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Patient adherence is an emerging topic and a matter of concern in clinical research. It applies to several different clinical trial facets.
Patient adherence is an emerging topic and a matter of concern in clinical research. Patient adherence can apply to several different clinical trial facets which may include adherence to study procedures, study visit compliance, medications, and adverse event reporting to name a few. The introduction of these risks during a clinical trial can result in not only increasing the cost of clinical trials, but also skewed outcomes.
To demonstrate, a 20%-30% decrease in medication adherence may result in increasing the patient sample size by 50% in order to maintain sufficient statistical power, and a 40% non-adherence rate would require a 200% increase in the sample size in order to maintain significant statistical power, resulting in increased clinical trial costs, and medical product approval delays.1 Additionally, up to 30% of clinical trial participants may be throwing out investigational product before study visits, and are untruthful about medication compliance when communicating to clinicians,1 which can impact regulatory dosing recommendations upon medical product approval.
Why are Patients Non-Adherent?
There are several reasons that may explain why patients are not adherent. Firstly, consent forms still remain too complicated for patients to understand, which results in confusion associated with study procedures and medication regiments. For example, consent form analysis at an oncology center revealed that only 6% of consent forms are written under an eighth grade level,1 and another study has shown that median consent form page length was 20 pages.2 Secondly, there tends to be a communications issue between physicians and patients. According to patient feedback, patients fear that they may disappoint the clinician, resulting in untruthful statements about study adherence.1 Lastly, asides from the fact that patients are people with busy lives, patients tend to be afraid that not adhering to study procedures would result in study teams dropping the patients out of a clinical trial.
Patient non-adherence manifests itself in many ways during a clinical trial (i.e., increasing sample sizes, shifting dosing requirements, etc.) and unfortunately study teams try to address the symptoms of non-adherence retrospectively. This article will discuss how study teams can proactively address patient non-adherence, and improve adherence outcomes via technological intervention.
Gamification is increasingly growing in popularity with patient engagement. Gamification essentially enables patients to visualize study progress and rewards patients for adhering to study outcomes. Gamification is typically deployed via a mobile application or a web-based platform. A recent study demonstrated that gamifying the diabetes prescription refill experience reduced the amount of time between refills by 39%. While minimal supportive data on gamification exists in clinical research, the aforementioned study suggests that gamification invokes intervention with patients. Nonetheless, this study also implies that gamification in a web based medium is more interactive with younger patient populations, which may pose challenges for studies that target older patients.
Text messaging has demonstrated positive results with patient adherence in a widely applicable geodemographic pool, and is a promising technology for clinical research. For instance, a study conducted in Asia has shown that text messaging not only improved medication adherence in post-surgery interventions, but, also reduced the number of adverse events, and mitigated non-adherence related symptoms;3 the average patient age in this study is 58, and patients exhibited varying levels of education ranging from primary school to university.3 Moreover, a recent analysis has proven that text messaging effectively increased clinical trial recruitment and enrollment, which may suggest that text messaging can also be an effective and efficient tool that captivates patients during clinical trial conduct.
Consent form Simplification and Digitalization
As mentioned previously, consent forms are too complicated for patients to understand, which introduces non-adherence risk. Leveraging communications expertise to simplify consent form verbiage can assist with knowledge transfer to patients. Including visualizations, study roadmaps and educational tools can also help patients with improving their understanding of study requirements and expectations. The introduction of e-consenting has brought about an entirely new way of communicating with patients, as study teams can now incorporate educational videos about clinical trials, quizzing and situational analysis. The Speak Out, But Speak Smart campaign is an excellent example of how video interactions can be used in consenting to better educate patients about a clinical trial, and provide appropriate patient training through scenario analysis. Such tools can prepare a patient before, during and after clinical trial participation.
The Key to Patient Adherence is Early and Responsive Intervention
It is widely known that study teams tend to react retrospectively to the symptoms of patient non-adherence. By implementing patient engagement technologies throughout a clinical trial, study teams can not only change patient intervention outcomes through better engagement, but also gather analytics to better to assess/categorize patient risk, and enhance engagement via intervening with high risk patients. To elaborate, if a study team detects via engagement analytics that a patient is at risk of not adhering to study requirements, study teams can implement proactive methods to re-engage the patient; essentially reacting through targeted engagement strategies. What technologies are you using to change patient behavior in clinical trials?