The Heart Failure Patient Foundation Position Statement on Research and Patient Involvement.

BACKGROUND: Heart Failure (HF) is a growing global public health problem affecting approximately 64 million people worldwide. OBJECTIVES: The Heart Failure Patient Foundation developed a position statement to advocate for adult patients with HF to be an active participant in research and for HF leaders to integrate patients throughout the research process. METHODS: A review of the literature and best practices was conducted. Based on the evidence, the HF Patient Foundation made recommendations regarding the inclusion of adult patients with HF throughout the research process. RESULTS: Healthcare clinicians, researchers and funding agencies have a role to ensure rigorous quality research is performed and implemented into practice. Inclusion of adult patients with HF throughout the research process can improve the lives of patients and families while advancing HF science. CONCLUSIONS: The HF Patient Foundation strongly advocates that patients with HF be involved in research from inception of the project through dissemination of findings to improve patient outcomes.

Operationalizing Equity, Inclusion, and Access in Research Practice at a Large Academic Institution.

INTRODUCTION: Healthcare advances are hindered by underrepresentation in prospective research; sociodemographic, data, and measurement infidelity in retrospective research; and a paucity of guidelines surrounding equitable research practices. OBJECTIVE: The Joint Research Practices Working Group was created in 2021 to develop and disseminate guidelines for the conduct of inclusive and equitable research. METHODS: Volunteer faculty and staff from two research centers at the University of Pennsylvania initiated a multi-pronged approach to guideline development, including literature searches, center-level feedback, and mutual learning with local experts. RESULTS: We developed guidelines for (1) participant payment and incentives; (2) language interpretation and translation; (3) plain language in research communications; (4) readability of study materials; and (5) inclusive language for scientific communications. Key recommendations include (1) offer cash payments and multiple payment options to participants when required actions are completed; (2) identify top languages of your target population, map points of contact, and determine available interpretation and translation resources; (3) assess reading levels of materials and simplify language, targeting 6th- to 8th-grade reading levels; (4) improve readability through text formatting and style, symbols, and visuals; and (5) use specific, humanizing terms as adjectives rather than nouns. CONCLUSIONS: Diversity, inclusion, and access are critical values for research conduct that promotes justice and equity. These values can be operationalized through organizational commitment that combines bottom-up and top-down approaches and through partnerships across organizations that promote mutual learning and synergy. While our guidelines represent best practices at one time, we recognize that practices evolve and need to be evaluated continuously for accuracy and relevance. Our intention is to bring awareness to these critical topics and form a foundation for important conversations surrounding equitable and inclusive research practices.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force.

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces the previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, and social care). This Explanation and Elaboration Report presents the new CHEERS 2022 28-item checklist with recommendations and explanation and examples for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals and the peer reviewers and editors assessing them for publication. Nevertheless, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, given that there is an increasing emphasis on transparency in decision making.

Reproducibility, relevance and reliability as barriers to efficient and credible biomedical technology translation.

Biomedical research accuracy and relevance for improving healthcare are increasingly identified as costly problems. Basic research data quality, reporting and methodology, and reproducibility are common factors implicated in this challenge. Preclinical models of disease and therapy, largely conducted in rodents, have known deficiencies in replicating most human conditions. Their translation to human results is acknowledged to be poor for decades. Clinical data quality and quantity is also recognized as deficient; gold standard randomized clinical trials are expensive. Few solid conclusions from clinical studies are replicable and many remain unpublished. The translational pathway from fundamental biomedical research through to innovative solutions handed to clinical practitioners is therefore highly inefficient and costly in terms of wasted resources, early claims from fundamental discoveries never witnessed in humans, and few new, improved solutions available clinically for myriad diseases. Improving this biomedical research strategy and resourcing for reliability, translational relevance, reproducibility and clinical impact requires careful analysis and consistent enforcement at both funding and peer review levels.

Consensus statement on measures to promote equitable authorship in the publication of research from international partnerships.

