By Bonny P. McClain
Clinical literature is filled with questionable evidence and poor data quality reported in randomized controlled clinical trials (RCTs) and observational studies. There is no need to become a statistician but it is critical that journalists have the skills to navigate the system and independently evaluate the quality of evidence. Clinical decisions may be based on inappropriate methods unless questioned and addressed by skilled journalists.
Health journalists in particular have an obligation and opportunity to tease the threads of innovation, drug discovery, and regulatory environments to provide informed context and a powerful narrative. Prior to the Affordable Care Act legislative process most health policy and health economics discussions were held behind committee walls in Washington, D.C., or in boardrooms of industry medical affairs departments. New advances in research, technology, development in devices combined with stakeholder demand for transparency in pricing, has spurred the need for powerful communication, dialogue, and networking.
This is particularly critical when evaluating studies regarding older adults and other vulnerable groups. When reviewing methodology, these factors should be taken into consideration. Older people tend to:
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Metabolize drugs differently than younger adults.
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Often struggle with multiple chronic conditions.
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Take multiple medications.
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May suffer from poor nutrition.
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Experience changes in metabolism.
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May have cognitive decline.
Any of these can affect the efficacy, management or side effects of a drug.
Additionally, clinical trials may exclude the very population a drug was developed to help, or may not adequately represent the target demographic. Even if older adults are part of the cohort, it’s important to consider whether a drug is being tested in community dwelling adults or on those who live in institutional settings. Side effects may also be more severe than in younger cohorts – leading to other, unanticipated consequences such as falls due to dizziness or loss of appetite from nausea.
Health care journalists should report from the intersection of research, clinical medicine, and “health economics and outcomes research” (HEOR). The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a valuable partner in navigating the complexity of a dynamically evolving healthcare system.
Pharmacoeconomics is a sub-discipline of health economics concerned with comparative value in drug therapies. The theme of the ISPOR 21st Annual International Meeting was “Value, Affordability, and Patient Centeredness: Can We Have It All?” The May meeting featured more than 1,800 presentations with close to 4,000 attendees representing 83 countries. Impossible to be in 1,800 places at one time, I focused on sessions targeted for value-frameworks and data visualization. Here are a few summaries followed by a list of potential story ideas. To view more of the presentations click here.
Workshop 15: Is Value Truly in the Eye of the Beholder? Analyzing the Heterogeneity of Outputs from ASCO, NCCN and DrugAbacus Oncology Value Frameworks and Exploring Implications for Cancer Drug Development
There are a variety of oncology valuation frameworks recently introduced in the U.S., including the American Society of Clinical Oncology (ASCO) Value Framework, National Comprehensive Cancer Networks (NCCN) Evidence Blocks, Memorial Sloan Kettering Cancer Center (MSKCC) Drug Abacus. Examine the variation in results generated by these methods when quantifying the value of different cancer treatments.
An overview of a few of the frameworks and the application of hypothetical drug profiles for comparison to the outputs were evaluated at the workshop. Drug profiles are generated specifically to illustrate an array of scores that the frameworks generate for identical drugs.
Source: Vikas Chawla presentation, ISPOR 21st Annual International Meeting
Workshop 16: Visualizing Data for Hypothesis Generation Using Large-Volume Health Care Claims Data
Many journalists are familiar with a variety of large databases for hypothesis generation.
Hypothesis-driven analyses of health care utilization data can provide important information about health outcomes and associated costs. Tools based on the published literature and via case studies were discussed for data exploration, identification of systematic patterns, and additional insights not limited by reliance on traditional statistical analysis. The Institute for Health Metrics and Evaluation graphic below provided an example of a Treemap.
Source: ISPOR 21st Annual International Meeting
Issue Panel 9: Next Generation Comparative Effectiveness Research – Are We Getting Organized to Facilitate Research For The Individual Patient?
Extending the granularity of comparative effectiveness research down to the individual patient requires the ability to handle big data generated from a variety of sources of evidence. The lack of consensus on how to organize, handle, analyze and interpret complex collections of data leads to a less than uniform methodology. How to evolve efficient patient centered comparative effectiveness research was discussed.
Source: Rachael Fleurence presentation, ISPOR 21st Annual International Meeting
Questions to Consider
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How does the methodology of the different value frameworks reflect the stated aim across different stakeholders — payer, provider, clinician, health policy?
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Review the literature and apply each framework to evaluate three different drug profiles — how are the outcomes altered?
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Discuss how the heterogeneity of outputs across different value frameworks can potentially impact drug development decision-making.
Resources
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ISPOR: Tools for Outcomes Researchers.
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ISPOR: Tools for Patients.
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Health News Review – An excellent review site to help consumers and reporters make sense of many of the studies, ads and claims out there.
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AHCJ core topic: Medical Studies
