Effectiveness of using activity-monitoring devices on patients with cardiovascular disease participating in cardiac rehabilitation programs: an umbrella review protocol.

OBJECTIVE: The objective of the review is to investigate the effectiveness of activity-monitoring devices and mobile applications on physical activity and health outcomes of patients with cardiovascular disease who are participating in cardiac rehabilitation programs. INTRODUCTION: Supporting patients with cardiovascular conditions to achieve and maintain healthy physical activity levels is the cornerstone of cardiac rehabilitation programs. The effectiveness of activity-monitoring devices and mobile applications (such as physical activity interventions) utilizing consumer-grade monitoring devices and applications to support patients to improve exercise levels during and after program completion has been investigated. Several systematic reviews evaluating the effectiveness of monitoring devices and applications have indicated varying clinical impact, depending on patient characteristics, stage of rehabilitation, and type of intervention. INCLUSION CRITERIA: This review will consider systematic reviews and/or meta-analyses of randomized controlled trials of patients who participated in cardiac rehabilitation programs that included a physical activity intervention that incorporated activity monitoring using electronic devices and/or mobile applications and reported activity and patient health outcomes. METHODS: MEDLINE, Embase, Sport Discus, The Cochrane Database of Systematic Reviews, Scopus, CINAHL, The International Network of Agencies for Health Technology Assessment (INAHTA) database, Epistemonikos, and Web of Science will be searched from inception to the present. PROSPERO will be searched for unpublished reviews. Articles will be screened by two independent reviewers for inclusion, and methodological quality will be assessed using a JBI critical appraisal tool. Data will be extracted from systematic reviews and a data synthesis of findings will be presented. The certainty will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42022298877.

Early computed tomography coronary angiography in adults presenting with suspected acute coronary syndrome: the RAPID-CTCA RCT.

BACKGROUND: Acute coronary syndrome is a common medical emergency. The optimal strategy to investigate patients who are at intermediate risk of acute coronary syndrome has not been fully determined. OBJECTIVE: To investigate the role of early computed tomography coronary angiography in the investigation and treatment of adults presenting with suspected acute coronary syndrome. DESIGN: A prospective, multicentre, open, parallel-group randomised controlled trial with blinded end-point adjudication. SETTING: Thirty-seven hospitals in the UK. PARTICIPANTS: Adults (aged ≥ 18 years) presenting to the emergency department, acute medicine services or cardiology department with suspected or provisionally diagnosed acute coronary syndrome and at least one of the following: (1) a prior history of coronary artery disease, (2) a cardiac troponin level > 99th centile and (3) an abnormal 12-lead electrocardiogram. INTERVENTIONS: Early computed tomography coronary angiography in addition to standard care was compared with standard care alone. Participants were followed up for 1 year. MAIN OUTCOME MEASURE: One-year all-cause death or subsequent type 1 (spontaneous) or type 4b (stent thrombosis) myocardial infarction, measured as the time to such event adjudicated by two cardiologists blinded to the computerised tomography coronary angiography ( CTCA ) arm. Cost-effectiveness was estimated as the lifetime incremental cost per quality-adjusted life-year gained. RESULTS: Between 23 March 2015 and 27 June 2019, 1748 participants [mean age 62 years (standard deviation 13 years), 64% male, mean Global Registry Of Acute Coronary Events score 115 (standard deviation 35)] were randomised to receive early computed tomography coronary angiography (n = 877) or standard care alone (n = 871). The primary end point occurred in 51 (5.8%) participants randomised to receive computed tomography coronary angiography and 53 (6.1%) participants randomised to receive standard care (adjusted hazard ratio 0.91, 95% confidence interval 0.62 to 1.35; p = 0.65). Computed tomography coronary angiography was associated with a reduced use of invasive coronary angiography (adjusted hazard ratio 0.81, 95% confidence interval 0.72 to 0.92; p = 0.001) but no change in coronary revascularisation (adjusted hazard ratio 1.03, 95% confidence interval 0.87 to 1.21; p = 0.76), acute coronary syndrome therapies (adjusted odds ratio 1.06, 95% confidence interval 0.85 to 1.32; p = 0.63) or preventative therapies on discharge (adjusted odds ratio 1.07, 95% confidence interval 0.87 to 1.32; p = 0.52). Early computed tomography coronary angiography was associated with longer hospitalisations (median increase 0.21 days, 95% confidence interval 0.05 to 0.40 days) and higher mean total health-care costs over 1 year (£561 more per patient) than standard care. LIMITATIONS: The principal limitation of the trial was the slower than anticipated recruitment, leading to a revised sample size, and the requirement to compromise and accept a larger relative effect size estimate for the trial intervention. FUTURE WORK: The potential role of computed tomography coronary angiography in selected patients with a low probability of obstructive coronary artery disease (intermediate or mildly elevated level of troponin) or who have limited access to invasive cardiac catheterisation facilities needs further prospective evaluation. CONCLUSIONS: In patients with suspected or provisionally diagnosed acute coronary syndrome, computed tomography coronary angiography did not alter overall coronary therapeutic interventions or 1-year clinical outcomes, but it did increase the length of hospital stay and health-care costs. These findings do not support the routine use of early computed tomography coronary angiography in intermediate-risk patients with acute chest pain. TRIAL REGISTRATION: This trial is registered as ISRCTN19102565 and Clinical Trials NCT02284191. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 37. See the NIHR Journals Library website for further project information.