Despite the acknowledged injustice and widespread existence of parachute research studies conducted in low- or middle-income countries by researchers from institutions in high-income countries, there is currently no pragmatic guidance for how academic journals should evaluate manuscript submissions and challenge this practice. We assembled a multidisciplinary group of editors and researchers with expertise in international health research to develop this consensus statement. We reviewed relevant existing literature and held three workshops to present research data and holistically discuss the concept of equitable authorship and the role of academic journals in the context of international health research partnerships. We subsequently developed statements to guide prospective authors and journal editors as to how they should address this issue. We recommend that for manuscripts that report research conducted in low- or middle-income countries by collaborations including partners from one or more high-income countries, authors should submit accompanying structured reflexivity statements. We provide specific questions that these statements should address and suggest that journals should transparently publish reflexivity statements with accepted manuscripts. We also provide guidance to journal editors about how they should assess the structured statements when making decisions on whether to accept or reject submitted manuscripts. We urge journals across disciplines to adopt these recommendations to accelerate the changes needed to halt the practice of parachute research.

Downstream funding success of early career researchers for resubmitted versus new applications: A matched cohort.

BACKGROUND: Early career researchers face a hypercompetitive funding environment. To help identify effective intervention strategies for early career researchers, we examined whether first-time NIH R01 applicants who resubmitted their original, unfunded R01 application were more successful at obtaining any R01 funding within 3 and 5 years than original, unfunded applicants who submitted new NIH applications, and we examined whether underrepresented minority (URM) applicants differentially benefited from resubmission. Our observational study is consistent with an NIH working group's recommendations to develop interventions to encourage resubmission. METHODS AND FINDINGS: First-time applicants with US medical school academic faculty appointments who submitted an unfunded R01 application between 2000-2014 yielded 4,789 discussed and 7,019 not discussed applications. We then created comparable groups of first-time R01 applicants (resubmitted original R01 application or submitted new NIH applications) using optimal full matching that included applicant and application characteristics. Primary and subgroup analyses used generalized mixed models with obtaining any NIH R01 funding within 3 and 5 years as the two outcomes. A gamma sensitivity analysis was performed. URM applicants represented 11% and 12% of discussed and not discussed applications, respectively. First-time R01 applicants resubmitting their original, unfunded R01 application were more successful obtaining R01 funding within 3 and 5 years than applicants submitting new applications-for both discussed and not discussed applications: discussed within 3 years (OR 4.17 [95 CI 3.53, 4.93]) and 5 years (3.33 [2.82-3.92]); and not discussed within 3 years (2.81 [2.52, 3.13]) and 5 years (2.47 [2.22-2.74]). URM applicants additionally benefited within 5 years for not discussed applications. CONCLUSIONS: Encouraging early career researchers applying as faculty at a school of medicine to resubmit R01 applications is a promising potential modifiable factor and intervention strategy. First-time R01 applicants who resubmitted their original, unfunded R01 application had log-odds of obtaining downstream R01 funding within 3 and 5 years 2-4 times higher than applicants who did not resubmit their original application and submitted new NIH applications instead. Findings held for both discussed and not discussed applications.

Toward an Anti-Racist Approach to Biomedical and Neuroscience Research.

Racism is a threat to public health. Race is a sociopolitical construct that has been used for generations to create disparities in educational access, housing conditions, exposure to environmental contaminants, and access to health care. Collectively, these disparities have a negative impact on the health of non-white Americans. The National Institutes of Health (NIH) funds biomedical research, including basic neuroscience research, aimed at understanding the mechanisms and consequences of health and disease in Americans. NIH has recently acknowledged its own structural racism, the disadvantage this perpetuates in the biomedical research enterprise, and has announced its commitment to eliminating these disparities. Here, we discuss different rates of disease in U.S. citizens from different racial backgrounds. We next describe ways in which the biomedical research enterprise (1) has contributed to health disparities and (2) can contribute to the solving this problem. Based on our own scientific expertise, we use neuroscience in general and mental health/addiction disorders more specifically as examples of a broader issue. The NIH, including its neuroscience-focused Institutes, and NIH-funded scientists, including neuroscientists, should prioritize research topics that reflect the health conditions that affect all Americans, not just white Americans.

Building Equitable Patient Partnerships during the COVID-19 Pandemic: Challenges and Key Considerations for Research and Policy.

