AMWA Journal

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Table of Contents and Masthead

Mon, 16 Dec 2024 00:00:00 -0800

Cardiovascular Disease in the Americas: Social Determinants, Public Health Policies, and Recommendations

Alan Silburn, MPH, BP, BN, FAWM — Mon, 16 Dec 2024 00:00:00 -0800

The purpose of this article is to examine the influence of social determinants of health on the global health problem of cardiovascular disease (CVD), particularly focused on the Americas region. CVD, which encompasses conditions such as coronary heart disease, heart failure, and cerebral vascular disease, is identified as the leading cause of mortality worldwide, with low- and middle-income countries bearing the brunt of its burden. The article discusses how factors such as economic status, education, environment, food supply, substance addiction, and health care accessibility contribute to the prevalence of CVD. Additionally, it explores current public health policies addressing CVD and provides recommendations for enhancing these policies to alleviate the burden of the disease. The recommendations include implementing tobacco control policies, raising the legal age for purchasing tobacco products, and advocating for comprehensive health care services. The article concludes by emphasizing the importance of tailored interventions, evidence-based policies, and evaluation strategies in combating CVD and improving public health outcomes.

Cardiovascular Disease in the Americas: Social Determinants, Public Health Policies, and Recommendations

Alan Silburn, MPH, BP, BN, FAWM — Mon, 16 Dec 2024 00:00:00 -0800

The purpose of this article is to examine the influence of social determinants of health on the global health problem of cardiovascular disease (CVD), particularly focused on the Americas. CVD, encompassing conditions such as coronary heart disease, heart failure, and cerebral vascular disease, is identified as the leading cause of mortality worldwide, with low- and middle-income countries bearing the brunt of its burden. The article discusses how factors such as economic status, education, physical environment, food supply, substance addiction, and health care accessibility contribute to the prevalence of CVD. Additionally, it explores current public health policies addressing CVD and provides recommendations for enhancing these policies to alleviate the burden of the disease. The recommendations include implementing tobacco control policies, raising the legal age for purchasing tobacco products, and advocating for comprehensive health care services. The article concludes by emphasizing the importance of tailored interventions, evidence-based policies, and evaluation strategies in combating CVD and improving public health outcomes.

Questions and Answers from Freelance Pros

Mon, 16 Dec 2024 00:00:00 -0800

How can I prepare my freelance business for the recession? Did you freeze or increase your pricing/rates at the beginning of the pandemic? If you did, are you making any further changes to those rates now? How do you handle payments from international clients? Is there an optimal payment method that has worked for you?

In this issue, our Freelance Focus contributors are:

Brian Bass

Melissa L. Bogen

Sherri Bowen

Lori De Milto

Cathryn D. Evans

Alex Howson

A Beginner’s Guide to Writing for Health Economics and Outcomes Research

Annie Cheang, PharmD, MS, BCPS — Mon, 16 Dec 2024 00:00:00 -0800

The rising costs of health care have prompted many organizations and payers to adopt value-based approaches in deciding which health inventions justify the expenditure, in which patient, and at what cost. Health economics and outcomes research (HEOR) evaluates the economic impact of health interventions and their patient-related outcomes. HEOR has long been used by international health technology assessment (HTA) bodies and US payors to inform reimbursement recommendations. Recent trends suggest that opportunities for medical writers in HEOR projects are likely to continue growing. These trends include the inclusion of real-world evidence (RWE) in the “totality of evidence” supporting regulatory approvals in the United States,¹ Canada,²and Europe³; the use of artificial intelligence to accelerate insights from electronic health records; and the application of HEOR to personalized medicine.⁴ The growing importance of HEOR evidence and the emergence of new regulatory frameworks will result in increased HEOR outputs and opportunities for medical writers to assist in these projects. This paper reviews opportunities for medical writers in HEOR projects and provides suggestions for medical writers who are working on a manuscript for an HEOR journal.

