PONE-D-22-15868Addressing a critical need: A randomised controlled feasibility trial of Acceptance and Commitment Therapy for bariatric surgery patients at 15-18 months post-surgeryPLOS ONE

Dear Dr. Barley,

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.

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Shahrad Taheri

Academic Editor

PLOS ONE

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Reviewers' comments:

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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: Yes

Reviewer #2: Partly

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

Reviewer #1: Yes

Reviewer #2: No

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Reviewer #1: No

Reviewer #2: No

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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: The authors reported about the results of a randomized controlled feasibility trial to test the feasibility and acceptability of ACT following bariatric surgery a randomized controlled trial of 10 sessions of group ACT or Usual Care Support Group control (SGC) was delivered 15- 18 months post bariatric surgery they concluded, that the trial

processes were feasible, but that the ACT intervention was not acceptable as delivered. Our data suggest changes to recruitment and intervention delivery that would address this.

First of all I would like to congratulate the authors for providing and consistently reporting this feasibility study. I do have some minor comments to the presentation, which could be easily addressed in a review.

The appropriate guideline is the "CONSORT statement on Pilot and Feasibility Trials (see BMJ 2016; 355:i5239 http://dx.doi.org/10.1136/bmj. i5239)". Please use this checklist, although the difference appears to be minor. The extra statement on page 6 might not be necessary.

p5: Is it possible to give a variable, by which "Acceptability of the ACT group therapy" is assessed.

p7 Randomization. Please give more details, e.g. the randomization procedure, software (R software package) and how the random allocation was implemented. Please give more details with respect to blinding. Single blinding is not very specific. How is blinding implemented.

P7 I fully understand, that a strong sample size argument could not be given here. But when the primary endpoint is specified, a precision argument for estimation could be given - even post hoc - to illustrate the argument.

p8. Please include a table with the descriptive measures of the secondary outcome scores.

P10 or elsewhere: Could you derive some recommendation about the trails primary endpoint variable. Could you derive some ideas about the minimal detectable difference, i.e. the minimal difference to be detected resulting in a change of patient care?

p11: Please skip the p-values You may argue from the estimates of the difference and CI'S from the multilevel models

Rosenberger WF, Lachin JM. (2015) Randomization in Clinical Trials, Second Edition. Wiley, New York. DOI:10.1002/9781118742112

1. In general, p-values should be given with at least 3 decimal digits to avoid misinterpretation.

Reviewer #2: As the manuscript title states, this study addresses a critical need. Namely, the provision of psychological care to support weight management post-bariatric surgery. This is a well designed feasibility study that evaluates ACT group therapy delivered by a clinical psychologist in comparison to an unstructured support group delivered by a psychology graduate with no training in XX, in people who are 15-18 months post-bariatric surgery. There are some significant challenges in feasibility discovered in terms of intervention uptake and retention and the authors are transparent about this. However, there are some issues with the analysis and reporting of the study that should be improved prior to publication.

Introduction

The introduction needs revision – specifically in terms of the review of previous research on ACT for weight management. For example, the authors introduce ACT by stating that “Third wave cognitive behavioural therapies ….. are evidenced in the general population.14 , 15. What do the authors mean by “evidenced in the general population”? The two papers they cite are a (now out of date) review of mindfulness-based interventions by O'Reilly et al and a small trial of people with overweight and obesity from 2009 by Forman et al. The authors should more fully describe the literature to date in people with overweight and obesity. More recent and comprehensive systematic reviews have been conducted (e.g. Lawlor et al 2020), as have larger trials with longer term follow up. (eg Formal et al 2019 doi: 10.1002/oby.22412.)

The authors then cite a very small Iranian study in people with obesity. Is the point that the authors are trying to make that this is the only study in people with obesity? I suggest that this is not correct and that the authors should describe all relevant literature in people with obesity.

A more comprehensive review of literature to date for post bariatric surgery should then be reported. How does this study differ from the previous literature and what gap does it seek to fill?

The discussion should end with the aims of the study, rather than a summary of the rest of the paper.

The authors should also be careful to avoid self-plagiarism of their protocol paper http://dx.doi.org/10.18203/2349-3259.ijct20194655

Minor point - Person first language would mean not using overweight as something people “are”. I appreciate that some people find “people with obesity” to be grammatically difficult. Given that the real focus here is on obesity, I would simply remove the stats on overweight.

Methods

The methods are largely well described, and deviations from the protocol are highlighted.

