Title: Development of a brief menstrual quality of life measure for women with heavy menstrual
bleeding
Version: 2 Date: 17 Nov 2022
Reviewer's report:
As the authors state, heavy menstrual bleeding frequently remains undiagnosed, or women
underestimate its importance. For this reason, any tool aiming at increasing women's awareness
of the subject is welcome.
However, the paper can only be accepted if the authors introduce some relevant changes.
The core of the work: producing a sensitive, simple tool to evaluate the impact of heavy
menstrual bleeding is probably attained, even if the validation process is not a conventional one.
But several details, as mentioned below, have to be clarified.
Considering splitting the work into more than one paper. Addressing the issue of impact on
the activity at the workplace in a separate article and skipping references to accompanying
Gynecological conditions will make the paper more clear and attractive
Specificaly:
In the introduction, the authors do not describe the previously existing tools and the need to
improve or substitute them to fulfil NICE recommendations(1)
The paper submitted contains, in fact, three different research activities that could probably be
published separetly: The generation of a simple tool to identify the impact of HMB on QoL, its
ability to detect heavy menstrual bleeding and/or a gynecological condition and the correlation
existing between a high rating of the questionnaire and a negative impact in performance at work.
A figure with a "flow diagram" would help the reader to understand the development of the
process of elaborating the studies.
The authors:" developed a pool of 39 items, informed by the Uterine Fibroid Symptom and
Quality of Life scale (UFS-QOL)" and "adapted the measure, so it only assessed the physical,
psychological, and social impact of HMB and other menstrual symptoms. "
Since UFS-QoL has only 37 items, they should explain the criteria for generating these "new"
questions.
In Table 1, the authors classify the 174 respondents into HMB and LLMB groups, but in the
previous text, they should have mentioned when and how they classified the members of this
first sample.
The role of the 18 menstruating women who participated in refining the QoL items is crucial. But
beyond "known to HD", the authors do not contribute information on social class, educational
level or other details that could influence their choice, especially if we consider that the tool was
aimed to be useful for low literacy patients.
The methodology and criteria used to reduce from 21 to 10 questions need to be specified.
Finally, there is not any reference to the adequacy of the questions to previously established
criteria (2) for these tools.
In the test validation, the authors consider that "the independent variables were severity of
menstrual bleeding and gynecological diagnosis".
It seems that the validity of a simplified tool to detect impairment of QoL should be "the golden
standard" or a similar tool measuring the same outcome. In this case, the validation only proves
the relationship between low QoL as detected by PERIOD-QoL and HMB.
Moreover: "Women were asked about gynaecological diagnoses with the question: "Have you
ever received a diagnosis for a gynaecological disorder? (for example, polycystic ovaries, heavy
menstrual bleeding, endometriosis etc.,)? YES/NO". Women wrote any diagnosis in the space
provided".    The purpose of this part of the paper is unclear and, in my opinion, introduces
"background noise" without improving the study's main goal.
It becomes even more evident when looking at table 4 whit a mix of diseases, pathological
diagnoses (Endometrial Hyperplasia, abnormal cervical cells) or conditions (lichen sclerosus)
having nothing to do with menstruation or HMB. Curiously, the condition more frequently
related to HMB, uterine fibroids, is underrepresented in the sample.
The authors acknowledge this information as a "weakness "in the discussion.
The information on gynaecological conditions does not contribute to the quality of the paper,
and the authors should consider withdrawing it. (Needles to comment on the mention of the term
"menorrhagia" among the answers by patients)
Very few is said on the questionnaire about "Period-related employment disruption"
The authors do not report the nine items finally used. On the criteria used to select the items, we
only know that "Women confirmed face validity of the items in Pilot Study 2 and the reliability
of the measure was good (#=.91)".
Impact on the activity at the working place is a very relevant issue that deserves a paper in its
own. The authors refer to 4 articles (8 to 11) in their bibliography addressing this point but is
not considered deeply in their paper.
In the discussion, the authors should refer to existing similar tools aiming at the same goal and
compare them with their work.
1.- Shaw RW, Brickley MR, Evans L, Edwards MJ. Perceptions of women on the impact of
menorrhagia on their health using multi-attribute utility assessment. Br J Obstet Gynaecol.
1998;105(11):1155-1159. doi:10.1111/j.1471-0528.1998.tb09968.x
2. - Clark TJ, Khan KS, Foon R, Pattison H, Bryan S, Gupta JK. Quality of life
instruments in studies of menorrhagia: a systematic review. Eur J Obstet Gynecol Reprod Biol.
2002;104(2):96-104. doi:10.1016/s0301-2115(02)00076-3
3.- Calaf J, Cancelo MJ, Andeyro M, et al. Development and Psychometric Validation of a
Screening Questionnaire to Detect Excessive Menstrual Blood Loss That Interferes in Quality
of Life: The SAMANTA Questionnaire. J Womens Health (Larchmt). 2020;29(7):1021-1031.
doi:10.1089/jwh.2018.7446
4.- Perelló J, Pujol P, Pérez M, Artés M, Calaf J. Heavy Menstrual Bleeding-Visual Analog
Scale, an Easy-to-Use Tool for Excessive Menstrual Blood Loss That Interferes with Quality-of-
Life Screening in Clinical Practice. Womens Health Rep (New Rochelle). 2022;3(1):483-490.
Published 2022 May 9. doi:10.1089/whr.2021.0139