Health System Decision Makers Research Articles

A global survey to understand general vaccine trust, COVID-19 and influenza vaccine confidence.

The COVID-19 pandemic has greatly impacted the way that the world views vaccines. While safe and effective, COVID-19 vaccines were, and continue to be met with hesitancy and misinformation. We aimed to understand public perceptions and trust in COVID-19 vaccinations and how the pandemic has impacted perceptions of non-COVID-19 vaccines. Survey data were collected between August 7, 2023-August 16, 2023, from 7,000 respondents aged 18 years and older from the United States (n = 1,000); Nigeria (n = 1,000); United Kingdom (n = 1,000); France (n = 1,000); Canada (n = 1,000); Brazil (n = 1,000); and India (n = 1,000). Trust in COVID-19 vaccines was highest in Brazil (84.6%) and India (80.4%) and lowest in the United States (63.5%) and France (55.0%). 47.5% of respondents agreed that they trust traditional protein-based vaccines more than mRNA vaccines, 13.5% disagree and 39.0% are neutral about their trust in protein-based versus mRNA vaccines. Overall, 53.9% of respondents reported that the COVID-19 pandemic impacted their perceptions of vaccines with half of these respondents (51.7%) reporting that the pandemic made them think that other vaccines are more important as they understand how critical vaccines can be at preventing serious illnesses. These data can be used by health system decision makers, public health and researchers to understand how vaccine trust impacts perceptions of COVID-19 and influenza vaccines globally and develop tailored interventions that address local concerns.

Adult day programs and their effects on individuals with dementia and their caregivers (ADAPT-DemCare): a realist synthesis to develop program theories on the how and why

BackgroundAdult day programs aim to facilitate aging in place by supporting the health and well-being of persons with dementia and providing respite to their caregivers. However, studies on the effects of day programs are inconclusive, and we especially lack insights into the context conditions and mechanisms of day programs that may produce different outcomes for different groups of persons with dementia and their caregivers. Our objective was to conduct a realist review, synthesizing research on day programs to develop program theories explaining how and why day programs do or do not produce positive or negative outcomes for different groups of persons with dementia, and caregivers.MethodsWe identified 14 literature reviews (including 329 references published between 1975 and 2021) on adult day programs. From this initial pool of studies, we will include those that focused on day program attendees with dementia or meaningful cognitive impairment, and/or their caregivers, and that report how day program contexts (C) and mechanisms (M) bring about outcomes (O) for attendees and caregivers. We will extract CMO statements (i.e., narratives that explain how and why day programs do or do not bring about certain outcomes for whom and under what circumstances). Using additional focused searches, citation mapping, citation tracking, and discussions with our researcher and expert team members, we will identify additional references. CMO statements will be synthesized, transformed into hypotheses, and linked and visualized to form program theories. Using focus groups and the James Lind Alliance Priority Setting Partnership method, we will discuss and prioritize our CMO statements and refine our program theories with 32 experts (older adults, caregivers, Alzheimer societies, caregiver organizations, day program staff and managers, and health system and policy decision makers). DiscussionBy identifying essential elements and processes of day programs and related knowledge gaps, this study will generate much-needed knowledge to leverage the full potential of day programs so they can provide appropriate care, preventing premature institutionalization, and unnecessary acute and primary care use. This will ultimately improve the quality of life of persons with dementia and their caregivers, alleviate caregiver burden, and reduce social costs. Systematic review registrationPROSPERO CRD42024504030

Supplementing systematic review findings with healthcare system data: pilot projects from the Agency for Healthcare Research and Quality Evidence-based Practice Center program

