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Gynecological Endocrinology

ISSN: (Print) (Online) Journal homepage: www.tandfonline.com/journals/igye20

Numerical rating scale for dysmenorrhea-related


pain: a clinimetric study

Guilherme Tavares de Arruda, Patricia Driusso, Jéssica Cordeiro Rodrigues,


Amanda Garcia de Godoy & Mariana Arias Avila

To cite this article: Guilherme Tavares de Arruda, Patricia Driusso, Jéssica Cordeiro
Rodrigues, Amanda Garcia de Godoy & Mariana Arias Avila (2022) Numerical rating scale for
dysmenorrhea-related pain: a clinimetric study, Gynecological Endocrinology, 38:8, 661-665,
DOI: 10.1080/09513590.2022.2099831

To link to this article: https://doi.org/10.1080/09513590.2022.2099831

Published online: 19 Jul 2022.

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https://www.tandfonline.com/action/journalInformation?journalCode=igye20
Gynecological Endocrinology
2022, VOL. 38, NO. 8, 661–665
https://doi.org/10.1080/09513590.2022.2099831

RESEARCH ARTICLE
DYSMENORRHEA

Numerical rating scale for dysmenorrhea-related pain: a clinimetric study


Guilherme Tavares de Arrudaa , Patricia Driussoa , Jéssica Cordeiro Rodriguesb , Amanda Garcia
de Godoya and Mariana Arias Avilaa
a
Study Group on Chronic Pain (NEDoC), Physical Therapy Post-Graduate Program and Physical Therapy Department, UFSCar, São Carlos, Brazil;
b
Laboratory of Research on Women’s Health (LAMU), Physical Therapy Post-graduate Program and Physical Therapy Department, UFSCar, São
Carlos, SP, Brazil

ARTICLE HISTORY
ABSTRACT Received 5 April 2022
Revised 19 June 2022
Objective: To evaluate the numerical rating scale (NRS) measurement properties in women with
Accepted 4 July 2022
dysmenorrhea. Methods: This was an online clinimetric study. Brazilian women aged over 18 years old Published online 19 July
with internet access to respond to online instruments were included in the study. We evaluated criterion 2022
validity (comparing women with and without dysmenorrhea), construct validity between the NRS and
the bodily pain domain of the SF-36, test-retest reliability, and measurement errors (in women with KEYWORDS
dysmenorrhea). Results: Two hundred thirty-eight women with and 192 without dysmenorrhea participated Dysmenorrhea; women’s
health; chronic pain;
in the study. For criterion validity, the area under the receiver operating characteristic curve was 0.902 validation study;
(95%CI, 0.873–0.931), and a cutoff point of 3 was considered to have the best sensitivity (83%) and measurement properties
specificity (86%). For construct validity, the NRS showed a moderate negative correlation with the SF-36
bodily pain domain (r=-0.46; p < 0.001). For test-retest reliability and measurement errors, 105 women
whose symptoms did not change between 7 and 10 days of retest, with intraclass correlation coefficient
= 0.90, standard error of measurement = 0.97, and smallest detectable change = 2.76 points. Conclusions:
The NRS can be considered a valid and reliable patient-reported outcome measure for assessing
dysmenorrhea-related pain intensity.

