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OBSTETRICS
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.

D uring their first trimester, 50-90%


of women experience nausea and
vomiting of pregnancy (NVP).1 A more
NVP can affect quality of life (QOL) in
pregnancy.4
When drug efficacy in the treatment of
case of NVP symptoms, the only specific
severity index is the Motherisk preg-
nancy-unique quantification of emesis
severe form of NVP, called hyperemesis NVP is evaluated or the evolution of and nausea (PUQE).5 The PUQE is per-
gravidarum, can also occur in 0.5-3% of signs and symptoms for this health prob- fectly appropriate to evaluate efficacy of
all pregnancies and may lead to hospital- lem are described, the change in NVP se- antiemetics, which have an effect in a
ization.2,3 It has been established that verity is the outcome of interest. In the short period of time. However, because
the PUQE covers symptoms that oc-
curred in the immediate past 12 hours,
From the Faculties of Pharmacy (Ms Lacasse, Ms Ferreira, and Dr Bérard) and Medicine
(Dr Rey), University of Montreal, and the Research Center (Ms Lacasse and Drs Rey and its use is restricted if we are interested in
Bérard), the Department of Obstetrics and Gynecology (Dr Rey), and the Department of NVP severity for a wider period, such as
Pharmacy, Sainte-Justine University Health Center (Ms Ferreira and Ms Morin), Montreal, the whole first trimester of pregnancy.
QC, Canada. Indeed, it is possible to have no severe
Presented at the 22nd International Conference on Pharmacoepidemiology and Therapeutic NVP in the past 12 hours but to have had
Risk Management, Lisbon, Portugal, Aug. 24-27, 2006. severe symptoms at some point during
Received Nov. 6, 2006; accepted May 30, 2007. the first trimester. Because of this limita-
Reprints: Anick Bérard, PhD, Research Center, CHU Sainte-Justine, 3175, Côte-Sainte- tion, the applicability of the PUQE is not
Catherine, Montreal (Quebec) H3T 1C5; anick.berard@umontreal.ca appropriate for all research questions.
This study was supported by the Fonds de la Recherche en Santé du Québec; A.L. is the Hence, there is an increasing need for a
recipient of a doctoral bursary from the Centre Hospitalier Universitaire Sainte-Justine; A.B. is the more global NVP severity index that
recipient of a career award from the Canadian Institutes of Health Research/Health Research
covers the entire first trimester of
Foundation and is on the endowment research Chair of the Famille Louis-Boivin on
“Medications, Pregnancy and Lactation” at the faculty of Pharmacy of the University of Montreal. pregnancy.
0002-9378/$34.00 • © 2008 Mosby, Inc. All rights reserved. • doi: 10.1016/j.ajog.2007.05.051 To provide a more comprehensive
measure of NVP severity, we sought to

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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

71.e2 American Journal of Obstetrics & Gynecology JANUARY 2008


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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,

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the use of ginger, acupressure, homeo-


