Outcome postponement as a potential patient centred measure of therapeutic benefit: examples in cardiovascular

Pierre Vladimir Ennezat1, Thierry Le Jemtel2, Shona Cosgrove3

  • 1Centre Hospitalier Régional Universitaire Grenoble-Alpes, Service de Cardiologie, Grenoble, France.

Acta Cardiologica
|December 5, 2018
PubMed

Insights

Presenting randomized controlled trial findings as average survival gain offers a clearer understanding of treatment effects compared to traditional metrics. This method aids both patients and physicians in evaluating drug efficacy and clinical trial outcomes.

Area of Science:

  • Clinical Trials
  • Cardiovascular Medicine
  • Medical Statistics

Background:

  • The interpretation of randomized controlled trials (RCTs) is significantly influenced by how their results are presented.
  • Traditional methods like absolute risk reduction (ARR), number needed to treat (NNT), and relative risk reduction (RRR) or hazard ratio are commonly used.
  • These conventional metrics may not always convey the full clinical impact effectively for patient and physician comprehension.

Purpose of the Study:

  • To explore average survival gain as an alternative and informative method for presenting RCT findings.
  • To assess the utility of outcome postponement in understanding treatment effects in cardiovascular trials.
  • To compare the clarity of survival gain with traditional metrics like hazard ratio and RRR.

Main Methods:

  • Analysis of recent cardiovascular RCTs involving medications like ezetimibe/simvastatin, evolocumab, canakinumab, ticagrelor, rivaroxaban, ivabradine, sacubitril/valsartan, and transfemoral aortic valve replacement (TAVR).
  • Calculation and comparison of average survival gain (outcome postponement) across different cardiovascular interventions.
  • Evaluation of the comprehensibility of survival gain versus hazard ratio and RRR.

Main Results:

  • Average survival gains varied significantly, from 4.9 days with ticagrelor versus clopidogrel in acute coronary syndrome patients to 117 days of life expectancy with TAVR for severe aortic stenosis.
  • These findings demonstrate a wide range of potential benefits when expressed as survival gain.
  • The study highlights the potential for survival gain to offer a more intuitive understanding of treatment benefits.

Conclusions:

  • Presenting RCT results using average survival gain (outcome postponement) can enhance understanding for both patients and physicians.
  • This alternative metric may be more easily grasped than hazard ratios or relative risk reduction.
  • Outcome postponement offers a valuable additional measure for evaluating the clinical impact of new drugs and interventions.

Related Concept Videos

Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
1.1K
Cardiovascular Drugs: Classification based on Therapeutic Indications01:18

Cardiovascular Drugs: Classification based on Therapeutic Indications

Cardiovascular diseases, encompassing a range of conditions, can significantly affect the heart's operations and the overall circulatory system. These conditions impair the heart's ability to pump blood, leading to a deficit in oxygen supply to crucial organs. Anomalies in the heart's electrical system, known as arrhythmias, can cause heartbeats to accelerate or slow down. Usually, heart rates increase during physical activity and decrease while resting or sleeping. However,...
4.2K
Benefits of Self-Esteem01:25

Benefits of Self-Esteem

Self-esteem—an individual's overall evaluation of their worth—plays a complex role in psychological functioning and well-being. It is often associated with many positive traits, such as confidence, optimism, and perseverance. Individuals with high self-esteem typically experience better sleep, manage peer pressure more effectively, and report greater life satisfaction. Conversely, low self-esteem has been consistently linked with increased risks of depression, anxiety, and poor...
207
Newton's Third Law: Examples01:08

Newton's Third Law: Examples

Newton's third law states that every action has an equal and opposite reaction. Consider a swimmer pushing off the side of a pool. They push against the wall of the pool with their feet and accelerate in the direction opposite to that of their push. This occurs because the wall exerts an equal and opposite force on the swimmer. Here, the forces do not cancel out each other as they are acting on different systems. In this case, there are two systems: the swimmer and the wall. If we select...
27.1K
Free Body Diagrams: Examples01:07

Free Body Diagrams: Examples

Solving problems that involve forces is easy using free-body diagrams. A free-body diagram is a sketch showing all the external forces that are acting on an object or system. The object or system is represented by a single isolated point (or free body). Only those forces acting on it that originate outside of the object or system—the external forces—are shown. The forces are represented by vectors extending outward from the free body. Imagine a person sitting on a chair. Here, the...
14.7K
Predicting Reaction Outcomes02:24

Predicting Reaction Outcomes

Kinetics describes the rate and path by which a reaction occurs. In contrast, thermodynamics deals with state functions and describes the properties, behavior, and components of a system. It is not concerned with the path taken by the process and cannot address the rate at which a reaction occurs. Although it does provide information about what can happen during a reaction process, it does not describe the detailed steps of what appears on an atomic or a molecular level. On the other hand,...
10.8K