WHY DID WE DO THE RESEARCH?: Chest pain is a common medical emergency. It is important to decide if the cause is a heart attack. The two tests that are often used are a heart recording (electrocardiogram) and a blood test (troponin levels). If both are normal, the cause of chest pain is unlikely to be a heart attack and the patient is often discharged home. If either test is positive or if the patient has had previous heart problems, then the patient may require further investigation. We wanted to test whether or not adding a heart scan called a computerised tomography coronary angiogram improved patients' care. HOW DID WE DO THE RESEARCH?: We carried out a randomised trial in which half of the patients attending hospital with chest pain had a computerised tomography coronary angiography scan as part of their assessment and half of the patients did not. In total, 1749 patients were recruited and followed up for 1 year. BRINGING IT ALL TOGETHER: The use of an additional early computerised tomography coronary angiography scan for chest pain patients of medium risk produced only small improvements in patient care.

Is IQWiG's 15% Threshold Universally Applicable in Assessing the Clinical Relevance of Patient-Reported Outcomes Changes? An ISPOR Special Interest Group Report.

This article discusses a recent methodological change to assess the additional benefit of drug intervention by the German Federal Joint Committee (Gemeinsamer Bundesausschuss), a key stakeholder in EUnetHTA21 (European Network for Health Technology Assessment joint consortium for future EU HTA regulation), methodological workstream. The German Federal Joint Committee (Gemeinsamer Bundesausschuss) set a universal individual response threshold at ≥ 15% of the scale range of the measurement instrument, for all patient-reported outcomes, to achieve an additional benefit rating for a given pharmaceutical intervention. This approach is originally based on a corresponding recommendation from the Institute for Quality and Efficiency in Health Care. The merits of this approach are reviewed from various perspectives, including the evidence basis, statistical and psychometric considerations, and regulatory perspectives by the ISPOR Clinical Outcomes Assessment Special Interest Group's multistakeholder group of authors (academia, contract research organizations, and industry). Particular focus is placed on the patient perspective within the Institute for Quality and Efficiency in Health Care approach. The article development incorporated feedback from ISPOR members during well-attended ISPOR US and European conference presentations and 2 formal rounds of written review. The authors concluded that the ≥ 15% response threshold is incongruent with previously defined and scientifically established thresholds and is not well-suited for universal implementation. Further scientific evidence and discussion among all stakeholders are needed, especially should this universal rule be considered in the context of future joint clinical assessments of health technologies in the European Union scheduled from 2025 onward.