Growth of Health Economics and Outcomes Research and Real-World Evidence in Medical Communication, and Opportunities for Medical Writers

Tom Drake, MA, Lisa Baker, PhD, Caitlin Rothermel, MPH — Mon, 16 Dec 2024 00:00:00 -0800

Over the past 2 decades, the expansion of health economics and outcomes research (HEOR) has been responsible for an increasing quantity of medical communication, providing evaluations of the economic, clinical, and quality of life outcomes of health care interventions. The discipline has evolved to include real-world evidence (RWE) collected outside traditional clinical trials. The International Society for Pharmacoeconomics and Outcomes Research plays a crucial role in advancing HEOR by promoting best practices and bridging the gap between research and practical application. Medical writers specializing in HEOR and RWE interpret and present data analyses to various stakeholders, supporting evidence-based decision-making. In this article, we describe the experiences of 2 medical writers who specialize in HEOR communication, the range of documents they work on, and the strengths of a good HEOR writer. The growing importance of HEOR and RWE in medical writing represents an expansion of value-based health care and patient-centric outcomes in the pharmaceutical and health care industries.

Navigating Real-World Evidence Reporting Guidelines

Laura E. Happe, PharmD, MPH, FAMCP, Meg Franklin, PharmD, PhD — Mon, 16 Dec 2024 00:00:00 -0800

Real-world evidence (RWE) has gained traction over the last several years and is now an integral part of the drug approval process\ and life cycle. Conducting well-designed studies and transparent reporting of studies has recently become the focus of guidance issued by multiple regulatory agencies and professional organizations across the globe. Knowledge of the available resources is paramount for medical writers. Although the first guidance, STROBE, dates back to 2007 and was widely known for its checklist for the reporting of observational studies, the advancements in electronic medical records, disease registries, and administration necessitated the development of the Reporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) guidance. ISPOR, the Professional Society for Health Economics and Outcomes Research and the International Society for Pharmacoepidemiology have developed guidance specific to the reporting of RWE studies and provided a template to assist with the description of longitudinal studies using routinely collected health care data. Although these options are helpful for a general approach to RWE reporting, other organizations like the European Society for Medical Oncology have recognized the need for guidelines for disease- specific research and have developed more specific guidance. Navigating the resources that are available is imperative for medical writers. This paper provides a guide to relevant contemporary resources to aid medical writers in the reporting and publication of RWE studies. Because of the expansiveness of the types of studies that fall under RWE, this paper focuses on traditional RWE studies that employ a longitudinal approach to the analysis of routinely collected health care data.

The First Dance

Brianna C. Landis — Mon, 16 Dec 2024 00:00:00 -0800

Creative Writing

The XYY Story as a Cautionary Tale: How Scientific Misinformation and Common Biases Can Negatively Impact Lives and Opinions

Helena I. Ebeling, Jonathan R. Beckwith, PhD — Mon, 16 Dec 2024 00:00:00 -0800

In recent decades, huge strides have been made in the field of genetics. Genomic analysis technology has enabled scientists to explore how genetics affect every aspect of human life and development. Genetic testing is poised to be at the forefront of contemporary medicine. Parents often grapple with the correlation of their child’s genetic mutations and serious diseases. At a time when misinformation spreads through the popular press like wildfire, we are recounting the XYY story as a cautionary tale to highlight the importance of scientists speaking up and standing against the misuse of genetic information.

Upcoming Events for Medical Communicators

Mon, 16 Dec 2024 00:00:00 -0800

Leaving the Lab for Biotechnology Writing: A Story of Zero Regrets

Cecilia Petrus, MSc, ELS, Paul Naphtali, MSc — Mon, 16 Dec 2024 00:00:00 -0800

Across North America, up to half of all PhD candidates reportedly withdraw from their program before completing their thesis.¹Paul Naphtali, MSc, was among the students who moved on, opting to work in the private sector. Over a year into founding his own medical writing business specializing in biotechnology (biotech) writing, he has no regrets. In this article, Naphtali shares his journey from the laboratory to working with biotech clients across the globe. He discusses the challenges he has encountered along the way and the crucial role that networking has played in overcoming them.

From the President

Shawn Watson, PharmD, PhD, BCPS — Mon, 16 Dec 2024 00:00:00 -0800

To the AMWA Membership,

I extend my heartfelt thanks to our very esteemed membership and the Nominating Committee for giving the honor to serve you.

