Ensuring quality in AFRINEST and SATT: Clinical standardization and monitoring

Stephen N. Wall, Corinne I. Mazzeo, Ebunoluwa A. Adejuyigbe, Adejumoke I. Ayede, Rajiv Bahl, Abdullah H. Baqui, William C. Blackwelder, Neal Brandes, Gary L. Darmstadt, Fabian Esamai, Patricia L. Hibberd, Marian Jacobs, Jerome O. Klein, Kasonde Mwinga, Nigel Campbell Rollins, Haroon Saloojee, Antoinette Kitoto Tshefu, Robinson D. Wammanda, Anita K.M. Zaidi, Shamim Ahmad Qazi

Research output: Contribution to journalArticle

Abstract

BACKGROUND:: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. METHODS:: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. CONCLUSIONS:: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials' results.

Original languageEnglish (US)
Pages (from-to)S39-S45
JournalPediatric Infectious Disease Journal
Volume32
Issue number9 SUPPL.
DOIs
StatePublished - Sep 1 2013

Keywords

  • Community-based research
  • Quality assurance
  • Trial monitoring

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

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    Wall, S. N., Mazzeo, C. I., Adejuyigbe, E. A., Ayede, A. I., Bahl, R., Baqui, A. H., Blackwelder, W. C., Brandes, N., Darmstadt, G. L., Esamai, F., Hibberd, P. L., Jacobs, M., Klein, J. O., Mwinga, K., Rollins, N. C., Saloojee, H., Tshefu, A. K., Wammanda, R. D., Zaidi, A. K. M., & Qazi, S. A. (2013). Ensuring quality in AFRINEST and SATT: Clinical standardization and monitoring. Pediatric Infectious Disease Journal, 32(9 SUPPL.), S39-S45. https://doi.org/10.1097/INF.0b013e31829ff801