Introduction most used PROM to assess pain intensity is the numerical rating
scale (NRS) [11].
Dysmenorrhea is a gynecological condition defined as menstrual The NRS is a single-item generic measure that assesses the
pain of uterine origin that is most common in women of repro- intensity of some health condition on a scale from zero to
ductive age [1]. Unlike secondary dysmenorrhea, in which pain 10. In pain studies, the NRS is relevant to assess pain intensity,
is associated with pelvic conditions such as endometriosis and where zero usually represents ‘no pain’ and 10 ‘the worst
fibroids, primary dysmenorrhea (PD) is believed to be caused
imaginable pain’. Because it is an one-dimensional item, the
by the increased release of prostaglandins during endometrial
administration of the NRS is quick, easy to understand [7],
shedding, leading to muscle ischemia and uterine hypoxia [2].
and can be useful for comparing pain intensity with other
The worldwide prevalence of dysmenorrhea ranges from 10% to
multidimensional instruments for different health conditions,
91.5% [2,3]. In addition to pain, other associated symptoms of
such as low back pain [12], neck pain [13], and knee osteo-
dysmenorrhea are fatigue, mood swings, insomnia, nausea, and
headaches [2]. Depending on pain intensity, women with dys- arthritis [14].
menorrhea may have limited physical and social activities [4], Although the relevance of NRS in the assessment of pain
absenteeism/presenteeism at school/work [2,3], and a decreased intensity in research and clinical practice has been recognized,
quality of life [5]. Dysmenorrhea is also an economic problem: the measurement properties of this PROM have not been eval-
treatment costs are considerable – about $4,053.00 with comple- uated in women with dysmenorrhea. This can help researchers
mentary and alternative medicine interventions per year [6] – and and clinicians to better assess the presence and intensity of
pain can interfere with a woman’s work productivity [2,6]. dysmenorrhea using a scale that is quick, simple, valid and
Pain is usually the main clinical complaint of women with reliable. In addition, the use of high-quality evidence PROMs
dysmenorrhea [7]. The assessment of pain intensity, defined as for measurement properties should be encouraged for valid and
‘how much a patient hurts, reflecting the overall magnitude of reliable measurements [15]. Unlike the Visual Analogue Scale
the pain experience’ [8], is essential to understand the impact (VAS), the NRS is better understood by the patients because it
a disease may cause [9] as well as to observe the effect of a is only necessary to mark a visible number from zero to 10
treatment on pain relief [10]. Patient-reported outcome measures [16], and it can be used on any online platform like Google
(PROMs) are recommended in clinical practice and clinical trials Forms as it is only necessary to mark numbers. Therefore, this
because they reflect the patients’ perception of their symptoms, study aimed to evaluate the measurement properties of the NRS
functional status, and health-related quality of life [10]. The in women with dysmenorrhea.

CONTACT Mariana Arias Avila m.avila@ufscar.br Physical Study Group on Chronic Pain (NEDoC) Therapy Post-Graduate Program and Physical Therapy
Department, Universidade Federal de São Carlos, Rodovia Washington Luís, Km 235, São Carlos 13565-905, SP, Brazil.
© 2022 Informa UK Limited, trading as Taylor & Francis Group
662 G. T. DE ARRUDA ET AL.