National governance of de-implementation of low-value care: a qualitative study in Sweden.

BACKGROUND: The de-implementation of low-value care (LVC) is important to improving patient and population health, minimizing patient harm and reducing resource waste. However, there is limited knowledge about how the de-implementation of LVC is governed and what challenges might be involved. In this study, we aimed to (1) identify key stakeholders' activities in relation to de-implementing LVC in Sweden at the national governance level and (2) identify challenges involved in the national governance of the de-implementation of LVC. METHODS: We used a purposeful sampling strategy to identify stakeholders in Sweden having a potential role in governing the de-implementation of LVC at a national level. Twelve informants from nine stakeholder agencies/organizations were recruited using snowball sampling. Semi-structured interviews were conducted, transcribed and analysed using inductive thematic analysis. RESULTS: Four potential activities for governing the de-implementation of LVC at a national level were identified: recommendations, health technology assessment, control over pharmaceutical products and a national system for knowledge management. Challenges involved included various vested interests that result in the maintenance of LVC and a low overall priority of working with the de-implementation of LVC compared with the implementation of new evidence. Ambiguous evidence made it difficult to clearly determine whether a practice was LVC. Unclear roles, where none of the stakeholders perceived that they had a formal mandate to govern the de-implementation of LVC, further contributed to the challenges involved in governing that de-implementation. CONCLUSIONS: Various activities were performed to govern the de-implementation of LVC at a national level in Sweden; however, these were limited and had a lower priority relative to the implementation of new methods. Challenges involved relate to unfavourable change incentives, ambiguous evidence, and unclear roles to govern the de-implementation of LVC. Addressing these challenges could make the national-level governance of de-implementation more systematic and thereby help create favourable conditions for reducing LVC in healthcare.

Health-related quality-of-life and health-utility reporting in critical care.

Mortality is a well-established patient-important outcome in critical care studies. In contrast, morbidity is less uniformly reported (given the myriad of critical care illnesses and complications of each) but may have a common end-impact on a patient's functional capacity and health-related quality-of-life (HRQoL). Survival with a poor quality-of-life may not be acceptable depending on individual patient values and preferences. Hence, as mortality decreases within critical care, it becomes increasingly important to measure intensive care unit (ICU) survivor HRQoL. HRQoL measurements with a preference-based scoring algorithm can be converted into health utilities on a scale anchored at 0 (representing death) and 1 (representing full health). They can be combined with survival to calculate quality-adjusted life-years (QALY), which are one of the most widely used methods of combining morbidity and mortality into a composite outcome. Although QALYs have been use for health-technology assessment decision-making, an emerging and novel role would be to inform clinical decision-making for patients, families and healthcare providers about what expected HRQoL may be during and after ICU care. Critical care randomized control trials (RCTs) have not routinely measured or reported HRQoL (until more recently), likely due to incapacity of some patients to participate in patient-reported outcome measures. Further differences in HRQoL measurement tools can lead to non-comparable values. To this end, we propose the validation of a gold-standard HRQoL tool in critical care, specifically the EQ-5D-5L. Both combined health-utility and mortality (disaggregated) and QALYs (aggregated) can be reported, with disaggregation allowing for determination of which components are the main drivers of the QALY outcome. Increased use of HRQoL, health-utility, and QALYs in critical care RCTs has the potential to: (1) Increase the likelihood of finding important effects if they exist; (2) improve research efficiency; and (3) help inform optimal management of critically ill patients allowing for decision-making about their HRQoL, in additional to traditional health-technology assessments.

How do HTA agencies perceive conditional approval of medicines? Evidence from England, Scotland, France and Canada.

