Polish Adaptation and Psychometric Validation of the PREM-C9 Questionnaire for Patients with Chronic Obstructive Pulmonary Disease

Round 1

Reviewer 1 Report

Thank you for the opportunity to revise the manuscript  "Polish Adaptation and Psychometric Validation of the PREMC9 questionnaire dedicated for patients with chronic obstructive pulmonary disease". The manuscript is well written. I have only minor comments:

1. Table 5 is unclear. Please provide a footnote and explain what presented numbers mean. If these are partial correlations the numbers that are bold and in italics would be weak correlations and unlikely significant.  P values are either significant or not, and cannot be "close to significant" (and as far as I can tell p values are not presented here).

2. Please round numbers including p values to 2 decimal points

3. Line 129 please provide a reference to the original study

4. Line 288, please delete dot in the middle of a sentence

Nice work.

Author Response

Thank you for your comments.

•  Table 5 (Correlations between questions in PREM-C9) has been corrected.  The correlation coefficients and p-value were written on separate rows. After consulting a statistician, we left the results with p values ​​of 3 decimal points.
• Line 129: REFERENCES to the original study for all questionnaires used are provided in section 2.2 (Measures)

Reviewer 2 Report

Many thanks for the opportunity to contribute to the peer review process for the original article submission to Healthcare entitled "Polish Adaptation and Psychometric Validation of the PREM-C9 questionnaire dedicated for patients with chronic obstructive pulmonary disease" (healthcare-2603804).

The following comments are offered for consideration to assist refining the reporting of your work

Overall it is suggested that the term 'patients' be reviewed/reconsidered for the purposes of this submission. This project was not an interventional study and as such subjects were not patients receiving care by the researchers or clinicians associated with any study design/parameters - consequently 'subjects' or 'participants' may be more appropriate language (or even 'individuals with COPD') throughout this submission

Page 1, Abstract, line 21 - suggest amending to utilize person first language '...42 patients with COPD.'

Introduction, line 36 - suggest amending such that sentence does not start with an abbreviation

Page 2, lines 60 & 65- suggest amending/rephrasing such that sentence does not start with an abbreviation

line 76 - correct typographical error 'asses'

line 87 - suggest amending to depersonalize 'It is believed that...'

Page 3, Materials and Methods, line 111 - suggest amending to utilize person first language '...42 patients with COPD was...'

Page 4, Figure 1, Stage 1 box - correct typographical error 'professnional' and 'bilanual'

Stage 6 box - suggest amending to utilize person first language '...42 patients with COPD'

line 127- suggest supplementing to include the ethics approval number (for transparency)

page 5, line 147 - suggest amending/rephrasing such that sentence does not start with an abbreviation 'The PREM-C9...'

line 155 - suggest amending to depersonalize 'questionnaire, authors used...'

line 161 suggest amending/rephrasing such that sentence does not start with an abbreviation 'The CAT considers...'

page 6, line 169 - superscript 'TM' (or just refer to as 'CAT')

line 185 - suggest amending/rephrasing such that sentence does not start with an abbreviation 'The EQ-5D-5L is...'

line 191 - suggest supplementing with further citation details of the software used (amending as per correct versions used by authors): '... StatSoft Inc. statistical package Statistica [StatSoft, Inc. (2011) STATISTICA (Data Analysis Software System),  Version 10. http://www.statsoft.com] and the SPSS program [IBM Corp. Released 2021. IBM SPSS Statistics for Windows, Version 28.0. Armonk, NY: IBM Corp].'

Page 7, Results, Table 2- is reporting to 2 decimal points here really adding value for reader with these variables? With exception of SD, it is suggested that all other reporting to a single decimal point would suffice.

line 218 - suggest rephrasing to avoid presumptive emotive language 'to suffer from'

line 226 - is 'proven' the most correct word here? It is suggested consideration to amend to something like 'affirmed' as an alternate.

line 227 - as above, suggest review word choice 'proved' - perhaps 'confirmed' or 'demonstrated' as alternates

Page 8, Table 4 - is reporting to 6 decimal points here really adding value for reader with these variables? Suggest modify to 3 dp at most for this reporting.

Page 9, Table 5- is reporting to 6 decimal points here really adding value for reader with these variables? Suggest modify to 3 dp at most for this reporting

Page 10, Table 7 - review style of reporting - decimal point as a comma in this table is inconsistent with style of other tables using a full stop

Discussion, line 284 - review formatting - double parenthesis evident, incorrectly

line 288 - review full stop within middle of sentiment '...proven [23]. and...

Page 11, line 333 - suggest review abbreviation for consistency - elsewhere in submission is 'HRQoL'

Author Response

Thank you for your comments.

 - We have added the consent number of the Bioethics Committee to the text.

• We supplemeted details of the used software.
• Typographical errors have been corrected.
• We have corrected sentences starting with abbreviations.
• We  corrected figure 1 (boxes: 1, 6)
• Table 2 we have rounded the entry to two decimal places based on the comments    of all reviewers.
• Tables:  4 and 5  we have rounded the entry to three decimal places.
• Table 7: we used full stop and modified to 3 decimal points. 

Reviewer 3 Report

Very interesting topic for potential readers of the magazine. However, some comments are made in order to improve the current version of the manuscript.

.- Title. Maybe “dedicated” could be eliminated

.- Abstract. The acronym “PREM-C9” is repeated up to five times. Review.

.- Keywords. Perhaps “COPD” could be a keyword in itself. Consider adding “PREM-C9”

.- Introduction.

On page 2, in the last part of the page, the acronym “PREM-C9” is repeated up to six times. Review.

.- Method.

Was sample size estimation made? Justify.

Other doubts arise: average age of the patients, degree of disease (e.g. GOLD A, B or E), comorbidities, etc.

Statistic analysis. It is missing knowing the versions of the statistical packages.

.- Discussion. First part of the discussion is a summary of the results. Idem, at the end of this section. There is a lack of greater confrontation or not of the results obtained. It should be noted that only nine bibliographic citations are listed in this section.

Implications and limitations of the study.

The first paragraph refers to other types of patients. Maybe it could be removed.

Perhaps reference could be made to the PREM-C9 itself as a limitation (e.g. question 4)

.- Conclusions. The second part of the second conclusion is not an objective of this work. Review.

.- Tables. 7 tables may be excessive in terms of number. Review.

.- References. 38 citations are provided, of which 22 are recent (that is, five years or less from its publication). !! Congratulations!!

Reference 20, year in bold.

Reference 31, check journal name. It should be listed as “Heart Lung Cir.” Idem with other citations, p.e 29,38.

It is okey.

Author Response

 Thank you for your comments.

Method.
Was sample size estimation made? Justify.

There are no uniform guidelines regarding sample size in validation studies. This was indicated in 5. Implications and limitations of the study along with the source. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5463570/ ] The sample size was similar to many other studies of this type and sufficient to allow statistical tests

average age of the patients, degree of disease (e.g. GOLD A, B or E), comorbidities, etc.

The basic demographic characteristics are given in Table 1. The age of the patients was typical for the diagnosis of COPD in Poland. The stage of the disease was determined using the CAT test and questions about mMRC dyspnea.

Statistic analysis. It is missing knowing the versions of the statistical packages.

We added this information.

First part of the discussion is a summary of the results. Idem, at the end of this section. There is a lack of greater confrontation or not of the results obtained. It should be noted that only nine bibliographic citations are listed in this section and Implications and limitations of the study. The first paragraph refers to other types of patients. Maybe it could be removed.

It should be emphasized that the discussion in the article was very difficult to conduct due to the lack of a significant number of studies that used the PREM-C9 questionnaire or another of the same type. For this reason, the authors decided to conduct the discussion more broadly, trying to capture the context of validation studies on PROMs and PREMs. We hope that with the development of research in this area, it will be possible to conduct a broader discussion in relation to PREM-C9.

Tables. 7 tables may be excessive in terms of number. - We changed it.

and:

-  We have made the recommended correction to the title.

- We have limited the number of repetitions of the „PREM-C9”  to the necessary     

           minimum.

- We have supplemented the „Keywords” with PREM-C9.

- We have corrected reference 31, 29, 38