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Validity of a modified Pregnancy-Unique Quantification of
Emesis and Nausea (PUQE) scoring index to assess
severity of nausea and vomiting of pregnancy
Anaïs Lacasse, BSc; Evelyne Rey, MD; Ema Ferreira, PharmD; Caroline Morin, BPharm, MSc; Anick Bérard, PhD
OBJECTIVE: The only validated nausea and vomiting of pregnancy traclass correlation coefficients were calculated to determine concor-
(NVP) severity index is the Motherisk Pregnancy-Unique Quantifica- dance between the 2 scores. Linear regression models were built to
tion of Emesis and Nausea (PUQE) index that covers symptoms in the measure the association between the modified-PUQE score and Short-
previous 12 hours. We sought to assess the validity of a modified- Form Health Survey QOL scores.
PUQE index that covers the entire first trimester of pregnancy by com-
RESULTS: Among participants (n ⫽ 287), the mean NVP severity
paring NVP severity scores between the 12-hour PUQE index and our
score was 5.7 vs 6.7 on the 12-hour PUQE and modified PUQE, re-
modified-PUQE index and by measuring the extent of the association
spectively (P ⬍ .05). There was substantial concordance between the
between the modified-PUQE score and quality-of-life (QOL) score dur-
indices (intraclass correlation coefficient, 0.71). Severity of NVP that
ing the first trimester of pregnancy.
was measured by the new modified index was associated with QOL.
STUDY DESIGN: A prospective study that included women who at-
CONCLUSION: We are confident that, on the basis of the modified-
tended the Centre Hospitalier Universitaire Sainte-Justine or René-
PUQE, the relationship between QOL and severity of NVP justify the
Laennec clinic for their prenatal visits was conducted from 2004-2006.
use of this new index.
Women were eligible if they were ⱖ18 years old and ⱕ16 weeks of
gestation at the time of their first prenatal visit. Women who reported Key words: intraclass correlation coefficients, modified NVP severity
NVP were asked to fill out the 12-hour PUQE, the modified PUQE in- index, nausea and vomiting of pregnancy (NVP), quality of life,
dex, and the Short-Form Health Survey QOL index simultaneously. In- validation
Cite this article as: Lacasse A, Rey E, Ferreira E, Morin C, Bérard A. Validity of a modified Pregnancy-Unique Quantification of Emesis and Nausea (PUQE)
scoring index to assess severity of nausea and vomiting of pregnancy. Am J Obstet Gynecol 2008;198:71.e1-71.e7.
TABLE 1
Pregnancy-Unique Quantification of Emesis and Nausea Index
Circle the answer that suit the best your situation for the last 12 hours.
................................................................................................................................................................................................................................................................................................................................................................................
1. In the last 12 hours, for how long have you felt nauseated or sick to your stomach?
................................................................................................................................................................................................................................................................................................................................................................................
Not at all ⱕ1 hr 2-3 hr 4-6 hr ⬎6 hr
................................................................................................................................................................................................................................................................................................................................................................................
(1) (2) (3) (4) (5)
................................................................................................................................................................................................................................................................................................................................................................................
2. In the last 12 hours, have you vomited or thrown up?
................................................................................................................................................................................................................................................................................................................................................................................
ⱕ7 times 5-6 times 3-4 times 1-2 times I did not throw up
................................................................................................................................................................................................................................................................................................................................................................................
(5) (4) (3) (2) (1)
................................................................................................................................................................................................................................................................................................................................................................................
3. In the last 12 hours, how many times have you had retching or dry heaves without bringing anything up?
................................................................................................................................................................................................................................................................................................................................................................................
None 1-2 times 3-4 times 5-6 times ⱖ7 times
................................................................................................................................................................................................................................................................................................................................................................................
(1) (2) (3) (4) (5)
................................................................................................................................................................................................................................................................................................................................................................................
Total score (sum of replies to 1, 2, and 3): mild NVP, ⱕ6; moderate NVP, 7-12; severe NVP, ⱖ 13. (From Koren G, Boskovic R, Hard M, Maltepe C, Navioz Y, Einarson A. Motherisk-PUQE
(pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy. Am J Obstet Gynecol 2002;186:S228-31. With permission.)
