OVERVIEW
Monitor data quality and improve both clinical and virtual spirometry measurements
Spirometry is dependent on good effort from the participant and optimal coaching by the operator to generate reliable test results that meet ATS/ERS guidelines. Our scientific spirometry quality review solution leverages a unique combination of data monitoring tools, human validation, and clear reporting to monitor data integrity, identifying potential quality issues as early as possible. Early intervention optimizes the potential for successful mitigations prior to any significant impact on overall study quality.
SOLUTIONS AND EXPERTISE
Customized solutions to monitor data quality beyond ATS/ERS standards
Ensuring the quality of each spirometry maneuver is essential for collecting accurate measurements and enhancing the participant experience.
Clario’s AI-based spirometry tools provide rapid feedback for spirometry tests, including which phase of the maneuver did not meet minimum standards and if the test should be repeated. This feedback is available for both in-clinic and virtual settings, increasing the potential that the maneuvers are performed correctly. By providing this feedback in near real-time, repeat testing can be undertaken within the same visit/time window.
Detect profile variability
Each individual’s lung function exhibits a characteristic pattern derived from the shape, dynamics and key features of their spirometry curves. The data can be analyzed for distinctive patterns, creating a personalized spirometry profile for each participant.
Once these personalized profiles are created, our Scientific Spirometry Quality Review services can analyze for variability both over time and between individual participants, allowing for detection of both implausible changes within an individual’s spirometry patterns over time and implausible similarity between individuals.
Monitor according to ATS/ERS quality standards
Adherence to ATS/ERS standards will increase the potential for more accurate PFT data, but this is not sufficient to ensure that the data is accurate enough to detect changes to the lung based on drug effect. Clario’s quality control solutions identify spirometry maneuvers that don’t meet minimum standards according to ATS and ERS best practices.
This rapid and precise feedback grades the quality of each effort and indicates whether it is acceptable or should be repeated.
By providing this guidance, our team and tools provide fast, accurate, and comprehensive feedback about the quality of spirometry maneuvers.
Beyond ATS/ERS guidelines
ATS /ERS standards are just the start. Clario’s services go beyond just proper technique analysis and provide a robust analysis of potential data vulnerabilities and communication of anomalous findings in the data.
Meeting ATS/ERS criteria confirms proper technique, but it does not fully address whether results are physiologically plausible, consistent over time, or free from site-related variability that can obscure true treatment effects.
Going beyond these standards enables deeper quality oversight to improve the quality of your trial data.
Service detail
Clario’s Scientific Spirometry Quality Review services work with both site-based and virtual spirometry to provide near-real-time feedback while collecting detailed data for further analysis.
Clario Standard overread
- Near-real-time overread based on ATS/ERS criteria to measure against ATS/ERS standards
- Additional QC by Clario respiratory experts to detect inappropriate technique
Additional reporting on data trends
Clario uses data reporting tools to spot trends in data to identify:
- Poorly performing sites
- Sites where potential irregular methodologies are detected
Review for irregular data
- Changes in lung function ‘profile’ over time
- Biologically implausible data for indication or demography
- Multiple study subjects of the same site present high levels of similarity
Expert clinicians supported by AI
- Clinician deep-dive based on reporting tool identification
- Debrief meeting with the sponsor to discuss action points
- Optional follow-up of study sites
FAQs
Why is spirometry quality control important to pulmonary function endpoint data?
High‑quality spirometry is fundamental to ensuring that pulmonary function endpoints provide an accurate assessment of true patient lung physiology, rather than reflecting variability introduced by suboptimal technique or inadequate effort. Rigorous quality control procedures are essential for producing measurements that are both precise and reproducible, thereby supporting the validity of longitudinal and treatment‑related comparisons.
Without robust quality control measures in place, inconsistent maneuver execution, insufficient patient instruction, or variability in operator technique can significantly diminish the reliability of collected data. Such issues may lead to measurement artifacts, inappropriate interpretation of lung function trends, and reduced confidence in study outcomes.
Comprehensive spirometry quality control protects the integrity of pulmonary function datasets, ensures adherence to regulatory and professional society standards, and enhances the credibility of clinical trial results. By minimizing sources of variability, strong QC and risk-based monitoring practices strengthen confidence that observed treatment effects accurately reflect physiological changes and are both clinically meaningful and scientifically defensible.
