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.

Základní údaje

Originální název

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

Autoři

BURKART, Tiziana L (756 Švýcarsko), Andrea KRAUS (703 Slovensko, domácí), Brigitte KOLLER (756 Švýcarsko), Giancarlo NATALUCCI (756 Švýcarsko), Beatrice LATAL (756 Švýcarsko), Jean-Claude FAUCHÈRE (756 Švýcarsko), Hans Ulrich BUCHER (756 Švýcarsko) a Christoph M RÜEGGER (756 Švýcarsko)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30209 Paediatrics

Stát vydavatele

Švýcarsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Kód RIV

RIV/00216224:14310/17:00096838

Organizační jednotka

Přírodovědecká fakulta

DOI

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

UT WoS

000404419400001

Klíčová slova anglicky

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

Štítky

NZ, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 10. 4. 2018 16:49, Ing. Nicole Zrilić

Anotace

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 a Christoph M RÜEGGER. Placebo by Proxy in Neonatal Randomized Controlled Trials: Does It Matter? Children-Basel. BASEL, SWITZERLAND: MDPI AG, 2017, roč. 4, č. 6, s. "nestránkováno", 8 s. ISSN 2227-9067. Dostupné z: 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 a Christoph M RÜEGGER. Placebo by Proxy in Neonatal Randomized Controlled Trials: Does It Matter? \textit{Children-Basel}. BASEL, SWITZERLAND: MDPI AG, 2017, roč.~4, č.~6, s.~''nestránkováno'', 8 s. ISSN~2227-9067. Dostupné z: https://dx.doi.org/10.3390/children4060043.

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