Lacasse. Validity of the modified-PUQE. Am J Obstet Gynecol 2008.
establish the validity of a modified- weeks of the first day of their last menses, comes that are related directly to NVP
PUQE index that covers the entire first (4) able to read and understand French (such as a pregnant woman’s ability to
trimester of pregnancy by comparing the or English, and (5) giving written take multivitamins, rates of emergency
NVP severity score between the original consent. Ethics approval was obtained room visits and hospitalization for NVP,
12-hour PUQE and our modified ver- from Centre Hospitalier Universitaire health care costs for NVP, and a
sion (modified-PUQE). In addition, we Sainte-Justine. woman’s self-reported scores of well-be-
measured the extent of the association At the end of their first prenatal visit, ing in NVP).7 Since then, the 12-hour
between the modified-PUQE score and women who accepted participation were PUQE has been used in several
QOL during the first trimester of preg- asked to fill out a self-administered ques- studies.8-13
nancy, which is a significant outcome tionnaire at home. Data on demographic
that is related to NVP. We put forward and socioeconomic variables, lifestyle Modified-PUQE
the hypothesis that the modified-PUQE information, medication use, nonphar- We slightly modified the original PUQE
is a good index to assess global NVP se- macologic methods use, and QOL were questionnaire to capture a wider period
verity in the first trimester of pregnancy. collected. Only women who reported ex- of pregnancy. The modified-PUQE (Ta-
Moreover, because NVP negatively af- periencing NVP were asked to fill out the ble 2) contains essentially the same 3
fects the physical and mental health of 12-hour PUQE and the modified-PUQE questions as the 12-hour PUQE but dif-
pregnant women,4 a valid modified- simultaneously. This validation study fers on the period for which the severity
PUQE should be associated with was done in the population of pregnant of NVP is assessed. Moreover, an intro-
women’s QOL. women who reported in the self-admin- ductory sentence specifies that the 3
istered questionnaire that they had expe- items cover symptoms that occurred
M ETHODS rienced NVP. from the beginning of the pregnancy.
Study population Consequently, when the modified-
and data collection 12-Hour PUQE PUQE is administered during the first
A prospective observational study on The Motherisk PUQE is based on 3 phys- trimester of pregnancy, we obtain a
pregnant women who had prenatal care ical symptoms of NVP and scores the ex- global evaluation of NVP symptoms
at the obstetrics and gynecology clinic of tent of nausea per day in hours, the during the first trimester. The scoring
Centre Hospitalier Universitaire Sainte- quantity of daily retching episodes, and calculations and global score interpreta-
Justine or René-Laennec clinic, both of the number of daily vomiting episodes in tion of the modified-PUQE are the same
which are affiliated to the University of the last 12 hours, as reported by women as for the 12-hour PUQE.
Montreal, Quebec, Canada, was con- (Table 1). The PUQE’s total score ranges
ducted from October 2004 to March between 3 and 15: a score between 3 and QOL
2006. Women were eligible if they were 6 is considered to indicate mild NVP; a QOL was measured with the standard
(1) at least 18 years of age, (2) at their first score between 7 and 12 is considered to version 12-item Short-Form Health Sur-
prenatal visit at the obstetric and gyne- indicate moderate NVP, and a score of vey (SF-12; SF-36.org, Lincoln, RI).14
cology clinic of the Centre Hospitalier ⱖ13 indicates severe NVP.5 After the This shorter version of the commonly
Universitaire Sainte-Justine or René- first round validations,5,6 the PUQE was used SF-36 yields 2 summary measures
Laennec clinic, (3) pregnant within 16 associated significantly with clinical out- of physical health summary (PCS) and
TABLE 2
Modified-PUQE
Circle the answer that best suits your situation from the beginning of your pregnancy.
................................................................................................................................................................................................................................................................................................................................................................................
1. On average in a day, for how long do you feel nauseated or sick to your stomach?
................................................................................................................................................................................................................................................................................................................................................................................
Not at all ⱕ1 hr 2-3 hr 4-6 hr ⬎6 hr
................................................................................................................................................................................................................................................................................................................................................................................
(1) (2) (3) (4) (5)
................................................................................................................................................................................................................................................................................................................................................................................
2. On average in a day, how many times do you vomit or thrown up?
................................................................................................................................................................................................................................................................................................................................................................................
ⱖ7 times 5-6 times 3-4 times 1-2 times I did not throw up
................................................................................................................................................................................................................................................................................................................................................................................
(5) (4) (3) (2) (1)
................................................................................................................................................................................................................................................................................................................................................................................
3. On average in a day, how many times do you have retching or dry heaves without bringing anything up?
................................................................................................................................................................................................................................................................................................................................................................................
None 1-2 times 3-4 times 5-6 times ⱖ7 times
................................................................................................................................................................................................................................................................................................................................................................................
(1) (2) (3) (4) (5)
................................................................................................................................................................................................................................................................................................................................................................................
Total score (sum of replies to 1, 2, and 3): mild NVP, ⱕ6; moderate NVP, 7-12; severe NVP, ⱖ13.
