Placebo by Proxy in Neonatal Randomized Controlled Trials: Does
It Matter?

J 2017

Placebo by Proxy in Neonatal Randomized Controlled Trials: Does It Matter?

BURKART, Tiziana L, Andrea KRAUS, Brigitte KOLLER, Giancarlo NATALUCCI, Beatrice LATAL et. al.

Basic information

Original name

Placebo by Proxy in Neonatal Randomized Controlled Trials: Does It Matter?

Authors

BURKART, Tiziana L (756 Switzerland), Andrea KRAUS (703 Slovakia, belonging to the institution), Brigitte KOLLER (756 Switzerland), Giancarlo NATALUCCI (756 Switzerland), Beatrice LATAL (756 Switzerland), Jean-Claude FAUCHÈRE (756 Switzerland), Hans Ulrich BUCHER (756 Switzerland) and Christoph M RÜEGGER (756 Switzerland)

Edition

Children-Basel, BASEL, SWITZERLAND, MDPI AG, 2017, 2227-9067

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30209 Paediatrics

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

RIV identification code

RIV/00216224:14310/17:00096838

Organization unit

Faculty of Science

DOI

http://dx.doi.org/10.3390/children4060043

UT WoS

000404419400001

Keywords in English

preterm infants; placebo by proxy; long-term outcome; randomized controlled trial

Abstract

V originále

Placebo effects emerging from the expectations of relatives, also known as placebo by proxy, have seldom been explored. The aim of this study was to investigate whether in a randomized controlled trial (RCT) there is a clinically relevant difference in long-term outcome between very preterm infants whose parents assume that verum (PAV) had been administered and very preterm infants whose parents assume that placebo (PAP) had been administered. The difference between the PAV and PAP infants with respect to the primary outcome–IQ at 5 years of age–was considered clinically irrelevant if the confidence interval (CI) for the mean difference resided within our pre-specified ±5-point equivalence margins. When adjusted for the effects of verum/placebo, socioeconomic status (SES), head circumference and sepsis, the CI was [-3.04, 5.67] points in favor of the PAV group. Consequently, our study did not show equivalence between the PAV and PAP groups, with respect to the pre-specified margins of equivalence. Therefore, our findings suggest that there is a small, but clinically irrelevant degree to which a preterm infant’s response to therapy is affected by its parents’ expectations, however, additional large-scale studies are needed to confirm this conjecture.

Citovat

BURKART, Tiziana L, Andrea KRAUS, Brigitte KOLLER, Giancarlo NATALUCCI, Beatrice LATAL, Jean-Claude FAUCHÈRE, Hans Ulrich BUCHER and Christoph M RÜEGGER. Placebo by Proxy in Neonatal Randomized Controlled Trials: Does It Matter? Children-Basel. BASEL, SWITZERLAND: MDPI AG, 2017, vol. 4, No 6, p. "nestránkováno", 8 pp. ISSN 2227-9067. Available from: https://dx.doi.org/10.3390/children4060043.

@article{1381926,
   author = {Burkart, Tiziana L and Kraus, Andrea and Koller, Brigitte and Natalucci, Giancarlo and Latal, Beatrice and Fauchère, JeanandClaude and Bucher, Hans Ulrich and Rüegger, Christoph M},
   article_location = {BASEL, SWITZERLAND},
   article_number = {6},
   doi = {http://dx.doi.org/10.3390/children4060043},
   keywords = {preterm infants; placebo by proxy; long-term outcome; randomized controlled trial},
   language = {eng},
   issn = {2227-9067},
   journal = {Children-Basel},
   title = {Placebo by Proxy in Neonatal Randomized Controlled Trials: Does It Matter?},
   url = {http://www.mdpi.com/2227-9067/4/6/43},
   volume = {4},
   year = {2017}
}

TY  - JOUR
ID  - 1381926
AU  - Burkart, Tiziana L - Kraus, Andrea - Koller, Brigitte - Natalucci, Giancarlo - Latal, Beatrice - Fauchère, Jean-Claude - Bucher, Hans Ulrich - Rüegger, Christoph M
PY  - 2017
TI  - Placebo by Proxy in Neonatal Randomized Controlled Trials: Does It Matter?
JF  - Children-Basel
VL  - 4
IS  - 6
SP  - "nestránkováno"
EP  - "nestránkováno"
PB  - MDPI AG
SN  - 22279067
KW  - preterm infants
KW  - placebo by proxy
KW  - long-term outcome
KW  - randomized controlled trial
UR  - http://www.mdpi.com/2227-9067/4/6/43
L2  - http://www.mdpi.com/2227-9067/4/6/43
N2  - Placebo effects emerging from the expectations of relatives, also known as placebo by proxy, have seldom been explored. The aim of this study was to investigate whether in a randomized controlled trial (RCT) there is a clinically relevant difference in long-term outcome between very preterm infants whose parents assume that verum (PAV) had been administered and very preterm infants whose parents assume that placebo (PAP) had been administered. The difference between the PAV and PAP infants with respect to the primary outcome–IQ at 5 years of age–was considered clinically irrelevant if the confidence interval (CI) for the mean difference resided within our pre-specified ±5-point equivalence margins. When adjusted for the effects of verum/placebo, socioeconomic status (SES), head circumference and sepsis, the CI was [-3.04, 5.67] points in favor of the PAV group. Consequently, our study did not show equivalence between the PAV and PAP groups, with respect to the pre-specified margins of equivalence. Therefore, our findings suggest that there is a small, but clinically irrelevant degree to which a preterm infant’s response to therapy is affected by its parents’ expectations, however, additional large-scale studies are needed to confirm this conjecture.
ER  -

BURKART, Tiziana L, Andrea KRAUS, Brigitte KOLLER, Giancarlo NATALUCCI, Beatrice LATAL, Jean-Claude FAUCHÈRE, Hans Ulrich BUCHER and Christoph M RÜEGGER. Placebo by Proxy in Neonatal Randomized Controlled Trials: Does It Matter? \textit{Children-Basel}. BASEL, SWITZERLAND: MDPI AG, 2017, vol.~4, No~6, p.~''nestránkováno'', 8 pp. ISSN~2227-9067. Available from: https://dx.doi.org/10.3390/children4060043.

Detailed Information on Publication Record