ObjectivesThe US Agency for Healthcare Research and Quality, through the Evidence-based Practice Center (EPC) Program, aims to provide health system decision makers with the highest-quality evidence to inform clinical decisions. However, limitations in the literature may lead to inconclusive findings in EPC systematic reviews (SRs). The EPC Program conducted pilot projects to understand the feasibility, benefits, and challenges of utilizing health system data to augment SR findings to support confidence in healthcare decision-making based on real-world experiences. Study Design and SettingThree contractors (each an EPC located at a different health system) selected a recently completed SR conducted by their center and identified an evidence gap that electronic health record (EHR) data might address. All pilot project topics addressed clinical questions as opposed to care delivery, care organization, or care disparities topics that are common in EPC reports. Topic areas addressed by each EPC included infantile epilepsy, migraine, and hip fracture. EPCs also tracked additional resources needed to conduct supplemental analyses. The workgroup met monthly in 2022-2023 to discuss challenges and lessons learned from the pilot projects. ResultsTwo supplemental data analyses filled an evidence gap identified in the SRs (raised certainty of evidence, improved applicability) and the third filled a health system knowledge gap. Project challenges fell under three themes: regulatory and logistical issues, data collection and analysis, and interpretation and presentation of findings. Limited ability to capture key clinical variables given inconsistent or missing data within the EHR was a major limitation. The workgroup found that conducting supplemental data analysis alongside an SR was feasible but adds considerable time and resources to the review process (estimated total hours to complete pilot projects ranged from 283 to 595 across EPCs), and that the increased effort and resources added limited incremental value. ConclusionSupplementing existing SRs with analyses of EHR data is resource intensive and requires specialized skillsets throughout the process. While using EHR data for research has immense potential to generate real-world evidence and fill knowledge gaps, these data may not yet be ready for routine use alongside SRs.

Development and validity testing of a matrix to evaluate maturity of clinical pathways: a case study in Saskatchewan, Canada

BackgroundHealthcare systems are transforming into learning health systems that use data-driven and research-informed approaches to achieve continuous improvement. One of these approaches is the use of clinical pathways, which are tools to standardize care for a specific population and improve healthcare quality. Evaluating the maturity of clinical pathways is necessary to inform pathway development teams and health system decision makers about required pathway revisions or implementation supports. In an effort to improve the development, implementation, and sustainability of provincial clinical pathways, we developed a clinical pathways maturity evaluation matrix. To explore the initial content and face validity of the matrix, we used it to evaluate a case pathway within a provincial health authority in Saskatchewan, Canada.MethodsBy using iterative consensus-based processes, we gathered feedback from stakeholders including patient and family partners, policy makers, clinicians, and quality improvement specialists, to rank, retain, or remove enablers and sub-enablers of the draft matrix. We tested the matrix on the Chronic Pain Pathway (CPP) for primary care in a local pilot area and revised the matrix based on feedback from the CPP development team leader.ResultsThe final matrix contains five enablers (i.e., Design, Ownership and Performer, Infrastructure, Performance Management, and Culture), 20 sub-enablers, and three trajectory definitions for each sub-enabler. Supplemental documents were created for six sub-enablers. The CPP scored 15 out of 40 possible points of maturity. Although the pathway scored highest in the Design enabler (10/12), it requires more attention in several areas, specifically the Ownership and Performer and the Performance Management enablers, each of which scored zero. Additionally, the Infrastructure and Culture enablers scored 2/4 and 3/8 points, respectively. These areas of the CPP are in need of improvement in order to enhance the overall maturity of the CPP.ConclusionsWe developed a clinical pathways maturity matrix to evaluate the various dimensions of clinical pathways’ development and implementation. The goals of this initial work were to develop and validate a tool to assess the maturity and readiness of new or existing pathways and to track pathways' revisions and improvements.

Developing a Framework for Examining and Improving Decision-Making in Complex Mental Health Systems

Developing a Framework for Examining and Improving Decision-Making in Complex Mental Health Systems

Counting what counts: assessing quality of life and its social determinants among nursing home residents with dementia

