Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic: Analysis of linked cohort data

Emily Peckham; Victoria Allgar; Suzanne Crosland; Paul Heron; Gordon Johnston; Elizabeth Newbronner; Panagiotis Spanakis; Ruth Wadman; Lauren Walker; Simon Gilbody

doi:10.1371/journal.pone.0258349

Peer Review History

Original SubmissionMarch 23, 2021
15 Jul 2021 Decision Letter - Stanton A. Glantz, Editor PONE-D-21-09538 Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic: analysis of linked cohort data PLOS ONE Dear Dr. Peckham, 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 Aug 29 2021 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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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: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No Reviewer #2: Yes ****** 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: No Reviewer #2: Yes ****** 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 ****** 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: Introduction References supporting the claim that people with SMI are at increased risk during a pandemic are not provided; while this statement has face validity, the authors should provide literature supporting this claim, even if it is only through referencing similar situations. Methods The data appear to rely solely on self-report of health behaviors; it is not clear whether these reports reflect actual behavior (historically, for example, self-reports about consumption of produce poorly reflect actual consumption). Better description of the OWLS subcohort is needed; current description does not meet research checklist guidelines (see Equator Network for details). Authors do not fully describe the questions in the survey instrument: no supplement with these details was included in the manuscript provided for review, nor was one mentioned in the text. Scaling of global health and wellbeing is rudimentary and given the potential overlap in underlying concepts, some estimation indicating whether these measures are loading together would be critical (e.g. factor analysis, SEQ). There is no indication of why a binary measure of race/ethnicity would be valid in this sample. No research supporting the decision to measure relative deprivation by postcode analysis is provided. Capitalize Poisson. 40.3% is not a majority; it is (apparently) a plurality. Critically, the specific dates used to define pre- and post-COVID periods are not provided. Results Response rate is not provided (please use standardized response rate from AAPOR or another comparable source). Race/ethnicity was proposed as a binary variable in methods but broken out by additional categories in results; this is inconsistent, and the choice of categories is not well-explained. Table 1 is difficult to read given that counts and percentages are placed in a single column; in addition, standard deviations for measures are not provided. Table 2 has similar issues, in addition, placing pre- and post-COVID variables vertically rather than horizontally makes it difficult to for the reader to assess changes. Table 4: unclear why univariate models are included at all; table formatting is challenging to read (eg CIs spread across multiple lines, significant associations not distinguished from non-significant with asterisks/bolding, spacing spreads results across multiple pages), and dependent variable is not explicitly stated. Associations between health-harming behaviors and deterioration raised questions of causality. It is unclear to what extent these behaviors would be unique to people with SMI. Discussion Comparisons in discussion suggest decreases in physical activity/increase in smoking but do not test for statistical significance, making it unclear whether these are meaningful. The sources of these claims are not linked to the results section (where the tests for significance should be reported). Links should be included as references not in the text of the manuscript. Conclusions re: the need for health services are not clearly linked to results. Data availability PLOS 1 historically requests that data underlying analysis be made available through a public repository, or, if held by an organization that limits access to data for reasons of confidentiality, for example a government agency that retains protected health information, that a detailed description of how to submit a formal data request and obtain a standardized dataset be provided, e.g. through a website with an explanation of what forms must be completed and what variables to request. The statement that data are “available upon request from the corresponding author” does not meet either standard. Reviewer #2: This is an interesting manuscript dealing with a timely topic. Overall, it is well-conducted, although the authors should address several points. Abstract -Some information on the participants features should be provided (sex, age) -There is no significant association between younger and an increase in health-risk behaviours since the IC comprises 1. This is not worth mentioning here. Introduction -It is mainly well-conducted, but I think that you should mention more relevant studies to support your argument. For instance, since the pandemic has affected health-risk behaviours in general population, this might be exacerbated in people with mental illness. Also, as a consequence of a lack of physical activity, mental health might be deteriorated https://pubmed.ncbi.nlm.nih.gov/32581985/ https://pubmed.ncbi.nlm.nih.gov/32793013/ -An initial hypothesis based on your rationale should be provided Methods -Could you provide more information on your sampling framework. It seems as if you have been selecting individuals by those mentioned criteria, but that is not sampling. -According to the procedure, only those who accepted were included in the study, thus there is a participation rate, I guess. -Were the questions to assess health-related behaviours or self-reported changes validated? -The way you explain why you use Poisson regression is too wordy. You don´t need to explain your prior plans -Why did you select such covariates? -Did you have missing values? Results -When you report decimals in your Tables, you should stick to always the same number of those -Table 4 needs to report the confounders you adjusted your models Discussion -Your study has three clear bias that should be mentioned: recall bias, selection bias (not real sampling), and causal bias, since your design does not allow to reach causes Conclusion -It is the first time I see citations in a Conclusion ****** 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?