically summarized gaps and barriers in the HTA of genetic and genomic applications, providing a thorough analysis and categorization of these issues. Various challenges surfaced across different domains, notably related to costs, economic evaluation, and clinical effectiveness. There is a need for exhaustive discussions on potential solutions to facilitate and enhance the assessment process for these genetic and genomic applications.

Frameworks based on the ACCE model, which have a limited health technology assessment (HTA) approach, have long been used in the assessment of genetic and genomic applications (GGAs). While ACCE frameworks are mainly focused on technical aspects, HTA assessments include economic and organizational aspects. The aim of this study was to develop a framework able to address a comprehensive assessment of GGAs.

We analyzed the most currently used HTA model in Europe, the EUnetHTA HTA Core Model®, to investigate its suitability as an HTA framework for GGAs and to identify any possible shortcomings in its evaluation. The Sapienza evaluation framework, which is based on a previous systematic review of assessment frameworks for GGAs, was used as the comparison. The HTA Core Model applications were then used as a basis for an assessment framework for GGAs, classified according to “GGA function/use setting” pairs.

The domains included in the Sapienza framework fully corresponded with the HTA Core Model. In addition, the “Screening Technology” application of the HTA Core Model was found to be suitable for diagnostic, pre-symptomatic, predictive, and carrier GGAs when used in screening settings. The “Diagnostic Technologies” application was deemed appropriate for the pairs “Diagnostic/Diagnosis”, “Pre-symptomatic/Diagnosis”, “Prognostic/Staging”, and “Pharmacogenetic/Staging”, although it may require additional considerations such as the need for screening in the case of germline mutations, the use of appropriate accuracy measures for prognostic GGAs, and the evaluation of the clinical utility of pharmacogenetic or prognostic GGAs.

The proposed approach is a flexible tool that allows assessment of GGAs using a shared and validated methodology that considers the technical aspect, clinical utility, economic value, and delivery models. We found that the HTA Core Model fits the needs of GGA assessment, although some GGA peculiarities should be further explored in the assessment process.

With the European Union Regulation on health technology assessment (HTA) approaching, there is concern about how to accommodate the large number of expected population, intervention, comparator, outcome(s), and study type (PICOS) questions and their uncertainty. Navigating uncertainty will prove essential to anticipate evidence requirements. This abstract presents preliminary results of the development of a metric that assesses uncertainty surrounding PICOS questions to eventually guide planning of evidence synthesis for joint clinical assessment (JCA) submission.

The metric will consist of pillars representing overarching themes of uncertainty. Each pillar will contain several elements influencing uncertainty for proposed PICOS questions. This study was conducted in two phases. In phase one, targeted literature searches of peer-reviewed and gray literature were conducted to identify the overarching metric pillars. These pillars were then validated by expert opinion. Similar research methods were used in phase two to inform the content of each of the pillars. Here we present the findings for phase one.

The targeted literature review in phase one resulted in multiple candidate elements for the uncertainty pillars. Elements were selected based on expert opinion, resulting in five main pillars. These pillars were considered most valuable for the determination of uncertainty surrounding individual PICOS questions and were considered crucial to HTA acceptance. Phase one resulted in the following pillars: (i) indication and subpopulations; (ii) type of intervention and comparators; (iii) societal and patient unmet need; (iv) type and quality of evidence source informing evidence synthesis; and (v) methodology of evidence synthesis.

This study lays the foundation for a metric to assess the uncertainty surrounding proposed PICOS questions for JCAs. The metric identifies existing uncertainties for PICOS questions, assesses potential issues for HTA acceptance, and guides possible evidence synthesis planning. A clear framework for anticipating uncertainty will prove essential in managing resources and expectations.

In the field of sexually transmitted infections (STI), high quality clinical practice guidelines (CPGs) have already been developed using rigorous methodology. To avoid duplicating effort, make cost-effective use of available resources, and facilitate customization to reflect local contexts, we adapted a CPG for prevention, care, and control of STIs in Catalonia, Spain.

The Guideline Adaptation Group (GAG) used the ADAPTE framework to guide transcontextual adaptation. The ADAPTE model has three phases: set-up; adaptation, with five main criteria for determining the relevance of a CPG and the adaptability of its recommendations (quality, currency, content, consistency, and acceptability or applicability); and finalization. We used the Spanish version of the AGREE II instrument to rate and select appropriate CPGs and the RIGHT-AD@pt checklist to guide reporting of the adaptation process. Each recommendation was given a level of evidence and a grade using the GRADE framework.

Once the feasibility of carrying out the adaptation was confirmed, the governance structure was defined, which comprised a steering committee (n=8 members) and an expert committee (n=93 members). Clinical questions were defined from 164 recommendations taken from a CPG published in 2009. The systematic search identified 759 records published from 2016 to 2023. Of these, 57 CPGs met the inclusion criteria. On average, items 10 and 12 of the AGREE II scored between five and seven points (moderate to high quality methodological rigor). Content and consistency are being analyzed and matrices are being prepared to assess acceptability and applicability.

The ADAPTE methodology provides structure, rigor, and efficiency to the transcontextual adaptation of CPG recommendations. We expect that its application will provide practical and timely recommendations on the prevention, care, and control of STIs in the Catalan context.