Materials and methods The Brazilian version of the SF-36, specifically the bodily pain
domain, has shown satisfactory intra-rater (r = 0.542) and
Study design and population inter-rater (r = 0.554) reliabilities [20].
This online clinimetric study was conducted in accordance with
the Declaration of Helsinki and was approved by the Institutional
Ethics Committee (CAAE 30232920.3.0000.5504), following the Statistical analysis
COnsensus-based Standards for the selection of health Measurement
Women with and without dysmenorrhea were included in the
INstruments (COSMIN) checklist [15]. The study was disclosed
criterion validity analysis, and comparisons between groups were
on social media apps (Facebook, Instagram, WhatsApp), and
performed using the Mann-Whitney U test and the chi-square
women willing to take part in the study contacted the researchers
or Fisher’s exact test. For criterion validity, the degree to which
and received a link to an online Google Form.
a PROM score is an adequate reflection of a ‘gold standard’
Women over 18 years old, able to read and write in Brazilian
[15], the receiver operating characteristic (ROC) curve was cal-
Portuguese, and with internet access to respond to online instru-
culated between the presence of dysmenorrhea by self-report
ments were included in the study. Postmenopausal women, preg-
(yes/no) and the NRS. The area under the ROC curve ≥0.8 was
nant women, those within 12 months after postpartum period,
considered to indicate excellent accuracy [21].
those with pelvic infection, and those who had not menstruated
Test-retest reliability, measurement errors, and hypothesis testing
in the previous 3 months were excluded from the study. The
for construct validity were performed only in women with dys-
data were collected between August 2020 and August 2021.
menorrhea. Construct validity is defined as the degree to which
After reading the consent form on Google Forms, women
the scores of a PROM are consistent with hypotheses, based on
interested in participating in the study clicked on ‘I declare that
the assumption that the PROM validly measures the construct to
I have read the terms above, understood it, and I agree to
be measured [15]. This measurement property was assessed using
participate in the research’. Women who agreed to participate
Pearson’s correlation, with r ≥ 0.5 indicating strong correlation;
were asked to indicate the initial day of their next menstruation
r = 0.3-0.49, moderate correlation; and r ≤ 0.29, weak correlation
so that researchers could contact them for the first assessment
[22]. We hypothesized that the NRS has a moderate negative
between days 6 and 9 (we assumed there was less chance that
correlation (r > 0.3) with SF-36 – bodily pain, because higher scores
the woman was experiencing dysmenorrhea-related pain during
on the NRS indicate worse pain and higher scores on the SF-36
this period) of the menstrual cycle. For the second assessment,
– bodily pain indicate less or no impact of pain on quality of life.
researchers contacted all the participants who responded to the
Test-retest reliability is defined as the degree to which the
first assessment seven to ten days later, which is a good retest
scores for patients who have not changed are the same for
time according to the COSMIN [15], and there was a very little
repeated measurements over time [15]. It was assessed using the
chance that women would have menstruated in this time interval.
intraclass correlation coefficient (ICC) with a two-way mixed-effect
Along with the NRS, participants also responded the 7-points
model with interaction for absolute agreement between mean
Global Rating of Change Scale (GRCS): ‘Regarding your period
measures. ICC > 0.75 was considered acceptable reliability.
pain, how would you describe it now compared to when it
Standard error of the measurement (SEM) and smallest detectable
started?’ with answers from ‘a very great deal better’ to ‘a very
change (SDC) at the individual level were calculated while Bland
great deal worse’ [17]; we considered variations of up to 2 points
and Altman graphs were created for the measurement errors,
to consider that women’s symptoms did not change [18].
defined as the systematic and random error of a patient’s score
that is not attributed to real changes in the construct to be mea-
sured [15]. SEM was calculated with the formula [diferenceSD/√2],
Instruments and data collection
with diferenceSD indicating the standard deviation (SD) of the dif-
Numerical rating scale ference between the test and retest scores of the NRS. The SDC
The NRS is a single-item 11-point scale used to assess menstrual was calculated using [SEM*1.96*√2] [23]. The limits of agreement
pain intensity; zero was considered the absence of pain, while (LoA) were calculated using the Bland and Altman graph with
10, the worst pain imaginable. Participants were instructed to [d- ± (1.96*diferenceSD)], where d is the average of the differences
use a single number that better defined their menstrual pain between the test and retest of the NRS. All analyses were per-
during the current menstrual cycle in the test and retest analysis formed using SPSS 22.0 (IBM, Armonk, NY, USA).
for the question ‘In relation to your last menstrual period, how The calculation of sample power was based on the correlation
would you rate your pain intensity?’. The NRS has a strong between NRS and the bodily pain domain in the G*Power 3.1.9.7
correlation (r = 0.96) [19] and agreement (97.9%) [11] with the software. A two-tailed correlation was used (α = 0.05, rH0 = 0.3
VAS score in women with dysmenorrhea. is the expected correlation for the initial hypothesis, sample size
of 238 women with dysmenorrhea, and rH1 = 0.455 is the cor-
relation observed in this study). Thus, the sample power is
Medical Outcomes Short-Form Health Survey – bodily pain (1-β)=0.795 for construct validity.
domain
The Medical Outcomes Short-Form Health Survey (SF-36) is a
multidimensional questionnaire that evaluates 8 different Results
domains: physical functioning, role limitations due to physical
health, emotional problems, energy/fatigue, emotional well-being, Figure 1 shows the study flowchart. Data from 430 women were
social functioning, bodily pain and general health. For the pres- analyzed: 238 (55.4%) with and 192 (44.7%) without dysmen-
ent study, we used the bodily pain domain to assess the impact orrhea. The characteristics of the participants included in the
of bodily pain on health-related quality of life, with scores from study are shown in Table 1. The mean age for women with and
0 to 100, with 0 indicating the worst impact of pain on quality without dysmenorrhea were 25.5 ± 5.6 and 26.0 ± 5.8 years, respec-
of life and 100 indicating no impact of pain on quality of life. tively. Among women with dysmenorrhea, 223 (93.7%) had PD
Gynecological Endocrinology 663

Figure 1. Flowchart of the study.

