PONE-D-20-39424

Barriers in Utilizing Lipid-Lowering Agents for U.S. Civilians Non-Institutionalized Population: A Theoretical Approach

PLOS ONE

Dear Dr. Abdullah A Alfaifi,

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Olga A Sukocheva, PhD

Academic Editor

PLOS ONE

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After careful examination of the manuscript, we invite you to revise your manuscript. All reviewers' and Editor's comments should be addressed.

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More relevant references should be included. Although the research design is appropriate the methods should be adequately described to indicate what is the main difference of your study from the previous similar analyses.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

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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: This study describes a theoretical approach used to identify predisposing and enabling factors which impact use of lipid lowering drugs in USA population. Authors adapted the Andersen Behavioral Model. The study analyzed associations among socioeconomic factors and the use of antihyperlipidemic agents using data from the 2018 Medical Expenditure Panel Survey. The study aim is not novel and does not add any new knowledge. However, it does confirm previously found associations. There are many problems with this study.

1. Authors stated that (line 84)…”no study has explored access to lipid-lowering medications for patients with high blood cholesterol in the United States”. This is not entirely true. Those studies below addressed similar questions:

• Navar AM, Taylor B, Mulder H, Fievitz E, Monda KL, Fievitz A, Maya JF, López JAG, Peterson ED. Association of Prior Authorization and Out-of-pocket Costs With Patient Access to PCSK9 Inhibitor Therapy. JAMA Cardiol. 2017 Nov 1;2(11):1217-1225. doi: 10.1001/jamacardio.2017.3451. PMID: 28973087; PMCID: PMC5963012.

• Whayne TF. Outcomes, Access, and Cost Issues Involving PCSK9 Inhibitors to Lower LDL-Cholesterol. Drugs. 2018 Mar;78(3):287-291. doi: 10.1007/s40265-018-0867-9. PMID: 29396831.

• Salami JA, Warraich HJ, Valero-Elizondo J, Spatz ES, Desai NR, Rana JS, Virani SS, Blankstein R, Khera A, Blaha MJ, Blumenthal RS, Katzen BT, Lloyd-Jones D, Krumholz HM, Nasir K. National Trends in Nonstatin Use and Expenditures Among the US Adult Population From 2002 to 2013: Insights From Medical Expenditure Panel Survey. J Am Heart Assoc. 2018 Jan 22;7(2):e007132. doi: 10.1161/JAHA.117.007132. PMID: 29358195; PMCID: PMC5850149.

Notably, Salami et al., (2018) were using the same data base for their analysis. None of the above refs were cited.

2. Another problem with the study presentation. Authors claimed in the title that the study is a theoretical approach, while it is a cross-sectional data analysis ( indicated in Methods). So , the title is confusing. There is no information about the study type in the abstract. Cross -sectional type of study should be reflected clearly. The whole study should be adjusted to the cross-sectional type. Discussion should accent this.

3. It is indicated (line 95) that “The MEPS sample is a subsample of the National Health Interview Survey (NHIS) that the National Center for Health Statistics conducts.” – however, there is no link to the data. Is it publicly available data? Or access was granted? It is not indicated; no links provided.

4. Reference presentation is not appropriate/correct the reference list according to the journal requirements.

5. Study limitations are missing and should be described.

Reviewer #2: The manuscript by Alfaifi et al "Barriers in Utilizing Lipid-Lowering Agents for U.S. Civilians Non-Institutionalized Population: A Theoretical Approach." performed important theoretical study and relevant to the current scenario. The design and organization of the manuscript is well and noted worthy. authors used good English. I recommend the manuscript for publication in current form.

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Reviewer #1: No

Reviewer #2: Yes: NAGENDRA YARLA

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Barriers in utilizing lipid-lowering agents in non-institutionalized population in the U.S.: Application of a theoretical Framework

PONE-D-20-39424R1

Dear Dr. Alfaifi,

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.

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Kind regards,

Olga A Sukocheva, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. 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: I am satisfied with the revised version of this manuscript; authors addressed all my suggestions properly.

Reviewer #2: The manuscript by Alfaifi et al "Barriers in Utilizing Lipid-Lowering Agents for U.S. Civilians Non-Institutionalized Population: A Theoretical Approach." performed important theoretical study and relevant to the current scenario. The design and organization of the manuscript is well and noted worthy. authors used good English. I recommend the manuscript for publication in current form. Authors addressed questions and there is no concerns from my side.

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7. 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? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: Yes: NAGENDRA YARLA