BackgroundMaximizing quality of life (QoL) is a major goal of care for people with dementia in nursing homes (NHs). Social determinants are critical for residents' QoL. However, similar to the United States and other countries, most Canadian NHs routinely monitor and publicly report quality of care, but not resident QoL and its social determinants. Therefore, we lack robust, quantitative studies evaluating the association of multiple intersecting social determinants with NH residents’ QoL. The goal of this study is to address this critical knowledge gap.MethodsWe will recruit a random sample of 80 NHs from 5 Canadian provinces (Alberta, British Columbia, Manitoba, Nova Scotia, Ontario). We will stratify facilities by urban/rural location, for-profit/not-for-profit ownership, and size (above/below median number of beds among urban versus rural facilities in each province). In video-based structured interviews with care staff, we will complete QoL assessments for each of ~ 4,320 residents, using the DEMQOL-CH, a validated, feasible tool for this purpose. We will also assess resident’s social determinants of QoL, using items from validated Canadian population surveys. Health and quality of care data will come from routinely collected Resident Assessment Instrument – Minimum Data Set 2.0 records. Knowledge users (health system decision makers, Alzheimer Societies, NH managers, care staff, people with dementia and their family/friend caregivers) have been involved in the design of this study, and we will partner with them throughout the study. We will share and discuss study findings with knowledge users in web-based summits with embedded focus groups. This will provide much needed data on knowledge users' interpretations, usefulness and intended use of data on NH residents’ QoL and its health and social determinants.DiscussionThis large-scale, robust, quantitative study will address a major knowledge gap by assessing QoL and multiple intersecting social determinants of QoL among NH residents with dementia. We will also generate evidence on clusters of intersecting social determinants of QoL. This study will be a prerequisite for future studies to investigate in depth the mechanisms leading to QoL inequities in LTC, longitudinal studies to identify trajectories in QoL, and robust intervention studies aiming to reduce these inequities.

Improved prevention of female genital schistosomiasis: piloting integration of services into the national health system in Côte d’Ivoire

IntroductionFemale genital schistosomiasis (FGS) is a neglected gynecological condition, putting women at-risk of poor sexual and reproductive health (SRH), including pregnancy complications or infertility. Early treatment of schistosomiasis with praziquantel is important to avoid disease progression to FGS as it is not always possible to reverse these symptoms. However, prevention programs with praziquantel have historically focused on school-aged children. Therefore, there is a gap to provide prevention services for young women in endemic areas, including Côte d’Ivoire.MethodsWe piloted integration of FGS prevention services into routine SRH care in seven health centers (Soubré district, Côte d’Ivoire, November 2020 to April 2021) and enrolled 56 health workers. We used mixed methods including key informant interviews, focus group discussions, and questionnaires to determine effectiveness, feasibility and acceptability of integration across health system decision makers, health workers and female patients (15 to 29 years old). For qualitative data, we used an inductive coding process to analyze themes. We used descriptive statistics to analyze quantitative data.ResultsInterviewed health workers perceived that the integrated services increased access and improved health outcomes for women (15 to 29 years old) due to the more comprehensive approach, although barriers to access included lack of transportation. Female patients surveyed at baseline (n=448) indicated there were no routine FGS prevention services. During the pilot, FGS prevention services were provided to >8500 women at-risk. Health workers interviewed at the end of the pilot indicated they could feasibly provide FGS prevention services as part of routine patient consultations, and they maintained knowledge from training on the key FGS health education points and the consultation processes to follow. The greatest challenge expressed by health workers was the high workload.DiscussionProvision of integrated healthcare in the health center setting is an effective and acceptable way to increase access to prevention services and provide holistic care for women (15 to 29 years old) in this setting in Côte d’Ivoire. Future scale-up will require further streamlining of the strategy, building on existing platforms, whilst ensuring reduced impact on workload and consideration of how to overcome barriers to accessing health centers.

A Multisite Electronic Health Record Integrated Remote Monitoring Intervention for Hypertension Improvement: Protocol for a Randomized Pragmatic Comparative Effectiveness Trial.