What defines an acceptable spirometry maneuver according to ATS/ERS standards?
According to established ATS/ERS guidelines, an acceptable spirometry maneuver must demonstrate several key technical characteristics. These include a rapid and forceful initiation of exhalation, a smooth and uninterrupted expiratory flow without evidence of cough, hesitation, glottic closure, or premature termination, and a sufficiently long exhalation to achieve a definitive end‑of‑test plateau. When applying 2019 standards, the maneuver also includes Phase IV, a rapid and forced inspiratory effort back to full inflation (Forced Inspiratory Vital Capacity [FIVC]). Collectively, these criteria ensure that each maneuver reflects maximal patient effort and yields pulmonary function measurements that are accurate, interpretable, and comparable across time points.
Clario’s scientific Spirometry Quality Review services evaluate all phases of the spirometry maneuver to determine adherence to ATS/ERS standards. This includes the start of test, mid-exhalation flow, end-of-test plateau, and forced inspiration back to full volume. The review process identifies specific aspects of each maneuver that do not meet acceptability or repeatability criteria and provides clear, actionable feedback to support corrective coaching and performance improvement. This comprehensive assessment helps ensure that the spirometry datasets collected in clinical trials are reliable, technically valid, and aligned with international quality expectations.
Is spirometry data reviewed in near real time or retrospectively?
Both approaches are utilized. Clario’s data monitoring algorithms provide near real-time quality feedback during spirometry testing, enabling participants and site personnel to identify and correct suboptimal maneuvers during the same visit. This near real time guidance supports the acquisition of acceptable and repeatable efforts, reduces the likelihood of unusable data, and minimizes the need for repeat visits or additional coaching sessions.
In addition, spirometry data can be reviewed retrospectively to identify quality issues that may not have been fully addressed at the time of testing. Retrospective analysis allows for detection of trends such as inconsistent technique, submaximal effort, or site-specific performance challenges. These insights enable targeted interventions, ongoing quality monitoring, and corrective actions that enhance the overall integrity and reliability of pulmonary function data throughout a study.
Together, real-time and retrospective review processes ensure comprehensive quality oversight, support adherence to ATS/ERS standards, and optimize site- and study-level data quality across the duration of clinical trials.
How does spirometry QC reduce endpoint variability and statistical noise?
Spirometry quality control plays a critical role in reducing endpoint variability and minimizing statistical noise by ensuring that maneuvers are performed consistently, meet ATS/ERS acceptability and repeatability criteria, and accurately reflect true patient effort, rather than technique‑related artifacts. By verifying that each maneuver adheres to standardized performance expectations, quality control procedures help ensure that pulmonary function measurements are both physiologically valid and comparable across sites and study visits.
Identifying suboptimal or poor‑quality maneuvers allows for timely intervention, including coaching of site personnel on appropriate corrective actions, reinforcement of proper technique, and clarification of protocol requirements. This continuous feedback loop promotes consistent participant performance and enhances standardization across the trial environment.
Through systematic monitoring and remediation, spirometry quality control reduces measurement error, improves data precision, and helps maintain the statistical power necessary to detect clinically meaningful treatment effects. Ultimately, robust QC and risk-based monitoring processes strengthen confidence in endpoint reliability and support the credibility of study findings.
How does spirometry QC support the regulatory process?
Spirometry quality control provides essential, auditable documentation that pulmonary function data have been collected, evaluated, and monitored in accordance with ATS/ERS technical standards and applicable regulatory expectations. This documented oversight establishes that each maneuver has undergone systematic review to verify acceptability, repeatability, and overall compliance with internationally recognized performance criteria.
Centralized quality control processes—supported by traceable review decisions, objective scoring methodologies, and standardized quality metrics—demonstrate consistent and proactive management of spirometry endpoints throughout a clinical trial. These processes help ensure data integrity by reducing variability, identifying deviations from expected performance, and enabling timely remediation when issues arise.
By maintaining a clear record of quality assessments and the rationale behind each review decision, sponsors are better positioned to respond confidently to regulatory or audit inquiries. Comprehensive QC documentation supports transparency, reinforces the reliability of pulmonary function endpoints, and provides objective evidence that spirometry data are robust, well‑governed, and suitable for regulatory evaluation.