Title: Health Related Quality Of Life Among Pregnant Women Living With HIV In Kenya,
Results From Comparing A Patient Generated Index And The Euroqol 5 Dimension 3 Level
Version: 1 Date: 09 Aug 2021
Reviewer's report:
General comments
The authors present the results of a nested cross-sectional survey study among pregnant women
living with HIV in Kenya. The study aims to use the patient-generated index to identify areas of
importance to pregnant women living with HIV and to assess the correlation between the PGI
and the EQ-5D-3L HRQoL questionnaire. A total of 100 women are included in the study, and
there was no correlation between the two instruments assessed. The authors conclude that the
PGI could complement generic HRQoL tools by highlighting areas of importance to the patients.
Some general comments:
In the title: consider replacing the comma after Kenya with a colon or semi-colon and adding
a hyphen to “patient-generated”
Throughout the manuscript
• Suggest using destigmatizing language and replacing “mother to child transmission” with
“perinatal transmission” and “HIV-positive” with “living with HIV”.
• Consider adding a hyphen to “health related” (quality of life)
• Consider adding a hyphen to “Disease specific”
• Consider adding a hyphen to “patient generated”
• The abbreviation of EQ-5D-3L should be rigorous throughout the manuscript (currently it is
abbreviated in 4-5 different ways).
Also, the manuscript should be proofread for correct English grammar and rigorousness.
See the specific comments below, which mainly are related to the specification of the methods,
clarifications, and an elaboration of the discussion.
Abstract
The abstract is too long (376 words) and would benefit from a more concise description of the
study.
For example, in the background paragraph, much focus is on the term HRQoL and not so much
on the actual context and purpose of the study.
Methods, page 2, line 25: Please elaborate EQ5D index – new abbreviation not previously
presented/described.
Background
The background section is quite long with much emphasis on the discussion of HRQoL as a
concept. As a result, why this study was necessary or its contribution to the field is less apparent.
Suggest shortening the second paragraph describing generic versus disease-specific HRQoL
measurements or moving some of the text/discussion to the Discussion section of the manuscript.
Also, since the BMC Women´s Health is focused on issues related to the health and wellbeing
of women, in particular, more emphasis could be put on why pregnant women living with HIV
are an area of interest.
Line 94-95, last sentence in the introduction – the abbreviation EQ-5D-3L has not been described
previously in the introduction.
Methods
There is some overlap between the different sub-sections in the Methods section. Suggest
reorganizing the methods section to include five main sub-sections: Study setting, Population
(incl. eligibility criteria and sample), Data collection, Data analysis, and Ethics.
Study setting and population
Section 2, line 103: “The clinics offer….” – please specify if this refers to health clinics in
general in Kenya/Wester Kenya or the four “public health facilities” participating in the study.
When is the study conducted?
Sample
Section 3, line 105: How was the convenient sample chosen – consecutively or based on specific
criteria? When is the enrollment period? Why 100 participants?
Section 3, line 107: The EQ-5D 3L has not been explained previously
Section 3, line 108: The WelTel trial? Is this the name of primary RCT? If so, the name of the
trial should be presented in the first paragraph of the Methods section.
Section 3, line 110: Is it important that the women were “escorted to the research assistants”?
Eligibility criteria
Section 4, line 112: Please specify if these are the eligibility criteria for the main RCT or this
nested study? And if there is any difference in the criteria in the two studies? Were there any
specific requirements to the duration of pregnancy when determining eligibility?
Section 5, line 115: please add a “data collection” heading to the sections describing the data
collection.
Section 5, line 115: “Pregnant women living with HIV enrolled in the trial…! – does this refer
to the women enrolled in this nested trial or the main RCT?
Data collection: were the interviews conducted at a specific visit/timepoint in relation to the
pregnancy or treatment cascade?
Section 6, line 123: In the Background section, the authors describe that “The PGI has been
used in diverse groups… (line 88)”. Does this also apply to the exact method used for the PGI
collection in this study? Is the PGI always collected in the three steps described or does this vary
depending on the specific PGI tool or population? If so, has the three-step method used in this
study been validated appropriately?
Section 7, line 137: The EQ5D-3L is a new abbreviation. As mentioned before, the EQ-5D-3L
has not been described earlier. Only the EQ-5D is described in the Background section of the
manuscript. Hence, the EQ-5D-3L should be described in more detail (domains, etc), including
the validation and translation of the scale concerning the specific study context and population.
