PONE-D-24-34920Physical measures of physical functioning as prognostic factors in predicting outcomes for neck and thoracic pain: protocol for a systematic reviewPLOS ONE

Dear Dr. Begum, 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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PLOS ONE

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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: Partly

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Partly

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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: Partly

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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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

Reviewer #3: Yes

Reviewer #4: Yes

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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: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: 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: No

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

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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: Decision: Major Revision

Thank you for submitting this protocol on a very relevant and timely topic. The systematic review you propose has the potential to fill significant gaps in the literature regarding the role of physical measures as prognostic factors for neck and thoracic pain. While the protocol demonstrates thoughtful planning, there are a few key areas that require more substantial clarification and revision to ensure the review's rigor and applicability.

Merits:

Important Research Focus: Addressing the prognostic value of physical measures for neck and thoracic pain is both necessary and valuable. These conditions have a significant impact on patients' quality of life, and better understanding the predictive factors for outcomes could greatly improve patient care and treatment planning.

Comprehensive Search Strategy: I appreciate the extensive search plan that includes multiple databases and the inclusion of non-English studies, which helps to minimize bias. This is a major strength of the review and will ensure that a broad spectrum of evidence is captured.

Patient Involvement: Including input from the Patient Partner Advisory Group is a commendable effort to incorporate patient perspectives, ensuring the relevance and applicability of the findings to real-world practice.

Aspects Requiring Major Revision:

Inconsistencies in Terminology and Conceptual Framework: There is a lack of clarity in how you define and differentiate between the types of physical measures you will analyze. Terms like "impairment-based," "performance-based," and "activity measures in a natural environment" are used, but the definitions and distinctions between these categories need further elaboration. Additionally, how these measures will be interpreted or weighted during the synthesis of the findings remains vague. Providing a clear conceptual framework for how these different measures will be assessed and categorized is critical for readers to fully understand your approach.

Ambiguity Regarding Outcome Measures: Although the protocol outlines that "no limitation will be placed on the types of outcomes evaluated," this may lead to an overly broad and unfocused review. Consider narrowing the scope to focus on specific, clinically relevant outcomes (e.g., pain, functional mobility, quality of life) that align with the prognostic factors under investigation. This will help ensure that your results are applicable to clinical practice and not overly diluted by including less relevant outcomes.

Lack of Specificity in Data Synthesis and Meta-Analysis Plans: The manuscript would benefit from a much more detailed explanation of how you plan to handle heterogeneity, particularly statistical heterogeneity. While the I² and Chi² tests are mentioned, there’s no clear plan for how different types of heterogeneity will be managed in practice. Will you conduct subgroup analyses? If so, based on which variables? Providing a more structured approach to data synthesis and interpretation is essential, particularly for a systematic review protocol. A clearer decision tree for when you will use a quantitative meta-analysis versus a narrative synthesis would also strengthen the protocol.

Handling of Bias and Quality Assessment: While QUIPS and GRADE are mentioned for assessing the risk of bias and evidence quality, the protocol doesn’t adequately explain how these tools will be applied in practice. Will you exclude studies with high risk of bias, or will they be weighted differently in the analysis? Further detail on how these assessments will impact the inclusion or exclusion of studies is necessary. Additionally, it would be useful to specify any plans for sensitivity analysis to assess the impact of studies with high risk of bias.

Translation and Use of Automated Tools: The use of ChatGPT for translating non-English studies is innovative but comes with risks regarding the accuracy and nuance of translations. While the manuscript mentions human verification of translations, it would benefit from a more detailed explanation of how you plan to ensure that essential details, such as medical terminology, are correctly interpreted. This is particularly important given the technical nature of the studies you are including.

Ethics and Patient Involvement: While the manuscript includes a section on patient involvement, it does not sufficiently elaborate on how patients contributed to the design or methodology of the study. A more detailed account of how patient perspectives shaped the review’s focus or design, beyond simply validating it, would add depth to the protocol and ensure that it aligns with patient-centered research principles.