Hypertension is a major contributor to various adverse health outcomes. Although previous studies have shown the benefits of home blood pressure (BP) monitoring over office-based measurements, there is limited evidence comparing the effectiveness of whether a BP monitor integrated into the electronic health record is superior to a nonintegrated BP monitor. In this paper, we describe the protocol for a pragmatic multisite implementation of a quality improvement initiative directly comparing integrated to nonintegrated BP monitors for hypertension improvement. We will conduct a randomized, comparative effectiveness trial at 3 large academic health centers across California. The 3 sites will enroll a total of 660 participants (approximately n=220 per site), with 330 in the integrated BP monitor arm and 330 in the nonintegrated BP control arm. The primary outcome of this study will be the absolute difference in systolic BP in mm Hg from enrollment to 6 months. Secondary outcome measures include binary measures of hypertension (controlled vs uncontrolled), hypertension-related health complications, hospitalizations, and death. The list of possible participants will be generated from a central data warehouse. Randomization will occur after enrollment in the study. Participants will use their assigned BP monitor and join site-specific hypertension interventions. Cross-site learning will occur at regular all-site meetings facilitated by the University of California, Los Angeles Value-Based Care Research Consortium. A pre- and poststudy questionnaire will be conducted to further evaluate participants' perspectives regarding their BP monitor. Linear mixed effects models will be used to compare the primary outcome measure between study arms. Mixed effects logistic regression models will be used to compare secondary outcome measures between study arms. The study will start enrolling participants in the second quarter of 2023 and will be completed by the first half of 2024. Results will be published by the end of 2024. This pragmatic trial will contribute to the growing field of chronic care management using remote monitoring by answering whether a hypertension intervention coupled with an electronic health record integrated home BP monitor improves patients' hypertension better than a hypertension intervention with a nonintegrated BP monitor. The outcomes of this study may help health system decision makers determine whether to invest in integrated BP monitors for vulnerable patient populations. ClinicalTrials.gov NCT05390502; clinicaltrials.gov/study/NCT05390502. PRR1-10.2196/45915.

A survey of COVID-19 vaccine acceptance across 23 countries in 2022.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continued to mutate and spread in 2022 despite the introduction of safe, effective vaccines and medications. Vaccine hesitancy remains substantial, fueled in part by misinformation. Our third study of Coronavirus Disease 2019 (COVID-19) vaccine hesitancy among 23,000 respondents in 23 countries (Brazil, Canada, China, Ecuador, France, Germany, Ghana, India, Italy, Kenya, Mexico, Nigeria, Peru, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Turkey, the United Kingdom and the United States), surveyed from 29 June to 10 July 2022, found willingness to accept vaccination at 79.1%, up 5.2% from June 2021. Hesitancy increased in eight countries, however, ranging from 1.0% (United Kingdom) to 21.1% (South Africa). Almost one in eight (12.1%) vaccinated respondents are hesitant about booster doses. Overall support for vaccinating children under 18 years of age increased slightly but declined among parents who were personally hesitant. Almost two in five (38.6%) respondents reported paying less attention to new COVID-19 information than previously, and support for vaccination mandates decreased. Almost a quarter (24%) of those who became ill reported taking medications to combat COVID-19 symptoms. Vaccination remains a cornerstone of the COVID-19 pandemic response, but broad public support remains elusive. These data can be used by health system decisionmakers, practitioners, advocates and researchers to address COVID-19 vaccine hesitancy more effectively.

Perspective: Telehealth - beyond legislation and regulation.

The World Health Organization describes health innovation as developing new or improved systems, policies, products, technologies, services or delivery approaches that improve health and well-being, specifically of vulnerable people. The study's objectives were to (a) explore the legislative and regulatory journey of telehealth across the Organisation for Economic Co-operation and Development and non-Organisation for Economic Co-operation and Development countries and (b) provide recommendations to strengthen health system performance. We reviewed information sources for Organisation for Economic Co-operation and Development and non-Organisation for Economic Co-operation and Development countries opportunistically, including government and medical board publications, media coverage and peer-reviewed papers, to provide a perspective on the legislative and regulatory telehealth journey. Our review of countries suggests that legislation and regulation remain essential for governance, accountability and assuring that healthcare professionals and technologies are safe and secure. However, there was no uniform approach to telehealth legislation and regulation, and the precautionary approach was observed in some countries. Different strategies appear to have been adopted for telehealth implementation. There is a need to go beyond legislation and regulation to strengthen health system performance and assure the future success of telehealth services. Health system decision makers should work with health system stakeholders to strategise and plan for telehealth services as it will have implications on the future delivery of healthcare services and the health system. Further research is needed to explore how policy frameworks may support innovations in healthcare, such as telehealth.