Shortly after becoming a Medical Writer 1 at PRA International in 2011, I joined the American Medical Writing Association, and my life has never been the same. This community has helped me to grow professionally, expand my network, and refine my craft. I have learned so much from the dedicated membership and staff. It was an absolute delight to serve at the chapter and national levels, and now I’m thrilled to begin my term as your president.

Introducing the 2024–2025 Board of Directors

Shawn Watson, PharmD, PhD, BCPS — Mon, 16 Dec 2024 00:00:00 -0800

Article III of the American Medical Writer Association (AMWA)’s bylaws states that a Board of Directors (BOD) will manage and control the affairs, property, and business of the organization. The BOD is responsible for approving the budget, the slate of nominees for elected office, and any proposed amendments to the constitution or bylaws. It also approves committees, work groups, and task forces and fulfills such other duties as are specifically mentioned in the constitution and bylaws and as required by law. Thus, the members of the BOD carry considerable responsibility.

In alignment with the AMWA bylaws, the BOD includes elected officers (President, President-Elect, Secretary, Treasurer, Immediate Past President), an executive director, a chair of the chapter advisory council, and at least 5 appointed at-large directors. The number of members on the BOD during the governance year shall be no less than 12 and no more than 17.

I am pleased to introduce the 2024-2025 BOD. This group of professionals reflects characteristics of the member population and has volunteered their time and talent to meet, discuss, and take action on items as they pertain to the organization.

AMWA Certificate in Regulatory Writing Core Knowledge

Lynne Munno, MA, MS, Aaron Van Etten, MS — Mon, 16 Dec 2024 00:00:00 -0800

The AMWA Regulatory Writing Core Knowledge Certificate was announced at the 2024 Medical Writing & Communication Conference in New Orleans, and the training modules that comprise the certificate are now available on the AMWA website. This new certificate is the first of 2 to address the goal of establishing consistent and formal training for regulatory writers. The development of these certificates, which have been in the works for some time, are summarized in this article.

The AMWA Medical Writing & Communication Conference Location Selection Process

Shawn Watson, Kim Korwek, Julie Phelan, Jen Minarcik, Susan Krug — Mon, 16 Dec 2024 00:00:00 -0800

The choice of location for the annual AMWA Medical Writing & Communication Conference is a complex and multifaceted decision, driven by a number of factors that ensure a positive and engaging experience for our members. To provide insight into this process, we want to share how venue selection is managed and the key considerations that shape our choices.

Dues Update in 2025 Supports AMWA’s Enhanced Member Value

Shari Rager — Mon, 16 Dec 2024 00:00:00 -0800

Remember 2020? Although the world seemed to press pause, medical communication certainly didn’t stop. With the increased need for information and clear communication, AMWA pressed forward to meet the needs of our members. As organizations everywhere grappled with unprecedented challenges, we froze membership dues at 2019 rates, providing stability when our members needed it.

Over the past 5 years, although our dues remained unchanged, AMWA has been quietly revolutionizing what it means to be a member. We’ve expanded services, pioneered new benefits, and remained steadfast in our mission to promote excellence in medical communication—all while navigating the seismic shifts in health care and the global economy.

As we look ahead to 2025, it’s time to reflect on the journey we’ve taken together and the transformative value we’ve built for our members. From launching the highly anticipated compensation report to creating an artificial intelligence (AI) task force, AMWA has evolved to meet the changing needs of medical communicators at every career stage.

From Novice to Expert: Establishing a Job Level Framework for Medical Writers

Mon, 16 Dec 2024 00:00:00 -0800

As part of the AMWA Medical Writing Apprentice Program Framework, the Job Leveling Workstream aims to establish a standardized skill set and competencies for career regulatory medical writers. Based on insight gathered from a survey conducted in September 2023 of 137 medical writing professionals, the workstream proposes 3 broad levels of regulatory medical writers: Level 1 (novice), Level 2 (established), and Level 3 (expert). Each level is defined by the scope and complexity of documents written, the writer’s role in these projects, and their expertise in associated tasks. An approximate number of years needed to achieve proficiency at each level is also proposed. The framework helps to standardize writing levels, aid hiring managers in evaluating applicants, assist medical writing departments in identifying training needs, and ultimately enhance resource usage.