Table 1. Characteristics of the study participants.


Dysmenorrhea No dysmenorrhea
Characteristics (n = 238) (n = 192) p value
Age (years), mean ± SD 25.5 ± 5.6 26 ± 5.8 0.412
Education, n (%) 0.074
Graduate school/ 208 (87.4) 179 (93.2)
University
High School 27 (11.3) 13 (6.8)
 Elementary School 3 (1.3) 0
Marital status, n (%) 0.145
Single 168 (70.6) 146 (76)
Married 27 (11.3) 20 (10.4)
 Divorced 3 (1.3) 6 (3.1)
 Other 40 (16.8) 20 (10.4)
Number of pregnancies 0.3 ± 0.7 0.3 ± 0.7 0.697
Menarche (years), 11.8 ± 1.4 12.2 ± 1.4 0.146
mean ± SD
Hormonal contraceptive 0.042
use, n (%)
 Yes 139 (58.4) 93 (48.4)
 No 99 (41.6) 99 (51.6)
SD: Standard deviation. Statistically significant differences are in bold.

and 15 (6.3%) had secondary dysmenorrhea. The number of


women with dysmenorrhea using oral contraceptives (58.4%) is
significantly higher than women without dysmenorrhea (51.6%).
Criterion validity was assessed with the area under the ROC
curve, which was 0.90 (95%CI 0.87 − 0.93). A cutoff point of 3
Figure 2. ROC curve for NRS criterion validity with dysmenorrhea self-report.
was considered to have the best sensitivity (83%) and specificity
(86%). Thus, NRS score ≥ 3 best screens for dysmenorrhea
(Figure 2). For construct validity, NRS showed a significant, were 0.97 points and 2.76 points, respectively. The 95% CI for
moderate negative correlation with the SF-36 bodily pain domain the mean difference included 0 (-0.070 to 0.172), indicating
(r=-0.46; p < 0.001). that there was no significant systematic bias between the NRS
For test-retest reliability and measurement errors, 152 (61.5%) test-retest measures. The lower (-3) and upper (2.68) LoA are
women with dysmenorrhea answered the instruments between shown in the Bland and Altman graph illustrated in Figure 3.
7 and 10 days of retest. However, 105 (69.1%) were stable
according to the GRCS in this period. The mean intensities of
menstrual pain in the test and retest were 5.1 ± 2.5 points and Discussion
5.2 ± 2.4 points, respectively. For test-retest reliability, the ICC
was excellent (ICC = 0.903; 95%CI 0.858 − 0.934). For measure- This is the first study to assess the measurement properties of
ment errors, the mean difference (d-) between test and retest NRS for women with dysmenorrhea. The present results provide
was −0.16 points. The SEM and the SDC at the individual level evidence of the validity and reliability of NRS for the assessment
664 G. T. DE ARRUDA ET AL.