Conclusion:

This manuscript has significant potential but requires substantial revision before it can move forward. The key areas that need attention include clarifying your conceptual framework and definitions of physical measures, providing more detail on how you will handle heterogeneity and bias, and refining the scope of outcome measures to ensure a focused and clinically relevant review. Additionally, the use of automated tools for translation requires careful oversight to avoid inaccuracies. With these major revisions, the manuscript will be much better positioned to provide robust and actionable insights for clinicians and researchers.

I recommend major revisions to address the concerns outlined above.

Thank you for your work, and I look forward to reviewing the revised manuscript.

Reviewer #2: This protocol outlines a systematic review aimed at summarizing evidence for physical measures of physical functioning as prognostic factors for outcomes in individuals with neck and thoracic pain. The authors propose a comprehensive search strategy across multiple databases, including grey literature, to identify prospective longitudinal cohort studies. They plan to assess risk of bias using the QUIPS tool and evaluate the quality of evidence using the GRADE approach. The review aims to address an important gap in the literature by providing a comprehensive overview of physical prognostic factors for neck and thoracic pain, which could inform clinical decision-making and patient care.

Limited discussion on handling of missing data: The protocol does not adequately address how missing data will be handled, which is crucial in prognostic studies. This omission could affect the quality and reliability of the review's findings. For example: If studies report standard errors without reporting standard deviations, will you attempt to estimate the missing standard deviations using appropriate statistical tools and calculators?

Despite this limitation, this systematic review protocol addresses an important gap in the literature and has the potential to provide valuable insights into physical prognostic factors for neck and thoracic pain outcomes.

Reviewer #3: This manuscript presents a well-structured protocol for a systematic review aimed at summarizing evidence regarding physical measures of physical functioning as prognostic factors in individuals with neck and thoracic pain. The topic is relevant, as neck and thoracic pain are significant public health concerns, and identifying prognostic factors could help improve patient outcomes and clinical decision-making. The methodology appears rigorous, and the authors have followed recognized guidelines such as PRISMA-P, which strengthens the validity of their approach. However, there are a few areas need improvements.

Major Points:

1. The manuscript does an excellent job highlighting the gap in the literature, particularly the need for a review that covers both neck and thoracic pain. However, the rationale for the inclusion of thoracic pain in this review could be further elaborated. Since thoracic pain is less studied compared to neck pain, an explicit discussion about how insights from thoracic pain will be combined with those from neck pain would strengthen the introduction. Will these two conditions be analyzed separately or together?

2. The manuscript mentions categorizing outcomes into impairment-based, performance-based, and activity measures. While this is an appropriate approach, more information is needed on how the authors will handle studies that assess these measures using different instruments. Will they attempt to standardize or pool data from different measurement tools, and if so, how? Additionally, it would be useful to include examples of specific outcome measures under each category to give readers a clearer sense of what is included.

3. The criteria for excluding studies based on non-neuromusculoskeletal origins of pain are appropriate, but the exclusion criteria regarding metabolic bone diseases such as osteoporosis could be reconsidered. Given that osteoporosis is common in older adults, and that neck and thoracic pain are also prevalent in this population, the exclusion may inadvertently omit relevant studies. The authors should either justify this decision more explicitly or consider including such studies with careful adjustment for confounding variables.

4. The authors have selected appropriate tools (QUIPS, GRADE) for assessing the risk of bias and quality of evidence. It would be beneficial to describe in more detail how the authors plan to integrate the findings from the QUIPS tool into the overall analysis. For example, will high-risk studies be excluded from the meta-analysis, or will they be included with sensitivity analyses?

Reviewer #4: The manuscript outlines a protocol for a systematic review investigating the use of physical measures of physical functioning as prognostic factors in predicting outcomes in individuals with neck and thoracic pain. The protocol is well-structured, and the methodology is clearly defined and aligned with best practices for systematic reviews. However, there are areas that require clarification and improvement to strengthen the protocol and ensure robust results.

1. The QUIPS tool is appropriately selected for risk of bias assessment. However, the manuscript should clarify how discrepancies in bias assessments will be handled between the two reviewers beyond consulting a third reviewer. A more structured approach, such as predefined criteria for resolving differences in bias ratings, could improve consistency and reduce potential reviewer bias.