Lacasse. Validity of the modified-PUQE. Am J Obstet Gynecol 2008.
mental health summary (MCS).15 Sum- ⬎0.8 to indicate almost perfect agree- ticipants was 32 ⫾ 4.6 years, and the
mary measures were calculated with the ment.16 Stratification of maternal age, mean gestational age at recruitment was
scores of the 12 items and range from gestational age, antiemetic use, and non- 11 ⫾ 1.7 weeks. Eighty-two percent of
0-100; higher scores represent better pharmacologic methods used to treat participants were white; most of the
QOL. PCS and MCS scores were calcu- NVP was performed. Finally, linear re- women were insured by their employer
lated with standard (United States) scor- gression models were built to measure or by their spouse’s employer for their
ing algorithms and were normalized the association between the modified- medications (72%), were working
with the use of the US general population PUQE score and physical or mental (75%), and were living with their spouse,
(mean, 50 ⫾ 10 [SD]). health during the first trimester of preg- family, or a friend (98%). Sixty-five per-
nancy, as measured by the SF-12. All sta- cent of women had completed a univer-
Statistical analysis tistical analyses were performed with sity degree, and 44% of the women had a
Descriptive statistics were used to mea- SAS software (v 8.02; SAS Institute, Cary, household income of ⬎$80,000/y.
sure the characteristics and QOL level of NC) and SPSS software (v 11.0.1; SPSS Twenty-eight percent of women had at
the study population. Means and SDs of Inc, Chicago, IL). least 1 other self-reported medical con-
the 12-hour PUQE and the modified- dition that included asthma (7.3%), ec-
PUQE global scores were compared with R ESULTS zema, migraine headaches, infections
the use of paired t-tests. A total of 509 pregnant women were eli- (7.0%), anemia (7.0%), depression
Validity of a new index can be assessed gible and were approached to participate (6.3%), hypothyroidism (3.5%), diabe-
by the extent to which a measure is able in the study. Of those, 474 women (93%) tes mellitus (1.4%), epilepsy (0.4%), and
to predict results of a gold standard16 or gave informed consent, and 366 women hypertension (0.4%). When asked what
important related outcomes17 or by the (77%) filled out and returned their ques- they had used in their first trimester to
degree to which indices that measure dif- tionnaire by mail. The major reasons for ease nausea and vomiting, 20.4% of
ferent concepts show a lower associa- not returning the questionnaire were women reported having used antiemet-
tion.17 Therefore, we compared our lack of time (8.4%), end of pregnancy ics, and 17.9% of the women reported
modified-PUQE to the 12-hour PUQE. (8.4%), no longer followed at the partic- using nonpharmacologic methods. Only
Moreover, validity was calculated by a ipating clinics (1.9%), or their spouse re- 11% of women who treated their NVP
comparison of the modified-PUQE fused to allow them to participate were using both antiemetics and non-
score to the physical and mental SF-12 (0.9%); the remainder of the women pharmacologic methods. NVP medica-
QOL scores, which are validated mea- who did not participate (80.4%) did not tions that were used most often were the
sures of QOL. Concordance between the send their questionnaire, even after a re- combination doxylamine/pyridoxine
modified-PUQE and the 12-hour PUQE minder call. For the present study, the (86% Diclectin), which is available in
was assessed with the use of the intraclass population consisted of 287 women Canada. Women also reported using
correlation coefficients (ICC) with 95% (78.4%) who reported having NVP dur- metoclopramide, dimenhydrinate, hy-
CIs. We considered an ICC of ⬍0.4 to ing the first trimester of pregnancy. droxyzine, meclizine, acetaminophen,
indicate poor agreement, 0.41-0.6 to in- Demographic and lifestyle character- or acid reflux medications. The non-
dicate moderate agreement, 0.61-0.8 to istics of the study population are pre- pharmacologic methods that were used
indicate substantial agreement, and sented in Table 3. The mean age of par- included lifestyle and dietary changes,
TABLE 4
Overall and stratified NVP severity scores measured by the 12-hour PUQE and the modified PUQE indices
Severity scores measured by the 2 indices N 12-hr PUQE scorea Modified PUQE scorea Paired t test
Overall 287 5.73 ⫾ 2.52 6.69 ⫾ 2.30 ⬍0.0001
................................................................................................................................................................................................................................................................................................................................................................................
Maternal age (y)
.......................................................................................................................................................................................................................................................................................................................................................................
ⱕ29 90 6.07 ⫾ 2.53 6.86 ⫾ 2.19 0.0008
.......................................................................................................................................................................................................................................................................................................................................................................
30-31 55 5.60 ⫾ 2.79 6.73 ⫾ 2.43 0.0002
.......................................................................................................................................................................................................................................................................................................................................................................
32-35 88 5.66 ⫾ 2.45 6.68 ⫾ 2.41 ⬍0.0001
.......................................................................................................................................................................................................................................................................................................................................................................
⬎35 54 5.45 ⫾ 2.33 6.43 ⫾ 2.21 ⬍0.0001
................................................................................................................................................................................................................................................................................................................................................................................