There is a growing disconnect between regulatory agencies that are promoting expedited approval to medicines based on early phase clinical evidence and health technology assessment (HTA) agencies that require robust clinical evidence to inform coverage decisions. This paper provides an assessment of the evidence gap between regulatory and HTA agencies on medicines receiving conditional marketing authorisation (CMA) and examines how HTA agencies in France, England, Scotland, and Canada interpret and appraise evidence for these medicines. A mixed methods research design was used to identify the types and frequency of parameters raised in the context of HTA decision-making for all conditional approvals in Europe and Canada between 2010 and 2017. Significant heterogeneity was found across the HTA agencies in England, Scotland, France, and Canada in the assessment of medicines receiving CMA, with the highest likelihood of rejection present in Quebec (50%) and Scotland (25%). Rejected medicines were more likely to have unresolved uncertainties related to the magnitude of clinical benefit, study design, and issues in economic modelling. More systematic use of joint early dialogue and conditional reimbursement pathways would help clarify evidence requirements and avoid delays in patient access to innovative medicines.

A call to action to harmonize patient-reported outcomes evidence requirements across key European HTA bodies in oncology.

Patient-reported outcome (PRO) data are increasingly being included in Health Technology Assessment (HTA) submissions for oncology drugs. This study aims to provide differences in PRO evidence requirements in oncology across key HTA bodies and calls for its harmonization. Method guidance provided by HTA bodies in Germany, France, and the UK, and analysis of HTA reports of 20 oncology case studies were evaluated in this review. Differences exist between HTA bodies regarding guidance on how PRO data should be collected, reported and analyzed as well as how the data are reviewed and considered in oncology HTAs. HTA bodies can play a key role to harmonize PRO method guidance in collaboration with regulators and sponsors.

Patient-reported outcomes (PRO) are information provided directly by the person who is experiencing a disease or undergoing a treatment, without additional interpretation by a clinician or caregiver. Along with other outcome measures, PROs may be included in the body of evidence used by health technology assessment bodies in their review. In this article, the authors summarize the guidance documents published by key health technology assessment agencies and reviewed 20 past cancer drug case studies to understand how different agencies use PROs when deciding on recommendations for new cancer treatments.

Novel and existing flexible survival methods for network meta-analyses.

Aim: Technical Support Document 21 discusses trial-based, flexible relative survival models. The authors generalized flexible relative survival models to the network meta-analysis (NMA) setting while accounting for different treatment-effect specifications. Methods: The authors compared the standard parametric model with mixture, mixture cure and nonmixture cure, piecewise, splines and fractional polynomial models. The optimal treatment-effect parametrization was defined in two steps. First, all models were run with treatment effects on all parameters and subsequently the optimal model was defined by removing uncertain treatment effects, for which the parameter was smaller than its standard deviation. The authors used a network in previously treated advanced non-small-cell lung cancer. Results: Flexible model-based NMAs impact fit and incremental mean survival and they increase corresponding uncertainty. Treatment-effect specification impacts incremental survival, reduces uncertainty and improves the fit statistic. Conclusion: Extrapolation techniques already available for individual trials can now be used for NMAs to ensure that the most plausible extrapolations are being used for health technology assessment submissions.

A systematic review of health state utility values in Thai cancer patients.

INTRODUCTION: Health state utility value (HSUV) is an important outcome of cost-utility analysis. The EQ-5D is commonly used to elicit the HSUV of economic analyses based on the recommendations of the Thai health technology assessment guidelines. Therefore, this study aimed to establish a dataset of utility values in patients with liver, lung, colorectal, breast, and cervical cancers at different stages in Thailand. AREAS COVERED: In total, 25 studies were identified in PubMed, Scopus, Thai Library Integrated System, Health Intervention and Technology Assessment Program, and Health System Research Institute from inception to May 2021. The EQ-5D 3 Level Version was commonly used to identify the HSUVs of Thai patients with cancer. Meanwhile, the use of the EQ-5D 5 Level Version was supported by psychometric testing. However, mapping techniques between disease-specific and health preference-based instruments was utilized. EXPERT OPINION: This study showed that patients with colorectal cancer had the highest HSUVs for both the earlier and metastatic stages. Additionally, the differences in HSUVs were found among studies because of the different chemotherapy treatments and elicitation methods. Therefore, it is generally recommended that health economists use HSUVs derived from using the same method during an economic evaluation.

