Usability of the Novel Liraglutide 3.0 mg Pen Injector Among Overweight or Obese Adult Patients With or Without Prior Injection Experience

Abstract

Obesity is a chronic disease often encompassed by a multitude of serious comorbidities, making its prevention and treatment public health priorities. Globally, by 2030, the numbers of adults who are overweight ( It has been shown that an increase in BMI is directly correlated with a reduction in life expectancy and increase in obesity-related comorbidities such as type 2 diabetes mellitus (T2DM).3-5 A 5-10% weight loss can provide clinically relevant improvements in obesity-related comorbidities and quality of life (QoL).6,7 Depending on BMI classification and the number/severity of comorbidities, behavioral therapy including dietary and physical activity changes, pharmacotherapy and (in the appropriate patient) bariatric surgery are recommended. 8,9 However, achieving and maintaining weight loss by diet and physical activity alone can be challenging.10-12 Pharmacotherapy supports weight loss and Background: Obesity is associated with multiple comorbidities and increased mortality, making it an important target for treatment. However, achieving and maintaining weight loss by diet and physical activity remains challenging, and may often require pharmacotherapy. Liraglutide 3.0 mg has recently been approved for weight management in the United States, Canada, and EU. The current analysis used a summative usability test to assess safety and effectiveness, ease of use, and training requirements for the novel liraglutide 3.0 mg pen injector.

Real‐World Clinical Effectiveness of Liraglutide 3.0 mg for Weight Management in Canada

“…Several prominent associations, including the Canadian Medical Association, recognize obesity as a chronic relapsing primary disease characterized by excessive accumulation and storage of fat in the body . Obesity is associated with many serious comorbidities, including hypertension, type 2 diabetes (T2D), cardiovascular disease, osteoarthritis, and certain types of cancer . The continued rise in the prevalence of obesity makes prevention and treatment public health priorities because it has been shown that an increase in BMI is correlated with a reduction of life expectancy and with an increase of obesity‐related comorbidities .…”

Improving the safety of disposable auto-injection devices: a systematic review of use errors

“…Firstly, some users were not aware that they had to activate the device by pushing a button (Robinson et al, 2014;Salter et al, 2014;Brown et al, 2013). Secondly, some users were not able to push the button with enough force to trigger the injection (Fujioka et al, 2015;Callis Duffin et al, 2016;Matfin et al, 2015;Demary et al, 2014). The same distinction could be made for devices that have to be activated by pressing them against the body.…”

“…This includes physical characteristics (hand size, mobility, flexibility, strength, etc. ), sensory performance and cognitive abilities (Fujioka et al, 2015;Food and Drug Administration, 2017). The application of information about human capabilities and limitations to device design in order to optimize a device's performance and safety is known as human factors engineering or usability engineering (Lange et al, 2015;Russ et al, 2013).…”

“…Operational difficulties represent cases in which users have problems performing a task. Signs of this include needing several attempts to perform a task, as well as comments or non-verbal signs indicating confusion or frustration (Fujioka et al, 2015). Figure 1 illustrates the propagation of a usability flaw, from violation of the corresponding design principle to the resulting use error and then the negative patient-related outcome.…”

“…In order to minimize this type of issue and to ensure that patients can take their treatment without running any risks, usability engineering is crucial for developing safe, effective devices (Fujioka et al, 2015). This requirement is also reflected in the guidelines issued by the regulatory authorities.…”