** For information about this choice, including consent withdrawal, please see our Privacy Policy. 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Revision 1
23 Aug 2021 Author Response a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. We are not able to share a de-identified data set as we do not have consent from the research participants to do this. We have checked with the GDPR team at the University of York and they have advised us that we cannot upload this data to a public repository without explicit consent from the study participants. They did however advise us that we could upload an aggregated data set which we are planning to do. We have consulted with the Research Ethics Committee that approved our study and they confirmed that it would be acceptable for us to upload the aggregated dataset to a public repository. We are currently preparing the data set for uploading and will send you the link as soon as it is done. As this is COVID-19 research, we didn’t want to delay the processing of the responses to the other comments hence we have submitted them now. Data requests for the full dataset may be sent to the Closing the Gap Network email: ctg-network@york.ac.uk whose Steering Committee manage our data access requests. Reviewer One Introduction 1. References supporting the claim that people with SMI are at increased risk during a pandemic are not provided; while this statement has face validity, the authors should provide literature supporting this claim, even if it is only through referencing similar situations. We have added a citation to support the statement that people with SMI may be at increased risk. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7250778/) Methods 2. The data appear to rely solely on self-report of health behaviors; it is not clear whether these reports reflect actual behavior (historically, for example, self-reports about consumption of produce poorly reflect actual consumption). We agree that self-reported data is not always accurate however there is no clear way of collecting objective data on health risk behaviours, e.g. smoking status can be verified by CO measurement but this cannot tell us how many cigarettes a person is smoking per day. This means that we have had to reply on self-report data. We have stated this as a limitation in our discussion. “Secondly, the survey relies on self-reported data and people may not accurately recall or may not want to accurately answer the question/s. However this is true for any form of survey that does not have a way of verifying the data provided. Thus the results should be interpreted with this in mind.” 3. Better description of the OWLS subcohort is needed; current description does not meet research checklist guidelines (see Equator Network for details). We apologise for this oversight. We have now attached a completed STROBE checklist, added additional text (page 21) to explain how the sub-cohort relates to the original cohort and added a flow diagram (Figure 1). “From the 2,932 participants in the CtG study that were eligible to be invited to OWLS, we selected a sample of 1,166 (39.8 %) participants to attempt to contact and successfully contacted 688 (59%). The survey was completed by 367 participants (31.5% of those eligible to be invited and 53.3% of those successfully contacted) see Figure 1.” 4. Authors do not fully describe the questions in the survey instrument: no supplement with these details was included in the manuscript provided for review, nor was one mentioned in the text. We are sorry for this omission. We have included the survey as a supplementary file 5. Scaling of global health and wellbeing is rudimentary and given the potential overlap in underlying concepts, some estimation indicating whether these measures are loading together would be critical (e.g. factor analysis, SEQ). We have amended the title on page 8 to “wellbeing” to provide greater clarity. These item under “wellbeing” are the four ONS Wellbeing questions. ”https://www.ons.gov.uk/peoplepopulationandcommunity/wellbeing/methodologies/surveysusingthe4officefornationalstatisticspersonalwellbeingquestions” We have scaled these using the standard scaling used by the ONS. This measure is widely used in ONS general population surveys. 6. There is no indication of why a binary measure of race/ethnicity would be valid in this sample. It is widely acknowledged that people from BAME groups are more at risk from COVID-19 and thus we wanted to test whether or not a person came from a minority group had any influence on behaviours harmful to health. We have added clarification about this to page 9. “As people form BAME backgrounds are more at risk from COVID-19 we wanted to determine whether they were also more at risk from health risk behaviours.” 7. No research supporting the decision to measure relative deprivation by postcode analysis is provided. We used this because this is how the UK Government and the Ministry of Housing and Communities measure relative deprivation. (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/853811/IoD2019_FAQ_v4.pdf) 8. Capitalize Poisson This has been corrected. 9. 40.3% is not a majority; it is (apparently) a plurality We have removed the term “majority” 10. Critically, the specific dates used to define pre- and post-COVID periods are not provided. We have clarified in the text on page 7 that before the pandemic refers to prior to the pandemic restrictions coming into force. In the results section we give the dates between which the participants completed the questionnaire (July 2020-December 2020) i.e. during the pandemic. “In the questionnaire before the pandemic refers to before the pandemic restriction came into force in the UK on the 23rd March.” Results 11. Response rate is not provided (please use standardized response rate from AAPOR or another comparable source). This has now been provided in the flow chart in Figure 1. 12. Race/ethnicity was proposed as a binary variable in methods but broken out by additional categories in results; this is inconsistent, and the choice of categories is not well-explained. We provide fuller demographics for the reader to have a fuller picture of the ethnicity composition of the study however in the model we categorised these into BAME and Non BAME for the reasons described in point 6. 13. Table 1 is difficult to read given that counts and percentages are placed in a single column; in addition, standard deviations for measures are not provided. It is standard reporting to quote ‘n’ and ‘%’ in the same column. Where measures are continuous we have provided the mean and standard deviation. For catergorical variables were quote ‘n’ and ‘%’ for each category. 14. Table 2 has similar issues, in addition, placing pre- and post-COVID variables vertically rather than horizontally makes it difficult to for the reader to assess changes. As the pre and post COVID variables are not the same it was unfortunately not possible to place them horizontally side by side. 15. Table 4: unclear why univariate models are included at all; table formatting is challenging to read (eg CIs spread across multiple lines, significant associations not distinguished from non-significant with asterisks/bolding, spacing spreads results across multiple pages), and dependent variable is not explicitly stated. Thank you for this advice, we have deleted the results of the univariate model and the CIs are now all on one line. In addition we have asterisked the significant results. 16. Associations between health-harming behaviors and deterioration raised questions of causality. We agree with this comment and acknowledge that we cannot determine causality. “We do not know whether an increase in health risk behaviours led to a deterioration in physical health or whether a deterioration in physical health led to people being less able to take care of themselves, and this relationship is likely to be bidirectional.” 17. It is unclear to what extent these behaviors would be unique to people with SMI. We agree that is it unclear to what extent these behaviours would be unique to people with SMI. We make comparisons to the general population throughout the discussion to provide context to the reader. Discussion 18. Comparisons in discussion suggest decreases in physical activity/increase in smoking but do not test for statistical significance, making it unclear whether these are meaningful. The sources of these claims are not linked to the results section (where the tests for significance should be reported). We were not able to test the changes in physical activity and smoking for significance as we didn’t have a pre and post measure. We captured the change via a single item for each behaviour which read “please let us know how each of the following habits might have changed since the pandemic restrictions began” with the possible responses “I don’t do that in general”, “More than usual”, “About the same” or “less than usual”. 19. Links should be included as references not in the text of the manuscript. We have included the links as references. Conclusions 20. re: the need for health services are not clearly linked to results. Thank you we have removed the word ‘health’ and now state that there is a need for services that target health risk behaviours, we believe this to be the case as any increase in health risk behaviour needs to be addressed especially in a group already at risk from higher levels of health risk behaviours and the subsequent effects on both physical and mental health. Health risk behaviours are in part what is leading to the mortality gap people with SMI currently experience. Data availability 21. PLOS 1 historically requests that data underlying analysis be made available through a public repository, or, if held by an organization that limits access to data for reasons of confidentiality, for example a government agency that retains protected health information, that a detailed description of how to submit a formal data request and obtain a standardized dataset be provided, e.g. through a website with an explanation of what forms must be completed and what variables to request. The statement that data are “available upon request from the corresponding author” does not meet either standard. Unfortunately we do not have ethical permission to upload patient level data to a public repository. We will discuss with PLOS ONE what we are able to do. Reviewer Two Abstract 1. Some information on the participants features should be provided (sex, age) We have added an additional sentence to the abstract with this information. “The mean age was 50.5 (range = 20 to 86, SD ± 15.69) with 51.0% male and 77.4% white British” 2. There is no significant association between younger and an increase in health-risk behaviours since the IC comprises 1. This is not worth mentioning here. Thank you, we have removed the reference to age as a significant association from the abstract. Introduction 3. It is mainly well-conducted, but I think that you should mention more relevant studies to support your argument. For instance, since the pandemic has affected health-risk behaviours in general population, this might be exacerbated in people with mental illness. Also, as a consequence of a lack of physical activity, mental health might be deteriorated https://pubmed.ncbi.nlm.nih.gov/32581985/ https://pubmed.ncbi.nlm.nih.gov/32793013/ Thank you these references have now been included. 4. An initial hypothesis based on your rationale should be provided In this study we sought to explore the health risk behaviours of people with SMI during COVID-19. The study is an exploratory study and as such is not derived from any theoretical framework, therefore we had no specific hypothesis about how health risk behaviours in people with SMI might have changed. We have clarified this at the end of the introduction. “This is an exploratory study rather than being derived from a theoretical framework.” 5. Could you provide more information on your sampling framework. It seems as if you have been selecting individuals by those mentioned criteria, but that is not sampling. We have created a flow diagram and added some additional information about the sampling to the manuscript. See response to Reviewer One comment 3. 6. According to the procedure, only those who accepted were included in the study, thus there is a participation rate, I guess. Yes, however we have now provided additional detail, see response to previous comment. 7. Were the questions to assess health-related behaviours or self-reported changes validated? Questions to assess health related behaviours were self-reported, see response to Reviewer One comment 2. 8. The way you explain why you use Poisson regression is too wordy. You don´t need to explain your prior plans We have included this for transparency as we have deviated from the plans in our pre-published analysis plan to prevent any future criticism about deviations from our plan. 9. Why did you select such covariates? The aim of the analysis was to explore the association between the changes in health risk behaviours and changes in physical and mental health adjusting for key sample characteristics. We selected these variables based on experts in the field, statisticians and our lived experience panel. 10. Did you have missing values? We have added details to Tables 1 and 2 regarding missing values. Results 11. When you report decimals in your Tables, you should stick to always the same number of those. Thank you for spotting this, this has now been corrected. 12. Table 4 needs to report the confounders you adjusted your models Table 4 previously reported both the univariate and multivariate models and so the associations in the univariate models for each independent variable were adjusted for the presence of the other variables in the model. Following the advice of Reviewer One we removed the univariate models from Table 4. Discussion 13. Your study has three clear bias that should be mentioned: recall bias, selection bias (not real sampling), and causal bias, since your design does not allow to reach causes We have added an additional point to the limitations about recall bias (see response to reviewer one, point 2). We used a sampling framework to sample participants from our cohort, rather than use a convenience sample, we have acknowledged in the limitations section that we may not have been able to contact the most vulnerable section of the SMI population and the efforts we went to, to do all we could to include them. We have not sought to make any claims about causation and have clarified this in the limitations section. “Thirdly, the design used in this study does not allow us to determine the causes of any changes in health related behaviours so we cannot be certain as to why behaviours might have changed.” Conclusion 14. It is the first time I see citations in a Conclusion We wanted to include these citations as we felt it was important for the reader to realise that we were not making statements that were not backed up by evidence. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0258349.r002
27 Sep 2021 Decision Letter - Jagdish Khubchandani, Editor Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic: analysis of linked cohort data PONE-D-21-09538R1 Dear Dr. Peckham, 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 for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, 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, Jagdish Khubchandani Academic Editor PLOS ONE Additional Editor Comments (optional): Thank you for the revisions and clarifications. 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 #2: All comments have been addressed ******** 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 #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? 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 #2: Yes ****** 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 #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 #2: (No Response) ****** 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 #2: No https://doi.org/10.1371/journal.pone.0258349.r003
Formally Accepted
5 Oct 2021 Acceptance Letter - Jagdish Khubchandani, Editor PONE-D-21-09538R1 Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic: analysis of linked cohort data Dear Dr. Peckham: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. 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 plosone@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. Jagdish Khubchandani Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0258349.r004

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