[Concepts and application of cost-benefit evaluation in an international overview]. / Grundkonzepte und Einsatz von Kosten-Nutzen-Bewertungen im internationalen Überblick.

Due to market access of high-priced new drugs, the financial burden on the health care system and the appropriateness of drug prices are often doubted. Is it time for a broader perspective of health technology assessment in Germany, which has so far focused on clinical value? Should cost and benefit aspects of new technologies be given equal weight in future assessments of market access for new technologies? The experiences of European neighbors and the Standing Committee on Vaccination with cost-benefit analyses are encouraging. Introducing cost-benefit analyses as a further decision criterion in the pricing of new technologies naturally creates additional work for the players involved but also offers the opportunity to provide transparent and understandable answers to the question of what a health improvement is worth. In view of the increasing financing challenges facing the statutory health insurance system in Germany, this question will continue to gain importance.

A hybrid approach to comparing parallel-group and stepped-wedge cluster-randomized trials with a continuous primary outcome when there is uncertainty in the intra-cluster correlation.

BACKGROUND/AIMS: To evaluate how uncertainty in the intra-cluster correlation impacts whether a parallel-group or stepped-wedge cluster-randomized trial design is more efficient in terms of the required sample size, in the case of cross-sectional stepped-wedge cluster-randomized trials and continuous outcome data. METHODS: We motivate our work by reviewing how the intra-cluster correlation and standard deviation were justified in 54 health technology assessment reports on cluster-randomized trials. To enable uncertainty at the design stage to be incorporated into the design specification, we then describe how sample size calculation can be performed for cluster- randomized trials in the 'hybrid' framework, which places priors on design parameters and controls the expected power in place of the conventional frequentist power. Comparison of the parallel-group and stepped-wedge cluster-randomized trial designs is conducted by placing Beta and truncated Normal priors on the intra-cluster correlation, and a Gamma prior on the standard deviation. RESULTS: Many Health Technology Assessment reports did not adhere to the Consolidated Standards of Reporting Trials guideline of indicating the uncertainty around the assumed intra-cluster correlation, while others did not justify the assumed intra-cluster correlation or standard deviation. Even for a prior intra-cluster correlation distribution with a small mode, moderate prior densities on high intra-cluster correlation values can lead to a stepped-wedge cluster-randomized trial being more efficient because of the degree to which a stepped-wedge cluster-randomized trial is more efficient for high intra-cluster correlations. With careful specification of the priors, the designs in the hybrid framework can become more robust to, for example, an unexpectedly large value of the outcome variance. CONCLUSION: When there is difficulty obtaining a reliable value for the intra-cluster correlation to assume at the design stage, the proposed methodology offers an appealing approach to sample size calculation. Often, uncertainty in the intra-cluster correlation will mean a stepped-wedge cluster-randomized trial is more efficient than a parallel-group cluster-randomized trial design.

Three Approaches to Improve a Practical Guide on EvidenceInformed Deliberative Processes for Health Benefit Package Design Comment on "Evidence-Informed Deliberative Processes for Health Benefit Package Design - Part II: A Practical Guide".

As countries around the world seek to deliver universal health coverage, they must prioritize which services to pay for with public funds, to whom, and at what cost. Countries are increasingly using health technology assessment (HTA) to identify which interventions provide the best value for money and merit inclusion in their health benefit packages (HBPs)-the explicit lists of health services provided using public funds. Oortwijn et al understand the importance of providing practical guidance on the foundation of HBP design, and their article, "Evidence-Informed Deliberative Processes for Health Benefit Package Design - Part II: A Practical Guide," provides recommendations for HTA bodies to improve the legitimacy of their decision-making by incorporating four elements in their HBP procedures: stakeholder involvement, evidence-informed evaluation, transparency, and appeal. This article proposes three approaches to enhance the value of the guide: moving from structure to compliance and performance, prioritizing key issues of legitimacy within HBP processes, and acknowledging potential the costs and risks associated with the use of this framework.