TABLE 3 pathic products, herbal teas, mint, or
Patient demographics (nⴝ287) lemon. Regarding pregnancy history,
Demographic Measure most women had had ⬎1 pregnancy
Age (y)a 31.67 ⫾ 4.62 (84%).
..............................................................................................................................................................................................................................................
Gestational age (wk) a
11.00 ⫾ 1.73 NVP was significantly more severe (ei-
..............................................................................................................................................................................................................................................
ther 12-hour PUQE or modified-PUQE)
Country of birth (n)
..................................................................................................................................................................................................................................... for women who were under 29 years of
Canada 188 (65.51%) age, were between 12-16 weeks of gesta-
.....................................................................................................................................................................................................................................
Other country 99 (34.49%) tion, and used antiemetics or nonphar-
..............................................................................................................................................................................................................................................
Race (n) macologic methods (Table 4). As for
.....................................................................................................................................................................................................................................
QOL, the physical component mean on
White 236 (82.23%)
..................................................................................................................................................................................................................................... the SF-12 was 42.81 ⫾ 9.07; the mental
Black 26 (9.06%) component mean on the SF-12 was 45.86
.....................................................................................................................................................................................................................................
Asian 9 (3.14%) ⫾ 8.39.
.....................................................................................................................................................................................................................................
Hispanic 16 (5.57%)
..............................................................................................................................................................................................................................................
Medication insurance plan (n) Modified-PUQE vs 12-hour PUQE
.....................................................................................................................................................................................................................................
As shown in Table 4, the modified-
Provincial plan (RAMQ) 81 (28.42%)
..................................................................................................................................................................................................................................... PUQE score (mean ⫾ SD, 6.69 ⫾ 2.30)
Other insurance 204 (71.58%) was significantly higher than the 12-hour
..............................................................................................................................................................................................................................................
Work status (n) PUQE score (mean, 5.73 ⫾ 2.52; P ⬍
.....................................................................................................................................................................................................................................
Student or not working 72 (25.17%) .0001). The same result was found in all
.....................................................................................................................................................................................................................................
maternal and gestational age strata and
Working 214 (74.83%)
.............................................................................................................................................................................................................................................. whether the women used antiemetics or
Living arrangement (n) nonpharmacologic methods (Table 4).
.....................................................................................................................................................................................................................................
With spouse or with someone (family or cotenant) 280 (97.90%) However, there was substantial concor-
.....................................................................................................................................................................................................................................
Living alone 6 (2.10%) dance between the 2 indices (ICC, 0.71;
..............................................................................................................................................................................................................................................
95% CI, 0.64-0.76; Table 5). When ma-
Education level (n)
..................................................................................................................................................................................................................................... ternal age, gestational age, antiemetic
Secondary school completed 24 (8.39%) use, and nonpharmacologic methods
.....................................................................................................................................................................................................................................
Professional certificate completed 25 (8.74%) use to treat NVP were stratified, ICCs
.....................................................................................................................................................................................................................................
College completed 52 (18.18%) showed substantial concordance in all
.....................................................................................................................................................................................................................................
strata, except for women who were tak-
University completed 185 (64.69%)
.............................................................................................................................................................................................................................................. ing antiemetics in their first trimester, at
Household income: CDN$/y (n) which time concordance was moderate
.....................................................................................................................................................................................................................................
⬍$20,000 37 (13.26%) (Table 5).
.....................................................................................................................................................................................................................................
$20,000-$39,999 51 (18.28%)
.....................................................................................................................................................................................................................................
$40,000-$59,999 36 (12.90%) Modified-PUQE vs QOL
.....................................................................................................................................................................................................................................
When the severity of NVP on the basis of
$60,000-$79,999 33 (11.83%)
..................................................................................................................................................................................................................................... the modified-PUQE score and QOL was
ⱖ$80,000 122 (43.73%) compared, severe NVP as measured by
..............................................................................................................................................................................................................................................
b
Comorbidities (n)
.....................................................................................................................................................................................................................................
the modified-PUQE was associated sig-
0 206 (71.78%) nificantly with lower physical and men-
.....................................................................................................................................................................................................................................
tal QOL as measured by the SF-12 (PCS:
1 70 (24.39%)
..................................................................................................................................................................................................................................... P ⬍ .0001; MCS: P ⫽ .0008; Figures 1
2 8 (2.79%) and 2).
.....................................................................................................................................................................................................................................
3 3 (1.05%)
..............................................................................................................................................................................................................................................
Antiemetic use in first trimester: yes (n) 57 (20.43%)
..............................................................................................................................................................................................................................................
C OMMENT
Nonpharmacologic methods use for NVP in first trimester: yes (n) 50 (17.92%) Our study showed that the modified-
..............................................................................................................................................................................................................................................
Gravidity (n) PUQE index was rating women as having
.....................................................................................................................................................................................................................................
more severe NVP than the 12-hour
Primigravid 47 (16.43%)
..................................................................................................................................................................................................................................... PUQE. As for validity, substantial con-
Multigravid 239 (83.57%) cordance between the 2 indices was
Continued on page 71.e5. found globally and in all maternal ages,
gestational ages, and nonpharmacologic