I did not understand the justification for the intervention costings. It states that : There were no extra hours or treatment costs because the ACT group was led by a Band 7 psychologist as part of their regular duties. However, the control group did not receive care from a Band 7 psychologist whereas the support group was led by A Band 4 psychology graduate with no formal therapy training. The cost difference here would be substantial. It appears later in the results that these different costs are taken into account, so perhaps this section just needs rephrasing to be much clearer.

Minor – It states that Loss to follow up and group attrition were recorded in a consort diagram (Figure 1). I suspect that they were recorded somewhere else. They are presenting in the diagram.

Results

Large number of patients were screened as eligible but chose not to take part (with a substantial number unable to commit to the treatment sessions.

While I appreciate the granularity of Table 2, this makes it very difficult to follow. It would be more meaningful to present the number of all ACT and all SGT participants attending each session.

The authors include the following paragraph in the results “The decision regarding the best primary and secondary outcome measures for a full RCT would require the careful consideration of many aspects of the proposed trial, including consensus in the most relevant patient-centred outcome to demonstrate efficacy. The data collected during this feasibility study for a range of outcomes would be sufficient to inform the necessary sample size calculations for a future trial through estimates of standard deviation of the chosen outcome.” This should be moved to the discussion and the authors should be specific about HOW the current study is informative – what decisions does it help make? Can the authors design a trial based on this data? If so, what does this trial look like. If not, what further studies are needed to inform a trial?

The original intention in the protocol was to use inductive thematic analysis. The authors say that they used the Theoretical Framework of Acceptability (TFA) instead. They describe this as an “evidence-based” method. However, the TFA is not a method for qualitative data analysis. It is a framework for defining acceptability. How was the analysis conducted?

Tables 3 and 4 appear to be trying to quantify qualitative data and do not ad value to the paper. The way coding is described also suggests a very un-qualitative approach. It appears that they just “coded” each time something was said that was relevant to pre-determined codes and the results simply repeats “one person said this, two people said Y” with little to no attempt to interpret or synthesise the data. Phrases like “X was coded most frequently” suggest that this was not a qualitative analysis, but rather a labelling exercise. The qualitative analysis should be revisited and an appropriate method used and described.

Discussion

I suspect that the discussion will change following reanalysis of the qualitative data using appropriate qualitative methods. The discussion should be edited to be clearer where there are findings from this study and where the authors are referring to findings from the general literature. Ideally, we should be able to discern the novel contribution of this study.

The strengths and limitations of the study should be clearly discussed

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Reviewer #1: No

Reviewer #2: No

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PONE-D-22-15868R1Addressing a critical need: A randomised controlled feasibility trial of Acceptance and Commitment Therapy for bariatric surgery patients at 15-18 months post-surgeryPLOS ONE

Dear Dr. Barley,

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 manuscript has been evaluated by two reviewers, and their comments are available below.

The reviewers have raised a number of concerns that need attention. They request additional information on methodological aspects of the study (e.g they find that the cost consequence method is not well described), and question why less than 50% of data was completed (trail retention issues?). Could you please revise the manuscript to carefully address the concerns raised?

Please submit your revised manuscript by Mar 12 2023 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.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Katrien Janin

Staff Editor

PLOS ONE

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Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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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: Partly

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

Reviewer #1: Yes

Reviewer #2: I Don't Know

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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: No

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

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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: (No Response)

Reviewer #2: The authors have done a reasonable job of responding to my earlier comments.

The qualitative analysis is still a little thin, but I think that is the nature of the data collected and is unlikely to improve.

Some further minor edits are suggested prior to publication

The following sentence does not make sense: Patients who expressed suicidal ideation (score >0 on 125 Q9, PHQ-9) or at psychiatry assessment [26], were unable to communicate in English or to commit to 126 attendance were excluded.

the cost consequence method is not well described. What was included in the analysis? How was this done?.

It is not clear how the ACT group was associated with a 0.07 QALY reduction in mean incremental QALY if mean QALYs accrued from baseline to 12 month 346 follow-up were: ACT (n=13) = 0.61 SD 0.26; SGC (n=19) = 0.59 SD 0.37.

The authors comment that data collection was feasible and acceptable, but less than 50% completed 12 month data collection. Tis suggests problems with data collection and trial retention.

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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: No

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Addressing a critical need: A randomised controlled feasibility trial of Acceptance and Commitment Therapy for bariatric surgery patients at 15-18 months post-surgery

PONE-D-22-15868R2

Dear Dr. Barley,

Thank you for submitting your manuscript to PLOS ONE; I sincerely apologise for the unusually delayed review timeframe. 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.

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PLOS ONE

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