Available tools to evaluate digital health literacy and engagement with eHealth resources: A scoping review.

Background: As eHealth and use of information and communication technologies (ICT) within healthcare becomes widespread, it is important to ensure that these forms of healthcare are accessible to the users. One factor that is key to accessing eHealth is digital health literacy. Objectives: This scoping review assesses available tools that can be used to evaluate digital health literacy. Methods: A systematic literature search was made in MEDLINE, CINAHL, APA PsychInfo, Ageline, AMED, and APA PsychArticles to present the tools currently in use to assess digital health literacy. A qualitative synthesis of the evidence was carried out using a data charting form created for this review. Extracted data included details of the population of investigation and digital health literacy tool used. A report was produced following PRISMA-ScR guidelines. Results: In total, 53 papers with adult participants and 3 with adolescent participants (aged between 12 and 19 years) were included in the scoping review. 5 questionnaires were identified that measured digital health literacy or attitudes towards the internet, of which the eHealth Literacy Scale (eHEALS) was the most commonly used questionnaire for both adults and children. Two children's questionnaires were often accompanied by a second task to verify the accuracy of the responses to the eHEALS questions. Conclusions: eHEALS is the most commonly used method to assess digital health literacy and assess whether an individual is able to engage actively with eHealthcare or virtual resources. However, care needs to be taken to ensure that its administration does not exclude digitally disadvantaged groups from completing it. Future research would benefit from assessing whether digital health literacy tools are appropriate for use in clinical settings, working to ensure that any scales developed in this area are practical and can be used to support the allocation of resources to ensure that people are able to access healthcare equitably.

Socially Disruptive Technologies, Contextual Integrity, and Conservatism About Moral Change.

This commentary is a response to Contextual Integrity as a General Conceptual Tool for Evaluating Technological Change by Elizabeth O'Neill (Philosophy & Technology (2022)). It argues that while contextual integrity (CI) might be an useful addition to the toolkit of approaches for ethical technology assessment, a CI approach might not be able to uncover all morally relevant impacts of technological change. Moreover, the inherent conservatism of a CI approach might be problematic in cases in which we encounter new kinds of morally problematic situations, such as climate change, or when technology reinforces historically grown injustices.

A Health Technology Assessment Based on Chinese Guidelines: Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Type 2 Diabetes Complicated with Cardiovascular Disease.

Purpose: According to the requirements of the "Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions", this health technology assessment provides an evidence-based basis for drug selection and rational clinical use of glucagon-like peptide-1 receptor agonist drugs in medical institutions. Methods: We consult the drug instructions, clinical treatment guidelines and search relevant documents in databases such as China national knowledge infrastructure, Wanfang, PubMed, and government websites such as National Medical Products Administration, Food and Drug Administration, European Medicines Agency, and Pharmaceuticals and Medical Devices Agency to collect and sort out the relevant information of the indications, pharmacological effects, guideline recommendations, drug prices and other information of glucagon-like peptide-1 receptor agonists, using a percentile system systematically evaluate the five dimensions of glucagon-like peptide-1 receptor agonists in terms of pharmaceutical properties, efficacy, safety, economy, and other attributes. Results: The final scores of the evaluation results from high to low are semaglutide (71.00 points), dulaglutide (68.75 points), liraglutide (67.50 points), exenatide (67.00 points), lixisenatide (63.50 points), polyethylene glycol loxenatide (58.00 points) and benaglutide (49.00 points). Conclusion: In clinical practice, semaglutide and dulaglutide are the top two drugs that can be used as recommended drugs. This health technology assessment can provide an evidence-based basis for hospital selection and rational use of glucagon-like peptide-1 receptor agonists. Clinicians can rationally choose and use drugs according to the patient's conditions and needs.