Experiences of Health Care Access Challenges for Back Pain Care Across the Rural-Urban Continuum in Canada: Protocol for Cross-sectional Research

Back pain is common and costly, with negative impacts on both individuals and the health care system. Rural, remote, and Indigenous populations are at greater risk of experiencing back pain compared to urban and non-Indigenous populations. Potential barriers to health care access among Canadians with chronic back pain (CBP) have been identified; however, no study has used lived experiences of people with CBP to drive the selection, analysis, and interpretation of variables most meaningful to patients. The aims of this study are to (1) engage with rural, remote, and urban Indigenous and non-Indigenous patients, health care providers, and health system decision makers to explore lived experiences among people with CBP in Saskatchewan, Canada; (2) cocreate meaningful indicators of CBP care access and effectiveness; and (3) identify program and policy recommendations to overcome access barriers to CBP care. In phase 1, one-on-one interviews with 30 people with current or past CBP and 10 health care providers residing or practicing in rural, remote, or urban Saskatchewan communities will be conducted. We will recruit Indigenous (n=10) and non-Indigenous (n=20) rural, remote, and urban people. In phase 2, findings from the interviews will inform development of a population-based telephone survey focused on access to health care barriers and facilitators among rural, remote, and urban people; this survey will be administered to 383 residents with CBP across Saskatchewan. In phase 3, phase 1 and 2 findings will be presented to provincial and national policy makers; health system decision makers; health care providers; rural, remote, and urban people with CBP and their communities; and other knowledge users at an interactive end-of-project knowledge translation event. A World Café method will facilitate interactive dialogue designed to catalyze future patient-oriented research and pathways to improve access to CBP care. Patient engagement will be conducted, wherein people with lived experience of CBP, including Indigenous and non-Indigenous people from rural, remote, and urban communities (ie, patient partners), are equal members of the research team. Patient partners are engaged throughout the research process, providing unique knowledge to ensure more comprehensive collection of data while shaping culturally appropriate messages and methods of sharing findings to knowledge users. Participant recruitment began in January 2021. Phase 1 interviews occurred between January 2021 and September 2022. Phase 2 phone survey was administered in May 2022. Final results are anticipated in late 2022. This study will privilege patient experiences to better understand current health care use and potential access challenges and facilitators among rural, remote, and urban people with CBP in Saskatchewan. We aim to inform the development of comprehensive measures that will be sensitive to geographical location and relevant to culturally diverse people with CBP, ultimately leading to enhanced access to more patient-centered care for CBP. DERR1-10.2196/42484.

7.A. Round table: Sustainable health system responses to meet the chronic health care needs of refugees from Ukraine

Abstract Background Since Russia's reinvasion of Ukraine on 24 February, more than 5 million people have fled the country. Most have gone to the neighbouring countries of Poland, Slovakia, Hungary, Romania, and Moldova. This vulnerable population has significant healthcare needs. Among the most challenging to address will be chronic non-communicable diseases (NCDs), including mental disorders, as these require long-term, continuous care and access to medicines. NCDs are already the biggest contributor to disease burden among Ukrainian adults. About a third have hypertension and 7% have diabetes. Refugees are also at increased risk of mental disorders due to exposure to trauma and ongoing daily stressors. Host country health systems are faced with the challenge of ensuring accessible and affordable care for NCDs and mental disorders to this population. There is no consensus on the most effective and sustainable approaches for achieving this. Objectives This workshop will provide a platform for sharing knowledge to support host country health systems. The objectives of the workshop are to i) identify sustainable health system approaches to providing quality health care for NCDs and mental disorders to refugees from Ukraine, and ii) establish research priorities to support host country health system decision-making. Format The workshop will consist of a panel with 4 speakers, followed by a roundtable discussion. Each panel member will make a short presentation (5 min) related to health system responses for NCDs and mental disorders in refugee populations. They will highlight challenges faced in the current crisis and evidence of approaches that have worked in other refugee contexts. The roundtable discussion will focus on the adaptation of evidence-based approaches to countries hosting refugees from Ukraine, and the research needed to support this. Interventions will be made by representatives from countries hosting refugees, including from WHO country offices, and from the WHO Europe Migration and Health Programme. All workshop participants will be invited to contribute. The discussion will be chaired by Natasha Azzopardi-Muscat, Director of the Division of Country Health Policies and Systems, WHO European Regional Office. A report on the conclusions of the workshop, including research priorities to support host country health systems, will be published. Key messages • Health systems receiving refugees from Ukraine will face challenges in providing them long-term and affordable care for NCDs and mental disorders. • Drawing on evidence, the workshop will help to identify sustainable health system responses to NCDs and mental disorders, and priorities for research to support host country health systems. Introduction Adrianna Murphy LSHTM, London, UK Impact of the crisis in Ukraine on neighbouring health systems Kayvan Bozorgmehr Bielefeld University, Bielefeld, Germany Financing to meet the chronic health care needs of refugees Triin Habicht Senior Health Economist, WHO Barcelona Office for Health Systems Strengthening, Barcelona, Spain Implementing responsive integrated mental health care for refugees Sergiy Bogdanov Centre for Mental Health and Psychosocial Support, National University of Kyiv Mohyla Academy, Kyiv, Ukraine Ensuring continuous access to NCD treatment among refugees Sigiriya Aebischer Perone Geneva University Hospitals, Geneva, Switzerland

