Ensuring data quality in home spirometry

Best practices and key considerations with remote spirometry testing

Dr. Kai Michael Beeh – Pulmonary Medical Scientific Expert

It is no secret that decentralized trials (DCTs) have gained acceptance within our industry since the onset of COVID-19 for both patients and clinicians. According to a December 2020 survey by McKinsey, 100% of pharma and CROs expected virtual trials to be a significant component of their portfolios, up from 38% in December 2019.¹ With so many partners to choose from, how do pharmaceutical companies decide which is right for them? 

The answer to this is not as easy as choosing between orange, purple and green; it’s selecting the best option on a scale with ten different hues of gray, making Clario the only company capable of distinguishing among them. This article focuses on best practices and key considerations with remote spirometry testing by sharing three critical success factors to consider when selecting a sponsor for your trials.

Achieving data quality

As clinical trial technology evolves, it provides more opportunities to gather end point data in a variety of hybrid and fully decentralized trials, but this cannot be at the expense of the data quality. For instance, during a pulmonary function test, the patient must exert maximum effort to achieve quality results. The nurse observes the patient to ensure accurate data collection when conducted on-site. This procedure is challenging even when performed on-site. It becomes increasingly difficult when the patient performs the assessment at home without active coaching. 

To reduce or eliminate any discrepancies in data quality, whether a patient is performing the pulmonary function test at the clinic or home, Clario developed iSpiro, a highly accurate, user-friendly decentralized spirometry solution. In 2021, Clario launched iSpiro Virtual Visits to connect the patient and nurse via video for remote coaching and expert guidance for the patients to ensure high-quality endpoint data is collected by the patient whether they are located at the site or at home.

Minimizing patient burden and cost

When it comes to home spirometry testing, patient experience must be top of mind. Pulmonary function testing should be as effective as possible to minimize the number of attempts by the patient and ensure the highest data quality is captured. In DCTs, patients often take on the role of the nurse. This can create greater challenges with patients being remote, leading to increased variability. The better we can mitigate the factors to reduce variability by educating and coaching the patient during the process with real-time remote coaching and virtual visits for patient guidance, the better the outcome for all involved.

For companies that perform fewer clinical trials, this is a daunting task. At Clario, we have experience and success in every clinical setting imaginable. With recent dynamic advancements in data collection, Clario provides unique technologies to obtain FEV1/FVC data from patients at home or under supervision by site personnel via remote transmission of data and video.

Ensuring patient safety

In conducting home spirometry testing, a patient’s safety is paramount. Safety concerns can quickly be treated on-site in a traditional clinical trials setting. However, at home, we must consider possibilities that could arise during the assessment – whether or not that concern is the direct result of the evaluation. Thus, connecting the nurse and patient for real-time observation and step-by-step instructions is essential to ensure the measurements’ quality, safeguard the patient’s safety, and mitigate any risks to their health or a company’s liability. Critical instructions could be as simple as ensuring the patient is sitting down.

As the clinical trials ecosystem rapidly evolves, the need for safe and reliable remote data collection is increasing. With iSpiro Virtual Visits, Clario delivers customer and patient-oriented innovations that facilitate decentralization.

On February 24, 2022, Clario will host a webinar where Clario respiratory experts and Dr. Kai Beeh will discuss challenges in ensuring data quality when not supported and coached virtually by experienced site personnel. Register for the webinar to learn more.

References:

¹https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials