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Mastering Standard Response Letters: A Tactical Breakdown of Medical Studies

As a medical writer and consultant, I’ve often been tasked with preparing standard response letters, documents designed to provide accurate responses to frequently asked or expected queries in the medical field. Recently, I’ve been focusing on breaking down studies in a way that is more engaging and less of a data dump for the customer, the healthcare professionals (HCPs) who use these documents.

In this industry, we have some resources (eg, CORE-4 guidelines) which offer excellent general guidance on standard response letters. However, I’ve noticed that these guides don’t delve deeply into the process of summarizing a study effectively. This observation, combined with feedback from HCPs who have expressed frustration at long, drawn out, and confusing standard responses, has inspired me to propose a new approach.

Keeping in mind the unique needs of HCPs, I suggest starting with the question that the response seeks to answer. This initial focus ensures the reader will quickly get the information most relevant to their query. Questions typically fall into one of the following categories:

  • Efficacy results
    • Primary outcomes
    • Secondary outcomes
  • Safety
    • General
    • Specific AEs
  • Treatment groups
    • Subgroup efficacy and safety
    • Comorbidity efficacy and safety
    • Pregnancy/lactation
  • Storage, Stability, Dosage, Administration, Ingredients
    • Temp excursions
    • Missed dose
    • Alternate administration
    • Switching
  • Mechanism of action (MOA), pharmacokinetics (PK), pharmacodynamics (PD)
  • Concomitant use
  • Comparisons

Once we’ve established the central question, we can then discuss key study details such as objective, design, patient population, treatments, and results. However, I’m suggesting a twist on the traditional format here. Inspired by the journalistic principle of “not burying the lede”, I propose starting the data summary with a summary sentence that directly answers the question.

Let’s consider the question, “Does febuxostat increase cardiovascular (CV) risk in patients with a history of heart attack?” Traditionally, you might expect a standard response letter to first outline the objectives, design, population, treatments, and so on of the relevant study. However, using the approach I’m proposing, we begin with a summary sentence directly addressing the question, then explain the context of the study.

For instance: “In a subgroup analysis of the CARES trial, patients with history of nonfatal myocardial infarction (MI) did not have an increased risk of CV events with febuxostat compared with allopurinol.”

The healthcare professional immediately gets an answer to their question. But don’t worry, we’re not neglecting the essential background information. Following the summary sentence, we explain the key points of the study design, elaborate on the specific outcome, and provide further context and data as needed. Here is the full summary:

In a subgroup analysis of the Cardiovascular (CV) Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial, patients with a history of nonfatal myocardial infarction (MI) did not have an increased risk of CV events with febuxostat compared with allopurinol. The CARES trial was a multicenter, randomized, double-blind noninferiority study, designed to determine if febuxostat was noninferior to allopurinol in terms of major CV events among patients with gout and CV disease. Key criteria for enrollment were a diagnosis of gout, a history of major CV disease, and certain levels of serum urate. 

Patients (N=6198) were randomly assigned to receive febuxostat or allopurinol daily, with dosage modifications for allopurinol depending on kidney function. Febuxostat dosages remained consistent regardless of kidney function.  At baseline there were 1197/3098 patients with history of nonfatal MI in the febuxostat group and 1231/3092 patients in the allopurinol group.

The primary composite endpoint (first occurrence of CV death, nonfatal MI, nonfatal stroke, or urgent revascularization for unstable angina) occurred at similar rates in both groups (10.8% in febuxostat group and 10.4% in allopurinol group; HR, 1.03; 95% CI, 0.87-1.23; p=0.66). Subgroup analysis of patients with a history of nonfatal MI found no significant difference between the two groups: 15.5% in the febuxostat group (185/1197) and 13.9% in the allopurinol group (171/1231; RR, 1.11; 95% CI, 0.92-1.35). A significant limitation of this study was the large number of patients who discontinued treatment (56.6%) and those who did not complete follow-up (45%).

I believe this “answer-first” approach respects the HCP’s need for quick, precise information, while maintaining a high level of detail and data integrity. It also promotes agility and precision in our standard response letters – a key tenet of my boutique approach to medical writing.

My goal is to ensure that your standard response letters are more than just a sterile presentation of facts. I want them to be a tool that enhances understanding, engages curiosity, and fosters more effective healthcare decision-making. Together, let’s refine standard responses and transform them into precise, agile, and finely crafted tools of communication.