How We Might Further Integrate Considerations of Environmental Impact When Assessing the Value of Health Technologies.

There is growing awareness of the impact health technologies can have on the environment and the negative consequences of these environmental impacts on human health. However, health system decision-makers may lack the expertise, data, or resources to incorporate environmental considerations when making decisions about the adoption and use of health technologies. In this article, we describe how health technology assessment (HTA) is evolving to address climate change by providing health system decision-makers with the information they can use to reduce the impact of health care systems on the environment. Our objective is to consider approaches for including the environment domain when conducting an HTA—in particular, the use of the deliberative process—and for determining when the domain should be included. We explore the challenges of gathering the relevant data necessary to assess the environmental impact of a health technology, and we describe a “triage” approach for determining when an in-depth environmental impact assessment is warranted. We also summarize related initiatives from HTA agencies around the world.

Facilitating bias in cost-effectiveness analysis: CHEERS 2022 and the creation of assumption-driven imaginary value claims in health technology assessment

The current standards for health technology cost-effectiveness assessment rest on the creation of lifetime assumption-driven modeled simulations for imaginary pricing and consequent patient access recommendations. A recent BMJ paper reports a detailed assessment of 8,192 cost-effectiveness analyses, concluding that industry-sponsored modeled claims were more likely to publish incremental cost-effectiveness ratios (ICERs) below a USD 50,000 threshold than non-industry sponsored studies, supporting the claim that the product was cost-effective. This is unsurprising; indeed, the opposite can occur with a modeled claim deliberately resulting in ICER is excess of USD 50,000. This methodology is well entrenched with the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 guidance for creating imaginary cost-effectiveness modeled claims ensuring the opportunity for deliberately manipulated cost-effectiveness claims. This overlooks limitations imposed by fundamental measurement, rendering assumption-driven simulations redundant analytical exercises. Manipulation of ICERs and claims for cost-effectiveness are mathematically impossible; including cost-utility thresholds, because the preference or utilities supporting creation of quality-of-life years (QALYs) are ordinal scores. Nevertheless, with the promotion of CHEERS 2022, the belief in imaginary modeled value claims is both facilitated and reinforced. With CHEERS 2022, there is a concerted effort, largely in self-interest, to perpetuate the current belief system. This is a self-defeating strategy. Rather than admitting to the deficiencies of assumption-driven simulated imaginary claims, leaders are maintaining that health system decision makers can ignore standards of normal science and fundamental measurement in value claims for pharmaceutical products. This disregard of standards that are commonplace in the sciences and mainstream social sciences perpetuates the opportunity for self-serving modeled claims; where models are a marketing vehicle leading to sponsored systematic bias in formulary submissions. This supports the need for a NEW START paradigm for health technology assessment, focusing on evaluable single-attribute value claims, meeting the required standards for normal science and fundamental measurement.

Facilitating bias in cost-effectiveness analysis: CHEERS 2022 and the creation of assumption-driven imaginary value claims in health technology assessment.