Results of the 2024 AMWA Member Experience Survey

Kimberly Korwek, Jennifer Minarcik, Sarah Dobney — Mon, 16 Dec 2024 00:00:00 -0800

The 2024 AMWA Member Experience Survey, conducted in the first quarter of 2024, was performed to assess the perceptions of AMWA members regarding the programs, resources, and services provided by the organization. The responses to the survey will be used by the Board of Directors (BOD) to inform decisions about program development, major initiatives, and the organization’s strategic direction.

Crumbling Sentences: Isolated and Expletive Pronouns Weaken the Foundation of Clear Medical Writing

Crystal R. Herron, PhD, ELS — Mon, 16 Dec 2024 00:00:00 -0800

The subject is the most foundational element of a sentence. When the subject is clear and concrete, the sentence starts strong, and readers can easily maintain their forward momentum in the story. When the subject is unclear, the sentence crumbles, and readers must backtrack in the text or carry a cognitive load as they continue reading. In medical writing, unclear subjects often appear as ambiguous pronouns in the form of isolated pronouns and expletive pronouns. These constructions create more work for readers by using an unclear referent or no referent at all. Fortunately, these 2 constructions can be refined to use clear, concrete nouns that help readers quickly and easily locate the subject of a sentence and continue forward in the story.

The Narrative Edge: The Power of Storytelling in Needs Assessments

Rhona Fraser, BVMS — Mon, 16 Dec 2024 00:00:00 -0800

The evolution of needs assessments (NAs) in continuing medical education grant proposals has transformed them from basic literature reviews of medical research into sophisticated, data-driven narratives that compellingly document the education needs of health care professionals. This article explores the critical role of storytelling in modern NAs, emphasizing how triangulating diverse data sources within a cohesive narrative effectively highlights targeted clinical practice gaps and demonstrates a genuine need for educational interventions.

Opportunity Abounds—Expand Your Medical Writing Skills in the Rapidly Growing Fields of Health Economics and Outcomes Research (HEOR) and Real-World Evidence (RWE)

Tom Drake, MA, CMPP — Mon, 16 Dec 2024 00:00:00 -0800

Over the past 40 plus years, the health care industry in the United States has developed and launched innovative bio/ pharmaceutical products and medical devices available to prescribers, insurers, patients, and their caregivers. An essential question is why the United States leads the world in bio/pharmaceutical innovation and blockbuster therapies, and yet the US health care system delivers some of the lowest health outcomes among industrialized democracies.¹ The United States ranks near or at the bottom of The Organisation for Economic Cooperation and Development (OECD) countries for longevity, morbidity, obesity, chronic diseases, and other health-related categories. Adding to this challenge is the fact that the United States spends nearly twice as much per capita on health expenditures than any other European Union or OECD country.

2024 Medical Communication Compensation Report Executive Summary

AMWA — Mon, 16 Dec 2024 00:00:00 -0800

As the leading professional association for medical communicators, the American Medical Writers Association (AMWA) has conducted periodic compensation surveys to benchmark salaries and income for employee and freelance medical communicators for the past 35 years. AMWA’s 2024 compensation survey, conducted by Association Research, Inc. (ARI), collected data from over 1,000 medical communication professionals reporting on the tax year ending December 2023.

AMWA is grateful to every medical writer, editor, and communicator who took the time to complete the survey. Your input is the foundation of the AMWA 2024 Medical Communication Compensation Report, recognized as one of the most reliable sources of income data, specifically for medical writers and editors across employment settings.

Leading this year’s work was AMWA’s Deputy Director, Shari Rager, MS, CAE, who collaborated closely with ARI and a volunteer review team including Gail Flores, PhD; Leena Knight, PhD; Stephen Palmer, PhD, ELS; Joanne Rosenberg, MS, ELS; Cynthia Saver, MS, RN; Linda Yih; and Kim Korwek, PhD (Board Liaison). Member support through survey participation and volunteer effort allows AMWA to create valuable resources for the field of medical communication.

The following is the Executive Summary, presented as published, from the 2024 Medical Communication Compensation Report. The full report may be downloaded by AMWA members as a benefit of membership.