Review for 10.1186/1471-230X-8-22 (2008)

Reviewer's report
Title:Written versus verbal patient information before gastrointestinal
endoscopy: a randomized trial
Version: 1Date:24 March 2008
Reviewer: Marc Zuckerman
Reviewer's report:
This is an interesting randomized clinical trial of oral patient information plus
written patient information versus oral information alone given prior to
gastrointestinal endoscopy (upper endoscopy or colonoscopy). It adds to the
literature on informed consent for gastrointestinal endoscopy. The questions
posed by the authors are well defined with the outcome variables being patients
global assessment of endoscopy and patient assessment of quality of
information. The methods are appropriate and well-described. The data are
sound. The manuscript adheres to the relevant standards for reporting and data
deposition. The discussion and conclusions are well balanced and adequately
supported by the data. Limitations of the work are not clearly addressed.
References are appropriate and up to date. The title could be revised to more
accurately reflect the objectives of the study. The writing is acceptable, but but
there are some areas that could be improved.
Minor Essential Revisions:
1. Pg 1 Title - This should more accurately reflect that written information is given
in addition to verbal information, e.g. Combined written and oral information prior
to gastrointestinalo endoscopy compared with oral information alone: a
randomized trial.
2. Pg 2 Abstract - Background, I suggest changing to "most effectively deliver"
3. Pg 2 Abstract - Objective, perhaps use "effects" instead of effectivenes,
4. Pg 4 Introduction - para 1, I suggest you remove "So far", rephrase "strict legal
situation", change to "such as Germany" remove "for example", add a comma
after form, change to "obtain informed consent". change to "comprehensively is
particularly", in para. 2 change to "adequately addressed".
5. Pg 5 Methods - change to "The oral information consisted of routine", change
to "each patient", change to "standard information that is regularly given".
6. Pg 6 Methods - change to "receiving a hypnotic drug" change to "during a
three-month period". Please clarify when inpatients were given the written
information, since it is stated that outpatients were sent the written information
within one week of the procedure.
7. Pg 7 Methods - Statistical analysis, The authors calculated and reported
means, but conducted Mann-Whitney tests. The authors should report the
medians, not the means. Clarify how the linear regression model was built; that
is, how were the variables chosen for inclusion in the final model(e.g. forward
selection approach or a backward elimination method).
8. Pg 8 Results - Consider changing headings to patient global assessment of
endoscopy and to patient assessment of quality of information.
9. Pg 9 Results - Clarify if this is stating that 18.1% of patients in the oral
information group alone claimed to have received the written information. My
copy has Figures 1,2 and 3 , instead of Figure 2, panels A, B, and C.
10. Pg 10 Discussion - Para. 2, change to "we found evidence"
11. Discussion - Add a paragraph regarding limitations of the study.
12. Pg 15 Table 1 - The columns should be written plus oral information, oral
information. Colonoscopy is misspelled.
13. Pg 16 Table 2 - Same comment on columns.
13. Pg 17 Table 3 - The columns should be written plus oral information, oral
information. Medians should be reported.
14. Pg 18 Table 4 - The title could include more information, e.g. Multivariate
linear regression model etc.
15. Pg 19 Figure legend - I do not have the Figure 1 flow chart in my copy. Figure
2 is listed with panel A, B, C, but I have the corresponding Figures 1, 2 and 3.
The bars are not labelled, so it is not clear what is being compared. These
figures may not be necssary, since the data is reported in the text.
What next?: Accept after minor essential revisions
Level of interest: An article whose findings are important to those with closely
related research interests
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.