Ensuring the accuracy and integrity of clinical outcome assessments is critical in research and healthcare decision-making. In this video, we explore the key challenges associated with using patient-reported outcome (PRO) measures and the best practices for avoiding common pitfalls.
From selecting the right instrument to implementing validated scoring methods, this discussion highlights the importance of upholding scientific standards in clinical research. Learn how proper licensing, form reviews, and eCOA implementation can help streamline data collection while maintaining regulatory compliance.
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ABOUT QUALITYMETRIC
QualityMetric works with the world’s leading healthcare and life sciences companies to measure and better understand outcomes through the creation, administration, and review of general and patient-specific health surveys. Founded in 1997, QM combines its proprietary scientifically validated general health and disease specific surveys with its enabling technology, advanced analytics, and sector expertise to work with all the world’s largest pharmaceutical companies in clinical trials and patient surveillance. For more information, please visit: QualityMetric.com
TRANSCRIPT
0:00
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0:06
Ensuring the accuracy and integrity of clinical outcome assessments is critical for research and healthcare. This discussion highlights key pitfalls in using patient-reported outcome (PRO) measures and best practices for avoiding errors.
0:28
The goals of this session are to examine why instrument developer requirements exist, what can go wrong when they aren’t followed, and how to work effectively with eCOA vendors and developers. Scientific integrity is the foundation of PRO measures—incorrect versions or improper scoring can compromise research findings and patient outcomes.
1:26
A common issue is the “Google’s Got My Back” fallacy, where researchers assume they can find validated instruments online. Many online versions contain missing items, incorrect wording, or invalid translations, making them unreliable for data collection. Always source PRO instruments from verified providers.
2:45
Another issue is the “I Know a Guy” fallacy, where teams rely on internal scoring algorithms without verification. Unverified algorithms can lead to incorrect calculations and misinterpretation of results. Ensuring the correct scoring method is crucial for maintaining data accuracy.
4:33
The “We Don’t Have Time for This” fallacy occurs when teams skip form review due to tight timelines. However, QualityMetric reviews over 100 forms daily and consistently finds errors that could impact study outcomes. Common mistakes include incorrect translations, response scales, and formatting issues that affect how data is captured and interpreted.
6:07
Form review is essential. After programming and QC, eCOA vendors submit screenshots for verification. The QualityMetric team reviews and provides corrections, ensuring that the final version is scientifically valid. The faster corrections are made, the quicker approval can be obtained.
6:52
QualityMetric ensures data integrity through structured processes, including instrument selection, implementation guidance, automated survey distribution, and standardized software solutions. Dedicated scientific teams assist sponsors, CROs, and eCOA vendors to ensure compliance and efficiency.
8:32
Most inquiries receive a response within 24 hours, with complex cases reviewed within three business days. Support includes answering detailed scientific questions and verifying scoring methodologies.
9:48
Timelines vary depending on study needs. Licensing a known instrument takes one to two business days, while translation or electronic adaptation can take weeks. QualityMetric offers over 190 translations of SF-36v2 and 150+ of SF-12, but electronic formatting may require additional time.
12:00
A kickoff call is highly recommended to align expectations, define roles, and set priorities—especially for multi-country studies. Ensuring all teams are informed early in the process helps prevent delays and costly errors.
15:00
Adding an instrument mid-study without understanding licensing and translation requirements can cause significant disruptions. PRO measures must be properly licensed, formatted, and reviewed for accuracy.
16:01
If an eCOA vendor is involved, additional agreements such as business associate agreements and data-sharing contracts may be required. Proper planning and early coordination can help avoid regulatory issues and study delays.
24:52
Thank you for attending this discussion on best practices for PRO measure implementation.
25:23
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#clinicaltrial #patientoutcomes #healthoutcomes #clinicaltrialmanagement #qualitymetric
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