How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer.

Background: The role of real-world evidence (RWE) in the development of anticancer therapies has been gradually growing over time. Regulators, payers and health technology assessment agencies, spurred by the rise of the precision medicine model, are increasingly incorporating RWE into their decision-making regarding the authorization and reimbursement of novel antineoplastic treatments. However, it remains unclear how this trend is viewed by clinicians in the field. This study aimed to investigate the opinions of these stakeholders with respect to RWE and its suitability for informing regulatory, reimbursement-related and clinical decisions in oncology. Methods: An online survey was disseminated to clinicians belonging to the network of the European Organisation for Research and Treatment of Cancer between May and July 2021. Results: In total, 557 clinicians across 30 different countries participated in the survey, representing 13 distinct cancer domains. Despite seeing the methodological challenges associated with its interpretation as difficult to overcome, the respondents mostly (75.0%) perceived RWE positively, and believed such evidence could be relatively strong, depending on the designs and data sources of the studies from which it is produced. Few (4.6%) saw a future expansion of its influence on decision-makers as a negative evolution. Furthermore, nearly all (94.0%) participants were open to the idea of sharing anonymized or pseudonymized electronic health data of their patients with external parties for research purposes. Nevertheless, most clinicians (77.0%) still considered randomized controlled trials (RCTs) to be the gold standard for generating clinical evidence in oncology, and a plurality (49.2%) thought that RWE cannot fully address the knowledge gaps that remain after a new antitumor intervention has entered the market. Moreover, a majority of respondents (50.7%) expressed that they relied more heavily on RCT-derived evidence than on RWE for their own decision-making. Conclusion: While cancer clinicians have positive opinions about RWE and want to contribute to its generation, they also continue to hold RCTs in high regard as sources of actionable evidence.

Assessing the Added Value of Vital Signs Extracted from Electronic Health Records in Healthcare Risk Adjustment Models.

Purpose: Patient vital signs are related to specific health risks and outcomes but are underutilized in the prediction of health-care utilization and cost. To measure the added value of electronic health record (EHR) extracted Body Mass Index (BMI) and blood pressure (BP) values in improving healthcare risk and utilization predictions. Patients and Methods: A sample of 12,820 adult outpatients from the Johns Hopkins Health System (JHHS) were identified between 2016 and 2017, having high data quality and recorded values for BMI and BP. We evaluated the added value of BMI and BP in predicting health-care utilization and cost through a retrospective cohort design. BMI, mean arterial pressure (MAP), systolic and diastolic BPs were summarized as annual aggregated values. Concurrent annual BMI and MAP changes were quantified as the difference between maximum and minimum recorded values. Model performance estimates consisted of repeated 10-fold cross validation, compared to base model point estimates for demographic and diagnostic, coded events: (1) patient age and sex, (2) age, sex, and the Charlson weighted index, (3) age, sex and the Johns Hopkins ACG system's DxPM risk score. Results: Both categorical BMI and BP were progressively indicative of disease comorbidity, but not uniformly related to health-care utilization or cost. Annual change in BMI and MAP improved predictions for most concurrent year outcomes when compared to base models. Conclusion: When a healthcare system lacks relevant diagnostic or risk assessment information for a patient, vital signs may be useful for a simple estimation of disease risk, cost and utilization.

Comparison of global treatment guidelines for locally advanced cervical cancer to optimize best care practices: A systematic and scoping review.