Data analysis
Line 146: “Table 1” refers to a results table and should thus be deleted here in the methods
section.
Line 146: Are means described with 95% confidence intervals?
Line 153: “The areas of importance…” – how were the areas of importance clustered and
summarized into themes? By one or several authors, through consensus?
Line 147- 152: How are the PGI scores interpreted?
Line 155: “The EQ-5D-3L results…” – domains not described (see earlier comment). Please add
reference if this is the correct way of summarizing the EQ-5D results and also of the validated
scores from Zimbabwe. How are the EQ-5D-3L results interpreted?
Ethics
Line 160-164: Suggest deleting the first section about the general description on doing research
among pregnant women and concentrating on the ethical aspects in the current study.
Results
Line 176: “..the participants had disclosed…” – how is disclosure defined? Is this disclosure to
one or more people?
Table 1: Percentages are only presented for disclosure and not for the other variables.
Frequencies and percentages should be presented for all variables and also include non-
applicable or missing numbers. For example, the percentages for disclosure only include yes
and no answers, not the newly diagnosed with HIV.
If possible, please add more information about the study population – how far along were the
women in their pregnancy, were they nulliparous, duration of living with HIV, the timing of
HIV diagnosis in relation to pregnancy,  were the women on ART treatment (which and for how
long), information on CD4 and HIV RNA, and comorbidities. This information indicates the
women’s overall health status, which is relevant when talking about HRQoL.
Line 187: Please present the standard deviation of mean summary score of the PGI in the text
Line 194: Please present the standard deviation of mean index score of the EQ-5D-3L in the text
Line 198: Please present the correlation coefficient
Discussion
Line 203: It is not clear what is meant by “helped reveal the perspective”. Suggest deleting
this first sentence or rewriting it to including the following sentence, where “helped reveal” is
specified.
Line 217 – 218: Not sure where the authors get the numbers stating that 84% of participants
reported an income of less than $1 per day. According to table 1, income was only available
for 31 of the participants of which 9 reported an income of < $50/month (29%). Furthermore, it
seems a bit fetched to draw any conclusions about income in the study population, when income
information was not available for 69% of the participants. The point that financial challenges are
prominently highlighted by participants is important and valid, but suggest deleting/rewriting
the section limiting to the participants with income information. Also, it could be argued that
women are especially vulnerable to financial challenges in the study setting.
Line 228-231: The line of arguing seems difficult in this section. Can anxiety be compared to the
broader concept of emotional wellbeing and relationships? As the authors point out, there can
be other reasons why emotional health is important to the women – such as stigma, issues with
becoming a mother, and HIV disclosure concerns (disclosure concerns are especially prevalent
during pregnancy and childbirth). Also, just because the women listed physical and emotional
concerns as areas of importance does not necessarily mean that they are negatively affected in
these areas – just that these areas are important to them and that they have been affected by
their HIV status.
The Discussion section would benefit from a discussion of the tools use – the PGI and
EQ-5D-3L individually and not only the correlation/difference between the two. For example,
the EQ-5D-3L consists of 5 domains listed in five items/questions, and this in itself limits the
assessment of the broader HRQoL concept. It is simply not possible to assess all aspects of
HRQoL with a five-item tool. Also, the themes derived by the PGI are quite broad and one
could argue that for example physical and emotional health are assessed by five domains the
EQ-5D-3L. Thus, the statement “These results….highlight the challenges of using a single
tool…” (line 233) may be correct, but it could also be that a short HRQoL assessment tool such
as the EQ-5D-3L may not be sufficient to fully capture all aspects of HRQoL.
Line 235: “areas affected by their HIV status” – does this imply negatively affected? Many areas
of HRQoL are affected by HIV, but they may not all be negative. They could just be a reflection
of change, and in some cases, a positive change. For example, some people living with HIV
take better care of themselves than before their HIV diagnosis and have closer/more meaningful
relationships.
Line 248: Not sure what is meant by the last sentence in the Discussion. Suggest rewriting.
Study limitations
Line 252: in the methods section, the authors write the PGI was interview administered (and
thus not self-administered). In this section, it is suggested that it was self-administered and that
education level impacted the administration. Does this mean, that only women with a certain
level of education managed to complete the PGI? Or how was this handled? And how does this
impact the study results?