Non-pharmacological delirium detection and management interventions for informal caregivers of older people at home: A scoping review protocol

Mary T. Fox; Ilo-Katryn Maimets; Jeffrey I. Butler; Souraya Sidani; Christina Godfrey

doi:10.1371/journal.pone.0308886

Peer Review History

Original SubmissionJune 21, 2024
23 Jul 2024 Decision Letter - Pedro Kallas Curiati, Editor PONE-D-24-24285Non-pharmacological delirium detection and management interventions for informal caregivers of older people at home: a scoping review protocolPLOS ONE Dear Dr. Fox, 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. The area of the proposed systematic review is of great interest, but the study protocol needs substantial revision prior to being considered for publication. I hope the reviewer's suggestions will help you in this process. Please submit your revised manuscript by Sep 06 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. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. 3. Please provide a complete Data Availability Statement in the submission form, ensuring you include all necessary access information or a reason for why you are unable to make your data freely accessible. If your research concerns only data provided within your submission, please write "All data are in the manuscript and/or supporting information files" as your Data Availability Statement. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Yes Reviewer #2: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Yes Reviewer #2: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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: No ****** 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 and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This proposal addresses a highly relevant topic, particularly due to the universally high incidence of delirium. The methodology appears to be suitable and interesting; however, the authors' assertion that “no reviews have identified and mapped the available evidence on interventions that aim to help informal caregivers identify and/or manage delirium in an older person at home.” requires further clarification. For illustrative examples, please refer to the attached articles. Young, J., Inouye, S. K., & Marcantonio, E. R. (2015). Delirium in older people. BMJ (Clinical research ed.), 350, h279. We searched Ovid MEDLINE, Embase, and the Cochrane Library for the past 6 years, from January 1, 2011 until March 16, 2017 using a combination of controlled vocabulary and keyword terms. Since delirium is more prevalent in older adults, the focus was on studies in elderly populations; studies based solely in the intensive care unit (ICU) and non-English-language articles were excluded. Advances in diagnosis can improve recognition and risk stratification of delirium. Prevention of delirium using nonpharmacologic approaches is documented to be effective, while pharmacologic prevention and treatment of delirium remains controversial. Patnode CD, Perdue LA, Rossom RC, Rushkin MC, Redmond N, Thomas RG, Lin JS. Screening for Cognitive Impairment in Older Adults: An Evidence Update for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Feb. Report No.: 19-05257-EF-1. PMID: 32129963. Caregiver and caregiver-patient dyad interventions including psychoeducation for the caregiver and care and case management interventions, reported in 88 trials (n=14,880), resulted in a consistent benefit on caregiver burden and depression outcomes. Effect sizes were mostly small, however, and were of unclear clinical significance. Little harm was evident in the few nonpharmacologic intervention trials that reported harms. Reviewer #2: Review comments Thank you for your protocol on a scoping review which will address an important, and under-researched topic. A few comments 1. Your introduction is written very much from the perspective of interventions that informal carers may continue at home, after a delirium in hospital. However, you also state that you will include papers for interventions commenced at home, where a person has developed delirium but not been admitted to hospital. I think the latter is potentially a very interesting area to explore, as interventions by informal carers may prevent hospital admission, and thus worsening of delirium. If you wish to include this scenario in your review, I suggest reframing your introduction. 2. In your introduction you write that there have been no reviews conducted on this topic but then say in an initial search you identified four studies which had not been included in previous reviews. Please clarify what these previous reviews were on, as it is not clear. 3. In outcomes (1) I would also include carers’ burden or stress, as this is likely to be a barrier to implementation of such interventions. 4. In outcomes (3) I would also include a question about what the characteristics of the caregivers were, if reported. i.e. is the intervention only feasible if the informal caregiver lives with the patient. Do they need a certain level of literacy / digital literacy. 5. Types of sources – this needs a little clarification and would read better if split up into individual statements, rather than use of multiple semicolons. You state that eligibility will be confirmed when the paper cites an intervention reported in an effectiveness study or the included effectiveness study cites the paper as providing additional information about the intervention, or when the study author(s) confirm that the paper describes the interventionyou will first search for any study which evaluates an intervention and then search for studies or grey literature which describes the intervention. Does the citation requirement refer just to the grey literature or also to qualitative studies as well? This will clearly narrow your inclusion criteria if so. Please then justify this in your methods. 6. Please describe where data will be available when the study is complete ****** 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: Dr Anna Seeley ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0308886.r001
