Reviewer's report 
 Quality of life and symptoms of menopause in the Estonian Postmenopausal Hormone Therapy trial Title: 
[ISRCTN35338757] 
 1  15 February 2007 Version: Date: 
 Edson Zangiacomi Martinez Reviewer: 
Reviewer's report: 
General 
I think this is an interesting paper. This manuscript describes a randomized trial for evaluating the effect of postmenopausal hormone therapy on quality of life and menopausal symptoms, and its results are of great utility for the therapeutic decision-making process. 
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Major Compulsory Revisions (that the author must respond to before a decision on publication can be reached) 
Is parity considered a discrete variable? How are treated the women with null parity in the calculus of the 
mean? It was treated as zero? I think it is not correct. 
Why the model was adjusted specifically for interactions between age and smoking status, age and 
employment status, and education and living place? 
In the analysis showed in table 2, the variables vaginal bleeding, hot flushes, ..., are dichotomous (or say, 
binary variables)? In page 10, second paragraph, is mentioned that “the number of bleeding episodes….”. 
This suggests a discrete variable! 
Page 11: What is a “borderline significance”? I think it is an erroneous interpretation of a p value equal to 
5%. Altman (1990) presents a cautionary note on p values: 
“The cut-off level for statistical significance is usually taken at 0.05, but sometimes at 0.01. These cut-offs are arbitrary and have no specific importance. It is ridiculous to interpret the results of a study differently according to whether the p value obtained was, say, 0.055 or 0.045. These p values should lead to very 
similar conclusions.” (Altman, Practical Statistics for Medical Research, Chapman & Hall, 1990). A 
significance test must be apt to reject or not reject the null hypothesis for a fixed significance level; a “borderline” result indicates an esoteric interpretation. 
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Minor Essential Revisions (such as missing labels on figures, or the wrong use of a term, which the author can be trusted to correct) 
Abbreviations should be spelled out at their first occurrence: OR, WHI, HERS, SD and CI. 
There is an extraneous p value in the introduction: “Hormone therapy also alleviated sleeping problems 
(p>0.0001)”. Is it correct? Is the correct expression “p<0.01”? 
Page 5: Details of the design, randomization, eligibility and recruitment are described in a previous article. 
However, relevant details should be described in the present article in a summary form. Why there are different sample sizes in each arm? A flow diagram based in CONSORT statements is useful to help 
improve the report of the trial design. See, for example, Begg CB, Cho MK, Eastwood S, Horton R, Moher 
D, Olkin I, Rennie D, Schulz KF, Simel DL., Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996;276:637-639. This flow diagram can to provide a simple and straightforward summary of the design and other aspects of the trial. 
Have the general linear mixed model used in the analysis showed in table 2 a logit link and a Bernoulli 
distribution for the independent variable? This is an interesting detail when you describe the statistical tool. 
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Discretionary Revisions (which the author can choose to ignore) 
Why were used two different versions of the software R? 
 Accept after minor essential revisions What next?: 
 An article of importance in its field Level of interest: 
 Acceptable Quality of written English: 
 Yes, and I have assessed the statistics in my report. Statistical review: 
Declaration of competing interests: 
I declare that I have no competing interests.