71.e4 American Journal of Obstetrics & Gynecology JANUARY 2008


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shorter recall period of the 12-hour


TABLE 3 PUQE. We put forward the hypothesis
Patient demographics (nⴝ287) that the new index is a more accurate
Continued from page 71.e4. measure of first trimester NVP than is
Demographic Measure the 12-hour PUQE. Indeed, even if in the
c
Body mass index (n) past 12 hours there were no severe NVP,
..............................................................................................................................................................................................................................................
Normal: ⱕ18.5-⬍25 kg/m 2
179 (65.33%) it does not mean that it was the case for
.....................................................................................................................................................................................................................................
Underweight: ⬍18.5 kg/m 2
12 (4.38%) the entire duration of the first trimester
..................................................................................................................................................................................................................................... of pregnancy. Furthermore, had we mea-
Overweight: ⱕ25-⬍30 kg/m 2
62 (22.63%)
..................................................................................................................................................................................................................................... sured NVP severity in a woman who had
Obese: ⱖ30 kg/m 2
21 (7.66%) just been hospitalized for hyperemesis
..............................................................................................................................................................................................................................................
Physical and mental QOL* gravidarum, mean scores on the modi-
.....................................................................................................................................................................................................................................
PCS SF-12 score 42.81⫾9.07 fied-PUQE and the 12-hour PUQE
.....................................................................................................................................................................................................................................
would have been different. Taken as a
MCS SF-12 score 45.86⫾8.39
.............................................................................................................................................................................................................................................. whole, even if the scores of the 2 indices
a
Data are given as mean ⫾ SD. were different, we were expecting con-
b
Includes asthma, anemia, depression, hypothyroidism, diabetes mellitus, epilepsy, hypertension, and various problems such
as infections, eczema, and migraine headaches.
cordance between the modified-PUQE
c
According to the World Health Organization criteria.22 and the 12-hour PUQE scores because
Lacasse. Validity of the modified-PUQE. Am J Obstet Gynecol 2008. they are very interrelated. These findings
that show divergence and some conver-
gence between the 2 indices enhance the
methods use strata; concordance was as measured by the SF-12 during the first credibility of the modified-PUQE.
moderate for women who used anti- trimester of pregnancy. Regarding the stratified results, within
emetics in their first trimester. Finally, The higher mean scores on the modi- the subgroup of women who used anti-
our results suggest an association be- fied-PUQE can be explained partly by emetics in their first trimester of preg-
tween severity of NVP that was mea- the lower prevalence of nausea, vomit- nancy, concordance between the 2 in-
sured by the modified-PUQE and QOL, ing, and retching events during the dices was moderate rather than

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.

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comparable. The standard version of the