health conditions. Thus, these PROMs do not have a memory


bias, and the response time is fast [26]. No significant systematic
errors were found in NRS measurements. These results are also
presented with the use of NRS in other health conditions such
as chronic pain [25,27] and endometriosis [26].
The present study shows that a PROM very used to assess
pain in other pain conditions [12–14] can also be used for
women with dysmenorrhea. In addition, this was the first study
to evaluate the NRS measurement properties for dysmenorrhea
in a large sample of women and we strictly followed the
COSMIN checklist to improve the quality of measurement prop-
erties. However, there are some limitations. First, although there
are no studies verifying the equivalence of the paper versus
electronic NRS administration methods for dysmenorrhea, in
low back pain, the electronic version of the NRS for pain showed
poor reliability with the paper NRS version, and both versions
should not be considered interchangeable in clinical practice
[28]. Second, the sample comprised women with internet access,
thus including only those with higher education/socioeconomic
Figure 3. Bland and Altman graph of dysmenorrhea pain intensity between test levels. This can be considered a sample selection error as it does
and retest.
not consider the sample of women with lower educational qual-
ifications. Therefore, we suggest that future studies should eval-
of pain intensity due to dysmenorrhea in women. For criterion uate the reliability of paper versus electronic NRS administrations
validity, there is still no gold-standard method for the assessment for dysmenorrhea in samples with different characteristics.
of dysmenorrhea, with patients’ self-reported data on dysmen- The NRS can be considered a valid and reliable PROM for the
orrhea symptoms still the most common method to diagnose assessment of dysmenorrhea pain intensity. In the absence of val-
dysmenorrhea [24]. In the present study, we used dysmenorrhea idated gold standards, the excellent values for validity and reliability
self-report data in the analysis of the ROC curve and found of the NRS obtained in this study indicate that this PROM may
excellent accuracy, high sensitivity, and specificity of the NRS be more useful for monitoring the intensity of dysmenorrhea pain,
to discriminate women with and without dysmenorrhea. These facilitating better communication between patients and clinicians
results suggest that NRS is an appropriate tool for differentiating regarding treatment response, and contributing to comparing the
women with and without dysmenorrhea. outcomes of future studies on the pain of dysmenorrhea.
Regarding construct validity, our initial hypothesis between
the NRS and SF-36 – bodily pain was confirmed: NRS showed
a moderate negative correlation with the SF-36 – bodily pain Acknowledgements
in women with dysmenorrhea, indicating strong construct, thus We thank the participants for their contribution to the study.
suggesting that the NRS a good way to assess dysmenorrhea-related
pain. The correlation between NRS and SF-36 – bodily pain
was moderate because both measures assess similar constructs, Conflicts of interest and source of funding
not identical ones. The SF-36 – bodily pain questionnaire mea-
sures the impact of bodily pain on quality of life. Although we The authors declare no conflict of interest.
did not find any studies that compared NRS with SF-36 – bodily
pain for dysmenorrhea, there was one study that correlated the
NRS with the VAS. The results of that study showed a signif- Data availability
icant, strong positive correlation (r = 0.957 and rho = 0.995) of
NRS with VAS in the assessment of menstrual pain in 1,387 Data from the present study will be made available at reasonable request.
women [19]. The author suggests the use of NRS in epidemi-
ological studies because VAS is more difficult to understand [19].
Although other studies have evaluated the test-retest reliability Disclosure statement
and measurement errors of the NRS for other health conditions No potential conflict of interest was reported by the authors.
such as low back pain [12,25], neck pain [13], and osteoarthritis
knee pain [14], our study is the first to evaluate these measure-
ment properties for dysmenorrhea. The test-retest reliability of Funding
the NRS for dysmenorrhea pain intensity was 0.903, indicating
that the measure has excellent reliability over time. The SEM for This study was partially financed by Coordination for Improvement of Higher
women with dysmenorrhea was 0.97 points, which means that it Education Personnel (CAPES), Brazil, Finance Code 001 and by São Paulo
is possible that there is 68% confidence that the true NRS score Research Foundation (process 2019/14672-7). The funders had no role in
study design, data collection and analysis, decision to publish, or preparation
ranges from −0.97 to +0.97 points of the observed NRS value,
of the manuscript.
and 95% confidence that this true score lies is between −1.94 and
+1.94 (± 2 SEM) points of the observed score. The individual
SDC of the NRS was 2.76 points, indicating that a change of at
ORCID
least 2.76 points in the NRS can be considered a true change in
pain intensity. Along with VAS, NRS is the single-item PROM Guilherme Tavares de Arruda https://orcid.org/0000-0001-5994-3247
most frequently used to assess real-time pain intensity in various Patricia Driusso http://orcid.org/0000-0001-8067-9786
Gynecological Endocrinology 665

Jéssica Cordeiro Rodrigues https://orcid.org/0000-0003-4080-9771 [14] Alghadir AH, Anwer S, Iqbal A, et al. Test-retest reliability, validity,
Amanda Garcia de Godoy https://orcid.org/0000-0002-4422-9179 and minimum detectable change of visual analog, numerical rating,
Mariana Arias Avila https://orcid.org/0000-0002-5081-5326 and verbal rating scales for measurement of osteoarthritic knee pain.
J Pain Res. 2018;11:851–856. 10.2147/JPR.S158847 [29731662]
[15] Mokkink LB, Prinsen CAC, Bouter LM, et al. The COnsensus-based
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