Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial

Abstract Background In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on...

Full description

Bibliographic Details
Main Authors: Sylvia Baedorf Kassis, Weidong Lu, Sarah A. White, Im Hee Shin, Sung Hwan Park, Young Ju Jeong, Chang Yao, Jennifer Ligibel, Barbara E. Bierer
Format: Article
Language:English
Published: BMC 2022-06-01
Series:BMC Complementary Medicine and Therapies
Subjects:
Online Access:https://doi.org/10.1186/s12906-022-03648-4
_version_ 1811242191888056320
author Sylvia Baedorf Kassis
Weidong Lu
Sarah A. White
Im Hee Shin
Sung Hwan Park
Young Ju Jeong
Chang Yao
Jennifer Ligibel
Barbara E. Bierer
author_facet Sylvia Baedorf Kassis
Weidong Lu
Sarah A. White
Im Hee Shin
Sung Hwan Park
Young Ju Jeong
Chang Yao
Jennifer Ligibel
Barbara E. Bierer
author_sort Sylvia Baedorf Kassis
collection DOAJ
description Abstract Background In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study's approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation. Methods The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality. The toolkit included: (1) a binder of essential study management documents and related monitoring logs for sites to complete and maintain (herein called regulator binder), (2) a study start-up checklist, (3) a self-assessment study conduct and oversight checklist to be completed regularly, and (4) a study close-out checklist. In addition, a process of regular virtual meetings to discuss documentation progress coupled with periodic external remote review of completed logs and checklists provided accountability checks. Results Over the course of the study, the sites in China and South Korea completed the entirety of the site performance self-monitoring toolkit, and successfully submitted their completed materials for review. The process of implementing a self-monitoring toolkit in a multinational integrative medicine study is described qualitatively. Periodic external review of the completed toolkit materials revealed categories of findings. Written follow-up reports were provided to sites and discussion of the documents occurred via separate virtual meetings. Conclusions Site study team self-monitoring provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities in higher risk studies. Iterative feedback and support appeared to drive a disciplined approach to maintaining regulatory document compliance and helped sustain investigator and study team engagement in the process. Trial registration ClinicalTrials.gov Identifier NCT03783546 (21/12/2018).
first_indexed 2024-04-12T13:48:12Z
format Article
id doaj.art-177c2155d93746bd91ed5d2c829dcf5c
institution Directory Open Access Journal
issn 2662-7671
language English
last_indexed 2024-04-12T13:48:12Z
publishDate 2022-06-01
publisher BMC
record_format Article
series BMC Complementary Medicine and Therapies
spelling doaj.art-177c2155d93746bd91ed5d2c829dcf5c2022-12-22T03:30:36ZengBMCBMC Complementary Medicine and Therapies2662-76712022-06-012211510.1186/s12906-022-03648-4Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trialSylvia Baedorf Kassis0Weidong Lu1Sarah A. White2Im Hee Shin3Sung Hwan Park4Young Ju Jeong5Chang Yao6Jennifer Ligibel7Barbara E. Bierer8Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and HarvardDepartment of Medical Oncology, Dana-Farber Cancer InstituteMulti-Regional Clinical Trials Center of Brigham and Women’s Hospital and HarvardDepartment of Medical Statistics & Informatics, School of Medicine, Daegu Catholic UniversityDepartment of Surgery, School of Medicine, Daegu Catholic UniversityDepartment of Surgery, School of Medicine, Daegu Catholic UniversityDepartment of Oncology, Jiangsu Provincial Hospital of Traditional Chinese MedicineDepartment of Medical Oncology, Dana-Farber Cancer InstituteMulti-Regional Clinical Trials Center of Brigham and Women’s Hospital and HarvardAbstract Background In 2019, investigators from China, South Korea and the United States of America initiated a coordinated multinational trial. The trial included three parallel randomized studies with a planned pooled analysis of individual patient data, to test the effectiveness of acupuncture on hot flash-related symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Given the study's approach, there was no central coordinating center or data monitoring committee for the study, so a site performance self-monitoring toolkit was developed and implemented to support study teams in collecting and maintaining high-quality regulatory information, and consistent review of study data and documentation. Methods The site performance self-monitoring toolkit was created based on best practices related to post-approval quality assurance/quality improvement (QA/QI) procedures that support data quality. The toolkit included: (1) a binder of essential study management documents and related monitoring logs for sites to complete and maintain (herein called regulator binder), (2) a study start-up checklist, (3) a self-assessment study conduct and oversight checklist to be completed regularly, and (4) a study close-out checklist. In addition, a process of regular virtual meetings to discuss documentation progress coupled with periodic external remote review of completed logs and checklists provided accountability checks. Results Over the course of the study, the sites in China and South Korea completed the entirety of the site performance self-monitoring toolkit, and successfully submitted their completed materials for review. The process of implementing a self-monitoring toolkit in a multinational integrative medicine study is described qualitatively. Periodic external review of the completed toolkit materials revealed categories of findings. Written follow-up reports were provided to sites and discussion of the documents occurred via separate virtual meetings. Conclusions Site study team self-monitoring provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities in higher risk studies. Iterative feedback and support appeared to drive a disciplined approach to maintaining regulatory document compliance and helped sustain investigator and study team engagement in the process. Trial registration ClinicalTrials.gov Identifier NCT03783546 (21/12/2018).https://doi.org/10.1186/s12906-022-03648-4Performance monitoringRegulatory binderSelf-assessmentQuality assuranceClinical trial
spellingShingle Sylvia Baedorf Kassis
Weidong Lu
Sarah A. White
Im Hee Shin
Sung Hwan Park
Young Ju Jeong
Chang Yao
Jennifer Ligibel
Barbara E. Bierer
Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial
BMC Complementary Medicine and Therapies
Performance monitoring
Regulatory binder
Self-assessment
Quality assurance
Clinical trial
title Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial
title_full Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial
title_fullStr Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial
title_full_unstemmed Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial
title_short Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial
title_sort developing and implementing a self monitoring toolkit for a coordinated multinational randomized acupuncture trial
topic Performance monitoring
Regulatory binder
Self-assessment
Quality assurance
Clinical trial
url https://doi.org/10.1186/s12906-022-03648-4
work_keys_str_mv AT sylviabaedorfkassis developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial
AT weidonglu developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial
AT sarahawhite developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial
AT imheeshin developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial
AT sunghwanpark developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial
AT youngjujeong developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial
AT changyao developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial
AT jenniferligibel developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial
AT barbaraebierer developingandimplementingaselfmonitoringtoolkitforacoordinatedmultinationalrandomizedacupuncturetrial