2. The protocol plans to include studies in multiple languages and use tools like ChatGPT for translation. While this is commendable, it is important to ensure the accuracy of translations in technical and clinical terminology. It is recommended to provide more details on the verification process for translated studies, especially how bilingual reviewers will be selected and how translation accuracy will be validated.

3. While the manuscript states that a meta-analysis will be performed if studies show homogeneity, it would benefit from a clearer explanation of how the authors will determine whether studies are sufficiently homogenous. For instance, more information on the thresholds for heterogeneity that will guide decisions to pool data would be useful. Additionally, the narrative synthesis section should be expanded to clarify how qualitative data will be synthesized, categorized, and presented if a meta-analysis is not possible.

4. The manuscript states that authors will be contacted for missing or unclear data, but it does not sufficiently explain how missing data will be handled if authors do not respond. A more detailed description of the imputation methods or sensitivity analyses for handling missing data would strengthen the robustness of the review.

5. While the protocol defines short-, medium-, and long-term follow-up periods, it does not specify how these timeframes will be standardized across different studies that may use varying definitions for follow-up. Including a more detailed strategy for dealing with differing follow-up periods, or defining a minimum acceptable follow-up length, would enhance comparability across studies.

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If you choose “no”, your identity will remain anonymous but your review may still be made public.

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Reviewer #1: Yes: Xiaoyi Zhang

Reviewer #2: No

Reviewer #3: No

Reviewer #4: Yes: Yuhang Liu

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Physical measures of physical functioning as prognostic factors in predicting outcomes for neck and thoracic pain: protocol for a systematic review

PONE-D-24-34920R1

Dear Dr. Rabea Begum,

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,

Cho-Hao Howard Lee, M.D.

Academic Editor

PLOS ONE

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: Partly

Reviewer #2: Yes

Reviewer #3: Yes

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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: Partly

Reviewer #2: Yes

Reviewer #3: 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

Reviewer #3: Yes

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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: Yes

Reviewer #3: 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

Reviewer #3: Yes

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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: Merits

1. Relevance and Timeliness: This protocol addresses a critical need for systematic evidence regarding physical functioning measures, providing insights applicable to a wide range of musculoskeletal conditions.

2. Rigorous Methodology: The adherence to Cochrane guidelines and the PRISMA-P framework ensures transparency and reliability, making this protocol a strong foundation for the planned systematic review.

3. Practical Implications: By examining prognostic factors for neck and thoracic pain, the study has the potential to inform clinical guidelines and improve the management of a widespread and burdensome condition.

Minor Suggestions for Revision

1. Clarify Conceptual Framework for Physical Measures: The manuscript discusses impairment-based, performance-based, and activity measures but could benefit from a more explicit conceptual framework. A schematic or brief table summarizing these categories, including examples and their relevance to outcomes, would aid reader understanding.

2. Expand on Clinical Implications: While the importance of understanding prognostic factors is noted, the discussion could be enhanced by outlining specific ways clinicians might use this information in practice (e.g., tailoring rehabilitation programs based on predictive physical measures).

3. Strengthen the Patient Involvement Section: The inclusion of patient advisory feedback is commendable. Providing more detail on how this input shaped the design, particularly regarding outcome selection and applicability, would align with patient-centered research principles.

4. Refine the Approach to Missing Data: The plan for handling missing data is sound but could be made more robust by outlining contingency strategies if significant data remain unavailable (e.g., exclusion of studies with critical gaps).

Recommendation: Minor Revision

This manuscript is well-prepared and addresses an important topic in musculoskeletal research. The suggested revisions aim to clarify certain aspects and enhance the overall impact of the protocol. Thank you for your thoughtful work, and I look forward to seeing the results of this review!

Reviewer #2: this systematic review protocol addresses an important gap in the literature and has the potential to provide valuable insights into physical prognostic factors for neck and thoracic pain outcomes. I don't have extra comments.

Reviewer #3: The authors have adequately addressed all of my concerns. I support the publication of this manuscript. Best of luck!

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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: Yes: Xiaoyi Zhang

Reviewer #2: No

Reviewer #3: No

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