The current standards for health technology cost-effectiveness assessment rest on the creation of lifetime assumption-driven modeled simulations for imaginary pricing and consequent patient access recommendations. A recent BMJ paper reports a detailed assessment of 8,192 cost-effectiveness analyses, concluding that industry-sponsored modeled claims were more likely to publish incremental cost-effectiveness ratios (ICERs) below a USD 50,000 threshold than non-industry sponsored studies, supporting the claim that the product was cost-effective. This is unsurprising; indeed, the opposite can occur with a modeled claim deliberately resulting in ICER is excess of USD 50,000. This methodology is well entrenched with the recently published Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 guidance for creating imaginary cost-effectiveness modeled claims ensuring the opportunity for deliberately manipulated cost-effectiveness claims. This overlooks limitations imposed by fundamental measurement, rendering assumption-driven simulations redundant analytical exercises. Manipulation of ICERs and claims for cost-effectiveness are mathematically impossible; including cost-utility thresholds, because the preference or utilities supporting creation of quality-of-life years (QALYs) are ordinal scores. Nevertheless, with the promotion of CHEERS 2022, the belief in imaginary modeled value claims is both facilitated and reinforced. With CHEERS 2022, there is a concerted effort, largely in self-interest, to perpetuate the current belief system. This is a self-defeating strategy. Rather than admitting to the deficiencies of assumption-driven simulated imaginary claims, leaders are maintaining that health system decision makers can ignore standards of normal science and fundamental measurement in value claims for pharmaceutical products. This disregard of standards that are commonplace in the sciences and mainstream social sciences perpetuates the opportunity for self-serving modeled claims; where models are a marketing vehicle leading to sponsored systematic bias in formulary submissions. This supports the need for a NEW START paradigm for health technology assessment, focusing on evaluable single-attribute value claims, meeting the required standards for normal science and fundamental measurement.

Concerns with Patient Reported Outcome Measurement and Value Claims for Therapy Response: The Case of Mavacamten and Symptomatic Hypertrophic Cardiomyopathy (SHCM).

Fundamental measurement is the basis for a rational assessment of patient reported outcome (PRO) value claims; both as response to therapy and the submission of credible and evaluable value claims to formulary committees and other health system decision makers. It is important to emphasize the importance of creating interval and ratio scales as opposed to nominal and ordinal scales to support value claims; a recognition that follows from acceptance of conjoint simultaneous measurement and the contribution of Rasch or modern measurement theory (RMT). Failure to appreciate the role of RMT has led thousands of researchers simply to apply numerals to events, inappropriately applying the techniques of classical statistical analysis, with the result that all that is produced are ordinal PRO scores. Instead, we should be aiming for interval and ratio scores based on a comprehensible latent trait and the application of the Rasch model. The purpose of this brief commentary is to review the measurement properties of PRO value claims for mavacamten (Camzyos; Bristol Myers Squibb) in symptomatic hypertrophic cardiomyopathy (SHCM) and to judge whether they have any validity when judged against the requirements of modern measurement theory. The assessment includes both the recent evidence report by the Institute for Clinical and Economic Review (ICER) for mavacamten as well as pivotal randomized trial (RCT) value claims that combine clinical endpoints with PROs that fail the standards of fundamental evidence. These include the Kansas City Cardiomyopathy Questionnaire (KCCQ), the New York Heart Association (NYHA) functional classification and the EuroQuol EQ-5D-5L multiattribute health related quality of life (HRQoL) preference instrument. The review concludes that apart from purely clinical claims based on the various pivotal trials, there are no PRO claims for mavacamten in SHCM that meet the required measurement standards.

Commentary: Data storytelling to aid health system decision-makers with population health issues for a specific location

Modern society is awash in data for health science, health system, and public health decision-making. These public data are often presented in various formats: Data tables, reports with data and bar charts, press releases with data, dashboards of key performance indicators, the traditional professional paper with data table and statistical results, etc. Software can display these data in various ways. The tacit assumption is that the reader/consumer of the data has the means to interpret these often complex health data for individual use and professional decision-making. We do not think that it is reasonable to make this assumption in all situations. Instead, maybe those of us who collect and analyze health data should include data storytelling as a way to make it easier for health system decision-makers to know and appreciate the next steps to be taken in the decision-making process given the data we prepared. The interpretation of data for action using a charticle and other techniques of infographics and health data storytelling may be more useful to health system decision-makers than the presentation of detailed facts and data and a scientific interpretation of those facts and data. This commentary illustrates the process of data storytelling using a charticle to help health system decision-makers interpret health data and use it as a foundation for action.

Collaboration between health system decision makers and professional researchers to coproduce knowledge, a scoping review.