Gestational age (wk)
.......................................................................................................................................................................................................................................................................................................................................................................
ⱕ10 119 5.77 ⫾ 2.48 6.79 ⫾ 2.35 ⬍0.0001
.......................................................................................................................................................................................................................................................................................................................................................................
11 70 5.68 ⫾ 2.35 6.45 ⫾ 2.17 0.0012
.......................................................................................................................................................................................................................................................................................................................................................................
12 50 6.30 ⫾ 2.60 7.18 ⫾ 2.42 ⬍0.0016
.......................................................................................................................................................................................................................................................................................................................................................................
13-16 48 5.11 ⫾ 2.70 6.28 ⫾ 2.21 0.0005
................................................................................................................................................................................................................................................................................................................................................................................
Antiemetic use 279
.......................................................................................................................................................................................................................................................................................................................................................................
Yes 57 6.51 ⫾ 2.34 7.73 ⫾ 2.35 ⬍0.0001
.......................................................................................................................................................................................................................................................................................................................................................................
No 222 5.55 ⫾ 2.54 6.46 ⫾ 2.21 0.0001
................................................................................................................................................................................................................................................................................................................................................................................
Nonpharmacologic methods use 279
.......................................................................................................................................................................................................................................................................................................................................................................
Yes 50 6.36 ⫾ 2.69 7.51 ⫾ 2.34 ⬍0.0001
.......................................................................................................................................................................................................................................................................................................................................................................
No 229 5.61 ⫾ 2.47 6.54 ⫾ 225 0.0001
................................................................................................................................................................................................................................................................................................................................................................................
a
Data are given as mean ⫾ SD.
Lacasse. Validity of the modified-PUQE. Am J Obstet Gynecol 2008.
60 60
Mental QOL SF-12 score
30
with a gold standard instrument, SF-12. 30
20 20
Second, the QOL evaluation was self-ad-
10 10
0
ministered because it is believed that the 0
3 4 5 6 7 8 9 10 11 12 13 14 15
data on QOL is more valid when an- 3 5 7 9 11 13 15
Modified-PUQE global score Modified-PUQE global score
naire. It has been argued that assessment interest is extended to the first trimester 9. Boskovic R, Einarson A, Maltepe C, Wolpin J,
of NVP cannot be done in a later period of pregnancy. Koren G. Diclectin therapy for nausea and vom-
iting of pregnancy: effects of optimal dosing. J
because accurate description of symp- In conclusion, the modified-PUQE Obstet Gynaecol Can 2003;25:830-3.
toms is subject to decreased recall.6 Re- tended to classify a woman’s NVP more 10. Einarson A, Maltepe C, Navioz Y, Kennedy
cently, a study that included 200 women severely than the 12-hour PUQE, and D, Tan MP, Koren G. The safety of ondansetron
who called an NVP healthline in their there was substantial concordance be- for nausea and vomiting of pregnancy: a pro-
spective comparative study. BJOG 2004;
first trimester of pregnancy confirmed tween the 2 indices. In addition, the new
111:940-3.
that retrospective evaluation of NVP modified index has been shown to be as- 11. Koren G, Maltepe C, Navioz Y, Wolpin J.
symptoms may produce recall bias.11 In- sociated with QOL. The information Recall bias of the symptoms of nausea and
deed in that study, women reported sig- that was collected in this study suggests vomiting of pregnancy. Am J Obstet Gynecol
nificantly more severe symptoms in the that the modified-PUQE is a valid index 2004;190:485-8.
12. McCauley L, Coleman S, Jacques D,
modified-PUQE than they had reported for the assessment of NVP severity and
Palmer B, Stanziano G. Safety and efficacy of
in the 12-hour PUQE, and multivariate that its use is justified to assess global ondansetron therapy for nausea and vomiting
analysis showed that time elapsed be- NVP severity in the first trimester of of pregnancy. Obstet Gynecol 2002;
tween calls negatively affected their re- pregnancy. f 99:S24.
13. Ahn E, Pairaudeau N, Pairaudeau N Jr, et al.
call. However, even if the modified-
A randomized cross over trial of tolerability and
PUQE tended to score a woman’s NVP compliance of a micronutrient supplement with
ACKNOWLEDGMENTS
as more severe than the 12-hour PUQE, low iron separated from calcium vs high iron
We thank the research nurses for the recruit-
our results do not support the presence ment of study participants in the different clinics combined with calcium in pregnant women [IS-
of recall bias. Indeed, if recall bias were (Ms Marie Saint-Jacques, Ms Valérie Tremblay, RCTN56071145]. BMC Pregnancy Childbirth
2006;6:10.
present with the modified-PUQE, con- and Ms Sophie Perreault).
14. Ware J Jr, Kosinski M, Keller SD. A 12-item
cordance between the 2 indices would short-form health survey: construction of scales
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