Revision 1
30 Jul 2024 Author Response Journal Requirements Comment: 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Response: We have carefully reviewed the manuscript to ensure it meets PLOS ONE's style requirements. Comment: 2. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. Response: We have ensured the ‘Funding Information’ and ‘Financial Disclosure’ sections match. The financial support provided did not include specific grant numbers. Comment: 3. Please provide a complete Data Availability Statement in the submission form, ensuring you include all necessary access information or a reason for why you are unable to make your data freely accessible. If your research concerns only data provided within your submission, please write "All data are in the manuscript and/or supporting information files" as your Data Availability Statement. Response: We have provided a complete Data Availability Statement in the submission form. Given that this is a protocol and does not report results, we selected “N/A” – No results are reported. We also indicate “No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.” Reviewer 1 Comment: This proposal addresses a highly relevant topic, particularly due to the universally high incidence of delirium. The methodology appears to be suitable and interesting; however, the authors' assertion that “no reviews have identified and mapped the available evidence on interventions that aim to help informal caregivers identify and/or manage delirium in an older person at home.” requires further clarification. For illustrative examples, please refer to the attached articles. Young, J., Inouye, S. K., & Marcantonio, E. R. (2015). Delirium in older people. BMJ (Clinical research ed.), 350, h279. We searched Ovid MEDLINE, Embase, and the Cochrane Library for the past 6 years, from January 1, 2011 until March 16, 2017 using a combination of controlled vocabulary and keyword terms. Since delirium is more prevalent in older adults, the focus was on studies in elderly populations; studies based solely in the intensive care unit (ICU) and non-English-language articles were excluded. Advances in diagnosis can improve recognition and risk stratification of delirium. Prevention of delirium using nonpharmacologic approaches is documented to be effective, while pharmacologic prevention and treatment of delirium remains controversial. Patnode CD, Perdue LA, Rossom RC, Rushkin MC, Redmond N, Thomas RG, Lin JS. Screening for Cognitive Impairment in Older Adults: An Evidence Update for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Feb. Report No.: 19-05257-EF-1. PMID: 32129963. Caregiver and caregiver-patient dyad interventions including psychoeducation for the caregiver and care and case management interventions, reported in 88 trials (n=14,880), resulted in a consistent benefit on caregiver burden and depression outcomes. Effect sizes were mostly small, however, and were of unclear clinical significance. Little harm was evident in the few nonpharmacologic intervention trials that reported harms. Response: We were unable to locate the recommended article by Young et al (2015). We believe that there may have been an error in the citation. However, we found the passage in a review article by Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in older persons: advances in diagnosis and treatment. Jama. 2017 Sep 26;318(12):1161-74.The Oh et al, 2017 review article restricted studies to RCTs which would have precluded the retrieval of descriptive studies which our review attempts to overcome. Also, the review article restricted studies to those published in English in the 6-year period prior to 2017 – which are major limitations given that delirium is a global issue and there is likely untapped knowledge published in other languages that could enhance understanding of how to help caregivers detect and manage delirium. Lastly, this review article was not focused on studies aiming to help informal caregivers detect and manage delirium. Consequently, this lack of focus likely precluded finding this body of knowledge. Thank you for drawing our attention to the Patnode et al (2020) review. However, the review questions and findings pertained to dementia and mild cognitive impairment, not delirium. Here is a passage that provides evidence of this (page 26): “We identified 224 trials representing more than 50,000 patients and or caregivers and three cohort studies with more than 190,000 patients that address the treatment or management of MCI or mild to moderate dementia”. Reviewer 2 Comment: Your introduction