Recent literature uses different terms and approaches to the collaboration between researchers and health system decision-makers in the research process. In 2012, the World Health Organisation proposed to "Embed research within decision-making processes". Yet, important contributions use other terms and perspectives for the same issue. This scoping review aimed to identify these terms, approaches, their application and eventual influence on the utilization of evidence. We searched papers published between January 2000 and February 2019 in English, Spanish, French and Portuguese in the databases of PubMed, Scielo, Google Scholar and EBSCOhost, thus accessing MedicLatina, MEDLINE Complete and eBook Collection. Our main inclusion criterion was the participation of health personnel in non-clinical research activities. We considered three domains for in depth analysis: Definition, name and description of the participation of decision makers and health staff; Forms of collaboration and actual/effective participation of health staff in research; Eventual influenceon the utilization of research results. We identified 607 articles and selected 74 for full text analysis. Nineteen different terms are currently used in twelve countries to describe the participation of health decision-makers and staff in research activities. Most publications refer to Integrated Knowledge Translation or Embedded Research, and were published in Canada and the United Kingdom. Forty-five papers discuss the participation of health staff in research activities; 20 leading the whole process and 21 as collaborators. The identification of the different terms and approaches to the close collaboration of health staff and decision-makers with professional researchers is essential to promote its effective application and influence on the utilization of evidence. Yet, it is also necessary to insist in their co-participation throughout the whole investigation process as a relevant way to improve research results uptake, strengthen health systems and advance towards universal health coverage.

Healthcare Professional Perspectives on the Use of Remote Patient-Monitoring Platforms during the COVID-19 Pandemic: A Cross-Sectional Study.

The COVID-19 pandemic created an urgent need to act to reduce the spread of the virus and alleviate congestion in healthcare services, protect health professionals, and help them maintain satisfactory quality and safety of care. Remote monitoring platforms (RPM) emerged as potential solutions. In this study, we evaluate, from health professionals’ perspectives, the capacity and contribution of two different digital platforms to maintain quality, safety, and patient engagement in care. A cross-sectional study was conducted using a survey in which a total of 491 health professionals participated. The results show that, in general, user perceptions of the quality and safety of care provided through the platforms were positive. The ease of access to health professionals’ services in general and shorter waiting times for patients were the two main features that were highly appreciated by most participants. However, some problems were encountered during the use of these two platforms, such as a lack of training and/or direct support for users. To improve the two platforms and maximize their use, the areas for improvement and the issues identified should be addressed as part of a collaborative process involving health professionals and patients as well as health system leaders, decision-makers, and digital platform providers.

Participatory Methods for Systems Modeling of Youth Mental Health: Implementation Protocol.

BackgroundDespite significant investment, mental health issues remain a leading cause of death among young people globally. Sophisticated decision analysis methods are needed to better understand the dynamic and multisector drivers of youth mental health. System modeling can help explore complex issues such as youth mental health and inform strategies to effectively respond to local needs and achieve lasting improvements. The advantages of engaging stakeholders in model development processes have long been recognized; however, the methods for doing so are often not well-described.ObjectiveThis paper aims to describe the participatory procedures that will be used to support systems modeling for national multisite implementation. The Right Care, First Time, Where You Live research program will focus on regional youth mental health applications of systems modeling in 8 different sites across Australia.MethodsThe participatory model development approach involves an iterative process of engaging with a range of participants, including people with lived experience of mental health issues. Their knowledge of the local systems, pathways, and drivers is combined with the academic literature and data to populate the models and validate their structure. The process centers around 3 workshops where participants interact and actively engage in group model-building activities to define, refine, and validate the systems models. This paper provides a detailed blueprint for the implementation of this process for mental health applications.ResultsThe participatory modeling methods described in this paper will be implemented at 2 sites per year from 2022 to 2025. The 8 selected sites have been chosen to capture variations in important factors, including determinants of mental health issues and access to services. Site engagement commenced in August 2021, and the first modeling workshops are scheduled to commence in February 2022.ConclusionsMental health system decision makers require tools to help navigate complex environments and leverage interdisciplinary problem-solving. Systems modeling can mobilize data from diverse sources to explore a range of scenarios, including the impact of interventions in different combinations and contexts. Involving stakeholders in the model development process ensures that the model findings are context-relevant and fit-for-purpose to inform decision-making.International Registered Report Identifier (IRRID)PRR1-10.2196/32988