BACKGROUND: Survival outcomes for cervical cancer differ between countries and world regions. Locally advanced cervical cancer (LACC) is associated with poorer outcomes than early-stage disease. Country-specific variations in diagnostic and treatment recommendations might contribute to differences in LACC outcomes among countries. OBJECTIVE: We compared international and country-specific guidelines for LACC diagnostic imaging and treatment recommendations. METHODS: A systematic literature review and targeted search were used to identify cervical cancer treatment guidelines published between January 1999-August 2021. Guidelines were identified via literature databases, health technology assessment databases, disease-specific websites, and health organization websites. The targeted search included guidelines from countries in regions known to have high cervical cancer prevalence or mortality. Non-English guidelines were translated by native speakers or online translation services. RESULTS: Forty-six guidelines from 31 countries, regions, and international organizations were compared (41/46 using staging criteria, 27 of which used 2009 FIGO). Most guidelines recommended imaging tests for diagnosis and staging. Chest X-ray, intravenous pyelogram, CT, and MRI were commonly recommended for diagnosis and staging while MRI and PET-CT were recommended for the assessment of lymph node status and distant metastases, with a preference for PET-CT over MRI. There was global consensus for cisplatin-based concurrent chemoradiation as primary treatment for stages IIB to IVA, with few exceptions. Treatment recommendations for stages IB2 to IIA2 varied. Most guidelines agreed on adjuvant concurrent chemoradiation after radical hysterectomy when there is a high recurrence risk, and adjuvant radiotherapy when there is an intermediate recurrence risk. Recommendations for other adjuvant and neoadjuvant therapies varied among the guidelines. CONCLUSIONS: Differences among treatment guidelines by LACC stage might be influenced by staging criteria used, resource availability, and prevention program effectiveness. Addressing these areas may unify guidelines and improve global outcomes. Review and update of guidelines will be important as novel LACC therapies become available.

Capacity Building for Health Technology Assessment in Jordan: Institutionalization and Its Use in Pricing and Reimbursement Decisions.

OBJECTIVES: This study aimed to describe the process of the institutionalization of health technology assessment (HTA) in Jordan. In particular, this study presents local policy perspectives on capacity building for HTA and the progress made toward its use in pricing and reimbursement decisions. HTA CAPACITY BUILDING: University-based education and professional development training in pharmacoeconomics and pharmaceutical policy have been the starting points to create a receptive environment, necessary expertise, and local tools across many settings in Jordan. International collaboration with HTA supporting bodies helped to build connections and informed policy development on local levels through projects, meetings, and discussions. HTA INSTITUTIONALIZATION AND ITS USE IN PRICING AND REIMBURSEMENT DECISIONS: Institutionalizing HTA in the King Hussein Cancer Center and the Royal Medical Services was the driving factor for HTA implementation and practice advancement; nevertheless, process transparency and experience sharing through reports and publications are still limited. The Jordan Food and Drug Administration's pricing and formulary decisions require pharmacoeconomic consultation in selected cases according to the Jordanian Drug Law. Nevertheless, there is a lack of local methodological guidelines for conducting HTA. In addition, HTA practitioners and the regulatory scope of future HTA activities in Jordan cannot be determined yet. RECOMMENDATIONS AND FUTURE DIRECTIONS: Over the past 2 decades, Jordan has crossed a number of milestones and advanced further to implement HTA as a tool for evaluating health interventions. As a next step, legislation is needed to mandate the use of HTA and to enhance transparency in decision-making processes.

Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project.

The field of medical devices has attracted considerable interest from scholarly research in health economics in recent years. Medical devices are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to healthcare systems. More research is needed to overcome existing gaps associated with evaluation of digital technologies, address challenges in the use of real-world data in generating evidence for decision-making and to uncover drivers of variation in access to medical devices across countries. Furthermore, the translation of the results and recommendations stemming from research projects into health technology assessment practices needs to be strengthened. The European Union (EU) project COMED aimed to address these gaps by improving existing research and developing new research streams on the methods for evaluation and diffusion of medical devices. The project also intended to provide directly applicable policy advice and tools to inform decision-making, with the aim of impacting public health in the EU. This Health Economics Supplement, together with references of other published outputs of the project, is intended to be the main source for researchers and policy makers seeking information on the COMED project.