is written very much from the perspective of interventions that informal carers may continue at home, after a delirium in hospital. However, you also state that you will include papers for interventions commenced at home, where a person has developed delirium but not been admitted to hospital. I think the latter is potentially a very interesting area to explore, as interventions by informal carers may prevent hospital admission, and thus worsening of delirium. If you wish to include this scenario in your review, I suggest reframing your introduction. Response: We have reframed the introduction by providing more information about the prevalence of delirium in the community-dwelling non-hospital population and its increasing prevalence with advancing age. We also explain that delirium often occurs at the onset of an older person’s acute illness or exacerbation of a chronic illness which may occur at home. We propose that caregivers need to be aware of the signs of delirium so that they can seek medical attention from their primary care providers which may prevent hospital admission and the worsening of delirium. Comment: In your introduction you write that there have been no reviews conducted on this topic but then say in an initial search you identified four studies which had not been included in previous reviews. Please clarify what these previous reviews were on, as it is not clear. Response: We now clarify that this search identified four unique articles that were not included in the four prior reviews that included studies conducted with the caregivers of older adults at home. Comment: In outcomes (1) I would also include carers’ burden or stress, as this is likely to be a barrier to implementation of such interventions. Response: We plan to synthesize the evidence on all caregiver outcomes including burden or stress. We have clarified this by including burden and stress as examples in the types of outcomes that may possibly be reported in studies. a) What outcomes have been examined (e.g., improvement in caregivers’ knowledge of delirium, ability to recognize delirium, ability to manage delirium, burden, and stress)? Comment: In outcomes (3) I would also include a question about what the characteristics of the caregivers were, if reported. i.e. is the intervention only feasible if the informal caregiver lives with the patient. Do they need a certain level of literacy / digital literacy. Response: In the section on review questions, we now include: 4. What were the characteristics of the caregivers that were included in the studies? a) What were the living arrangements of the caregivers (e.g., living with the patient)? b) What was the level of literacy of the caregivers (e.g., health and digital literacy, reading level)? We opted not to locate this question in the outcomes to ensure conceptual clarity. Comment: Types of sources – this needs a little clarification and would read better if split up into individual statements, rather than use of multiple semicolons. You state that eligibility will be confirmed when the paper cites an intervention reported in an effectiveness study or the included effectiveness study cites the paper as providing additional information about the intervention, or when the study author(s) confirm that the paper describes the intervention you will first search for any study which evaluates an intervention and then search for studies or grey literature which describes the intervention. Does the citation requirement refer just to the grey literature or also to qualitative studies as well? This will clearly narrow your inclusion criteria if so. Please then justify this in your methods. Response: We have removed the semi-colon and have split the sentence up to enhance its readability. There is no citation requirement. We now number the criteria so that readers can clearly see that any one criterion can be met for the paper to be eligible. We now state “The eligibility of these descriptive papers will be confirmed when 1) the paper cites an intervention reported in an effectiveness study, 2) the included effectiveness study cites the paper as providing additional information about the intervention, or 3) the study author(s) confirm that the paper describes the intervention. Comment: Please describe where data will be available when the study is complete Response: We now explain that the data will be available from the first author upon request. Attachments Attachment Submitted filename: Delirium SR_Response to Reviewers_30_july2024.docx https://doi.org/10.1371/journal.pone.0308886.r002
1 Aug 2024 Decision Letter - Pedro Kallas Curiati, Editor Non-pharmacological delirium detection and management interventions for informal caregivers of older people at home: a scoping review protocol PONE-D-24-24285R1 Dear Dr. Fox, 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 Editorial Manager® 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, Pedro Kallas Curiati, M.D., Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0308886.r003
Formally Accepted
12 Sep 2024 Acceptance Letter - Pedro Kallas Curiati, Editor PONE-D-24-24285R1 PLOS ONE Dear Dr. Fox, 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. Pedro Kallas Curiati Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0308886.r004

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