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Key Learnings from Auditing of the uCARE Pilot Study Data

February 21st 2020

Key Learnings from Auditing of the uCARE Pilot Study Data: An Interview with Audit Committee Members

The uCARE’s pilot study, Ureteral Stenting After Ureteroscopy for Stone Treatment: A Global Perspective of Indications and Outcomes was completed in the last quarter of 2019. This was a 1-year prospective, observational, international, multicentre registry study. The registry reviewed current global clinical practices on postoperative ureteral stenting after ureteroscopy for stone treatment. The primary objective of this study was to assess current indications of postoperative ureteral stenting after ureteroscopy for urinary stone treatment. This study involved a total of 50 centres worldwide and accrued a total of 2,543 patients.

Assuring the quality and the usefulness of the data from human clinical research is crucial because it strengthens the public’s confidence on the data collected during the study and consequently, on the conclusions made from the study. A significant amount of time and expense conducting clinical trials and registry studies arises from the need to ensure that the resulting data are accurate.

The task of auditing study data represents a huge undertaking. The audit committee, chaired by Dr. Ranan Dasgupta, is currently auditing the stenting data, which will be finalized in early 2020. We have asked two of the audit committee members, Dr. Samuel Yee and Dr. Yigit Akin, to provide us their perspectives on their experience with electronic auditing of the registry data.   

Dr. Yigit Akin, MD
Associate Professor of Urology, Department of Urology
Izmir Katip Celebi University School of Medicine
Izmir-Turkey

Can you briefly describe how you became a part of the uCARE Audit Committee?

I worked in different universities in my community. I am also director of a scientific project at my department of Izmir Katip Celelbi University Urology Clinic. When I learned that SIU has an Office for scientific projects covering the whole world, I wanted to be a part of it. Thus, I became a member of the uCARE Audit Committee.

What are your thoughts on the role of uCARE in connecting urologists and their patients to research?

uCARE studies look to the future. When clinicians involve their patients in a uCARE study, scientists all over the world would learn about the results. This is sharing the science. Additionally, topics of the uCARE studies cover the mostly seen problems in the clinics.

Based on your experience with the auditing of the first uCARE study, how do envision the role of the Audit committee evolving in the future?

The Audit committee makes the detailed assessment of the study. In addition, the committee reviews the data and contributes to the integrity of the study.

What key takeaways can you share with us regarding this experience of electronic auditing of the ureteral stenting study?
Detailed and critical evaluation of the study is feasible with electronic auditing.

Samuel Yee, MD, MBBS(HK), FRCSEd(Urol), FCSHK(Urol), FHKAM(Surgery)
Consultant Urologist, Honorary Clinical Associate Professor, Prince of Wales Hospital, The Chinese University of Hong Kong

Can you briefly describe how you became a part of the uCARE Audit Committee?

My initial encounters with SIU was through Dr. Rafael Sanchez-Salas in the project for the Joint SIU-ICUD International Consultation (Image-guided Therapies for Prostate and Kidney Cancers), and through Dr. Jean de la Rosette in the series of eGrand Rounds in Hong Kong. It is my honour to be invited by Dr. de la Rosette to be part of the uCARE project.

What are your thoughts on the role of uCARE in connecting urologists and their patients to research?

The uCARE programme includes different centres in the world focusing on common clinical topics in the field of urology. While most professional bodies can only connect urologists of certain subspecialty and from a specific region, SIU’s uCARE provides a platform across the globe to potentially advance a wide spectrum of scientific research. This allows uCARE to make an impact on the global level.

Based on your experience with the auditing of the first uCARE study, how do you envision the role of the Audit committee evolving in the future?

The challenge to audit a multi-centre research is to handle a large amount of data within a short period of time, with documents in different languages. To facilitate the process, I believe the audit committee would be involved in the initial logistic planning of the research projects in the future, e.g. standardizing consent form format, data entry process ,etc. This may enhance the quality of audit as well as the research outcome.

What key takeaways can you share with us regarding this experience of electronic auditing of the ureteral stenting study?

The current electronic platform Castor EDC is very convenient. Patient data retrieval is quick and neat. However, we still require individual centres to send us a scanned copy of the source file for auditing, which is often a rate-limiting step of the process. Furthermore, our research support team, Ms. Christine Albino and Ms. Brittany Scarfo, spent a lot of effort to ensure data availability and compliance of the participating centres. Hopefully from this experience, we can modify the process to make our work more efficient.

About the uCARE Audit Committee

The audit committee for uCARE was established to assure data quality and validity in the studies conducted by uCARE. The committee’s primary role is to validate the completeness, accuracy and reliability of the data after the study, or data cleanup, particularly when there are open-ended sections on the electronic case report form (eCRF) (e.g. for adverse events and concomitant medications). The members of the Audit Committee represent a good balance between technical background, seniority of high standing and junior spirit.

Audit Committee
Chair: Ranan Dasgupta, MBBChir, MA, MD, FRCS(Urol) (United Kingdom)

Members:
Manuel Castanheira de Oliveira, MD (Portugal)
Yigit Akin, MD (Turkey)
Samuel Yee, MD, MBBS(HK), FRCSEd(Urol), FCSHK(Urol), FHKAM(Surgery)  (Hong Kong)
Jorge Jaunarena, MD (Argentina)

 

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