The unequal social and economic burden of the COVID-19 pandemic is evident in racialized and low-income communities across Canada. Importantly, social inequities have not been adequately addressed and current public policies are not reflective of the needs of diverse populations. Public participation in decision-making is crucial and there is, therefore, a pressing need to increase diversity of representation in patient partnerships in order to prevent the further exclusion of socially marginalized groups from research and policy making. Deliberate effort and affirmative action are needed to meaningfully engage and nurture diverse patient partnerships by broadening the scope of the patient community to include excluded or underrepresented individuals or groups. This will help us co-develop ways to enhance access and equity in healthcare and prevent the systematic reproduction of structural inequalities that have already been heightened by the COVID-19 pandemic.

State of Research Quality and Knowledge Transfer and Translation and Capacity Strengthening Strategies for Sound Health Policy Decision-Making in Palestine.

Objectives: Over the last 2 decades, the World Health Organization (WHO) has proposed a global strategy and initiatives to establish a Health Research System (HRS) focusing on Health Research Quality and Standardization (HRQS), Health Research Knowledge Transfer and Dissemination (HRKTD), and Health Research Translation and Utilization into Health Care Decisions and Policies (HRTUDP). Despite the increase in health research productivity over the past several decades, HRS Capacity (HRSC) in Palestine and in the Middle East and North Africa (MENA) region has rarely been objectively evaluated. This study aims at eliciting the perceptions of HRS performers in Palestine in order to understand the status of HRSC, identify gaps, and generate policies and solutions capable of strengthening HRSC in Palestine. Methods: Key informants from three sectors, namely government, academia, and local and international organizations, were selected purposively based on different sampling methods: criterion, critical case, snowball, and homogeneous sampling. Fifty-two in-depth interviews with key informants and a total of fifty-two individuals, participating in six focus groups, were conducted by the principal investigator in Palestine. Data were analyzed by using MAXQDA 12. Results: The overall pattern of the Palestinian HRSC is relatively weak. The key findings revealed that while HR productivity in Palestine is improving, HRQS is at an average level and quality guidelines are not followed due to paucity of understanding, policies, and resources. HRKTD is a central challenge with both a dearth of conceptualization of translational science and inadequate implementation. The factors related to inadequate HRKTD include lack of awareness on the part of the researchers, inadequate regulatory frameworks and mechanisms for both communication and collaboration between and among researchers and policy-makers and clinicians, and lack of availability of, and credibility in, systematized and reliable HR data. Despite the limited knowledge translation, in general, HRTUDP is not considered an essential decision-making methodology mainly due to the lack of interface between knowledge producers (researchers) and users (policymakers), understanding level, HR credibility and availability of applied research, and governance, resources, and political fluctuations. Recommendations to strengthen HRS in Palestine include: a consolidated research regulatory framework and an effective capacity strengthening strategy overseen by Palestinian authorities; the promotion of HRQS and concepts and practices of translational science; and, most importantly, the use of findings for evidence-based policies and practice. Conclusion: Strengthening HRSC is both an imperative step and an opportunity to improve the Palestinian health system and ensure it is based on research evidence and knowledge. Building a successful HRS characterized by capacities of high-quality research and well-disseminated and translated knowledge is a prerequisite to effective health systems and services. This can be achieved by political commitment to support such strengthening, a consolidated leadership and governance structure, and a strong operational capacity strengthening strategy.

Management of diabetes mellitus through teleconsultation during COVID-19 and similar scenarios - Guidelines from Indian Council of Medical Research (ICMR) expert group.

INTRODUCTION: Emergence of COVID-19 pandemic has led to increased use of telemedicine in health care delivery. Telemedicine facilitates long-term clinical care for monitoring and prevention of complications of diabetes mellitus. GUIDELINES: Precise indications for teleconsultation, clinical care services which can be provided, and good clinical practices to be followed during teleconsultation are explained. Guidance on risk assessment and health education for diabetes risk factors, counselling for blood glucose monitoring, treatment compliance, and prevention of complications are described. CONCLUSION: The guidelines will help physicians in adopting teleconsultation for management of diabetes mellitus, facilitate access to diabetes care and improve health outcomes.