Ensuring quality in AFRINEST and SATT: clinical standardization and monitoring.
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.
Saving Newborn Lives, Save the Children, Washington, DC 20036, USA. swall@savechildren.org
Stephen N
SN
Wall
Corinne I
CI
Mazzeo
Ebunoluwa A
EA
Adejuyigbe
Adejumoke I
AI
Ayede
Rajiv
R
Bahl
Abdullah H
AH
Baqui
William C
WC
Blackwelder
Neal
N
Brandes
Gary L
GL
Darmstadt
Fabian
F
Esamai
Patricia L
PL
Hibberd
Marian
M
Jacobs
Jerome O
JO
Klein
Kasonde
K
Mwinga
Nigel Campbell
NC
Rollins
Haroon
H
Saloojee
Antoinette Kitoto
AK
Tshefu
Robinson D
RD
Wammanda
Anita K M
AK
Zaidi
Shamim Ahmad
SA
Qazi
D017954:Africa South of the Sahara; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001459:Bangladesh; D035843:Biomedical Research / Q000193:education / Q000458:organization & administration / Q000592:standards; D057189:Checklist; D003153:Community Health Services / Q000379:methods / Q000592:standards*; D003150:Community Health Workers / Q000193:education; D015340:Epidemiologic Research Design; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy*; D010154:Pakistan; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards*; D018805:Sepsis / Q000188:drug therapy*
D000900:Anti-Bacterial Agents