Reviewer's report
Title:Psychometric properties of the Confidence and Trust in Delivery
Questionnaire (CTDQ): A pilot study
Version: 3Date:17 June 2012
Reviewer: Heather Rowe
Reviewer's report:
Advice from the ethical committee of the German Society for Nursing Science is
referred to. Notwithstanding any opinion of an in-country committee, however,
the international standards for publication of ethically compliant research are
spelt out in the COPE (Committee on Publication Ethics) GUIDELINES ON
GOOD PUBLICATION PRACTICE, 1999
(http://publicationethics.org/static/1999/1999pdf13.pdf) .
Two articles in these guidelines are relevant to this paper:
Article (2) Research protocols should seek to answer speci#c questions, rather
than just collect data.
The authors of the manuscript under review have elected not to address this
problem and do not provide a good justification for the study. They describe four
other questionnaires for use during pregnancy that investigate women’s
expectations about the forthcoming birth and that tap related psychological
constructs to those in the CTDQ piloted in the study. Of particular is relevance to
the CTDQ is “the Childbirth Self-Efficacy Inventory (CBSEI) [9] introduced by
Lowe in 1993 (that) focuses on self-efficacy and coping expectancies“. The
authors state that “we wanted to develop a short but reliable instrument that
focuses more on the fundamental aspects of confidence and trust as meaningful
dimensions and sources of support”. However, questions remain about why
these “fundamental aspects” are “meaningful dimensions and sources of
support”. No empirical or theoretical justification for the importance of these
related constructs is provided and the psychological constructs themselves not
elaborated. Nor do the authors make any argument about how a new
questionnaire would inform clinical care, what a high or low score might mean in
clinical practice or how the results of the study would add to existing knowledge.
In response to reviewers’ comments, the authors argue that this kind of
information is not relevant to the manuscript because the investigators were only
interested in the psychometric properties of the CTDQ. However, at least brief
reference to this should be made in the introduction to any paper reporting on the
questionnaire, whether or not a detailed justification has been made in a previous
publication (which it appears not to have been in this case).
Therefore no clear case has been made that the study was not “just to collect
data” (COPE, 1999) and the study fails this test of ethical research.
The second problem is spelt out in Article 7of the COPE Guidelines.
Article (7) Formal and documented ethical approval from an appropriately
constituted research ethics committee is required for all studies involving people,
medical records, and anonymised human tissues.
It is well understood that inter-country differences in requirements for ethical
approval for human research mean that this Article of the COPE statement is
implemented in practice with some flexibility. For example, some
resource-constrained countries do not have institutional ethics review boards. It
is common practice under these circumstances for journal editors to require that
authors identify the ethical principles that apply in their study and clearly describe
how the research protocol has addressed each principle. This enables important
research that has been conducted in the absence of institutional ethical review to
be published. The authors of this manuscript have not done this and there are
some ethically problematic features of the research protocol.
First, the principle of voluntary participation: The authors state that recruitment of
participants was carried out by midwives in antenatal clinics. Using clinicians to
recruit participants to a study creates a dependant relationship between a
recruiter and a potential participant. These relationships are usually not permitted
in ethically compliant research because they compromise the capacity of an
individual to make a voluntary decision (not) to participate in the research. The
research protocol fails this test of ethical compliance - avoidance of dependent or
unequal relationships.
The second problem related to Article 7 is the use of anonymous questionnaires.
Women who are pregnant were asked sensitive, personal information relating to
their hopes, fears and expectations for the birth of their baby. Contemplating the
impending birth is anxiety-provoking for many women and therefore the
questionnaire had the potential to arouse psychological distress. Anonymity in
this circumstance means that women who become distressed or scored high or
low ( both scores likely to be indicative of distress) could not be identified and
offered individual assistance. The research protocol therefore fails this test of
ethically compliant research – protecting participants from potential harm.
Level of interest: An article of limited interest
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests