Smoking as a risk factor for lower extremity peripheral artery disease in women compared to men: A systematic review and meta-analysis

Ying Xu; Anna Louise Pouncey; Zien Zhou; Mark Woodward; Katie Harris

doi:10.1371/journal.pone.0300963

Peer Review History

Original SubmissionDecember 22, 2023
15 Feb 2024 Decision Letter - Athanasios Saratzis, Editor PONE-D-23-43121Smoking as a risk factor for lower extremity peripheral artery disease in women compared to men: a systematic review and meta-analysisPLOS ONE Dear Dr. Xu, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Mar 31 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Thanks for the opportunity to review this manuscript reporting the results of a meta-analysis of studies reporting whether the relationship between smoking and peripheral arterial disease differs by sex. The authors have carried out a rigorous review of available literature and a statistically sound meta-analysis. Prior to publication, I recommend a few minor edits to be made: Introduction/Discussion: • Important to explain to the reader that there is significant under-recognition of cardiovascular risk in women and failure to recognise the importance of secondary prevention, sex-related differences in clinical presentation, and delay in presentation and misperception of cardiovascular disease in women. These factors contribute to peripheral arterial disease being underdiagnosed and understudied in women (see doi:10.1007/S11883-018-0742-X and PMID: 34010613). As well as in the introduction, it is worth emphasising this point in the discussion: Lines 313 – 326. Methodology: • Line 82 - Authors mention passive smoking is not included yet they have included it in their search strategy • Increased risk of bias given that only one reviewer has screened and identified articles – please discuss this in the limitations of the manuscript. (see: https://doi.org/10.1016/j.jclinepi.2020.01.005) • The authors state that they contacted individuals of potentially eligible studies. Please include how this was carried out and whether it was standardised. Results: • Line 149 & 150 – Please include SD of mean follow up & IQR of median follow up of the studies. Reviewer #2: The authors submitted a systematic review and meta-analysis concerning smoking as risk factor for PAD in women related to men. The methodology is sound, and the conclusions justified. The discussion is weighty but addresses a variety of sex related differences in PAD. I think this paper excellent and is an important addition to the literature, complements on their work. Thanks to authors for adhering to their Prospero submission. One major comment: Line 100: The authors report only one reviewer screening all the documents by title, abstract and full text. This one reviewer also performed all the extractions with a second reviewer. Please account for this in your limitation section, as it introduces bias. Minor comments: Line 86: diagnostic and procedure codes, are these listed anywhere, can they be included? Line 103: did you use a programme for citation review? Line 110: how much missing data did you encounter, is this reported in the results? Line 120: did you look at the level of agreement between your two reviewers? i.e. via cohen kappa. Line 143: may be worth stating this an upper-middle income country still. Line 326: this sentence can strengthened with the result included within the sentence. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? 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Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0300963.r001
Revision 1
6 Mar 2024 Author Response Reviewer #1: Thanks for the opportunity to review this manuscript reporting the results of a meta-analysis of studies reporting whether the relationship between smoking and peripheral arterial disease differs by sex. The authors have carried out a rigorous review of available literature and a statistically sound meta-analysis. Prior to publication, I recommend a few minor edits to be made: Introduction/Discussion: • Important to explain to the reader that there is significant under-recognition of cardiovascular risk in women and failure to recognise the importance of secondary prevention, sex-related differences in clinical presentation, and delay in presentation and misperception of cardiovascular disease in women. These factors contribute to peripheral arterial disease being underdiagnosed and understudied in women (see doi:10.1007/S11883-018-0742-X and PMID: 34010613). As well as in the introduction, it is worth emphasising this point in the discussion: Lines 313 – 326. Response: Thank you for this good point. Other than the paragraph in Discussion, we have added more background for PAD in women in the Introduction, and now it reads “The importance of cardiovascular risk in women is under-recognized, especially for peripheral artery disease (PAD). Due to higher rates of asymptomatic disease or atypical symptoms in women with PAD, they are often diagnosed at later stages of the disease, and thus are less likely to receive interventions to prevent advanced PAD and adverse outcomes of amputation, coronary heart disease (CHD), and stroke [1].” (lines 50 to 54) Methodology: • Line 82 - Authors mention passive smoking is not included yet they have included it in their search strategy Response: This is a good point too. We did include “Passive Smoking” as a subject heading for one database CINAHL by mistake and it would unnecessarily increase the number of identified records and workload. We updated our search on 3 March 2024 and corrected this error. In this search, we also removed “Limit S4 to Research or Journal Article, Human” in the CINAHL, because applying limits to “Research or Journal Article” did not reduce the number of identified records and the function of limit to “Human” was not available in this search. No additional studies were added into our review from this updated search, but there were three additional records (listed below) that were excluded in the full-text screening process (S2 File), under “No reports on the association between smoking and peripheral arterial disease”: Baretella O, Buser L, Andres C, Häberli D, Lenz A, Döring Y, et al. Association of sex and cardiovascular risk factors with atherosclerosis distribution pattern in lower extremity peripheral artery disease. Front Cardiovasc Med. 2023;10:1004003. doi: 10.3389/fcvm.2023.1004003. Martelli E, Zamboni M, Sotgiu G, Saderi L, Federici M, Sangiorgi GM, et al. Sex-Related Differences and Factors Associated with Peri-Procedural and 1 Year Mortality in Chronic Limb-Threatening Ischemia Patients from the CLIMATE Italian Registry. J Pers Med. 2023;13(2). doi: 10.3390/jpm13020316. Onofrei V, Adam CA, Marcu DTM, Leon MM, Cumpăt C, Mitu F, et al. Gender Differences and Amputation Risk in Peripheral Artery Disease-A Single-Center Experience. Diagnostics (Basel). 2023;13(19). doi: 10.3390/diagnostics13193145. • Increased risk of bias given that only one reviewer has screened and identified articles – please discuss this in the limitations of the manuscript. (see: https://doi.org/10.1016/j.jclinepi.2020.01.005) Response: We have now added this as a limitation (lines 348 to 351) “First, the literature search, screening, and data extraction were conducted by one reviewer, although reference lists and citation trails were sourced to capture studies that may be missed out, and data extraction was checked multiple times by this reviewer and by a second reviewer.” • The authors state that they contacted individuals of potentially eligible studies. Please include how this was carried out and whether it was standardised. “The authors of a few potentially eligible studies were contacted for their published full-text reports.” Response: We added more details on how and whether standardised (lines 104 to 106). “The authors of a few potentially eligible studies were contacted by emails with subjects/titles and contents drafted in a similar manner, for their published full-text reports.” As an example, here is an email to Professor Päivi Korhonen, email address: Arto.heikkila@fi mnet.fi Dear Professor Päivi Korhonen, Re Heikkilä A, Venermo M, Kautiainen H, Aarnio P, Korhonen P. Short stature in men is associated with subclinical peripheral arterial disease. Vasa. 2016 Nov;45(6):486-490. doi: 10.1024/0301-1526/a000566. Please I may introduce myself. My name is Ying Xu. I am a Research Fellow at the George Institute for Global Health and Conjoint Lecture at the University of New South Wales in Sydney. I am conducting a systematic review and meta-analysis on sex difference in smoking as a risk factor for peripheral artery disease. I find the above-mentioned article of yours probably meet our inclusion criteria, but I cannot find the full text. May I please ask whether you would be happy to share the published full-text PDF or a word accepted version? Many thanks, Ying Results: • Line 149 & 150 – Please include SD of mean follow up & IQR of median follow up of the studies. Response: we have now added the interquartile interval “(interquartile interval 11.8, 13.3 years)” (lines 160 to 161) for one study, but the numbers were not reported by other studies. Reviewer #2: The authors submitted a systematic review and meta-analysis concerning smoking as risk factor for PAD in women related to men. The methodology is sound, and the conclusions justified. The discussion is weighty but addresses a variety of sex related differences in PAD. I think this paper excellent and is an important addition to the literature, complements on their work. Thanks to authors for adhering to their Prospero submission. One major comment: Line 100: The authors report only one reviewer screening all the documents by title, abstract and full text. This one reviewer also performed all the extractions with a second reviewer. Please account for this in your limitation section, as it introduces bias. Minor comments: Line 86: diagnostic and procedure codes, are these listed anywhere, can they be included? Response: This is related to cohort studies, and we have now added the following text and point readers to S2b Table for codes “Hospitalized or fatal PAD were identified using International Classification of Diseases and/or procedure codes in all cohort studies (S2b Table for codes) [14, 21-23]. One study used Health Data Research UK’s PAD phenotyping definitions and coding system and additionally identified PAD diagnoses in primary care [21].” (lines 161 to 164) We also added “(search for “PH236” on https://phenotypes.healthdatagateway.org/ )” in S2b Table for one study, England 2015, Pujades-Rodriguez, as a completed list would be lengthy. Line 103: did you use a programme for citation review? Response: We did not use a separate programme, although we have added more details on our citation review, which now it reads “Each included study was identified on the Web of Science database, from where studies on the reference list and subsequent studies that cited it were exported to Endnote, followed by the same title, abstract, and full-text screening process.” (lines 107 to 110) Line 110: how much missing data did you encounter, is this reported in the results? Response: In the Methods we now report that “When relevant information was not reported in a study, we presented it as missing value.”, and in the Results that ”All extracted information (S2a-d Table, Figs 2 and 3) were found in the studies. There were some missing data in S2e Table, as the numbers of former, current, and/or never smokers among women, men, and/or the whole study sample were not reported in a few studies [15, 18, 22, 25-27, 29, 30].” (lines 150 to 153) Line 120: did you look at the level of agreement between your two reviewers? i.e. via cohen kappa. Response: We have now added Cohen’s kappa along with some interpretations for reliability. In the Method, it reads “Interrater reliability was measured by Cohen’s kappa.” (line 127) In the Results, it reads “Cohen’s kappa was 0.42 for 28 items with 2 levels and 1 for 4 items with 3 levels in cohort studies. It was 0.46 for 52 items with 2 levels and 0.52 for 39 items with 3 levels in cross-sectional studies. After discussion, two reviewers reached agreements for all ratings in the quality assessments.” (lines 175 to 178) In the Discussion, “Second, Cohen’s kappa between two reviewers for quality assessment was largely in the 0.4 to 0.59 range, indicating moderate level of agreement [46]. (lines 351 to 353) Line 143: may be worth stating this an upper-middle income country still. Response: We made the sentence clearer as suggested, and it now reads “Three studies were conducted in an upper-middle income country, China [27-29].” (line 149-150) Line 326: this sentence can strengthened with the result included within the sentence. Response: We added the key finding to support this statement. Now, it reads “Our results suggested at least the same value of smoking abstinence in women and men, considering the observed equal hazardous effects or inconsistencies in the direction of sex differences.” (lines 342 to 344) Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0300963.r002
8 Mar 2024 Decision Letter - Athanasios Saratzis, Editor Smoking as a risk factor for lower extremity peripheral artery disease in women compared to men: a systematic review and meta-analysis PONE-D-23-43121R1 Dear Dr. Xu, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at http://www.editorialmanager.com/pone/ and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Athanasios Saratzis Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0300963.r003
Formally Accepted
1 Apr 2024 Acceptance Letter - Athanasios Saratzis, Editor PONE-D-23-43121R1 PLOS ONE Dear Dr. Xu, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Athanasios Saratzis Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0300963.r004

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