TABLE 5 SF-12 covered the past 4 weeks, and NVP
Overall and stratified ICCs between the 12-hour PUQE severity on the modified-PUQE was
and the modified PUQE indices measured since the beginning of preg-
Variable N ICC (95% CI) nancy. However, given that women were
Overall 287 0.71 (0.64-0.76) on average 11 weeks pregnant at the time
..............................................................................................................................................................................................................................................
Maternal age (y) of recruitment and that NVP appear be-
.....................................................................................................................................................................................................................................
tween week 4 and 6 of gestation,19 it is
ⱕ29 90 0.61 (0.46-0.73)
..................................................................................................................................................................................................................................... reasonable to assume that the time win-
30-31 55 0.69 (0.52-0.80) dows were equivalent for the 2 measures
.....................................................................................................................................................................................................................................
32-35 88 0.76 (0.66-0.84) in this study.
.....................................................................................................................................................................................................................................
⬎35 54 0.79 (0.66-0.87) NVP were significantly more severe
..............................................................................................................................................................................................................................................
for women who were ⬍29 years old, who
Gestational age (wk)
..................................................................................................................................................................................................................................... were between 12 and 16 weeks of preg-
ⱕ10 119 0.74 (0.64-0.81) nancy, and who used antiemetics or were
.....................................................................................................................................................................................................................................
11 70 0.66 (0.50-0.78) using nonpharmacologic methods
.....................................................................................................................................................................................................................................
12 50 0.74 (0.57-0.85) (measured either by the 12-hour PUQE
.....................................................................................................................................................................................................................................
or the modified-PUQE). These results
13-16 48 0.63 (0.42-0.78)
.............................................................................................................................................................................................................................................. are consistent with the published litera-
Antiemetic use 279 ture. In fact, low maternal age is associ-
.....................................................................................................................................................................................................................................
Yes 57 0.57 (0.36-0.73) ated with a high prevalence of symptoms
.....................................................................................................................................................................................................................................
No 222 0.73 (0.66-0.78) of NVP.20 Patterns of severity in the dif-
..............................................................................................................................................................................................................................................
ferent strata are consistent with the fact
Nonpharmacologic methods use 279
..................................................................................................................................................................................................................................... that NVP episodes are peaking in preva-
Yes 50 0.72 (0.55-0.83) lence and severity by the 8th-12th week
.....................................................................................................................................................................................................................................
No 229 0.70 (0.62-0.76) of gestation.19 As we can suspect, the de-
Lacasse. Validity of the modified-PUQE. Am J Obstet Gynecol 2008. cision to use antiemetics or nonpharma-
cologic methods to alleviate NVP may
substantial. This may be explained by the The fact that this study showed an as- reflect more severe NVP. In addition, as
fact that, in this group, the 12-hour sociation between the severity of NVP as expected, QOL scores in our study pop-
PUQE captured only the severity of NVP measured by the modified-PUQE and ulation were lower than in the general
for women under antiemetic treatment, QOL as measured by the SF-12 during US female population (SF-12 PCS, 49.1/
whereas the modified-PUQE captured the first trimester of pregnancy is the ma- MCS, 49.415) and higher than in women
the NVP severity before women started jor argument towards its validity. QOL is who experience severe NVP (SF-36 PCS,
their antiemetic therapy. Because anti- an outcome of direct importance for 32.8/MCS, 29.94).
emetics alleviate symptoms, this could The drawback of the 12-hour PUQE
women who experience NVP. The asso-
be at the origin of the lower concordance and even the Rhodes score is that they
ciation between NVP and QOL has been
between the 12-hour PUQE and the cannot reflect events that happened be-
established effectively already in the lit-
modified-PUQE scores in this subgroup. fore the administration of the question-
erature. NVP can significantly impair
physical functioning and can even lead
FIGURE 1 to depression.4,18 Our results suggest FIGURE 2
Association between modified- that the modified-PUQE is a valid index Association between modified-
PUQE measure of NVP severity to assess global NVP severity in the first PUQE measure of NVP severity
and physical QOL trimester of pregnancy. In choosing this
and mental QOL
(SE ⴝ 12, PCS) aspect for this validation study, it was es-
(SE ⴝ 12, MCS)
70 70 y = -0,75x + 50,68 (p = .0008)
y = -1,66x + 53,99 (p < .0001) sential to have the ability to score QOL in
Physical QOL SF-12 score

60 60
Mental QOL SF-12 score

50 an accurate way and thus to avoid inac- 50

40 curacy bias. First, QOL was measured 40

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

Lacasse. Validity of the modified-PUQE. Am J Obstet


swered by the subjects themselves. Lacasse. Validity of the modified-PUQE. Am J Obstet
Gynecol 2008. The time windows when QOL and Gynecol 2008.
NVP severity were measured were quite

71.e6 American Journal of Obstetrics & Gynecology JANUARY 2008


www.AJOG.org Obstetrics Research

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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JANUARY 2008 American Journal of Obstetrics & Gynecology 71.e7

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