This study outlines a tutoring program supported by the Brazilian Ministry of Health (MoH), which aimed to develop clinical practice guidelines (CPGs) through Health Technology Assessment Centers (Nuclei of Health Technology Assessment or NATS) for the Brazilian Unified Health System (SUS). It emphasizes the integration of CPGs into health technology assessment development processes, focusing on methodological rigor, reproducibility, and reliability.

The program combined face-to-face and virtual meetings and engaged MoH representatives, methodologists, and researchers. It focused on the MoH Methodological Guideline for Developing Clinical Guidelines, which follows the Guidelines International Network and United States Institute of Medicine recommendations. This approach facilitated planning and creation of CPGs across diverse NATS.

Between 2021 and 2023, 60 professionals from 10 NATS participated, aiding in developing or updating 16 CPGs. These CPGs addressed 93 research questions. The CPG development phase averaged 317 days (interquartile range [IQR] 252 to 402), while the MoH assessment and public consultation took about 63 days (IQR 45 to 94). Additionally, nine Protocolos Clínicos e Diretrizes Terapêuticas (official guidelines from the Brazilian MoH) required technology assessments for SUS reimbursement, leading to 14 HTA reports. Eight technologies were favorably reviewed and recommended in the CPGs.

This tutoring program significantly improved the development of CPGs in Brazil, enhancing their methodological rigor and standardization. It also effectively integrated HTA into the CPG development process, addressing clinical needs and enriching public health decision-making.

The intra-arterial catheter (invasive method) is the clinical and reference standard for continuous blood pressure (BP) monitoring. Continuous noninvasive blood pressure (CNBP) monitoring methods, for example applanation tonometry, volume clamp, and cuffless BP monitoring devices are gaining popularity. This review clarified the evidence on the accuracy of CNBP monitoring devices, which could potentially replace invasive monitoring in clinical care.

A systematic search was carried out to look for systematic reviews with the following elements:

• • Population: patients needing continuous BP monitoring;

• • Intervention: CNBP monitoring devices;

• • Comparator: intra-arterial BP monitoring; and

• • Outcomes: accuracy of BP monitoring.

The databases searched included PubMed (MEDLINE), Epistemonikos, and the Cochrane Database of Systematic Reviews. Two reviewers independently reviewed the search results and shortlisted relevant articles for retrieval of full texts. Included reviews were critically appraised with the AMSTAR 2 instrument and the findings were summarized in a narrative synthesis.

Three systematic reviews with meta-analyses of fairly good quality were included. The included primary studies were conducted in perioperative or critical care settings. Subgroup analyses by CNBP monitoring method were included in each meta-analysis. The findings from the systematic reviews were consistent. On average, CNBP devices consistently measured lower systolic BPs than the invasive method (mean difference <0) and measured higher diastolic BPs and mean arterial pressures than the invasive method (mean difference >0), with wide ranging 95 percent limits of agreement. It was evident from subgroup analyses that the measurements obtained from different CNBP methods varied significantly.

This rapid review found the accuracy of CNBP monitoring devices to be suboptimal in comparison with invasive monitoring. CNBP devices should not be routinely used but may be considered when there is difficult arterial access, or in patients who do not require arterial puncture for other purposes.

Transcatheter aortic valve replacement (TAVR) has become a leading treatment for patients with severe aortic stenosis (AS). Recent studies comparing TAVR outcomes with balloon-expandable valves (BEVs) and self-expandable valves (SEVs) show generally similar results, although BEVs have lower rates of moderate-to-severe aortic regurgitation and pacemaker implantation. This study aimed to compare the clinical outcomes of SEVs and BEVs in Taiwan.

The Taiwan National Health Insurance Research Database (NHIRD) is a representative claims database capturing 99.9 percent of residents. We identified patients who underwent TAVR with either a SEV or BEV in 2021 using the NHIRD. The outcomes were six-month survival, length of hospital stay (LOS) and intensive care unit (ICU) stay, postoperative complications, and healthcare expenditure. We used inverse probability of treatment weighting (IPTW) based on age, gender, and Charlson Comorbidity Index score to identify the effect of TAVR valve type on LOS and ICU stay, postoperative complications, and healthcare expenditure. Differences between SEVs and BEVs for IPTW-weighted Kaplan-Meier curves of overall survival were measured with the log rank test.

Among the patients identified who underwent TAVR, 366 received a SEV and 132 received a BEV. The mean ages were 82.70 (standard deviation [SD] 8.08) years and 82.25 (SD 7.53) years, respectively. The hazard ratio for six-month mortality rate for SEVs compared with BEVs was 2.78 (95% confidence interval 1.52, 5.09). The six-month mortality rate was also significantly higher for SEVs than for BEVs (13.11% versus 4.55%). For clinical outcomes, the mean total LOS (14.78 [SD 12.19] versus 14.45 [SD 12.96] days), mean ICU stay (5.91 [SD 9.78] versus 6.23 [SD 8.04] days), rate of complications (<3%) and in-hospital healthcare costs (USD43,285 [SD 11,993] versus USD42,920 [SD 13,931]) were similar for both groups. The results were also similar after weighting.

Patients in Taiwan who underwent TAVR with BEVs had better survival outcomes than those who received SEVs, while other clinical and cost outcomes were comparable between the valve types.